Gossamer Bio (GOSS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Regulatory and clinical progress

• Completed a Type B pre-NDA meeting with the FDA in June, with positive feedback and no filing issues anticipated; NDA submission planned within weeks and acceptance expected by late November.

• Addressed upcoming debt and refinanced, improving cash position; regained worldwide rights to seralutinib, now only subject to low single-digit royalties.

• Phase III top-line p-value was 0.032, missing the EMA's stricter threshold but meeting FDA's updated guidance for rare diseases; FDA's collaborative tone and new draft guidance support the regulatory path.

• FDA focused on clinical meaningfulness, risk-benefit (especially liver safety), and subgroup analyses, particularly for CTD-associated PAH and other high-need populations.

• NDA will include comprehensive data: phase II and III results, imaging, echo, preclinical, and subgroup analyses, aiming for a broad label for WHO Group 1 PH patients.

Market positioning and commercial strategy

• Seralutinib expected to be used after standard dual therapy, with strong interest in combination with sotatercept due to synergistic effects.

• Rapid early uptake anticipated due to pent-up demand among patients intolerant or unresponsive to current therapies; prostacyclins expected to move to later lines due to tolerability issues.

• CTD-associated PAH, representing about 30% of the U.S. population, is seen as a key target due to superior efficacy and safety compared to competitors.

• Commercial launch will be managed internally, leveraging a focused sales force suitable for the rare disease market.

Clinical community and feedback

• Strong support from clinicians, especially for seralutinib's tolerability and efficacy in difficult-to-treat populations; imaging data seen as highly impressive.

• Tolerability is a major differentiator, with clinicians valuing the potential for patients to remain on therapy longer compared to existing options.

• Positive feedback from trial investigators and steering committee, particularly regarding the CTD subgroup and anti-fibrotic properties.