Key Highlights

• Nuvectis in-licensed ex-China rights to ciprocopan (NXP100) and NXP200 from Haisco Pharmaceutical Group, transforming the company into a late-stage clinical development firm.

• Ciprocopan received its first global approval in China in July 2026 for the treatment of PNH patients previously untreated with complement inhibitors.

• FDA discussions regarding the U.S. regulatory pathway for ciprocopan in PNH are underway, with an update expected before year-end 2026.

• Cash position stood at approximately $140 million, expected to fund operations into the second half of 2029.

Nuvectis Pharma, Inc.(NASDAQ:NVCT), a clinical-stage biopharmaceutical company focused on complement-related conditions and oncology, reported its third-quarter 2026 financial results alongside a series of developments that have reshaped its pipeline and strategic direction. The company's in-licensing deal with Haisco Pharmaceutical Group for two late-stage drug candidates has positioned Nuvectis as a potential contender in the complement inhibitor space, while its cash reserves provide a multi-year operational runway.

A Transformative In-Licensing Transaction

The quarter's defining event was the completion of an in-licensing agreement with Haisco Pharmaceutical Group for the ex-China rights to ciprocopan (NXP100), a Complement Factor B inhibitor, and NXP200, a paradox-breaker BRAF inhibitor. The deal, combined with a follow-on public offering anchored by healthcare-focused investors, fundamentally altered Nuvectis' development profile.

Ciprocopan achieved its first regulatory approval worldwide in July 2026, when Chinese authorities cleared it for patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. A second Marketing application in China for previously treated PNH patients is under review, with approval anticipated in Q1 2027. Additional clinical programs in China include a Phase 3 study in IgA nephropathy and a Phase 2 trial in lupus nephritis.

U.S. Regulatory Path Takes Shape

Nuvectis is currently in discussions with the U.S. FDA about whether the clinical data supporting ciprocopan's approval in China could form the basis for a marketing application in the United States. An update on these discussions is expected before the end of 2026. The company also plans to submit a U.S. Investigational New Drug (IND) application for ciprocopan in an indication beyond PNH by year-end.

Chairman and CEO Ron Bentsur highlighted ciprocopan's potential dosing advantage, noting its once-daily oral formulation compared to injectable treatments and Fabhalta, another oral Complement Factor B inhibitor that requires twice-daily dosing. Phase 3 data from a head-to-head study conducted in China comparing ciprocopan to eculizumab (Soliris) in treatment-naive PNH patients demonstrated an efficacy advantage for ciprocopan.

Oncology Candidate Shows Early Promise

On the oncology side, expanded Phase 1b results for NXP200 in patients with BRAF V600-mutated recurrent or progressive glioma were presented at the 2026 ESMO Congress. The data showed durable responses, including complete responses, with activity also observed in patients who had previously received a BRAF inhibitor. NXP200 received Breakthrough Therapy Designation from China's Center for Drug Evaluation for this indication. Nuvectis expects to submit a U.S. IND for NXP200 by year-end.

Financial Position Provides Extended Runway

Nuvectis ended Q3 2026 with approximately $140 million in cash, which the company described as the highest financial position in its history. This funding is expected to support operations into the second half of 2029, extending beyond multiple anticipated clinical and regulatory milestones.

Looking Ahead

Nuvectis Pharma has rapidly evolved from a small-cap oncology company into a multi-asset, late-stage development firm with programs spanning hematology, nephrology, and oncology. The outcome of FDA discussions on ciprocopan's U.S. regulatory path will be a critical near-term catalyst, while Phase 3 results and additional data readouts across both NXP100 and NXP200 could further define the company's trajectory into 2027.