Nuvectis Pharma (NVCT) Status update summary

Strategic portfolio expansion and licensing agreement

• Announced an exclusive global ex-China in-licensing deal for two late-stage drug candidates, NXP100 and NXP200, from Eisai and Haisco, transforming the pipeline with a focus on complement-mediated diseases and oncology.

• The deal includes NXP100, a once-daily oral complement factor B inhibitor, and NXP200, a paradox breaker BRAF inhibitor for BRAF-altered cancers.

• Haisco receives up to $40 million upfront/near-term, up to $1.421 billion in milestones, and tiered royalties, retaining rights in China, India, and select Southeast Asia territories.

• Both compounds have strong intellectual property protection, with patents expiring in 2043 (NXP100) and 2042 (NXP200).

• Eisai's and Haisco's track records and recent successful licensing deals with major pharma companies highlight the quality of the partnership.

Clinical and regulatory status of NXP100

• NXP100 is a once-daily oral Factor B inhibitor in late-stage development for complement-mediated diseases, with two marketing authorization applications under review in China for PNH and approvals expected in late 2026 and early 2027.

• Supported by Phase 3 data showing superiority over eculizumab in treatment-naive and C5-inhibitor-failure patients.

• Ongoing pivotal phase III study in IgA nephropathy and phase II study in lupus nephritis in China.

• Phase II data in IgA nephropathy suggest potentially greater treatment effect than Fabhalta and comparable efficacy to leading BAFF-APRIL inhibitors, but as an oral therapy.

• Strong IP protection with patents expiring in 2043 and potential blockbuster opportunity as the first once-daily factor B inhibitor.

Market landscape and competitive positioning for NXP100

• PNH market projected to exceed $5 billion in 2026, with potential to double in 8 years; Fabhalta is the only FDA-approved oral Factor B inhibitor.

• NXP100 offers once-daily oral dosing versus Fabhalta’s twice-daily regimen.

• Demonstrated similar or superior efficacy to Fabhalta and clear superiority over SOLIRIS in PNH, with the convenience of once-daily oral dosing.

• NXP100’s efficacy and safety profile in PNH and IgAN is comparable to Fabhalta and best-in-class injectable competitors.

• Strong IP protection and potential for first-mover advantage as a once-daily oral therapy.