NXP-800

The study is designed to evaluate the safety and clinical activity of NXP900 in combination with osimertinib in patients with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC) whose cancers initially responded to treatment with osimertinib but subsequently acquired resistance to treatmentFort Lee, NJ, Dec. 17, 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 initiation of the Phase 1b study of NXP900 in combination with osimertinib in patients with EGFRmut+ NSCLC. NXP900, an oral small molecule drug candidate, is a potent inhibitor of the SRC and YES1kinases. The brand name for Osimertinib is Tagrisso®, marketed by Astra Zeneca. Tagrisso, a 3rd generation EGFR inhibitor is broadly used in patients with NSCLCmut+ as single agent or in combination with chemotherapy as a first or later line of therapy. It has been described in the scientific literature that activation of the SRC/YES1 pathway drives resistance to EGFR inhibitor therapy in EGFRmut+ NSCLC. NXP900 Phase 1b Clinical Program The Phase 1b program was initiated with the NXP900 single agent (monotherapy) study following the successful completion of a Phase 1a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteers. The ongoing single agent study evaluates the safety and clinical activity of NXP900 in patients with specific genetic alterations selected based on their characteristics as either direct or dependent targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. Today marks the commencement of the first combination study of NXP900 as part of the Phase 1b program. Phase 1b of NXP900 in Combination with Osimertinib in Patients with EGFRmut+ NSCLC Eligible patients for this study include those with unresectable, metastatic or locally advanced EGFRmut+ NSCLC who have been previously treated with, and had a response to, osimertinib in the first or second line setting as a single agent or in combination with chemotherapy. Patients whose tumors harbor mutations in the EGFR domain that are known to cause resistance to osimertinib, or who have other known oncogenic drivers other than EGFR mutation are not eligible. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are pleased to announce the initiation of the NXP900 plus osimertinib combination study, as we continue to advance the NXP900 clinical program and unlock NXP900’s promising therapeutic potential.” Mr. Bentsur added, “The clinical benefit and improved outcomes afforded by osimertinib to patients with EGFRmut+ NSCLC are well known, and we believe, based on extensive medical and scientific literature and proof of concept experiments done by us and others, that a combination with NXP900 has the potential to extend these benefits in patients who acquired resistance to osimertinib, using an all oral combination of osimertinib and NXP900.” Mr. Bentsur concluded, “We expect 2026 to be an exciting year with multiple data readouts from both the single agent and combination studies, and we look forward to providing updates from the program throughout the year." About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company’s assets include two clinical-stage drug candidates, NXP900 and NXP800. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and the Phase 1b program has been initiated. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. For additional information about Nuvectis Pharma please visit: https://nuvectis.com. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate”, "believe”, "contemplate”, "could”, "estimate”, "expect”, "intend”, "seek”, "may”, "might”, "plan”, "potential”, "predict”, "project”, "target”, "aim”, "should”, "will”, "would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and the timing and safety and efficacy data expectations for the monotherapy and combination components of the NXP900 Phase 1b program and estimates and projections regarding our financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q3 2025 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact Ron BentsurChairman, Chief Executive Officer and Presidentrbentsur@nuvectis.com Media Relations Contact Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com

Nov. 25, 2025 -- Nuvectis Pharma, Inc. (NASDAQ: NVCT, the “Company”), 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 that the Company will host a virtual Key Opinion Leader Meeting on Tuesday, December 2, 2025 at 8:00 AM ET to discuss the NXP900 Phase 1b Program in Advanced Solid Tumors, including the combination with osimertinib in non-small cell lung cancer. To register for the event, click here. The event will feature Alexander Spira, MD, PhD, FACP, FASCO (Chief Scientific Officer, NEXT Oncology) and Asier Uncita-Broceta, MPharm, MSc, PhD (Professor of Chemistry, University of Edinburgh) who will join Company management to discuss the NXP900 development program. The discussion will focus on key NXP900 preclinical and clinical data to date and the strategy for the monotherapy and combination components of the NXP900 Phase 1b clinical program. Dr. Alexander Spira is the Chief Scientific Officer of NEXT Oncology. He serves as Chair of the US Oncology Research Executive Committee and is a member of US Oncology National Policy Board Executive Committee. He is also a faculty member at Johns Hopkins School of Medicine, where he is an Assistant Professor of Oncology. He has authored many important manuscripts in highly prestigious journals such as the New England Journal of Medicine, Journal of Clinical Research, and Clinical Cancer Research, involving innovative new therapies for the treatment of cancer. In addition to his work with NEXT Oncology, Dr. Spira is deeply engaged in advancing targeted cancer treatments through Phase 1 clinical trials. His areas of interest include immunotherapy, personalized medicine, gastrointestinal cancers, thoracic and lung cancers, and sarcomas. Recognized as a “Top Doctor” by both Northern Virginia Magazine and Washingtonian Magazine, Dr. Spira received the prestigious Castle Connolly “America’s Top Doctor” award in 2014. Dr. Spira will continue to serve as the Co-Director, Virginia Cancer Specialists’ Research Institute, and Director of Virginia Cancer Specialists’ Thoracic and Phase I Program. Dr. Spira earned his medical degree from the New York University School of Medicine, completing his internship and residency at the Hospital of the University of Pennsylvania, and his medical oncology fellowship at Johns Hopkins Hospital. Dr. Spira also received his PhD from the New York School of Arts and Sciences. Dr. Asier Uncita-Broceta received his PhD in Medicinal Chemistry from the Universidad of Granada (Spain) in 2004 and completed his postdoctoral training in the fields of cell delivery and chemical biology in the School of Chemistry of the University of Edinburgh. He joined the Cancer Research UK Edinburgh Centre as a group leader in 2010, where he established the Innovative Therapeutics Lab in 2010 (first chemistry lab of the Institute). Asier was promoted to Reader in 2015 and Full Professor in 2018. Asier is an Elected Member of the RSE Young Academy of Scotland, Associate Editor of Frontiers in Chemistry and Editorial Board Member of Scientific Reports. He is PI of Edinburgh Drug Discovery and Chemistry Director of the Edinburgh Cancer Discovery Unit. Among his awards highlight the CRUK Pioneer Award 2015, the EPSRC Healthcare Technology Challenge Award 2015 and the RSE/Patrick Neill Medal 2016. NXP900 is a selective orally administered small molecule type 1.5 SRC/YRS1 kinase inhibitor. NXP900’s unique mechanism of action was designed to completely shut-down the YES1/SRC pathway by inhibiting both the catalytic and scaffolding functions of the SRC pathway, while avoiding paradoxical activation of pro-oncogenic signaling, a phenomenon observed with type 1 inhibitors. NXP900 completed a Phase 1a dose escalation study in patients with advanced solid tumors. A Phase 1b single agent dose expansion study is underway in patients with advanced solid tumors with pathogenic mutations. Data from a recently completed drug-drug interaction study support initiation of enrollment in the Phase 1b dose expansion combination arm, anticipated to begin by YE 2025. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company's lead drug candidate, NXP900, is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900’s unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and is being evaluated in a Phase 1b program. The Company is also considering next steps for NXP800, an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. The content above comes from the network. if any infringement, please contact us to modify.