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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 2024
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number 001-35813
ORAMED PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 98-0376008 | |
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
|
| 1185 Avenue of the Americas, Third Floor, New York, NY | 10036 | |
| (Address of Principal Executive Offices) | (Zip Code) |
844-967-2633
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol | Name of each exchange on which registered | ||
| Common Stock, par value $0.012 | ORMP | Nasdaq Capital Market, Tel Aviv Stock Exchange |
Securities registered pursuant to Section 12(g) of the Act:
None.
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐ No ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Date File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☐ | ||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates as of the last business day of the registrant’s most recently completed second fiscal quarter was $131,190,607 based on a price of $3.58, being the last price at which the shares of the registrant’s common stock were sold on the Nasdaq Capital Market prior to the end of the most recently completed second fiscal quarter.
As of March 27, 2025, the registrant had 40,850,455 shares of common stock issued and outstanding.
TABLE OF CONTENTS
INTRODUCTION AND USE OF CERTAIN TERMS
As used in this Annual Report on Form 10-K, the terms “we,” “us,” “our,” the “Company,” and “Oramed” mean Oramed Pharmaceuticals Inc. and our wholly-owned subsidiaries, unless otherwise indicated. All dollar amounts refer to U.S. dollars unless otherwise indicated.
On December 31, 2024, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS 3.647 to $1.00. Unless indicated otherwise by the context, statements in this Annual Report on Form 10-K that provide the dollar equivalent of NIS amounts or provide the NIS equivalent of dollar amounts are based on such exchange rate.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements contained in this Annual Report on Form 10-K that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws and the Israeli securities law. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Annual Report on Form 10-K. Additionally, statements concerning future matters are forward-looking statements. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking statements appear in “Item 1. Business” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as elsewhere in this Annual Report on Form 10-K and include, among other statements, statements regarding the following:
| ● | our plan to evaluate potential strategic opportunities; | |
| ● | our potential repurchases of shares of our common stock; |
| ● | the possibility that the anticipated benefits of the 2023 Scilex Transaction and 2024 Refinancing (as defined below) are not realized when expected or at all, including as a result of the impact of, or problems arising from, the ability of Scilex Holding Company, or Scilex, to repay the Notes and the ability of the Company to realize the value of the warrants; |
| ● | our Profit Sharing Loan Agreement expose us to potential market, liquidity, and execution risks; |
| ● | the JV Agreement (as defined herein) includes potential delays and, indemnification liabilities, and the impact of the Spin Off (as defined below) could affect our financial position, operations, and ability to realize anticipated benefits from the joint venture, or OraTech and Spin Off; |
| ● | our exposure to potential litigation; |
| ● | our ability to enhance value for our stockholders; |
| ● | the expected development and potential benefits from our products; |
| ● | the prospects of entering into additional license agreements, or other partnerships or forms of cooperation with other companies or medical institutions; |
| ● | future milestones, conditions and royalties under our license agreements; |
| ● | the potential of the Oravax Medical Inc., or Oravax, vaccine to protect against the coronavirus, or COVID-19, pandemic; |
| ● | our research and development plans, including preclinical and clinical trials plans and the timing of enrollment, obtaining results and conclusion of trials; |
| ● | our belief that our technology has the potential to deliver medications and vaccines orally that today can only be delivered via injection; |
| ● | the competitive ability of our technology based on product efficacy, safety, patient convenience, reliability, value and patent position; |
| ● | the potential market demand for our products; |
| ● | our ability to obtain patent protection for our intellectual property; |
| ● | our expectation that our research and development expenses will continue to be our major expenditure; |
| ● | our expectations regarding our short- and long-term capital requirements; |
| ● | our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; and |
| ● | information with respect to any other plans and strategies for our business. |
Although forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements can only be based on facts and factors known by us at the time of such statements. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those discussed herein, including those risks described in “Item 1A. Risk Factors,” and expressed from time to time in our other filings with the Securities and Exchange Commission, or SEC. In addition, historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic results referred to in this Annual Report on Form 10-K could be interpreted differently in light of additional research, clinical and preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report on Form 10-K. Except as required by law, we undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Annual Report on Form 10-K. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Annual Report on Form 10-K which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
PART I
ITEM 1. BUSINESS.
Description of Business
We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins.
We have developed an oral dosage form intended to withstand the harsh environment of the stomach and effectively deliver active biological insulin or other proteins. The excipients in the formulation are not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.
On January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As a result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1 Phase 3 trial data and found that subpopulations of patients with pooled specific parameters, such as body mass index, or BMI, baseline HbA1c and age, responded well to oral insulin. Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical trial to the U.S. Food and Drug Administration, or the FDA. We intend to initiate study during 2025. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
On January 22, 2024, we along with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or Initial JV Agreement, with Hefei Tianhui Biotech Co., Ltd. or HTIT, and its subsidiary Technowl Limited or HTIT Sub. OraTech will focus on developing and commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.
On February 7, 2025, we and HTIT entered into a Joint Venture Agreement, or the JV Agreement, amending the Initial JV Agreement signed on January 22, 2024. To execute the JV Agreement, we formed OraTech Pharmaceuticals, Inc., or OraTech, which will serve as the joint venture entity. We currently hold 100% of OraTech shares. OraTech was formed to advance the development and commercialization of oral insulin, combining our proprietary technology and funding with HTIT’s manufacturing capabilities. Through this partnership, OraTech will have the technology, resources, and production capacity to bring oral insulin to market. The agreement also outlines the spin-off of OraTech, or the Spin Off, requiring regulatory filings and the distribution of the majority of OraTech’s shares held by us to our shareholders. Both we and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.
The Initial Closing, set for April 30, 2025, or the Initial Closing, includes an investment of $40,000,000 by HTIT and $7,500,000 by us into OraTech . Additionally, we will transfer all our intellectual property rights to OraTech. The second closing, contingent on the listing of OraTech’s shares on Nasdaq, involves a $20,000,000 investment by HTIT and an additional $7,500,000 investment by us, or the Second Closing. It is expected to close by May 31, 2025, but no later than September 1, 2025. Upon completion of the Initial Closing and the Second Closing, both HTIT and we will receive OraTech shares, resulting in ownership of 50% for each of HTIT and us, excluding the impact of the contemplated distribution of OraTech shares to our shareholders.
As part of the JV Agreement, HTIT will receive $20,000,000 at the Initial Closing and $10,000,000 at the Second Closing under a supply agreement with OraTech.
2023 Scilex Transaction and 2024 Refinancing
2023 Scilex Transaction
On September 21, 2023, we entered into and consummated transactions, or, collectively, the 2023 Scilex Transaction, with Scilex, pursuant to which Scilex issued to us:
| a. | A senior secured promissory note, or the Tranche A Note, with a principal amount of $101,875,000, maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable in-kind. Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024, September 21, 2024, and December 21, 2024, with the balance due on March 21, 2025. In January 2025, we extended Tranche A Note maturity from March 21, 2025 to December 31, 2025. As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior to March 21, 2024, an exit fee of approximately $3,056,000 was. Since the Tranche A Note was not repaid by March 21, 2024, we are entitled to the above-mentioned exit fee at the maturity date of the Tranche A Note. As of March 27, 2025, Scilex has repaid $69,200,000 of the amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined below). |
| b. |
Warrants to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share, or the Closing Penny Warrants, and four additional warrants, or the Subsequent Penny Warrants, each for 2,125,000 shares of Scilex common stock with an exercise price of $0.01 per share. The Closing Penny Warrants vested on September 21, 2023, and each of the Subsequent Penny Warrants vested on each of March 19, 2024, June 17, 2024, September 15, 2024 and December 14, 2024. The Closing Penny Warrants and the Subsequent Penny Warrants shall become exercisable on the earliest of (i) March 14, 2025 and (ii) the date on which the Tranche A Note has been repaid in full. As of March 27, 2025, the Closing Penny Warrants and the Subsequent Penny Warrants are fully vested.
On October 30, 2024, we exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were exercisable at such time. As a result, we hold 6,500,000 shares of common stock of Scilex. |
| c. | Transferred warrants, or the Transferred Warrants, to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per share, fully exercisable and expiring on November 10, 2027. On September 20, 2024, we sold the Transferred Warrants for consideration of $300,000 (see below). As a result, as of March 27, 2025 we do not hold any Transferred Warrants. |
On September 20, 2024, we and Scilex entered into an extension agreement, or the Extension Agreement, to extend the due date of the September 21, 2024 payment under the Tranche A Note. Pursuant to the Extension Agreement, Scilex paid us $2,000,000 on September 23, 2024, which payment is to be applied as follows: (i) $1,700,000 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300,000 to purchase the Transferred Warrants as mentioned above.
2024 Refinancing
On October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant to which the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 7,500,000 shares of Scilex common stock, or Tranche B Warrants. We purchased 50% of Tranche B Note and Tranche B Warrants and therefore hold an aggregate principal amount of $25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants.
Scilex received from us, in consideration for our part in Tranche B Notes and the Tranche B Warrants issued to us, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500,000.
Royalty Purchase Agreement
In addition, on October 8, 2024, we and certain institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement or the RPA with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to the RPA, the RPA Purchasers acquired the right to receive, in the aggregate, 8% of net sales worldwide for 10 years of certain purchase receivables, or the Purchased Receivables with respect to ZTlido (lidocaine topical system) 1.8%, SP-103 (lidocaine topical system) 5.4%, and any related, improved, successor, replacement or varying dosage forms of the foregoing. We acquired the right to receive 50% of the Purchased Receivables, as more fully described in the RPA and therefore hold the right to receive 4% royalties.
In consideration for our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche A Note.
Following the refinancing as described above, on October 8, 2024, Scilex used $12,500,000 of the net proceeds from the proceeds of the Tranche B Note for the repayment of the outstanding balance under the Tranche A Note.
ZTLido Rest of the World Binding Agreement
In addition, on October 8, 2024, we and certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License Term Sheet, regarding a license and development agreement, or the Lido License Agreement, with respect to services, compositions, products, dosages and formulations comprising lidocaine, including without limitation, the product and any future product defined as a “Product” under Scilex Pharma’s existing (i) Product Development Agreement, dated as of May 11, 2011, with Oishi Koseido Co., Ltd., or Oishi, and Itochu Chemical Frontier Corporation, or Itochu, as amended, and (ii) the associated Commercial Supply Agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as amended.
Subject to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, we anticipate that we and such institutional investors will hold the Lido License Agreement through a joint venture, RoyaltyVest, Inc., or RoyaltyVest.
In consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200,000 per year toward expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other than certain excluded designated territories , or the ROW Territory, and (c) each of RoyaltyVest and Scilex will receive 50% percent of the net revenue (less expenses) generated from any Product in the ROW Territory. The term sheet is subject to entering into a definitive agreement (signed on February 22, 2025, see below) and subject to the consent of Oishi and Itochu to the Lido License Agreement.
Tranche B Note Consent
On January 2, 2025, we and other Tranche B noteholders entered into deferral and consent agreements with Scilex or the Tranche B Consent, deferring Scilex’s first amortization payment under the Tranche B Note to October 8, 2026. In consideration, we received approximately $877,000 and 2,500,000 shares of Scilex common stock.
In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
| 1. | Scilex and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales of Gloperba and Elyxyb in certain territories outside of the United States , or RoW, of which, we are entitled to 2% royalties. Gloperba, an oral liquid colchicine formulation for gout, and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s portfolio. The definitive agreement was signed on February 28, 2025. |
| 2. | The Tranche B Noteholders have the option to fund up to 50% of the cash purchase price for RoW product rights to Gloperba and Elyxyb (excluding Elyxyb in Canada) and will receive proportional revenues from commercialization and licensing. |
Tranche A Note Maturity Date Extension Amendment
On January 21, 2025, we entered into an amendment to the Tranche A Note, or the Tranche A Extension Amendment, extending the maturity date from March 21, 2025, to December 31, 2025 or the Extended Maturity Date. Interest will continue to accrue and be payable on the Extended Maturity Date. In consideration of the extension, we received 3,250,000 shares of Scilex common stock.
Lidocaine License Agreement
As part of the ROW License Term Sheet, on February 22, 2025, we, through its 50% ownership in RoyaltyVest, entered into a license agreement with Scilex. Under this agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products, including ZTlido (lidocaine topical system 1.8%) and SP-103, in the ROW Territory. As part of the arrangement, RoyaltyVest and Scilex will each receive 50% of the net profits from the commercialization of these products. Given our 50% ownership in RoyaltyVest, we effectively holds a 25% in the profits generated under this agreement.
BioXcel
In order to diversify our investments as a part of our use of cash strategy, on March 4, 2025, we participated in a registered direct offering by BioXcel Therapeutics, Inc. (Nasdaq: BTAI), or BioXcel, acquiring 2,000,000 shares of BioXcel’s common stock and accompanying warrants to purchase up to an additional 2,000,000 shares. The shares and warrants were purchased at a combined offering price of $3.50 per share and warrant, representing 50% of the total 4,000,000 shares issued in the offering. The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the date of issuance.
BioXcel is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.
As of March 27, 2025, we have sold 869,992 shares and continues to hold 1,130,008 shares of BioXcel common stock.
Real Estate Transactions
Additionally, as a part of our cash management strategy, we have engaged in certain real estate transactions.
In January 2025, we entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000 (approximately $1,586,000). The transaction is structured in installments, and as of March 27, 2025, we have paid approximately $1,210,000 toward the acquisition price. Under the agreement, the developer is responsible for executing all development-related activities, and we and the developer will share the profits upon the future sale of the property.
On March 24, 2025, we entered into a loan agreement to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of $22,650,000. The loan has a one-year maturity and is secured by a first-ranking mortgage on a property valued at approximately $800,000,000, providing significant collateral coverage. The loan bears an annual interest rate of 12%.
Research and Development
Oral Insulin
Type 2 Diabetes: We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin capsule, ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with either diet alone or with diet and metformin. In 2023, we completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical trial to the FDA. We intend to initiate this study during 2025. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
Joint Venture Agreement: As mentioned above, on February 7, 2025, we entered into JV Agreement with HTIT. The collaboration combines our POD technology with HTIT’s manufacturing capabilities, creating a synergy. This integration of technology and manufacturing expertise will enable us to ensure consistent, high-quality production at scale, setting new standards for oral protein delivery.
OraTech is backed by a substantial capital and operational commitment. These resources support the initiation of a Phase 3 clinical trial in the U.S. As mentioned above, by leveraging insights from prior clinical studies, we have strategically designed this refined Phase 3 trial to focus on key patient subpopulations that we believe have the highest potential to demonstrate efficacy.
Oral Vaccine
On March 18, 2021, we entered into a license agreement with Oravax, a 63% owned joint venture to commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt. Ltd.’s proprietary vaccine technology involving a triple antigen virus like particle.
In October 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of a Phase 1 clinical trial, meeting primary or secondary endpoints of safety and immunogenicity. These results included significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to virus like particle vaccine antigens observed in the majority of the patients dosed, and no safety issues were observed, including mild symptoms. Cohort B completed dosing in January 2023. Cohort B measured Immunoglobulin G, or IGG, against the spike (S) protein, showing positive IGG in approximately 55% of the patients dosed. We are currently evaluating our path forward for Oravax’s oral vaccines for COVID-19.
Impact of Current Events
On October 7, 2023, the State of Israel was attacked by Hamas, a group designated as a terrorist organization by the United States, and the State of Israel subsequently declared war on Hamas. Since that time, Israel has been engaged in a multi-front armed conflict with combatants located in Gaza, the West Bank, Syria, Iran, Lebanon and Yemen. The situation in the region remains volatile and the possibility of renewed conflicts persist. As of March 27, 2025, we believe that there is no immediate risk to our business operations related to these events. For further information, see “Item 1A. Risk Factors,” under “We are affected by the political, economic and military risks of having operations in Israel.”
Real Estate Investments
On November 7, 2024, our Board of Directors, or the Board, approved investments of up to $10,000,000 in real estate assets. This decision aligns with our strategic approach to capital allocation, leveraging opportunities in the current real estate market where we have identified attractive investment prospects. With interest rates expected to decline and valuations presenting favorable entry points, the Board believes these investments could provide long-term value appreciation and potential income streams, further strengthening our financial position. As we continues to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. On February 13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.
Diabetes Market Overview
Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that causes sugar to be absorbed into cells, where the sugar is converted into energy needed for daily life. The cause of diabetes is attributed both to genetics (type 1 diabetes, or T1D) and, most often, to environmental factors such as obesity and lack of exercise (T2D). According to the International Diabetes Federation, or IDF, approximately 537 million adults (20-79 years) worldwide suffered from diabetes in 2021 and the IDF projects this number will increase to 783 million by 2045. According to the American Diabetes Association, or ADA, in 2023, the United States there were approximately 37 million people with diabetes. Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation.
Intellectual Property and Patents
We own a portfolio of patents and patent applications covering our technologies, and we are aggressively protecting these technology developments on a worldwide basis.
We maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United States and other commercially significant markets. We hold 26 patent applications currently pending, with respect to various compositions, methods of production and oral administration of proteins and exenatide. Expiration dates for pending patents, if granted, will fall between 2026 and 2039.
We hold 140 patents, eight of which were issued during the year ended December 31, 2024, including patents issued by the United States, Swiss, German, French, U.K., Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong Kong, Chinese, European and Indian patent offices that cover a part of our technology, which allows for the oral delivery of proteins; patents issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norwegian, Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices that cover part of our technology for the oral delivery of exenatide; and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K. and Japanese patent offices for treating diabetes.
Consistent with our strategy to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign counterparts of such applications. We believe that our success will depend on our ability to obtain patent protection for our intellectual property.
Our patent strategy is as follows:
| ● | Aggressively protect all current and future technological developments to assure strong and broad protection by filing patents and/or continuations in part as appropriate, |
| ● | Protect technological developments at various levels, in a complementary manner, including the base technology, as well as specific applications of the technology, and |
| ● | Establish comprehensive coverage in the United States and in all relevant foreign markets in anticipation of future commercialization opportunities. |
Trademarks and Trade Secrets
We have trademark applications pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada, China, Colombia, the European Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, Philippines, Russia, Singapore, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, U.S.A., Uzbekistan and Vietnam.
We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board, technical review board and other advisors, to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as the exclusive property of the Company. There can be no assurance, however, that all persons who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.
Out-Licensed Technology
Entera Bio
In June 2010, our wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement with DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions Ltd.), or DNA, for the establishment of Entera Bio Ltd., or Entera.
In March 2011, Oramed Ltd. sold shares of Entera to DNA, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to DNA, the Company received, among other payments, ordinary shares of DNA (see also note 3 to our audited consolidated financial statements).
As part of this agreement, Oramed Ltd. entered into a patent transfer agreement, or the Patent Transfer Agreement, according to which Oramed Ltd. assigned to Entera all of its rights to a patent application related to the oral administration of proteins that it has licensed to Entera since August 2010, in return for royalties of 3% of Entera’s net revenues and a license back of that patent application for use in respect of diabetes and influenza. As of December 31, 2024, Entera had not paid any royalties to Oramed Ltd. During the years ended December 31, 2024 and 2023, we did not sell any of DNA’s ordinary shares. As of December 31, 2024, we held approximately 1.4% of DNA’s outstanding ordinary shares and approximately 0.3% of Entera’s outstanding ordinary shares.
HTIT
On November 30, 2015, we entered into a Technology License Agreement, or TLA, with HTIT and on December 21, 2015, these parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016, or the HTIT License Agreement. According to the HTIT License Agreement, we granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and Hong Kong, related to our oral insulin capsule, ORMD-0801, or the Product. Pursuant to the HTIT License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to our technology and ORMD-0801 capsule, and will pay (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the territory, or Royalties, and (ii) an aggregate of $37,500,000, of which $3,000,000 was payable immediately, $8,000,000 will be paid subject to our entry into certain agreements with certain third parties, and $26,500,000 will be payable upon achievement of certain milestones and conditions. In the event that we will not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of our patents covering the technology in the territory in 2033, the Royalties rate may be reduced, under certain circumstances, to 5%. The royalty payment obligation shall apply during the period of time beginning upon the first commercial sale of the Product in the territory, and ending upon the later of (i) the expiration of the last-to-expire licensed patents in the territory; and (ii) 15 years after the first commercial sale of the Product in the territory. The HTIT License Agreement shall remain in effect until the expiration of the royalty term. The HTIT License Agreement contains customary termination provisions. Through December 31, 2024, we received aggregate milestone payments of $20,500,000 out of the aggregate amount of $37,500,000.
On August 21, 2020, we received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA.
Pursuant to the terms of the JV Agreement, each of us, HTIT and HTIT Sub, irrevocably released and waived (i) any claims and demands against each other party in connection with the TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of the TLA.
HTIT has submitted a Marketing Authorization Application to China’s regulators for the oral insulin capsule in China. Since the TLA was novated to OraTech, OraTech is expected to receive royalties from any future sales in China On March 18, 2021, we entered into a license agreement, or the Oravax License Agreement, with Oravax, a 63% owned joint venture to commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt.
Oravax License
Ltd.’s proprietary vaccine technology involving a triple antigen virus like particle, or the Oravax product.
In consideration for the grant of the license under the Oravax License Agreement, we will receive (i) royalties equal to 7.5% on net sales, as defined in the Oravax License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the license during the term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received by Oravax from a permitted sublicensee and (iii) other payments ranging between $25,000,000 to $100,000,000, based on certain sales milestones being achieved by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members, of which two members will be appointed by us, that will oversee the ongoing research, development, clinical and regulatory activity with respect to the Oravax product. In addition, we agreed to buy and Oravax agreed to issue to us 1,890,000 shares of common stock of Oravax, representing 63% of the common stock of Oravax for the aggregate amount of $1,500,000. Akers Biosciences Inc. contributed $1,500,000 in cash to Oravax and a license agreement to the Oravax product.
Medicox License
On November 13, 2022, we entered into a distribution license agreement with Medicox Co., Ltd., or Medicox, an emerging biotech company with a consortium of proven partnerships in the Republic of Korea. The agreement grants Medicox the exclusive license to apply for regulatory approval and distribute ORMD-0801 for ten years in the Republic of Korea. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay Oramed up to $15,000,000 in developmental milestones, $2,000,000 of which were received by Oramed in 2022, and up to 15% royalties on gross sales. Medicox will also be responsible for gaining regulatory approval in the Republic of Korea. This agreement was assigned to OraTech.
Government Regulation
The Drug Development Process
Regulatory requirements for the approval of new drugs vary from one country to another. In order to obtain approval to market our drug portfolio, we need to go through a different regulatory process in each country in which we apply for such approval. In some cases, information gathered during the approval process in one country can be used as supporting information for the approval process in another country. As a strategic decision, we decided to first explore the FDA regulatory pathway. The following is a summary of the FDA’s requirements.
The FDA requires that pharmaceutical and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction to the general public. Clinical testing, known as clinical trials or clinical studies, is either conducted internally by life science, pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.
The process of conducting clinical trials is highly regulated by the FDA, as well as by other governmental and professional bodies. Below we describe the principal framework in which clinical trials are conducted, as well as describe a number of the parties involved in these trials.
Protocols. Before commencing human clinical trials, the sponsor of a new drug or therapeutic product must submit an IND application to the FDA. The application contains, among other documents, what is known in the industry as a protocol. A protocol is the blueprint for each drug study. The protocol sets forth, among other things, the following:
| ● | Who must be recruited as qualified participants, |
| ● | How often to administer the drug or product, |
| ● | What tests to perform on the participants, and |
| ● | What dosage of the drug or amount of the product to give to the participants. |
Institutional Review Board. An institutional review board is an independent committee of professionals and lay persons which reviews clinical research trials involving human beings and is required to adhere to guidelines issued by the FDA. The institutional review board does not report to the FDA, but its records are audited by the FDA. Its members are not appointed by the FDA. All clinical trials must be approved by an institutional review board. The institutional review board’s role is to protect the rights of the participants in the clinical trials. It approves the protocols to be used, the advertisements which the company or CRO conducting the study proposes to use to recruit participants, and the form of consent which the participants will be required to sign prior to their participation in the clinical trials.
Clinical Trials. Human clinical trials or testing of a potential product are generally done in three stages known as Phase 1 through Phase 3 testing. The names of the phases are derived from the regulations of the FDA. Generally, there are multiple trials conducted in each phase.
Phase 1. Phase 1 trials involve testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people at a time. Phase 1 trials determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body. This phase lasts an average of six months to a year.
Phase 2. Phase 2 trials involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition. Phase 2 testing typically lasts an average of one to two years. In Phase 2, the drug is tested to determine its safety and effectiveness for treating a specific illness or condition. Phase 2 testing also involves determining acceptable dosage levels of the drug. Phase 2 trials may be split into Phase 2a and Phase 2b sub-trials. Phase 2a trials may be conducted with patient volunteers and are exploratory (non-pivotal) trials, typically designed to evaluate clinical efficacy or biological activity. Phase 2b trials are conducted with patients defined to evaluate definite dose range and evaluate efficacy. If Phase 2 trials show that a new drug has an acceptable range of safety risks and probable effectiveness, a company will generally continue to review the substance in Phase 3 trials.
Phase 3. Phase 3 trials involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify effectiveness and long-term safety on a large scale. These trials generally last two to three years. Phase 3 trials are conducted at multiple locations or sites. Like the other phases, Phase 3 requires the site to keep detailed records of data collected and procedures performed.
Biological License Application. The results of the clinical trials for a biological product are submitted to the FDA as part of a Biological License Application, or BLA. Following the completion of Phase 3 trials, assuming the sponsor of a potential product in the United States believes it has sufficient information to support the safety and effectiveness of its product, the sponsor will generally submit a BLA to the FDA requesting that the product be approved for marketing. The application is a comprehensive, multi-volume filing that includes the results of all clinical trials, information about the drug’s composition, and the sponsor’s plans for producing, packaging and labeling the product. The FDA’s review of an application can take a few months to many years, with the average review lasting 18 months. Once approved, drugs and other products may be marketed in the United States, subject to any conditions imposed by the FDA. Approval of a BLA provides 12 years of exclusivity in the U.S. market.
Phase 4. The FDA may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as Phase 4 trials, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness. In recent years, the FDA has increased its reliance on these trials. Phase 4 trials usually involve thousands of participants. Phase 4 trials also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.
European Regulation. Similar to the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to the European Medicines Agency, or EMA, for the registration of the product. The approval process in Europe consists of several stages, which together are summed up to 210 days from the time of submission of the application (net, without periods in which the sponsor provides answers to questions raised by the agency) following which, a Marketing Approval may be granted. During the approval process, the sponsor’s manufacturing facilities will be audited in order to assess Good Manufacturing Practice compliance.
The drug approval process is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.
Other Regulations
Various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities. They include, among others, the U.S. Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation. The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial costs. In addition, the extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted and may have a material adverse effect on our business, financial condition, results of operations and prospects.
Competition
Competition in the area of biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain regulatory approval for testing, manufacturing and marketing. Our competitors include major pharmaceutical, medical products, chemical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly greater than ours. In addition, many biotechnology companies have formed collaborations with large, established companies to support research, development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors that are used for the treatment of the diseases and health conditions that we have targeted for product development. We can provide no assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic areas that are targeted by us. The foregoing factors could have a material adverse effect on our business, prospects, financial condition and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.
Competition within our sector is increasing, so we will encounter competition from existing firms that offer competitive solutions in diabetes treatment solutions. These competitive companies could develop products that are superior to, or have greater market acceptance, than the products being developed by us. We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition and greater financial, marketing and other resources.
Our competition will be determined in part by the potential indications for which our technology is developed and ultimately approved by regulatory authorities. In addition, the first product to reach the market in a therapeutic or preventive area is often at a significant competitive advantage relative to later entrants to the market. Accordingly, the relative speed with which we, or our potential corporate partners, can develop products, complete the clinical trials and approval processes and supply commercial quantities of the products to the market are expected to be important competitive factors. Our competitive position will also depend on our ability to attract and retain qualified scientific and other personnel, develop effective proprietary products, develop and implement production and marketing plans, obtain and maintain patent protection and secure adequate capital resources. We expect our technology, if approved for sale, to compete primarily on the basis of product efficacy, safety, patient convenience, reliability, value and patent position.
We anticipated that our oral insulin capsule would be a competitive diabetes drug because of its anticipated efficacy and safety profile; however, there are other treatment options for T1D and T2D patients, such as insulin injections, insulin pumps or a combination of diet, exercise and oral medication which improve the body’s response to insulin or cause the body to produce more insulin.
Scientific Advisory Board
We maintain a Scientific Advisory Board consisting of internationally recognized scientists who advise us on scientific and technical aspects of our business. The Scientific Advisory Board meets to review specific projects and to assess the value of new technologies and developments to us. In addition, individual members of the Scientific Advisory Board meet with us to provide advice in their particular areas of expertise. The Scientific Advisory Board consists of the following members, information with respect to whom is set forth below: Dr. Roy Eldor, Professor Ele Ferrannini, Dr. Alexander Fleming, Professor Avram Hershko, Dr. Julio Rosenstock, Dr. Jay Skyler and Dr. Anne Peters.
Dr. Roy Eldor, MD, PhD, joined the Oramed Scientific Advisory Board in July 2016. He is an endocrinologist, internist and researcher with over twenty years of clinical and scientific experience. He is currently Director of the Diabetes Unit at the Institute of Endocrinology, Metabolism & Hypertension at the Tel-Aviv Sourasky Medical Center. Prior to that, Dr. Eldor served as Principal Scientist at Merck Research Laboratories, Clinical Research – Diabetes & Endocrinology. He previously served as a senior physician in internal medicine at the Diabetes Unit in Hadassah Hebrew University Hospital in Jerusalem, Israel; and the Diabetes Division at the University of Texas Health Science Center in San Antonio, Texas. Dr. Eldor is a recognized expert, with over 50 peer reviewed papers and book chapters, and has been a guest speaker at numerous international forums.
Professor Ele Ferrannini, MD, joined the Oramed Scientific Advisory Board in February 2007. He is a past President to the European Association for the Study of Diabetes (EASD), which supports scientists, physicians and students from all over the world who are interested in diabetes and related subjects in Europe and performs functions similar to that of the American Diabetes Association in the United States. Professor Ferrannini has worked with various institutions including the Department of Clinical & Experimental Medicine at the University of Pisa School of Medicine, and CNR (National Research Council) Institute of Clinical Physiology in Pisa, Italy; and the Diabetes Division, Department of Medicine at the University of Texas Health Science Center in San Antonio, Texas. He has extensive training in internal medicine and endocrinology, and has specialized in diabetes trials. Professor Ferrannini has received a Certificate of the Educational Council for Foreign Medical Graduates from the University of Bologna, and completed a subspecialty in Diabetes and Metabolic Diseases at the University of Torino, cum laude. He has published over 500 original papers and 50 book chapters and he is a “highly cited researcher,” according to the Institute for Scientific Information.
Dr. Alexander Fleming, MD, joined the Oramed Scientific Advisory Board in December 2019. Dr. Fleming, an endocrinologist, is Founder and Executive Chairman of Kinexum, a strategic advisory firm. From 1986 to 1998, he served at the FDA as a supervisory medical officer in the Division of Metabolism and Endocrine Drug Products and was responsible for landmark approvals of the first statin, metformin, and other endocrine and metabolic therapies. He also represented the FDA at the World Health Organization and on multiple expert working groups of the International Conference on Harmonization (ICH). Dr. Fleming coined the term, Metabesity, which refers to the constellation of major chronic diseases and the aging process itself, all which share common metabolic root causes and potential preventive therapies. He organized the first Congress on Metabesity in London in October 2017, followed by annual conferences. In 2020, Dr. Fleming founded the non-profit Kitalys Institute as a means of producing Metabesity conferences and advancing interventions of any kind that can improve health and healthspan.
Professor Avram Hershko, MD, PhD, joined the Oramed Scientific Advisory Board in July 2008. Professor Hershko served as a physician in the Israel Defense Forces from 1965 to 1967. After a post-doctoral fellowship with Gordon Tomkins at the University of San Francisco from 1969 to 1972, he joined the faculty of the Haifa Technion becoming a professor in 1980. He is now Distinguished Professor in the Unit of Biochemistry in the B. Rappaport Faculty of Medicine of the Technion in Haifa, Israel. Professor Hershko’s main research interests concern the mechanisms by which cellular proteins are degraded, a formerly neglected field of study. Professor Hershko and his colleagues showed that cellular proteins are degraded by a highly selective proteolytic system. This system tags proteins for destruction by linkage to a protein called ubiquitin, which had previously been identified in many tissues, but whose function was previously unknown. Subsequent work by Professor Hershko and many other laboratories has shown that the ubiquitin system has a vital role in controlling a wide range of cellular processes, such as the regulation of cell division, signal transduction and DNA repair. Professor Hershko was awarded the Nobel Prize in Chemistry in 2004, jointly with his former PhD student Aaron Ciechanover and their colleague Irwin Rose. His many honors include the Israel Prize for Biochemistry (1994), the Gairdner Award (1999), the Lasker Prize for Basic Medical Research (2000), the Wolf Prize for Medicine (2001) and the Louisa Gross Horwitz Award (2001). Professor Hershko is a member of the Israel Academy of Sciences since 2000 and a Foreign Associate of the U.S. Academy of Sciences since 2003.
Dr. Julio Rosenstock, MD, joined the Oramed Scientific Advisory Board in January 2020. Dr. Rosenstock is the Senior Scientific Advisor and Director of Velocity Clinical Research at Medical City, Dallas, Texas, and a Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas, Texas. He is board certified in Internal Medicine, Endocrinology and Metabolism. His clinical and research activities have focused on exploring novel agents and therapeutic strategies to improve glycemic control, particularly early combination therapies in Type 2 Diabetes. Over the last 30 years, he has participated in hundreds of clinical trials and has had an active role in the development of new oral agents, incretin-related therapies and insulin formulations, often acting as a lead clinical investigator and scientific advisor on the design and reporting of these clinical trials. Dr. Rosenstock has been the author or co-author of 386 peer-reviewed manuscripts (H-index 124) and several hundreds of scientific abstracts and he is considered a key opinion leader in Type 2 Diabetes. He has also contributed to 13 book chapters on various topics in the field of diabetes and is considered a key opinion leader in Type 2 Diabetes.
Dr. Jay Skyler, MD, MCAP, FRCP, joined the Oramed Scientific Advisory Board in January 2020. Dr. Skyler is Professor of Medicine, Pediatrics and Psychology in the Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami Leonard M. Miller School of Medicine. He previously held the position of Director of the Division of Endocrinology, Diabetes and Metabolism. In addition, Dr. Skyler is Deputy Director of Clinical Research and Academic Programs at the Diabetes Research Institute, and an Adjunct Professor of Pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado in Denver. Dr. Skyler’s research focuses on the clinical aspects of diabetes, specifically the conduct of randomized controlled clinical trials. From 1993 to 2015, he was Chairman of the National Institute of Health (NIDDK)-sponsored Diabetes Prevention Trial–- Type 1 (DPT-1) and its successor Type 1 Diabetes Trial Net, a nationwide and global network conducting clinical trials to prevent T1D.
Dr. Anne Peters, MD, joined the Oramed Scientific Advisory Board in June 2022. Dr. Peters is Professor of Medicine at the Keck School of Medicine of the University of Southern California (USC) and Director of the USC Clinical Diabetes Programs. Dr. Peters earned her medical degree from the Pritzker School of Medicine at the University of Chicago and performed an internal medicine residency at Stanford University and an endocrinology fellowship at Cedars-Sinai Medical Center. She previously directed the clinical diabetes programs at Cedars-Sinai Medical Center and UCLA in California. Her research has focused on testing new approaches for diagnosing and treating diabetes and developing systems of care to improve outcomes in diabetic under-resourced populations. Dr. Peters has consulted for many entities, including the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health to help guide the development and use of treatments for diabetes. In addition to being an investigator for more than 40 research studies, Dr. Peters has published over 200 articles, has written four books, and has given more than 500 lectures locally, nationally, and internationally. She has been on multiple guideline writing committees for the treatment of both type 1 and type 2 diabetes. She was a recipient of the ADA Outstanding Physician Clinician Award, the Bernardo Houssay Award from the National Minority Quality Forum and received an Endocrine Society Laureate Award for Public Service.
Employees
We believe it is imperative to attract and retain top talent for all positions in the Company. We seek to make Oramed an inclusive, diverse and safe workplace, with meaningful compensation, benefits and wellness programs and opportunities.
We have experienced personnel involved in our research and development programs, as well as appropriate clinical/regulatory, quality assurance and other personnel needed to advance through clinical trials or have engaged the services of experts in the field for these requirements. As of December 31, 2024, we have contracted with thirteen individuals for employment or consulting arrangements. Of our staff, four are senior management, three are engaged in research and development work, and the remaining six are involved in corporate and administration work.
We provide competitive compensation, health and retirement programs for our employees. We offer variable pay in the form of bonuses and stock-based compensation for eligible employees. We also provide our employees with additional benefits such as team-building and educational offsite activities and gym facilities. We believe that this provides a comprehensive package to engage, motivate and retain our employees as a cohesive unit unified in its goal to achieve the Company’s strategy and objectives.
Additional Information
Additional information about us is contained on our Internet website at www.oramed.com. Information on our website is not incorporated by reference into this report. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge on our website under “SEC Filings” as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Reports filed with the SEC are made available on its website at www.sec.gov and are also available on the website of the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange at www.tase.co.il. The following corporate governance documents are also posted on our website: Code of Ethics, Whistleblowing Policy and the charters for each of the Audit Committee, Compensation Committee and Nominating Committee of our Board.
ITEM 1A. RISK FACTORS.
An investment in our securities involves a high degree of risk. You should consider carefully the following information about these risks, together with the other information contained in this Annual Report on Form 10-K before making an investment decision. Our business, prospects, financial condition and results of operations may be materially and adversely affected as a result of any of the following risks. The value of our securities could decline as a result of any of these risks. You could lose all or part of your investment in our securities. Some of the statements in “Item 1A. Risk Factors” are forward-looking statements. The following risk factors are not the only risk factors facing the Company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.
Summary Risk Factors
Risks Related to Our Business
| ● | Our strategic review process may not be successful or timely. |
| ● | Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction. |
| ● | We continue, and in the future expect, to incur losses, and we may need substantial additional capital in order to satisfy our business objectives. |
| ● | We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others. |
| ● | Our success was primarily dependent on the successful commercialization of our oral insulin capsule. |
| ● | We have limited experience in conducting clinical trials. |
| ● | We can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable. |
| ● | We may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own. |
| ● | Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens. |
| ● | We may not realize the full benefit from our distribution license agreement with Medicox. |
| ● | The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises. |
| ● | Healthcare policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S. healthcare system, may harm our future business. |
| ● | We face uncertainties related to Oravax’s oral COVID-19 vaccine. |
Risks Related to Our Real Estate Investments
Risks Related to the Notes
| ● | We have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to service its obligations under the Note and defaults on such Note, it could have a material adverse effect on our business. |
| ● | We may have difficulty realizing the full value of the Warrants. |
Risks Related to our Common Stock
| ● | Future sales of our common stock by our existing stockholders could adversely affect our stock price. |
| ● | Our failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of our common stock. |
| ● | As the market price of our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock when you want or at prices you find attractive. |
Risks Related to JV Agreement
| ● | On February 7, 2025, we and HTIT entered into a JV Agreement that amending the original agreement signed on January 22, 2024 or the Supplemental Agreement. If we fail to complete the transactions contemplated under the JV Agreement as supplemented by the Supplemental Agreement with HTIT, if such joint venture is not successful, or if we fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on the full market potential of our drug products and technology. |
| ● | We may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement. |
| ● | We may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business. |
| ● | Our business and assets will be less diversified following the Spin Off. |
Risks Related to Conducting Business in Israel
| ● | We are affected by the political, economic and military risks of having operations in Israel. |
| ● | It may be difficult to enforce a U.S. judgment against us or our officers and directors and to assert U.S. securities laws claims in Israel. |
General Risk Factors
| ● | Changes to tax laws could have a negative effect on us or our stockholders. |
| ● | Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security. |
Risks Related to Our Business
Our strategic review process may not be successful or timely.
Following the results of the ORA-D-013-1 Phase 3 trial, we conducted a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate. We submitted a protocol ORA-D-013-3 titled, “A Double-Blinded, Placebo-controlled, Double Dummy Multi-center Randomized, Phase 3 Study to Evaluate the efficacy and safety in subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One to Three Glucose-lowering Agents” to the FDA on September 12, 2024. We intend to initiate study during 2025. Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, including among others, continuation as a stand-alone business, capital raises, or one or more acquisitions, mergers or business combinations or other strategic transactions. Potential counterparties in a strategic transaction involving us may place minimal or no value on our assets. While we are devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated, or lead to any stockholder value. Any potential transaction would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to third parties in a potential transaction with us on reasonable terms. The process of reviewing alternative strategic paths may be time consuming, may involve the dedication of significant resources and may require us to incur significant costs and expenses. It could negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation in connection with this process or any resulting transaction. If we are not successful in setting forth a new strategic path for the Company, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and other stakeholders and the value of our securities may be adversely impacted. In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of the Company could cause our stock price to fluctuate significantly. There can be no guarantee that the process of evaluating alternative strategic paths will result in our entering into or completing potential transactions within the anticipated timing or at all.
If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.
Although there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management and may disrupt our business. The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose us to other operational and financial risks, including: increased near-term and long-term expenditures; exposure to unknown liabilities; higher than expected acquisition or integration costs; incurrence of substantial debt or dilutive issuances of equity securities to fund future operations; write-downs of assets or goodwill or incurrence of non-recurring, impairment or other charges; increased amortization expenses; impairment of relationships with key suppliers of any acquired business due to changes in management and ownership; inability to retain our key employees; and possibility of future litigation. Any of the above risks could have a material adverse effect on our business, financial condition, and prospects.
Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.
Our ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction, the loss of whose services may adversely impact the ability to consummate such transaction. Our cash conservation activities may yield unintended consequences, such as attrition and reduced employee morale, which may cause remaining employees to seek alternative employment. Our ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining personnel. If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business operations.
We may become involved in securities and stockholder litigation that could divert management’s attention and harm the Company’s business, and insurance coverage may not be sufficient to cover all costs and damages.
In the past, securities and stockholder litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. The market price of our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial. We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.
We continue, and in the future expect, to incur losses.
Successful evaluation and completion of our remaining development programs and our transition to normal operations are dependent upon obtaining necessary regulatory approvals from the FDA prior to selling our products within the United States, and foreign regulatory approvals must be obtained to sell our products internationally. There can be no assurance that we will receive regulatory approval of any of our product candidates, and a substantial amount of time may pass before we achieve a level of revenues adequate to support our operations. We expect to incur substantial expenditures in connection with our research and development programs, our strategic evaluation process, as well as the regulatory approval process with FDA and other agencies for each of our current or future product candidates during their respective developmental periods. Obtaining marketing approval will be directly dependent on our ability to implement the necessary regulatory steps required to obtain marketing approval in the United States and in other countries. We cannot predict the outcome of these activities.
Based on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such time. If there are unexpected increases in our operating expenses, we may need to seek additional financing during the next 12 months.
We may need substantial additional capital in order to satisfy our business objectives.
To date, we have financed our operations principally through offerings of securities and we may require substantial additional financing at various intervals in order to implement any potential strategic alternative, to continue our remaining or potential future research and development programs, including significant requirements for operating expenses including intellectual property protection and enforcement, for pursuit of regulatory approvals, and for commercialization of our remaining or future products. We can provide no assurance that additional funding will be available on a timely basis, on terms acceptable to us, or at all. In the event that we are unable to obtain such financing, we may not be able to implement the actions we decide to take as part of our strategic review process, and we will not be able to fully develop and commercialize our technology or pursue new technology. Our future capital requirements will depend upon many factors, including:
| ● | the results of our strategic review process and any new strategic direction we decide to take; |
| ● | continued scientific progress in our research and development programs; |
| ● | costs and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions; |
| ● | competing technological and market developments; |
| ● | our ability to establish additional collaborative relationships; and |
| ● | effects of commercialization activities and facility expansions if and as required. |
If we cannot secure adequate financing when needed, we may be required to delay, scale back or eliminate one or more of our existing or planned courses of action or research and development programs, or to enter into license or other arrangements with third parties to commercialize products or technologies that we would otherwise seek to develop ourselves and commercialize ourselves. In such event, our business, prospects, financial condition and results of operations may be adversely affected as we may be required to scale-back, eliminate, or delay development efforts or product introductions or enter into royalty, sales or other agreements with third parties in order to commercialize our products.
We have a history of losses and can provide no assurance as to our future operating results.
We do not have sufficient revenues from our research and development activities to fully support our operations. Consequently, we have incurred net losses since inception. We currently have only licensing revenues and no product revenues, and may not succeed in developing or commercializing any products which could generate product revenues. We do not expect to have any products on the market for several years. In addition, development of our product candidates requires a process of pre-clinical and clinical testing, during which our products could fail. For example, in January 2023, the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. We may not be able to enter into agreements with one or more companies experienced in the manufacturing and marketing of therapeutic drugs and, to the extent that we are unable to do so, we will not be able to market our product candidates. Eventual profitability will depend on our success in developing, manufacturing, and marketing our product candidates or in pursuing a successful strategic alternative. As of December 31, 2024 and 2023, we had working capital of approximately $137,536,000 and approximately $109,370,000, respectively, and stockholders’ equity of approximately $146,265,000 and approximately $163,821,000, respectively. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
We rely upon patents to protect our technology.
The patent position of biopharmaceutical and biotechnology firms is generally uncertain and involves complex legal and factual questions. We do not know whether any of our current or future patent applications will result in the issuance of any patents. Even issued patents may be challenged, invalidated or circumvented. Patents may not provide a competitive advantage or afford protection against competitors with similar technology. Competitors or potential competitors may have filed applications for, or may have received patents and may obtain additional and proprietary rights to compounds or processes used by or competitive with ours. In addition, laws of certain foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States.
Patent litigation is widespread in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to form strategic alliances, conduct clinical testing or manufacture and market any products under development. If challenged, our patents may not be held valid. We could also become involved in interference proceedings in connection with one or more of our patents or patent applications to determine priority of invention. If we become involved in any litigation, interference or other administrative proceedings, we will likely incur substantial expenses and the efforts of our technical and management personnel will be significantly diverted. In addition, an adverse determination could subject us to significant liabilities or require us to seek licenses that may not be available on favorable terms, if at all. We may be restricted or prevented from manufacturing and selling our products in the event of an adverse determination in a judicial or administrative proceeding or if we fail to obtain necessary licenses.
We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others.
Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We currently hold several pending patent applications in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering oral administration of insulin and other proteins and oral administration of exenatide and proteins and 140 patents issued by the United States and various other countries’ patent offices that cover a part of our technology, which allows for the oral delivery of proteins; patents issued by various patent offices that cover part of our technology for the oral delivery of exenatide; and patents issued by patent offices for treating diabetes. Further, we rely on a combination of trade secrets and non-disclosure and other contractual agreements and technical measures to protect our rights in our technology. We depend upon confidentiality agreements with our officers, directors, employees, consultants, and subcontractors, as well as collaborative partners, to maintain the proprietary nature of our technology. These measures may not afford us sufficient or complete protection, and others may independently develop technology similar to ours, otherwise avoid our confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition and results of operations. We believe that our technology is not subject to any infringement actions based upon the patents of any third parties; however, our technology may in the future be found to infringe upon the rights of others. Others may assert infringement claims against us or against companies to which we have licensed our technology, and if we should be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, our ability to continue to use our technology could be materially restricted or prohibited. If this event occurs, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Licenses or royalty agreements required in order for us to use this technology may not be available on terms acceptable to us, or at all. These claims could result in litigation, which could materially adversely affect our business, prospects, financial condition and results of operations. Further, we may need to indemnify companies to which we licensed our technology in the event that such technology is found to infringe upon the rights of others.
Our commercial success will also depend significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Patent applications are, in many cases, maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications are filed. In the event of infringement or violation of another party’s patent, we may be prevented from pursuing product development or commercialization. See “Item 1. Business—Description of Business— Intellectual Property and Patents.”
Our success was primarily dependent on the successful commercialization of our oral insulin capsule.
The successful commercialization of our principal product, the oral insulin capsule, was crucial for our success. On January 12, 2023, we announced top-line results from the phase 3 trial of our oral insulin capsule, which did not meet its primary or secondary endpoints, and indicated that we expect to discontinue oral insulin clinical activities for T2D. At present, following the results of the ORA-D-013-1 Phase 3 trial, we conducted a comprehensive analysis of the data and found that subpopulations of patients with pooled specific parameters responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. . Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities. Even if we succeed in commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its development. Principally, these risks include the following:
| ● | Future clinical trial results may show the same results as the ORA-D-013-1 Phase 3 trial; |
| ● | Future clinical trial results may be inconsistent with previous preliminary testing results and data from our earlier trials may be inconsistent with clinical data; |
| ● | Even if our oral insulin capsule is shown to be safe and effective for its intended purposes in future clinical trials, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices; |
| ● | Our ability to complete the development and commercialization of the oral insulin capsule for our intended use is significantly dependent upon our ability to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide basis; |
| ● | Even if our oral insulin capsule is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that there will be market acceptance of our product; and |
| ● | Our competitors may develop therapeutics or other treatments which are superior or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues. |
Our business may be seriously harmed if our analysis does not produce positive results, if we are unable to find a path forward to continue development of our oral insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with any of these risks, or if we are unable to successfully commercialize our oral insulin capsule for some other reason.
We have limited experience in conducting clinical trials.
Clinical trials must meet FDA and foreign regulatory requirements. We have limited experience in designing, conducting and managing the preclinical trials and clinical trials necessary to obtain regulatory approval for our product candidates in any country. In the past, we entered into agreements with Integrium LLC and other consultants to assist us in designing, conducting and managing our various clinical trials in the United States, Europe and Israel. Any failure of a consultant to fulfill their obligations could result in significant additional costs as well as delays in designing, consulting and completing clinical trials on our products.
Our clinical trials may encounter delays, suspensions or other problems.
We may encounter problems in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate our clinical trials at any phase. These problems could include the possibility that we may not be able to conduct clinical trials at our preferred sites, enroll a sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at all. For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site. Furthermore, we, the FDA or foreign regulatory agencies may suspend clinical trials at any time if we or they believe the subjects participating in the trials are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical trial process or conduct of the investigation. If clinical trials of any of the product candidates fail, we will not be able to market the product candidate which is the subject of the failed clinical trials. The FDA and foreign regulatory agencies could also require additional clinical trials, which would result in increased costs and significant development delays. Our failure to adequately demonstrate the safety and effectiveness of a pharmaceutical product candidate under development could delay or prevent regulatory approval of the product candidate and could have a material adverse effect on our business, prospects, financial condition and results of operations. For example, see “Item 1. Business—Description of Business— Research and Development” regarding the results of the ORA-D-013-1 Phase 3 trial that did not meet its primary or secondary endpoints. Finally, the COVID-19 pandemic impacted clinical trials generally in recent years, and we experienced approximately six months of delays in clinical trials due to slow-downs of recruitment for trials generally related to COVID-19. We may experience further delays in site initiation and patient enrollment, failures to comply with study protocols, delays in the manufacture of our product candidates for clinical testing and other difficulties in starting or competing our clinical trials.
Initial success in the completed and ongoing early-stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.
Positive results in a clinical trial may not be replicated in subsequent or confirmatory trials. Additionally, success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained. Any of our product’s failure to show sufficient efficacy in patients with the targeted indication, or if such studies are discontinued for any other reason, could negatively impact our development and commercialization goals for these products and our stock price could decline. Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. As a result, preliminary and interim data should be viewed with caution until the final data are available. We have invested in clinical studies of medicines that have not met the primary clinical endpoints in their Phase 3 studies or have been discontinued for other reasons. For example, in January 2023, we reported that ORA-D-013-1 trial did not meet its primary or secondary endpoint. Even if later stage clinical trials are successful, regulatory authorities may delay or decline approval of our product candidates.
There are a number of factors that could cause a clinical study to fail or be delayed, including: (i) the clinical study may produce negative or inconclusive results; (ii) regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory requirements; (iii) we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse side effects of a product on subjects or lack of efficacy in the trial; (iv) we, or our partners, may decide, or regulators may require us, to conduct additional preclinical testing or clinical studies; (v) change in rates of enrollment and dropout among clinical trial participants; (vi) differences in the size and type of the patient populations; (vii) changes in and adherence to the dosing regimen and other clinical trial protocols; and (viii) people who enroll in the clinical study may later drop out due to adverse events, a perception they are not benefiting from participating in the study, fatigue with the clinical study process or personal or other issues. The occurrence of any of these events could result in significant costs and expense, have an adverse effect on our business, financial condition and results of operations and/or cause our stock price to decline or experience periods of volatility.
Clinical trials of our products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control.
Third parties who conduct clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any phase. These problems could include the possibility that they may not be able to conduct clinical trials at their preferred sites, enroll a sufficient number of patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at all. For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site. In addition, these third parties are not controlled by us and may conduct these trials in a manner in which we disagree or which may prove to be unsuccessful. Furthermore, domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe the subjects participating in the trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial process or conduct of the investigation. If such clinical trials conducted by third parties fail, it could have a material adverse effect on our business, prospects, financial condition and results of operations.
We can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable.
The testing, marketing and manufacturing of any of our products will require the approval of the FDA or regulatory agencies of other countries. We cannot predict with any certainty the amount of time necessary to obtain regulatory approvals, including from the FDA or other foreign regulatory authorities, and whether any such approvals will ultimately be granted. In any event, review and approval by the regulatory bodies is anticipated to take a number of years. Preclinical and clinical trials may reveal that one or more of our products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. For example, in January 2023, we announced that our ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a result, we decided to terminate our ORA-D-013-2 Phase 3 trial, conducted a comprehensive analysis of the data and found that subpopulations of patients with pooled specific parameters, responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. Moreover, obtaining approval for certain products may require the testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining necessary regulatory approvals of any proposed product and failure to receive such approvals would have an adverse effect on the product’s potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a product may be found to be ineffective or unsafe due to conditions or facts which arise after development has been completed and regulatory approvals have been obtained. In this event we may be required to withdraw such product from the market. See “Item 1. Business—Description of Business—Government Regulation.”
We are dependent upon third party suppliers of our raw materials and for other services.
We are dependent on outside vendors for our entire supply of the oral insulin capsules and do not currently have any long-term agreements in place for the supply of oral insulin capsules, which is still necessary if we decide to continue development of these projects. While we believe that there are numerous sources of supply available, if the third party suppliers were to cease production, or otherwise fail to supply us with quality raw materials in sufficient quantities on a timely basis and we were unable to contract on acceptable terms for these services with alternative suppliers, our ability to produce our products and to conduct testing and clinical trials would be materially adversely affected.
We rely on suppliers, vendors, outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize, co-promote and sell our products, manage certain marketing, IT, data and other business unit and functional services and meet their contractual, regulatory and other obligations. Using these third parties poses a number of risks, such as: (i) they may not perform to our standards or legal requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines to some CROs; (ii) they may not produce reliable products; (iii) they may not perform in a timely manner; (iv) they may not maintain confidentiality of our proprietary information; (v) they may incur a significant cyberattack or business disruption; (vi) they may be subject to government orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders; (vii) disputes may arise with respect to ownership of rights to technology developed with our partners; and (viii) disagreements could cause delays in, or termination of, the research, development or commercialization of the product or result in litigation or arbitration. The failure of any critical third party to meet its obligations; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on our operations and results. In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including the local pharmaceutical code, the U.S. Foreign Corrupt Practice Act of 1977, the U.K. Bribery Act of 2010, the EU’s General Data Protection Regulations, and other similar laws and regulations, during the performance of their obligations for us, we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences.
We may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own.
DNA’s ordinary shares are traded on the Tel Aviv Stock Exchange and Entera’s ordinary shares and Scilex’s and BioXcel’s common stock are traded on the Nasdaq Stock Market, which are subject to market fluctuations. In addition, the shares of Scilex, DNA and Entera have historically experienced low trading volume compared to the level of shares we hold. As a result, there is no guarantee that we will be able to resell those shares at the prevailing market prices or that we will realize a positive return on such shares.
Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.
Currently, we believe that either we are not within the definition of “Investment Company” as the term is defined under the Investment Company Act of 1940, or the 1940 Act, or, alternatively, we may rely on one or more of the 1940 Act’s exemptions. As of December 31, 2024, we held approximately 1.4% of DNA’s outstanding ordinary shares, approximately 0.3% of Entera’s outstanding ordinary shares, and beneficially own approximately 15.7% of BioXcel’s outstanding common stock. Further, we hold the Tranche A Note and Tranche B Note and in consideration of deferring Scilex’s first amortization payment under the Tranche B Note to October 8, 2026, we received, in addition to a nominal payment, 2,500,000 shares of Scilex Common Stock. We have also investments in real estate and real estate lending transactions as described elsewhere in this Annual Report. In order not to be regulated as an investment company under the 1940 Act, unless we can qualify for an exclusion, we must ensure that we are engaged primarily in a business other than investing, reinvesting or trading in securities and that our activities do not include investing, reinvesting, owning, holding or trading “investment securities” constituting more than 40% of our total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis. We intend to continue to conduct our operations and ongoing investments into DNA, BioXcel, Entera and Scilex and our real estate transaction in a manner that will exempt us from the registration requirements of the 1940 Act. If we were to be deemed to be an investment company because of our investments, we would be required to register as an investment company under the 1940 Act. Alternatively, to continue qualifying for the exemption, we could be required to dispose of the securities holdings or other investments, which could have a material adverse effect on our business, results of operations and financial condition. The 1940 Act places significant restrictions on the capital structure and corporate governance of a registered investment company and materially restricts its ability to conduct transactions with affiliates. Compliance with the 1940 Act could also increase our operating costs. Such changes could have a material adverse effect on our business, results of operations and financial condition.
We may not realize the full benefit from our distribution license agreement with Medicox.
Our distribution license agreement with Medicox provides that Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule and pay us up to $15,000,000 in developmental milestones, $2,000,000 of which have already been received by us. If we are not successful in finding a mutually agreed way to continue our collaboration following the results of the ORA-D-013-1 Phase 3 trial, or if Medicox is not successful in independently advancing the oral insulin candidate, we may not realize the benefits from this collaboration.
We are highly dependent upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products.
Our long-term strategy is to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. Such planned strategic partnership, or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational support for global clinical trials, post marketing trials, label expansions and other regulatory requirements concerning future clinical development in the United States and elsewhere. We currently lack the resources to manufacture any of our product candidates on a large scale and we have no sales, marketing or distribution capabilities. In the event we are not able to enter into a collaborative agreement with a partner, or partners, on commercially reasonable terms, or at all, we may be unable to commercialize our products, which would have a material adverse effect upon our business, prospects, financial condition and results of operations.
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises.
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As a result, our products could become obsolete before we recoup any portion of our related research and development and commercialization expenses. These industries are highly competitive, and this competition comes both from biotechnology firms and from major pharmaceutical and chemical companies. Many of these companies have substantially greater financial, marketing and human resources than we do (including, in some cases, substantially greater experience in clinical testing, manufacturing and marketing of pharmaceutical products). We also experience competition in the development of our products from universities and other research institutions and compete with others in acquiring technology from such universities and institutions. We face the risk that new market entrants and existing competition may try to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete. In addition, our research and development efforts may target diseases and conditions for which there are existing therapies or therapies that are being developed by our competitors. Further, any products resulting from our research and development efforts might not be able to compete successfully with others’ existing and future products. See “Item 1. Business—Description of Business—Competition.”
Our financial position or results could be negatively affected by product liability claims.
It is possible that we will be responsible for potential product liability stemming from product research, development or manufacturing and may face an even greater risk if any product candidate that we develop is commercialized. If we cannot successfully defend ourselves against claims that products we develop independently or with our partners caused injuries, we could incur substantial liabilities. Regardless of the merit or eventual outcome of such claims, any liability claims may result in, among other things, decreased demand for any product that we may develop, loss of revenues, significant time and costs to defend the related litigation, initiation of investigations by regulators and injury to our reputation and significant negative media attention. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. Our clinical trials are covered by liability insurance, but notwithstanding such coverage, our financial position or results could be negatively affected by product liability claims.
We have limited senior management resources and may be required to obtain more resources to manage our growth.
We expect the expansion of our business, as well as the activities we take as a result of our strategic review process, to place a significant strain on our limited managerial, operational and financial resources. We will be required to expand our operational and financial systems significantly and to expand, train and manage our work force in order to manage the expansion of our operations. Our failure to fully integrate our new employees into our operations could have a material adverse effect on our business, prospects, financial condition and results of operations. Our ability to attract and retain highly skilled personnel is critical to our operations and expansion. We face competition for these types of personnel from other technology companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than we have. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms or at all. If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition and results of operations will be materially adversely affected. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1. Business—Description of Business—Employees.”
We depend upon our senior management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage.
We currently depend upon the efforts and abilities of our senior executives, as well as the services of several key consultants and other key personnel, including Dr. Miriam Kidron, our Chief Scientific Officer. The loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations. We do not maintain “key man” life insurance policies for any of our senior executives. In addition, recruiting and retaining qualified scientific personnel to perform future research and development work will be critical to our success. There is currently a shortage of employees with expertise in developing, manufacturing and commercialization of products and related clinical and regulatory affairs, and this shortage is likely to continue. Competition for skilled personnel is intense and turnover rates are high. Our ability to attract and retain qualified personnel may be limited. Our inability to attract and retain qualified skilled personnel would have a material adverse effect on our business, prospects, financial condition and results of operations.
Our existing and any future joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we expect from these arrangements.
We are currently party to certain joint ventures, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize assets to or in these joint ventures or other joint ventures that we may enter.
Our participation in our existing joint ventures is subject to risks, including the following:
| ● | We share approval rights over certain major decisions affecting the ownership or operation of the joint ventures and any assets owned by the joint ventures; |
| ● | We may need to contribute additional capital in order to preserve, maintain or grow the joint ventures and their investments; |
| ● | Our joint venture investors may have economic or other business interests or goals that are inconsistent with our business interests or goals and that could affect our ability to fully benefit from the assets owned by the joint ventures; |
| ● | Our joint venture investors may be subject to different laws or regulations than us, which could create conflicts of interest; |
| ● | Our joint ventures may have license and other agreements with other investors, which we are not party to and have no control over; |
| ● | Our ability to sell our interests in, or sell additional assets to, the joint ventures or the joint ventures’ ability to sell additional interests of, or assets owned by, the joint ventures when we so desire are subject to the approval rights of the other joint venture investors under the terms of the agreements governing the joint ventures; and |
| ● | Disagreements with our joint venture investors could result in litigation or arbitration that could be expensive and distracting to management and could delay important decisions. |
Any of the foregoing risks could have a material adverse effect on our business, financial condition and results of operations. Further, these, similar, enhanced or additional risks, including possible risks of the other joint venture investors having licensed assets to the joint venture, may apply to any future additional or amended joint ventures that we may enter into.
Healthcare policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S. healthcare system, may harm our future business.
Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the products that we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party payors. These limitations could in turn reduce the amount of revenues that we will be able to generate in the future from sales of our products and licenses of our technology.
In 2010, the federal government enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry. In addition to requiring most individuals to have health insurance and establishing new regulations on health plans, this legislation requires discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid. In addition, the legislation imposes an annual fee, which has increased annually, on sales by branded pharmaceutical manufacturers. There can be no assurance that our business will not be materially adversely affected by these increased rebates, fees and other provisions. In addition, these and other initiatives in the United States may continue the pressure on drug pricing, especially under the Medicare and Medicaid programs, and may also increase regulatory burdens and operating costs. The announcement or adoption of any such initiative could have an adverse effect on potential revenues from any product that we may successfully develop. An expansion in government’s role in the U.S. healthcare industry may lower the future revenues for the products we are developing and adversely affect our future business, possibly materially.
In September 2017, members of the U.S. Congress introduced legislation with the announced intention to repeal and replace major provisions of the Patient Protection and Affordable Care Act, or the ACA. In addition to those efforts, on October 12, 2017, an executive order was issued that modified certain aspects of the ACA. Following several years of litigation in the federal courts, in June 2021, the U.S. Supreme Court upheld the ACA when it dismissed a legal challenge to the ACA’s constitutionality. Further attempts to repeal or to repeal and replace the ACA may continue. In addition, various other healthcare reform proposals have also emerged at the federal and state level. We cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on us.
We are exposed to fluctuations in currency exchange rates.
A considerable amount of our expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses such as some clinical trials and payroll costs are generated in other currencies such as NIS and Euro. Most of the time, our non-dollar assets are not totally offset by non-dollar liabilities. Due to the foregoing and to the fact that our financial results are measured in dollars, our results could be adversely affected as a result of a strengthening or weakening of the dollar compared to these other currencies. During the years ended December 31, 2019, 2020 and 2021, the dollar depreciated in relation to the NIS, which raised the dollar cost of our Israeli based operations and adversely affected our financial results, while during the year ended December 31, 2022, 2023 and 2024, the dollar increased in relation to the NIS, which reduced the dollar cost of our Israeli based operations costs. In addition, our results could also be adversely affected if we are unable to guard against currency fluctuations in the future. Although we may in the future decide to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we currently do not hedge our exposure to foreign currency exchange risks. These transactions, however, may not adequately protect us from future currency fluctuations and, even if they do protect us, may involve operational or financing costs we would not otherwise incur.
We face uncertainties related to Oravax’s oral COVID-19 vaccine.
We face uncertainties related to Oravax’s oral COVID-19 vaccine, including uncertainties related to the risk that our continued development programs may not be successful, commercially viable or receive approval from regulatory authorities. Other companies may produce superior or competitive oral or other products that make Oravax’s oral COVID-19 vaccine not commercially worthwhile. Even if we succeed in developing the product, the demand for any product we may develop may no longer exist, given the fluid nature of the COVID-19 pandemic, including possible decreased demand for vaccines due to weaker strains, the need for different vaccines for new variants of the virus or an end of the pandemic that may render Oravax’s vaccine obsolete.
Risks Related to Our Real Estate Investments
Our investments in real estate may expose us to market and liquidity risks that could adversely affect our financial condition and results of operations. On November 7, 2024, our Board approved investments of up to $10,000,000 in real estate assets, and additional investments of up to $20,000,000 On February 13, 2025. While we believe these investments present attractive opportunities, the real estate market is subject to fluctuations due to economic conditions, interest rate changes, and other external factors beyond our control. A downturn in the real estate market or an extended period of declining property values could negatively impact the returns on our investments. Additionally, real estate investments tend to be relatively illiquid, which may limit our ability to quickly exit or reallocate capital in response to market changes. Since our approach focuses on entrepreneurial real estate investments rather than direct property ownership or management, we are also exposed to risks associated with deal execution, market timing, and the financial health of investment partners or counterparties. If any of these risks materialize, they could adversely affect our financial position and ability to generate anticipated returns.
Risks Related to the Notes
We have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to service its obligations under the Note and defaults on such Note, it could have a material adverse effect on our business.
On September 21, 2023, we were issued the Tranche A Note in an aggregate principal amount of $101,875,000 by Scilex pursuant to the Scilex SPA. The Note originally matured on March 21, 2025 and is payable in six principal installments, with the first installment paid on December 21, 2023. In January 2025, we extended Tranche A Note maturity from March 21, 2025 to December 31, 2025. Interest under the Note accrues at a fluctuating per annum interest rate equal to the sum of (1) the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Note) and (2) eight and one half percent (8.5%), payable in-kind on a monthly basis.
On October 7, 2024, we entered into an agreement to refinance a portion of the Tranche A Note and pay off certain other indebtedness of Scilex. We were issued an aggregate principal amount of $25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants. In addition, on October 8, 2024, we entered into the RPA with Scilex to holds the right to receive 4% royalties.
There is no guarantee that Scilex will be able to service its repayment obligations under the Note. Although the Note is secured by a first priority security interest in and liens on all of the assets of Scilex and its subsidiaries, no assurance can be made that Scilex will be able to repay the Tranche A Note and Tranche B Notes, or the Notes, when due or that we will be able to foreclose on such assets and recover enough value upon the sale of such assets to repay the amounts owed to us. In such an event, we could lose all or a substantial portion of our loan investment. Additionally, Scilex has disclosed in its periodic reports filed with the SEC that there is substantial doubt about its ability to continue as a going concern. If Scilex is unable to continue as a going concern or defaults on the Notes, we may be unable to recover some or all of the principal amount of the Note, which could have a material adverse effect on our business, financial condition and results of operations.
We may have difficulty realizing the full value of the Warrants.
The Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Note has been repaid in full, and (iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the fifth anniversary of the issuance date. For purposes of the Penny Warrants, the Management Sale Trigger Date is generally the first date that certain members of Scilex management engage in certain sales or other similar transfers of shares of Scilex Common Stock or other of Scilex’s or any of its subsidiaries’ securities, subject to certain exceptions as are customary for lock-up agreements executed by directors and officers in connection with financings or similar transactions.
The Subsequent Penny Warrants will vest and become exercisable on the date that is the later of (i) Subsequent Penny Warrant Vesting Date, and (ii) the earliest of (A) March 14, 2025, (B) the date on which the Note has been repaid in full and (C) the Management Sale Trigger Date, if any. Each Subsequent Penny Warrant will expire on the date that is the fifth anniversary of the issuance date; provided that, if the Notes are repaid in full prior to the Subsequent Penny Warrant Vesting Date applicable to such Subsequent Penny Warrant, such Subsequent Penny Warrant will expire on the date the Notes are repaid in full.
Because of the foregoing restrictions on exercisability of the Closing Penny Warrant and the Subsequent Penny Warrants, we may not be able to exercise the Warrants for shares of Scilex Common Stock at a time when it would be financially beneficial for us to do so. Accordingly, there is no guarantee that we will be able to realize the full or any value of the Warrants.
Risks Related to our Common Stock
Future sales of our common stock by our existing stockholders could adversely affect our stock price.
The market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market, or the perception that these sales could occur. We experienced a significant decline in the market price of our common stock and a significant increase in trading volume after announcing the results of our ORA-D-013-1 Phase 3 trial in January 2023. Any strategic decision we make as a result of our strategic review process may also negatively affect our common stock price or cause volatility in the market price of our common stock. Sales of large amounts of our securities or large variations in trading volume might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. As of March 27, 2025, we had outstanding 40,850,455 shares of common stock, a large majority of which are freely tradable. Giving effect to the exercise in full of all of our outstanding warrants, options and restricted stock units, or RSUs, including those currently unexercisable or unvested, we would have outstanding 44,599,618 shares of common stock.
Our issuance of warrants, options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of our common stock as well as a dilutive effect.
We have issued and may continue to issue warrants, options, RSUs and convertible notes at, above or below the current market price. As of March 27, 2025, we had outstanding warrants exercisable for 20,000 shares of common stock at a weighed average exercise price of $4.13 and options exercisable for 1,548,633 shares of common stock at a weighted average exercise price of $7.09. We also had outstanding RSUs for 589,781 shares of common stock. In addition to the dilutive effect of a large number of shares of common stock and a low exercise price for the warrants and options, there is a potential that a large number of underlying shares of common stock may be sold in the open market at any given time, which could place downward pressure on the trading of our common stock.
Because we will not pay cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize their investment.
We have not paid any cash dividends on our common stock and do not intend to pay cash dividends in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our business. Any credit agreements which we may enter into with institutional lenders or otherwise may restrict our ability to pay dividends. Whether we pay cash dividends in the future will be at the discretion of our Board and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that our Board decides is relevant.
Our failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of our common stock.
Our common stock is currently listed on the Nasdaq Capital Market. In order to maintain this listing, we must satisfy minimum financial and other requirements. Nasdaq Listing Rule 5550(a)(2) requires the minimum bid price of our common stock on the Nasdaq Capital Market to remain above $1.00. If the bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be in violation of Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we would have 180 calendar days to regain compliance with the minimum bid requirement.
While we intend to engage in efforts to maintain compliance, and thus maintain our listing, there can be no assurance that we will continue to meet all applicable Nasdaq Capital Market requirements in the future, especially in light of any strategic transaction we may choose to undertake. If our common stock were removed from listing with the Nasdaq Capital Market, it may be subject to the so-called “penny stock” rules. The SEC has adopted regulations that define a “penny stock” to be any equity security that has a market price per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange, which is the exception on which we currently rely. For any transaction involving a “penny stock,” unless exempt, the rules impose additional sales practice requirements on broker-dealers, subject to certain exceptions. If our common stock were delisted and determined to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock on the secondary market.
If our common stock is delisted and there is no longer an active trading market for our shares, it may, among other things: cause stockholders difficulty in selling our shares without depressing the market price for the shares or selling our shares at all; substantially impair our ability to raise additional funds; result in a loss of institutional investor interest and fewer financing opportunities for us; and/or result in costly litigation, significant liabilities and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business and results of operations.
A delisting would also reduce the value of our equity compensation plans, which could negatively impact our ability to retain employees.
As the market price of our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock when you want or at prices you find attractive.
The price of our common stock is currently listed on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange and constantly changes. In recent years, the stock market in general has experienced extreme price and volume fluctuations. We expect that the market price of our common stock will continue to fluctuate. These fluctuations may result from a variety of factors, many of which are beyond our control. For example, we experienced a significant decline in the market price of our common stock after announcing the results of our ORA-D-013-1 Phase 3 trial in January 2023. These factors include:
| ● | market acceptance of our new strategy, once determined and announced; |
| ● | clinical trial results and the timing of the release of such results; |
| ● | the amount of cash resources and our ability to obtain additional funding; |
| ● | announcements of research activities, business developments, technological innovations or new products by us or our competitors; |
| ● | entering into or terminating strategic relationships; |
| ● | changes in government regulation; |
| ● | departure of key personnel; |
| ● | disputes concerning patents or proprietary rights; |
| ● | changes in expense level; |
| ● | future sales of our equity or equity-related securities; |
| ● | public concern regarding the safety, efficacy or other aspects of the products or methodologies being developed; |
| ● | activities of various interest groups or organizations; |
| ● | media coverage; and |
| ● | status of the investment markets. |
Future sales of common stock or the issuance of securities senior to our common stock or convertible into, or exchangeable or exercisable for, our common stock could materially adversely affect the trading price of our common stock, and our ability to raise funds in new equity offerings.
Future sales of substantial amounts of our common stock, including pursuant to any strategic opportunity, the ATM Agreement (as defined below), or other equity-related securities in the public market or privately, or the perception that such sales could occur, could adversely affect prevailing trading prices of our common stock and could impair our ability to raise capital through future offerings of equity or other equity-related securities. We anticipate that we will need to raise capital through offerings of equity and equity related securities. We can make no prediction as to the effect, if any, that future sales of shares of our common stock or equity-related securities, or the availability of shares of common stock for future sale, will have on the trading price of our common stock.
Our stockholders may experience significant dilution as a result of any additional financing using our equity securities.
To the extent that we raise additional funds by issuing equity securities, including in connection with any strategic opportunity or pursuant to the ATM Agreement, our stockholders may experience significant dilution. Additionally, we may, from time to time or in connection with a strategic alternative, issue additional shares of common stock at a discount from the current trading price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of convertible debt securities, preferred stock or common stock. If we issue common stock or securities convertible into common stock, our common stockholders would experience additional dilution and, as a result, our stock price may decline.
Risks Related to JV Agreement
If we fail to complete the transactions contemplated under the JV Agreement as supplemented by the Supplemental Agreement with HTIT , if such joint venture is not successful, or if we fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on the full market potential of our drug products and technology.
In joint ventures, we share ownership and management of a company with one or more parties who may not have the same goals, strategies, priorities, business incentives or resources as we do and may compete with us outside the joint venture. Joint ventures are intended to be operated for the benefit of all co-owners, rather than for our exclusive benefit. Operating a business as a joint venture often requires additional organizational formalities as well as time-consuming procedures for sharing information and making decisions that must further take into consideration our partners’ interests. In joint ventures, we are required to foster our relationships with our co-owners as well as promote the overall success of the joint venture, and if a co-owner changes, relationships deteriorate or strategic objectives diverge, our success in the joint venture may be materially adversely affected. Further, because most of the benefits from a successful joint venture are shared among the co-owners, we do not receive all the benefits from our successful joint ventures.
In addition, because we share ownership and management with one or more parties, we may have limited control over the actions of a joint venture, particularly when we own a minority interest. As a result, we may be unable to prevent violations of applicable laws or other misconduct by a joint venture, adverse human rights or other impacts or the failure to satisfy contractual obligations by one or more parties. Moreover, a joint venture may not be subject to the same financial reporting, corporate governance or compliance approaches that we follow. To the extent another party makes decisions that negatively impact the joint venture or internal control issues arise within the joint venture, we may have to take responsive actions, or we may be subject to penalties, fines or other punitive actions or suffer reputational harm for these activities.
The consummation of the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement, is subject to the satisfaction or waiver of certain other closing conditions.
If we do not successfully complete the closing conditions, this may harm our ability to complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement, as well as additional clinical trials and marketing of our oral insulin candidate. In addition, this may cause irreparable harm to our financial position and business operations.
Furthermore, there can be no assurances that OraTech will receive the necessary regulatory approvals for the Phase 3 oral insulin trial in the United States or that our drug products and our technology will be developed and commercialized successfully. In addition, OraTech will subject us to a number of risks including risks relating to the lack of full control of OraTech, potential disagreements with HTIT about how to manage OraTech that may result in the delay or termination of the commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources, conflicting interests of OraTech, and OraTech and its business not being profitable.
While we believe that our board representation, voting rights and other contractual rights with respect to OraTech will serve to mitigate some of these risks, we may have disagreements with the other directors and HTIT that could impair our ability to influence OraTech to act in a manner that we believe is in the best interest of us.
We may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement.
Pursuant to the Supplemental Agreement, the Initial Closing will be April 30, 2025. Subject to the completion and satisfaction of applicable closing conditions, the Second Closing shall occur on a date specified in the applicable closing notice, which such date shall be no later than the fifth business day after the satisfaction or waiver of the applicable closing conditions, provided, however, that the Second Closing shall not be consummated before April 30, 2025 unless the shares of OraTech’s common stock have been approved for listing and trading on the Nasdaq Stock Market prior to April 30, 2025. In the event the parties fail to consummate the Second Closing on or before April 30, 2025, solely due to the failure of not achieving the Listing, the parties agreed to consummate the Second Closing on or before May 31, 2025. Notwithstanding the foregoing, the provisions with respect to the Second Closing may be terminated by either HTIT or us if the Second Closing has not occurred by September 1, 2025, subject to certain conditions.
There are no assurances that the applicable parties will consummate either the Initial Closing or the Second Closing, of the Spin Off or complete the closing conditions such closings are subject to. If we do not successfully complete such closings in a timely manner, or at all, this may harm OraTech’s ability to complete the transactions contemplated by the JV Agreement and the Supplemental Agreement, which may in turn cause irreparable harm to our financial position and business operations.
We may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business.
We may not be able to achieve the full strategic and financial benefits expected to result from the Spin Off and such benefits may be delayed or not occur at all. The Spin Off is designed to enhance strategic and management focus, provide a distinct corporate identity, and allow us to efficiently allocate resources and deploy capital. We may not achieve these and other anticipated benefits for a variety of reasons, including the following:
| ● | the Spin Off will require significant amounts of management’s time and effort, which may divert management’s attention from operating and growing our business; |
| ● | following the Spin Off, OraTech may be more susceptible to economic downturns and other adverse events than if it was still a part of the Company; |
| ● | following the Spin Off, our business will be less diversified than prior to the Spin Off; |
| ● | following the Spin Off, our business will experience a loss of scale and access to certain financial, managerial, and professional resources as well as product and brand power influence and recognition with some customers from which we have benefited in the past; |
| ● | actions required to separate the respective businesses could disrupt our operations; and |
| ● | if we fail to achieve some or all of the benefits expected to result from the Spin Off, or if such benefits are delayed, our business could be harmed. |
Until the Spin Off occurs, the business of OraTech will remain our business segment. Completion of the Spin Off remains subject to the satisfaction or waiver of certain conditions.
Potential indemnification liabilities to HTIT pursuant to the JV Agreement, as supplemented by the Supplemental Agreement could materially and adversely affect our financial condition, results of operations, and cash flows.
The JV Agreement, as supplemented by the Supplemental Agreement, among other things, provides for indemnification obligations designed to make the Company and the OraTech financially responsible for certain liabilities that may exist relating to its business activities. If we and the OraTech are required to indemnify HTIT under the circumstances set forth in the JV Agreement, as supplemented by the Supplemental Agreement, we may be subject to substantial liabilities.
We potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with OraTech
The agreements we and OraTech entered into in connection with the Spin Off have been negotiated while OraTech is still a part of our business. The terms of the agreements negotiated in the context of the Spin Off relate to, among other things, the allocation of assets, intellectual property, liabilities, rights, and other obligations between OraTech and us, among others. Arm’s-length negotiations between OraTech and an unaffiliated third-party in another form of transaction, such as a buyer in a sale of a business transaction, may have resulted in more favorable terms to the unaffiliated third-party.
Our business and assets will be less diversified following the Spin Off
In connection with the transactions contemplated by the JV Agreement as supplemented by the Supplemental Agreement, on February 7, 2025, we entered into that certain Asset Transfer Agreement or the Asset Transfer Agreement with OraTech and Oramed Ltd., pursuant to which, we and Oramed Ltd. have agreed to transfer to OraTech all of our and their rights, titles, and interests in the Transferred IP, Business Contracts, Business Information, and Regulatory Information (each as defined in the Asset Transfer Agreement and collectively, or the Transferred Assets), as part of the capital contribution to be made to OraTech, in consideration for the issuance to us of certain Shares (as defined in the JV Agreement) in OraTech.
If such Transferred Assets are transferred to OraTech in connection with the Spin Off, OraTech will have all rights, title and interest in such Transferred Assets, and we will no longer have all rights, title and interest in such Transferred Assets, meaning that our business and assets will be less diversified following the Spin Off, which may in turn affect our operations and our financial position.
The financial position and business operations of the OraTech could be impacted by HTIT’s ability to perform its obligations under certain contracts with us.
In connection with the Spin Off, we have entered into a number of agreements with HTIT, including a supply agreement and a license agreement that govern our ongoing relationship with HTIT. Our success depends, in part, on the maintenance of our ongoing relationship with HTIT, HTIT’s performance of its obligations under these agreements, including HTITs maintenance of the quality of products and services and certain other trademarks and intellectual property that we license to HTIT. If we are unable to maintain a good relationship with HTIT, or if HTIT does not perform its obligations under our agreements with HTIT, the business of OraTech, its operations and its financial position may be negatively impacted.
The Spin Off may expose us to potential liabilities arising out of state and federal fraudulent conveyance laws.
If we file for insolvency or bankruptcy within certain timeframes following the Spin Off, a court could deem the Spin Off or certain internal restructuring transactions undertaken by us in connection therewith to be a fraudulent conveyance or transfer. Fraudulent conveyances or transfers are defined to include transfers made or obligations incurred with the actual intent to hinder, delay or defraud current or future creditors or transfers made or obligations incurred for less than reasonably equivalent value when the debtor was insolvent, or that rendered the debtor insolvent, inadequately capitalized or unable to pay its debts as they become due. In such circumstances, a court could void the transactions or impose substantial liabilities upon us, which could adversely affect our financial condition and our results of operations. Whether a transaction is a fraudulent conveyance or transfer will vary depending upon the jurisdiction whose law is being applied.
Risks Related to Conducting Business in Israel
We are affected by the political, economic and military risks of having operations in Israel.
We have operations in the State of Israel, and we are directly affected by political, economic and security conditions in that country. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors and a state of hostility, varying in degree and intensity, has led to security and economic problems for Israel. In addition, acts of terrorism, armed conflicts or political instability in the region could negatively affect local business conditions and harm our results of operations. We cannot predict the effect on the region of any diplomatic initiatives or political developments involving Israel or the Palestinians or other countries and territories in the Middle East. Recent political events, including political uprisings, social unrest and regime change, in various countries in the Middle East and North Africa have weakened the stability of those countries and territories, which could result in extremists coming to power. In addition, Iran has threatened to attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon. This situation has escalated in the past and may potentially escalate in the future to violent events which may affect Israel and us. On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. Israel has been in an ongoing state of war with Hamas since that time. Following the attack by Hamas, Hezbollah, a terrorist organization in Lebanon has also launched missile, rocket, and shooting attacks against Israeli military sites, troops, and Israeli towns in northern Israel. In response to these attacks, the Israeli army has carried out a number of targeted strikes on sites belonging to Hezbollah in southern Lebanon and in October 2024, the Israeli military initiated a ground operation in Lebanon, primarily near the Israel-Lebanon border. As of the end of November 2024, Israel entered into a ceasefire agreement with Hezbollah, but there are no guarantees as to whether the agreement will hold or whether further hostilities will resume.
In April and October 2024, Iran launched missile and unmanned aerial vehicle, or UAV, attacks on Israel. Most of the missiles and UAVs were intercepted by Israel’s defense systems, with support from the United States and other countries, including regional allies, preventing significant damage and resulting in no casualties. Despite the successful interceptions, the attacks posed an elevated threat to Israel’s security.
In December 2024, Ba’athist Syria, led by President Bashar al-Assad, collapsed during a major offensive by opposition forces made up of several competing rebel groups. In response, the Israeli Defense Forces took control over a United Nations-designated buffer zone over Mount Hermon that separates Israel and Syria. Simultaneously, Israel conducted targeted military strikes against military assets in Syria, aiming to eliminate any chemical weapons storage sites that could be used by rebel groups and further weaken Iran’s operational capabilities in the region. While the transitional government of Syria has indicated that it is interested in reconstruction and stability rather than a continuation of conflicts with Israel, there are no guarantees that there will be no future escalation of hostilities or that Syria will not permit other neighboring countries to launch attacks at Israel from its territory.
It is possible that other terrorist organizations, including Palestinian military organizations in the West Bank, as well as other hostile countries, such as Iran, will join the hostilities. Although we believe that there is no immediate risk to our business operations related to these events, our business, prospects, financial condition and results of operations could be materially adversely affected if such hostilities involving Israel continue or escalate or if trade or scientific cooperation between Israel and its current partners is interrupted or curtailed. Moreover, we cannot predict how this war will ultimately affect Israel’s economy in general, which may involve a downgrade in Israel’s credit rating by rating agencies (such as the recent downgrade by Moody’s of its credit rating of Israel from A1 to A2, in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, as well as the downgrade of its outlook rating from “stable” to “negative”). We may also be targeted by cyber terrorists specifically because we are an Israeli-related company.
All adult male and female permanent residents of Israel, unless exempt, may be required to perform military reserve duty annually. Additionally, all such residents are subject to being called to active duty at any time under emergency circumstances, and several hundred thousand Israeli military reservists were drafted to perform immediate military service during the current war with Hamas and other hostile elements, such as Hezbollah in Lebanon. Some of our employees may in the future be obligated to perform annual military reserve duty, although none were called up for reserves in the current war. If called up, such persons may be absent from their positions for a lengthy period of time. We can provide no assurance that such requirements will not have a material adverse effect on our business, prospects, financial condition and results of operations in the future, particularly if emergency circumstances occur.
It may be difficult to enforce a U.S. judgment against us or our officers and directors and to assert U.S. securities laws claims in Israel.
Almost all of our directors and officers are nationals and/or residents of countries other than the United States. As a result, service of process upon us, our Israeli subsidiary and our directors and officers, may be difficult to obtain within the United States. Furthermore, because the majority of our assets and investments, and most of our directors and officers are located outside the United States, it may be difficult for investors to enforce within the United States any judgments obtained against us or any such officers or directors. Additionally, it may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws because Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to such claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law.
Subject to specified time limitations and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli courts may enforce a U.S. judgment in a civil matter, including a judgment based upon the civil liability provisions of the U.S. securities laws, as well as a monetary or compensatory judgment in a non-civil matter, provided that the following key conditions are met:
| ● | subject to limited exceptions, the judgment is final and non-appealable; |
| ● | the judgment was given by a court competent under the laws of the state in which the court is located and is otherwise enforceable in such state; |
| ● | the judgment was rendered by a court competent under the rules of private international law applicable in Israel; |
| ● | the laws of the state in which the judgment was given provides for the enforcement of judgments of Israeli courts; |
| ● | adequate service of process has been effected and the defendant has had a reasonable opportunity to present its arguments and evidence; |
| ● | the judgment and its enforcement are not contrary to the law, public policy, security or sovereignty of the State of Israel; |
| ● | the judgment was not obtained by fraud and does not conflict with any other valid judgment in the same matter between the same parties; and |
| ● | an action between the same parties in the same matter was not pending in any Israeli court at the time the lawsuit was instituted in the U.S. court. |
If any of these conditions are not met, Israeli courts will likely not enforce the applicable U.S. judgment.
General Risk Factors
Changes to tax laws could have a negative effect on us or our stockholders.
At any time, the U.S. federal or state income tax laws, or the administrative interpretations of those laws, may be amended. Federal and state tax laws are constantly under review by persons involved in the legislative process, the U.S. Internal Revenue Service, the U.S. Department of the Treasury and state taxing authorities. Changes to the tax laws, regulations and administrative interpretations, which may have retroactive application, could adversely affect us. Our stockholders are encouraged to consult with their tax advisors about the potential effects that changes in law may have on them and their ownership of our securities.
Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates could be delayed.
We also maintain compliance programs to address the potential applicability of restrictions against trading while in possession of material, nonpublic information generally and in connection with a cyber-security breach. However, a breakdown in existing controls and procedures around our cyber-security environment may prevent us from detecting, reporting or responding to cyber incidents in a timely manner and could have a material adverse effect on our financial position and value of our stock.
Our management will have significant flexibility in using the net proceeds of any offering of securities.
We intend generally to use the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and product development activities, and for general corporate purposes, including general working capital purposes. Our management will have significant flexibility in applying the net proceeds of any such offering and we will necessarily be using our capital when we decide on new strategic initiatives. The actual amounts and timing of expenditures will vary significantly depending on a number of factors, including the amount of cash used in our operations and our research and development efforts. Management’s failure to use these funds effectively would have an adverse effect on the value of our common stock and could make it more difficult and costly to raise funds in the future.
Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders.
The Delaware General Corporation Law contains provisions that may have the effect of making more difficult or delaying attempts by others to obtain control of the Company, even when these attempts may be in the best interests of stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited takeovers or delay or prevent changes in our control or management, including transactions in which stockholders might otherwise receive a premium for their shares of common stock over then current market prices. These provisions may also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
Not applicable.
ITEM 1C. CYBERSECURITY.
The Board recognizes the critical importance of maintaining the trust and confidence of our business partners, employees and clinical trial participants. The Audit Committee is responsible for reviewing our policies with respect to cybersecurity risks and relevant contingent liabilities and risks that may be material to the Company, including risks from third parties and business partners.
We generally seek to address cybersecurity risks by implementing security measures on our internal computer systems and ensuring that third parties and business partners implement similar measures. These security measures include firewalls, intrusion prevention and detection systems, anti-malware functionality and access controls, which are evaluated by our external IT consultant and improved through vulnerability assessments and cybersecurity threat intelligence.
Our Chief Operating and Business Officer is responsible for implementing protection measures for our information systems from cybersecurity threats and promptly responding to any cybersecurity incidents.
To date, risks from cybersecurity threats have not materially affected us and we do not currently believe any risks from cybersecurity threats are reasonably likely to affect the Company, including our business strategy, results of operations or financial condition. For further information, see “Item 1A. Risk Factors,” under “Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.”
ITEM 2. PROPERTIES.
We believe that our existing facilities are suitable and adequate to meet our current business requirements. In the event that we should require additional or alternative facilities, we believe that such facilities can be obtained on short notice at competitive rates.
ITEM 3. LEGAL PROCEEDINGS.
From time to time we may become subject to litigation incidental to our business. We are not currently a party to any material legal proceedings.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Common Stock
Our common stock is traded on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange, in each case under the symbol “ORMP.”
Holders
As of March 27, 2025, there were 40,850,455 shares of our common stock issued and outstanding held of record by approximately 40 registered stockholders. We believe that a significant number of stockholders hold their shares of our common stock in brokerage accounts and registered in the name of stock depositories and are therefore not included in the number of stockholders of record.
Unregistered Sales of Equity Securities and Use of Proceeds
No unregistered sales of equity securities were made during the three months ended December 31, 2024.
Issuer Purchases of Equity Securities
In June 2024, our Board authorized a stock buyback and retirement program pursuant to which we may, from time to time, repurchase up to $20,000,000 in maximum value of our common stock. Share repurchases may be executed through various means, including, without limitation, open market transactions, privately negotiated transactions or otherwise in compliance with Rule 10b-18 under the Exchange Act. The stock buyback program does not obligate us to purchase any shares and expires in 12 months. The authorization for the stock buyback program may be terminated, increased or decreased by our Board in its discretion at any time.
We have repurchased and retired 1,036,976 shares of our common stock under this program for approximately $2,494,000, including approximately $10,000 excise tax, at an average price of $2.36 per share. All purchases were funded with cash on hand.
The following sets forth information with respect to repurchase and retirement made by the Company of its shares of common stock during the fourth quarter ended December 31, 2024:
| Period | Total
number of shares purchased |
Average price paid per share |
Total number of shares purchased as part of publicly announced plans or programs |
Approximate dollar value of shares that may yet be purchased under the plans or programs |
||||||||||||
| October 1-31, 2024 | - | - | - | $ | 18,708,193 | |||||||||||
| November 1-30, 2024 | 252,802 | $ | 2.327 | 252,802 | $ | 18,119,189 | ||||||||||
| December 1-31, 2024 | 244,722 | $ | 2.463 | 244,722 | $ | 17,515,906 | ||||||||||
| Total | 497,524 | 497,524 | ||||||||||||||
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the audited consolidated financial statements and the related notes included elsewhere herein and in our audited consolidated financial statements.
In addition to our audited consolidated financial statements, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in “Cautionary Statement Regarding Forward-Looking Statements” and “Item 1A. Risk Factors.”
Overview of Operations
We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins.
We have developed an oral dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver active insulin or other proteins. The formulation is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.
On January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As a result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1 Phase 3 trial data and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
As detailed above, in September 2023, we entered into the 2023 Scilex Transaction, which included a senior secured promissory note (Tranche A Note) and warrants. In October 2024, we participated in the 2024 Refinancing, purchasing a portion of the Tranche B Note and acquiring royalty rights under a Purchase and Sale Agreement. Additional agreements secured the right to receive royalties from certain products of Scilex. We believe that these transactions collectively strengthened our financial position and expanded our commercial interests.
Results of Operations
The table and discussion that follows includes a comparison of our results of operations and liquidity and capital resources for the years ended December 31, 2024 and 2023. For a comparison of our results of operations and financial condition for the year ended December 31, 2023 and the year ended December 31, 2022, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 6, 2024.
| Year ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| (dollar amounts in thousands, except per share data) | ||||||||
| Revenues | $ | - | $ | 1,340 | ||||
| Research and development expenses | (6,324 | ) | (8,971 | ) | ||||
| Sales and marketing | - | 287 | ||||||
| General and administrative expenses | (6,457 | ) | (8,425 | ) | ||||
| Interest expenses | (853 | ) | (2,037 | ) | ||||
| Financial income (expenses), net | (2,286 | ) | 22,894 | |||||
| Income (loss) before taxes on income | (15,920 | ) | 5,088 | |||||
| Taxes on income | (3,183 | ) | - | |||||
| Net income (loss) for the year | (19,103 | ) | 5,088 | |||||
| Net income (loss) attributable to Company’s stockholders | (19,060 | ) | 5,525 | |||||
| Net loss attributable to non-controlling interest | (43 | ) | (437 | ) | ||||
| Net income (loss) for the year | (19,103 | ) | 5,088 | |||||
| Basic income (loss) per share of common stock | $ | (0.48 | ) | $ | 0.14 | |||
| Diluted income (loss) per share of common stock | $ | (0.48 | ) | $ | 0.14 | |||
| Weighted average shares of common stock outstanding used in computing basic income (loss) per share of common stock | 40,828,380 | 40,315,068 | ||||||
| Weighted average shares of common stock outstanding used in computing diluted income (loss) per share of common stock | 40,828,380 | 40,566,901 | ||||||
Revenues
Revenues consist of proceeds related to the Amended and Restated Technology License Agreement, dated December 21, 2015, between us and HTIT, or as further amended by the parties on June 3, 2016 and July 24, 2016, the HTIT License Agreement, that are recognized on a cumulative basis when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, through the expected product submission date by HTIT of June 2023.
We did not recognize revenues for the year ended December 31, 2024, compared to revenues of approximately $1,340,000 for the year ended December 31, 2023. The decrease was due to recognition of revenues through June 30, 2023, the product submission date by HTIT.
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with research and development are expensed as incurred.
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.
Clinical activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training and program management.
Clinical trial and preclinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase of materials, cost of manufacturing of the oral insulin and exenatide capsules, payments for patient recruitment and treatment, as well as salaries and related expenses of research and development staff.
Research and development expenses for the year ended December 31, 2024 decreased by 30% to approximately $6,324,000, compared to approximately $8,971,000 for the year ended December 31, 2023. The decrease was mainly due to lower expenses related to our Phase 3 trials that were terminated and was partially offset by stock-based compensation expenses and costs related to the new Phase 3 clinical trial preparations.
Government Grants
The Government of Israel encourages research and development projects through the IIA, pursuant to the R&D Law. Under the R&D Law, a research and development plan that meets specified criteria is generally eligible for a grant of up to 50% of certain approved research and development expenditures. Each plan must be approved by the IIA.
From August 2009 to March 2014, our subsidiary Oramed Ltd. was awarded five government grants amounting to a total net amount of NIS 8,000,000 (approximately $2,214,000 during such period) from the IIA. We used these funds to support further research and development and clinical trials of our oral insulin capsule and oral GLP-1 analog candidate during the period from February 2009 to December 2014.
In the years ended December 31, 2024 and 2023, we did not recognize any research and development grants.
Under the terms of the grants we had received from the IIA, we were obligated to pay royalties of 3% on all revenues derived from the sale of the products developed pursuant to the funded plans, including revenues from licensed ancillary services. Royalties were generally payable up to a maximum amount equaling 100% of the grants received (dollar linked) with the addition of interest at an annual rate based on the SOFR rate. On February 27, 2025, we paid approximately $2,031,000 to the IIA, and, as result, we are free of our obligations to the IIA.
The R&D Law generally requires that a product developed under a program be manufactured in Israel. However, when applying for a grant, the applicant may declare that part of the manufacturing will be performed outside of Israel or by non-Israeli residents and if the IIA is convinced that performing some of the manufacturing abroad is essential for the execution of the program, it may still approve the grant. This declaration will be a significant factor in the determination of the IIA as to whether to approve a program and the amount and other terms of the benefits to be granted. If a company wants to increase the volume of manufacturing outside of Israel after the grant has been approved, it may transfer up to 10% of the company’s approved Israeli manufacturing volume, measured on an aggregate basis, outside of Israel after first notifying the IIA thereof (provided that the IIA does not object to such transfer within 30 days). In addition, upon the approval of the IIA, a portion greater than 10% of the manufacturing volume may be performed outside of Israel. In any case of transfer of manufacturing out of Israel, the grant recipient is required to pay royalties at an increased rate, which may be substantial, and the aggregate repayment amount is increased up to 120% or 150% of the grant received (dollar linked) with the addition of interest at an annual rate based on the SOFR rate, depending on the portion of the total manufacturing volume that is performed outside of Israel. The approval we received from the IIA for the License Agreement was subject to payment of increased royalties and an increased ceiling, all in accordance with the provisions of the R&D Law. The R&D Law further permits the IIA, among other things, to approve the transfer of manufacturing rights outside of Israel in exchange for the import of different manufacturing into Israel as a substitute, in lieu of the increased royalties.
The R&D Law also provides that know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to third parties in Israel without the approval of the research committee, which approval may be subject to the payment of royalties from the sale. Such approval is not required for the sale or export of any products resulting from such research or development. The R&D Law further provides that the know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to any third parties outside Israel absent IIA approval which may be granted in certain circumstances as follows: (a) the grant recipient pays to the IIA a portion of the sale or license price paid in consideration for the purchase or license of such IIA-funded know-how or the price paid in consideration for the sale of the grant recipient itself, as the case may be, in accordance with certain formulas included in the tracks published under the R&D Law; (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded know-how; or (c) such transfer of IIA-funded know-how is made in the context of IIA approved research and development cooperation projects or consortia.
The R&D Law imposes reporting requirements with respect to certain changes in the ownership of a grant recipient. The R&D Law requires the grant recipient to notify the IIA of any change in control of the recipient or a change in the holdings of the means of control of the recipient that results in a non-Israeli entity or person becoming an interested party in the recipient, and requires the new non-Israeli interested party to undertake to the IIA to comply with the R&D Law. In addition, the rules of the IIA may require the provision of additional information or representations in respect of certain such events. For this purpose, “control” is defined as the ability to direct the activities of a company other than any ability arising solely from serving as an officer or director of the company. A person is presumed to have control if such person holds 50% or more of the means of control of a company. “Means of control” refers to voting rights or the right to appoint directors or the chief executive officer. An “interested party” of a company includes a holder of 5% or more of its outstanding share capital or voting rights, its chief executive officer and directors, someone who has the right to appoint its chief executive officer or at least one director, and a company with respect to which any of the foregoing interested parties holds 25% or more of the outstanding share capital or voting rights or has the right to appoint 25% or more of the directors.
Failure to meet the R&D Law’s requirements may subject us to mandatory repayment of grants received by us (together with interest and penalties), as well as expose us to criminal proceedings. In addition, the Israeli government may from time to time audit sales of products which it claims incorporate technology funded through IIA programs which may lead to additional royalties being payable on additional products.
Sales and Marketing Expenses
Sales and marketing expenses include the salaries and related expenses of our commercial functions, consulting costs and other general expenses.
We did not recognize any sales and marketing expenses for the year ended December 31, 2024, compared to an income of approximately $287,000 for the year ended December 31, 2023. The income primarily resulted from the reversal of previously recognized expenses related to forfeited employee stock options, following the termination of an executive officer in fiscal year 2023.
General and Administrative Expenses
General and administrative expenses include the salaries and related expenses of our management, consulting expenses, legal and professional fees, travel expenses, business development expenses, insurance expenses and other general expenses.
General and administrative expenses for the year ended December 31, 2024 decreased by 23% to approximately $6,457,000, compared to approximately $8,425,000 for the year ended December 31, 2023. This decrease was mainly due to the reversal of previously recognized expenses following the resignation of certain executive officers.
Interest Expenses
Interest expenses were approximately $853,000 for the year ended December 31, 2024, compared to approximately $2,037,000 for the year ended December 31, 2023, since the Short-Term Borrowings (as defined below) received from Discount Bank Ltd. were terminated during the second quarter of 2024 (see below).
Financial Income, Net
Net financial loss was approximately $2,286,000 for the year ended December 31, 2024, compared to approximately $22,894,000 net financial income for the year ended December 31, 2023. The change was mainly due to the revaluation of the investments in Scilex and lower interest income on deposits.
Liquidity and Capital Resources
From our inception through December 31, 2024, we have incurred losses in an aggregate amount of approximately $176,616,000. During that period and through December 31, 2024, we have financed our operations through several private placements of our common stock, as well as public offerings of our common stock, raising a total of approximately $255,384,000, net of transaction costs. During that period, we also received cash consideration of approximately $28,001,000 from the exercise of warrants and options. We expect to seek additional financing through similar sources in the future, as needed. As of December 31, 2024, we had approximately $54,420,000 of available cash and approximately $55,281,000 of short-term bank deposits. In addition, we hold various of interest in certain investments, including in Scilex and others, as further detailed in this report.
From inception through December 31, 2024, we have not generated significant revenues from our operations. Although, we have increased the research and development activities related to the new Phase 3 clinical trial, our research and development activities have been significantly reduced while we conducted a strategic review process, following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials. Following the preparation and expected initiation of the revised phase 3 trial (ORA-D-013-3) we expect to increase our research and development expenses, either directly or through OraTech.
Based on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such time. If there are increases in our operating expenses, we may need to seek additional financing during the next 12 months. We may also need additional funds to realize the decisions made as part of our strategic review process. We cannot predict the outcome of these activities.
On August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term Borrowings. The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66% to 7.38%, were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of principal and interest at each respective maturity. As of December 31, 2024, we repaid the entire Short-Term Borrowings amount.
As of December 31, 2024, our total current assets were approximately $143,221,000 and our total current liabilities were approximately $5,685,000. On December 31, 2024, we had a working capital surplus of approximately $137,536,000 and an accumulated loss of approximately $176,616,000. As of December 31, 2023, our total current assets were approximately $162,584,000 and our total current liabilities were approximately $53,214,000. On December 31, 2023, we had a working capital surplus of approximately $109,370,000 and an accumulated loss of approximately $157,556,000. The increase in working capital surplus was mainly due an increase in cash and cash equivalents together with a decrease in short-term borrowings that was partially offset by a decrease in short-term deposits and investments at fair value.
During the year ended December 31, 2024, cash and cash equivalents increased to approximately $54,420,000 from approximately $9,055,000 as of December 31, 2023. The increase was mainly due to the reasons described below.
Operating activities used cash of approximately $8,412,000 in the year ended December 31, 2024, compared to approximately $10,295,000 used in the year ended December 31, 2023. Cash used in operating activities consisted mainly of changes in fair value of investments partially offset by net loss resulting from research and development and general and administrative expenses.
Investing activities provided cash of approximately $105,817,000 in the year ended December 31, 2024, compared to cash used for investing activities of approximately $73,038,000 in the year ended December 31, 2023. Cash provided by investing activities in the year ended December 31, 2024 consisted primarily of proceeds from short-term deposits and proceeds from repayments by Scilex under the Tranche A Note. Cash used by investing activities in the year ended December 31, 2023 is mainly due to our investment in Scilex and the purchase of short-term deposits, partially offset by the proceeds of short-term deposits.
Financing activities used cash of approximately $52,036,000 in the year ended December 31, 2024, compared to cash of approximately $51,978,000 provided in the year ended December 31, 2023. Cash used for financing activities in the year ended December 31, 2024, consisted primarily of repayments of the Short-Term Borrowings and repurchases of our shares. Cash provided by financing activities in the year ended December 31, 2023, consisted primarily of the Short-Term Borrowings. Our primary financing activities for the year ended December 31, 2024, were as follows:
| ● |
In March 2024, we entered into the ATM Agreement with Rodman & Renshaw LLC and StockBlock Securities LLC as sales agents, or the Agents, pursuant to which we may issue and sell in transactions that are deemed to be “at the market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act, shares of our common stock, par value $0.012 per share, having a maximum aggregate offering price of up to $75,000,000 from time to time through the Agents.
Any sales of shares of common stock pursuant to the ATM Agreement will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-257926), which was declared effective by the SEC on July 26, 2021, the prospectus contained therein and a prospectus supplement related thereto dated March 18, 2024, filed with the SEC. The Agents may sell our common stock (A) in privately negotiated transactions with our consent; (B) as block transactions; or (C) by any other method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on The Nasdaq Capital Market or sales made into any other existing trading market for our common stock. As of December 31, 2024, no shares had been issued under the ATM Agreement. |
| ● |
In June 2024, our Board authorized a stock buyback program pursuant to which we may, from time to time, repurchase and retire up to $20,000,000 in maximum value of our common stock.
During the year ended December 31, 2024, we repurchased and retired 1,036,976 shares of our common stock under this program for approximately $2,494,000, including approximately $10,000 excise tax, at an average price of $2.36 per share. All repurchases were funded with cash on hand. |
| ● | On August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term Borrowings. The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66% to 7.38%, were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of principal and interest at each respective maturity. As of December 31, 2024, we repaid the entire Short-Term Borrowings amount. |
Trend Information
Following the results of the Phase 3 trials for our oral insulin capsule candidate, ORMD-0801, we conducted a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate, and we worked on a protocol for a new Phase 3 clinical trial that was submitted to the FDA. Conducting this clinical trial, whether independently or as part of OraTech, will require significant funds and resources. Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders. At this time, we cannot foresee how these strategic decisions will impact our financial results and operations.
Planned Expenditures
In previous years, we primarily invested in research and development. If we proceed to conduct a new clinical trial for our oral insulin candidate, we expect that in the upcoming years our research and development expenses will continue to be our major operating expense; however, if this clinical trial is conducted through OraTech, these costs will be borne by Oratech and not by us.
Critical Accounting Estimates
Our significant accounting policies are more fully described in the notes to our accompanying consolidated financial statements. We believe that the accounting policy below is critical for one to fully understand and evaluate our financial condition and results of operations.
The discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Investments at fair value: On September 21, 2023 and on October 7, 2024 we entered into the 2023 Scilex Transaction and 2024 Refinancing, respectively. We elected the fair value option for each of the components under 2023 Scilex Transaction and 2024 Refinancing in order to reduce operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income, net and include interest income on the Notes and Royalties received.
Determining the fair value of the components above required significant judgment with regards to the expected repayment date of the Notes which also impacts the number of Subsequent Penny Warrants to be issued to us. The total value of the 2023 Scilex Transaction (and of each of its components) was valued on a weighted average of the different scenarios.
On September 4, 2024, we entered into a loan agreement to finance a real estate project or the Profit Sharing Loan Agreement. We decided to designate the Profit Sharing Loan Agreement as a whole under the fair-value option. The valuation of the Profit Sharing Loan Agreement was based on various project profit scenarios derived from the appraiser’s report.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are exposed to a variety of risks, including changes in interest rates, foreign currency exchange rates, changes in the value of our marketable securities and inflation.
As of December 31, 2024, we had approximately $54,420,000 in cash and cash equivalents and approximately $55,281,000 in short term bank deposits.
We aim to preserve our financial assets, maintain adequate liquidity and maximize return while minimizing exposure to market risks. Such policy further provides that we should hold most of our current assets in bank deposits. As of today, the currency of our financial assets is mainly in U.S. dollars.
Marketable securities
We own 1,701,357 common shares of DNA, 6,500,000 shares of Scilex Common Stock and 117,000 ordinary shares of Entera, which are presented in our financial statements as marketable securities. Marketable securities are presented at fair value and their realization is subject to certain limitations if sold through the market, and we are therefore exposed to market risk. There is no assurance that at the time of sale of the marketable securities the price per share will be the same or higher, nor that we will be able to sell all of the securities at once given the volume of securities we hold. Entera shares and the Closing Penny Warrants are traded on Nasdaq in U.S. dollars, while DNA shares are traded on the Tel Aviv Stock Exchange in NIS. We are also exposed to changes in the market price of the Scilex, Entera and DNA shares and the Closing Penny Warrants, as well as to exchange rates fluctuations in the NIS currency compared to the U.S. dollar with respect to the DNA shares.
Interest Rate Risk
We invest a major portion of our cash surplus in bank deposits in banks in Israel. Since the bank deposits typically carry fixed interest rates, financial income over the holding period is not sensitive to changes in interest rates, but only the fair value of these instruments. However, our interest gains from future deposits may decline in the future as a result of changes in the financial markets.
The Note issued by Scilex is based on the SOFR rate. Our interest income may decline in the future as a result of a change in the SOFR rate.
Foreign Currency Exchange Risk
A significant portion of our expenditures, including salaries, clinical research expenses, consultants’ fees and office expenses relate to our operations in Israel. The cost of those Israeli operations, as expressed in U.S. dollars, is influenced by the extent to which any increase in the rate of inflation in Israel is not offset (or is offset on a lagging basis) by a devaluation of the NIS in relation to the U.S. dollar. If the U.S. dollar declines in value in relation to the NIS, it will become more expensive for us to fund our operations in Israel. In addition, as of December 31, 2024, we own net balances in NIS of approximately $2,078,000. Assuming a 10% appreciation of the NIS against the U.S. dollar, we would experience an exchange rate gain of approximately $231,000, while assuming a 10% devaluation of the NIS against the U.S. dollar, we would experience an exchange rate loss of approximately $189,000.
The exchange rate of the U.S. dollar to the NIS, based on exchange rates published by the Bank of Israel, was as follows:
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Average rate for period | 3.70 | 3.69 | ||||||
| Rate at period-end | 3.65 | 3.63 | ||||||
We do not use any currency hedging transactions of options or forwards to decrease the risk of financial exposure from fluctuations in the exchange rate of the U.S. dollar against the NIS.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
See Item 15 of this Annual Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective.
Management’s Annual Report on Internal Control over Financial Reporting
Our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act. The Company’s internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Internal control over financial reporting includes policies and procedures that:
| ● | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions; |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and |
| ● | provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our internal control over financial reporting as of December 31, 2024 based on the current framework for Internal Control-Integrated Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.
Based on this evaluation, our management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2024 at a reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
(a) Disclosure Pursuant to Item 5.03 of Form 8-K. Amendments to Bylaws
On March 27, 2025, the Board amended and restated our by-laws, or the Amended and Restated By-Laws. The Amended and Restated By-Laws became effective as of March 27, 2025. The changes to the Amended and Restated By-Laws include (i) in a contested election, a director nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors (an election shall be considered contested if, as of the last date on which nominees for director may be submitted in accordance with the Amended and Restated By-laws, the nominees for election to the Board of Directors exceed the number of positions on the Board to be filled by election at that meeting); and (ii) clarification that the officers of the Company shall be a Chief Executive Officer, a President, a Secretary and a Treasurer. This description of the amendments to the Amended and Restated By-Laws is qualified in its entirety by reference to the text of the Amended and Restated By-Laws filed as Exhibit 3.2 to this Annual Report on Form 10-K.
(b) Termination of Rule 10b5–1 Trading Arrangements
Not applicable.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Directors and Executive Officers
The name and age of each of our directors and executive officers, his or her position with us and the period during which such person has served as a director or executive officer of the Company are set forth below.
| Name | Age | Position | Serving Since | ||||
| Nadav Kidron | 50 | President, Chief Executive Officer, Director and Chairman (effective as of June 30, 2022) | 2006 | ||||
| Dr. Miriam Kidron | 84 | Chief Scientific Officer and Director | 2006 | ||||
| Avraham Gabay | 40 | Chief Financial Officer and Treasurer | 2024 | ||||
| Joshua Hexter | 54 | Chief Operating & Business Officer | 2019 | ||||
| Daniel Aghion | 43 | Director | 2024 | ||||
| Dr. Arie Mayer | 68 | Director | 2019 | ||||
| Yehuda Reznick | 77 | Director | 2024 | ||||
| Leonard Sank | 59 | Director | 2007 | ||||
| Benjamin Shapiro | 41 | Director | 2023 |
Mr. Derovan, our former Chief Legal Officer and Secretary, ended his service with the Company on March 5, 2024. Mr. Silberman, our former Chief Financial Officer, Treasurer and Secretary, ended his service with the Company on July 11, 2024.
Dr. Miriam Kidron is Mr. Nadav Kidron’s mother. There are no other directors or officers of the Company who are related by blood or marriage.
Business Experience
The following is a brief account of the education and business experience during at least the past five years of each of our directors and of our executive officers who are not also directors, indicating the principal occupation during that period, and the name and principal business of the organization in which such occupation and employment were carried out.
Mr. Nadav Kidron was appointed President, Chief Executive Officer and director in March 2006, and Chairman of the Board effective as of June 30, 2022. He is also Chairman of the board of MDG Real Estate Global, Ltd., director of Israel Advanced Technology Industries organization and until 2016 was a director of Entera Bio Ltd. In 2009, he was a fellow at the Merage Foundation for U.S.-Israel Trade Programs for executives in the life sciences field. From 2003 to 2006, he was the managing director of the Institute of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003, he was a legal intern at Wine, Mishaiker & Ernstoff Law Offices in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International MBA from Bar Ilan University, Israel.
We believe that Mr. Kidron’s qualifications to serve on our Board include his familiarity with the Company as its founder, his experience in capital markets, as well as his knowledge and familiarity with corporate management.
Dr. Miriam Kidron was appointed Chief Scientific Officer and director in March 2006. Dr. Kidron is a pharmacologist and a biochemist with a Ph.D. in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the Diabetes Unit at Hadassah University Hospital in Jerusalem, Israel. Dr. Kidron was formerly a visiting professor at the Medical School at the University of Toronto (Canada), and is a member of the American, European and Israeli Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger Award.
We believe that Dr. Kidron’s qualifications to serve on our Board include her expertise in the Company’s technology, as it is based on her research, as well as her experience and relevant education in the fields of pharmacology and diabetes.
Mr. Avraham Gabay was appointed Chief Financial Officer, Treasurer and Secretary in June 2024. Prior to his appointment, Mr. Gabay served as interim chief financial officer of BiomX Inc. (NYSE American: PHGE) during 2023. From 2021 until 2023, Mr. Gabay served as the chief financial officer at Oravax Inc., a 63% owned subsidiary of the Company. From 2019 until 2021, Mr. Gabay was the chief financial officer of the Company. From 2015 to 2019, Mr. Gabay served as VP Finance at Orcam Technologies Ltd. From 2014 to 2015, Mr. Gabay provided economic services in the advisory department of KPMG Israel, a certified public accounting firm, and from 2013 to 2014, he worked in the tax department of the law firm Gornitzky & Co. In addition, Mr. Gabay serves as a director on the board of Iintoo Ltd. (TASE: INTO). Mr. Gabay holds a bachelor’s degree in law and accounting (magna cum-laude) from Tel-Aviv University and is a certified public accountant in Israel and a member of the Israeli Bar Association.
Mr. Joshua Hexter was appointed Chief Operating and Business Officer in September 2019. Prior to his appointment, Mr. Hexter served as Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018 to 2019, a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products. From 2013 to 2018, Mr. Hexter served as Chief Operating Officer and VP Business Development of the Company and from 2007 to 2013, Mr. Hexter was a Director or Executive Director of BioLineRx Ltd. (Nasdaq/TASE: BLRX), a biopharmaceutical development company dedicated to identifying, in-licensing and developing innovative therapeutic candidates. Prior to his employment with BioLineRx, Mr. Hexter was a member of the board of directors and Chief Executive Officer of Biosensor Systems Design, Inc., a company developing market-driven biosensors. Mr. Hexter holds a bachelor’s degree from the University of Wisconsin and a master’s degree in management from Boston University.
Dr. Daniel Aghion became a director in January 2024. Dr. Aghion has been a neurosurgeon at Memorial Neuroscience Institute in Florida since 2016, where he treats patients with a wide array of spine disorders, including severe degenerative spine diseases, spine trauma, cancer in the spine, spine tumors, peripheral nerve surgery and more. Dr. Aghion holds a Bachelor of Science degree from the University of Michigan and an MD from the Sackler School of Medicine at Tel Aviv University. He completed his residency at Rhode Island Hospital in 2015, and a complex spine fellowship at Johns Hopkins University in Baltimore in 2016.
We believe that Dr. Aghion’s qualifications to serve on the Board include his extensive practical and academic medical background.
Dr. Arie Mayer became a director in December 2019. Dr. Mayer is currently the Managing Director and Chairman of the Board of Sigma-Aldrich Israel Ltd. and has held that position since January 2010. Dr. Mayer has held various roles with Sigma-Aldrich Israel Ltd. since 1995 and was instrumental in introducing and developing the Cell Culture and Molecular Biology business for Sigma Aldrich Israel Ltd. Dr. Mayer holds a Bachelor of Science degree in chemistry from Hebrew University and a Ph.D. in biochemistry from Israel Institute of Technology.
We believe that Dr. Mayer’s qualifications to serve on our Board include his experience as an executive in the biotechnology industry, with knowledge in managing large organizations, as well as his experience and relevant education in the fields of chemistry and biochemistry.
Mr. Yehuda Reznick became a director in April 2024. Mr. Reznick served as an audit partner at Kesselman & Kesselman CPA, a member of PricewaterhouseCoopers International Limited, from 1999 until 2014. Prior to joining Kesselman & Kesselman, he was a tax and audit partner at Shachak, Peer Reznick CPA for sixteen years. Mr. Reznick currently serves on the board of directors of Oravax Medical Inc., an affiliate of the Company. Since 2019, Mr. Reznick has also served on the board of directors of Hiron-Trade Investments & Industrial Buildings Ltd (TASE: HRON). Mr. Reznick previously served on the board of directors of Bonus Biogroup Ltd (OTC: BBIXF) from 2017 to 2023.
We believe that Mr. Reznick’s qualifications to serve on the Board include his extensive operational experience and his business background and acumen.
Mr. Leonard Sank became a director in October 2007. Mr. Sank is a South African entrepreneur and businessman, whose interests lie in entrepreneurial endeavors and initiatives, with over 30 years’ experience of playing significant leadership roles in developing businesses. Mr. Sank serves on the boards of a few national businesses and local non-profit charity organizations in Cape Town, where he resides.
We believe that Mr. Sank’s qualifications to serve on our Board include his years of experience in development stage businesses, as well as his experience serving as a director of many entities.
Mr. Benjamin Shapiro became a director in May 2023. Mr. Shapiro is a successful entrepreneur and business professional who co-founded The Daily Wire, a successful, industry leading, international media outlet in June 2015. Since May 2015, he has been host of “The Ben Shapiro Show,” a popular podcast, and he is the author of numerous New York Times best-selling books. Mr. Shapiro earned a B.A. in Political Science from UCLA in 2004, summa cum laude, and a law degree from Harvard Law School in 2007, cum laude.
We believe that Mr. Shapiro’s qualifications to serve on the Board include his extensive operational experience and his business background and acumen.
Board of Directors
There are no agreements with respect to the election of directors. Each director is currently elected for a period of one year at our annual meeting of stockholders and serves until the next such meeting and until his or her successor is duly elected or until his or her earlier resignation or removal. The Board may also appoint additional directors. A director so chosen or appointed will hold office until the next annual meeting of stockholders and until his or her successor is duly elected and qualified or until his or her earlier resignation or removal.
The Board has determined that Dr. Daniel Aghion, Dr. Arie Mayer, Yehuda Reznick, Leonard Sank and Benjamin Shapiro are independent as defined under the rules promulgated by the Nasdaq. Except for Dr. Arie Mayer and Mr. Reznick, each of whom serves on the board of directors of Oravax, a company 63% owned by us, none of the independent directors has any material relationship with us besides serving on our Board.
We have determined that each of the directors is qualified to serve as a director of the Company based on a review of the experience, qualifications, attributes and skills of each director. In reaching this determination, we have considered a variety of criteria, including, among other things: character and integrity; ability to review critically, evaluate, question and discuss information provided, to exercise effective business judgment and to interact effectively with the other directors; and willingness and ability to commit the time necessary to perform the duties of a director.
Board Meeting Attendance
During the year ended December 31, 2024, our Board held six meetings and took action by written consent on nine occasions. Except Mr. Benjamin Shapiro, all of our directors attended at least 75% of the aggregate number of meetings of the Board and the committees that were held during the period such director served on the Board. Board members are encouraged to attend our annual meetings of stockholders.
Board Evaluation Process
Our Board is committed to continuous improvement and conducts a board and committee evaluation process each year, to ensure that our Board maintains optimal composition and functions effectively.
As part of this process, the members of our Board complete a confidential written assessment of the performance, oversight and composition of the Board and its committees that is submitted to the Company secretary. The results are then reported back to the full Board. After the evaluations, the Board and management work to improve upon any issues presented during the evaluation process and to identify opportunities that may lead to further improvement.
Committees
Audit Committee and Audit Committee Financial Expert
The members of our Audit Committee are Dr. Daniel Aghion, Dr. Arie Mayer and Yehuda Reznick. Our Board has determined that Mr. Reznick is an “audit committee financial expert” as set forth in Item 407(d)(5) of Regulation S-K based on his experience as set forth above, and that all members of the Audit Committee are “independent” as defined by the rules of the SEC and the Nasdaq rules and regulations. The Audit Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com. The primary responsibilities of our Audit Committee include:
| ● | Overseeing the accounting and financial reporting processes of the Company and the audits of the financial statements of the Company; |
| ● | Appointing, compensating and retaining our registered independent public accounting firm; |
| ● | Overseeing the work performed by any outside accounting firm; |
| ● | Assisting the Board in fulfilling its responsibilities by reviewing: (i) the financial reports provided by us to the SEC, our stockholders or to the general public and (ii) our internal financial and accounting controls; |
| ● | Reviewing the Company’s policies with respect to cyber security risks and relevant contingent liabilities and risks that may be material to the Company; |
| ● | Recommending, establishing and monitoring procedures designed to improve the quality and reliability of the disclosure of our financial condition and results of operations; and |
| ● | Reviewing major financial risk exposures and the steps management has taken to monitor and control such exposures, and discussing the guidelines and polices to govern the process by which risk assessment and management is undertaken. |
Our Audit Committee met four times and took action by written consent on four occasions during the year ended December 31, 2024.
Compensation Committee
The members of our Compensation Committee are Dr. Daniel Aghion, Yehuda Reznick and Leonard Sank. The Board has determined that all of the members of the Compensation Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations. The Compensation Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com. The primary responsibilities of our Compensation Committee include:
| ● | Reviewing, negotiating and approving, or recommending for approval by our Board the salaries and incentive compensation of our executive officers; |
| ● | Administering our equity based plans and making recommendations to our Board with respect to our incentive-compensation plans and equity-based plans; |
| ● | Making recommendations to our Board with respect to director compensation; and |
| ● | Authority to exercise all rights, authority and functions of the Board under our Clawback Policy. |
The Compensation Committee meets as often as it deems necessary, without the presence of any executive officer when approving compensation, except that the Company’s Chief Executive Officer, at the discretion of the Compensation Committee, may be present during the approval of, or deliberations with respect to, the compensation of other executive officers. The Compensation Committee may delegate any authority granted to it to one or more subcommittees of the Compensation Committee, in its sole discretion.
Our Compensation Committee met two times and took action by written consent on four occasions during the year ended December 31, 2024.
Nominating Committee
The members of our Nominating Committee are Dr. Arie Mayer and Leonard Sank. The Board has determined that all of the members of the Nominating Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations. The Nominating Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com. The primary responsibilities of our Nominating Committee include:
| ● | Overseeing the composition and size of the Board, developing qualification criteria for Board members based on background, skills, experience and diversity, and actively seeking, interviewing and screening individuals qualified to become Board members for recommendation to the Board; |
| ● | Recommending the composition of the Board for each annual meeting of stockholders; and |
| ● | Reviewing periodically with the Chairman of the Board and the Chief Executive Officer the succession plans relating to positions held by directors, and making recommendations to the Board with respect to the selection and development of individuals to occupy those positions. |
Our Nominating Committee met once and took one action by written consent during the year ended December 31, 2024.
Code of Ethics
We have adopted a Code of Ethics and Business Conduct for our senior officers, directors and employees. A copy of the Code of Ethics and Business Conduct is located at our website at www.oramed.com. We intend to satisfy the disclosure requirement regarding any amendment to, or a waiver from, a provision of the Code of Ethics that applies to our Chief Executive Officer, Chief Financial Officer or controller, or persons performing similar functions and that relates to the Code of Ethics by posting such information on our website, www.oramed.com.
Insider Trading Policy
We have adopted an insider trading policy, or the Policy, governing the purchase, sale and other transactions in our securities that applies to our directors, officers, employees, including part-time and temporary employees, and other covered persons, including immediate family members and entities controlled by any of the foregoing persons, as well as by the Company itself.
The Policy prohibits, among other things, insider trading and certain speculative transactions in our securities (including short sales, buying put and selling call options and other hedging or derivative transactions in our securities) and establishes a regular blackout period schedule during which directors, executive officers, employees, and other covered persons may not trade in the Company’s securities, as well as certain pre-clearance procedures that directors and executive officers must observe prior to effecting any transaction in our securities.
The Company believes that the Policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to the Company. A copy of the Policy is filed as Exhibit 19.1 to this Form 10-K.
ITEM 11. EXECUTIVE COMPENSATION.
Compensation Discussion and Analysis
This section explains the policies and decisions that shape our executive compensation program, including its specific objectives and elements, as it relates to our “named executive officers,” or NEOs.
Our NEOs for the year ended December 31, 2024 are those three individuals listed in the “Summary Compensation Table” below. The Compensation Committee believes that our executive compensation is appropriately designed to incentivize our NEOs to work for our long-term prosperity, is reasonable in comparison with the levels of compensation provided by comparable companies and reflects a reasonable cost. We believe our NEOs are critical to the achievement of our corporate goals, through which we can drive stockholder value.
The Compensation Committee of our Board is comprised solely of independent directors as defined by Nasdaq and non-employee directors as defined by Rule 16b-3 under the Exchange Act. The Compensation Committee has the authority and responsibility to review and approve the compensation of our President and Chief Executive Officer and other executive officers. Other information concerning the structure, roles and responsibilities of our Compensation Committee is set forth in “Board Meetings and Committees—Compensation Committee” section.
Our executive compensation program and our NEOs’ compensation packages are designed around the following objectives:
| ● | attract, hire, and retain talented and experienced executives; |
| ● | motivate, reward and retain executives whose knowledge, skills and performance are critical to our success; |
| ● | ensure fairness among the executive management team via recognizing the contributions of each executive to our success; |
| ● | focus executive behavior on achievement of our corporate objectives and strategy; and |
| ● | align the interests of management and stockholders by providing management with longer-term incentives through equity ownership. |
The Compensation Committee reviews the allocation of compensation components regularly to ensure alignment with strategic and operating goals, competitive market practices and legislative changes. The Compensation Committee does not apply a specific formula to determine the allocation between cash and non-cash forms of compensation. Certain compensation components, such as base salaries, benefits and perquisites, are intended primarily to attract, hire, and retain well-qualified executives. Other compensation elements, such as long-term incentive opportunities, are designed to motivate and reward performance. Long-term incentives are intended to reward NEOs for our long-term performance and executing our business strategy, and to strongly align NEOs’ interests with those of stockholders.
With respect to equity compensation, the Compensation Committee makes awards to executives under our Amended and Restated 2019 Incentive Plan, or the 2019 Plan. Executive compensation is paid or granted based on such matters as the Compensation Committee deems appropriate, including our financial and operating performance and the alignment of the interests of the executive officers and our stockholders.
Elements of Compensation
Our executive officer compensation program is comprised of: (i) base salary or monthly compensation; (ii) discretionary bonus; (iii) long-term equity incentive compensation in the form of stock option and RSU grants; and (iv) benefits and perquisites.
In establishing overall executive compensation levels and making specific compensation decisions for our NEOs in the year ended December 31, 2024, the Compensation Committee considered a number of criteria, including the executive’s position, scope of responsibilities, prior base salary and annual incentive awards and expected contribution.
Generally, our Compensation Committee reviews and, as appropriate, approves compensation arrangements for the NEOs from time to time but not less than once each year. The Compensation Committee also takes into consideration the President and Chief Executive Officer’s recommendations for executive compensation of the other NEOs. The President and Chief Executive Officer generally presents these recommendations at the time of our Compensation Committee’s review of executive compensation arrangements.
During the year ended December 31, 2024, the Compensation Committee received consulting services from Aon Solutions UK Limited., or Aon, with regard to management compensation. The Compensation Committee engaged the consultant to review the Company’s current compensation plans for its management and collect and analyze data regarding management compensation at other companies comparable to the Company, in order to provide a competitive compensation benchmark. Aon collected SEC filings data regarding U.S. and Israeli compensation practices and developed a peer group of the following U.S. and Israeli companies: ALX Oncology Holdings Inc., AN2 Therapeutics, Inc., Anavex Life Sciences Corp., Atossa Therapeutics Inc., aTyr Pharma, Inc., Chimerix, Inc., Compugen Ltd., Fulcrum Therapeutics, Inc., Immunic, Inc., Marinus Pharmaceuticals, Inc., MediciNova, Inc., Pluri Biotech Ltd., Rani Therapeutics, Inc., Relmada Therapeutics, Inc., Rezolute, Inc., Vistagen Therapeutics, Inc., vTv Therapeutics Inc. and Zevra Therapeutics, Inc.. Following its review, Aon provided recommendations for cash and equity compensation at various percentiles for the Compensation Committee’s consideration.
Base Salary
The Compensation Committee performs a review of base salaries and monthly compensation for our NEOs from time to time as appropriate. In determining salaries, the Compensation Committee members also take into consideration the scope of the NEOs’ responsibilities and independent third-party market data, such as compensation surveys to industry, individual experience and performance and contribution to our clinical, regulatory, commercial and operational performance. None of the factors above has a dominant weight in determining the compensation of our NEOs, and our Compensation Committee considers the factors as a whole when considering such compensation. In addition, our Compensation Committee uses comparative data regarding compensation paid by peer companies in order to obtain a general understanding of current trends in compensation practices and ranges of amounts being awarded by other public companies, and not as part of an analysis or a formula.
We believe that a competitive base salary and monthly compensation is a necessary element of any compensation program that is designed to attract and retain talented and experienced executives. We also believe that attractive base salaries can motivate and reward executives for their overall performance. Base salary and monthly compensation are established in part based on the individual experience, skills and expected contributions to our performance, as well as such executive’s performance during the prior year. Generally, we believe that executives’ base salaries should be targeted near the median of the range of salaries for executives in similar positions with similar responsibilities, experience and performance at comparable companies. Compensation adjustments are made occasionally based on changes in an executive’s level of responsibility, company progress or on changed local and specific executive employment market conditions.
In November 2024, our Compensation Committee increased the base salary of our NEOs by 15% (effective July 1, 2024 as it deemed this to be a reasonable rate based on, among other factors, such NEO’s responsibilities and the report from Aon, as it determined the salaries were not in line with market compensation.
Performance Based Bonus
Our NEOs are eligible to receive discretionary annual bonuses based upon performance. The amount of annual bonus to our NEOs is based on various factors, including, among others, the achievement of scientific and business goals and our financial and operational performance. The Compensation Committee takes into account the overall performance of the individuals, as well as the overall performance of the Company over the period being reviewed and the recommendation of management. For any given year, the compensation objectives vary, but relate generally to strategic factors such as developments in our clinical path, the execution of a license agreement for the commercialization of product candidates, the establishment of key strategic collaborations, the build-up of our pipeline and financial factors such as capital raising. Bonuses are awarded generally based on corporate performance, with adjustments made within a range for individual performance, at the discretion of the Compensation Committee. The Compensation Committee determines, on a discretionary basis, the size of the entire bonus pool and the amount of the actual award to each NEO. The overall payment is also based on historic compensation of the NEOs.
We believe that annual bonuses payable based on the achievement of short-term corporate goals incentivize our NEOs to create stockholder value and attain short-term performance objectives.
Long-Term Equity Incentive Compensation
Long-term incentive compensation allows the NEOs to share in any appreciation in the value of our common stock. The Compensation Committee believes that stock participation aligns executive officers’ interests with those of our stockholders. Equity incentive awards are generally made at the commencement of employment and following a significant change in job responsibilities, or to meet other special retention or performance objectives. The amounts of the awards are designed to reward past performance and create incentives to meet long-term objectives. Awards are made at a level expected to be competitive within the biotechnology industry, as well as with Israeli-based companies. Awards are made on a discretionary basis and not pursuant to specific criteria set out in advance. In determining the amount of each grant, the Compensation Committee also takes into account the number of shares held by the executive prior to the grant. The vesting schedule for NEOs generally provides for annual installments for new grants, though the Compensation Committee also utilizes quarterly vesting from time to time, as well as performance-based vesting. The Compensation Committee believes that time-based vesting encourages recipients to build stockholder value over a long period of time and that performance-based vesting encourages recipients to achieve goals that benefit the Company.
As part of its engagement in the year ended December 31, 2024 described above, Aon also provided consulting services in connection with grants of equity awards to our executive officers. Aon reviewed annual long-term incentive grants at peer companies, as well as such grants made by companies in the broader market, based on a blend of Black-Scholes valuations and grants as a percentage of the applicable company’s capitalization. Following such consultation, the Compensation Committee is considering alternative models and equity vehicles for future equity-based grants.
Benefits and Perquisites
Generally, benefits available to NEOs are available to all employees on similar terms and include welfare benefits, paid time-off, life and disability insurance and other customary or mandatory social benefits in Israel. We provide some of our NEOs with a phone and a company car, which are customary benefits in Israel to managers and officers.
We do not believe that the benefits and perquisites described above deviate materially from the customary practice for compensation of executive officers by other companies similar in size and stage of development in Israel. These benefits represent a relatively small portion of the executive officers’ total compensation.
Say-on-Pay Vote
Our stockholders approved, on an advisory basis, our executive compensation program at our annual meeting of stockholders held on August 1, 2024. Over 90% of votes cast were voted “for” the compensation of our named executive officers as described in the proxy statement for last year’s annual meeting of stockholders. The Compensation Committee did not specifically rely on the results of the prior vote in making any compensation-related decisions during the year ended December 31, 2024.
SUMMARY COMPENSATION TABLE
The following table sets forth the compensation earned by our NEOs for the years ended December 31, 2024 and 2023.
| Name and Principal Position | Year | Salary
($) (1) |
Bonus
($) (1)(2) |
RSUs
and PSUs Awards ($) (3) |
All
Other Compensation ($) (1)(4) |
Total
($) |
||||||||||||||||||
| Nadav Kidron | 2024 | 540,145 | 270,767 | 1,224,760 | 62,017 | 2,097,689 | ||||||||||||||||||
| President, Chief Executive Officer and Chairman | 2023 | 462,988 | 242,576 | 904,920 | 48,738 | 1,659,222 | ||||||||||||||||||
| Dr. Miriam Kidron | 2024 | 408,104 | 155,291 | 951,545 | 19,607 | 1,534,547 | ||||||||||||||||||
| Chief Scientific Officer and director(5) | 2023 | 347,405 | 139,123 | 605,480 | 17,423 | 1,109,431 | ||||||||||||||||||
| Avraham Gabay (6) | 2024 | 119,925 | 49,623 | 450,084 | 28,583 | 648,215 | ||||||||||||||||||
| Chief Financial Officer | ||||||||||||||||||||||||
| (1) | Amounts paid for Salary, Bonus and All Other Compensation that were originally denominated in NIS were translated into U.S. Dollars at the then average exchange rate for the period. |
| (2) | Bonuses were granted at the discretion of the Compensation Committee. |
| (3) |
For RSU and performance stock unit, or PSU, awards, the amounts reflect the grant date fair value, as calculated pursuant to ASC Topic 718 “Compensation–Stock Compensation.” The assumptions used to determine the fair value of the RSU awards are set forth in note 10 to our audited consolidated financial statements. Our NEOs will not realize the value of these awards in cash unless and until the awards vest and the underlying shares are issued and subsequently sold.
On January 2, 2025, we granted 328,500 PSUs that shall veste upon at the earliest of (1) the closing of a JV transaction with HTIT; or (2) the repayment to us of the value of our principal investment in Scilex plus 10%. We modified 294,000 outstanding PSUs that were granted, adjusting the vesting criteria and performance targets. As of March 27, 2025, all PSUs that granted achieved the first updated performance target. |
| (4) | See “All Other Compensation Table” below. |
| (5) | Dr. Kidron receives compensation from Oramed Ltd. through KNRY, Ltd., or KNRY. See “—Employment and Consulting Agreements” below. |
| (6) | Mr. Gabay was appointed as Chief Financial Officer, effective June 18, 2024. |
All Other Compensation Table
The “All Other Compensation” amounts set forth in the Summary Compensation Table above consist of the following:
| Name | Year | Automobile- Related Expenses ($) |
Manager’s Insurance (1)($) |
Education Fund ($) |
Total ($) |
|||||||||||||||
| Nadav Kidron | 2024 | 30,505 | 25,158 | 6,354 | 62,017 | |||||||||||||||
| 2023 | 21,191 | 21,711 | 5,836 | 48,738 | ||||||||||||||||
| Dr. Miriam Kidron | 2024 | 19,607 | - | - | 19,607 | |||||||||||||||
| 2023 | 17,423 | - | - | 17,423 | ||||||||||||||||
| Avraham Gabay | 2024 | 8,854 | 17,822 | 1,907 | 28,583 | |||||||||||||||
| (1) | Manager’s insurance and education funds are customary benefits provided to employees based in Israel. Manager’s insurance is a combination of severance savings (in accordance with Israeli law), defined contribution tax-qualified pension savings and disability insurance premiums. An education fund is a savings fund of pre-tax contributions to be used after a specified period of time for educational or other permitted purposes. |
Employment and Consulting Agreements
On July 1, 2008, Oramed Ltd. entered into a consulting agreement with KNRY whereby Dr. Miriam Kidron, through KNRY, provides services as Chief Scientific Officer of both the Company and Oramed Ltd., or the Miriam Kidron Consulting Agreement.
The Miriam Kidron Consulting Agreement is terminable by either party upon 140 days prior written notice. The agreement, as amended, provides that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. Pursuant to the agreement, each of KNRY and Dr. Miriam Kidron agreed that during the term of the agreement and for a 12-month period thereafter, none of them will compete with Oramed Ltd. nor solicit employees of Oramed Ltd. Starting January 1, 2024, Dr. Miriam Kidron receives a monthly consulting fee of NIS 117,040. Effective as of July 1, 2024, the monthly consulting fee is NIS 134,550.
Effective November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd., whereby Nadav Kidron, through Shnida Ltd., provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that Shnida Ltd. will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. Effective as of January 1, 2024, Nadav Kidron receives a monthly consulting fee of NIS 96,825. Effective as of July 1, 2024, the monthly consulting fee is NIS 111,349. Pursuant to the agreement, Shnida Ltd. and Nadav Kidron each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company.
In addition, we, through Oramed Ltd., have entered into an employment agreement with Nadav Kidron, effective as of November 1, 2022, pursuant to which, effective as of January 1, 2024, Mr. Kidron receives gross monthly salary of NIS 51,591 in consideration for his services as President and Chief Executive Officer of Oramed Ltd. Effective as of July 1, 2024, Mr. Kidron receives gross monthly salary of NIS 59,330 in consideration for his services as President and Chief Executive Officer of Oramed Ltd. In addition, Mr. Kidron is provided with a phone and a company car pursuant to the terms of his agreement.
We, through Oramed Ltd., have entered into an employment agreement with Avraham Gabay as of June 6, 2024, pursuant to which Mr. Gabay was appointed as Chief Financial Officer, Treasurer and Secretary of the Company and Oramed Ltd., effective June 18, 2024. In accordance with the employment agreement, as amended, Mr. Gabay’s current gross monthly salary is NIS 68,000, and he will be provided with a company car allowance pursuant to the terms of his agreement.
We have entered into indemnification agreements with our directors and officers pursuant to which we agreed to indemnify each director and officer for any liability he or she may incur by reason of the fact that he or she serves as our director or officer, to the maximum extent permitted by law.
Potential Payments upon Termination or Change-in-Control
We have no plans or arrangements in respect of remuneration received or that may be received by our NEOs to compensate such officers in the event of termination of employment (as a result of resignation or retirement).
According to our NEOs’ employment agreements, upon a termination in connection with a change-in-control that occurs during the period that is three months prior and 12 months after the event, the following “double trigger” change-in-control provisions shall apply:
| ● | The President and Chief Executive Officer will be entitled to receive 18 months severance. |
| ● | All other NEOS will be entitled to receive 12 months severance. |
| ● | Severance shall be defined as base salary plus bonuses over the severance period. For U.S.-based persons, COBRA payments equivalent to healthcare benefits values will be provided over the severance period. |
| ● | Full vesting acceleration of all outstanding unvested equity incentives. |
Pension, Retirement or Similar Benefit Plans
We have no arrangements or plans under which we provide pension, retirement or similar benefits for directors or executive officers. Our directors and executive officers may receive stock options, RSUs or restricted shares at the discretion of our Compensation Committee in the future.
Policy Relating to Recovery of Erroneously Awarded Compensation
Our Board has adopted an executive compensation clawback policy, administered by our Compensation Committee, which provides for the recoupment (or clawback) from current and former executive officers of certain compensation in the event of an accounting restatement resulting from material noncompliance with financial reporting requirements under the federal securities laws of the United States. In the event the Company is required to prepare an accounting restatement of its financial statements due to the Company’s material non-compliance with any financial reporting requirement under the securities laws, the Compensation Committee will require prompt reimbursement or forfeiture of any excess incentive compensation (as defined in the clawback policy) received by any covered executive officer during the three completed years immediately preceding the date on which the Company is required to prepare an accounting restatement.
OUTSTANDING EQUITY AWARDS AT DECEMBER 31, 2024
The following table sets forth information concerning stock options and stock awards held by the NEOs as of December 31, 2024.
| Option Awards | Stock Awards | |||||||||||||||||||||
| Name | Number
of Securities Underlying Unexercised Options (#) Exercisable |
Number
of Securities Underlying Unexercised Options (#) Unexercisable |
Option
Exercise Price ($) |
Option
Expiration Date |
Number
of shares that have not vested (#) |
Market value of shares that have not vested ($) |
||||||||||||||||
| Nadav Kidron | 49,000 | (1) | - | 7.77 | 6/30/27 | |||||||||||||||||
| 97,000 | (2) | - | 8.14 | 1/31/28 | ||||||||||||||||||
| 196,500 | (3)(4) | - | 3.16 | 2/26/29 | ||||||||||||||||||
| 190,000 | (5) | - | 4.80 | 1/8/30 | ||||||||||||||||||
| 150,000 | (6) | 10.40 | 2/3/31 | |||||||||||||||||||
| 53,500 | (7) | 53,500 | (7) | 13.89 | 1/3/32 | |||||||||||||||||
| 116,127 | (8) | 3.91 | 9/17/32 | |||||||||||||||||||
| 792,082 | (11)(12)(13)(14)(15)(16) | 1,916,838 | ||||||||||||||||||||
| Dr. Miriam Kidron | 69,999 | (17) | - | 7.77 | 6/30/27 | |||||||||||||||||
| 47,000 | (18) | - | 8.14 | 1/31/28 | ||||||||||||||||||
| 104,000 | (19)(4) | - | 3.16 | 2/26/29 | ||||||||||||||||||
| 100,000 | (20) | 4.80 | 1/8/30 | |||||||||||||||||||
| 100,000 | (21) | 10.40 | 2/3/31 | |||||||||||||||||||
| 36,000 | (22) | 36,000 | (22) | 13.89 | 1/3/32 | |||||||||||||||||
| 32,079 | (23) | 3.91 | 9/17/32 | |||||||||||||||||||
| 570,085 | (24)(25)(26)(27)(29)(30) | 1,379,606 | ||||||||||||||||||||
| Avraham Gabay | 174,040 | (31)(32) | 421,177 | |||||||||||||||||||
| (1) | On June 30, 2017, 147,000 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $7.77 per share; 49,000 of such options vested on December 31, 2017 and the remainder vested in two equal installments of 49,000 on each of December 31, 2018 and December 31, 2019, subject to the Company share price reaching the target of $9.50 and $12.50 per share, respectively. The options expire on June 30, 2027. As of December 31, 2021, 98,000 of these options were forfeited. |
| (2) | On January 31, 2018, 97,000 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $8.14 per share; 97,000 of such options vested in four equal installments of 24,250 on each of January 1, 2019, January 1, 2020, January 1, 2021 and January 1, 2022. The options expire on January 31, 2028. |
| (3) | On February 26, 2019, 196,500 options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $3.16 per share; 196,500 of such options vested in four equal installments of 49,125 on each of December 31, 2019, December 31, 2020, December 31, 2021 and December 31, 2022. The options expire on February 26, 2029. For additional information, see footnote 5 below. |
| (4) | On September 11, 2019, these options were canceled and re-granted under the 2019 Plan in the same amounts and under the same terms as the original grants. |
| (5) | On January 8, 2020, 190,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $4.80 per share. 190,000 of the options vested in four equal installments of 47,500 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December 31, 2023. The options expire on January 8, 2030. |
| (6) | On February 3, 2021, 150,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $10.40 per share. 112,500 of the options vested in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022 and December 31, 2023, and December 31, 2024. The options expire on February 3, 2031. |
| (7) | On January 3, 2022, 107,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $13.89 per share. 53,500 options vested in two equal installments of 26,750 on each of January 1, 2023, January 1, 2024, and the remainder shall vest in two equal installments of 26,750 on January 1, 2025 and January 1, 2026. The options expire on January 3, 2032. |
| (8) | On September 18, 2022, 116,127 options were granted to Nadav Kidron under the Oravax Medical Inc. 2021 Long-Term Incentive Plan at an exercise price of $3.91 per share. 116,127 of the options vested in four installments on each of September 18, 2022, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on September 17, 2032. |
| (9) | On November 13, 2014, 9,788 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The RSUs vested in two equal installments, each of 4,894 shares, on November 30 and December 31, 2014. The shares of common stock underlying the RSUs will be issued upon request of the grantee. |
| (10) | On February 23, 2015, 79,848 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The RSUs vested in 23 installments consisting of one installment of 6,654 shares on February 28, 2015 and 22 equal monthly installments of 3,327 shares each, commencing March 31, 2015. The shares of common stock underlying the RSUs will be issued upon request of the grantee. |
| (11) | On February 3, 2021, 300,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. 100,000 RSUs vested on August 31, 2021 and the remainder shall vest per the following: 100,000 shares shall vest upon our common stock achieving a specified price per share, and 100,000 shall vest upon our achievement of certain business objectives. |
| (12) | On January 3, 2022, 63,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. The RSUs vested in two equal installments, each of 15,750 shares on January 1, 2023 and on January 1, 2024. The shares of common stock underlying the RSUs will be issued upon request of the grantee. The remainder shall vest in two equal installments of 15,750 on each of January 1, 2025 and January 1, 2026. |
| (13) | On July 28, 2022, 126,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 42,000 RSUs vested on January 1, 2024. The shares of common stock underlying the RSUs will be issued upon request of the grantee. The remainder shall vest in two equal installments of 42,000 on each of January 1, 2025 and January 1, 2026. |
| (14) | On April 17, 2023, 279,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 162,750 RSUs vested in seven equal quarterly installments of 23,250 starting May 1, 2023 and the remainder of 116,250 shall vest in five equal quarterly installments of 23,250 starting February 1, 2025. |
| (15) | On January 4, 2024, 329,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 109,668 RSUs vested in twelve equal quarterly installments of 27,417 starting January 8, 2024. |
| (16) | On January 4, 2024, 141,000 PSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. The total amount of the PSUs shall vest when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo model, based on the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| (17) | On June 30, 2017, 69,999 options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $7.77 per share; Such options vested in three equal installments of 23,333 on each of December 31, 2017, December 31, 2018 and December 31, 2019. The options have an expiration date of June 30, 2027. |
| (18) | On January 31, 2018, 47,000 options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $8.14 per share; 47,000 of such options vested in four equal installments of 11,750 on each of January 1, 2019, January 1, 2020, January 1, 2021 and January 1, 2022. The options expire on January 31, 2028. |
| (19) | On February 26, 2019, 104,000 options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $3.16 per share; 104,000 of such options vested in four equal installments of 26,000 on each of December 31, 2019, December 31, 2020, December 31, 2021 and December 31, 2022. The options expire on February 26, 2029. For additional information, see footnote 4 above. |
| (20) | On January 8, 2020, 100,000 options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $4.80 per share. 100,000 of the options vested in four equal installments of 25,000 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December 31, 2023. The options expire on January 8, 2030. |
| (21) | On February 3, 2021, 100,000 options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $10.40 per share. 100,000 of such options vested in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022 and December 31, 2023 and December 31, 2024. The options expire on February 3, 2031. |
| (22) | On January 3, 2022, 72,000 options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $13.89 per share. 36,000 of such options vested in two equal installments of 25,000 on each of January 1, 2023 and January 1, 2024. The remaining 36,000 of the options shall vest in two equal installments of 25,000 on each of January 1, 2025 and January 1, 2026. The options expire on January 3, 2032. |
| (23) | On September 18, 2022, 32,079 options were granted to Dr. Miriam Kidron under the Oravax Medical Inc. 2021 Long-Term Incentive Plan at an exercise price of $3.91 per share. 32,079 of the options vested in four installments on each of September 18, 2022, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on September 17, 2032. |
| (24) | On February 3, 2021, 200,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Dr. Miriam Kidron. 66,666 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 66,667 shares shall vest upon our common stock achieving a specified price per share, and 66,667 shall vest upon our achievement of certain business objectives. |
| (25) | On January 3, 2022, 42,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. 21,000 vested on two equal installments of 10,500 on each of January 1, 2023 and January 1, 2024. The remaining 21,500 shall vest in two equal installments of 10,500 on each of January 1, 2025 and January 1, 2026. |
| (26) | On July 28, 2022, 84,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. 28,000 vested on one installment on January 1, 2024. The remaining 56,000 shall vest in two equal installments of 28,000 on each of January 1, 2025 and January 1, 2026. |
| (27) | On April 17, 2023, 213,000 RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. 124,249 RSUs vested in seven equal quarterly installments of 17,750 starting May 1, 2023 and the remainder of 88,751 shall vest in five equal quarterly installments of 17,750 starting February 1, 2025. The shares of common stock underlying the RSUs will be issued upon request of the grantee. |
| (28) | On April 17, 2023, 53,500 performance-based RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. 120,000 RSUs vested in one installment on May 26, 2023, upon our common stock achieving a specified price per share. The shares of common stock underlying the RSUs will be issued upon request of the grantee. |
| (29) | On January 4, 2024, 295,500 RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. The RSUs vested in twelve equal quarterly installments of 24,625 starting January 8, 2024. The shares of common stock underlying the RSUs will be issued upon request of the grantee. |
| (30) | On January 4, 2024, 74,000 PSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. The total amount of the PSUs shall vest when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo model, based on the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| (31) | On June 21, 2024, 140,040 RSUs representing a right to receive shares of the Company’s common stock were granted to Avraham Gabay. 93,360 shall vest in one installment on June 18, 2026 and 46,680 shall vest in four equal quarterly installments of 11,670 starting September 18, 2026. |
| (32) | On June 20, 2024, the Company granted 34,000 PSUs representing a right to receive shares of the Company’s common stock to Avraham Gabay. The total amount of the PSUs shall vest upon the later of (i) June 18, 2026 and (ii) when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $73, using the Monte-Carlo model, based on the quoted closing market share price of $2.21 on the Nasdaq Capital Market on the date of grant. |
On January 2, 2025, we granted 1,023,000 RSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers. The total amount of the RSUs shall vest in equal quarterly installments of approximately 85,249 over a three year period starting with the first quarterly vesting on January 1, 2025. Also on January 2, 2025, we granted 328,500 PSUs representing a right to receive shares of the Company’s common stock to our executive officers. The total amount of the PSUs shall vest upon at the earliest of (1) the closing of OraTech transaction with HTIT; or (2) the repayment to the Company of the value of its principal investment in Scilex plus 10%. The total fair value of these PSUs on the date of grant was $792 based on the quoted closing market share price of $2.41 on the Nasdaq Capital Market on the date of grant. As of March 27, 2025, all PSUs that were granted to the Company’s executive officers achieved the first updated performance target.
DIRECTOR COMPENSATION
The following table provides information regarding compensation earned by, awarded or paid to each person for serving as a director who is not an executive officer during the year ended December 31, 2024:
|
Name of Director |
Fees Earned or Paid in Cash ($) |
Stock
Awards (1)(2)($) |
Option
Awards (1)(2)($) |
All
Other Compensation ($) |
Total ($) |
|||||||||||||||
| Daniel Aghion(6) | 39,645 | 94,992 | - | - | 134,637 | |||||||||||||||
| Dr. Arie Mayer | 41,963 | 93,987 | - | - | 135,950 | |||||||||||||||
| Yehuda Reznik(3) | 29,537 | 71,091 | - | - | 100,628 | |||||||||||||||
| Yadin Rozov(5) | 1,913 | 92,780 | - | - | 94,693 | |||||||||||||||
| Leonard Sank | 41,117 | 93,987 | - | - | 135,104 | |||||||||||||||
| Benjamin Shapiro | 30,000 | 83,817 | - | - | 113,817 | |||||||||||||||
| (1) | As of December 31, 2024, our non-employee directors then in office held options to purchase shares of our common stock and RSUs as follows: |
| Name of Director | Aggregate Number of Shares Underlying Stock Awards |
Aggregate Number of Shares Underlying Option Awards |
||||||
| Daniel Aghion(6) | 32,204 | - | ||||||
| Dr. Arie Mayer(4) | 55,831 | 45,398 | ||||||
| Yehuda Reznik(3) | 25,314 | 15,398 | ||||||
| Yadin Rozov(5) | - | - | ||||||
| Leonard Sank | 55,831 | 46,773 | ||||||
| Benjamin Shapiro | 39,600 | - | ||||||
| (2) | The amounts reflect the grant date fair value, as calculated pursuant to ASC 718, of these option awards. The assumptions used to determine the fair value of the option awards are set forth in note 10 to our audited consolidated financial statements included in the Annual Report. Our directors will not realize the value of these awards in cash unless and until these awards are exercised and the underlying shares subsequently sold. |
| (3) | Mr. Reznik joined the Board effective on April 1, 2024. |
| (4) | Includes 15,398 option awards granted by Oravax for Dr. Mayer’s service as a member of the Board of Directors of Oravax. |
| (5) | Mr. Rozov resigned from the Board on January 17, 2024 and forfeited his unvested RSUs and Options. |
| (6) | Mr. Aghion joined the Board on January 1, 2024. |
Our directors are entitled to reimbursement for reasonable travel and other out-of-pocket expenses incurred in connection with attendance at meetings of our Board. Based on a report provided to the Compensation Committee by Aon in 2023, effective as of January 1, 2024, each independent director is entitled to receive as remuneration for his or her service as a member of the Board a sum equal to $30,000 and a grant of 5,070 RSUs per annum. The Chairman of our Board is entitled to receive an additional sum equal to $25,500, other than if the Chairman is an executive officer. The members of our Audit Committee are each entitled to receive an additional sum equal to $6,000 and a grant of 2,230 RSUs. The members of our Compensation Committee are each entitled to receive an additional sum equal to $4,500 and a grant of 1,520 RSUs. The members of our Nominating Committee are each entitled to receive an additional sum equal to $4,000 and a grant of 505 RSUs. All cash remuneration is to be paid quarterly after the close of each quarter. The RSUs vest on April 1, July 1, October 1 and January 1 of each year, subject to Compensation Committee approval each year. Our executive officers did not receive additional compensation for service as directors. The Board may award special remuneration to any director undertaking any special services on behalf of us other than services ordinarily required of a director.
On January 2, 2025 the Compensation Committee, approved that in addition to the current annual compensation for the board members, a flat cash fee of $500 per meeting will be paid to each director for attendance at every meeting beyond six meetings per year, and an additional $2,000 in cash will be paid to each director per meeting of over three hours which he or she attends, regardless of the number of meetings.
Other than as described above, we have no present formal plan for compensating our directors for their service in their capacity as directors. Other than indicated above, no director received and/or accrued any compensation for his services as a director, including committee participation and/or special assignments during the year ended December 31, 2024. In addition, during 2024 the directors granted an aggregate of 142,500 RSUs that will vest in three equal annual installments starting January 1, 2025.
The Company’s Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
We do not have any formal policy that requires the Company to grant, or avoid granting, equity-based compensation at certain times. We do not grant equity awards in anticipation of the release of material nonpublic information that is likely to result in changes to the price of our common stock, and do not time the public release of such information based on award grant dates. The timing of any equity grants to executive officers or directors in connection with new hires, promotions, or other non-routine grants is tied to the event giving rise to the award (such as an executive officer’s commencement of employment or promotion effective date).
During the year ended December 31, 2024, there were no equity grants made to our executive officers during any period beginning four business days before the filing of a periodic report or current report disclosing material non-public information and ending one business day after the filing or furnishing of such report with the SEC.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Stock Option Plans
Our Board adopted the 2008 Plan and the 2019 Plan in order to attract and retain quality personnel.
The 2008 Plan, which is no longer utilized for new grants, provided for the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively referred to as “awards.” Under the 2008 Plan, as amended, 2,400,000 shares were reserved for the grant of awards. As of December 31, 2024, options with respect to 2,287,989 shares had been granted, of which 275,673 had been forfeited, 308,804 had been exercised and 1,420,504 have expired. As of December 31, 2024, 525,824 RSUs had been granted, none of them have vested and the shares of common stock underlying those RSUs have not been issued and 34,118 have been forfeited.
The 2019 Plan provides for the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively referred to as “awards.” Under the 2019 Plan, 1,000,000 shares were initially reserved for the grant of awards. On June 29, 2020, and August 3, 2020, respectively, our Board and stockholders approved to amend and restate the 2019 Plan, the principal change being an increase in the number of shares of common stock available under the 2019 Plan from 1,000,000 shares to 3,000,000 shares. On June 30, 2022, our Board and stockholders approved to amend and restate the 2019 Plan, the principal change being an increase in the number of shares of common stock available under the 2019 Plan from 3,000,000 shares to 7,500,000 shares. Stock options granted under the 2019 Plan may be either incentive stock options under the provisions of Section 422 of the Code, or non-qualified stock options. Under the amended 2019 Plan, 7,500,000 shares are reserved for the grant of awards, which may be issued at the discretion of our Board from time to time. As of December 31, 2024, options with respect to 1,863,646 shares have been granted, of which 282,043 had been forfeited, 66,978 had been exercised and none of them were expired. As of December 31, 2024, 4,808,060 RSUs had been granted, of which 290,125 have vested and the shares of common stock underlying those RSUs have not been issued and 808,196 have been forfeited. Since the Company had granted options during the time after the 2008 Plan allegedly terminated, and out of an abundance of caution, the Company canceled these grants and re-granted certain of the options under 2019 Plan in the same amounts and under the same terms as the original grants.
The following table sets forth additional information with respect to our equity compensation plans as of December 31, 2024:
| Plan category | Number
of securities to be issued upon exercise of outstanding options, RSUs and rights (a) |
Weight- average exercise price of outstanding options, RSUs and rights (b) |
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) |
|||||||||
| Equity compensation plans approved by security holders | 3,947,562 | $ | 2.80 | 2,148,993 | ||||||||
| Equity compensation plans not approved by security holders | - | - | - | |||||||||
| Total | 3,947,562 | $ | 2.80 | 2,148,993 | ||||||||
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth certain information regarding the beneficial ownership of our common stock as of March 27, 2025 by: (1) each person who is known by us to own beneficially more than 5% of our common stock; (2) each of our current directors; (3) each of our NEOs; and (4) all of our directors and executive officers as a group. On such date, we had 40,850,455 shares of common stock outstanding.
As used in the table below and elsewhere in this form, the term “beneficial ownership” with respect to a security consists of sole or shared voting power, including the power to vote or direct the vote, and/or sole or shared investment power, including the power to dispose or direct the disposition, with respect to the security through any contract, arrangement, understanding, relationship or otherwise, including a right to acquire such power(s) during the 60 days following March 27, 2025. Inclusion of shares in the table does not, however, constitute an admission that the named stockholder is a direct or indirect beneficial owner of those shares. Unless otherwise indicated, (1) each person or entity named in the table has sole voting power and investment power (or shares that power with that person’s spouse) with respect to all shares of common stock listed as owned by that person or entity and (2) the address of each of the individuals named below is: c/o Oramed Pharmaceuticals Inc., 1185 Avenue of the Americas, Third Floor, New York, New York 10036.
|
Name and Address of Beneficial Owner |
Number
of Shares |
Percentage of Shares Beneficially Owned |
||||||
| Nadav Kidron #+ | 3,193,699 | (1) | 7.6 | % | ||||
| Dr. Miriam Kidron #+ | 1,256,332 | (2) | 3.0 | % | ||||
| Avraham Gabay+ | 137,340 | (3) | * | |||||
| Dr. Daniel Aghion # | 18,820 | * | ||||||
| Dr. Arie Mayer # | 90,634 | (4) | * | |||||
| Yehuda Reznik# | 15,560 | * | ||||||
| Leonard Sank # | 109,294 | (5) | * | |||||
| Benjamin Shapiro # | 1,930,070 | (6) | 4.7 | % | ||||
| All current executive officers and directors, as a group (nine persons) | 7,533,336 | (7) | 18.2 | % | ||||
| Greater than 5% holders | ||||||||
| BML Investment Partners, L.P. | 2,643,907 | (8) | 6.6 | % | ||||
| * | Less than 1% |
| # | Director |
| + | NEO |
| (1) | Includes 953,884 shares of common stock issuable upon the exercise of outstanding stock options, 86,791 shares of common stock issuable upon the vesting of RSUs. Mr. Nadav’s beneficial ownership includes the 218,603 shares of common stock held by Xiaopeng Li, a former director of the Company, over which he holds a proxy. |
| (2) | Includes 474,999 shares of common stock issuable upon the exercise of outstanding stock options, 59,625 shares of common stock issuable upon the vesting of RSUs, and 610,917 shares of common stock underlying vested RSUs that are issuable upon request. |
| (3) | Includes 15,666 shares of common stock issuable upon the vesting of RSUs. |
| (4) | Includes 27,500 shares of common stock issuable upon the exercise of outstanding stock options and 2,500 shares of common stock issuable upon the vesting of RSUs. |
| (5) | Includes 44,273 shares of common stock issuable upon the exercise of outstanding stock options and 2,500 shares of common stock issuable upon the vesting of RSUs. |
| (6) | Includes 1,666 shares of common stock issuable upon the vesting of RSUs. |
| (7) | Includes 1,677,656 shares of common stock issuable upon the exercise of options beneficially owned by the referenced persons, 208,997 shares of common stock issuable upon the vesting of RSUs and 610,917 shares of common stock underlying vested RSUs that are issuable upon request. |
| (8) | Based on Schedule 13G/A, filed on February 13, 2025. BML Investment Partners, L.P. is a Delaware limited partnership whose sole general partner is BML Capital Management, LLC. The managing member of BML Capital Management, LLC is Braden M. Leonard. As a result, Braden M. Leonard is deemed to be the indirect owner of the shares held directly by BML Investment Partners, L.P. Despite such shared beneficial ownership, the reporting persons disclaim that they constitute a statutory group within the meaning of Rule 13d-5(b)(1) of the Exchange Act. The address of BML Investment Partners, L.P. is 65 E Cedar, Suite 2 Zionsville, IN 46077. |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
During the years ended December 31, 2024 and 2023, except for compensation arrangements described elsewhere herein, we did not participate in any transaction, and we are not currently participating in any proposed transaction, or series of transactions, in which the amount involved exceeded the lesser of $120,000 or one percent of the average of our total assets at year end for the last two completed years, and in which, to our knowledge, any of our directors, officers, five percent beneficial security holders, or any member of the immediate family of the foregoing persons had, or will have, a direct or indirect material interest.
Our policy is to enter into transactions with related persons on terms that, on the whole, are no less favorable than those available from unaffiliated third parties. Based on our experience in the business sectors in which we operate and the terms of our transactions with unaffiliated third parties, we believe that all of the transactions described below met this policy standard at the time they occurred. All related person transactions are approved by our Board.
The Board has determined that Dr. Daniel Aghion, Dr. Arie Mayer, Yehuda Reznick, Leonard Sank and Benjamin Shapiro are independent as defined under the rules promulgated by Nasdaq.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
The aggregate fees billed by Kesselman & Kesselman, Certified Public Accountants (Isr.), a member of PricewaterhouseCoopers International Limited, independent registered public accounting firm, for services rendered to us during the years ended December 31, 2024 and 2023:
| 2024 | 2023 | |||||||
| Audit Fees(1) | $ | 124,882 | $ | 132,501 | ||||
| Audit-Related Fees(2) | 1,500 | 1,500 | ||||||
| Tax Fees(3) | 17,986 | 31,363 | ||||||
| All Other Fees | - | - | ||||||
| Total Fees | $ | 144,368 | $ | 165,364 | ||||
| (1) | Amount represents fees paid for professional services for the audit of our consolidated financial statements, review of our interim condensed consolidated financial statements included in quarterly reports and services that are normally provided by our independent registered public accounting firm in connection with statutory and regulatory filings or engagements. |
| (2) | Represents fees paid for services rendered in connection with the IIA requirements. |
| (3) | Represents fees paid for tax consulting services. |
SEC rules require that before the independent registered public accounting firm are engaged by us to render any auditing or permitted non-audit related service, the engagement be: (1) pre-approved by our Audit Committee; or (2) entered into pursuant to pre-approval policies and procedures established by the Audit Committee, provided the policies and procedures are detailed as to the particular service, the Audit Committee is informed of each service, and such policies and procedures do not include delegation of the Audit Committee’s responsibilities to management.
The Audit Committee pre-approves all services provided by our independent registered public accounting firm. All of the above services and fees were reviewed and approved by the Audit Committee before the services were rendered.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
| (a) | Index to Financial Statements |
The following consolidated financial statements are filed as part of this Annual Report on Form 10-K:
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Oramed Pharmaceuticals Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Oramed Pharmaceuticals Inc. and its subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of comprehensive income (loss), changes in equity and cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F-
Investments at fair value
As described in Note 4 to the consolidated financial statements, the Company has approximately $34,808 thousand investments at fair value recorded as of December 31, 2024 relating to Tranche A note, Tranche B note, warrants and royalty purchase agreement payment issued to the Company by Scilex Holding Company. Management applied significant judgment in estimating the fair value of the investments recorded, which also impacted the results of operations of the Company by approximately $4,359 thousand for the change in fair value of such investments in the year ended December 31, 2024. The fair value estimation involved the use of significant estimates and assumptions with respect to the repayment dates and amounts of the notes and royalties.
The principal considerations for our determination that performing procedures relating to investments at fair value is a critical audit matter are (i) the high degree of auditor judgment and subjectivity in performing procedures relating to the fair value measurement of the investments recorded, due to significant judgment by management when developing the estimate; (ii) significant audit effort in evaluating the significant assumptions relating to the repayment dates and amounts of the notes and royalties; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others (i) reading the related agreements and (ii) testing management’s process for estimating the fair value of the investments. Testing management’s process included evaluating the appropriateness of the valuation methods, testing the completeness and accuracy of the data provided by management, and evaluating the reasonableness of significant assumptions related to the repayment dates and amounts of the notes and royalties. Professionals with specialized skill and knowledge were used to assist in the evaluation of the Company’s models.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel Aviv, Israel
March 27, 2025
We have served as the Company’s auditor since 2008.
Kesselman & Kesselman, 146 Derech Menachem Begin St. Tel-Aviv 6492103, Israel, P.O Box 50005 Tel-Aviv 6150001 Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il ORAMED PHARMACEUTICALS INC. CONSOLIDATED BALANCE SHEETS In thousands (except share and per share data)
F-
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 54,420 | $ | 9,055 | ||||
| Short-term deposits (note 2) | 55,281 | 95,279 | ||||||
| Marketable securities (note 3) | 3,441 | - | ||||||
| Investments at fair value (note 4) | 28,788 | 57,713 | ||||||
| Prepaid expenses and other current assets | 1,291 | 537 | ||||||
| Total current assets | 143,221 | 162,584 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long-term deposits | 2 | 7 | ||||||
| Investments at fair value (note 4) | 7,387 | 51,035 | ||||||
| Marketable securities (note 3) | - | 1,807 | ||||||
| Other non-marketable equity securities (note 5) | 3,524 | 3,524 | ||||||
| Amounts funded in respect of employee rights upon retirement | 32 | 27 | ||||||
| Property and equipment, net | 698 | 873 | ||||||
| Operating lease right of use assets | 414 | 694 | ||||||
| Total long-term assets | 12,057 | 57,967 | ||||||
| Total assets | $ | 155,278 | $ | 220,551 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued expenses (note 6) | $ | 5,140 | $ | 1,609 | ||||
| Short-term borrowings (note 7) | - | 51,013 | ||||||
| Payable to related parties (note 14b) | 329 | 325 | ||||||
| Operating lease liabilities | 216 | 267 | ||||||
| Total current liabilities | 5,685 | 53,214 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term deferred revenues | 4,000 | 4,000 | ||||||
| Employee rights upon retirement | 30 | 28 | ||||||
| Provision for uncertain tax position (note 12f) | - | 11 | ||||||
| Operating lease liabilities | 156 | 342 | ||||||
| Other liabilities | 60 | 63 | ||||||
| Total long-term liabilities | 4,246 | 4,444 | ||||||
| COMMITMENTS (note 8) | ||||||||
| EQUITY | ||||||||
| EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS: | ||||||||
| Common stock, $ 0.012 par value (60,000,000 authorized shares as of December 31, 2024 and December 31, 2023; 39,919,545 and 40,338,979 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively) | 480 | 485 | ||||||
| Additional paid-in capital | 322,401 | 320,892 | ||||||
| Accumulated deficit | (176,616 | ) | (157,556 | ) | ||||
| Total stockholders’ equity | 146,265 | 163,821 | ||||||
| Non-controlling interests | (918 | ) | (928 | ) | ||||
| Total equity | 145,347 | 162,893 | ||||||
| Total liabilities and equity | $ | 155,278 | $ | 220,551 | ||||
The accompanying notes are an integral part of the consolidated financial statements.
F-
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
In thousands (except share and per share data)
| Year ended December 31, |
Year ended December 31, |
|||||||
| 2024 | 2023 | |||||||
| REVENUES | $ | $ | 1,340 | |||||
| RESEARCH AND DEVELOPMENT EXPENSES | (6,324 | ) | (8,971 | ) | ||||
| SALES AND MARKETING | 287 | |||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | (6,457 | ) | (8,425 | ) | ||||
| OPERATING LOSS | (12,781 | ) | (15,769 | ) | ||||
| INTEREST EXPENSES (note 11b) | (853 | ) | (2,037 | ) | ||||
| FINANCIAL INCOME (EXPENSES), NET (note 11a) | (2,286 | ) | 22,894 | |||||
| INCOME (LOSS) BEFORE TAX EXPENSES | (15,920 | ) | 5,088 | |||||
| TAX EXPENSES | (3,183 | ) | ||||||
| NET INCOME (LOSS) | $ | (19,103 | ) | $ | 5,088 | |||
| NET INCOME (LOSS) ATTRIBUTABLE TO: | ||||||||
| COMPANY’S STOCKHOLDERS | (19,060 | ) | 5,525 | |||||
| NON-CONTROLLING INTERESTS | (43 | ) | (437 | ) | ||||
| NET INCOME (LOSS) | $ | (19,103 | ) | $ | 5,088 | |||
| BASIC INCOME (LOSS) PER SHARE OF COMMON STOCK | $ | (0.48 | ) | $ | 0.14 | |||
| DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK | $ | (0.48 | ) | $ | 0.14 | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC INCOME (LOSS) PER SHARE OF COMMON STOCK | 40,828,380 | 40,315,068 | ||||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK | 40,828,380 | 40,566,901 | ||||||
The accompanying notes are an integral part of the consolidated financial statements.
F-
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
in thousands
Attributable to Company’s Stockholders
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | paid-in | Accumulated | stockholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | $ | capital | deficit | equity | interests | Equity | ||||||||||||||||||||||
| In thousands | ||||||||||||||||||||||||||||
| BALANCE AS OF JANUARY 1, 2024 | 40,339 | 485 | 320,892 | (157,556 | ) | 163,821 | (928 | ) | 162,893 | |||||||||||||||||||
| STOCK-BASED COMPENSATION | 618 | 7 | 3,991 | 3,998 | 3,998 | |||||||||||||||||||||||
| STOCK-BASED COMPENSATION OF SUBSIDIARY | - | 53 | 53 | |||||||||||||||||||||||||
| REPURCHASE AND RETIREMENT OF COMMON STOCK | (1,037 | ) | (12 | ) | (2,482 | ) | (2,494 | ) | (2,494 | ) | ||||||||||||||||||
| NET LOSS | (19,060 | ) | (19,060 | ) | (43 | ) | (19,103 | ) | ||||||||||||||||||||
| BALANCE AS OF DECEMBER 31, 2024 | 39,920 | 480 | 322,401 | (176,616 | ) | 146,265 | (918 | ) | 145,347 | |||||||||||||||||||
Attributable to Company’s Stockholders
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | paid-in | Accumulated | stockholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | $ | capital | deficit | equity | interests | Equity | ||||||||||||||||||||||
| In thousands | ||||||||||||||||||||||||||||
| BALANCE AS OF JANUARY 1, 2023 | 39,564 | 476 | 314,417 | (163,081 | ) | 151,812 | (656 | ) | 151,156 | |||||||||||||||||||
| SHARES ISSUED FOR SERVICES | 3 | * | 9 | 9 | 9 | |||||||||||||||||||||||
| ISSUANCE OF COMMON STOCK, NET | 193 | 2 | 2,426 | 2,428 | 2,428 | |||||||||||||||||||||||
| STOCK-BASED COMPENSATION | 579 | 7 | 4,040 | 4,047 | 4,047 | |||||||||||||||||||||||
| STOCK-BASED COMPENSATION OF SUBSIDIARY | - | - | 165 | 165 | ||||||||||||||||||||||||
| NET INCOME (LOSS) | - | 5,525 | 5,525 | (437 | ) | 5,088 | ||||||||||||||||||||||
| BALANCE AS OF DECEMBER 31, 2023 | 40,339 | 485 | 320,892 | (157,556 | ) | 163,821 | (928 | ) | 162,893 | |||||||||||||||||||
| * | Represents an amount of less than $1. |
The accompanying notes are an integral part of the consolidated financial statements.
F-
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
In thousands
| Year ended December 31, |
Year ended December 31, |
|||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net income (loss) | $ | (19,103 | ) | $ | 5,088 | |||
| Adjustments required to reconcile net income (loss) to net cash used in operating activities: | ||||||||
| Depreciation | 193 | 196 | ||||||
| Exchange differences, accrued interest on deposits and held to maturity bonds | (2,700 | ) | (2,172 | ) | ||||
| Changes in fair value of investments | 7,413 | (16,392 | ) | |||||
| Stock-based compensation | 4,053 | 4,212 | ||||||
| Shares issued for services | - | 9 | ||||||
| Funds in respect of employee rights upon retirement | (5 | ) | (3 | ) | ||||
| Change in accrued interest on short-term borrowings to maturity | (1,463 | ) | 1,463 | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | (356 | ) | 852 | |||||
| Accounts payable, accrued expenses and related parties | 3,525 | (2,225 | ) | |||||
| Net changes in operating lease | 43 | 8 | ||||||
| Deferred revenues | - | (1,340 | ) | |||||
| Liability for employee rights upon retirement | 2 | 7 | ||||||
| Other liabilities | (14 | ) | 2 | |||||
| Total net cash used in operating activities | (8,412 | ) | (10,295 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property and equipment | (18 | ) | (254 | ) | ||||
| Purchase of short-term deposits | (54,450 | ) | (91,369 | ) | ||||
| Proceeds from redemption of short-term deposits | 97,152 | 109,760 | ||||||
| Exercise of Closing Penny Warrants and Subsequent Penny Warrants | (65 | ) | - | |||||
| Long-term investments | (1,307 | ) | (99,550 | ) | ||||
| Proceeds from long-term deposits | 5 | - | ||||||
| Proceeds from long-term investments | 64,500 | 5,000 | ||||||
| Proceeds from maturity of held to maturity securities | - | 3,375 | ||||||
| Total net cash provided by (used in) investing activities | 105,817 | (73,038 | ) | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from issuance of common stock, net of issuance costs | - | 2,428 | ||||||
| Repurchase and retirement of common stock | (2,484 | ) | - | |||||
| Loans received | - | 99,550 | ||||||
| Loans repaid | (49,550 | ) | (50,000 | ) | ||||
| Tax withholdings related to stock-based compensation settlements | (2 | ) | - | |||||
| Total net cash provided by (used in) financing activities | (52,036 | ) | 51,978 | |||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (4 | ) | (54 | ) | ||||
| INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 45,365 | (31,409 | ) | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 9,055 | 40,464 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF YEAR | $ | 54,420 | $ | 9,055 | ||||
| (A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS: | ||||||||
| Interest paid | $ | 2,316 | $ | 574 | ||||
| Interest received | $ | 7,376 | $ | 5,156 | ||||
| (B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES: | ||||||||
| 2024 Refinancing Tranche A | (21,575 | ) | - | |||||
| 2024 Refinancing Tranche B | 25,000 | - | ||||||
| Excise tax for repurchase and retirement of common stock | (10 | ) | - | |||||
| Recognition of operating lease right-of-use assets and liabilities | 58 | - | ||||||
| Derecognition of right-of-use asset | (26 | ) | - | |||||
| Derecognition of lease liability | 23 | - | ||||||
The accompanying notes are an integral part of the consolidated financial statements
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:
| a. | General |
Oramed Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company,” unless the context indicates otherwise), a Delaware corporation, was incorporated on April 12, 2002.
On February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the provisional patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes.
On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development.
On March 18, 2021, the Company entered into a license agreement with Oravax Medical Inc. (“Oravax”) and holds 63% of the issued and outstanding share capital of Oravax, on a fully diluted basis, as of the date of issuance. Consequently, Oramed consolidates Oravax in its consolidated financial statements since that time.
On July 1, 2024, the Company incorporated a wholly-owned subsidiary in Nevada, Oramed NewCo, Inc. (“OraTech”), which intends to serve as the company for the joint venture with Hefei Tianhui Biotech Co., Ltd. (“HTIT”), see note 15 (b)
On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter of 2023 and concluded that no impairment was required.
In 2023, the Company completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c and age, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, on September 12, 2024 the Company submitted protocol ORA-D-013-3 Phase 3 to focus on the subpopulations with the higher probability to show efficacy. The Company intends to initiate a study during 2025. Moreover, the Company is examining its existing pipeline and has commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders.
See note 4 regarding 2023 Scilex Transaction and 2024 Refinancing.
See note 7 regarding Short-Term Borrowings.
See note 15 regarding JV Supplemental Agreement.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| b. | Basis of presentation |
The consolidated financial statements included herein have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
| c. | Use of estimates in the preparation of financial statements |
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the financial statements date and the reported revenues and expenses during the reporting periods. Actual results could differ from those estimates.
As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to stock-based compensation and to the investments at fair value (for further details, see note 4).
| d. | Functional currency |
The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the U.S. dollar (“$” or “dollar”). Therefore, the functional currency of the Company and its subsidiaries is the dollar.
Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in foreign currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For foreign transactions and other items reflected in the statements of operations, the following exchange rates are used: (1) for transactions – exchange rates at transaction dates or average rates and (2) for other items (derived from non-monetary balance sheet items such as depreciation) – historical exchange rates. The resulting transaction gains or losses are carried to financial income or expenses, as appropriate.
| e. | Repurchase and retirement of common stock |
The Company debited the common stock account by the par value of the shares retired and allocated the excess of the repurchase price over the par value of the shares to additional paid in capital.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| f. | Principles of consolidation |
The consolidated financial statements include the accounts of the Company and its subsidiaries. All inter-company transactions and balances have been eliminated in consolidation.
| g. | Cash equivalents |
The Company considers all short-term, highly liquid investments, which include short-term deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents.
| h. | Fair value measurement: |
The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows:
| Level 1: | Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. | |
| Level 2: | Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. | |
| Level 3: | Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| h. | Fair value measurement (continued): |
The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows:
| December 31, 2024 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Assets: | ||||||||||||||||
| Marketable Securities | ||||||||||||||||
| DNA | 424 | 424 | ||||||||||||||
| Entera | 248 | 248 | ||||||||||||||
| Scilex | 2,769 | 2,769 | ||||||||||||||
| Subsequent Penny Warrants (see note 4) | 2,772 | 2,772 | ||||||||||||||
| Warrants Note B (see note 4) | 548 | 548 | ||||||||||||||
| Tranche A Note (see note 4) | 13,714 | 13,714 | ||||||||||||||
| Tranche B Note (see note 4) | 15,798 | 15,798 | ||||||||||||||
| Royalty Purchase Agreement (see note 4) | - | 1,976 | 1,976 | |||||||||||||
| Profit Sharing Loan Agreement (see note 4 (e)) | 1,367 | 1,367 | ||||||||||||||
| $ | 3,441 | $ | 2,772 | $ | 33,403 | $ | 39,616 | |||||||||
| December 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Assets: | ||||||||||||||||
| Marketable Securities | ||||||||||||||||
| DNA | 297 | - | - | 297 | ||||||||||||
| Entera | 70 | - | - | 70 | ||||||||||||
| Transferred Warrants (see note 4) | 1,440 | - | - | 1,440 | ||||||||||||
| Closing Penny Warrant (see note 4) | - | 9,180 | - | 9,180 | ||||||||||||
| Subsequent Penny Warrants (see note 4) | - | - | 6,502 | 6,502 | ||||||||||||
| The Note (see note 4) | - | - | 93,066 | 93,066 | ||||||||||||
| $ | 1,807 | $ | 9,180 | $ | 99,568 | $ | 110,555 | |||||||||
As of December 31, 2024, and December 31, 2023, the carrying amounts of cash equivalents, short-term deposits, Short-Term Borrowings (as defined in Note 7), and accounts payable approximate their fair values due to the short-term maturities of these instruments.
The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| i. | Marketable securities |
The Company measured the securities (investments in equity securities of DNA group (T.R.) Ltd. (“DNA”), Entera Bio Ltd. (“Entera”) and Scilex Holding Company (“Scilex”) at fair value, with changes in fair value recognized in earnings. The Company intends to exercise these investments during 2025, and has classified the marketable securities as short-term accordingly.
| j. | Other non-marketable equity securities |
The Company also invested in non-marketable equity securities, through an investment in a privately held company. This equity investment does not have a readily determinable fair value. The investment is measured under the measurement alternative in Accounting Standards Codification (“ASC”) 321 “Investments – Equity Securities” to the extent such an investment is not subject to consolidation or the equity method. Under the measurement alternative, this equity investment is carried at cost, less any impairment, adjusted for changes resulting from observable price changes in transactions for an identical or similar investment of the same issuer. The investment would be impaired in accordance with the provisions of ASC 820 “Fair Value Measurement” if, based on a qualitative assessment of impairment indicators, the fair value of the investment is less than its carrying amount. If considered impaired, the difference between the carrying amount and fair value would be recorded in the consolidated statement of income (loss). For further details, see note 5.
| k. | Investments, at fair value |
The Company invested in the Tranche A Note (as defined in note 4), Tranche B Note (as defined in note 4) (collectively the “Notes”), Penny Warrants and Royalty Purchase Agreement issued by Scilex, for which it has elected the fair value option. Under the Fair Value Option Subsections of ASC Subtopic 825-10, Financial Instruments – Overall, the Company has the irrevocable option to report financial assets at fair value on an instrument-by-instrument basis.
Scilex also issued to the Company the Note A Transferred Warrants and Note B Warrants (as defined in note 4) that meet the definition of a derivative under ASC 815 “Derivatives and Hedging”. Therefore, the Warrants will be measured at fair value initially and on every reporting period.
The Company entered into a loan agreement to finance a real estate project. The Company decided to designate the Profit Sharing Loan Agreement (as define in note 4) as a whole under the Fair-Value option in accordance with ASC Topic 825 “Financial Instruments”.
Changes in the fair value are recorded under financial income (expenses), net.
| l. | Concentration of credit risks |
Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents, short and long-term deposits, which are deposited in major financial institutions, Profit Sharing Loan Agreement, Royalty Purchase Agreement and the Notes. The Company is of the opinion that the credit risk in respect of these balances is remote, except for the Profit Sharing Loan Agreement, Royalty Purchase Agreement and the Notes for which the Company is of the opinion there is a credit risk, which is reflected in its fair value measurement (for further details, see note 4).
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| m. | Income taxes |
| 1. | Deferred taxes |
Deferred taxes are determined utilizing the asset and liability method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. See note 12.
Taxes that would apply in the event of disposal of investments in the Israeli subsidiary have not been taken into account in computing deferred taxes, as it is the Company’s intention to hold this investment, not to realize it.
| 2. | Uncertainty in income tax |
The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. Such liabilities are classified as long-term, unless the liability is expected to be resolved within 12 months from the balance sheet date. The Company’s policy is to include interest and penalties related to unrecognized tax benefits within income tax expenses.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| n. | Revenue recognition |
HTIT
On November 30, 2015, the Company entered into a Technology License Agreement, with HTIT and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”).
As of December 31, 2024, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through December 31, 2024. Through December 31, 2023, the Company recognized revenue associated with this agreement in the aggregate amount of $20,382, of which $1,340 was recognized in the year ended December 31, 2023, and deferred the remaining amount of $2,000, which is presented as long-term deferred revenues on the consolidated balance sheet. The Company did not recognize revenue related to the HTIT License Agreement in the year ended December 31, 2024. See note 15 regarding the JV Supplemental Agreement.
Medicox
On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. For further details, see note 8b.
Under ASC 606 “Revenue from Contracts with Customers,” the Company identified Medicox as a customer and the Medicox License Agreement as a contract with a customer.
The Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its commercialization efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801, which the Company views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as no party other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing services, that are contingent on the completion and success of the commercialization efforts.
The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company during the year ended December 31, 2022 and is currently presented under long-term deferred revenues. It also contains variable consideration of contractual milestone payments and sales-based royalties.
The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of December 31, 2024, this support has not commenced, and no revenue was recognized from the Medicox License Agreement.
If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized at a later stage, going forward. The Company notes that its Phase 3 trial did not meet its primary or secondary endpoints (see note 1a.1).
If Medicox chooses to terminate the agreement as a result of the outcome of the Phase 3 trials, the Company will accelerate revenue recognition and recognize it at such time.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| o. | Research and development |
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, stock-based compensation, employee benefits, the cost of supplies, the cost of services provided by outside contractors, including services related to the Company’s clinical trials, clinical trial expenses and the full cost of manufacturing drug for use in research and preclinical development. All costs associated with research and development are expensed as incurred.
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources a substantial portion of its clinical trial activities, utilizing external entities such as Clinical Research Organizations (“CROs”), independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. For each clinical trial that the Company conducts, clinical trial costs are expensed immediately.
| p. | Stock-based compensation |
Equity awards granted to employees are accounted for using the grant date fair value method. The grant date fair value is determined as follows: for stock options with an exercise price and only service conditions using the Black Scholes pricing model, for stock options and restricted stock units (“RSUs”) with market conditions using a Monte Carlo model and for RSUs with service conditions based on the grant date share price. The fair value of share based payment awards is recognized as an expense over the requisite service period. The expected term is the length of time until the expected dates of exercising the award and is estimated using the simplified method due to insufficient specific historical information of employees’ exercise behavior, unless the award includes a market condition, in which case the contractual term is used. The volatility is based on a historical volatility, by statistical analysis of the weekly share price for past periods. The Company elected to recognize compensation cost for awards granted to employees that have a graded vesting schedule using the accelerated method based on the multiple-option award approach. For awards with market conditions, compensation expense is not reversed if the market conditions are not satisfied.
The Company elects to account for forfeitures as they occur.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| q. | Income (loss) per share of common stock |
Basic net earnings (loss) per common share are computed by dividing the net earnings (loss) attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested RSUs. Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share for the year ended December 31, 2024 because all such securities are anti-dilutive for the year ended December 31, 2024.
For the diluted earnings per share calculation for the year ended December 31, 2023, the weighted average number of shares outstanding during the year is adjusted for the potential dilution that could occur in connection with employee share-based payment, using the treasury stock method. The difference in the denominator results from the dilutive impact of 251,833 RSUs.
The weighted average number of stock options, warrants and RSUs excluded from the calculation of diluted income (loss) per share was 4,582,421 and 1,227,506 for the years ended December 31, 2024 and December 31, 2023, respectively.
| r. | Leases |
The Company leases real estate and cars for use in its operations, which are classified as operating leases. In addition to rent, the leases may require the Company to pay directly for fees, insurance, maintenance and other operating expenses.
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right of use assets and operating lease liabilities in the consolidated balance sheets. Right of use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. Lease expenses are recognized on a straight-line basis over the lease term.
The Company elected the practical expedient to not separate lease and non-lease components for all of its leases.
Lease terms will include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate the lease.
The Company’s lease agreements have remaining lease terms ranging from 4 months to 2.5 years. Some of these agreements include options to extend the leases for up to an additional 5 years and some include options to terminate the leases immediately. See Note 8d.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| s. | New accounting pronouncements |
Recently adopted accounting pronouncements
In November 2023, the Financial Accounting Standard Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures.” This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280 “Segment Reporting”. The Company adopted this standard in the current period retrospectively to all prior periods presented in its financial statements, see note 13.
Recently issued accounting pronouncements, not yet adopted
In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for years beginning after December 15, 2026, and interim periods within years beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 2 - SHORT-TERM DEPOSITS:
Composition:
| December 31, | ||||||||||||||||
| 2024 | 2023 | |||||||||||||||
| Annual interest rate |
Amount | Annual interest rate |
Amount | |||||||||||||
| Dollar deposits | 5.65-5.75 | % | 55,281 | 6.35-6.81 | % | $ | 95,279 | |||||||||
NOTE 3 - MARKETABLE SECURITIES:
| a. | Composition: |
The Company’s marketable securities include investments in equity securities of DNA, Entera and Scilex.
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Short-term: | ||||||||
| DNA (see b below) | $ | 424 | $ | - | ||||
| Entera (see c below) | 248 | - | ||||||
| Scilex (see d below) | 2,769 | - | ||||||
| $ | 3,441 | - | ||||||
| Long-term: | ||||||||
| DNA (see b below) | $ | - | $ | 297 | ||||
| Entera (see c below) | - | 70 | ||||||
| Transferred Warrants (see note 4) | - | 1,440 | ||||||
| $ | - | $ | 1,807 | |||||
| b. | DNA |
DNA’s ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of the securities on the measurement date.
During the years ended December 31, 2024 and 2023, the Company did not sell any of DNA’s ordinary shares. As of December 31, 2024, the Company owns approximately 1.4% of DNA’s outstanding ordinary shares.
The cost of the securities as of both December 31, 2024 and 2023 was $595.
| c. | Entera |
Entera ordinary shares have been traded on the Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value from such date, since it has a readily determinable fair value.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 3 - MARKETABLE SECURITIES (continued):
| d. | Scilex |
Scilex ordinary shares are traded on the Nasdaq Capital Market. The fair value of those securities is measured at the quoted prices of the securities on the measurement date.
On November 4, 2024 the Company exercised 6,500,000 of the Penny Warrant to shares. (for more details, see note 4).
NOTE 4 - INVESTMENTS, AT FAIR VALUE:
2023 Scilex Transaction and 2024 Refinancing
2023 Scilex Transaction
On September 21, 2023, the Company entered into and consummated the transactions (collectively, the “2023 Scilex Transaction”) contemplated by a securities purchase agreement with Scilex, pursuant to which Scilex issued to the Company:
| a. | A senior secured promissory note (the “Tranche A Note”), with a principal amount of $101,875, maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable in-kind. Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024, September 21, 2024, and December 21, 2024, with the balance due on March 21, 2025. In January 2025, the Company extended Tranche A Note maturity from March 21, 2025 to December 31, 2025. As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior to March 21, 2024, an exit fee of $3,056 is due. Since the Tranche A Note was not repaid by that date, the Company is entitled to the above-mentioned exit fee at the maturity date of the Tranche A Note. As of December 31, 2024, Scilex has repaid $69,200 of the amount due under the Tranche A Note. See the description of the Extension Agreement (as defined below). | |
| The Tranche A Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic subsidiaries of Scilex and is secured by a first priority security interest in and liens on all of the assets of Scilex, subject to customary and mutually agreed permitted liens and except for certain specified exemptions. |
| b. | Warrants to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share (the “Closing Penny Warrants”) and four additional warrants (the “Subsequent Penny Warrants”) each for 2,125,000 shares of Scilex common stock with an exercise price of $0.01 per share. The Closing Penny Warrants were vested on September 21, 2023, and each of the Subsequent Penny Warrants vested quarterly during 2024. The Closing Penny Warrants and the Subsequent Penny Warrants shall become exercisable on the earliest of (i) March 14, 2025 and (ii) the date on which the Tranche A Note has been repaid in full.
As of December 31, 2024, 4,500,000 Closing Penny Warrants were vested according to the terms of Tranche A Note, 8,500,000 Subsequent Penny Warrants were vested according to the terms of the Tranche A Note and as per the Extension Agreement (as defined below).
According to the Extension Agreement (as defined below), 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants have become exercisable.
On October 30, 2024, the Company exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were exercisable at such time. As a result the Company holds 6,500,000 shares of common stock of Scilex. |
| c. | Transferred warrants (the “Transferred Warrants”) to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per share, fully exercisable and expiring on November 10, 2027. On September 20, 2024, the Company sold the Transferred Warrants for consideration of $300 (see below). As a result, as of December 31, 2024 the Company does not hold any Transferred Warrants. |
F-
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2023 Scilex Transaction and 2024 Refinancing (continued)
2023 Scilex Transaction (continued)
The Company accounted for the Transferred Warrants as derivatives measured at fair value.
The Company elected the fair value option for the Tranche A Note and the Penny Warrants in order to reduce operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income (expense), net and include interest income on the Tranche A Note.
The valuation was performed based on several scenarios. Each scenario took into consideration the present value of the Tranche A Note’s cash flows (including the exit fee and the prepayment premium) and the Warrants’ value. The total value of the 2023 Scilex Transaction (and of each of its components) was valued on a weighted average of the different scenarios.
The discount rate of the Tranche A Note was based on the B- rating zero curve in addition to a risk premium which takes into account the credit risk of Scilex and ranged between 112% to 113%.
The fair value of the Transferred Warrants was based on their closing price on the Nasdaq Capital Market. The fair value of the Penny Warrants was calculated based on the closing price of the Scilex common stock on the Nasdaq Capital Market.
On September 20, 2024, the Company and Scilex entered into an extension agreement (the “Extension Agreement”) to extend the due date of the September 21, 2024 payment. Pursuant to the Extension Agreement, Scilex paid to the Company $2,000 on September 23, 2024, which payment is to be applied as follows: (i) $1,700 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300 to purchase the Transferred Warrants.
The table below represents the fair value composition of the Tranche Note A:
| December 31, 2024 | December 31, 2023 | |||||||||||||||||||||||
| Short term | Long term | Total | Short term | Long term | Total | |||||||||||||||||||
| Tranche Note A | $ | 13,714 | - | $ | 13,714 | $ | 57,713 | $ | 35,353 | $ | 93,066 | |||||||||||||
| Closing Penny Warrant | - | - | - | - | $ | 9,180 | $ | 9,180 | ||||||||||||||||
| Subsequent Penny Warrants | $ | 2,772 | - | $ | 2,772 | - | $ | 6,502 | $ | 6,502 | ||||||||||||||
| Transferred Warrants | - | - | - | - | $ | 1,440 | $ | 1,440 | ||||||||||||||||
| Total | $ | 16,486 | - | $ | 16,486 | $ | 57,713 | $ | 52,475 | $ | 110,188 | |||||||||||||
As of December 31, 2023, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) by $7,801.
As of December 31, 2024, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) by $8,114.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2024 Refinancing
In October 2024, the Company entered into the transactions (collectively, the “2024 Refinancing”) pursuant to which Scilex issued to the Company:
a. Convertible Notes SPA
The Company entered into a securities purchase agreement (the “Convertible Notes SPA”) with certain institutional investors (together with the Company, the “Buyers”) and Scilex to refinance a portion of the Tranche A Note and pay off certain other indebtedness of Scilex. Pursuant to the Convertible Notes SPA, the Buyers purchased in a registered offering by Scilex (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000 (the “Tranche B Notes”) repayable on a quarterly basis for 2 years, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants to purchase up to 7,500,000 shares of Scilex common stock (the “Tranche B warrants”). The Company purchased 50% of Tranche B Notes and Tranche B Warrants and therefore holds an aggregate principal amount of $25,000 of the Tranche B Notes and 3,750,000 Tranche B Warrants.
Scilex received from the Company, in consideration for the Tranche B Notes and the Tranche B Warrants issued to the Company, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500.
b. Royalty Purchase Agreement
The Company and certain institutional investors (together with the Company, the “RPA Purchasers”) entered into a Purchase and Sale Agreement (the “Royalty Purchase Agreement”) with Scilex and Scilex Pharmaceuticals Inc. (“Scilex Pharma”). Pursuant to the Royalty Purchase Agreement, the RPA Purchasers acquired the right to receive, in the aggregate, 8% of net sales worldwide for 10 years (the “Purchased Receivables”) with respect to ZTlido (lidocaine topical system) 1.8%, SP-103 (lidocaine topical system) 5.4%, and any related, improved, successor, replacement or varying dosage forms of the foregoing. The Company acquired the right to receive 50% of the Purchased Receivables and therefore holds the right to receive 4% royalties.
In consideration for its interest in the Purchased Receivables, the Company exchanged and reduced $2,500 of the principal balance under the Tranche A Note.
c. ZTlido Rest of the World Binding Agreement
The Company and certain other institutional investors and Scilex entered into a binding term sheet (the “ROW License Term Sheet”), regarding a license and development agreement (the: “Lido License Agreement”), with respect to services, compositions, products, dosages and formulations comprising lidocaine, including without limitation, the product and any future product defined as a “Product” under Scilex Pharma’s existing (i) Product Development Agreement, dated as of May 11, 2011, with Oishi Koseido Co., Ltd. (“Oishi”), and Itochu Chemical Frontier Corporation (“Itochu”), as amended, and (ii) the associated Commercial Supply Agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as amended.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2024 Refinancing (continued)
c. ZTLido Rest of the World Binding Agreement (continued):
Subject to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, it is anticipated that the Company and such institutional investors will hold the Lido License Agreement through a joint venture, RoyaltyVest, Inc. (“RoyaltyVest”).
In consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200 per year toward expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other than certain excluded designated territories (the “ROW Territory”), and (c) each of RoyaltyVest and Scilex will receive 50% percent of the net revenue (less expenses) generated from any Product in the ROW Territory.
The term sheet is subject to entering into a definitive agreement (see note 15) and subject to the consent of Oishi and Itochu to the Lido License Agreement.
As of December 31, 2024, the fair value of the ROW License was immaterial, inter alia, as it remains contingent upon third-party approvals and the future execution of agreements.
The institutional investors who are parties to the Convertible Notes SPA, Royalty Purchase Agreement and ROW License Term Sheet are all inter-related.
Following the refinancing as described above, on October 8, 2024, Scilex used $12,500 of the net proceeds from the proceeds of the Tranche B Note for the partial repayment of the outstanding balance under the Tranche A Note.
The Company elected the fair value option for the Tranche B Note and the Royalty Purchase Agreement, The Note B Warrants meet the definition of a derivative, and therefore will be measured at fair value. Changes in value are recorded under financial income (expense), net and include interest income on the Tranche B Note.
The valuation of the Tranche B Note’s was performed based on the binomial model, using a discount rate of 110.33%. Presented below is the summary of the assumptions and estimates that were used for the valuation:
| Parameters and Assumptions | ||||
| Share Price | $ | 0.43 | ||
| Conversion Rate | 1.04 | |||
| Floor Rate | 1.04 | |||
| Expected Term | 1.77 Years | |||
| Volatility | 61.99 | % | ||
| Risk Free Rate | 4.16 | % | ||
The fair value of the Note B Warrants was calculated based on Black and Scholes model.
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ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2024 Refinancing (continued)
c. ZTLido Rest of the World Binding Agreement (continued):
Presented below is the summary of the assumptions and estimates that were used for the valuation of the Warrants:
| Parameters and Assumptions | ||||
| Share Price | $ | 0.43 | ||
| Exercise Price | $ | 1.04 | ||
| Expected Term | 4.77 Years | |||
| Volatility | 63.14 | % | ||
| Risk Free Rate | 4.33 | % | ||
| Dividend Rate | 0 | % |
The value of the Royalty Purchase Agreement was calculated according to the royalty payment schedule and the aggregation of discounted cash flows derived from the royalty payments, using a discount rate of 110.33%.
As of December 31, 2024, the fair value of the Tranche B Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) is $9,833.
The table below represents the fair value composition of the Tranche B Note:
| December 31, 2024 | ||||||||||||
| Short term | Long term | Total | ||||||||||
| Tranche B Note | $ | 11,263 | $ | 4,535 | $ | 15,798 | ||||||
| Warrant | $ | 548 | $ | 548 | ||||||||
| Royalty Purchase Agreement | $ | 1,039 | $ | 937 | $ | 1,976 | ||||||
| Total | $ | 12,302 | $ | 6,020 | $ | 18,322 | ||||||
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ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2024 Refinancing (continued)
c. ZTLido Rest of the World Binding Agreement (continued):
The table below represents the fair value cycle of 2023 Scilex Transaction and 2024 Refinancing Transaction throughout December 31, 2023 and December 31, 2024:
| Tranche A | Tranche B | Total | ||||||||||
| Balance as of December 31, 2022 | ||||||||||||
| 2023 Scilex Transaction | 101,875 | 101,875 | ||||||||||
| Cash received from note repayment | (5,000 | ) | (5,000 | ) | ||||||||
| Change in fair value | 13,313 | 13,313 | ||||||||||
| Balance as of December 31, 2023 | 110,188 | 110,188 | ||||||||||
| 2024 Refinancing (*) | (21,575 | ) | 25,000 | 3,425 | ||||||||
| Proceeds from the sale of Transferred Warrants | (300 | ) | (300 | ) | ||||||||
| Cash received from Tranche A Note repayment | (64,200 | ) | (64,200 | ) | ||||||||
| Exercised warrants (**) | (6,123 | ) | (6,123 | ) | ||||||||
| Amounts receivable from the royalty agreement (***) | (398 | ) | (398 | ) | ||||||||
| Change in fair value | (1,504 | ) | (6,280 | ) | (7,784 | ) | ||||||
| Balance as of December 31, 2024 | 16,486 | 18,322 | 34,808 | |||||||||
| (*) | The amount was recorded as part of the financial income (expenses), net. |
| (**) | On October 30, 2024 the Company exercised 4,500,000 Closing Penny Warrants, and 2,000,000 Subsequent Penny Warrants into 6,500,000 shares of common stock of Scilex and as a result, these shares are not part of the Tranche A Note and presented under fair value investment. |
| (***) | The amount is included under prepaid expenses and other current assets. |
Financial income (expenses) recognized in respect of 2023 Scilex Transaction and 2024 Refinancing, for the years ended December 31, 2024 and 2023, were ($4,359) and $13,313, respectively.
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ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2024 Refinancing (continued)
c. ZTLido Rest of the World Binding Agreement (continued):
The table below represents the fair value breakdown as of December 31, 2024:
| Tranche A Note | Tranche B Note | Total | ||||||||||||||||||
| Amount | Fair Value | Amount | Fair Value | Fair Value | ||||||||||||||||
| The Notes | 7,675 | 13,714 | 25,000 | 15,798 | 29,512 | |||||||||||||||
| Warrants | 6,500 | 2,772 | 3,750 | 548 | 3,320 | |||||||||||||||
| Royalty Purchase Agreement payment | 1,976 | 1,976 | ||||||||||||||||||
| December 31, 2024 | 16,486 | 18,322 | 34,808 | |||||||||||||||||
For more details see note 15, subsequent events.
| e. | Profit Sharing Loan Agreement |
On September 4, 2024, the Company entered into a loan agreement (the “Profit Sharing Loan Agreement”) with Rabi Binyamin 4 Tama 38 Ltd. (the “Borrower”) to finance a real estate project (the “Project”). According to the terms of the Profit Sharing Loan Agreement, Oramed agreed to loan NIS 5.5 million ($1,523) (the “Loan Principal”) to the Borrower. NIS 4.7 million ($1,307) was loaned upon signing the Profit Sharing Loan Agreement and an additional NIS 0.8 million ($216) will be loaned upon certain milestones which are expected to occur in the first half of 2025. Upon completion of the Project, the Company is entitled to receive the Loan Principal and the greater of: (i) 20% annual interest of the Loan Principal and (ii) 40% of the Project profits.
The Company decided to designate the Profit Sharing Loan Agreement as a whole under the Fair-Value option in accordance with ASC Topic 825 “Financial Instruments”. The valuation of the Profit Sharing Loan Agreement was based on various project profit scenarios derived from the appraiser’s report. The Company used the Wang Transform model, a risk-neutral probabilities method, with an expected term of 4.01 years, a curve rate of 13.9% and a risk spread of 0.43%.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 5 - OTHER NON-MARKETABLE EQUITY SECURITIES:
On August 26, 2022, the Company entered into a stock purchase agreement with Diasome Pharmaceuticals, Inc. (“Diasome”), a privately-held company, pursuant to which the Company purchased shares of Series B preferred stock of Diasome for an aggregate purchase price of approximately $2,700. Following the purchase, the Company holds less than 5% of the issued and outstanding stock of Diasome. The stock purchase agreement provides the Company with the option to purchase additional preferred shares of stock on a pro rata basis at similar terms to the terms and conditions of the current round contingent upon Diasome achieving certain milestones.
The Company’s non-marketable equity securities are an investment in a company without a readily determinable fair value. The Company accounts for this investment under the measurement alternative in ASC 321, whereby the equity investment is recorded at cost, less impairment. The carrying amount is subsequently remeasured to its fair value in accordance with the provisions of ASC 820 when observable price changes occur as of the date the transaction occurred, or it is impaired. Any adjustments to the carrying amount are recorded in the consolidated statements of comprehensive income (loss).
During the year ended December 31, 2023, the Company recorded an $824 increase in value due to the closing in June 2023 of a Series C preferred investment round in Diasome. The change was recorded using the transaction price of similar securities issued by Diasome, adjusted for contractual rights and obligations of the securities held by the Company. During the year ended December 31, 2024, there was no change in the value of the Diasome investment.
NOTE 6 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Accounts payable | $ | 789 | $ | 551 | ||||
| Payroll and related accruals | 407 | 453 | ||||||
| Income tax | 3,204 | - | ||||||
| Accrued liabilities | 740 | 605 | ||||||
| $ | 5,140 | $ | 1,609 | |||||
NOTE 7 - SHORT-TERM BORROWINGS:
On August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. (the “Short-Term Borrowings”). The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66% to 7.38%, and are secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note (for further details, see note 4). The Short-Term Borrowings are paid in one payment of principal and interest at each respective maturity. As of December 31, 2024, the Company repaid the entire Short-Term Borrowings amount.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - COMMITMENTS:
| a. |
On August 21, 2020, the Company received a letter from HTIT, disputing certain pending payment obligations of HTIT under the Technology License Agreement (“TLA”). The payment obligation being disputed is $6,000, out of which only an amount of $2,000 has been received and has been included in deferred revenue in each of the consolidated balance sheets as of the years ended December 31, 2024, and December 31, 2023.
On February 7, 2025, the Company and HTIT entered into a JV Agreement (as defined in note 15). Pursuant to the terms of the JV Agreement, each of the Company, the Subsidiary and HTIT irrevocably released and waived (i) any claims and demands against each other party in connection with the TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of the TLA. For more details see note 15. |
| b. |
On November 13, 2022, the Company entered the Medicox License Agreement with Medicox.
The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. The Medicox License Agreement is for ten years, but the parties have the right to terminate it with a 180 days-notice.
Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay the Company up to $15,000 in developmental milestones, $2,000 of which were received by the Company in 2022, and up to 15% royalties on gross sales. Medicox will also be responsible for obtaining a regulatory approval in the Republic of Korea.
For the Company’s revenue recognition policy, see note 1m. |
| c. | Grants from the Israel Innovation Authority (“IIA”) |
Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on SOFR.
At the time the grants were received, successful development of the related projects was not assured. The total amount that was received through December 31, 2024 was $2,214 ($2,587 including interest). All grants were received before the year ended August 31, 2020 and recorded as a reduction of research and development expenses at that time.
As of December 31, 2024, the liability to the IIA was $59. The royalty expenses which are related to the funded project were recognized in cost of revenues in the relevant periods.
As of December 31, 2024, the Company has paid a total amount of $556 to the IIA.
For additional details see note 15.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - COMMITMENTS (continued):
| d. | Leases |
On August 2, 2020, the Subsidiary entered into a lease agreement for its facilities in Israel. The lease agreement is for a period of 60 months commencing September 1, 2020. The Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees, as of December 31, 2024 is approximately NIS 435 ($119). As security for its obligation under this lease agreement, the Company provided a bank guarantee in an amount equal to three monthly lease payments. For accounting purposes, the lease period is 60 months.
On December 2, 2021, the Subsidiary entered into an addendum (the “Addendum”) to the current lease agreement for its facilities in Israel. The Addendum refers to the lease of an additional space of 264 square meters for a period of 60 months commencing February 1, 2022. The Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees, is approximately NIS 435 ($119). As security for its obligation under the Addendum, the Company provided a bank guarantee in an amount equal to three monthly lease payments. For accounting purposes, the lease commenced on February 1, 2022 as the Subsidiary did not have access to the space until that date. For accounting purposes, the lease period is 60 months.
The total expenses related to leases were $265 for the year ended December 31, 2024, and $236 for the year ended December 31, 2023.
The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of December 31, 2024 and 2023:
| December 31, 2024 |
December 31, 2023 |
|||||||
| Operating right-of-use assets | $ | 414 | $ | 694 | ||||
| Operating lease liabilities, current | 216 | 267 | ||||||
| Operating lease liabilities long-term | 156 | 342 | ||||||
| Total operating lease liabilities | $ | 372 | $ | 609 | ||||
| Weighted Average of Remaining Lease Term | ||||||||
| Operating leases | 1.8 | 2.5 | ||||||
| Weighted Average Discount Rate | ||||||||
| Operating leases | 3.52 | % | 3.15 | % | ||||
Operating cash flows from operating lease for the years Ended December 31, 2024 and 2023 were $264 and $267, respectively.
Lease payments for the Company’s right-of-use assets over the remaining lease periods as of December 31, 2024 are as follows:
| December 31, 2024 |
||||
| 2025 | $ | 225 | ||
| 2026 | 141 | |||
| 2027 | 18 | |||
| Total undiscounted lease payments | 384 | |||
| Less: Interest* | (12 | ) | ||
| Present value of lease liabilities | $ | 372 | ||
| * | Future lease payments were discounted by 3%-7% interest rate. |
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - COMMITMENTS (continued):
| e. | Clinical Research Organization Services Agreement |
On September 23, 2024, the Subsidiary entered into a Clinical Research Organization Services Agreement with a third party, to retain it as a clinical research organization (“CRO”). The services covered by the agreement include strategic planning, expert consultation, data processing, regulatory, clerical, project management and other research and development services requested by the Company for the Phase 3 clinical trial. As consideration for its services, the Company will pay the CRO a total amount of $11,577 during the term of the engagement and based on achievement of certain milestones, of which $775 recognized in research and development expenses through December 31, 2024.
NOTE 9 - STOCKHOLDERS’ EQUITY:
The following are the significant capital stock transactions that took place during the years ended December 31, 2024 and 2023:
| a. | On September 1, 2021, the Company entered into a controlled equity offering agreement (the “Cantor Equity Distribution Agreement”) with Cantor Fitzgerald & Co., as agent, pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000, through a sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus supplement dated September 1, 2021. The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the Cantor Equity Distribution Agreement. As of December 31, 2023 1,971,447 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $26,253, no shares were issued in 2024. The agreement terminated on March 17, 2024. |
| b. | On March 18, 2024, the Company entered into an at the market offering (the “StockBlock ATM Agreement”) with Rodman & Renshaw LLC and StockBlock Securities LLC, as agent, pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $75,000, through a sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated March 18, 2024 and prospectus supplement dated September 1, 2021. The Company will pay the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the StockBlock ATM Agreement. As of December 31, 2024 no shares had been issued under the StockBlock ATM Agreement. |
| c. | As of December 31, 2024, the Company had outstanding warrants exercisable starting February 25, 2020 for 20,000 shares of common stock at an exercise price of $4.13 per share and expiring on April 15, 2029. |
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 9 - STOCKHOLDERS’ EQUITY (continued):
The following table presents the warrant activity for the years ended December 31, 2024 and 2023:
| Year ended December 31, | ||||||||||||||||
| 2024 | 2023 | |||||||||||||||
| Warrants | Weighted- Average Exercise Price |
Warrants | Weighted- Average Exercise Price |
|||||||||||||
| Warrants outstanding at beginning of year | 20,000 | $ | 4.13 | 150,705 | $ | 4.71 | ||||||||||
| Issued | - | $ | - | - | $ | - | ||||||||||
| Exercised | - | $ | - | - | $ | - | ||||||||||
| Expired | - | $ | - | (130,705 | ) | $ | 4.80 | |||||||||
| Warrants outstanding at end of year | 20,000 | $ | 4.13 | 20,000 | $ | 4.13 | ||||||||||
| Warrants exercisable at end of year | 20,000 | $ | 4.13 | 20,000 | $ | 4.13 | ||||||||||
| d. | Buyback program |
In June 2024, the Company’s board of directors authorized a stock buyback program pursuant to which the Company may, from time to time, repurchase and retire up to $20,000 in maximum value of its common stock. The stock buyback program does not obligate the Company to purchase any shares and expires in 12 months. The authorization for the stock buyback program may be terminated, increased or decreased by the Company’s board of directors in its discretion at any time.
During 2024, the Company repurchased and retired 1,036,976 shares of its common stock under this program for approximately $2,494, including $10 excise tax, at an average price of $2.36 per share. All repurchases were funded with cash on hand.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION:
The Company makes awards only under the 2019 Plan, under which, the Company had reserved a pool of 7,500,000 shares of the Company’s common stock which may be issued at the discretion of the board of directors from time to time. Under this 2019 Plan, each option or RSU is exercisable into one share of common stock of the Company. The options may be exercised after vesting and in accordance with vesting schedules which will be determined by the board of directors for each grant. The maximum term of the options and RSUs is 10 years.
The following are the significant stock options, RSUs transactions with employees and board members made during the years ended December 31, 2024 and 2023:
| a. | On April 17, 2023, the Company granted an aggregate of 868,500 RSUs representing a right to receive shares of the Company’s common stock to executive officers and board members of the Company. The RSUs will vest in twelve equal quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $1,980, using the quoted closing market share price of $2.28 on the Nasdaq Capital Market on the date of grant. |
| b. | On April 17, 2023, the Company granted an aggregate of 245,500 performance based RSUs (“PSUs”) representing a right to receive shares of the Company’s common stock to executive officers of the Company. The PSUs vested on May 26, 2023, upon the Company’s common stock achieving and maintaining a specified price per share. The total fair value of these PSUs on the date of grant was $550, using the Monte-Carlo model. |
| c. | On May 1, 2023, the Company granted an aggregate of 20,000 RSUs representing a right to receive shares of the Company’s common stock to a new board member. The RSUs will vest in twelve quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $49, using the quoted closing market share price of $2.45 on the Nasdaq Capital Market on the date of grant. |
| d. | On January 4, 2024, the Company granted an aggregate of 941,500 RSUs representing a right to receive shares of the Company’s common stock to executive officers of the Company. The RSUs will vest in twelve equal quarterly installments starting January 8, 2024. The total fair value of these RSUs on the date of grant was $2,250 using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION (continued):
| e. | On January 4, 2024, the Company granted 294,000 PSUs representing a right to receive shares of the Company’s common stock to executive officers of the Company. The total amount of the PSUs shall vest when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo model, based on the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| f. | On January 4, 2024, the Company granted an aggregate of 187,610 RSUs representing a right to receive shares of the Company’s common stock to board members of the Company. 37,610 RSUs will vest in three equal quarterly installments starting April 1, 2024. 150,000 RSUs will vest in three equal annual installments starting January 1, 2025. The total fair value of these RSUs on the date of grant was $448, using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| g. | On January 30, 2024, the Company granted an aggregate of 3,750 RSUs representing a right to receive shares of the Company’s common stock to board member of the Company. The RSUs will vest in four equal quarterly installments starting April 1, 2024. The total fair value of these RSUs on the date of grant was $11, using the quoted closing market share price of $2.98 on the Nasdaq Capital Market on the date of grant. |
| h. | On April 17, 2024, the Company granted an aggregate of 29,800 RSUs representing a right to receive shares of the Company’s common stock to board member of the Company. 7,300 RSUs will vest in three equal quarterly installments starting July 1, 2024. 22,500 RSUs will vest in three equal annual installments starting January 1, 2025. The total fair value of these RSUs on the date of grant was $69, using the quoted closing market share price of $2.33 on the Nasdaq Capital Market on the date of grant. |
| i. | On June 20, 2024, the Company granted 34,000 PSUs representing a right to receive shares of the Company’s common stock to the Company’s Chief Financial Officer. The total amount of the PSUs shall vest upon the later of (i) June 18, 2026 and (ii) when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $73, using the Monte-Carlo model, based on the quoted closing market share price of $2.21 on the Nasdaq Capital Market on the date of grant. |
| j. | On June 21, 2024, 140,040 RSUs representing a right to receive shares of the Company’s common stock were granted to executive officer. 93,360 shall vest in one installment on June, 18 2026 and 46,680 shall vest in four equal quarterly installments starting September 9, 2026. The total fair value of these RSUs on the date of grant was $305, using the quoted closing market share price of $2.18 on the Nasdaq Capital Market on the date of grant. |
| k. | On November 11, 2024, the Company granted an aggregate of 135,000 RSUs representing a right to receive shares of the Company’s common stock to executive officers of the Company. The RSUs vested on the date of grant. The total fair value of these RSUs on the date of grant was $321, using the quoted closing market share price of $2.38 on the Nasdaq Capital Market on the date of grant. |
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION (continued):
| l. | Options to employees, directors and non-employees |
A summary of the status of the stock options granted to employees and directors as of December 31, 2024 and 2023 and changes during the years ended on those dates, is presented below:
| Year ended December 31, | ||||||||||||||||
| 2024 | 2023 | |||||||||||||||
| Number of options |
Weighted average exercise price |
Number of options |
Weighted average exercise price |
|||||||||||||
| $ | $ | |||||||||||||||
| Options outstanding at beginning of year | 1,909,676 | 8.03 | 2,041,676 | 8.47 | ||||||||||||
| Changes during the year: | ||||||||||||||||
| Granted | - | - | ||||||||||||||
| Forfeited | (49,125 | ) | 13.92 | (132,000 | ) | 14.81 | ||||||||||
| Expired | (199,543 | ) | 13.40 | - | - | |||||||||||
| Exercised | - | - | - | - | ||||||||||||
| Options outstanding at end of year | 1,661,008 | 7.21 | 1,909,676 | 8.03 | ||||||||||||
| Options exercisable at end of year | 1,442,258 | 6.91 | 1,479,426 | 7.15 | ||||||||||||
Expenses recognized in respect of stock options granted to employees and directors, for the years Ended December 31, 2024 and 2023, were $213 and $811, respectively.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION (continued):
| m. | Options to employees, directors and non-employees |
The following table presents summary information concerning the options granted to employees and directors outstanding as of December 31, 2024:
| Exercise prices $ | Number outstanding | Weighted Average Remaining Contractual Life Years |
Weighted average exercise price $ |
|||||||||
| 1-6 | 840,500 | 4.83 | 3.94 | |||||||||
| 6.23-9.12 | 283,008 | 2.80 | 7.96 | |||||||||
| 10.40-20.19 | 537,500 | 6.50 | 11.94 | |||||||||
| 1,661,008 | 5.02 | 7.21 | ||||||||||
As of December 31, 2024, there were $122 of unrecognized compensation costs related to non-vested options previously granted to employees and directors. The unrecognized compensation costs are expected to be recognized over a weighted average period of 0.6 years.
47,000 options granted to non-employees were outstanding and exercisable as of December 31, 2024 and 2023. The Company recorded no stock-based compensation related to non-employees’ awards during the years ended December 31, 2024 and 2023. During the years ended December 31, 2024 and 2023, no options were exercised.
As of December 31, 2024, there were no unrecognized compensation costs related to non-vested options previously granted to non-employees.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION (continued):
| m. | Options to employees, directors and non-employees (continued): |
The following table presents summary information concerning the options granted to non-employees outstanding as of December 31, 2024:
| Range of exercise prices $ |
Number outstanding | Weighted Average Remaining Contractual Life Years |
Weighted Average Exercise Price $ |
|||
| 3.74-5.08 | 47,000 | 4.98 | 4.31 |
| n. | Restricted stock units |
The following table summarizes the activities for unvested RSUs and PSUs granted to employees and directors for the years ended December 31, 2024 and 2023:
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Number of RSUs | ||||||||
| Outstanding at the beginning of year | 1,834,362 | 1,561,570 | ||||||
| Changes during the year: | ||||||||
| Granted | 1,792,460 | 1,134,000 | ||||||
| Issued | (617,542 | ) | (574,791 | ) | ||||
| Forfeited | (405,945 | ) | (286,417 | ) | ||||
| Expired | (50,770 | ) | - | |||||
| Outstanding at the end of the year | 2,552,565 | 1,834,362 | ||||||
| Vested during the year | 925,937 | 521,625 | ||||||
| Vested and unissued at year end | 520,531 | 212,136 | ||||||
The Company recorded compensation expenses related to RSUs of $3,787 for the year ended December 31, 2024 and $3,210 for the year ended December 31, 2023.
As of December 31, 2024, there were unrecognized compensation costs of $1,630 related to RSUs. The unrecognized compensation costs are expected to be recognized over a weighted average period of 0.68 year.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - STOCK-BASED COMPENSATION (continued):
| n. | Restricted stock units (continued): |
The Company recorded compensation expenses related to RSUs granted to non-employees of $26 for the year ended December 31, 2023. No compensation expenses recorded for the year ended December 31, 2024.
As of December 31, 2024, there were no unrecognized compensation costs related to RSUs.
The Company recorded total compensation expenses of $4,053 and $4,212 for the years ended December 31, 2024 and 2023, respectively. $1,998 and $1,718 were included in Research and Development expenses, $2,055 and $2,933 were included in General and Administrative expenses and $0 and $(440) were included in Sales and Marketing for the years ended December 31, 2024 and 2023, respectively.
For additional information regarding RSUs and PSUs granted in 2025, see note 15.
NOTE 11 - FINANCIAL INCOME AND EXPENSES:
| a. | Financial income |
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Income from interest on deposits | $ | 4,128 | $ | 8,016 | ||||
| Exchange rate differences, net | 174 | - | ||||||
| Income from interest on corporate bonds | - | 10 | ||||||
| Revaluation of investments, net | - | 16,461 | ||||||
| Money Market Interest Income | 870 | 143 | ||||||
| Other | 67 | - | ||||||
| $ | 5,239 | $ | 24,630 | |||||
| b. | Financial expenses |
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Exchange rate differences, net | $ | - | $ | 124 | ||||
| Bank and broker commissions | 15 | 29 | ||||||
| Revaluation of securities, net | 3,114 | 69 | ||||||
| Revaluation of investments, net (see note 4) | 4,302 | - | ||||||
| Fees regarding Scilex transaction | 94 | 1,514 | ||||||
| Interest expenses | 853 | 2,037 | ||||||
| $ | 8,378 | $ | 3,773 | |||||
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 12 - TAXES ON INCOME:
Taxes on income included in the consolidated statements of comprehensive income (loss) represent current taxes due to taxable income of the Company.
| a. | Corporate taxation in the U.S. |
The applicable corporate tax rate for the Company is 21%.
As of December 31, 2024, the Company has utilized all of its outstanding net operating loss (“NOL”). Oravax had an accumulated tax loss carryforward of approximately $3,386 (as of December 31, 2023, $3,374). Under U.S. tax laws, subject to certain limitations, carryforward tax losses originating in tax years beginning after January 1, 2018, have no expiration date, but they are limited to 80% of the company’s taxable income in any given tax year. Carryforward tax losses originating in tax years beginning prior to January 1, 2018, expire 20 years after the year in which incurred.
| b. | Corporate taxation in Israel |
The Subsidiary is taxed in accordance with Israeli tax laws. The corporate tax rate applicable to 2024 and 2023 is 23%.
As of December 31, 2024, the Subsidiary and Oravax Medical Ltd. had an accumulated tax loss carryforward of approximately $114,000 (as of December 31, 2023, approximately $102,000). Under the Israeli tax laws, carryforward tax losses have no expiration date.
| c. | Deferred income taxes |
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| In respect of: | ||||||||
| Net operating loss carryforward | $ | 26,797 | $ | 27,757 | ||||
| Research and development expenses | 1,220 | 2,731 | ||||||
| Revaluation of investments | 5,608 | (2,611 | ) | |||||
| Other temporary differences | 2,495 |
596 | ||||||
| Less - valuation allowance | (36,120 | ) | (28,473 | ) | ||||
| Net deferred tax assets | $ | $ | ||||||
Deferred taxes are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carryforwards are expected to be available to reduce taxable income. As the achievement of required future taxable income is uncertain, the Company recorded a full valuation allowance.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 12 - TAXES ON INCOME (continued):
| d. | Income (Loss) before taxes on income and income taxes included in the consolidated statements of comprehensive income (loss) |
| Year ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Income (loss) before taxes on income: | ||||||||
| U.S. | $ | (8,853 | ) | $ | 11,604 | |||
| Outside U.S. | (7,067 | ) | (6,516 | ) | ||||
| $ | (15,920 | ) | $ | 5,088 | ||||
| Taxes on income (tax benefit): | ||||||||
| Current: | ||||||||
| U.S. (*) | 3,183 | |||||||
| Outside U.S. | ||||||||
| $ | 3,183 | $ | ||||||
| (*) | Based on anticipated gains from the 2023 Scilex Transaction and 2024 Refinancing, the Company anticipates taxable income for the year ending December 31, 2024. As a result, the Company fully utilized its tax loss carryforward and incurred associated tax expenses. During the year ended December 31, 2024, the Company recognized tax expenses of $3,194. Tax provision of $3,194 has been classified to Accounts payable and accrued expenses. |
| e. | Reconciliation of the statutory tax benefit to effective tax expense |
Following is a reconciliation of the theoretical tax expense, assuming all income is taxed at the regular tax rates applicable to companies in the United States, and the actual tax expense:
| Year ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Income (loss) before income taxes as reported in the consolidated statement of comprehensive income (loss) | $ | (15,920 | ) | $ | 5,088 | |||
| Statutory tax (benefit) expense – 21% | (3,343 | ) | 1,068 | |||||
| Increase (decrease) in income taxes resulting from: | ||||||||
| Change in the balance of the valuation allowance for deferred tax | 7,647 | (4,332 | ) | |||||
| Disallowable deductions | (878 | ) | 731 | |||||
| Influence of different tax rate applicable to the Subsidiary and Oravax Medical Ltd. | (219 | ) | (305 | ) | ||||
| Prior year adjustments | (13 | ) | 2,838 | |||||
| Uncertain tax position | (11 | ) | ||||||
| Taxes on income for the reported year | $ | 3,183 | $ | |||||
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 12 - TAXES ON INCOME (continued):
| f. | Uncertainty in Income Taxes |
ASC 740, “Income Taxes” requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of the effective tax rate and consequently, affect the operating results of the Company. The Company recognizes interest and penalties related to its tax contingencies as income tax expense.
The following table summarizes the activity of the Company unrecognized tax benefits:
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| Balance at Beginning of Year | $ | 11 | $ | 11 | ||||
| Decrease in uncertain tax positions for the current year | (11 | ) | - | |||||
| Balance at End of Year | $ | - | $ | 11 | ||||
The Company does not expect unrecognized tax expenses to change significantly over the next 12 months.
The Company is subject to U.S. Federal income tax examinations for the tax years of 2020 through 2023.
The Subsidiary is subject to Israeli income tax examinations for the tax years of 2019 through 2023.
| g. | Valuation Allowance Rollforward |
| Year ended | ||||||||||||
| Balance at beginning of year |
Additions (deductions) |
Balance at end of year |
||||||||||
| Allowance in respect of carryforward tax losses: | ||||||||||||
| Year ended December 31, 2024 | $ | 28,473 | $ | 7,647 | $ | 36,120 | ||||||
| Year ended December 31, 2023 | 32,805 | (4,332 | ) | 28,473 | ||||||||
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 13 - SEGMENT REPORTING:
The Company’s Chief Executive Officer, serving as the Chief Operating Decision Maker (CODM), evaluates operational performance and makes resource allocation decisions based on net income (loss), which is reported in the consolidated statements of comprehensive income (loss). The Company has determined that it operates in a single reportable segment, focused on research and development activities related to its proprietary products and technologies.
The CODM monitors budgeted versus actual net income (loss), using this measure to assess segment performance and guide financial planning, which is consistent with the financial statements. In addition to its research and development activities, the Company holds financial investments, including a material investment in Scilex, see note 4. The CODM monitors these investments separately from operational performance. Income and expenses related to financial instruments are reported as finance income (expenses) in the consolidated statements of comprehensive income (loss), reflecting their distinct nature from core business operations.
NOTE 14 - RELATED PARTY TRANSACTIONS:
| a. | On July 1, 2008, the Subsidiary entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the Chief Scientific Officer, whereby the President and Chief Executive Officer and the Chief Scientific Officer, through KNRY, provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days, prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the Consulting Agreements and that the monthly consulting fee paid to the President and Chief Executive Officer and the Chief Scientific Officer is NIS 146,705 ($40) and NIS 106,400 ($29), respectively. |
Following the relocation of the President and Chief Executive Officer to the State of Israel, the Company entered into two agreements with the President and Chief Executive Officer, replacing his above-mentioned consulting agreement through KNRY, substantially on the same terms, in order to allocate his time and services between the Company and the Subsidiary.
Effective as of January 1, 2024, the monthly consulting fee of the Chief Scientific Officer is NIS 117,040 ($32). Effective as of July 1, 2024, the monthly consulting fee of the Chief Scientific Officer is NIS 134,550 ($37).
Effective November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd. (“Shnida”), whereby the President and Chief Executive Officer, through Shnida, provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that Shnida will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. Effective as of January 1, 2024, the President and Chief Executive Officer receives a monthly consulting fee of NIS 96,825 ($26). Effective as of July 1, 2024, the monthly consulting fee of the President and Chief Executive Officer is NIS 111,349 ($31). Pursuant to the agreement, Shnida and the President and Chief Executive Officer each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company.
In addition, the Company, through the Subsidiary, has entered into an employment agreement with the President and Chief Executive Officer, effective as of November 1, 2022, pursuant to which, effective as of January 1, 2024, the President and Chief Executive Officer receives gross monthly salary of NIS 51,591 ($14) in consideration for his services as President and Chief Executive Officer of the Subsidiary. Effective as of July 1, 2024, the President and Chief Executive Officer receives gross monthly salary of NIS 59,330 ($16) in consideration for his services as President and Chief Executive Officer of the Subsidiary. In addition, the President and Chief Executive Officer is provided with a phone and a company car pursuant to the terms of his agreement.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 14 - RELATED PARTY TRANSACTIONS (continued):
| b. | Balances with related parties: |
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Accounts payable and accrued expenses - Shnida | $ | 175 | $ | 160 | ||||
| Accounts payable and accrued expenses - KNRY | 154 | 165 | ||||||
| Total payable to related parties | $ | 329 | $ | 325 | ||||
| c. | Expenses to related parties: |
| Year
ended December 31, |
||||||||
| 2024 | 2023 | |||||||
| KNRY | $ | 563 | $ | 486 | ||||
| Shnida | 514 | 445 | ||||||
| Nadav Kidron (President and Chief Executive Officer) | $ | 297 | $ | 296 | ||||
NOTE 15 - SUBSEQUENT EVENTS:
| A. | RSUs granted |
On January 2, 2025, the Company granted 1,023,000 RSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers. The total amount of the RSUs shall vest in equal quarterly installments of approximately 85,249 over a three year period starting with the first quarterly vesting on January 1, 2025. The total fair value of these RSUs on the date of grant was $2,465 based on the quoted closing market share price of $2.41 on the Nasdaq Capital Market on the date of grant.
| B. | PSUs granted |
On January 2, 2025, the Company granted 328,500 PSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers. The total amount of the PSUs shall vest upon at the earliest of (1) the closing of a joint venture (“JV”) transaction with HTIT; or (2) the repayment to the Company of the value of its principal investment in Scilex plus 10%. The total fair value of these PSUs on the date of grant was $792 based on the quoted closing market share price of $2.41 on the Nasdaq Capital Market on the date of grant.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 15 - SUBSEQUENT EVENTS (continued):
| B. | PSUs granted (continued): |
The Company modified 294,000 outstanding PSUs that were granted to the Company’s Executive Officers, adjusting the vesting criteria and performance targets. The Company will recognize stock-based compensation expense equal to the unrecognized grant-date fair value of the original award plus any incremental fair value arising from the modification over the remaining requisite service period.
As of March 27, 2025, all PSUs that granted to the Company’s Executive Officers achieved the first updated performance target.
| C. | Scilex investment |
Tranche B Note Consent
On January 2, 2025, the Company and other Tranche B Noteholders entered into deferral and consent agreements with Scilex (the “Tranche B Consent”), deferring Scilex’s first amortization payment under the Tranche B Note to October 8, 2026. In consideration, the Company received $877 ($555 of the principal amount and $322 accrued interest), and 2,500,000 Scilex Common Stock shares.
In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
| ● | Scilex and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales of Gloperba and Elyxyb, excluding Elyxyb sales in Canada, with the Company entitled to 2%. Gloperba, an oral liquid colchicine formulation for gout, and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s portfolio. The agreement was signed on February 28, 2025. | |
| ● | The Tranche B Noteholders have the option to fund up to 50% of the cash purchase price for Ex-US Product Rights to Gloperba and Elyxyb (excluding Elyxyb in Canada) and will receive proportional revenues from commercialization and licensing. | |
| ● | Scilex granted the Tranche B Noteholders exclusive rights to develop and commercialize Elyxyb in Canada, entitling them to 50% of net revenue. |
Tranche A Note Maturity Date Extension Amendment
On January 21, 2025, the Company entered into an amendment to the Tranche A Note (the “Tranche A Extension Amendment”), extending the maturity date from March 21, 2025, to December 31, 2025 (the “Extended Maturity Date”). Interest will continue to accrue and be payable on the Extended Maturity Date. In consideration of the extension, the Company received 3,250,000 shares of Scilex Common Stock.
Lidocaine License Agreement
As part of the binding term sheet signed with Scilex under the Tranche B Note, on February 22, 2025, the Company, through its 50% ownership in RoyaltyVest, entered into an additional License Agreement with Scilex. Under this agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products, including ZTlido (lidocaine topical system 1.8%) and SP-103, outside the United States. As part of the arrangement, RoyaltyVest and Scilex will each receive 50% of the net profits from the commercialization of these products. Given the Company’s 50% ownership in RoyaltyVest, Oramed effectively holds a 25% share in the profits generated under this agreement.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 15 - SUBSEQUENT EVENTS (continued):
| D. | Real Estate – Castel |
In January 2025, the Company entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800 ($1,586). The transaction is structured in installments, and as of March 27, 2025, the Company has paid $1,210 toward the acquisition price. Under the agreement, the developer is responsible for executing all development-related activities, and the company and the developer will share the profits upon the future sale of the property. The Company is currently evaluating the appropriate accounting treatment.
| E. | JV Supplemental Agreement |
On February 7, 2025, the Company and HTIT entered into a Joint Venture Agreement (the “JV Agreement”), amending the original agreement signed on January 22, 2024. The JV was formed to advance the development and commercialization of oral insulin, combining the Company’s proprietary technology and funding with HTIT’s manufacturing capabilities. Through this partnership, the JV will have the technology, resources, and production capacity to bring oral insulin to market.
The initial closing, set for April 30, 2025, includes an investment of $40,000 by HTIT and $7,500 by the Company into OraTech. Additionally, the Company will transfer all its intellectual property rights to OraTech. Upon completion, both HTIT and the Company will receive OraTech shares.
The second closing, contingent on Nasdaq listing approval, involves a $20,000 investment by HTIT and an additional $7,500 investment by the Company. It is expected to close by May 31, 2025, but no later than September 1, 2025.
The agreement also outlines the spin-off of OraTech, requiring regulatory filings and the distribution of at least 60% of the Company’s stake in OraTech to its shareholders. Both the Company and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.
As part of the JV Agreement, HTIT will receive $20,000 at the initial closing and $10,000 at the second closing under a Supply Agreement with OraTech.
| F. | IIA Payment |
on February 18, 2025, the Company received approval from the Israel Innovation Authority (IIA) to transfer all of its IIA-funded technology to OraTech in accordance with the terms of the JV agreement. This approval was granted upon the condition that the Company pays the aggregate IIA grant amount, plus accrued interest, less all royalties paid to date.
On February 27, 2025, the Company fulfilled its payment obligation by remitting $2,031 to the IIA, and as result the Company has no further obligations to the IIA.
F-
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 15 - SUBSEQUENT EVENTS (continued):
| G. | BioXcel |
On March 4, 2025, the Company, through RoyaltyVest, participated in a registered direct offering by BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (“BioXcel”), acquiring 2,000,000 shares of BioXcel’s common stock and accompanying warrants to purchase up to an additional 2,000,000 shares. The shares and warrants were purchased at a combined offering price of $3.50 per share and warrant, representing 50% of the total 4,000,000 shares issued in the offering. The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the date of issuance.
BioXcel is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.
As of March 27, 2025, the Company, through RoyaltyVest, has sold 869,992 shares and continues to hold 1,130,008 shares of BioXcel common stock.
| H. | Real Estate Transactions |
On March 24, 2025, the Company entered into a loan agreement to finance a purchase of a real estate asset in Jerusalem Israel in the amount of $22,650. The loan has a one-year maturity and is secured by a first-ranking mortgage on a property valued at approximately $800,000, providing significant collateral coverage. The loan bears an annual interest rate of 12%.
F-
| (b) | Exhibits |
| * | Filed herewith. |
| ** | Furnished herewith. |
| + | Management contract or compensation plan. |
| § | Certain exhibits and similar attachments to this agreement have been omitted in accordance with Item 601(a)(5) of Regulation S-K. A copy of any omitted exhibit or other attachment will be furnished supplementary to the SEC upon request. |
ITEM 16. FORM 10-K SUMMARY.
None.
SIGNATURES
Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ORAMED PHARMACEUTICALS INC. | |
| /s/ Nadav Kidron | |
| Nadav Kidron, | |
| President and Chief Executive Officer | |
| Date: March 27, 2025 |
Pursuant to the requirements of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| /s/ Nadav Kidron | March 27, 2025 | |
| Nadav Kidron, | ||
| President and Chief Executive Officer and Director | ||
| (principal executive officer) | ||
| /s/ Avraham Gabay | March 27, 2025 | |
| Avraham Gabay, | ||
| Chief Financial Officer | ||
| (principal financial and accounting officer) | ||
| /s/ Daniel Aghion | March 27, 2025 | |
| Daniel Aghion, | ||
| Director | ||
| /s/ Miriam Kidron | March 27, 2025 | |
| Miriam Kidron, | ||
| Director | ||
| /s/ Arie Mayer | March 27, 2025 | |
| Arie Mayer, | ||
| Director | ||
| /s/ Yehuda Reznick | March 27, 2025 | |
| Yehuda Reznick, | ||
| Director | ||
| /s/ Leonard Sank | March 27, 2025 | |
| Leonard Sank, | ||
| Director | ||
| /s/ Benjamin Shapiro | March 27, 2025 | |
| Benjamin Shapiro, | ||
| Director |
74
Exhibit 3.2
ORAMED PHARMACEUTICALS INC.
FOURTH AMENDED AND RESTATED BY-LAWS
ARTICLE I
OFFICES
1. The location of the registered office of the Corporation, and the name of its registered agent, shall be as set forth in the Certificate of Incorporation.
2. The Corporation shall in addition to its registered office in the State of Delaware establish and maintain an office or offices at such place or places as the Board of Directors may from time to time find necessary or desirable.
ARTICLE II
CORPORATE SEAL
The Corporation may or may not have a corporate seal, as may be determined from time to time by the Board of Directors. If adopted, the corporate seal of the Corporation shall have inscribed thereon the name of the Corporation and may be in such form as the Board of Directors may determine. Such seal may be used by causing it or a facsimile thereof to be impressed, affixed or otherwise reproduced.
ARTICLE III
MEETINGS OF STOCKHOLDERS
1. All meetings of the stockholders shall be held at the registered office of the Corporation in the State of Delaware or at such other place, as shall be determined from time to time by the Board of Directors. The Board of Directors may, in its sole discretion, determine that any meeting of the stockholders shall not be held at any place, but may instead be held solely by means of remote communication in accordance with Section 211 of the General Corporation Law of the State of Delaware.
2. The annual meeting of stockholders shall be held on such day and at such time as may be determined from time to time by resolution of the Board of Directors, when they shall elect, by majority vote pursuant to Section 5 of this Article III, directors to hold office until the annual meeting of stockholders held next after their election and their successors are respectively elected and qualified, or until their earlier death, disqualification, resignation or removal; provided, however, that in a contested election, a nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors. An election shall be considered contested if, as of the last date on which nominees for director may be submitted in accordance with these By-laws, the nominees for election to the Board of Directors exceeds the number of positions on the Board of Directors to be filled by election at that meeting. If an incumbent director is not re-elected, the director shall tender his or her resignation to the Board of Directors. The Nominating and Corporate Governance Committee of the Board of Directors (or any future committee the equivalent thereof) will make a recommendation to the Board of Directors on whether to accept or reject the resignation, or whether other action should be taken. The Board of Directors will act on the recommendation of such committee and will publicly disclose its decision within ninety (90) days from the date of the certification of the election results. A director who tenders his or her resignation may not participate in any meeting of the Board of Directors or any committee thereof until the Board of Directors has determined not to accept his or her resignation. Any other proper business may be transacted at the annual meeting.
3. The holders of at least one third (1/3) of the stock issued and outstanding and entitled to vote on the subject matter, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business, except as otherwise expressly provided by statute, by the Certificate of Incorporation or by these By-laws. If, however, such holders shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote on the subject matter, present in person or by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting (except as otherwise provided by statute). At such adjourned meeting at which a quorum is present, any business may be transacted which might have been transacted at the meeting as originally notified.
4. At all meetings of the stockholders each stockholder having the right to vote on the subject matter shall be entitled to vote in person, or by proxy, but no proxy shall be voted or acted upon more than three years after its date, unless the proxy provides for a longer period.
5. Unless otherwise provided in the Certificate of Incorporation, at each meeting of the stockholders each stockholder shall have one vote for each share of capital stock having voting power, registered in his or her name on the books of the Corporation at the record date fixed for voting in accordance with these By-laws, or otherwise determined, with respect to such meeting. Unless a different or minimum vote is required by law or regulation applicable to the Corporation or its securities, by the Certificate of Incorporation, by these By-laws or by the rules or regulations of any stock exchange applicable to the Corporation, in which case such different or minimum vote shall be the applicable vote on the matter, all matters coming before any meeting of the stockholders, including the election of directors, shall be decided by a majority of the votes cast by the holders of shares of stock present in person or represented by proxy at such meeting and entitled to vote on the subject matter, a quorum being present; provided, however, that in a contested election, a nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors. Votes cast shall include votes “for” and votes “against” and exclude “abstentions” and “broker non-votes” with respect to the subject matter.
6. Notice of each meeting of the stockholders shall be given to each stockholder entitled to vote thereat not less than ten (10) nor more than sixty (60) days before the date of the meeting. Such notice shall state the place, date and hour of meeting, the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the meeting, the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
7. The Corporation shall prepare, no later than the tenth (10th) day before each meeting of stockholders, a complete list of the stockholders entitled to vote at said meeting (provided, however, if the record date for determining the stockholders entitled to vote is less than ten (10) days before the date of the meeting, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date), arranged in alphabetical order, showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting for a period of 10 days ending on the day before the meeting date, (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (b) during ordinary business hours, at the principal place of business of the Corporation. In the event that the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation.
8. Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute, may be called by the majority of the Board of Directors, but such meetings may not be called by any other person or persons.
9. Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the Corporation’s notice of meeting.
10. The order of business at each meeting of stockholders shall be determined by the person presiding over the meeting.
11. (a) In order that the Corporation may determine the stockholders entitled to consent to corporate action by consent and without a meeting of stockholders, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which date shall not be more than ten (10) days after the date upon which the resolution fixing the record date is adopted by the Board of Directors. Any stockholder of record seeking to have the stockholders authorize or take corporate action by consent in lieu of a meeting of stockholders shall, by written notice delivered to the Secretary of the Corporation at the principal executive offices of the Corporation, request that the Board of Directors fix a record date. The written notice must contain the information set forth in Section 11(b) of this Article III. The Board of Directors shall promptly, but in all events within ten (10) days after the date on which such written notice is received by the Secretary of the Corporation, determine the validity of the request, and if appropriate, adopt a resolution fixing the record date (unless a record date has previously been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III). If no record date has been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III or otherwise within ten (10) days after the date on which such written notice is received by the Secretary of the Corporation, the record date for determining stockholders entitled to consent to corporate action by consent and without a meeting, when no prior action by the Board of Directors is required by applicable law, shall be the first date after the expiration of such ten (10) day time period on which a signed consent setting forth the action taken or proposed to be taken is delivered to the Corporation by delivery to its registered office in Delaware by hand or by certified or registered mail, return receipt requested, to its principal place of business or to any officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded. If no record date has been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III and prior action by the Board of Directors is required by applicable law, the record date for determining stockholders entitled to consent to corporate action by consent and without a meeting shall be at the close of business on the date on which the Board of Directors adopts the resolution taking such prior action.
(b) Any stockholder’s notice required by Section 11(a) of Article III must describe the action that the stockholder proposes to take by consent. For each such proposal, every notice by a stockholder must state (x) the information required by Section 2 of Article IV and Section 2 of Article V as though such stockholder was intending to make a nomination or to bring any such business before a meeting of stockholders and (y) the text of the proposal (including the text of any resolutions to be effected by consent and the language of any proposed amendment to these By-Laws). In addition to the foregoing, the notice must state as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the notice is given a representation whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends to (x) deliver a proxy statement and/or consent solicitation statement to stockholders of at least the percentage of the Corporation’s outstanding capital stock required to effect the action by consent either to solicit consents or to solicit proxies to execute consents, and/or (y) otherwise solicit proxies or consents from stockholders in support of the action to be taken by consent. The Corporation may require the stockholder of record and/or beneficial owner requesting a record date for proposed stockholder action by consent to furnish such other information as it may reasonably require to determine the validity of the request for a record date.
(c) In the event of the delivery, in the manner provided by this Section 11 of Article III and applicable law, to the Corporation of consent or consents to take corporate action and/or any related revocation or revocations, the Corporation shall engage independent inspectors of elections for the purpose of performing promptly a ministerial review of the validity of the consents and any consent revocations. For the purpose of permitting the inspectors to perform such review, no stockholder action by consent and without a meeting shall be effective until such inspectors have completed their review, determined that the requisite number of valid and unrevoked consents delivered to the Corporation in accordance with this Section 11 of Article III and applicable law have been obtained to authorize or take the action specified in the consents, and certified such determination for entry in the records of the Corporation kept for the purpose of recording the proceedings of meetings of stockholders. Nothing contained in this Section 11(c) of Article III shall in any way be construed to suggest or imply that the Board of Directors or any stockholder shall not be entitled to contest the validity of any consent or revocation thereof, whether before or after such certification by the independent inspectors, or to take any other action (including, without limitation, the commencement, prosecution or defense of any litigation with respect thereto, and the seeking of injunctive relief in such litigation).
(d) No stockholder consent to corporate action without a meeting of stockholders shall be effective to take the corporate action referred to therein unless, within sixty (60) days after the first date a consent is delivered in accordance with this Section 11 of Article III, a valid consent or valid consents signed by a sufficient number of stockholders to take such action are delivered to the Corporation in the manner prescribed in this Section 11 of Article III and applicable law, and not revoked.
ARTICLE IV
STOCKHOLDER PROPOSALS
1. At an annual meeting of stockholders, only such stockholder business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting of stockholders, stockholder business (other than the nominations of persons for election to the Board of Directors, which shall be set forth in Article V) must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article IV is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article IV. In addition, any proposal of stockholder business (other than the nomination of persons for election to the Board of Directors) must be a proper matter for stockholder action.
2. For business (other than the nomination of persons for election to the Board of Directors, which shall be governed by Article V herein) to be properly brought before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose the business must deliver a timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
(i) to be timely, the advance notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first anniversary date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date that is more than thirty (30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual meeting of stockholders, including in the event that no annual meeting was held in the previous year), notice by the proponent stockholder in order to be timely must be so delivered, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation, not earlier than the close of business on the 120th day prior to the annual meeting and not later than the close of business on the later of the 90th day prior to the date of such annual meeting or, if the first “Public Announcement” (as hereinafter defined in Section 9 of Article V) of the date of such annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s notice as described above;
(ii) in addition, to be timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business days after the record date for the meeting (in the case of the update and supplement required to be made as of the record date), and not later than eight (8) business days prior to the date for the meeting, or if the meeting is adjourned or postponed, on the first practicable date after any adjournment or postponement thereof (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof);
(iii) the proponent stockholder must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the Corporation’s books and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
(iv) the proponent stockholder must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of capital stock or other securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares of capital stock or other securities of the Corporation or with a price or value derived in whole or in part from the price or value of any shares of capital stock or other securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction or arrangement having characteristics of a long or short position or ownership interest in any shares of capital stock or other securities of the Corporation, whether or not any such instrument or right shall be subject to settlement in the underlying shares of capital stock or other securities of the Corporation or otherwise, and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the price or value of shares of capital stock or other securities of the Corporation directly or indirectly owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement, arrangement, understanding or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any shares of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding or relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent stockholder has engaged in or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the economic risk of shares of capital stock or other securities of the Corporation by, manage the risk of share price changes for, or increase or decrease the voting power of, such proponent stockholder with respect to shares of capital stock or other securities of the Corporation, or which provides, directly or indirectly, the opportunity to profit from any increase or decrease in the price or value of the shares of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated or separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the proponent stockholder, directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any interests described in clause (d), (g) any proportionate interest in any security of the Corporation or derivative instruments held, directly or indirectly, by a general or limited partnership or limited liability company or similar entity in which a proponent stockholder is a general partner or, directly or indirectly, beneficially owns any interest in a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the manager or managing member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the last 12 months in any security of the Corporation (for purposes of these By-Laws, a person shall be deemed to have a “Short Interest” in a security if such person, directly or indirectly, though any contract, arrangement, understanding, relationship or otherwise, has the opportunity to profit or share in any profit derived from any decrease in the value of the subject security), (i) any direct or indirect legal, economic or financial interest (including Short Interest) of a proponent stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation or (2) any meeting of stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any business proposed by any proponent stockholder under Article IV, (j) any direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative, administrative or otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant involving the Corporation or any of its officers, directors or employees, or any affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the proposal pursuant to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder;
(v) the proponent stockholder must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by the immediately preceding clause (iv) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on whose behalf the business proposed to be brought before the annual meeting is being brought, (b) any affiliate or associate (each within the meaning of Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, (c) any stockholder or stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group for purposes of Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such business;
(vi) the proponent stockholder must represent to the Corporation, as part of the advance notice, whether the proponent intends individually or as part of a group, to (x) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve or adopt the proposal, and/or (y) to otherwise solicit proxies in support of such proposal;
(vii) the proponent stockholder must disclose to the Corporation, as part of its advance notice: (a) a reasonably brief description of the business desired to be brought before the meeting, the reasons for conducting such business at the meeting and any material interest of such stockholder and beneficial owner, if any, in such business, (b) the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the By-Laws of the Corporation, the language of the proposed amendment), and (c) a reasonably detailed description of all agreements, arrangements and understandings between such proponent and the beneficial owner, if any, and any other person or persons (including their names) in connection with the proposal of such business by such stockholder;
(viii) the proponent stockholder must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder is a holder of record of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation entitled to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the stockholder business specified in the notice;
(ix) the proponent stockholder must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the information set forth in the advance notice; and
(x) the proponent stockholder must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial and record owners) known by the proponent stockholder to support the stockholder business to be proposed by the proponent stockholder and, to the extent known, the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
3. In addition to the provisions of Section 2 of this Article IV, a stockholder shall also comply with all applicable requirements of state law and all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
4. Nothing in these By-laws shall be deemed to affect any rights of stockholders to request the inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended. Subject to Rule 14a-8 and Rule 14a-19 under the Securities Exchange Act of 1934, as amended, nothing in these By-laws shall be construed to permit any stockholder, or give any stockholder the right, to include or have disseminated or described in the Corporation’s proxy statement any nomination of director or directors or any other business proposal.
5. Except as otherwise expressly provided in any applicable rule or regulation promulgated under the Securities Exchange Act of 1934, as amended, only such business (other than the election of directors as set forth in Article V) shall be conducted at an annual meeting of stockholders as shall have been brought before the meeting in accordance with the procedures of this Article IV. Except as otherwise provided by law, the chairperson of the meeting shall have the power and duty (i) to determine whether any business proposed to be brought before the meeting was proposed in accordance with the provisions of this Article IV (including whether the proponent stockholder solicited (or are part of a group which solicited) or did not so solicit, as the case may be, proxies or votes in support of the proponent stockholder’s proposal in compliance with the proponent stockholder’s representation as required by clause (vi) of Section 2 of Article IV) and (ii) if any proposed business was not proposed in compliance with Article IV, to declare that such proposed business shall not be transacted. Notwithstanding the foregoing provisions of this Article IV, unless otherwise required by law, if the proponent stockholder (or a qualified representative of the proponent stockholder) does not appear at the annual meeting of stockholders of the Corporation to present the proposed business, such proposed business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 5 of Article IV, to be considered a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
ARTICLE V
STOCKHOLDER DIRECTOR NOMINATIONS
1. At an annual meeting of stockholders, only such nominations of persons for the election of directors shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting of stockholders, nominations of persons for election to the Board of Directors must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article V.
2. Notwithstanding anything in these By-laws to the contrary, for the nomination of persons for election to the Board of Directors to be properly brought before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose such nominations must deliver a timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
(i) to be timely, the advance notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first anniversary date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date that is more than thirty (30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual meeting of stockholders, including in the event that no annual meeting was held in the previous year), notice by the proponent stockholder in order to be timely must be so delivered, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation, not earlier than the close of business on the 120th day prior to the annual meeting and not later than the close of business on the later of the 90th day prior to the date of such annual meeting or, if the first Public Announcement of the date of such annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s notice as described above;
(ii) in addition, to be timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business days after the record date for the meeting (in the case of the update and supplement required to be made as of the record date), and not later than eight (8) business days prior to the date for the meeting, or if the meeting is adjourned or postponed, on the first practicable date after any adjournment or postponement thereof (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof);
(iii) in the event that the number of directors to be elected to the Board of Directors is increased by the Board of Directors, and there is no Public Announcement by the Corporation naming all of the nominees for director or specifying the size of the increased Board of Directors at least one hundred (100) days prior to the first anniversary of the preceding year’s annual meeting, a stockholder’s notice required by Section 2 of this Article V shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than the close of business on the 10th day following the day on which such Public Announcement is first made by the Corporation;
(iv) the proponent stockholder must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the Corporation’s books and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
(v) the proponent stockholder must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of capital stock or other securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares of capital stock or other securities of the Corporation or with a price or value derived in whole or in part from the price or value of any shares of capital stock or other securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction or arrangement having characteristics of a long or short position or ownership interest in any shares of capital stock or other securities of the Corporation, whether or not any such instrument or right shall be subject to settlement in the underlying shares of capital stock or other securities of the Corporation or otherwise, and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the price or value of shares of capital stock or other securities of the Corporation directly or indirectly owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement, arrangement, understanding or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any shares of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding or relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent stockholder has engaged in or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the economic risk of shares of capital stock or other securities of the Corporation by, manage the risk of share price changes for, or increase or decrease the voting power of, such proponent stockholder with respect to shares of capital stock or other securities of the Corporation, or which provides, directly or indirectly, the opportunity to profit from any increase or decrease in the price or value of the shares of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated or separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the proponent stockholder, directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any interests described in clause (d), (g) any proportionate interest in any security of the Corporation or derivative instruments held, directly or indirectly, by a general or limited partnership or limited liability company or similar entity in which a proponent stockholder is a general partner or, directly or indirectly, beneficially owns any interest in a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the manager or managing member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the last 12 months in any security of the Corporation, (i) any direct or indirect legal, economic or financial interest (including Short Interest) of a proponent stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation or (2) any meeting of stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any nomination proposed by any proponent stockholder under Article V, (j) any direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative, administrative or otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant involving the Corporation or any of its officers, directors or employees, or any affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder (collectively, the information in this clause (v), the “Stockholder Information”);
(vi) the proponent stockholder must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by the immediately preceding clause (v) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on whose behalf the nomination proposed to be brought before the annual meeting is made, (b) any affiliate or associate (each within the meaning of Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, and, (c) any stockholder or stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group for purposes of Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such nomination;
(vii) the proponent stockholder must represent to the Corporation, as part of the advance notice, whether the proponent or any of its respective affiliates, associates or others acting in concert therewith intends individually or as part of a group, to (a) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to elect the nominee and/or (b) to otherwise solicit proxies in support of such nomination, including to solicit proxies in support of director nominees other than the Corporation’s nominees in accordance with Rule 14a-19 under the Securities Exchange Act of 1934, as amended;
(viii) the proponent stockholder must disclose to the Corporation, as part of the advance notice, as to each person whom the proponent stockholder proposes to nominate for election as a director (a) all information about the proposed nominees that would be required to be to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in a contested election pursuant to Section 14 of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (including such person’s written consent to being named in the proxy statement, including the Corporation’s proxy statement, as a nominee of the proponent stockholder and to serving as a director if elected), (b) a complete and accurate description of all direct and indirect compensation and other material monetary agreements, arrangements and understandings (whether written or oral) during the past three years, and any other material relationships, between or among such stockholder and beneficial owner, if any, and their respective affiliates and associates, or others acting in concert therewith, on the one hand, and each proposed nominee, and his or her respective affiliates and associates, or others acting in concert therewith, on the other hand, including, without limitation all information that would be required to be disclosed pursuant to Rule 404 promulgated under Regulation S-K if the stockholder making the nomination and any beneficial owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were the “registrant” for purposes of such rule and such proposed nominee were a director or executive officer of such registrant, (c) a completed and signed questionnaire, representation and agreement and any and all other information required by Section 4 of Article V, and (d) the Stockholder Information for such person and any member of the immediate family of such person, or any affiliate or associate of such person, or any person acting in concert therewith;
(ix) the proponent stockholder must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder is a holder of record of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation entitled to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the nomination(s) specified in the notice;
(x) the proponent stockholder must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the information set forth in the advance notice; and
(xi) the proponent stockholder must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial and record owners) known by the proponent stockholder to support the nomination(s) made by the proponent stockholder and, to the extent known, the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
3. Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be elected pursuant to the Corporation’s notice of meeting (i) by or at the direction of the Board of Directors or any committee thereof or (ii) provided that the Board of Directors has determined that directors shall be elected at such meeting, by any stockholder of the Corporation (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article V. In the event the Corporation calls a special meeting of stockholders for the purpose of electing one (1) or more directors to the Board of Directors, any such proponent stockholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if the notice required by Section 2 of Article V shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days prior to the special meeting, and no later than ninety (90) days prior to the special meeting, or the tenth (10th) day following the day on which the Corporation first makes a public announcement of the date of the special meeting at which directors are to be elected. In no event shall the public announcement of an adjournment or postponement of a special meeting commence a new time period (or extend any time period) for the giving of a stockholder’s notice as described above.
4. In addition to the requirements set forth elsewhere in these By-Laws, to be eligible to be a nominee for election or re-election as a director of the Corporation, such proposed nominee or a person on such proposed nominee’s behalf must deliver (with respect to a nomination made by a proponent pursuant to Section 2 of Article V, in accordance with the time periods for delivery of timely notice under Section 2 of Article V), to the Secretary of the Corporation at the principal executive offices of the Corporation a completed and signed questionnaire with respect to the background and qualifications of such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made (which questionnaire shall be provided by the Secretary of the Corporation upon written request of any stockholder of record identified by name within ten business days of such written request) and a written representation and agreement (in the form provided by the Secretary of the Corporation upon written request of any stockholder of record identified by name within ten business days of such written request) that such proposed nominee (i) is not and will not become a party to (a) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such proposed nominee, if elected as a director of the Corporation, will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation or (b) any Voting Commitment that could limit or interfere with such proposed nominee’s fiduciary duties under applicable law, (ii) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed to the Corporation, and (iii) would be in compliance, if elected as a director of the Corporation, and will comply with, all applicable publicly disclosed corporate governance, code of conduct and ethics, conflict of interest, confidentiality, corporate opportunities, trading and any other policies and guidelines of the Corporation applicable to directors.
5. The Corporation may also require, as a condition to any such nomination being deemed properly brought before an annual or special meeting, any proponent stockholder or proposed nominee to furnish such other information as may reasonably be required by the Corporation to determine the eligibility of such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable stockholder’s understanding of the independence, or lack thereof, of such nominee.
6. In addition, if the proponent stockholder has provided notice pursuant to Rule 14a-19(b) of the Securities Exchange Act of 1934, as amended, the proponent stockholder shall deliver to the Corporation no later than ten (10) days prior to the date of the meeting or any adjournment or postponement thereof reasonable evidence that it has complied with the requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended.
7. Compliance with the provisions of this Article V is the sole and exclusive method for stockholders to nominate candidates for election to the Board of Directors at an annual or special meeting of stockholders. No person shall be eligible for election as a director of the Corporation at an annual or special meeting of stockholders unless nominated in accordance with the procedures set forth in this Article V. The number of nominees that a proponent stockholder may nominate for election at an annual or special meeting (or in the case of a proponent stockholder giving the notice on behalf of a beneficial owner, the number of nominees a proponent stockholder may nominate for election at the annual or special meeting on behalf of such beneficial owner) shall not exceed the number of directors to be elected at such annual or special meeting. For the avoidance of doubt, a stockholder shall not be entitled to make additional or substitute nominations at an annual or special meeting following the expiration of the time periods set forth in these By-Laws. Unless otherwise required by law, if any proponent stockholder (i) provides notice pursuant to Rule 14a-19(b) under the Securities Exchange Act of 1934, as amended, and (ii) subsequently fails to comply with any requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended, or any other rules or regulations thereunder, then the Corporation shall disregard any proxies or votes solicited for such nominees and such nominations shall be disregarded. Except as otherwise provided by law or herein, the chairperson of the meeting shall have the power and duty (i) to determine whether a nomination was made in accordance with the provisions of this Article V (including whether the proponent stockholder or any of its respective affiliates, associates or others acting in concert therewith solicited (or are part of a group which solicited) or did not so solicit, as the case may be, proxies or votes in support of the proponent stockholder’s nominee in compliance with the proponent stockholder’s representation as required by clause (vii) of Section 2 of Article V) and (ii) if any proposed nomination was not made in compliance with Article V, to declare that such nomination shall be disregarded. Notwithstanding the foregoing provisions of Article V, unless otherwise required by law, if the proponent stockholder (or a qualified representative of the proponent stockholder) does not appear at the annual or special meeting of stockholders of the Corporation to present a nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 7 of Article V, to be considered a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
8. In addition to the provisions of this Article V, a stockholder shall also comply with all applicable requirements of state law and all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
9. For purposes of these By-laws, “Public Announcement” shall mean disclosure in a press release reported by a national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder.
ARTICLE VI
DIRECTORS
1. The business and affairs of the Corporation shall be managed under the direction of a Board of Directors, which may exercise all such powers and authority for and on behalf of the Corporation as shall be permitted by law, the Certificate of Incorporation or these By-laws. Each of the directors shall hold office until the next annual meeting of stockholders and until his or her successor has been elected and qualified or until his or her earlier death, disqualification, resignation or removal.
2. The Board of Directors is empowered to appoint a Chairman of the Board of Directors. The Chairman shall act as chairman of all meetings of the Board of Directors and as the presiding person at all special and annual meetings of stockholders, unless the Board of Directors shall appoint a different individual as chairman of any meeting of the Board of Directors or as the presiding person at any special or annual meeting of stockholders, and the chairman or presiding person shall have control over the agenda of any such meetings, all in accordance with the provisions of these By-laws and the Certificate of Incorporation. The Chairman shall perform such other duties as may from time to time be assigned to him by the Board of Directors.
3. The Board of Directors may hold their meetings within or outside of the State of Delaware, at such place or places as it may from time to time determine.
4. The number of directors comprising the Board of Directors shall be such number as may be from time to time fixed exclusively by resolution of the Board of Directors. In case of any increase in the number of directors, a majority of the remaining members of the Board of Directors, although such majority is less than a quorum, shall have the sole and exclusive power and authority to elect each additional director to fill any newly created directorship, to hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, disqualification, resignation or removal. No decrease in the number of directors shall shorten the term of any incumbent director.
5. If any directorship becomes vacant, by reason of death, resignation, disqualification, removal or otherwise, a majority of the directors then in office, although less than a quorum, shall have the sole and exclusive authority to fill the vacancy by electing a successor who shall hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, resignation, disqualification or removal.
6. Any director may resign at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any such resignation shall take effect upon receipt thereof by the Corporation, or at such later time or date as may be specified therein.
ARTICLE VII
COMMITTEES OF DIRECTORS
1. The Board of Directors may designate an Executive Committee and one or more other committees, each such committee to consist of one or more directors of the Corporation. The Executive Committee shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation (except as otherwise expressly limited by statute), including the power and authority to declare dividends and to authorize the issuance of stock, and may authorize the seal of the Corporation to be affixed to all papers which may require it. Each such committee shall have such of the powers and authority of the Board of Directors as may be provided from time to time in resolutions adopted by the Board of Directors.
2. The requirements with respect to the manner in which the Executive Committee and each such other committee shall hold meetings and take actions shall be set forth in the resolutions of the Board of Directors designating the Executive Committee or such other committee.
ARTICLE VIII
MEETINGS OF DIRECTORS; ACTION WITHOUT A MEETING
1. Regular meetings of the Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as may be determined from time to time by resolution of the Board of Directors.
2. Special meetings of the Board of Directors shall be held whenever called by the President of the Corporation or the majority of the directors then in office on at least 24 hours’ notice to each director. Except as may be otherwise specifically provided by statute, by the Certificate of Incorporation or by these By-laws, the purpose or purposes of any such special meeting need not be stated in such notice, although the time and place of the meeting shall be stated.
3. At all meetings of the Board of Directors, the presence in person of a majority of the total number of directors shall be necessary and sufficient to constitute a quorum for the transaction of business, and, except as otherwise provided by statute, by the Certificate of Incorporation or by these By-laws, if a quorum shall be present the act of a majority of the directors present shall be the act of the Board of Directors.
4. Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting if all the members of the Board of Directors or such committee, as the case may be, consent thereto in writing or by electronic transmission and any consent may be documented, signed and delivered in any manner permitted by Section 116 of the General Corporation Law of the State of Delaware. After an action is taken, the consent or consents or electronic transmissions shall be filed with the minutes of proceedings of the Board of Directors or committee, in the same paper or electronic form as the minutes are maintained. Any director may participate in a meeting of the Board of Directors, or any committee designated by the Board of Directors, by means of a conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting pursuant to this sentence shall constitute presence in person at such meeting.
ARTICLE IX
OFFICERS
1. The officers of the Corporation shall be chosen by the Board of Directors and shall be a Chief Executive Officer, a President, a Secretary and a Treasurer. The Board of Directors may also choose one or more Vice Presidents, Assistant Secretaries and Assistant Treasurers, and such other officers as it shall deem necessary. Any number of offices may be held by the same person.
2. The salaries of all officers of the Corporation shall be fixed by the Board of Directors, or in such manner as the Board of Directors may prescribe.
3. The officers of the Corporation shall hold office until their successors are elected and qualified, or until their earlier resignation or removal. Any officer may be at any time removed from office by the Board of Directors, with or without cause. If the office of any officer becomes vacant for any reason, the vacancy may be filled by the Board of Directors.
4. Any officer may resign at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any such resignation shall take effect upon receipt thereof by the Corporation or at such later date as may be specified therein.
5. The Chief Executive Officer shall have general supervision and direction of the business and affairs of the Corporation, subject, however, to the direction and control of the Board of Directors. The Chief Executive Officer may sign and execute in the name of the Corporation deeds, mortgages, bond, contracts or other instruments. The Chief Executive Officer shall perform all duties incident to the office of the Chief Executive Officer and shall, when requested, counsel with and advise the other officers of the Corporation and shall perform such other duties as the Board of Directors may from time to time determine.
6. The President shall have such powers and perform such duties as from time to time may be assigned to him by the Chief Executive Officer or the Board of Directors.
7. The Vice Presidents shall have such powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
8. The Secretary shall perform all duties incident to the office of the Secretary and shall have such powers and duties as may be delegated to him by the Chief Executive Officer or the Board of Directors.
9. The Assistant Secretary shall, in case of the absence of the Secretary, perform the duties and exercise the powers of the Secretary, and shall have such other powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
10. The Treasurer shall have the custody of the corporate funds and securities, and shall deposit or cause to be deposited under his or her direction all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors or pursuant to authority granted by it. He shall render to the Chief Executive Officer and the Board of Directors whenever they may require it an account of all his or her transactions as Treasurer and of the financial condition of the Corporation. He shall have such other powers and duties as may be delegated to him by the Chief Executive Officer or the Board of Directors.
11. The Assistant Treasurer shall, in case of the absence of the Treasurer, perform the duties and exercise the powers of the Treasurer, and shall have such other powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
ARTICLE X
FORM OF CERTIFICATES; UNCERTIFICATED SHARES
Shares of the capital stock of the Corporation may be certificated or uncertificated, as provided under the General Corporation Law of the State of Delaware. Each stockholder holding certificated shares of capital stock of the Corporation, upon written request to the transfer agent or registrar of the Corporation, shall be entitled to a certificate representing such shares of capital stock of the Corporation in such form as may from time to time be prescribed by the Board of Directors. Any such certificate shall be signed by any two authorized officers of the Corporation, which shall include, without limitation, the Chairman of the Board of Directors, the Chief Executive Officer, the President, any Vice President, the Treasurer, any Assistant Treasurer, the Secretary and any Assistant Secretary.
ARTICLE XI
FISCAL YEAR
The fiscal year of the Corporation shall be as determined from time to time by resolution duly adopted by the Board of Directors.
ARTICLE XII
NOTICES AND WAIVERS
1. Whenever by statute, by the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any director, such provision shall not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States mail, postage prepaid, directed to such director at his or her address as it appears on the records of the Corporation, and such notice shall be deemed to be given at the time when the same shall be thus deposited. Notice of meetings of the Board of Directors may also be given to any director by telephone or by electronic transmission, and in the latter event the notice shall be deemed to be given at the time such notice, addressed to such director at the address hereinabove provided, is transmitted by facsimile, electronic mail or other electronic transmission.
2. Whenever by statute, by the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any stockholder, such provision shall not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States mail, postage prepaid, directed to such stockholder at his or her mailing address as it appears on the records of the Corporation, and such notice shall be deemed to be given at the time when the same shall be thus deposited. Such notice may also be given (i) by courier service, and such notice shall be deemed to be given upon the earlier of when the notice is received or left at the stockholder’s address or (ii) by electronic transmission directed to the stockholder’s electronic mail address as it appears on the records of the Corporation, and such notice shall be deemed to be given when directed to such stockholder’s electronic mail address unless the stockholder has notified the Corporation in writing or by electronic transmission of an objection to receiving notice by electronic mail or such notice is prohibited by Section 232(e) of the General Corporation Law of the State of Delaware. A notice by electronic mail will include a prominent legend that the communication is an important notice regarding the Corporation.
3. Without limiting the manner by which notice otherwise may be given effectively to stockholders, any notice to stockholders given by the Corporation under any provision of the General Corporation Law of the State of Delaware, the Certificate of Incorporation, or these By-laws shall be effective if given by another form of electronic transmission consented to by the stockholder to whom the notice is given. Any such consent shall be revocable by the stockholder by written notice or electronic transmission to the Corporation. Any such consent shall be deemed revoked if (i) the Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such consent and (ii) such inability becomes known to the Secretary or an Assistant Secretary or to the transfer agent, or other person responsible for the giving of notice; provided, however, the inadvertent failure to discover such inability shall not invalidate any meeting or other action.
4. Notice given pursuant to Section 3 of this Article XII shall be deemed given: (i) if by facsimile telecommunication, when directed to a number at which the stockholder has consented to receive notice; (ii) if by a posting on an electronic network together with separate notice to the stockholder of such specific posting, upon the later of (A) such posting and (B) the giving of such separate notice; and (iii) if by any other form of electronic transmission, when directed to the stockholder. An affidavit of the Secretary or an Assistant Secretary or of the transfer agent or other agent of the Corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein. For purposes of this Article XII, “electronic transmission” means any form of communication, not directly involving the physical transmission of paper, including the use of, or participation in, 1 or more electronic networks or databases (including 1 or more distributed electronic networks or databases), that creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
5. Whenever by statute, by the Certificate of Incorporation or by these By-laws a notice is required to be given, a written waiver thereof, signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of any stockholder or director at any meeting thereof shall constitute a waiver of notice of such meeting by such stockholder or director, as the case may be, except as otherwise provided by statute.
ARTICLE XIII
INDEMNIFICATION
1. The Corporation shall indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that such person is or was a director or officer of the Corporation, or is or was serving at the request of the Corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe such person’s conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that such person’s conduct was unlawful. Notwithstanding the provisions of this Section 1, except as otherwise provided in Section 4 of this Article XIII, the Corporation shall be required to indemnify any person referenced in this Section 1 in connection with an action, suit or proceeding (or part thereof) commenced by such person only if the commencement of such action, suit or proceeding (or part thereof) by the person was authorized in the specific case by the Board of Directors.
2. The Corporation shall indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that such person is or was a director or officer of the corporation, or is or was serving at the request of the Corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation and except that no such indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the Corporation unless and only to the extent that the Court of Chancery of the State of Delaware (the “Court of Chancery”) or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such Court of Chancery or such other court shall deem proper.
3. Expenses (including attorneys’ fees) incurred by a present or former officer or director in defending any civil, criminal, administrative or investigative action, suit or proceeding shall be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Corporation as authorized in this Article XIII. Such expenses (including attorneys’ fees) incurred by employees and agents may be so paid upon such terms and conditions, if any, as the Corporation deems appropriate.
4. The indemnification and advancement of expenses provided by, or granted pursuant to, the other Sections of this Article XIII shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any By-law, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another capacity while holding such office.
5. The Corporation may, but shall not be required to, purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the Corporation would have the power to indemnify such person against such liability under the provisions of this Article XIII.
6. For purposes of this Article XIII, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors or officers so that any person who is or was a director or officer of such constituent corporation, or is or was serving at the request of such constituent corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this Article XIII with respect to the resulting or surviving corporation as such person would have with respect to such constituent corporation if its separate existence had continued.
7. For purposes of this Article XIII, references to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request of the Corporation” shall include service as a director or officer of the Corporation which imposes duties on, or involves services by, such director or officer with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner such person reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Corporation” as referred to in this Article XIII.
8. The indemnification and advancement of expenses provided by, or granted pursuant to, this Article XIII shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and administrators of such a person.
9. If this Article or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each director or officer to the fullest extent not prohibited by any applicable portion of this Article that shall not have been invalidated, or by any other applicable law. If this Article shall be invalid due to the application of the indemnification provisions of another jurisdiction, then the Corporation shall indemnify each director and officer to the fullest extent under any other applicable law.
10. The Corporation may indemnify every person who was or is a party or is or was threatened to be made a party to any action, suit, or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was an employee or agent of the corporation or, while an employee or agent of the Corporation, is or was serving at the request of the corporation as an employee or agent or trustee of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including counsel fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding, to the extent permitted by Delaware law.
11. The Corporation’s obligation, if any, to indemnify or to advance expenses to any person serving at its request as a director or officer of another corporation, partnership, joint venture, trust or other enterprise shall be reduced by any amount such person may collect as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust or other enterprise.
ARTICLE XIV
FORUM SELECTION
1. Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery (or, if and only if the Court of Chancery lacks subject matter jurisdiction, any state or federal court located within the State of Delaware) and any appellate court thereof shall be the sole and exclusive forum for (i) any derivative action, suit, or proceeding brought on behalf of the Corporation, (ii) any action, suit, or proceeding asserting a claim of breach of fiduciary duty owed by any current or former director, officer, employee, or stockholder of the Corporation to the Corporation or the Corporation’s stockholders or any action asserting a claim for aiding and abetting any such breach of fiduciary duty, (iii) any action, suit, or proceeding arising pursuant to any provision of the General Corporation Law of the State of Delaware or the Certificate of Incorporation or these By-laws (as each may be amended from time to time), (iv) any claim as to which the General Corporation Law of the State of Delaware confers jurisdiction upon the Court of Chancery, or (v) any action, suit, or proceeding asserting a claim against the Corporation or its current or former directors, officers, employees, or stockholders governed by the internal affairs doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties named as defendants therein.
2. Unless the Corporation consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
3. Notwithstanding the foregoing, the provisions of this Article XIV shall not apply to suits brought to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended, or any other claim for which the federal courts of the United States have exclusive jurisdiction.
4. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of the provisions of this Article XIV. If any provision or provisions of this Article XIV shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provisions in any other circumstance and of the remaining provisions of this Article XIV (including, without limitation, each portion of any sentence of this Article XIV containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable) and the application of such provision to other persons or entities and circumstances shall not in any way be affected or impaired thereby.
ARTICLE XV
AMENDMENT OF BY-LAWS
The By-laws of the Corporation may be altered, amended or repealed, and new By-laws may be adopted, by the Board of Directors. In addition, the By-laws of the Corporation may be altered, amended or repealed, and new By-laws may be adopted, by the stockholders of the Corporation by the affirmative vote of the holders of a majority in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon.
17
Exhibit 3.3
ORAMED PHARMACEUTICALS INC.
FOURTH AMENDED AND RESTATED BY-LAWS
ARTICLE I
OFFICES
1. The location of the registered office of the Corporation, and the name of its registered agent, shall be as set forth in the Certificate of Incorporation.
2. The Corporation shall in addition to its registered office in the State of Delaware establish and maintain an office or offices at such place or places as the Board of Directors may from time to time find necessary or desirable.
ARTICLE II
CORPORATE SEAL
The Corporation may or may not have a corporate seal, as may be determined from time to time by the Board of Directors. If adopted, the corporate seal of the Corporation shall have inscribed thereon the name of the Corporation and may be in such form as the Board of Directors may determine. Such seal may be used by causing it or a facsimile thereof to be impressed, affixed or otherwise reproduced.
ARTICLE III
MEETINGS OF STOCKHOLDERS
1. All meetings of the stockholders shall be held at the registered office of the Corporation in the State of Delaware or at such other place, as shall be determined from time to time by the Board of Directors. The Board of Directors may, in its sole discretion, determine that any meeting of the stockholders shall not be held at any place, but may instead be held solely by means of remote communication in accordance with Section 211 of the General Corporation Law of the State of Delaware.
2. The annual meeting of stockholders shall be held on such day and at such time as may be determined from time to time by resolution of the Board of Directors, when they shall elect, by majority vote pursuant to Section 5 of this Article III, directors to hold office until the annual meeting of stockholders held next after their election and their successors are respectively elected and qualified, or until their earlier death, disqualification, resignation or removal; provided, however, that in a contested election, a nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors. An election shall be considered contested if, as of the last date on which nominees for director may be submitted in accordance with these By-laws, the nominees for election to the Board of Directors exceeds the number of positions on the Board of Directors to be filled by election at that meeting. If an incumbent director is not re-elected, the director shall tender his or her resignation to the Board of Directors. The Nominating and Corporate Governance Committee of the Board of Directors (or any future committee the equivalent thereof) will make a recommendation to the Board of Directors on whether to accept or reject the resignation, or whether other action should be taken. The Board of Directors will act on the recommendation of such committee and will publicly disclose its decision within ninety (90) days from the date of the certification of the election results. A director who tenders his or her resignation may not participate in any meeting of the Board of Directors or any committee thereof until the Board of Directors has determined not to accept his or her resignation. Any other proper business may be transacted at the annual meeting.
3. The holders of at least one third (1/3) of the stock issued and outstanding and entitled to vote on the subject matter, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business, except as otherwise expressly provided by statute, by the Certificate of Incorporation or by these By-laws. If, however, such holders shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote on the subject matter, present in person or by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting (except as otherwise provided by statute). At such adjourned meeting at which a quorum is present, any business may be transacted which might have been transacted at the meeting as originally notified.
4. At all meetings of the stockholders each stockholder having the right to vote on the subject matter shall be entitled to vote in person, or by proxy, but no proxy shall be voted or acted upon more than three years after its date, unless the proxy provides for a longer period.
5. Unless otherwise provided in the Certificate of Incorporation, at each meeting of the stockholders each stockholder shall have one vote for each share of capital stock having voting power, registered in his or her name on the books of the Corporation at the record date fixed for voting in accordance with these By-laws, or otherwise determined, with respect to such meeting. Unless a different or minimum vote is required by law or regulation applicable to the Corporation or its securities, by the Certificate of Incorporation, by these By-laws or by the rules or regulations of any stock exchange applicable to the Corporation, in which case such different or minimum vote shall be the applicable vote on the matter, all matters coming before any meeting of the stockholders, including the election of directors, shall be decided by a majority of the votes cast by the holders of shares of stock present in person or represented by proxy at such meeting and entitled to vote on the subject matter, a quorum being present; provided, however, that in a contested election, a nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors. Votes cast shall include votes “for” and votes “against” and exclude “abstentions” and “broker non-votes” with respect to the subject matter.
6. Notice of each meeting of the stockholders shall be given to each stockholder entitled to vote thereat not less than ten (10) nor more than sixty (60) days before the date of the meeting. Such notice shall state the place, date and hour of meeting, the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the meeting, the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
7. The Corporation shall prepare, no later than the tenth (10th) day before each meeting of stockholders, a complete list of the stockholders entitled to vote at said meeting (provided, however, if the record date for determining the stockholders entitled to vote is less than ten (10) days before the date of the meeting, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date), arranged in alphabetical order, showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting for a period of 10 days ending on the day before the meeting date, (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (b) during ordinary business hours, at the principal place of business of the Corporation. In the event that the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation.
8. Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute, may be called by the majority of the Board of Directors, but such meetings may not be called by any other person or persons.
9. Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the Corporation’s notice of meeting.
10. The order of business at each meeting of stockholders shall be determined by the person presiding over the meeting.
11. (a) In order that the Corporation may determine the stockholders entitled to consent to corporate action by consent and without a meeting of stockholders, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which date shall not be more than ten (10) days after the date upon which the resolution fixing the record date is adopted by the Board of Directors. Any stockholder of record seeking to have the stockholders authorize or take corporate action by consent in lieu of a meeting of stockholders shall, by written notice delivered to the Secretary of the Corporation at the principal executive offices of the Corporation, request that the Board of Directors fix a record date. The written notice must contain the information set forth in Section 11(b) of this Article III. The Board of Directors shall promptly, but in all events within ten (10) days after the date on which such written notice is received by the Secretary of the Corporation, determine the validity of the request, and if appropriate, adopt a resolution fixing the record date (unless a record date has previously been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III). If no record date has been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III or otherwise within ten (10) days after the date on which such written notice is received by the Secretary of the Corporation, the record date for determining stockholders entitled to consent to corporate action by consent and without a meeting, when no prior action by the Board of Directors is required by applicable law, shall be the first date after the expiration of such ten (10) day time period on which a signed consent setting forth the action taken or proposed to be taken is delivered to the Corporation by delivery to its registered office in Delaware by hand or by certified or registered mail, return receipt requested, to its principal place of business or to any officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded. If no record date has been fixed by the Board of Directors pursuant to the first sentence of this Section 11(a) of Article III and prior action by the Board of Directors is required by applicable law, the record date for determining stockholders entitled to consent to corporate action by consent and without a meeting shall be at the close of business on the date on which the Board of Directors adopts the resolution taking such prior action.
(b) Any stockholder’s notice required by Section 11(a) of Article III must describe the action that the stockholder proposes to take by consent. For each such proposal, every notice by a stockholder must state (x) the information required by Section 2 of Article IV and Section 2 of Article V as though such stockholder was intending to make a nomination or to bring any such business before a meeting of stockholders and (y) the text of the proposal (including the text of any resolutions to be effected by consent and the language of any proposed amendment to these By-Laws). In addition to the foregoing, the notice must state as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the notice is given a representation whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends to (x) deliver a proxy statement and/or consent solicitation statement to stockholders of at least the percentage of the Corporation’s outstanding capital stock required to effect the action by consent either to solicit consents or to solicit proxies to execute consents, and/or (y) otherwise solicit proxies or consents from stockholders in support of the action to be taken by consent. The Corporation may require the stockholder of record and/or beneficial owner requesting a record date for proposed stockholder action by consent to furnish such other information as it may reasonably require to determine the validity of the request for a record date.
(c) In the event of the delivery, in the manner provided by this Section 11 of Article III and applicable law, to the Corporation of consent or consents to take corporate action and/or any related revocation or revocations, the Corporation shall engage independent inspectors of elections for the purpose of performing promptly a ministerial review of the validity of the consents and any consent revocations. For the purpose of permitting the inspectors to perform such review, no stockholder action by consent and without a meeting shall be effective until such inspectors have completed their review, determined that the requisite number of valid and unrevoked consents delivered to the Corporation in accordance with this Section 11 of Article III and applicable law have been obtained to authorize or take the action specified in the consents, and certified such determination for entry in the records of the Corporation kept for the purpose of recording the proceedings of meetings of stockholders. Nothing contained in this Section 11(c) of Article III shall in any way be construed to suggest or imply that the Board of Directors or any stockholder shall not be entitled to contest the validity of any consent or revocation thereof, whether before or after such certification by the independent inspectors, or to take any other action (including, without limitation, the commencement, prosecution or defense of any litigation with respect thereto, and the seeking of injunctive relief in such litigation).
(d) No stockholder consent to corporate action without a meeting of stockholders shall be effective to take the corporate action referred to therein unless, within sixty (60) days after the first date a consent is delivered in accordance with this Section 11 of Article III, a valid consent or valid consents signed by a sufficient number of stockholders to take such action are delivered to the Corporation in the manner prescribed in this Section 11 of Article III and applicable law, and not revoked.
ARTICLE IV
STOCKHOLDER PROPOSALS
1. At an annual meeting of stockholders, only such stockholder business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting of stockholders, stockholder business (other than the nominations of persons for election to the Board of Directors, which shall be set forth in Article V) must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article IV is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article IV. In addition, any proposal of stockholder business (other than the nomination of persons for election to the Board of Directors) must be a proper matter for stockholder action.
2. For business (other than the nomination of persons for election to the Board of Directors, which shall be governed by Article V herein) to be properly brought before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose the business must deliver a timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
(i) to be timely, the advance notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first anniversary date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date that is more than thirty (30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual meeting of stockholders, including in the event that no annual meeting was held in the previous year), notice by the proponent stockholder in order to be timely must be so delivered, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation, not earlier than the close of business on the 120th day prior to the annual meeting and not later than the close of business on the later of the 90th day prior to the date of such annual meeting or, if the first “Public Announcement” (as hereinafter defined in Section 9 of Article V) of the date of such annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s notice as described above;
(ii) in addition, to be timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business days after the record date for the meeting (in the case of the update and supplement required to be made as of the record date), and not later than eight (8) business days prior to the date for the meeting, or if the meeting is adjourned or postponed, on the first practicable date after any adjournment or postponement thereof (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof);
(iii) the proponent stockholder must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the Corporation’s books and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
(iv) the proponent stockholder must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of capital stock or other securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares of capital stock or other securities of the Corporation or with a price or value derived in whole or in part from the price or value of any shares of capital stock or other securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction or arrangement having characteristics of a long or short position or ownership interest in any shares of capital stock or other securities of the Corporation, whether or not any such instrument or right shall be subject to settlement in the underlying shares of capital stock or other securities of the Corporation or otherwise, and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the price or value of shares of capital stock or other securities of the Corporation directly or indirectly owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement, arrangement, understanding or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any shares of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding or relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent stockholder has engaged in or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the economic risk of shares of capital stock or other securities of the Corporation by, manage the risk of share price changes for, or increase or decrease the voting power of, such proponent stockholder with respect to shares of capital stock or other securities of the Corporation, or which provides, directly or indirectly, the opportunity to profit from any increase or decrease in the price or value of the shares of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated or separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the proponent stockholder, directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any interests described in clause (d), (g) any proportionate interest in any security of the Corporation or derivative instruments held, directly or indirectly, by a general or limited partnership or limited liability company or similar entity in which a proponent stockholder is a general partner or, directly or indirectly, beneficially owns any interest in a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the manager or managing member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the last 12 months in any security of the Corporation (for purposes of these By-Laws, a person shall be deemed to have a “Short Interest” in a security if such person, directly or indirectly, though any contract, arrangement, understanding, relationship or otherwise, has the opportunity to profit or share in any profit derived from any decrease in the value of the subject security), (i) any direct or indirect legal, economic or financial interest (including Short Interest) of a proponent stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation or (2) any meeting of stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any business proposed by any proponent stockholder under Article IV, (j) any direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative, administrative or otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant involving the Corporation or any of its officers, directors or employees, or any affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the proposal pursuant to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder;
(v) the proponent stockholder must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by the immediately preceding clause (iv) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on whose behalf the business proposed to be brought before the annual meeting is being brought, (b) any affiliate or associate (each within the meaning of Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, (c) any stockholder or stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group for purposes of Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such business;
(vi) the proponent stockholder must represent to the Corporation, as part of the advance notice, whether the proponent intends individually or as part of a group, to (x) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve or adopt the proposal, and/or (y) to otherwise solicit proxies in support of such proposal;
(vii) the proponent stockholder must disclose to the Corporation, as part of its advance notice: (a) a reasonably brief description of the business desired to be brought before the meeting, the reasons for conducting such business at the meeting and any material interest of such stockholder and beneficial owner, if any, in such business, (b) the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the By-Laws of the Corporation, the language of the proposed amendment), and (c) a reasonably detailed description of all agreements, arrangements and understandings between such proponent and the beneficial owner, if any, and any other person or persons (including their names) in connection with the proposal of such business by such stockholder;
(viii) the proponent stockholder must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder is a holder of record of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation entitled to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the stockholder business specified in the notice;
(ix) the proponent stockholder must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the information set forth in the advance notice; and
(x) the proponent stockholder must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial and record owners) known by the proponent stockholder to support the stockholder business to be proposed by the proponent stockholder and, to the extent known, the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
3. In addition to the provisions of Section 2 of this Article IV, a stockholder shall also comply with all applicable requirements of state law and all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
4. Nothing in these By-laws shall be deemed to affect any rights of stockholders to request the inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended. Subject to Rule 14a-8 and Rule 14a-19 under the Securities Exchange Act of 1934, as amended, nothing in these By-laws shall be construed to permit any stockholder, or give any stockholder the right, to include or have disseminated or described in the Corporation’s proxy statement any nomination of director or directors or any other business proposal.
5. Except as otherwise expressly provided in any applicable rule or regulation promulgated under the Securities Exchange Act of 1934, as amended, only such business (other than the election of directors as set forth in Article V) shall be conducted at an annual meeting of stockholders as shall have been brought before the meeting in accordance with the procedures of this Article IV. Except as otherwise provided by law, the chairperson of the meeting shall have the power and duty (i) to determine whether any business proposed to be brought before the meeting was proposed in accordance with the provisions of this Article IV (including whether the proponent stockholder solicited (or are part of a group which solicited) or did not so solicit, as the case may be, proxies or votes in support of the proponent stockholder’s proposal in compliance with the proponent stockholder’s representation as required by clause (vi) of Section 2 of Article IV) and (ii) if any proposed business was not proposed in compliance with Article IV, to declare that such proposed business shall not be transacted. Notwithstanding the foregoing provisions of this Article IV, unless otherwise required by law, if the proponent stockholder (or a qualified representative of the proponent stockholder) does not appear at the annual meeting of stockholders of the Corporation to present the proposed business, such proposed business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 5 of Article IV, to be considered a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
ARTICLE V
STOCKHOLDER DIRECTOR NOMINATIONS
1. At an annual meeting of stockholders, only such nominations of persons for the election of directors shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting of stockholders, nominations of persons for election to the Board of Directors must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article V.
2. Notwithstanding anything in these By-laws to the contrary, for the nomination of persons for election to the Board of Directors to be properly brought before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose such nominations must deliver a timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
(i) to be timely, the advance notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first anniversary date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date that is more than thirty (30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual meeting of stockholders, including in the event that no annual meeting was held in the previous year), notice by the proponent stockholder in order to be timely must be so delivered, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation, not earlier than the close of business on the 120th day prior to the annual meeting and not later than the close of business on the later of the 90th day prior to the date of such annual meeting or, if the first Public Announcement of the date of such annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s notice as described above;
(ii) in addition, to be timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business days after the record date for the meeting (in the case of the update and supplement required to be made as of the record date), and not later than eight (8) business days prior to the date for the meeting, or if the meeting is adjourned or postponed, on the first practicable date after any adjournment or postponement thereof (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof);
(iii) in the event that the number of directors to be elected to the Board of Directors is increased by the Board of Directors, and there is no Public Announcement by the Corporation naming all of the nominees for director or specifying the size of the increased Board of Directors at least one hundred (100) days prior to the first anniversary of the preceding year’s annual meeting, a stockholder’s notice required by Section 2 of this Article V shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation not later than the close of business on the 10th day following the day on which such Public Announcement is first made by the Corporation;
(iv) the proponent stockholder must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the Corporation’s books and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
(v) the proponent stockholder must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of capital stock or other securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares of capital stock or other securities of the Corporation or with a price or value derived in whole or in part from the price or value of any shares of capital stock or other securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction or arrangement having characteristics of a long or short position or ownership interest in any shares of capital stock or other securities of the Corporation, whether or not any such instrument or right shall be subject to settlement in the underlying shares of capital stock or other securities of the Corporation or otherwise, and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the price or value of shares of capital stock or other securities of the Corporation directly or indirectly owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement, arrangement, understanding or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any shares of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding or relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent stockholder has engaged in or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the economic risk of shares of capital stock or other securities of the Corporation by, manage the risk of share price changes for, or increase or decrease the voting power of, such proponent stockholder with respect to shares of capital stock or other securities of the Corporation, or which provides, directly or indirectly, the opportunity to profit from any increase or decrease in the price or value of the shares of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated or separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the proponent stockholder, directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any interests described in clause (d), (g) any proportionate interest in any security of the Corporation or derivative instruments held, directly or indirectly, by a general or limited partnership or limited liability company or similar entity in which a proponent stockholder is a general partner or, directly or indirectly, beneficially owns any interest in a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the manager or managing member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the last 12 months in any security of the Corporation, (i) any direct or indirect legal, economic or financial interest (including Short Interest) of a proponent stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation or (2) any meeting of stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any nomination proposed by any proponent stockholder under Article V, (j) any direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative, administrative or otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant involving the Corporation or any of its officers, directors or employees, or any affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder (collectively, the information in this clause (v), the “Stockholder Information”);
(vi) the proponent stockholder must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by the immediately preceding clause (v) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on whose behalf the nomination proposed to be brought before the annual meeting is made, (b) any affiliate or associate (each within the meaning of Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, and, (c) any stockholder or stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group for purposes of Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such nomination;
(vii) the proponent stockholder must represent to the Corporation, as part of the advance notice, whether the proponent or any of its respective affiliates, associates or others acting in concert therewith intends individually or as part of a group, to (a) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to elect the nominee and/or (b) to otherwise solicit proxies in support of such nomination, including to solicit proxies in support of director nominees other than the Corporation’s nominees in accordance with Rule 14a-19 under the Securities Exchange Act of 1934, as amended;
(viii) the proponent stockholder must disclose to the Corporation, as part of the advance notice, as to each person whom the proponent stockholder proposes to nominate for election as a director (a) all information about the proposed nominees that would be required to be to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in a contested election pursuant to Section 14 of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (including such person’s written consent to being named in the proxy statement, including the Corporation’s proxy statement, as a nominee of the proponent stockholder and to serving as a director if elected), (b) a complete and accurate description of all direct and indirect compensation and other material monetary agreements, arrangements and understandings (whether written or oral) during the past three years, and any other material relationships, between or among such stockholder and beneficial owner, if any, and their respective affiliates and associates, or others acting in concert therewith, on the one hand, and each proposed nominee, and his or her respective affiliates and associates, or others acting in concert therewith, on the other hand, including, without limitation all information that would be required to be disclosed pursuant to Rule 404 promulgated under Regulation S-K if the stockholder making the nomination and any beneficial owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were the “registrant” for purposes of such rule and such proposed nominee were a director or executive officer of such registrant, (c) a completed and signed questionnaire, representation and agreement and any and all other information required by Section 4 of Article V, and (d) the Stockholder Information for such person and any member of the immediate family of such person, or any affiliate or associate of such person, or any person acting in concert therewith;
(ix) the proponent stockholder must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder is a holder of record of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation entitled to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the nomination(s) specified in the notice;
(x) the proponent stockholder must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the information set forth in the advance notice; and
(xi) the proponent stockholder must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial and record owners) known by the proponent stockholder to support the nomination(s) made by the proponent stockholder and, to the extent known, the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
3. Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be elected pursuant to the Corporation’s notice of meeting (i) by or at the direction of the Board of Directors or any committee thereof or (ii) provided that the Board of Directors has determined that directors shall be elected at such meeting, by any stockholder of the Corporation (a) who is a stockholder of record of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on the record date for the determination of stockholders of the Corporation entitled to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the meeting and (c) complies with the notice procedures set forth in this Article V. In the event the Corporation calls a special meeting of stockholders for the purpose of electing one (1) or more directors to the Board of Directors, any such proponent stockholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if the notice required by Section 2 of Article V shall be delivered to, or mailed and received by, the Secretary of the Corporation at the principal executive offices of the Corporation no earlier than one hundred and twenty (120) days prior to the special meeting, and no later than ninety (90) days prior to the special meeting, or the tenth (10th) day following the day on which the Corporation first makes a public announcement of the date of the special meeting at which directors are to be elected. In no event shall the public announcement of an adjournment or postponement of a special meeting commence a new time period (or extend any time period) for the giving of a stockholder’s notice as described above.
4. In addition to the requirements set forth elsewhere in these By-Laws, to be eligible to be a nominee for election or re-election as a director of the Corporation, such proposed nominee or a person on such proposed nominee’s behalf must deliver (with respect to a nomination made by a proponent pursuant to Section 2 of Article V, in accordance with the time periods for delivery of timely notice under Section 2 of Article V), to the Secretary of the Corporation at the principal executive offices of the Corporation a completed and signed questionnaire with respect to the background and qualifications of such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made (which questionnaire shall be provided by the Secretary of the Corporation upon written request of any stockholder of record identified by name within ten business days of such written request) and a written representation and agreement (in the form provided by the Secretary of the Corporation upon written request of any stockholder of record identified by name within ten business days of such written request) that such proposed nominee (i) is not and will not become a party to (a) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such proposed nominee, if elected as a director of the Corporation, will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation or (b) any Voting Commitment that could limit or interfere with such proposed nominee’s fiduciary duties under applicable law, (ii) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed to the Corporation, and (iii) would be in compliance, if elected as a director of the Corporation, and will comply with, all applicable publicly disclosed corporate governance, code of conduct and ethics, conflict of interest, confidentiality, corporate opportunities, trading and any other policies and guidelines of the Corporation applicable to directors.
5. The Corporation may also require, as a condition to any such nomination being deemed properly brought before an annual or special meeting, any proponent stockholder or proposed nominee to furnish such other information as may reasonably be required by the Corporation to determine the eligibility of such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable stockholder’s understanding of the independence, or lack thereof, of such nominee.
6. In addition, if the proponent stockholder has provided notice pursuant to Rule 14a-19(b) of the Securities Exchange Act of 1934, as amended, the proponent stockholder shall deliver to the Corporation no later than ten (10) days prior to the date of the meeting or any adjournment or postponement thereof reasonable evidence that it has complied with the requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended.
7. Compliance with the provisions of this Article V is the sole and exclusive method for stockholders to nominate candidates for election to the Board of Directors at an annual or special meeting of stockholders. No person shall be eligible for election as a director of the Corporation at an annual or special meeting of stockholders unless nominated in accordance with the procedures set forth in this Article V. The number of nominees that a proponent stockholder may nominate for election at an annual or special meeting (or in the case of a proponent stockholder giving the notice on behalf of a beneficial owner, the number of nominees a proponent stockholder may nominate for election at the annual or special meeting on behalf of such beneficial owner) shall not exceed the number of directors to be elected at such annual or special meeting. For the avoidance of doubt, a stockholder shall not be entitled to make additional or substitute nominations at an annual or special meeting following the expiration of the time periods set forth in these By-Laws. Unless otherwise required by law, if any proponent stockholder (i) provides notice pursuant to Rule 14a-19(b) under the Securities Exchange Act of 1934, as amended, and (ii) subsequently fails to comply with any requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended, or any other rules or regulations thereunder, then the Corporation shall disregard any proxies or votes solicited for such nominees and such nominations shall be disregarded. Except as otherwise provided by law or herein, the chairperson of the meeting shall have the power and duty (i) to determine whether a nomination was made in accordance with the provisions of this Article V (including whether the proponent stockholder or any of its respective affiliates, associates or others acting in concert therewith solicited (or are part of a group which solicited) or did not so solicit, as the case may be, proxies or votes in support of the proponent stockholder’s nominee in compliance with the proponent stockholder’s representation as required by clause (vii) of Section 2 of Article V) and (ii) if any proposed nomination was not made in compliance with Article V, to declare that such nomination shall be disregarded. Notwithstanding the foregoing provisions of Article V, unless otherwise required by law, if the proponent stockholder (or a qualified representative of the proponent stockholder) does not appear at the annual or special meeting of stockholders of the Corporation to present a nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 7 of Article V, to be considered a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
8. In addition to the provisions of this Article V, a stockholder shall also comply with all applicable requirements of state law and all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
9. For purposes of these By-laws, “Public Announcement” shall mean disclosure in a press release reported by a national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder.
ARTICLE VI
DIRECTORS
1. The business and affairs of the Corporation shall be managed under the direction of a Board of Directors, which may exercise all such powers and authority for and on behalf of the Corporation as shall be permitted by law, the Certificate of Incorporation or these By-laws. Each of the directors shall hold office until the next annual meeting of stockholders and until his or her successor has been elected and qualified or until his or her earlier death, disqualification, resignation or removal.
2. The Board of Directors is empowered to appoint a Chairman of the Board of Directors. The Chairman shall act as chairman of all meetings of the Board of Directors and as the presiding person at all special and annual meetings of stockholders, unless the Board of Directors shall appoint a different individual as chairman of any meeting of the Board of Directors or as the presiding person at any special or annual meeting of stockholders, and the chairman or presiding person shall have control over the agenda of any such meetings, all in accordance with the provisions of these By-laws and the Certificate of Incorporation. The Chairman shall perform such other duties as may from time to time be assigned to him by the Board of Directors.
3. The Board of Directors may hold their meetings within or outside of the State of Delaware, at such place or places as it may from time to time determine.
4. The number of directors comprising the Board of Directors shall be such number as may be from time to time fixed exclusively by resolution of the Board of Directors. In case of any increase in the number of directors, a majority of the remaining members of the Board of Directors, although such majority is less than a quorum, shall have the sole and exclusive power and authority to elect each additional director to fill any newly created directorship, to hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, disqualification, resignation or removal. No decrease in the number of directors shall shorten the term of any incumbent director.
5. If any directorship becomes vacant, by reason of death, resignation, disqualification, removal or otherwise, a majority of the directors then in office, although less than a quorum, shall have the sole and exclusive authority to fill the vacancy by electing a successor who shall hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, resignation, disqualification or removal.
6. Any director may resign at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any such resignation shall take effect upon receipt thereof by the Corporation, or at such later time or date as may be specified therein.
ARTICLE VII
COMMITTEES OF DIRECTORS
1. The Board of Directors may designate an Executive Committee and one or more other committees, each such committee to consist of one or more directors of the Corporation. The Executive Committee shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation (except as otherwise expressly limited by statute), including the power and authority to declare dividends and to authorize the issuance of stock, and may authorize the seal of the Corporation to be affixed to all papers which may require it. Each such committee shall have such of the powers and authority of the Board of Directors as may be provided from time to time in resolutions adopted by the Board of Directors.
2. The requirements with respect to the manner in which the Executive Committee and each such other committee shall hold meetings and take actions shall be set forth in the resolutions of the Board of Directors designating the Executive Committee or such other committee.
ARTICLE VIII
MEETINGS OF DIRECTORS; ACTION WITHOUT A MEETING
1. Regular meetings of the Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as may be determined from time to time by resolution of the Board of Directors.
2. Special meetings of the Board of Directors shall be held whenever called by the President of the Corporation or the majority of the directors then in office on at least 24 hours’ notice to each director. Except as may be otherwise specifically provided by statute, by the Certificate of Incorporation or by these By-laws, the purpose or purposes of any such special meeting need not be stated in such notice, although the time and place of the meeting shall be stated.
3. At all meetings of the Board of Directors, the presence in person of a majority of the total number of directors shall be necessary and sufficient to constitute a quorum for the transaction of business, and, except as otherwise provided by statute, by the Certificate of Incorporation or by these By-laws, if a quorum shall be present the act of a majority of the directors present shall be the act of the Board of Directors.
4. Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting if all the members of the Board of Directors or such committee, as the case may be, consent thereto in writing or by electronic transmission and any consent may be documented, signed and delivered in any manner permitted by Section 116 of the General Corporation Law of the State of Delaware. After an action is taken, the consent or consents or electronic transmissions shall be filed with the minutes of proceedings of the Board of Directors or committee, in the same paper or electronic form as the minutes are maintained. Any director may participate in a meeting of the Board of Directors, or any committee designated by the Board of Directors, by means of a conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting pursuant to this sentence shall constitute presence in person at such meeting.
ARTICLE IX
OFFICERS
1. The officers of the Corporation shall be chosen by the Board of Directors and shall be a Chief Executive Officer, a President, a Secretary and a Treasurer. The Board of Directors may also choose one or more Vice Presidents, Assistant Secretaries and Assistant Treasurers, and such other officers as it shall deem necessary. Any number of offices may be held by the same person.
2. The salaries of all officers of the Corporation shall be fixed by the Board of Directors, or in such manner as the Board of Directors may prescribe.
3. The officers of the Corporation shall hold office until their successors are elected and qualified, or until their earlier resignation or removal. Any officer may be at any time removed from office by the Board of Directors, with or without cause. If the office of any officer becomes vacant for any reason, the vacancy may be filled by the Board of Directors.
4. Any officer may resign at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any such resignation shall take effect upon receipt thereof by the Corporation or at such later date as may be specified therein.
5. The Chief Executive Officer shall have general supervision and direction of the business and affairs of the Corporation, subject, however, to the direction and control of the Board of Directors. The Chief Executive Officer may sign and execute in the name of the Corporation deeds, mortgages, bond, contracts or other instruments. The Chief Executive Officer shall perform all duties incident to the office of the Chief Executive Officer and shall, when requested, counsel with and advise the other officers of the Corporation and shall perform such other duties as the Board of Directors may from time to time determine.
6. The President shall have such powers and perform such duties as from time to time may be assigned to him by the Chief Executive Officer or the Board of Directors.
7. The Vice Presidents shall have such powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
8. The Secretary shall perform all duties incident to the office of the Secretary and shall have such powers and duties as may be delegated to him by the Chief Executive Officer or the Board of Directors.
9. The Assistant Secretary shall, in case of the absence of the Secretary, perform the duties and exercise the powers of the Secretary, and shall have such other powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
10. The Treasurer shall have the custody of the corporate funds and securities, and shall deposit or cause to be deposited under his or her direction all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors or pursuant to authority granted by it. He shall render to the Chief Executive Officer and the Board of Directors whenever they may require it an account of all his or her transactions as Treasurer and of the financial condition of the Corporation. He shall have such other powers and duties as may be delegated to him by the Chief Executive Officer or the Board of Directors.
11. The Assistant Treasurer shall, in case of the absence of the Treasurer, perform the duties and exercise the powers of the Treasurer, and shall have such other powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
ARTICLE X
FORM OF CERTIFICATES; UNCERTIFICATED SHARES
Shares of the capital stock of the Corporation may be certificated or uncertificated, as provided under the General Corporation Law of the State of Delaware. Each stockholder holding certificated shares of capital stock of the Corporation, upon written request to the transfer agent or registrar of the Corporation, shall be entitled to a certificate representing such shares of capital stock of the Corporation in such form as may from time to time be prescribed by the Board of Directors. Any such certificate shall be signed by any two authorized officers of the Corporation, which shall include, without limitation, the Chairman of the Board of Directors, the Chief Executive Officer, the President, any Vice President, the Treasurer, any Assistant Treasurer, the Secretary and any Assistant Secretary.
ARTICLE XI
FISCAL YEAR
The fiscal year of the Corporation shall be as determined from time to time by resolution duly adopted by the Board of Directors.
ARTICLE XII
NOTICES AND WAIVERS
1. Whenever by statute, by the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any director, such provision shall not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States mail, postage prepaid, directed to such director at his or her address as it appears on the records of the Corporation, and such notice shall be deemed to be given at the time when the same shall be thus deposited. Notice of meetings of the Board of Directors may also be given to any director by telephone or by electronic transmission, and in the latter event the notice shall be deemed to be given at the time such notice, addressed to such director at the address hereinabove provided, is transmitted by facsimile, electronic mail or other electronic transmission.
2. Whenever by statute, by the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any stockholder, such provision shall not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States mail, postage prepaid, directed to such stockholder at his or her mailing address as it appears on the records of the Corporation, and such notice shall be deemed to be given at the time when the same shall be thus deposited. Such notice may also be given (i) by courier service, and such notice shall be deemed to be given upon the earlier of when the notice is received or left at the stockholder’s address or (ii) by electronic transmission directed to the stockholder’s electronic mail address as it appears on the records of the Corporation, and such notice shall be deemed to be given when directed to such stockholder’s electronic mail address unless the stockholder has notified the Corporation in writing or by electronic transmission of an objection to receiving notice by electronic mail or such notice is prohibited by Section 232(e) of the General Corporation Law of the State of Delaware. A notice by electronic mail will include a prominent legend that the communication is an important notice regarding the Corporation.
3. Without limiting the manner by which notice otherwise may be given effectively to stockholders, any notice to stockholders given by the Corporation under any provision of the General Corporation Law of the State of Delaware, the Certificate of Incorporation, or these By-laws shall be effective if given by another form of electronic transmission consented to by the stockholder to whom the notice is given. Any such consent shall be revocable by the stockholder by written notice or electronic transmission to the Corporation. Any such consent shall be deemed revoked if (i) the Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such consent and (ii) such inability becomes known to the Secretary or an Assistant Secretary or to the transfer agent, or other person responsible for the giving of notice; provided, however, the inadvertent failure to discover such inability shall not invalidate any meeting or other action.
4. Notice given pursuant to Section 3 of this Article XII shall be deemed given: (i) if by facsimile telecommunication, when directed to a number at which the stockholder has consented to receive notice; (ii) if by a posting on an electronic network together with separate notice to the stockholder of such specific posting, upon the later of (A) such posting and (B) the giving of such separate notice; and (iii) if by any other form of electronic transmission, when directed to the stockholder. An affidavit of the Secretary or an Assistant Secretary or of the transfer agent or other agent of the Corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein. For purposes of this Article XII, “electronic transmission” means any form of communication, not directly involving the physical transmission of paper, including the use of, or participation in, 1 or more electronic networks or databases (including 1 or more distributed electronic networks or databases), that creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
5. Whenever by statute, by the Certificate of Incorporation or by these By-laws a notice is required to be given, a written waiver thereof, signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of any stockholder or director at any meeting thereof shall constitute a waiver of notice of such meeting by such stockholder or director, as the case may be, except as otherwise provided by statute.
ARTICLE XIII
INDEMNIFICATION
1. The Corporation shall indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that such person is or was a director or officer of the Corporation, or is or was serving at the request of the Corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe such person’s conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that such person’s conduct was unlawful. Notwithstanding the provisions of this Section 1, except as otherwise provided in Section 4 of this Article XIII, the Corporation shall be required to indemnify any person referenced in this Section 1 in connection with an action, suit or proceeding (or part thereof) commenced by such person only if the commencement of such action, suit or proceeding (or part thereof) by the person was authorized in the specific case by the Board of Directors.
2. The Corporation shall indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that such person is or was a director or officer of the corporation, or is or was serving at the request of the Corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation and except that no such indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the Corporation unless and only to the extent that the Court of Chancery of the State of Delaware (the “Court of Chancery”) or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such Court of Chancery or such other court shall deem proper.
3. Expenses (including attorneys’ fees) incurred by a present or former officer or director in defending any civil, criminal, administrative or investigative action, suit or proceeding shall be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Corporation as authorized in this Article XIII. Such expenses (including attorneys’ fees) incurred by employees and agents may be so paid upon such terms and conditions, if any, as the Corporation deems appropriate.
4. The indemnification and advancement of expenses provided by, or granted pursuant to, the other Sections of this Article XIII shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any By-law, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another capacity while holding such office.
5. The Corporation may, but shall not be required to, purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the Corporation would have the power to indemnify such person against such liability under the provisions of this Article XIII.
6. For purposes of this Article XIII, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors or officers so that any person who is or was a director or officer of such constituent corporation, or is or was serving at the request of such constituent corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this Article XIII with respect to the resulting or surviving corporation as such person would have with respect to such constituent corporation if its separate existence had continued.
7. For purposes of this Article XIII, references to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request of the Corporation” shall include service as a director or officer of the Corporation which imposes duties on, or involves services by, such director or officer with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner such person reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Corporation” as referred to in this Article XIII.
8. The indemnification and advancement of expenses provided by, or granted pursuant to, this Article XIII shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and administrators of such a person.
9. If this Article or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each director or officer to the fullest extent not prohibited by any applicable portion of this Article that shall not have been invalidated, or by any other applicable law. If this Article shall be invalid due to the application of the indemnification provisions of another jurisdiction, then the Corporation shall indemnify each director and officer to the fullest extent under any other applicable law.
10. The Corporation may indemnify every person who was or is a party or is or was threatened to be made a party to any action, suit, or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was an employee or agent of the corporation or, while an employee or agent of the Corporation, is or was serving at the request of the corporation as an employee or agent or trustee of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including counsel fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding, to the extent permitted by Delaware law.
11. The Corporation’s obligation, if any, to indemnify or to advance expenses to any person serving at its request as a director or officer of another corporation, partnership, joint venture, trust or other enterprise shall be reduced by any amount such person may collect as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust or other enterprise.
ARTICLE XIV
FORUM SELECTION
1. Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery (or, if and only if the Court of Chancery lacks subject matter jurisdiction, any state or federal court located within the State of Delaware) and any appellate court thereof shall be the sole and exclusive forum for (i) any derivative action, suit, or proceeding brought on behalf of the Corporation, (ii) any action, suit, or proceeding asserting a claim of breach of fiduciary duty owed by any current or former director, officer, employee, or stockholder of the Corporation to the Corporation or the Corporation’s stockholders or any action asserting a claim for aiding and abetting any such breach of fiduciary duty, (iii) any action, suit, or proceeding arising pursuant to any provision of the General Corporation Law of the State of Delaware or the Certificate of Incorporation or these By-laws (as each may be amended from time to time), (iv) any claim as to which the General Corporation Law of the State of Delaware confers jurisdiction upon the Court of Chancery, or (v) any action, suit, or proceeding asserting a claim against the Corporation or its current or former directors, officers, employees, or stockholders governed by the internal affairs doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties named as defendants therein.
2. Unless the Corporation consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
3. Notwithstanding the foregoing, the provisions of this Article XIV shall not apply to suits brought to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended, or any other claim for which the federal courts of the United States have exclusive jurisdiction.
4. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of the provisions of this Article XIV. If any provision or provisions of this Article XIV shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provisions in any other circumstance and of the remaining provisions of this Article XIV (including, without limitation, each portion of any sentence of this Article XIV containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable) and the application of such provision to other persons or entities and circumstances shall not in any way be affected or impaired thereby.
ARTICLE XV
AMENDMENT OF BY-LAWS
The By-laws of the Corporation may be altered, amended or repealed, and new By-laws may be adopted, by the Board of Directors. In addition, the By-laws of the Corporation may be altered, amended or repealed, and new By-laws may be adopted, by the stockholders of the Corporation by the affirmative vote of the holders of a majority in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon.
Exhibit 4.2
DESCRIPTION
OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12
OF THE SECURITIES EXCHANGE ACT OF 1934
The following description of the securities of Oramed Pharmaceuticals Inc. (the “Company”) is a summary only. This summary is not complete and is subject to and qualified by the provisions of the Company’s Certificate of Incorporation, as amended (the “Charter”), and By-laws, as amended and restated (the “By-laws”), which are filed as exhibits to the Company’s Annual Report on Form 10-K for the fiscal year ended August 31, 2020 and the Company’s Current Report on Form 10-K filed March 27, 2025, respectively, and are incorporated by reference herein.
Common Stock
Pursuant to the Company’s Charter, the Company is authorized to issue up to sixty million (60,000,000) shares of common stock, par value $0.012 per share (the “Common Stock”).
The Common Stock is traded on The Nasdaq Capital Market and the Tel Aviv Stock Exchange, in each case under the symbol “ORMP”.
The holders of shares of Common Stock vote together as one class on all matters as to which holders of Common Stock are entitled to vote. Except as otherwise required by applicable law, all voting rights are vested in and exercised by the holders of Common Stock with each share of Common Stock being entitled to one vote, including in all elections of directors. The Company does not have a classified board of directors (the “Board”). Generally, all matters to be voted on by stockholders must be approved by a majority of the votes cast by the holders of shares of stock present in person or represented by proxy at such meeting and entitled to vote on the subject matter, a quorum being present. However, in the case of a contested election of directors, a director nominee shall be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors (an election shall be considered contested if, as of the last date on which nominees for director may be submitted in accordance with the By-laws, the nominees for election to the Board exceed the number of positions on the Board to be filled by election at that meeting).
The holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the Board out of legally available funds therefore. The Company has not declared any dividends on its Common Stock and does not anticipate paying any dividends on its Common Stock in the foreseeable future.
In the event of the Company’s liquidation, dissolution or winding up, holders of the Common Stock are entitled to share ratably in all assets remaining after payment of liabilities. The Common Stock has no cumulative voting rights and no preemptive or other rights to subscribe for shares of the Company.
There are no redemption or sinking fund provisions applicable to the Common Stock. All shares of Common Stock currently outstanding are fully paid and non-assessable.
The Company is permitted to issue, and has from time to time, issued warrants and options to purchase shares of the Common Stock, as well as restricted stock units.
The Company’s bylaws provide that the Court of Chancery of the State of Delaware (the “Court Chancery”) is the exclusive forum for state law claims for (i) any derivative action, suit, or proceeding brought on behalf of the Company (ii) any action, suit, or proceeding asserting a claim of breach of fiduciary duty owed by any current or former director, officer, employee, or stockholder of the Company to the Company or the Company’s stockholders or any action asserting a claim for aiding and abetting any such breach of fiduciary duty, (iii) any action, suit, or proceeding arising pursuant to any provision of the General Corporation Law of the State of Delaware or the Certificate of Incorporation or these By-laws (as each may be amended from time to time), (iv) any claim as to which the General Corporation Law of the State of Delaware confers jurisdiction upon the Court of Chancery, or (v) any action, suit, or proceeding asserting a claim against the Company or its current or former directors, officers, employees, or stockholders governed by the internal affairs doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties named as defendants therein. To the fullest extent permitted by law, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
Anti-Takeover Effects of the Company’s Charter and By-Laws
In addition to provisions under Delaware law, the Company’s Charter and By-Laws contain provisions that could have the effect of discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. In particular, the Charter and/or By-Laws, as applicable, among other things:
| ● | provide the Board with the exclusive authority to call special meetings of the stockholders; |
| ● | provide the Board with the ability to alter the By-Laws without stockholder approval and require the affirmative vote of the holders of a majority in voting power of the outstanding shares of capital stock of the Company entitled to vote thereon to alter the By-Laws without Board approval; |
| ● | provide rules for stockholder action by written consent, including procedures for a record date to be set by the Board in connection with such action, information requirements, the engagement of an independent inspector of election and timing requirements; | |
| ● | provide the Board with the exclusive authority to fix the number of directors constituting the whole Board; and |
| ● | provide that vacancies on the Board may be filled by a majority of directors in office, although less than a quorum. |
Such provisions may have the effect of discouraging a third-party from acquiring the Company, even if doing so would be beneficial to the Company’s stockholders. These provisions are intended to enhance the likelihood of continuity and stability in the composition of the Board and in its policies, and to discourage some types of transactions that may involve an actual or threatened change in control of the Company. These provisions are designed to reduce the Company’s vulnerability to an unsolicited acquisition proposal and to discourage some tactics that may be used in proxy fights. The Company believes that the benefits of increased protection of its potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure the Company outweigh the disadvantages of discouraging such proposals because, among other things, negotiation of such proposals could result in an improvement of their terms. However, these provisions could have the effect of discouraging others from making tender offers for shares of the Company’s Common Stock and, as a consequence, they also may inhibit fluctuations in the market price of the shares of the Company’s Common Stock that could result from actual or rumored takeover attempts. These provisions also may have the effect of preventing changes in the Company’s management.
Exhibit 10.72
Second Amendment to Consulting Agreement
This Second Amendment to Consulting Agreement (this “Second Amendment”) is entered into as of November 7, 2024 and is effective as of July 1, 2024, by and between Oramed Pharmaceuticals Inc., a company incorporated under the laws of the State of Delaware, with an address at 20 Mamilla Ave., Jerusalem, Israel 9414904 (the “Company”) and Shnida Ltd., a company incorporated under the laws of the State of Israel, (company I.D. no. 514519016) with an address at 32 Eliezer Hagadol Street, Jerusalem (the "Consultant").
WHEREAS, the Company and the Consultant entered into a consulting agreement, effective as of November 1, 2022 and amended as of April 27, 2023 and as of January 8, 2024(the “Consulting Agreement”); and
WHEREAS, the Company and the Consultant desire to amend the terms and conditions of the Consulting Agreement as set forth herein.
NOW, THEREFORE, the Company and the Consultant agree as follows:
| 1. | Amendment to Section 6. Section 6 of the Consulting Agreement is hereby amended and restated in its entirety to read as follows: |
Compensation. Effective January 1, 2024 (inclusive), the Company shall pay to the Consultant in consideration for the performance of the Consulting Services, a gross monthly amount of NIS 111,348 (the “Consideration”), subject to the receipt by the Company of an invoice from the Consultant.
| 2. | Except for the changes and/or additions stated herein, all the other terms of the Consulting Agreement shall remain valid and bind the parties without any change. In the case of a contradiction between the provisions of this Second Amendment and the provisions of the Consulting Agreement, the provisions of this Second Amendment shall prevail. Without limiting the generality of the foregoing, the term “Agreement” as used in the Consulting Agreement shall be deemed to be the Consulting Agreement as amended by this Second Amendment. |
IN WITNESS WHEREOF, the parties have executed this Third Amendment to Consulting Agreement as of the date written above.
| ORAMED PHARMACEUTICALS INC. | SHNIDALTD. | |||
| By: | /s/ Avi Gabay | By: | /s/ Nadav Kidron | |
| Name: | Avi Gabay | Name: | Nadav Kidron | |
| Title: | Chief Financial Officer | Title: | Chief Executive Officer | |
I hereby confirm that I have read this Second Amendment, understood its terms and agree to be personally bound by all its terms and provisions.
| /s/ Nadav Kidron | ||
| Nadav Kidron |
Exhibit 10.73
Second Amendment to Employment Agreement
This Second Amendment to Employment Agreement (this “Second Amendment”) is entered into as of November 7, 2024 and is effective as of July 1, 2024, by and between Nadav Kidron, an individual residing in Jerusalem, Israel (the “Executive”), and Oramed Ltd., a company incorporated under the laws of the State of Israel, with an address at 20 Mamilla Ave., Jerusalem, Israel 9414904 (the “Company”).
WHEREAS, the Company and the Executive entered into an employment agreement, effective as of November 1, 2022 and amended as of April 27, 2023 and as of January 8, 2024 (the “Employment Agreement”); and
WHEREAS, Company and the Executive desire to amend the terms and conditions of the Employment Agreement as set forth herein.
NOW, THEREFORE, the Company and the Executive agree as follows:
| 1. | Section 2.1(a) of the Employment Agreement will be amended and replaced as follows: |
The Executive shall be entitled to a gross monthly amount of NIS 59,330 (the “Salary”).
| 2. | Except for the changes and/or additions stated herein, all the other terms of the Employment Agreement shall remain valid and bind the parties without any change. In the case of a contradiction between the provisions of this Second Amendment and the provisions of the Employment Agreement, the provisions of this Second Amendment shall prevail. Without limiting the generality of the foregoing, the term “Agreement” as used in the Employment Agreement shall be deemed to be the Employment Agreement as amended by this Second Amendment. |
IN WITNESS WHEREOF, the parties have executed this third Amendment to Employment Agreement as of the date written above.
| Oramed Ltd. | |
| /s/ Avi Gabay | |
| Avi Gabay, CFO | |
| /s/ Nadav Kidron | |
| Nadav Kidron |
Exhibit 10.74
AGREEMENT AND AMENDMENT NO. 10
This AGREEMENT AND AMENDMENT NO. 10 (this “Ninth Amendment”) is made as of November 7, 2024 and is effective as of July 1, 2024, by and between Oramed Ltd., a company incorporated under the laws of the State of Israel, # 513976712 with an address at Mamilla, 20, Jerusalem, Israel 9414904 (the “Company”), and KNRY, Ltd., a company incorporated under the laws of the State of Israel, # 513836502 with an address at 2 Elza Street, Jerusalem, Israel 93706 (the “Consultant”).
WHEREAS:
A. The Company and the Consultant are parties to that certain consulting agreement dated as of July 1, 2008, as amended on July 13, 2013, on November 13, 2014, on July 21, 2015, on June 27, 2016, on June 30, 2017, on January 10, 2020, on September 19, 2021, on April 17, 2023 and on January 8, 2024 (collectively, the “Consulting Agreement”), for services to be provided by Dr. Miriam Kidron Israeli I.D. number 9665993 (“Miriam”); and
B. The Company and the Consultant wish to amend the Consulting Agreement to revise the terms of the Consultant compensation thereunder.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements herein contained, the parties hereto covenant and agree as follows:
| 1. | Amendment to Section 6. Section 6 of the Consulting Agreement is hereby amended and restated in its entirety to read as follows: |
“Compensation. Effective July 1, 2024 (inclusive), the Company shall pay to the Consultant in consideration for the performance of the Consulting Services, a gross monthly amount of 134,550 + VAT (the “Consideration”), subject to the receipt by the Company of an invoice from the Consultant. Each of the Consultant and Miriam hereby declares that neither of them has, nor shall have in the future, any claims or demands in respect of amounts paid prior to May 2008.”
| 2. | Except for the changes and/or additions stated herein, all the other terms of the Consulting Agreement shall remain valid and bind the parties without any change. In the case of a contradiction between the provisions of this Ninth Amendment and the provisions of the Consulting Agreement, the provisions of this Ninth Amendment shall prevail. Without limiting the generality of the foregoing, the term “Agreement” as used in the Consulting Agreement shall be deemed to be the Consulting Agreement as amended by this Ninth Amendment. |
IN WITNESS WHEREOF, the parties have executed this Ninth Amendment to Consulting Agreement as of the date first written above.
| ORAMED LTD. | KNRYLTD. | |||
| By: | /s/ Avi Gabay | By: | /s/ Miriam Kidron | |
| Name: | Avi Gabay | Name: | Miriam Kidron | |
| Title: | Chief Financial Officer | |||
Exhibit 19.1
ORAMED PHARMACEUTICALS INC.
INSIDER TRADING POLICY
Effective: March 20, 2025
This policy sets forth guidelines for all Insiders (as defined below) of Oramed Pharmaceuticals Inc. (together with its subsidiaries when the context so requires, “Oramed”) with respect to transactions in Oramed securities. This policy arises from Oramed’s responsibilities as a public company whose shares of common stock are quoted on the Nasdaq Capital Market, or Nasdaq, and on the Tel Aviv Stock Exchange, or TASE, under the symbol “ORMP.” Failure to comply with these guidelines could result in a serious violation of the securities laws by you and/or Oramed and can involve both civil and criminal penalties. It is important that you review this policy carefully.
| I. | Reason for Policy |
Oramed is subject to the insider trading laws in the United States and Israel. Under United States law, an individual may be subject to fines of up to $5,000,000 and up to twenty years in jail for violating the securities laws by engaging in transactions in securities at a time when in possession of material non-public information. In addition, the U.S. Securities and Exchange Commission (the “SEC”) may seek the imposition of a civil penalty of up to three times the profits made or losses avoided from the trading. Insider traders must also disgorge any profits made and are often subjected to an injunction against future violations. Violators can also be barred from serving as officers or directors of public companies. Individuals also may be subjected to civil liability in private lawsuits. The foregoing penalties are subject to amendment from time to time.
Without regard to the penalties that may be imposed by others, willful violation of this policy constitutes grounds for dismissal from the Board of Directors of Oramed (the “Board”), termination of your employment or, with respect to consultants, representatives or independent contractors, termination of your engagement, with Oramed.
Insider trading proscriptions are not limited to trading by the insider alone; it is also illegal to advise others to trade on the basis of material non-public information or to share material non-public information with others if you know or should have known that they will use such information to purchase or sell Oramed securities. This practice is called “tipping.” Liability in such cases can extend both to the “tippee”—the person who purchased or sold Oramed securities based on this material non-public information—and to the “tipper,” the Insider himself or herself. Even if you are not in possession of material non-public information regarding Oramed, do not recommend to any other person that they buy or sell securities of Oramed because your recommendation could be imputed to Oramed and may be misleading if you do not have all of the relevant information.
Finally, the appearance of insider trading can cause a substantial loss of confidence in Oramed and its securities on the part of the public and the securities markets. This could obviously have an adverse impact on Oramed and its stockholders. Accordingly, avoiding the appearance of engaging in transactions on the basis of material non-public information can be as important as avoiding a transaction actually based on such information. Furthermore, if your transactions become the subject of scrutiny, they will be viewed after the fact with the benefit of 20/20 hindsight. Accordingly, before engaging in any transaction you should carefully consider how regulators and others might view your transaction with such hindsight and, if you have the slightest doubt, consult with Oramed’s Chief Financial Officer (“CFO”).
In the event an Insider becomes aware of a possible violation of this policy by another Insider, he or she should contact Oramed’s CFO, without delay, by telephone at +1 844 967 2633 (U.S.) or +972 2-566-0001 (Israel) or by email at avi@oramed.com.
| II. | Applicability of Policy |
1. “Insiders” Defined. This policy applies to any “Insider” of Oramed, including any (a) member of the Board and officer of Oramed, (b) employee of Oramed, including part-time or temporary employees, and (c) consultant, representative, or independent contractor (e.g., accountants, attorneys and investment bankers) who have access to material non-public information of Oramed. This policy also applies to family members and other members of an Insiders’ household as well as family members who do not live in their home but whose transactions in Oramed securities are directed by or are subject to the influence or control of the Insider, as well as any entities that an Insider influences or controls, including any corporations, partnerships or trusts (collectively, “Controlled Entity”). Insiders are responsible for the compliance with this policy by such Insider’s family members and Controlled Entities.
2. “Access Insiders” Defined. This policy imposes additional restrictions upon Insiders who may have increased access to material information concerning Oramed that has not been disclosed to the public (see below for a definition of “material information”), referred to as “Access Insiders.” Access Insiders are: (a) members of the Board of Oramed, (b) the Chief Executive Officer, Chief Financial Officer, presidents, general managers, vice presidents, controllers, vice controllers, treasurers, corporate secretaries and accounting personnel of Oramed and (c) the family members and Controlled Entities of the foregoing persons. Access Insiders are subject to additional procedures and restrictions described in Section VI below.
3. Inside Information Regarding Other Companies. This policy and the guidelines described herein also apply to material non-public information relating to other companies, including Oramed’s customers, vendors or suppliers or companies with which Oramed is considering merger and acquisition transactions (“business partners”), when that information is obtained in the course of employment with, or other services performed on behalf of, Oramed, as well as other companies that may be impacted by material non-public information regarding Oramed. Civil and criminal penalties, and termination of employment, may result from trading on inside information regarding Oramed’s business partners. All personnel should treat material non-public information about Oramed’s business partners with the same care required with respect to information related directly to Oramed.
4. Tail Period. If you are aware of material non-public information when your employment or service terminates, you may not trade in Oramed securities until that information has become public or is no longer material.
5. Applicability to Oramed. In addition, Oramed itself must comply with securities laws applicable to its own securities trading activities, and must not engage in any transaction involving a purchase or sale of its securities, including any offer to purchase or offer to sell or other disposition of its securities, when it is in possession of material nonpublic information concerning Oramed, other than in compliance with applicable law, subject to the policies and procedures adopted by Oramed and the exceptions listed in Section VII of this policy to the extent applicable.
| III. | Definition of Material Non-Public Information |
It is not possible to define all categories of “material” information. In general, information should be regarded as material if its disclosure would reasonably be expected to have an effect (whether positive or negative) on the price of a company’s securities or if there is a likelihood that it would be considered important by a reasonable investor in making a decision regarding the purchase or sale of Oramed securities. Both positive and negative information can be material, as well as information that forecasts whether an event may or may not occur.
Although it may be difficult under this standard to determine whether certain information is material, there are various categories of information that would almost always be regarded as material. Examples of such information are: earnings information and quarterly or annual results; guidance on earnings estimates; clinical results; product and research developments; marketing plans; major licensing transactions; government inspections, approvals or other regulatory actions; status of patent applications; changes in senior management; proposed payment of a dividend or change in dividend policy; planned share splits or repurchases; new equity or debt offerings; other events regarding Oramed securities (e.g., defaults on debt, changes to the rights of security holders); major changes in accounting policies; collaborations, mergers, acquisitions or divestitures, and significant litigation matters. Moreover, material information does not have to be related to a company’s business. For example, advance knowledge of the contents of a forthcoming article that is expected to affect the market price of a security can be material. If any Insider has questions as to the materiality of information, he or she should contact the CFO of Oramed for clarification.
Information is considered “non-public” unless it has been broadly disseminated in a manner that makes the information available to investors generally and investors have had a reasonable time to digest the information. Common examples of broad dissemination include annual, quarterly and current reports filed with the SEC, earnings releases, press releases and other information that is widely reported in the media. Generally, a “reasonable time” following the release of the information to the public would require at least one full Nasdaq trading day after the information became public.
| IV. | Prohibited Transactions |
1. Trading while in Possession. Insiders may not engage in a transaction (purchase or sale, including any offer to purchase or offer to sell or other disposition of Oramed’s securities) in Oramed shares or Oramed debt securities, as well as other securities for which Oramed’s securities serve as underlying assets (e.g., options, RSUs or PSUs) (collectively, “Oramed securities”) at any time between the date on which any material non-public material information becomes known to the individual, including information regarding other companies referred to in Section II.3 above, and the close of business of at least one full Nasdaq trading day after such information is publicly disclosed. Nasdaq is generally open for trading Monday through Friday. If, for example, Oramed publicly disclosed information on a Monday, then you may not trade in Oramed securities until Wednesday.
2. Speculative Trading. No Insider may engage in transactions of a speculative nature with regard to Oramed securities at any time. All Insiders are prohibited from short-selling Oramed common stock or engaging in transactions involving Oramed-based derivative securities. “Derivative Securities” are options, warrants, stock appreciation rights or similar rights whose value is derived from the value of an equity security, such as Oramed common stock. This prohibition includes, but is not limited to, trading in Oramed-based put and call option contracts, transacting in straddles, and the like. However, as indicated below, holding and exercising options or other derivative securities granted under Oramed’s employee stock option or equity incentive plans is not prohibited by this policy.
3. Short Sales. Short sales of Oramed securities (i.e., the sale of a security that the seller does not own) may evidence an expectation on the part of the seller that the securities will decline in value, and therefore have the potential to signal to the market that the seller lacks confidence in Oramed’s prospects. In addition, short sales may reduce a seller’s incentive to seek to improve Oramed’s performance. For these reasons, short sales of Oramed securities are prohibited. In addition, Section 16(c) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), prohibits officers and directors from engaging in short sales. (Short sales arising from certain types of hedging transactions are governed by the paragraph below captioned “Hedging Transactions.”)
4. Hedging Transactions. Hedging or monetization transactions can be accomplished through a number of possible mechanisms, including through the use of financial instruments such as prepaid variable forwards, equity swaps, collars and exchange funds. Such hedging transactions may permit a director, officer or employee to continue to own Oramed securities obtained through employee benefit plans or otherwise, but without the full risks and rewards of ownership. When that occurs, the director, officer or employee may no longer have the same objectives as Oramed’s other shareholders. Therefore, directors, officers and employees are prohibited from engaging in any such transactions.
5. Margin Accounts and Pledged Securities. Securities held in a margin account as collateral for a margin loan may be sold by the broker without the customer’s consent if the customer fails to meet a margin call. Similarly, securities pledged (or hypothecated) as collateral for a loan may be sold in foreclosure if the borrower defaults on the loan. Because a margin sale or foreclosure sale may occur at a time when the pledgor is aware of material non-public information or otherwise is not permitted to trade in Oramed securities, directors, officers and other employees are prohibited from holding Oramed securities in a margin account or otherwise pledging Oramed securities as collateral for a loan. (Pledges of Oramed securities arising from certain types of hedging transactions are governed by the paragraph above captioned “Hedging Transactions.”)
6. Open Orders. Any Insider who has placed a limit order or open instruction to buy or sell Oramed securities shall bear responsibility for canceling such instructions immediately in the event restrictions are imposed on their ability to trade in accordance with this policy.
| V. | Open Window and Blackout Periods |
All Insiders are subject to the following blackout procedures. If you are an Insider involved in the preparation or review of Oramed’s financial statements and related public disclosures, Oramed will notify you that you are subject to these blackout procedures. If you have any uncertainty whether you are covered by the blackout procedures, please contact the CFO.
1. Quarterly Blackout Periods: Oramed’s announcement of its quarterly financial results almost always has the potential to have a material effect on the market for Oramed securities. Therefore, to avoid even the appearance of trading on the basis of material non-public information, regardless of whether or not you are aware of any material non-public information, you may not trade in Oramed securities during the period beginning on the first day following the end of each fiscal quarter and ending on the day after the first full trading day following the day on which Oramed's quarterly or annual results are released in the United States.
For example, if Oramed announces quarterly or annual results before trading begins on a Tuesday, the first time you can buy or sell Oramed securities is the opening of the market on Wednesday (assuming you are not aware of other material non-public information at that time). However, if Oramed announces quarterly or annual results after trading begins on that Tuesday, the first time you can buy or sell Oramed securities is the opening of the market on Thursday (assuming you are not aware of other material non-public information at that time).
Oramed will endeavor to send out a notice each quarter setting forth the specific dates for the quarterly “blackout” and “open window” periods to those persons to whom the blackout procedures apply.
2. Event Specific Blackout Periods. From time to time, an event may occur that is material to Oramed and is known by only a few Insiders. So long as the event remains material and non-public, the persons who are aware of the event, as well as other persons designated by the CFO, may not trade in Oramed securities. The existence of an event-specific blackout will not be announced, other than to those who are aware of the event giving rise to the blackout. Any person made aware of the existence of an event-specific blackout should not disclose the existence of the blackout to any other person.
3. Prohibited Transactions: Transactions prohibited during blackout periods include:
| ● | Open market purchase or sale of Oramed securities; |
| ● | Purchase or sale of Oramed securities through a broker; |
| ● | Sales of the shares upon exercise of Oramed stock options; |
| ● | Broker-assisted cashless exercises of Oramed stock options; |
| ● | Switching existing balances into or out of, or elections with respect to, Oramed’s stock fund in a 401(k) plan or other benefit plans; and |
| ● | New discretionary cash investments in any dividend reinvestment plan of Oramed. |
4. Hardship Exceptions: A person who is subject to a blackout period and who has an unexpected and urgent need to sell Oramed securities in order to generate funds may, in appropriate circumstances, be permitted to sell Oramed securities even during the blackout period, subject to approval from the CFO, after concluding that such person is not in possession of material non-public information. Under no circumstance will a hardship exception be granted during an event-specific blackout period or to a director or an executive officer.
5. No Safe Harbor. It is important to emphasize that the institution of blackout periods is an internal Oramed policy. It does not create a “safe harbor” or otherwise insulate a person from the consequences of insider trading, which could include severe criminal and civil sanctions. Even if a blackout period is not in effect, at no time may you trade in Oramed securities if you are aware of material non-public information about Oramed, until at least one full business day following the public disclosure of such information.
| VI. | Additional Procedures for Access Insiders |
1. Pre-clearance.
| a) | All Access Insiders must inform and receive pre-clearance from Oramed’s CFO whenever they intend to execute a transaction in Oramed securities, including the placing of limit orders, a stock plan transaction (such as an option exercise), or a gift, loan, pledge, contribution to a trust or any other transfer, at least three (3) business days in advance of the proposed transaction. The CFO is under no obligation to approve a trade or transaction submitted for pre-clearance, and may determine not to permit the trade. If pre-clearance is denied, such denial must be kept confidential by the person requesting pre-clearance. The CFO must inform and receive pre-clearance for such transactions from the CEO. |
| b) | When obtaining pre-clearance to execute a trade in Oramed securities, such individuals will be responsible for verifying with the CFO that (i) they do not possess any material non-public information regarding Oramed, (ii) Oramed has not imposed any blackout periods or other restrictions on their ability to engage in trades, and (iii) the transaction would not trigger a “short-swing” profit disgorgement, as described in Section VI.3 below. If the individual has not completed the trade within three (3) trading days of notification of the intention to trade, then the individual must re-confirm their pre-clearance with Oramed’s CFO that they intend to execute a trade and the individual must re-verify the non-existence of any restrictions on such trade. |
| c) | Before each transaction in Oramed securities, each such officer and director should contact the CFO regarding (a) compliance with Rule 144 under the Securities Act of 1933, as amended, which contains guidelines for the sale of privately issued shares and sales by affiliates of Oramed, if such sales are not covered by an effective registration statement, to the extent applicable, and (b) the reporting of purchases, sales, gifts or other transactions of shares through the filing of Form 4s or other applicable filings with the SEC. |
| d) | Following execution of any transaction in Oramed securities by an Access Insider who is subject to these pre-clearance procedures (including transactions effected pursuant to a trading plan established pursuant to Rule 10b5-1 under the Exchange Act (“Rule 10b5-1”)), such trade or transaction must be reported to the CFO on the same day in which such a transaction occurs. Each such report should include the date of the transaction, quantity of securities, price and broker-dealer (if any) through which the transaction was effected. |
| e) | The CFO assumes no responsibility for, and approval from the CFO does not protect the Access Insider from, the consequences of prohibited insider trading. Ultimately, you are the one responsible for ensuring compliance with this policy in all respects. Any internal policy, guideline, action or general advice of Oramed, the CFO or any other employee or director does not in any way constitute legal advice or insulate an individual from liability under applicable securities laws. |
2. Section 16 Reporting Requirements. Section 16 of the Exchange Act and the SEC’s rules thereunder require all of Oramed’s executive officers, directors and greater than 10% stockholders (collectively, “Section 16 Insiders”) to report their beneficial ownership of Oramed’s equity securities and any subsequent changes in that ownership.
| a) | A Form 3 must be filed within 10 calendar days of becoming a Section 16 Insider. This report discloses the reporting person’s beneficial interest in Oramed’s equity securities and must be filed even if such person does not own any of Oramed’s equity securities. |
| b) | A Form 4 must be filed to report acquisitions and dispositions of Oramed’s equity securities, including (i) any open market sale or purchase of Oramed’s equity securities (including pursuant to a Rule 10b5-1 plan), (ii) any grant, exercise or conversion of restricted stock or derivative securities (e.g., stock options), (iii) any transfers to or from indirect forms of ownership, such as transfers to trusts, (iv) any gifts and (v) any intra-plan transfers involving Oramed’s equity securities held under pension or retirement plans. A Form 4 must generally be filed within two business days of the date of execution of the transaction (not the settlement date or subsequent closing or delivery date). |
| c) | A Form 5 must be filed within 45 days after Oramed’s fiscal year-end by every individual or entity who was a Section 16 Insider at any time during the prior fiscal year to report (i) certain small acquisitions of Oramed’s equity securities, (ii) certain miscellaneous transactions, such as inheritances and (iii) any transaction during the last fiscal year that was required to be reported on a Form 3 or Form 4 but was not reported. Transactions that may be reported following fiscal year-end on a Form 5 may be reported earlier on a Form 4. Oramed encourages the use of the Form 4 early reporting option to help prevent transactions from going unreported following fiscal year-end and to help eliminate the need to file a Form 5. |
| d) | Under SEC rules, the preparation and filing of Section 16 reports are the sole responsibility of the Section 16 Insider. However, Oramed assists its directors and executive officers in preparing and filing these forms. Oramed can only facilitate compliance by directors and executive officers to the extent they provide Oramed with the required information for making their reports. Oramed does not assume any legal responsibility in this regard. |
3. Short-Swing Trading. Short-term trading of Oramed securities may be distracting to the person and may unduly focus the person on Oramed’s short-term stock market performance instead of Oramed’s long-term business objectives. For these reasons, any Section 16 Insider who purchases Oramed securities in the open market may not sell any Oramed securities of the same class during the six months following the purchase (or vice versa). In addition, under Israeli law, an Access Insider of Oramed who buys and sells, or sells and buys, Oramed securities within a three-month period is presumed to have traded on inside information, unless it can be proven that he or she did not have any material non-public information at the time of the transaction. Since it would be very difficult to rebut this presumption, all such persons are advised to monitor carefully the timing of any purchases and sales of Oramed securities so as to avoid triggering this provision of Israeli law. To ensure compliance with short-swing trading requirements, all Section 16 Insiders are required to obtain pre-clearance and report trades in accordance with Section VI.1 above.
4. Disgorgement of Profits on Short-Swing Transactions. Under Section 16(b) of the Exchange Act, any profit realized by a Section 16 Insider on a “short-swing” transaction (e.g., a non-exempt purchase and sale, or sale and purchase, of Oramed’s equity securities within a period of less than six months) must be disgorged to Oramed upon demand by Oramed or a stockholder acting on Oramed’s behalf. By law, Oramed cannot waive or release any claim it may have under Section 16(b), or enter into an enforceable agreement to provide indemnification for amounts recovered under Section 16(b).
| VII. | Exceptions |
The only exceptions to the policy are set forth below. It does not matter that the Insider may have decided to engage in a transaction before learning of the material non-public information or that delaying the transaction might result in economic loss. It is also irrelevant that publicly disclosed information about Oramed might, even aside from the undisclosed material information, provide a substantial basis for engaging in the transaction. Additionally, there are no limits on the size of a transaction that will trigger insider trading liability; relatively small trades have in the past occasioned investigations and lawsuits. You simply cannot trade in Oramed securities while in possession of material non-public information about Oramed. The only exceptions to the policy are as follows:
1. Exercise of an option, vesting of an RSU or PSU under Oramed’s share option plan. Note that this exception does not include (a) any sale of stock as part of a broker-assisted cashless exercise of an option, or any other market sale for the purpose of generating the cash needed to pay the exercise price of an option or (b) a subsequent sale of the shares acquired pursuant to the exercise of an equity award under the Oramed share option plan.
2. Bona fide gifts of securities are not deemed to be transactions for the purposes of this policy. Whether a gift is truly bona fide will depend on the circumstances surrounding each gift. The more unrelated the donee is to the donor, the more likely the gift would be considered “bona fide” and not a “transaction.” For example, gifts to charities, religious institutions and service organizations would clearly not be “transactions.” On the other hand, gifts to dependent children followed by a sale of the “gift” securities in close proximity to the time of the gift may imply some economic benefit to the donor and, therefore, make the gift non-bona fide.
3. The restrictions set forth in the preceding paragraphs shall not apply to sales made pursuant to a Qualified Selling Plan. For purposes of this exception, a “Qualified Selling Plan” is a written plan for selling Oramed’s securities which meets each of the following requirements: (a) the plan is adopted by the Insider or temporary Insider during a period when the Insider or temporary Insider is not in possession of material non-public information; (b) the plan is adhered to strictly by the Insider or temporary Insider; (c) the plan either (i) specifies the amount of securities to be sold and the date on which the securities are to be sold, (ii) includes a written formula or algorithm, or computer program, for determining the amount of securities to be sold and the price at which and the date on which the securities are to be purchased or sold, or (iii) does not permit the Insider or temporary Insider to exercise any subsequent influence over how, when, or whether to effect sales; provided, in addition, that any other person who, pursuant to the plan, does exercise such influence must not have been aware of the material non-public information when doing so; (d) the plan includes a representation from the Insider adopting the plan that such Insider (i) is not aware of any material nonpublic information about Oramed or its securities and (ii) is adopting the plan in good faith and not as part of a plan or scheme to evade the prohibitions of Rule 10b-5 under the Exchange Act; (e) the plan provides that trading under the plan cannot begin until the later of (i) 90 days after the adoption of the plan or (ii) two business days following the disclosure of Oramed’s financial results in a Form 10-Q or Form 10-K for the fiscal quarter in which the plan is adopted (such period being referred to as the “cooling-off period”, but, in either case, not to exceed 120 days following the adoption of the plan, and provided that if the Insider is not a director or officer of Oramed, such cooling-off period shall be at least 30 days rather than the longer periods set forth above); and (e) at the time it is adopted the plan conforms to all other requirements of Rule 10b5-1 under the Exchange Act as then in effect. Rule 10b5-1 provides an affirmative defense from insider trading liability under the U.S. federal securities laws for trading plans that meet the above requirements.
Oramed requires that the entry into, modification or termination of any Qualified Selling Plan be approved in writing in advance by the CFO, at least five (5) business days prior to the proposed entry into such plan. Qualified Selling Plans generally may not be adopted outside an open window period or during a blackout period and may only be adopted when the person adopting the plan is not aware of material non-public information.
In accordance with Rule 10b5-1 under the Exchange Act, any change to the amount, price, or timing of the purchase or sale of securities underlying a Qualified Selling Plan constitutes termination of the Qualified Plan and the adoption of a new Qualified Selling Plan, which triggers the cooling-off period described above. No Insider may have more than one Qualified Selling Plan for purchases or sales of securities on the open market during the same period. In addition, no Insider may have more than one single-trade Qualified Plan during any 12-month period. A single-trade plan is one that has the practical effect of requiring the purchase or sale of securities as a single transaction. With respect to overlapping Qualified Selling Plans, an Insider may have two separate plans provided (i) the later-commencing plan does not begin until all trades have been completed under the first plan or the first plan expires without execution, and trading during the cooling-off period that would have applied if the later-commencing plan was adopted on the date the earlier-commencing plan terminates and (ii) the separate plans satisfy all other conditions applicable to Qualified Selling Plans. With respect to overlapping Qualified Selling Plans, an Insider may have separate plans for “sell-to-cover” transactions in which an Insider instructs an agent to sell securities in order to satisfy tax withholding obligations at the time an equity award vests. Any such additional plan must only authorize qualified “sell-to-cover” transactions. With respect to single-trade Qualified Selling Plans, an Insider may have a single-trade plan for “sell-to-cover” transactions.
VIII. Modifications to Policy
Oramed may at any time change this policy or adopt such other policies or procedures that it considers appropriate to carry out the purposes of this policy. Notice of any such change will be delivered to you by email (or other delivery option in Oramed’s discretion). You will be deemed to have received, be bound by and agree to revisions of this policy when such revisions have been delivered to you.
| IX. | Acknowledgement |
Please sign the attachment acknowledging that you have read and agree to comply with this policy and return it to Oramed’s CFO, by email at avi@oramed.com. If you have any questions, please contact Oramed’s CFO.
ACKNOWLEDGEMENT
Please sign below acknowledging that you have read and agree to abide by Oramed’s Insider Trading Policy.
I received, reviewed and agree to be bound by Oramed’s Insider Trading Policy.
| Date: | |
| Signature | |
| Name | |
| Title | |
| Return this Acknowledgment to the CFO of Oramed. |
Insider Trading Policy Acknowledgment
Exhibit 21.1
SUBSIDIARIES
Oramed Ltd. – Incorporated in the State of Israel
Oramed HK Limited – Incorporated in Hong Kong
OraTech Pharmaceuticals, Inc. – Incorporated in State of Nevada (100% owned by Oramed Pharmaceuticals Inc.)
Oravax Medical Inc. – Incorporated in the State of Delaware (63% owned by Oramed Pharmaceuticals Inc.)
RoyaltyVest, LTD. - Incorporated in the British Virgin Islands (50% owned by Oramed Pharmaceuticals Inc.)
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-163919, 333-190222, 333-199120, 333-213835, 333-234303, 333-244380 and 333-266105) of Oramed Pharmaceuticals Inc. of our report dated March 27, 2025 relating to the financial statements, which appears in this Form 10-K.
| /s/ Kesselman & Kesselman | |
| Certified Public Accountants (Isr.) | |
| A member firm of PricewaterhouseCoopers International Limited | |
| Tel-Aviv, Israel | |
| March 27, 2025 | |
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Nadav Kidron, certify that:
| 1. | I have reviewed this Annual Report on Form 10-K of Oramed Pharmaceuticals Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant ’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: March 27, 2025 | By: | /s/ Nadav Kidron |
| Nadav Kidron | ||
| President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Avraham Gabay, certify that:
| 1. | I have reviewed this Annual Report on Form 10-K of Oramed Pharmaceuticals Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant ’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: March 27, 2025 | By: | /s/ Avraham Gabay |
| Avraham Gabay | ||
| Chief Financial Officer |
Exhibit 32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350
In connection with the annual report of Oramed Pharmaceuticals Inc., or the Company, on Form 10-K for the period ended December 31, 2024, as filed with the Securities and Exchange Commission on the date hereof, or the Report, I, Nadav Kidron, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, that to my knowledge:
| 1. | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Date: March 27, 2025 | By: | /s/ Nadav Kidron |
| Nadav Kidron | ||
| Chief Executive Officer |
Exhibit 32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350
In connection with the annual report of Oramed Pharmaceuticals Inc., or the Company, on Form 10-K for the period ended December 31, 2024, as filed with the Securities and Exchange Commission on the date hereof, or the Report, I, David Silberman, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, that to my knowledge:
| 1. | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Date: March 27, 2025 | By: | /s/ Avraham Gabay |
| Avraham Gabay | ||
| Chief Financial Officer |