Financial Performance - Net loss for the third quarter of 2025 was $7.5 million, compared to a net loss of $4.2 million for the same period in 2024, reflecting a 80.9% increase[6] - The company reported a basic and diluted net loss per common share of $0.44 for the third quarter of 2025, compared to $0.24 for the same period in 2024[15] Cash and Liquidity - Cash and cash equivalents increased to $35.4 million as of September 30, 2025, up from $18.5 million as of December 31, 2024, representing a 91.5% increase[4] - Interest income for the third quarter of 2025 was $0.3 million, compared to $0.2 million for the same period in 2024, indicating a 50% increase[8] - The cash runway is projected to support the company's operations into the third quarter of 2027[5] Research and Development - Research and development expenses rose to $5.8 million for the third quarter of 2025, up from $2.8 million in the same quarter of 2024, marking a 107.1% increase[7] - The company completed the NXP900 Phase 1a dose escalation study, demonstrating robust pharmacodynamic responses at clinically relevant doses[5] - The NXP900 Phase 1b program has been initiated, with the single agent study currently underway and the combination portion expected to start by year-end[5] Balance Sheet - Total liabilities as of September 30, 2025, were $11.6 million, compared to $8.9 million as of December 31, 2024, reflecting a 30.5% increase[13] - The total shareholders' equity increased to $24.0 million as of September 30, 2025, up from $9.7 million as of December 31, 2024, representing a 147.0% increase[13]

Core Viewpoint - Nuvectis Pharma, Inc. reported its financial results for Q3 2025, highlighting advancements in its clinical programs, particularly the Phase 1b program for NXP900, and a significant increase in cash reserves due to a public offering. Financial Results - Cash and cash equivalents increased to $35.4 million as of September 30, 2025, from $18.5 million as of December 31, 2024, reflecting a $16.9 million increase primarily from a public offering and At-the-Market facility utilization [3] - The net loss for Q3 2025 was $7.5 million, up from $4.2 million in Q3 2024, with a $3.4 million increase attributed to a one-time $2.0 million milestone expense for NXP900 and $0.7 million for a clinical study [4] - Research and development expenses were $5.8 million for Q3 2025, compared to $2.8 million in Q3 2024, marking a $3.0 million increase [5] - General and administrative expenses rose to $2.0 million in Q3 2025 from $1.5 million in Q3 2024, an increase of $0.5 million [5] - Interest income for Q3 2025 was $0.3 million, up from $0.2 million in Q3 2024 [6] Clinical Development - The Phase 1b program for NXP900 has been initiated, with the single-agent study currently underway, aiming to demonstrate clinical efficacy in advanced cancers [7] - The Phase 1a dose escalation study for NXP900 was successfully completed, showing robust pharmacodynamic responses at clinically relevant doses [7] - A clinical drug-drug interaction study in healthy volunteers was also completed, supporting the strategy for combination therapy [7] - Poster presentations at the 2025 AACR-NCI-EORTC conference highlighted the emerging clinical profile of NXP900 and supported a biomarker-based patient selection strategy [7] Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious unmet medical needs in oncology, with its lead program NXP900 being an oral small molecule inhibitor targeting SRC Family of Kinases [8] - The company is also considering next steps for NXP800, which has shown anti-cancer activity in specific ovarian cancer cases [8]

Financial Performance and Expectations - The company has incurred losses since its inception and has not generated any revenue, expecting continued losses for the foreseeable future[11]. - The company will require substantial additional capital to finance its operations and achieve its goals, which may lead to delays or reductions in research and development if capital is not raised[11]. - The company does not intend to pay dividends on its common stock in the foreseeable future, limiting returns to stock value appreciation[17]. Product Development and Regulatory Risks - The company is substantially dependent on the success of its product candidate, NXP900, which is still in the development phase[11]. - The company has initiated a limited number of clinical trials with a small number of patients currently enrolled, with no completed trials to date[11]. - The development and commercialization of pharmaceutical products are subject to extensive regulation, and the company may not obtain necessary regulatory approvals for its product candidates[11]. - Clinical trials are expensive and time-consuming, with uncertain outcomes that may not predict future results[11]. - The company faces risks related to the manufacturing of its product candidates, which may encounter difficulties or interruptions[14]. Operational and Organizational Aspects - The company currently has 13 full-time employees and plans to grow its organization to meet operational needs[17]. External Factors - Tariffs and other trade measures could adversely affect the company's business, results of operations, financial position, and cash flows[11].

Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical-stage biopharmaceutical efforts, particularly focusing on the NXP900 program, which aims to address unmet medical needs in oncology through innovative precision medicines [1][2]. Financial Results - As of September 30, 2025, the company reported cash and cash equivalents of $35.4 million, an increase of $16.9 million from $18.5 million at the end of 2024, primarily due to a public offering and the use of an At-the-Market facility [3]. - The net loss for the third quarter of 2025 was $7.5 million, compared to $4.2 million for the same period in 2024, marking an increase of $3.4 million, largely due to a one-time milestone expense of $2.0 million for NXP900 and $0.7 million for a clinical study [4]. - Research and development expenses were $5.8 million for the third quarter of 2025, up from $2.8 million in the same quarter of 2024, reflecting an increase of $3.0 million [5]. - General and administrative expenses rose to $2.0 million in the third quarter of 2025 from $1.5 million in the same quarter of 2024, an increase of $0.5 million [5]. - Interest income for the third quarter of 2025 was $0.3 million, compared to $0.2 million in the same period of 2024 [6]. Business Progress - The Phase 1b program for NXP900 has been initiated, with the single-agent study currently underway, aiming to provide preliminary evidence of clinical efficacy in advanced cancers [8]. - The Phase 1a dose escalation study for NXP900 has been successfully completed, demonstrating robust pharmacodynamic responses at clinically relevant doses [8]. - A clinical drug-drug interaction study in healthy volunteers has also been successfully completed, supporting the strategy for combination therapy [8]. - The company expects its cash runway to support operations into the third quarter of 2027 [8]. Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious oncology conditions, with its lead program NXP900 being an oral small molecule inhibitor targeting SRC Family of Kinases [9].

Core Insights - Nuvectis Pharma, Inc. is advancing its lead program NXP900, a precision medicine targeting SRC/YES1 inhibition for oncology applications, with recent positive results from Phase 1a studies [1][2][3] Clinical Development - The Phase 1a dose escalation and drug-drug interaction studies for NXP900 have shown a favorable safety profile, with common adverse events being Grade 1-2 diarrhea, fatigue, and nausea [5] - NXP900 demonstrated a robust pharmacodynamic response at doses of 150 mg/day and above, indicating its potential effectiveness [5] - The ongoing Phase 1b study is evaluating NXP900 as a monotherapy in patients with advanced solid tumors exhibiting specific genomic alterations [5] Mechanism of Action - NXP900 operates through a unique mechanism that inhibits both the catalytic and scaffolding functions of SRC kinases, leading to comprehensive shutdown of the signaling pathway [3][2] - Preclinical data presented at the conference supports the biomarker patient selection strategy for the Phase 1b program [2] Future Directions - The company is preparing to initiate the combination portion of the Phase 1b program and will provide clinical data updates as the program progresses [2] - Nuvectis is also considering next steps for NXP800, another investigational drug targeting recurrent, platinum-resistant ovarian cancer [3]

Core Insights - Nuvectis Pharma, Inc. is set to present its clinical findings on NXP900 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1] Group 1: Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious unmet medical needs in oncology [3] - The lead program, NXP900, is an oral small molecule inhibitor targeting SRC Family of Kinases (SFK), including SRC and YES1, with a unique mechanism that inhibits both catalytic and scaffolding functions [3] - NXP900 has completed a Phase 1a dose escalation study and is currently being evaluated in a Phase 1b program [3] Group 2: Upcoming Presentations - The first poster presentation will cover clinical safety, pharmacokinetics, pharmacodynamics, and cytochrome P450 interactions for NXP900, presented by Gerald Falchook, MD, on October 23, 2025, from 12:30 to 4 pm ET [2] - The second poster presentation will focus on the efficacy of NXP900 in inhibiting tumor growth in FAT1 mutated xenograft models, presented by Asier Unciti-Broceta on the same date and time [2]

Core Insights - Nuvectis Pharma, Inc. has appointed Dr. Juan Sanchez to its Board of Directors, bringing extensive experience in biotech and capital markets [1][3] - Dr. Sanchez previously served as Vice President of Corporate Communications and Investor Relations at Intra-Cellular Therapies, which was acquired by Johnson & Johnson for $14.6 billion in April 2025 [2][3] - The company is entering a new growth phase with the initiation of the Phase 1b program for its lead drug candidate, NXP900, aimed at treating advanced and treatment-resistant cancers [3][4] Company Overview - Nuvectis Pharma focuses on developing innovative precision medicines for serious unmet medical needs in oncology [4] - The lead program, NXP900, is an oral small molecule inhibitor targeting SRC Family of Kinases (SFK), having completed a Phase 1a dose escalation study and currently being evaluated in a Phase 1b program [4] - The company is also exploring next steps for NXP800, which has shown anti-cancer activity in specific ovarian cancer cases [4] Dr. Juan Sanchez's Background - Dr. Sanchez has over 30 years of experience in healthcare, combining roles in patient care, research analysis, and executive leadership in biopharmaceuticals [3] - His tenure at Intra-Cellular Therapies included the successful development and commercialization of CAPLYTA (lumateperone) [3] - Dr. Sanchez holds advanced degrees in International Affairs, Business Administration, and Medicine, and has practiced medicine for five years in Colombia [3]

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].