Nuvectis Pharma (NVCT) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Executive leadership and recent transactions

• CEO and co-founder has a track record of drug approvals and successful exits in biotech, with recent experience leading the company through a transformative transaction with Haisco and a $115 million follow-on offering.

• The Haisco partnership resulted from a two-year relationship, bringing in two key compounds: NXP100 (Factor B inhibitor) and NXP200 (oncology asset).

• Extensive due diligence was conducted on Haisco assets, with comfort drawn from Haisco's recent deals with AbbVie and Eli Lilly.

Product differentiation and market opportunity

• NXP100 is a once-daily oral Factor B inhibitor, offering a convenience advantage over FABHALTA, which is twice daily.

• Factor B inhibitors are expected to overtake the $5–8 billion PNH market by the end of the decade, with potential for the class to exceed $10 billion as new indications emerge.

• NXP100 demonstrated superior efficacy to SOLIRIS in head-to-head studies, with hemoglobin increases more than double those of SOLIRIS and a safety profile nearly identical to FABHALTA.

Development and regulatory strategy

• NXP100 has initial approval in China for PNH-naive patients, with a second approval for pretreated patients expected by year-end.

• U.S. regulatory path includes a pre-IND meeting with the FDA in Q4 2026, followed by a PK study and up to two pivotal trials starting in H1 2027, aiming for NDA submission in H1 2029 and potential launch by end of 2029 or early 2030.

• Phase III designs are expected to mirror prior successful studies, with ~35 patients per arm and 24-week endpoints.