Gossamer Bio (GOSS) investor relations material

Strategic and operational updates

• Transitioning from R&D to commercialization, with infrastructure buildout for a 2027 launch of saralutinib.

• Commercial strategy includes brand development, patient services, market access, and payer engagement.

• Partner Chiesi will commercialize outside the US, with Gossamer booking US sales and retaining final say on strategy.

• Commercial team to include about 60 sales reps, with pre-launch activities starting 4–6 months before launch.

• High ROI expected due to a static US customer base, minimizing patient capture costs.

Clinical development and trial design

• Phase III PROCERA study for saralutinib in PAH is set for a major data readout in early 2026, with primary endpoint six-minute walk and detailed secondary endpoint disclosure.

• Study design improved over Phase II by expanding site visits, QA/QC, and enrolling a sicker, more responsive patient population.

• Enrichment strategies targeted higher-risk patients, with more Class III patients than previous studies.

• Ongoing registrational study for PH ILD (Serenada) leverages operational synergies from PROCERA, with first patient enrollment expected by year-end.

• About 60% site overlap between PROCERA and Serenada, using the same CRO and field force.

Efficacy, safety, and regulatory perspectives

• Clinically meaningful improvement in six-minute walk is 20–25 meters; study powered for 30 meters with high statistical power.

• Safety profile and durability of effect are key differentiators, with ongoing positive feedback from KOLs and regulatory agencies.

• Only nine patients in PROCERA were on stable sotatercept, limiting combination data but highlighting potential safety advantages.

• FDA dialogue is positive; statistical significance above 0.05 is expected to be sufficient for approval.

• Filing planned for July 2026, with commercial approval targeted for March 2027.