Nuvectis Pharma (NVCT) Update / Briefing August 12, 2025 08:30 AM ET Speaker0Greetings, and welcome to the Nuvectis Pharma NXP-nine hundred Phase Ib Study Initiation Conference Call. At this time, all participants are in listen only mode. As a reminder, this conference is being recorded. Joining me on the call today will be Ron Bensour, Co Founder, Chairman, and Chief Executive Officer of Nuvectis Pharma. Also joining us for Q and A are Enrique Prasadu, Co Founder, Executive Vice President, Chief Scientific ...

The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program and the overall market opportunity for NXP900 Fort Lee, NJ, Aug. 11, 20 ...

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 ...

The increase in net loss in the second quarter of 2025 was primarily due to the NXP900 DDI study, which has been completed. The three months ended June 30, 2025, also includes $1.8 million of non-cash stock-based compensation. Exhibit 99.1 Nuvectis Pharma, Inc. Reports Second Quarter 2025 Financial Results and Business Highlights August 5, 2025, Fort Lee, NJ - Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovati ...

NXP900 becomes the lead drug candidate after successfully completing the Phase 1a dose escalation study in patients with advanced solid tumors and a drug-drug interaction study in healthy volunteers; initiation of Phase 1b program is imminentStrengthened cash position following a July At-The-Market (ATM) shares acquisition by a healthcare-dedicated institutional investor; June 30, 2025 proforma cash position of approximately $39 million FORT LEE, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. ...

Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types NXP900 successfully completed a clinical drug-drug interaction (DDI) study in healthy volunteers and the Phase 1a dose escala ...

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].

Company Overview - Nuvectis Pharma focuses on precision medicine for oncology with unmet medical needs[6] - The company has ongoing clinical trials for NXP800 and NXP900[6] - Management team has a track record with 3 approved drugs in 4 indications in the US and EU[6] - The company's cash runway extends into 2027[6] NXP800 - NXP800 shows substantial antitumor activity in ARID1a-mutated ovarian carcinoma xenografts[13] - Clinical data from the Phase 1b trial shows antitumor activity, including one patient with an unconfirmed partial response and six patients with stable disease[17] - NXP800 targets cancers with ARID1a mutations, with an estimated 2,300 ovarian cancer patients, 23,600 endometrial carcinoma patients, 1,400 cholangiocarcinoma patients, 25,600 urothelial cancer patients, 9,070 hepatocellular cancer patients, and 6,600 gastric cancer patients in the US[18] NXP900 - NXP900 is a potent, novel, small molecule inhibitor of YES1/SRC signaling[21] - NXP900 achieves approximately 90% inhibition of SRC autophosphorylation (pSRC) after a single dose at doses ≥150 mg/day[33] - NXP900 is being evaluated in a Phase 1a dose escalation clinical trial[21]

Financial Data and Key Metrics Changes - The company finished the first quarter with just under $30 million in cash, with a projected cash runway extending into the first quarter of 2027, indicating a strong financial position for a small company in the current market [51]. Business Line Data and Key Metrics Changes - NXP-800 is currently in a Phase Ib program targeting aggressive subsets of ovarian cancer, with early data showing a partial response and stable disease in initial patients, although there were concerns regarding thrombocytopenia [15][17]. - NXP-900 is in a Phase 1a dose escalation, with early indications of safety and significant SRC inhibition, suggesting it may be a best-in-class SRC inhibitor [35][39]. Market Data and Key Metrics Changes - The addressable patient populations for NXP-800 and NXP-900 vary significantly, with potential expansions into larger indications like endometrial cancer if positive signals are observed in ongoing studies [22]. Company Strategy and Development Direction - The company is focused on precision medicine in oncology, aiming to address severe unmet medical needs with targeted therapies [4]. - There is a strategic emphasis on developing NXP-900 as a transformational drug with potential applications across multiple tumor types, leveraging its selective inhibition of SRC kinases [24][28]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data updates for both NXP-800 and NXP-900, indicating that the next few months could be eventful and potentially transformational for the company [51][53]. - The management team highlighted their extensive experience in successfully bringing drugs to market, which they believe positions the company well for future success [6]. Other Important Information - The insider ownership is significant, with co-founders and major shareholders collectively owning about 50-55% of the company, reflecting strong alignment with shareholder interests [51]. - The company has seen consistent insider buying since going public, indicating confidence in the company's future prospects [51]. Q&A Session Summary Question: What is the current status of NXP-800 and NXP-900? - NXP-800 is in a Phase Ib program with encouraging early results, while NXP-900 is completing Phase 1a and preparing to enter Phase 1b soon [51][53].

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]