Nuvectis Pharma reports progress on NXP900 clinical trials, financial results, and increased cash reserves. Phase 1b program initiated.
Quiver AI Summary
Nuvectis Pharma, Inc. has announced the initiation of its Phase 1b program for NXP900, a treatment targeting advanced cancers with a focus on demonstrating clinical efficacy as a monotherapy and in combination with other therapies. The Phase 1a dose escalation study has been successfully completed, showing strong pharmacodynamic responses, and a drug-drug interaction study also yielded positive results. The company presented its findings at the 2025 AACR-NCI-EORTC International Conference, reinforcing its biomarker-based patient selection strategy. Nuvectis reported a cash position of $35.4 million as of September 30, 2025, sufficient to support operations through the third quarter of 2027 despite a net loss of $7.5 million in the last quarter, influenced by one-time expenses related to the NXP900 program. The company remains focused on advancing its clinical initiatives and expects to achieve significant milestones in the near future.
Potential Positives
- NXP900 Phase 1b program initiated with a focus on advanced cancers, indicating progress in clinical development.
- Successful completion of the Phase 1a dose escalation study, demonstrating robust pharmacodynamic responses, supports the case for efficient once-daily oral dosing.
- Cash runway extended to support operations into Q3 2027, improving financial stability and operational confidence.
- Poster presentations at a major oncology conference highlight NXP900's emerging clinical profile and support for biomarker-based patient selection, potentially enhancing the company’s visibility and reputation in the industry.
Potential Negatives
- Significant increase in net loss from $4.2 million in Q3 2024 to $7.5 million in Q3 2025, indicating deteriorating financial performance.
- Research and development expenses grew substantially from $2.8 million in Q3 2024 to $5.8 million in Q3 2025, raising concerns about cost management.
- The cash runway implies the need for continued funding through 3Q 2027, which may lead to potential dilution for shareholders if additional capital is raised in the future.
FAQ
What is the status of the NXP900 Phase 1b program?
The NXP900 Phase 1b program has been initiated, aiming to evaluate clinical efficacy in advanced cancer patients.
What preliminary results have been reported for NXP900?
The Phase 1a dose escalation study showed robust pharmacodynamic responses and supports once-daily oral dosing for NXP900.
What financial position does Nuvectis Pharma have as of Q3 2025?
Nuvectis Pharma reported cash and cash equivalents of $35.4 million as of September 30, 2025.
How does NXP900 function in cancer treatment?
NXP900 is an oral small molecule inhibitor targeting SRC Family of Kinases, disrupting cancer signaling pathways comprehensively.
What were the recent expenses reported for Nuvectis Pharma?
The net loss for the three months ended September 30, 2025, was reported at $7.5 million, primarily due to R&D expenses.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
FORT LEE, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- In a release issued under the same headline on November 4, 2025 at 07:30 ET by Nuvectis Pharma, Inc. (NASDAQ: NVCT), the tables were not included. The tables have been added and the corrected release follows:
- NXP900 Phase 1b program initiated; single agent study underway, aiming to provide preliminary evidence of clinical efficacy in patients with molecularly and histologically defined advanced cancers; initiation of the combination portion of the program expected by year-end
- NXP900 Phase 1a dose escalation study successfully completed highlighting robust pharmacodynamic responses at clinically relevant doses facilitating once-daily oral dosing
- NXP900 clinical drug-drug interaction study in healthy volunteers successfully completed supporting our strategy for combination therapy
- Poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics highlight the emerging clinical profile of NXP900 and provide further support for the biomarker-based patient selection strategy
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Cash runway expected to support the company’s operations into 3Q-2027
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 third quarter 2025 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “Our activity in the third quarter focused on advancing the clinical work required to support our ambitious Phase 1b program for NXP900, which recently commenced.” Mr. Bentsur continued, “Our goal for the Phase 1b program is to showcase NXP900's therapeutic potential, both as a single agent and in combination with certain market-leading therapies with the aim of reversing acquired resistance to these drugs. With the Phase 1b monotherapy component already underway, and the expected upcoming initiation of the combination component, we continue to make strides towards achieving this goal." Mr. Bentsur added, "To support and inform the Phase 1b program, we completed the NXP900 Phase 1a dose escalation study and the drug-drug interaction study in healthy volunteers and are pleased with NXP900’s emerging clinical profile, especially with the deep pharmacodynamic response observed at clinically relevant doses.” Mr. Bentsur concluded, “We believe that our cash position and focus on efficient operations will enable us to achieve the key milestones and potential value inflection points for the NXP900 Phase 1b program.”
Third Quarter 2025 Financial Results
Cash and cash equivalents were $35.4 million as of September 30, 2025, compared to $18.5 million as of December 31, 2024. The increase of $16.9 million in the cash balance as of the end of the third quarter of 2025 is a result primarily of our public offering in February 2025 and the utilization of our At-the-Market facility, partially offset by the operating expenses for the first nine months of 2025.
The Company's net loss was $7.5 million for the three months ended September 30, 2025, compared to $4.2 million for the three months ended September 30, 2024, an increase in net loss of $3.4 million. The increase in net loss in the third quarter of 2025 was primarily due to a one-time $2.0 million milestone achievement expense for NXP900 and $0.7 million related to the clinical drug-drug interaction study. The three months ended September 30, 2025 also includes $1.5 million of non-cash stock-based compensation.
Research and development expenses, including non-cash stock-based compensation, were $5.8 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, an increase of $3.0 million.
General and administrative expenses, including non-cash stock-based compensation, were $2.0 million for the three months ended September 30, 2025, compared to $1.5 million for the three months ended September 30, 2024, an increase of $0.5 million.
Interest income was $0.3 million for the three months ended September 30, 2025, compared to $0.2 million for the three months ended September 30, 2024.
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's lead program, NXP900, is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and is being evaluated in a Phase 1b program. The Company is also considering next steps for NXP800, an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. For additional information about Nuvectis Pharma please visit: https://nuvectis.com/
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which 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 and interpretations of data and information available, including but not limited to preclinical and clinical data generated to date for NXP900, the timing and data expectations for the NXP900 Phase 1b program and estimates and projections regarding our financial condition. The outcomes 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. Furthermore, certain forward-looking statements are based on assumptions regarding future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q2 2025 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
Media Relations Contact
Kevin Gardner
LifeSci Advisors
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NUVECTIS PHARMA, INC.
BALANCE SHEET (USD in thousands, except per share and share amounts) |
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| September 30, | December 31, | ||||||||||||||||
| 2025 | 2024 | ||||||||||||||||
| Assets | |||||||||||||||||
| CURRENT ASSETS | |||||||||||||||||
| Cash and cash equivalents | $ | 35,442 | $ | 18,533 | |||||||||||||
| Other current assets | 145 | 74 | |||||||||||||||
| TOTAL CURRENT ASSETS | 35,587 | 18,607 | |||||||||||||||
| TOTAL ASSETS | $ | 35,587 | $ | 18,607 | |||||||||||||
| Liabilities and Shareholders’ Equity | |||||||||||||||||
| CURRENT LIABILITIES | |||||||||||||||||
| Accounts payables | $ | 6,439 | $ | 2,498 | |||||||||||||
| Payable offering costs | 75 | — | |||||||||||||||
| Accrued liabilities | 65 | 840 | |||||||||||||||
| Employee compensation and benefits | 4,998 | 5,556 | |||||||||||||||
| TOTAL CURRENT LIABILITIES | 11,577 | 8,894 | |||||||||||||||
| TOTAL LIABILITIES | 11,577 | 8,894 | |||||||||||||||
| COMMITMENTS AND CONTINGENCIES | |||||||||||||||||
| SHAREHOLDERS’ EQUITY | |||||||||||||||||
| Common Shares, $0.00001 par value – 60,000,000 shares authorized as of September 30, 2025, and December 31, 2024, 25,639,896, and 19,495,683 shares issued and outstanding as of September 30, 2025, and December 31, 2024, respectively | * | * | |||||||||||||||
| Additional paid in capital | 116,383 | 82,958 | |||||||||||||||
| Accumulated deficit | (92,373 | ) | (73,245 | ) | |||||||||||||
| TOTAL SHAREHOLDERS’ EQUITY | 24,010 | 9,713 | |||||||||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 35,587 | $ | 18,607 | |||||||||||||
* Represents an amount lower than $1 USD.
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NUVECTIS PHARMA, INC.
STATEMENT OF OPERATIONS (USD in thousands, except per share and share amounts) |
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| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||
| OPERATING EXPENSES | ||||||||||||||||||
| Research and development | $ | 5,774 | $ | 2,819 | $ | 13,067 | $ | 8,422 | ||||||||||
| General and administrative | 2,020 | 1,540 | 6,890 | 4,976 | ||||||||||||||
| OPERATING LOSS | (7,794 | ) | (4,359 | ) | (19,957 | ) | (13,398 | ) | ||||||||||
| Finance income | 332 | 206 | 829 | 646 | ||||||||||||||
| NET LOSS | $ | (7,462 | ) | $ | (4,153 | ) | $ | (19,128 | ) | $ | (12,752 | ) | ||||||
| EFFECT OF WARRANT MODIFICATION | (2,429 | ) | — | (2,429 | ) | — | ||||||||||||
| TOTAL NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS | $ | (9,891 | ) | $ | (4,153 | ) | $ | (21,557 | ) | $ | (12,752 | ) | ||||||
| BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING | $ | (0.44 | ) | $ | (0.24 | ) | $ | (1.01 | ) | $ | (0.75 | ) | ||||||
| Basic and diluted weighted average number of common shares outstanding | 22,719,057 | 17,230,559 | 21,351,228 | 16,898,040 | ||||||||||||||