Gossamer Bio (GOSS) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Company focus and pipeline

• Focused on seralutinib, a multikinase inhibitor for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

• Global phase III PROSERA trial for PAH enrolling at 174 sites in 31 countries, with data expected Q4 next year.

• Second phase III for PH-ILD planned to start next year, targeting a larger, underserved patient population.

• Commercial launch with partner Chiesi targeted for 2027, with PH-ILD approval to follow.

Clinical data and trial progress

• Phase II TORREY trial showed 14% reduction in pulmonary vascular resistance (PVR), with further improvements in open-label extension (OLE) up to 25%.

• Statistically significant improvements in right heart biomarkers and echocardiogram parameters observed.

• Safety profile differentiated by mild adverse events (headache, cough) and no major safety concerns at 72 weeks.

• Phase III PROSERA trial is enriching for sicker patients using REVEAL Lite composite to better demonstrate efficacy.

Competitive landscape and market dynamics

• Recent failure of a competitor’s inhaled imatinib trial attributed to underdosing and lack of preclinical PK work.

• Enrollment in PROSERA trial benefitting from real-world safety concerns with Winrevair (sotatercept), especially in the US.

• Majority of PROSERA enrollment expected from outside the US, mainly Europe, due to delayed Winrevair launch there.