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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): February 25, 2025
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 February 25, 2025, Nuvectis Pharma, Inc. issued a press release to provide a corporate update and to announce its financial results for the fiscal year ended December 31, 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 February 25, 2025. | |
| 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: February 25, 2025 | ||
| By: | /s/ Ron Bentsur | |
| Ron Bentsur | ||
| Chairman, Chief Executive Officer and President | ||
Exhibit 99.1
Nuvectis Pharma, Inc. Reports 2024 Financial Results and Business Highlights
| · | NXP800 Phase 1b study in patients with platinum resistant, ARID1a-mutated ovarian cancer is ongoing; Orphan Drug Designation granted by the U.S. FDA. Updated Phase 1b results anticipated in Q2 2025 |
| · | NXP900 Phase 1a dose escalation study continues to enroll, preparation for the start of the Phase 1b program is underway. Phase 1b program expected to begin in mid-2025 |
| · | Follow-on offering completed in February 2025 extends cash runway into 2027 |
Fort Lee, NJ, February 25, 2025 (GLOBE NEWSWIRE) - 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 year ended December 31, 2024 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “In 2024, Nuvectis made important progress in the development of our two clinical-stage drug candidates, NXP800 and NXP900. NXP800 was granted Orphan Drug Designation by the U.S. FDA for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. Enrollment is ongoing in the Phase 1b clinical trial, in which patients with platinum resistant, ARID1a-mutated ovarian cancer are currently being treated with a dose of 75mg/day, on an intermittent dosing schedule. We intend to provide an update from this study in the second quarter and plan to provide the first data from the investigator-initiated study in cholangiocarcinoma later this year.”
Mr. Bentsur continued, "For NXP900, enrollment continues in the Phase 1a dose escalation clinical trial and we are pleased with the emerging clinical profile of NXP900, based on safety, pharmacokinetics and pharmacodynamics information to date. In parallel, preparations are underway to begin the Phase 1b program in mid-year. This program is designed to evaluate NXP900 as monotherapy in YES1/SRC-driven solid tumors, and in combination with EGFR and ALK inhibitors, in patients with non-small cell lung cancer. Positive results could showcase NXP900’s potential broad applicability in these large oncology markets.
Mr. Bentsur concluded, "Our successful follow-on offering, completed this month, provided Nuvectis with $15.5M in gross proceeds, which extend our cash runway into 2027. Based on the continued progress with the NXP800 and NXP900 programs, the strength and drug development expertise of our team, and expanded cash resources, I believe Nuvectis is well-positioned to generate meaningful results in our clinical portfolio in 2025 and beyond." Cash and cash equivalents were $18.5 million as of December 31, 2024, compared to $19.1 million as of December 31, 2023.
Full Year 2024 Financial Results
The decrease of $0.6 million was a result of the Company's continued operations, offset by access to our at-the-market offering facility.
The Company's net loss was $19.0 million for the year ended December 31, 2024, compared to $22.3 million for the year ended December 31, 2023, a decrease in net loss of $3.3 million. Net loss for the 2024 fiscal year included $4.9 million in non-cash stock-based compensation.
Research and development expenses, including non-cash stock-based compensation were $12.9 million for the year ended December 31, 2024, compared to $15.4 million for the year ended December 31, 2023, a decrease of $2.5 million.
General and administrative expenses, including non-cash stock-based compensation were $6.9 million for the year ended December 31, 2024, compared to $7.5 million for the year ended December 31, 2023, a decrease of $0.6 million.
Interest income was $0.8 million for the year ended December 31, 2024, compared to $0.6 million for the year ended December 31, 2023, an increase of $0.2 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. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900’s unique mechanism of action enables it to inhibit 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.
For more information on Nuvectis, please visit our website at https://nuvectis.com/.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. 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, including preclinical and clinical safety and efficacy data generated to date for NXP800 and NXP900, 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 and data regarding the preclinical studies for NXP800 and NXP900, and the Phase 1a data for NXP800 and the NXP900 Phase 1a study data to date, as well as the clinical expectations for the ongoing NXP800 Phase 1b study in platinum-resistant, ARID1a-mutated ovarian carcinoma, including the potential ability of the 75mg/day dose intensity in the NXP800 Phase 1b study to generate satisfactory safety and efficacy results, 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 the timing for completion of the clinical trials, including the ongoing NXP800 Phase 1b study in platinum-resistant ARID1a-mutated ovarian cancer and the investigator-initiated study in cholangiocarcinoma, and statements regarding NXP900's therapeutic potential and the expected timing for the completion of the Phase 1a dose-escalation study and start of the NXP900 Phase 1b program. 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 3Q 2024 Form 10-Q and our other public filings with the U.S. 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 SHEETS
(USD in thousands, except per share and share amounts)
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 18,533 | $ | 19,126 | ||||
| Other current assets | 74 | 59 | ||||||
| TOTAL CURRENT ASSETS | 18,607 | 19,185 | ||||||
| TOTAL ASSETS | $ | 18,607 | $ | 19,185 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payables | $ | 2,498 | $ | 2,771 | ||||
| Accrued liabilities | 840 | 415 | ||||||
| Employee compensation and benefits | 5,556 | 3,798 | ||||||
| TOTAL CURRENT LIABILITIES | 8,894 | 6,984 | ||||||
| TOTAL LIABILITIES | 8,894 | 6,984 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Common Shares, $0.00001 par value – 60,000,000 shares authorized as of December 31, 2024, and December 31, 2023, 19,495,683, and 17,418,886 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively | * | * | ||||||
| Additional paid in capital | 82,958 | 66,446 | ||||||
| Accumulated deficit | (73,245 | ) | (54,245 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 9,713 | 12,201 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 18,607 | $ | 19,185 | ||||
| * | Represent amount lower than $1,000 USD. |
NUVECTIS PHARMA, INC.
STATEMENT OF OPERATIONS
(USD in thousands, except per share and share amounts)
| For the year ended | For the year ended | |||||||
| December 31, 2024 | December 31, 2023 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | 12,918 | $ | 15,380 | ||||
| General and administrative | 6,929 | 7,517 | ||||||
| OPERATING LOSS | (19,847 | ) | (22,897 | ) | ||||
| Finance income | 847 | 637 | ||||||
| NET LOSS | $ | (19,000 | ) | $ | (22,260 | ) | ||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (19,000 | ) | $ | (22,260 | ) | ||
| BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING | $ | (1.11 | ) | $ | (1.43 | ) | ||
| Basic and diluted weighted average number of common shares outstanding | 17,113,169 | 15,556,655 | ||||||