Gossamer Bio (GOSS) Presents at Goldman Sachs 45th Annual Global Healthcare Conference summary

Pipeline overview and clinical development

• Seralutinib was acquired to improve upon imatinib, targeting CSF1R, PDGF, and c-KIT with higher specificity and potency, and designed for inhaled delivery to maximize lung exposure and minimize systemic effects.

• Phase II TORREY study showed statistically significant reduction in pulmonary vascular resistance (PVR) and a trend in six-minute walk, with more pronounced effects in sicker patients (functional class III).

• Open Label Extension (OLE) demonstrated durable and continued improvements in PVR and six-minute walk up to 72 weeks, with a consistent safety profile.

• Both sicker and less sick patients showed improvement, including those on multiple background therapies, with no additional safety risks.

• PROSERA phase III is enrolling a sicker patient population, with global site expansion, and aims for top-line data by end of next year.

Market landscape and competitive positioning

• Sotatercept’s approval has increased demand but is expected to benefit only about 30% of patients, leaving significant unmet need for additional therapies.

• Enrollment for PROSERA is strong, with a focus on ex-U.S. markets where sotatercept is not yet available, including South America, Japan, and Saudi Arabia.

• The patient mix in PROSERA is more diverse and sicker than in TORREY, with a lower six-minute walk cap and risk score stratification to match the population studied in sotatercept trials.

• Physicians are interested in delaying prostacyclin use and exploring earlier use or combination of seralutinib and sotatercept.

• Seralutinib’s inhaled route and safety profile may increase patient acceptability compared to existing therapies.

Strategic partnerships and expansion

• Collaboration with Chiesi provides capital and cost-sharing, enabling a phase III PH-ILD trial years earlier than planned and expanding into a market twice the size of PAH.

• Chiesi’s global respiratory footprint complements U.S. leadership, with Gossamer retaining control over clinical development and commercialization in the U.S.

• The partnership does not preclude future M&A opportunities.

• Chiesi’s expertise in respiratory diseases and established presence in Europe and rare diseases in the U.S. supports broader strategic ambitions.

• Future indications may include PH-IPF, PH-COPD, and IPF, leveraging Chiesi’s interests and infrastructure.