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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 5, 2024
Immunome, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39580 | 77-0694340 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 665
Stockton Drive, Suite 300 Exton, Pennsylvania |
19342 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (610) 321-3700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name
of each exchange on which registered |
||
| Common Stock, $0.0001 par value per share | IMNM | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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. ¨
Item 1.01 Entry into a Material Definitive Agreement.
License Agreement
On January 5, 2024, Immunome, Inc. (the “Company”) entered into a license agreement (“License Agreement”) with Zentalis Pharmaceuticals, Inc. (“Zentalis”), pursuant to which the Company received an exclusive, worldwide, royalty-bearing, sublicensable license under certain intellectual property relating to Zentalis’ proprietary antibody-drug conjugate (“ADC”) platform technology, ROR1 antibodies and ADCs targeting ROR1 to exploit products covered by or incorporating the licensed intellectual property rights. Under the License Agreement, the Company is required to use commercially reasonable efforts to develop an ADC targeting ROR1, two additional ADCs, and commercialize any product that has received regulatory approval.
Under the License Agreement, the Company paid to Zentalis upfront consideration totaling $35 million in cash and shares of Company common stock. The Company is obligated to pay Zentalis up to $150 million in development and regulatory milestones for the first product containing an ADC targeting ROR1 (a “ROR1 ADC Product”) to achieve such milestones and commercial milestones on ROR1 ADC Products. The Company is also obligated to pay to Zentalis mid-to-high single digit royalties on ROR1 ADC Products. In addition, the Company is obligated to pay Zentalis $25 million in development and regulatory milestones for the first product from each of the first five additional development programs using the licensed platform technology to generate products, and mid single digit royalties on products from each such program. The Company’s royalty payment obligation will commence, on a product-by-product and country-by-country basis, on the first commercial sale of such product in such country and will expire on the latest of (a) the ten (10)-year anniversary of such first commercial sale for such product in such country, (b) the expiration of regulatory exclusivity for such product in such country, and (c) the expiration of the last-to-expire valid claim of a licensed patent covering such product in such country.
The License Agreement will continue until the expiration of all royalty payment obligations. The License Agreement may be terminated early by (a) either party in its entirety upon (i) the other party’s uncured material breach, subject to a notice and cure period, (ii) any insolvency event of the other party or (iii) prolonged force majeure, (b) the Company, either in its entirety or in part, for convenience upon a specified period prior written notice, or (c) Zentalis (i) in its entirety if the Company challenges one of the licensed patents or (ii) fails to meet certain development activity benchmarks within specified time periods.
Stock Issuance Agreement
Concurrently with the execution of the License Agreement, the Company entered into a stock issuance agreement (the “Stock Issuance Agreement”) with Zentalis, pursuant to which the Company issued 2,298,586 shares of the Company’s common stock (the “Shares”), as partial consideration for the rights licensed to the Company from Zentalis pursuant to the License Agreement.
Pursuant to the terms of the Stock Issuance Agreement, Zentalis has agreed not to, without the Company’s prior approval or invitation and subject to certain conditions and exceptions, among other things, directly or indirectly acquire additional shares of the Company’s securities or material assets, seek or propose a tender or exchange offer, merger or other business combination involving the Company, or seek or propose any recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction with respect to the Company, solicit proxies or consents to vote any securities of the Company, or undertake other specified actions related to the potential acquisition of additional securities of the Company (collectively, the “Standstill Restrictions”). The Standstill Restrictions will expire on the one-year anniversary of the effective date of the Stock Issuance Agreement.
The Stock Issuance Agreement also provides that until the six-month anniversary of the Closing Date (as defined in the Stock Issuance Agreement), Zentalis will hold and not sell greater than 50% of the Shares, subject to certain exceptions. Further, Zentalis has agreed, subject to certain exceptions, that until the one-year anniversary of the Closing Date, any transfer of the Shares by Zentalis that exceed 15% of the average daily trading volume of the Company’s stock over the five-trading day period ending on the trading day immediately prior to such trading date shall be made pursuant to a block trade or other disposition through a market participant designated by the Company.
The Company has agreed to use its commercially reasonable efforts to (x) file a resale registration statement with the Securities and Exchange Commission (the “SEC”) registering the Shares for resale on or before the date 7 days following the earlier of (i) April 1, 2024 and (ii) the date the Company files its annual report on Form 10-K for the year ended December 31, 2023 and (y) cause such resale registration statement to be declared effective as soon as practicable after the filing thereof but no later than 60 calendar days after the filing thereof or by 5 trading days from when the Company is notified that the SEC will not review the resale registration statement or that it will not be subject to further review.
The Company has also agreed to, among other things, indemnify Zentalis, its affiliates, partners, members, officers, directors, agents and representatives from certain liabilities and pay all fees and expenses (excluding any legal fees of Zentalis, and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Stock Issuance Agreement.
The foregoing is only a brief description of the material terms of the License Agreement and the Stock Issuance Agreement, does not purport to be a complete statement of the rights and obligations of the parties under these agreements and the transactions contemplated thereby, and is qualified in its entirety by the full text of the Stock Issuance Agreement and the License Agreement, copies of which will be filed as exhibits to a subsequent filing with the Securities and Exchange Commission.
On January 8, 2024, the Company and Zentalis issued a joint press release announcing the transactions described above. A copy of the joint press release is attached to this report as Exhibit 99.1.
Item 3.02. Unregistered Sales of Equity Securities
See the description set forth under Item 1.01 above with respect to the Stock Issuance Agreement, which is incorporated into this Item 3.02 by reference. The Shares are being issued to Zentalis pursuant to the exemption from the registration requirements provided in Section 4(a)(2) of the Securities Act for transactions by an issuer not involving any public offering. Accordingly, the Shares have not been registered under the Securities Act and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act.
Forward-Looking Statements
Certain statements contained in this Current Report on Form 8-K regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). The Company may use words and phrases such as “believe,” “intend,” “may,” “potential,” “suggests,” “will,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward looking statements include, but are not limited to, statements regarding the expansion and advancement of the Company’s pipeline and its approach and strategy related to its pipeline, including ZPC-21; the potential for ZPC-21 to be best-in-class; the timeline for submitting an IND, if any, for ZPC-21; the potential for Zentalis to receive milestone payments and/or royalties for ZPC-21; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, risks related to the ability to realize the anticipated benefits of the license agreement; costs related to integrating ZPC-21 into the Company’s pipeline and pursuing the contemplated asset development path; the risk that the Company may not submit an IND for ZPC-21 the end of the first quarter of 2025 or at all; the Company’s ability to grow and successfully execute on its business plan, including advancing its current pipeline and any additionally acquired assets into the clinic and expanding its pipeline through its technology platforms, proprietary toolbox and strategic transactions, if any; the ability of the Company to identify, conduct and complete IND-enabling studies; changes in the applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for the Company’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect it; the Company’s ability to manage clinical trials or studies; the risk that pre-clinical data may not be predictive of clinical data; the complexity of numerous regulatory and legal requirements that the Company needs to comply with to operate its business; the reliance on the Company’s management and Board of Directors; the prior experience and successes of the Company’s management team and directors are not necessarily indicative of any future success; uncertainties related to the Company’s capital requirements, expected cash runway and ability to raise additional funds; the failure to obtain, adequately protect, maintain or enforce the Company’s intellectual property rights; and other risks and uncertainties indicated from time to time described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 16, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 9, 2023, and in the Company’s other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, the Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, the Company does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this Current Report on Form 8-K to conform these statements to actual results or to changes in their expectations.
Item 9.01 Financial Statements and Exhibits.
| (d) Exhibits | ||
| Exhibit No. | Description | |
| 99.1 | Joint Press Release of the Company and Zentalis, dated January 8, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements 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.
| IMMUNOME, INC. | ||
| Date: January 8, 2024 | By: | /s/ Clay Siegall |
| Clay Siegall, Ph.D. | ||
| President and Chief Executive Officer | ||
Exhibit 99.1
Immunome Exclusively Licenses Zentalis ROR1 Antibody-Drug Conjugate and Proprietary Technology Platform
- Exclusive worldwide license agreement for preclinical ROR1 ADC, on track to submit IND in 1Q 2025 -
- Proprietary ADC platform enhances Immunome’s development of next-generation ADC programs -
- Zentalis to receive up-front payment of $35 million in cash and Immunome common stock and is eligible to receive up to $275 million of milestone payments and mid-to-high single-digit royalties -
Bothell, WA, San Diego, CA and New York, NY – January 8, 2024 – Immunome, Inc. (Nasdaq: IMNM) and Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), today announced that they have entered into an exclusive, worldwide license agreement under which Immunome has licensed from Zentalis ZPC-21, a preclinical ROR1 antibody-drug conjugate (ADC) with best-in-class potential on track for IND submission in 1Q 2025, and Zentalis’ proprietary ADC platform technology.
“This agreement strengthens Immunome’s pipeline while expanding our ADC toolbox,” said Clay B. Siegall, Ph.D., Chairman and Chief Executive Officer of Immunome. “ZPC-21’s preclinical activity across multiple models suggest best-in-class potential against ROR1, a clinically validated target that is relevant to both solid tumors and hematological malignancies. We intend to efficiently advance ZPC-21 through IND and into clinical development.”
Dr. Siegall continued: “The next generation of transformative ADCs will be built through combining rigorously selected targets with innovative linker-payload platforms. We believe that the linker-payload technology that underlies ZPC-21 may compare favorably to the platforms of successful ADC franchises— a testament to Zentalis’ deep understanding of medicinal chemistry and cancer biology. Immunome will now evaluate and advance Zentalis’ platform technology in the context of our multiple discovery-stage ADC programs against undisclosed targets.”
Under the terms of the deal, Zentalis will receive an up-front payment of $35 million in cash and Immunome common stock. Zentalis will be eligible to receive up to $275 million of milestone payments for ZPC-21 and the platform technology in addition to mid-to-high single-digit royalties.
“Immunome’s leadership team’s track record of advancing paradigm-changing ADCs, along with Zentalis’ commitment to apply cutting-edge medicinal chemistry to anti-cancer agents, makes Immunome the ideal partner to advance our ADC platform,” said Cam Gallagher, President of Zentalis. “This transaction realizes immediate value for our shareholders while enabling the Zentalis team to focus on advancing azenosertib, our oral WEE1 inhibitor with first-in-class and best-in-class potential, through multiple ongoing clinical studies in tumor types with high unmet need.”
Leerink Partners is acting as exclusive financial advisor to Zentalis
About Immunome, Inc.
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and ADCs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
For more information, visit www.immunome.com or follow us on Twitter and LinkedIn.
About Zentalis Pharmaceuticals, Inc.
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors and hematologic malignancies. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors and homologous recombination deficient tumors. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in both New York and San Diego.
For more information, please visit www.zentalis.com. Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Zentalis and Immunome may use words and phrases such as “believe,” “intend,” “may,” “potential,” “suggests,” “will,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward looking statements include, but are not limited to, statements regarding the expansion and advancement of Immunome’s pipeline and Immunome’s approach and strategy related to its pipeline, including ZPC-21; the potential for ZPC-21 to be best-in-class; the timeline for submitting an IND, if any, for ZPC-21; the potential for Zentalis to receive milestone payments and/or royalties for ZPC-21; the first-in-class and best-in-class potential of Zentalis’ product candidate, azenosertib; the potential for the licensing transaction to enable Zentalis to focus on advancing the development of azenosertib; the potential for azenosertib to address unmet need; and other statements regarding each company’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, risks related to the ability to realize the anticipated benefits of the license agreement; costs related to integrating ZPC-21 into Immunome’s pipeline and pursuing the contemplated asset development path; the risk that Immunome may not submit an IND for ZPC-21 by the end of the first quarter of 2025 or at all; Immunome’s ability to grow and successfully execute on its business plan, including advancing its current pipeline and any additionally acquired assets into the clinic and expanding its pipeline through its technology platforms, proprietary toolbox and strategic transactions, if any; the ability of Immunome to identify, conduct and complete IND-enabling studies; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect it; Immunome’s ability to manage clinical trials or studies; the risk that Immunome’s pre-clinical data may not be predictive of clinical data; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management and Board of Directors; the prior experience and successes of the Immunome’s management team and directors are not necessarily indicative of any future success; uncertainties related to Immunome’s capital requirements, expected cash runway and ability to raise additional funds; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; Zentalis’ limited operating history, which may make it difficult to evaluate its current business and predict its future success and viability; Zentalis has and expects to continue to incur significant losses; Zentalis’ need for additional funding, which may not be available; Zentalis’ plans, including the costs thereof, of development of any diagnostic tools; Zentalis’ substantial dependence on the success of its lead product candidates; the outcome of Zentalis’ preclinical testing and early trials may not be predictive of the success of later clinical trials; Zentalis’ failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during Zentalis’ clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations for Zentalis; Zentalis’ failure to obtain U.S. or international marketing approval; Zentalis’ product candidates may cause serious adverse side effects; Zentalis’ inability to maintain its collaborations, or the failure of these collaborations; Zentalis’ reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to Zentalis’ intellectual property; Zentalis’ ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and other risks and uncertainties indicated from time to time described in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with Securities and Exchange Commission (“SEC”) on March 16, 2023, Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 9, 2023, and in Immunome’s other filings with the SEC, and in Zentalis’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with SEC on March 1, 2023, Zentalis’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 6, 2023, and in Zentalis’ other filings with the SEC. Immunome and Zentalis caution that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, each of Immunome and Zentalis operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, neither Immunome nor Zentalis undertakes any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Immunome Investor Contact
Max Rosett
Interim Chief Financial Officer
investors@immunome.com
Zentalis Investor Contact
Adam Bero, Ph.D.
Kendall Investor Relations
abero@kendallir.com