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].

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]

Core Viewpoint - Nuvectis Pharma, Inc. (NVCT) shows significant upside potential with a mean price target of $19.25, indicating a 108.8% increase from the current trading price of $9.22 [1] Price Targets and Analyst Estimates - The mean estimate consists of four short-term price targets with a standard deviation of $4.35, suggesting variability in analyst predictions [2] - The lowest estimate of $15 indicates a 62.7% increase, while the highest estimate suggests a 171.2% surge to $25 [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction [9] Earnings Estimates and Analyst Agreement - Analysts have shown increasing optimism about NVCT's earnings prospects, with a positive trend in earnings estimate revisions [11] - Over the last 30 days, two estimates have increased, leading to a 14.2% rise in the Zacks Consensus Estimate [12] - NVCT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

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 March 31, 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 ...

Financial Performance - The net loss for the first quarter of 2025 was $5.3 million, compared to a net loss of $4.2 million for the same period in 2024, representing an increase of $1.1 million [4]. - The basic and diluted net loss per common share outstanding was $0.27 for the first quarter of 2025, compared to $0.25 for the same period in 2024 [15]. Cash and Assets - Cash and cash equivalents increased to $29.9 million as of March 31, 2025, from $18.5 million as of December 31, 2024, reflecting a $11.4 million increase due to a public offering [3]. - The total assets as of March 31, 2025, were $30.1 million, compared to $18.6 million as of December 31, 2024 [13]. - The total liabilities as of March 31, 2025, were $9.2 million, unchanged from December 31, 2024 [13]. - The company completed a financing round of $15.5 million, extending its cash runway into the first quarter of 2027 [5]. Expenses - Research and development expenses rose to $3.7 million for the first quarter of 2025, up from $2.7 million in the same quarter of 2024, an increase of approximately 37% [6]. - General and administrative expenses were $1.9 million for the first quarter of 2025, compared to $1.7 million for the same period in 2024, an increase of about 11.8% [6]. Clinical Development - NXP900 demonstrated a robust pharmacodynamic response and acceptable safety profile in the Phase 1a dose escalation study, with plans to enter Phase 1b for specific genetic alterations [2]. - The company is advancing two clinical-stage drug candidates, NXP800 and NXP900, targeting serious conditions in oncology [8].

Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical programs, particularly NXP900 and NXP800, while reporting a financial update for Q1 2025, highlighting increased cash reserves and ongoing clinical trials [2][3][4]. Financial Results - Cash and cash equivalents increased to $29.9 million as of March 31, 2025, from $18.5 million as of December 31, 2024, due to a public offering that generated net proceeds of $14.0 million [3]. - The net loss for Q1 2025 was $5.3 million, compared to a net loss of $4.2 million in Q1 2024, reflecting an increase of $1.1 million [4]. - Research and development expenses rose to $3.7 million in Q1 2025 from $2.7 million in Q1 2024, an increase of $1.0 million [5]. - General and administrative expenses were $1.9 million for Q1 2025, up from $1.7 million in Q1 2024, an increase of $0.2 million [5]. Clinical Development Updates - NXP900 is in the Phase 1a dose escalation study, showing a robust pharmacodynamic response and acceptable safety profile in patients with advanced cancers [2][8]. - The Phase 1b study for NXP900 will enroll patients with specific genetic alterations to evaluate its therapeutic potential [2]. - NXP800 is currently in a Phase 1b study for platinum-resistant, ARID1a mutated ovarian cancer, with updates expected in the coming months [2][8]. Company Overview - Nuvectis Pharma focuses on developing innovative precision medicines for serious oncology conditions, with two clinical-stage drug candidates: NXP800 and NXP900 [7]. - NXP800 is an oral small molecule GCN2 activator, while NXP900 is an oral small molecule inhibitor targeting SRC Family of Kinases [7][9].

Core Insights - Nuvectis Pharma, Inc. has provided updates on the Phase 1a dose-escalation study of NXP900, indicating robust pharmacodynamic responses and an acceptable safety profile with no dose limiting toxicity identified up to 250 mg/day [1][5][6] - The company is preparing to initiate the Phase 1b program, focusing on biomarker-selected cancers and evaluating NXP900 in combination with leading therapies for resistant non-small cell lung cancer (NSCLC) [4][5] Group 1: Clinical Study Highlights - NXP900 demonstrated systemic exposure that increased with dosage, achieving clinically relevant concentrations starting at 150 mg/day, with over 90% SRC inhibition observed in patient samples after a single dose [6] - The study included 29 patients with advanced cancers, with a median age of 62 years, where common treatment-emergent adverse events were mostly Grade 1-2 [6] Group 2: Preclinical Data and Rationale - Preclinical data supports NXP900's potential as a single agent and in combination with existing therapies to overcome resistance in NSCLC, particularly targeting YES1 gene amplifications and Hippo pathway alterations [1][3][4] - The addition of NXP900 to market-leading EGFR and ALK inhibitors reversed resistance, highlighting its potential in addressing unmet clinical needs in NSCLC [6] Group 3: Company Overview - Nuvectis Pharma, Inc. is focused on developing innovative precision medicines for oncology, with NXP900 being an oral small molecule inhibitor of the SRC Family of Kinases [7] - The company is also developing another candidate, NXP800, for different cancer indications, showcasing a diverse pipeline in oncology [7]