エドガーで原本を確認する
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): August 6, 2024
Nuvectis Pharma, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware (State or Other Jurisdiction of Incorporation) |
001-41264 (Commission File Number) |
86-2405608 (IRS Employer Identification No.) |
1 Bridge Plaza Suite 275
Fort Lee, NJ 07024
(Address of Principal Executive Offices)
(201) 614-3150
(Registrant’s telephone number, including area code)
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:
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of Class | Trading Symbol(s) | Exchange Name |
| Common Stock | NVCT | Nasdaq Capital Market |
| ¨ | Written communications pursuant to Rule 425 under the Securities Act. |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
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 2.02. | Results of Operations and Financial Condition. |
On August 6, 2024, Nuvectis Pharma, Inc. issued a press release to provide a corporate update and to announce its financial results for the second quarter ended June 30, 2024. A copy of such press release is being furnished as Exhibit 99.1 to this report.
The information, including Exhibit 99.1, in this Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall otherwise be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibit is furnished herewith:
| Exhibit Number |
Description | |
| 99.1 | Press release issued by Nuvectis Pharma, Inc., dated August 6, 2024. | |
| 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Nuvectis Pharma, Inc. | ||
| (Registrant) | ||
Date: August 6, 2024 |
||
| By: | /s/ Ron Bentsur | |
| Ron Bentsur | ||
| Chairman, Chief Executive Officer and President | ||
Exhibit 99.1
Nuvectis Pharma, Inc. Reports Second Quarter 2024 Financial Results and Business Highlights
August 6, 2024, Fort Lee, NJ - Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported its financial results for the second quarter 2024 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "During the second quarter we continued to advance our clinical trials for NXP800 and NXP900. For NXP800, the Phase 1b clinical trial in platinum resistant, ARID1a-mutated ovarian cancer is continuing to enroll patients at approximately 15 clinical sites in the United States and United Kingdom and we remain on track to provide an update from this study during this fall. In addition, the Investigator-sponsored clinical trial in cholangiocarcinoma is also recruiting patients, and we plan to provide an update from this trial by the end of 2024. For NXP900, the dose escalation clinical trial is ongoing, and so far, three cohorts have been completed with no reports of dose limiting toxicities. We are continuing to plan the next steps in the development of NXP900, with particular interest in combination strategies with EGFR and ALK inhibitors in patients with advanced non-small cell lung cancer resistant to EGFR and ALK targeting drugs. Lastly, we continue to effectively manage our financial resources, which we believe can take us through the key milestones for both development programs”.
Second Quarter 2024 Financial Results
Cash, and cash equivalents were $18.1 million as of June 30, 2024 compared to $19.5 million as of March 31, 2024. The decrease of $1.4 million in the cash balance during the second quarter of 2024 is a result of the operating expenses for the quarter, partially offset by the utilization of the at-the market facility.
The Company's net loss was $4.4 million for the three months ended June 30, 2024, compared to $5.8 million for the three months ended June 30, 2023, a decrease in net loss of $1.4 million, rounded. Net loss for the second quarter of 2024 fiscal year included $1.3 million in non-cash stock-based compensation.
Research and development expenses, including non-cash stock-based compensation, were $2.9 million for the three months ended June 30, 2024, compared to $4.3 million for the three months ended June 30, 2023, a decrease of $1.4 million, rounded.
General and administrative expenses, including non-cash stock-based compensation, were $1.7 million for the three months ended June 30, 2024, compared to $1.5 million for the three months ended March 31, 2023, an increase of $0.2 million.
Interest income was $0.2 million for the three months ended June 30, 2024, compared to $0.1 million for the three months ended June 30, 2023, an increase of $0.1 million.
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.
Forward Looking Statements
Certain statements in this presentation constitute “forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date for NXP800 and NXP900, the Phase 1a data generated for NXP800 and the clinical expectations for the NXP800 Phase 1b study, including statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma, cholangiocarcinoma, and potentially other cancer indications, and timing of and expectations for the Phase 1a study for NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in our 2023 Form 10-K and our other public filings with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
201-614-3151
rbentsur@nuvectis.com
Media Relations Contact
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
NUVECTIS PHARMA, INC.
BALANCE SHEET
(USD in thousands, except per share and share amounts)
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 18,116 | $ | 19,126 | ||||
| Other current assets | 182 | 59 | ||||||
| TOTAL CURRENT ASSETS | 18,298 | 19,185 | ||||||
| TOTAL ASSETS | $ | 18,298 | $ | 19,185 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payables | $ | 1,846 | $ | 2,771 | ||||
| Accrued liabilities | 310 | 415 | ||||||
| Employee compensation and benefits | 3,614 | 3,798 | ||||||
| TOTAL CURRENT LIABILITIES | 5,770 | 6,984 | ||||||
| TOTAL LIABILITIES | 5,770 | 6,984 | ||||||
| COMMITMENTS AND CONTINGENCIES, | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Common Shares, $0.00001 par value – 60,000,000 shares authorized as of June 30, 2024, and December 31, 2023, 18,748,751, and 17,418,886 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | * | * | ||||||
| Additional paid in capital | 75,372 | 66,446 | ||||||
| Accumulated deficit | (62,844 | ) | (54,245 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 12,528 | 12,201 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 18,298 | $ | 19,185 | ||||
| * | Represents an amount lower than $1,000 USD. |
NUVECTIS PHARMA, INC.
STATEMENT OF OPERATIONS
(USD in thousands, except per share and share amounts)
| Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | $ | 2,943 | $ | 4,262 | $ | 5,603 | $ | 6,629 | ||||||||
| General and administrative | 1,700 | 1,510 | 3,436 | 3,244 | ||||||||||||
| OPERATING LOSS | (4,643 | ) | (5,772 | ) | (9,039 | ) | (9,873 | ) | ||||||||
| Finance income | 215 | 64 | 440 | 116 | ||||||||||||
| NET LOSS | $ | (4,428 | ) | $ | (5,708 | ) | $ | (8,599 | ) | $ | (9,757 | ) | ||||