Nuvectis Pharma Announces the Initiation of the Phase 1b Study of NXP900 in Combination with Osimertinib in Patients with NSCLC

Rhea-AI Summary

Nuvectis Pharma (NASDAQ: NVCT) announced the initiation of a Phase 1b study of oral SRC/YES1 inhibitor NXP900 in combination with osimertinib (Tagrisso) for patients with EGFR-mutant non-small cell lung cancer (EGFRmut+ NSCLC) who initially responded to osimertinib and later acquired resistance.

The program follows a completed Phase 1a dose-escalation and a drug-drug interaction study; the single-agent Phase 1b study is ongoing. The company expects multiple clinical data readouts from single-agent and combination studies in 2026.

Positive

• Initiation of a Phase 1b combination study with osimertinib
• Completed Phase 1a dose-escalation and DDI study prior to combination
• Oral SRC/YES1 inhibitor targeting a documented resistance pathway

Negative

• No clinical efficacy readouts reported yet for the NXP900+osimertinib combination
• Study excludes tumors with known osimertinib-resistance EGFR mutations, narrowing eligible population

Key Figures

Phase 1a patients 33 patients NXP900 Phase 1a dose-escalation program

Dose range 20–300 mg once daily NXP900 Phase 1a dosing levels

Effective dose threshold ≥150 mg/day Dose with robust pharmacodynamic response for NXP900

Cash & equivalents $35.4M As of Sept 30, 2025 (Q3 2025)

Q3 2025 net loss $7.5M Quarter ended Sept 30, 2025

Equity raise 3,105,000 shares at $5.00 February 2025 offering for $14.0M net

ATM sales 1,707,309 shares for $13.5M gross ATM activity in Q3 2025 ($13.1M net)

CEO purchase 5,000 shares at $5.72 Open-market Form 4 transaction on 11/05/2025

Market Reality Check

$8.85 Last Close

Volume Volume 67,597 is below the 20-day average of 95,659, suggesting limited pre-news positioning. normal

Technical Trading slightly above the 200-day MA of 7.56 and 33.25% below the 52-week high of 11.52.

Peers on Argus 1 Down

Biotech peers show mixed moves, with names like AARD at -3.33% and TIL at +2.27%, indicating stock-specific rather than sector-wide dynamics for NVCT.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	KOL event announcement	Positive	+1.7%	Announced virtual KOL meeting to discuss NXP900 Phase 1b strategy.
Nov 04	Earnings & update	Positive	-7.5%	Q3 2025 results with NXP900 progress but higher net loss reported.
Nov 04	Earnings & update	Positive	-7.5%	Detailed Q3 financials and NXP900 advancement alongside increased expenses.
Oct 27	Clinical poster data	Positive	+5.7%	Phase 1a safety and pharmacodynamic data plus DDI findings for NXP900.
Oct 16	Conference preview	Positive	+0.0%	Announced upcoming NXP900 posters at AACR-NCI-EORTC conference.

Pattern Detected

Recent NXP900 data and program updates often saw positive or mixed price reactions, while earnings updates with the same clinical themes drew negative responses.

Recent Company History

Over the past few months, Nuvectis has repeatedly highlighted progress for NXP900, including Phase 1a dose-escalation data, poster presentations at the 2025 AACR-NCI-EORTC conference, and the start of the Phase 1b monotherapy study. An earnings update on Nov 4, 2025 combined this clinical progress with higher losses and equity raises, which coincided with a -7.55% move. A late-November KOL event previewed the osimertinib combination now being formally initiated in this news.

Market Pulse Summary

This announcement advances NXP900 into its first Phase 1b combination with osimertinib for EGFRmut+ NSCLC patients who developed resistance, building on earlier Phase 1a safety and pharmacodynamic data. Recent history shows consistent program execution, conference visibility, and insider share purchases. Investors may watch for 2026 data readouts, safety and activity signals in the combination cohort, and how these results complement the ongoing monotherapy study.

Key Terms

non-small cell lung cancer medical

"osimertinib in patients with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

epidermal growth factor receptor medical

"patients with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer"

A protein on the surface of many cells that acts like an antenna or switch controlling cell growth and repair; certain changes (mutations) can make it stuck in the “on” position, driving uncontrolled cell division. Investors watch it because drugs or tests that target this receptor can become valuable therapies or diagnostic tools, shaping clinical trial outcomes, regulatory approvals, and potential revenue for companies in the healthcare sector.

egfr inhibitor medical

"Tagrisso, a 3rd generation EGFR inhibitor is broadly used in patients with NSCLCmut+"

An epidermal growth factor receptor (EGFR) inhibitor is a medicine that blocks a specific protein on some cancer cells that acts like a ‘on’ switch for growth; by turning that switch off, the drug can slow or stop tumor growth. Investors care because these drugs are often tied to clear clinical tests, targeted patient groups, patent-protected sales and regulatory decisions, so trial results, safety issues or approvals can sharply change a company’s value.

drug-drug interaction medical

"completion of a Phase 1a dose escalation study ... and a clinical drug-drug interaction study in healthy volunteers."

When one medication changes how another medication works or how the body handles it, that is a drug-drug interaction; it can make a drug stronger, weaker, or produce unexpected side effects—think of mixing two recipes and getting a very different dish. Investors pay attention because interactions can alter a drug’s safety profile, limit who can use it, trigger label warnings or additional testing, and therefore affect sales, market access, and regulatory risk.

AI-generated analysis. Not financial advice.

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 treatment

Fort 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 EGFR^mut+ 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 3^rd generation EGFR inhibitor is broadly used in patients with NSCLC^mut+ 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 EGFR^mut+ 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 EGFR^mut+ NSCLC

Eligible patients for this study include those with unresectable, metastatic or locally advanced EGFR^mut+ 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 EGFR^mut+ 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 Bentsur
Chairman, Chief Executive Officer and President
rbentsur@nuvectis.com

Media Relations Contact

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

FAQ

What did Nuvectis Pharma announce on December 17, 2025 about NVCT?

Nuvectis announced the start of a Phase 1b study of NXP900 combined with osimertinib in EGFRmut+ NSCLC patients who acquired resistance to osimertinib.

What is the goal of the NVCT NXP900 plus osimertinib Phase 1b study?

To evaluate the safety and clinical activity of oral NXP900 in combination with osimertinib in patients who initially responded to osimertinib but later developed resistance.

What prior studies supported the NVCT Phase 1b combination study?

Nuvectis completed a Phase 1a dose-escalation in advanced solid tumors and a clinical drug-drug interaction study in healthy volunteers.

Which patients are eligible for the NVCT NXP900 plus osimertinib study?

Patients with unresectable, metastatic or locally advanced EGFRmut+ NSCLC who previously responded to osimertinib and do not have known osimertinib-resistance EGFR mutations or other non-EGFR oncogenic drivers.

What mechanism does NXP900 target in NVCT’s study?

NXP900 is described as a potent oral inhibitor of the SRC and YES1 kinases, pathways linked to acquired resistance to EGFR inhibitors.

When can investors expect clinical data from NVCT’s NXP900 program?

The company indicated it expects multiple data readouts in 2026 from both single-agent and combination studies.