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 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].

Core Insights - Nuvectis Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative precision medicines for oncology, addressing serious unmet medical needs [1][3] - The company is developing two clinical-stage drug candidates: NXP800 and NXP900, with NXP800 in a Phase 1b trial for platinum-resistant, ARID1a-mutated ovarian carcinoma and cholangiocarcinoma, and NXP900 in a Phase 1a dose escalation study [3] Event Details - Nuvectis Pharma will present at the 3rd Annual H.C. Wainwright Global BioConnect Investor Conference on May 20, 2025, from 10:30 to 11:00 a.m. ET [2]

Phase 1a dose-escalation study data update: treatment with NXP900 resulted in exposure levels leading to robust pharmacodynamic responses across a range of tolerated doses; NXP900 has an acceptable safety profile, dose limiting toxicity dose level has not been identified in doses up to 250 mg/day Preclinical posters strengthen the NXP900 clinical development strategy as single agent in biomarker-targeted cancers and in combination with market leading therapies to overcome resistance in NSCLC Fort Lee, NJ ...

Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical-stage drug candidate NXP900, a novel YES1/SRC kinase inhibitor, with upcoming presentations at the 2025 American Association for Cancer Research Meeting, highlighting its potential in treating advanced solid tumors and overcoming drug resistance in non-small cell lung cancer (NSCLC) [1][2]. Group 1: NXP900 Development - NXP900 is currently in a Phase 1a dose escalation study, demonstrating potent single-agent activity and synergy with ALK inhibitors in ALK-resistant NSCLC models [2][4]. - The drug targets YAP1 signaling in NSCLC cell lines and shows sensitivity in endocrine therapy-resistant luminal A breast cancer cell lines [2][4]. Group 2: Presentation Details - Nuvectis will present findings related to NXP900 in various sessions at the 2025 AACR Meeting, including "First-in-Human Phase I Clinical Trials" and "Drug Resistance in Molecular Targeted Therapies," scheduled for April 29th [3]. - Specific presentation times include sessions from 9:00 AM to 12:00 PM and 2:00 PM to 5:00 PM on the same day [3]. Group 3: Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious unmet medical needs in oncology, with two clinical-stage candidates: NXP800 and NXP900 [4]. - NXP800 is an oral small molecule GCN2 activator in trials for platinum-resistant ovarian carcinoma and cholangiocarcinoma, while NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases [4].