Fort Lee, NJ, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), 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 announced the appointment of Juan Sanchez, MD, to its Board of Directors. Dr. Sanchez is a seasoned biotech executive with expertise in industry, capital markets and medicine, having most recently served as Vice President of Corporate Commu ...

Company Overview - Nuvectis Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative precision medicines for serious unmet medical needs in oncology [2] - The company has two clinical-stage drug candidates: NXP900 and NXP800 [2] Drug Candidates - NXP900 is an oral small molecule inhibitor targeting the SRC Family of Kinases (SFK), including SRC and YES1, with a unique mechanism that inhibits both catalytic and scaffolding functions [2] - NXP900 has completed a Phase 1a dose escalation study, and the Phase 1b program has been initiated [2] - NXP800 is an oral small molecule GCN2 activator that has shown anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, with potential exploration in other cancer types [2] Upcoming Events - Senior management will participate in the H.C. Wainwright Global Investment Conference, with a corporate presentation available for on-demand viewing starting September 5, 2025 [1] - The conference will take place from September 8-10, 2025, where the company will also attend virtual one-on-one meetings [1]

Summary of Nuvectis Pharma NXP-nine Hundred Phase Ib Study Initiation Conference Call Company Overview - **Company**: Nuvectis Pharma - **Drug Candidate**: NXP-nine hundred - **Focus**: Development of NXP-nine hundred for oncology treatments, specifically targeting serious conditions with unmet medical needs Key Points and Arguments 1. **Phase 1b Program Initiation**: The initiation of the Phase 1b program for NXP-nine hundred is a significant milestone for Nuvectis, aiming to address several cancers with high unmet medical needs [4][18] 2. **Unique Mechanism of Action**: NXP-nine hundred is a selective oral small molecule, SRC S1 kinase inhibitor, with a unique mechanism that allows complete shutdown of SRC signaling, which is believed to provide a therapeutic advantage [8][9] 3. **Strong Financial Position**: Nuvectis has a robust cash position of approximately $39 million as of June 30, 2025, expected to sustain operations for over two years without immediate financial concerns [5] 4. **Phase 1a Study Results**: The Phase 1a study demonstrated good tolerability with no dose-limiting toxicity observed, and a pharmacodynamic response showing over 90% inhibition of SRC autophosphorylation at clinically relevant doses [6][8] 5. **Target Patient Populations**: The Phase 1b study will focus on patients with specific genetic alterations, including YES-one gene amplification and mutations in FAT1 and NF2, which are associated with advanced solid tumors [10][11] 6. **Combination Therapy Rationale**: The combination approach aims to reverse acquired resistance to existing targeted therapies, addressing a significant clinical need in oncology [12][15] 7. **Market Opportunity**: The potential addressable patient populations for NXP-nine hundred are substantial, with examples including over 23,000 patients annually with FAT1 alterations in lung and head and neck cancers [15][39] 8. **Regulatory Considerations**: There is potential for accelerated approval based on the ability to reverse acquired resistance, which is a major issue in lung cancer treatment [36][37] 9. **Expected Response Rates**: The expected response rate for the combination therapy is projected to be in the range of 15-20%, with aspirations for higher rates to attract investment and regulatory interest [24][39] 10. **Patient Enrollment Strategy**: The study plans to enroll approximately 100 patients across various genetic alteration groups, starting with 15 sites in the U.S. [47][49] Additional Important Content - **Clinical Execution Focus**: Nuvectis emphasizes rigorous clinical execution and the generation of high-quality data as critical to demonstrating meaningful clinical benefits for patients [18] - **Comparison with Other SRC Inhibitors**: NXP-nine hundred is positioned as a more potent SRC inhibitor compared to existing options like dasatinib and sarcatinib, with a superior inhibition profile [63][66] - **Future Data Sharing**: Nuvectis expects to share data from the Phase 1b study throughout 2026, highlighting the drug's therapeutic potential [18] This summary encapsulates the essential information from the conference call, focusing on the company's strategic direction, drug development, and market potential.

Core Viewpoint - Nuvectis Pharma, Inc. has initiated the Phase 1b clinical program for NXP900, aimed at addressing unmet medical needs in oncology through innovative precision medicines [1][4]. Phase 1b Program Overview - The Phase 1b program follows a successful dose escalation study and includes both a single agent component and a combination component, with the latter expected to start later this year [2][6]. - The single agent component will evaluate patients with specific genetic alterations, while the combination component will assess NXP900 alongside EGFR and ALK inhibitors for non-small cell lung cancer (NSCLC) patients who have developed resistance [3][6]. Target Patient Populations - The program targets patients with advanced solid tumors harboring specific genetic alterations, including YES1 amplification and Hippo Pathway alterations [3][7]. - Specific tumor types include YES1 amplified or FAT1 mutated NSCLC, NF2 mutated mesothelioma, and renal cancer, among others [7]. Executive Commentary - The CEO of Nuvectis expressed excitement about the Phase 1b program, highlighting NXP900's potential as a significant treatment option for various cancers and the confidence shown by a recent investment from a healthcare-specialized institutional investor [4][6]. Company Background - Nuvectis Pharma focuses on developing precision medicines for serious oncology conditions, with NXP900 being an oral small molecule inhibitor targeting SRC Family of Kinases [9]. - The company also has another clinical-stage candidate, NXP800, which has shown anti-cancer activity in specific ovarian cancer types [9].

Core Insights - Nuvectis Pharma has advanced its targeted oncology drug NXP900 to lead program status after completing early-stage clinical studies, despite reporting a net loss of $6.3 million for Q2 2025, an increase from $4.4 million in Q2 2024 [1][5][7]. Financial Performance - The company reported no revenue for Q2 2025, consistent with the previous year [2]. - The net loss increased by 43.2% year-over-year, from $4.4 million in Q2 2024 to $6.3 million in Q2 2025 [2][7]. - Research and development expenses rose to $3.6 million, up 24.1% from $2.9 million in Q2 2024 [2][7]. - General and administrative expenses surged to $3.0 million, a significant increase of 76.5% from $1.7 million in Q2 2024 [2][7]. - Cash and cash equivalents stood at $26.8 million as of June 30, 2025, with a pro forma cash position of approximately $39 million following a fundraising event [8][9]. Clinical Development - NXP900 has completed critical studies, including a Phase 1a dose escalation trial and a drug-drug interaction study, paving the way for the initiation of the Phase 1b program [5][11]. - NXP800 has not shown significant new clinical progress, with no new study initiations or regulatory milestones reported during this period [6][11]. Strategic Focus - The company is concentrating on early-stage clinical trials for its main compounds, NXP900 and NXP800, with a focus on demonstrating safety and clinical efficacy [4][11]. - Management plans to explore potential opportunities for NXP800 in additional cancer types, although no new data has been established [6][11]. Future Outlook - The next six to twelve months will be critical for clinical studies related to NXP900 and NXP800, with a focus on patient enrollment and trial results [11][12]. - Management has not provided quantitative financial guidance but emphasizes the importance of clinical milestones as key indicators of future success [11].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (State or Other J ...

[Nuvectis Pharma Q2 2025 Earnings Release](index=1&type=section&id=Nuvectis%20Pharma%20Q2%202025%20Earnings%20Release) [Business Highlights and CEO Commentary](index=1&type=section&id=Business%20Highlights%20and%20CEO%20Commentary) Nuvectis highlighted significant progress in Q2 2025, with its lead candidate NXP900 successfully completing Phase 1a and a drug-drug interaction (DDI) study, positioning it for an imminent Phase 1b launch, while also planning to explore new indications for NXP800, and a July ATM share acquisition strengthened its proforma cash to approximately $39 million, extending its operational runway into the second half of 2027 - **NXP900** successfully completed Phase 1a dose escalation and a drug-drug interaction study, with Phase 1b program initiation imminent[2](index=2&type=chunk)[6](index=6&type=chunk) - New opportunities for **NXP800** are planned for exploration in cancer types such as endometrial and prostate cancer[2](index=2&type=chunk) - A July At-The-Market (ATM) share acquisition boosted proforma cash to approximately **$39 million** as of June 30, 2025, extending operational funding into the second half of 2027[2](index=2&type=chunk)[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a net loss of $6.3 million for Q2 2025, an increase from $4.4 million in Q2 2024, primarily due to costs associated with the completed NXP900 DDI study, with both R&D and G&A expenses rising year-over-year, and the cash balance increasing to $26.8 million at quarter-end, boosted by a public offering earlier in the year - Cash and cash equivalents stood at **$26.8 million** as of June 30, 2025, an increase of **$8.3 million** from December 31, 2024, primarily resulting from a public offering in February 2025[3](index=3&type=chunk) Key Financial Metrics (Q2) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Net Loss | $6.3 | $4.4 | +$1.9 | | R&D Expenses | $3.6 | $2.9 | +$0.7 | | G&A Expenses | $3.0 | $1.7 | +$1.3 | - The increase in net loss for Q2 2025 was primarily driven by the NXP900 DDI study, with the quarter's results also including **$1.8 million** of non-cash stock-based compensation[4](index=4&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section provides the detailed unaudited financial statements for the period ended June 30, 2025, including the Balance Sheet and the Statement of Operations, which detail the company's financial position and performance [Balance Sheet](index=4&type=section&id=Balance%20Sheet) As of June 30, 2025, Nuvectis' balance sheet showed total assets of $27.0 million, a significant increase from $18.6 million at year-end 2024, driven by a rise in cash from financing activities, while total liabilities also increased to $10.1 million from $8.9 million over the same period Balance Sheet Summary | Account | June 30, 2025 (Thousands USD) | Dec 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Cash and cash equivalents | 26,793 | 18,533 | | Total Assets | 27,007 | 18,607 | | Total Liabilities | 10,135 | 8,894 | | Total Shareholders' Equity | 16,872 | 9,713 | [Statement of Operations](index=5&type=section&id=Statement%20of%20Operations) The statement of operations for the three and six months ended June 30, 2025, reflects increased operating expenses and a wider net loss compared to the same periods in 2024, with the net loss per share for the second quarter being $(0.30), up from $(0.26) in the prior-year quarter Statement of Operations (Three Months Ended June 30) | Metric | 2025 (Thousands USD) | 2024 (Thousands USD) | | :--- | :--- | :--- | | Operating Loss | (6,595) | (4,643) | | Net Loss | (6,334) | (4,428) | | Net Loss Per Share | ($0.30) | ($0.26) | Statement of Operations (Six Months Ended June 30) | Metric | 2025 (Thousands USD) | 2024 (Thousands USD) | | :--- | :--- | :--- | | Operating Loss | (12,163) | (9,039) | | Net Loss | (11,666) | (8,599) | | Net Loss Per Share | ($0.56) | ($0.51) |

Core Viewpoint - Nuvectis Pharma, Inc. is positioned for growth following significant advancements in its clinical programs and a strengthened financial position, with a focus on innovative precision medicines for oncology [2][8]. Financial Performance - As of June 30, 2025, cash and cash equivalents increased to $26.8 million from $18.5 million at the end of 2024, primarily due to a public offering in February 2025 [3]. - The net loss for the second quarter of 2025 was $6.3 million, an increase from $4.4 million in the same period of 2024, attributed mainly to the completion of the NXP900 drug-drug interaction study [4]. - Research and development expenses rose to $3.6 million in Q2 2025 from $2.9 million in Q2 2024, while general and administrative expenses increased to $3.0 million from $1.7 million in the same period [5]. Clinical Development - NXP900 has successfully completed its Phase 1a dose escalation study and a drug-drug interaction study, paving the way for the imminent initiation of the Phase 1b program [2][8]. - The company plans to explore NXP800 in additional cancer types, including endometrial and prostate cancers, over the coming months [2]. Cash Position - Following a share acquisition by a healthcare-focused institutional investor, the proforma cash position as of June 30, 2025, is approximately $39 million, expected to fund operations into the second half of 2027 [2][8].

Core Insights - Nuvectis Pharma, Inc. has provided final clinical data from the Phase 1b study of NXP800 in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer and is progressing towards the initiation of the Phase 1b program for NXP900 [1][4] Group 1: NXP800 Clinical Data - In the Phase 1b study, 17 patients were treated with NXP800 at a target dose of 75 mg/day, with data available for 13 patients, resulting in 2 partial responses and 3 stable diseases [2][6] - Thrombocytopenia was identified as a key toxicity but was managed effectively by switching to an intermittent dosing schedule [2][6] - The company will not pursue further development of NXP800 in ovarian cancer but will explore its potential in other cancer types such as endometrial and prostate cancers [2][4] Group 2: NXP900 Development - The NXP900 DDI study has been successfully completed, supporting its potential combination with EGFR and ALK inhibitors in non-small cell lung cancer [3][6] - The Phase 1a dose-escalation study for NXP900 evaluated doses from 20 to 300 mg/day, with no dose-limiting toxicity reached, and demonstrated a robust pharmacodynamic response at doses of 150 mg/day and higher [3][6] - The initiation of the Phase 1b study for NXP900 is expected in the coming weeks, aiming to evaluate its safety and efficacy as a single agent and in combination with other anti-cancer agents [3][6] Group 3: Company Strategy and Future Outlook - The CEO of Nuvectis emphasized the decision to focus on advancing NXP900 due to the challenges and resource requirements associated with further developing NXP800 in ovarian cancer [4] - The company believes that NXP800 remains an active agent and will evaluate its feasibility in other cancer types in the coming months [4][6] - Nuvectis Pharma is positioned to leverage the therapeutic potential of NXP900 as it moves forward with its clinical programs [4][5]

Core Viewpoint - Nuvectis Pharma, Inc. has successfully completed a clinical drug-drug interaction (DDI) study for NXP900, indicating its potential as a combination partner with leading therapies in oncology [1][5]. Company Overview - Nuvectis Pharma, Inc. is a biopharmaceutical company focused on developing innovative precision medicines for serious unmet medical needs in oncology, currently advancing two clinical-stage drug candidates, NXP800 and NXP900 [4]. NXP900 Clinical Study Details - The DDI study involved 14 healthy volunteers and aimed to determine if NXP900 is an inducer of CYP3A, classifying its induction as weak, moderate, or strong according to ICH M12 guidelines [6]. - NXP900 was classified as a weak inhibitor of CYP3A, as it increased the concentration of Midazolam, a known CYP3A sensitive substrate, by less than 2-fold [6]. - No serious or severe adverse events were reported during the study; the most common adverse events were mild to moderate diarrhea and non-infection related increases in white blood cell counts [6]. Future Development Plans - The company plans to advance NXP900 into a Phase 1b program, which will test its therapeutic potential as a single agent and in non-chemotherapy based combinations with leading EGFR and ALK inhibitors [3]. - The Phase 1b program is set to begin in the coming weeks, focusing on patients whose cancers are expected to be sensitive to SRC/YES1 inhibition [3]. Mechanism of Action - NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1, with a unique mechanism that inhibits both the catalytic and scaffolding functions of the SRC kinase, providing complete shutdown of the signaling pathway [4].