Nuvectis Pharma (NVCT) Status Update summary

Program initiation and strategic overview

• Initiated Phase 1B study for NXP900, a selective oral SRC/YES1 kinase inhibitor, targeting unmet needs in oncology and advanced solid tumors with specific genetic alterations.

• NXP900 is positioned as a 'pipeline in a pill' with potential across multiple cancer types, aiming for transformative impact.

• Company holds a strong cash position of ~$39 million, providing over two years of operational runway to reach key milestones.

• Recent acquisition of shares by a prominent healthcare institutional investor signals confidence in the program.

• Phase 1A studies showed good tolerability and robust pharmacodynamic response, with >90% Src inhibition at clinically relevant doses.

Study design and patient populations

• Phase 1B evaluates NXP900 as a single agent and in combination with EGFR/ALK inhibitors in advanced cancers, including NSCLC with acquired resistance.

• Single agent arm targets YES1 amplified or FAT1 mutated NSCLC, NF2 mutated mesothelioma and renal cancer, and other tumors with Hippo Pathway alterations.

• Patient selection is based on genetic alterations (YES1 amplification, FAT1/NF2 mutations) identified via routine sequencing panels.

• Four groups of ~25 patients each are planned, with initial enrollment of 12 per group and expansion based on response.

• Sites are all in the U.S. and equipped for rapid patient screening.

Scientific rationale and competitive differentiation

• NXP900’s unique mechanism inhibits both catalytic and scaffolding functions of Src, unlike other inhibitors.

• Preclinical and clinical data support targeting YES1, FAT1, and NF2 alterations, with potential to overcome resistance to targeted therapies.

• Drug-drug interaction studies show NXP900 is a weak CYP3A inducer, supporting safe combination with EGFR/ALK inhibitors.

• Prior studies with less potent Src inhibitors showed limited activity, but NXP900’s potency and patient enrichment strategy are expected to yield better outcomes.

• Protocol designed to maximize likelihood of observing therapeutic effect based on robust preclinical and early clinical data.