Gossamer Bio (GOSS) Corporate presentation summary

Strategic and clinical highlights

• Focused on developing treatments for rare, fatal lung diseases, with seralutinib as the lead asset targeting pulmonary arterial hypertension (PAH) and future expansion into PH-ILD.

• Seralutinib is a potential first-in-class, inhaled tyrosine kinase inhibitor (TKI) designed to address underlying disease mechanisms in PAH by targeting PDGFR, CSF1R, and c-KIT.

• Completed Phase 3 PROSERA study in PAH, showing clinically meaningful and statistically supported gains, especially in higher-risk patients, and a favorable safety profile.

• Reacquired worldwide rights to seralutinib, consolidating global decision-making and increasing economic participation.

• Strengthened capital structure through debt reduction and new capital infusions, positioning for upcoming regulatory milestones.

Clinical efficacy and safety data

• PROSERA Phase 3 demonstrated a placebo-adjusted improvement in 6-minute walk distance (6MWD) of +13.3 meters (p=0.0320) overall, and +20.0 meters (p=0.0207) in higher-risk subgroups.

• Key secondary endpoints, including NT-proBNP reduction, clinical improvement, and risk score reduction, favored seralutinib, with amplified effects in higher-risk patients.

• Safety profile was favorable: serious adverse events were lower than placebo (16.0% vs. 18.9%), with manageable adverse events consistent with inhaled delivery.

• No new or unexpected safety signals; liver enzyme elevations were reversible and cough was typically mild and transient.

Regulatory and market outlook

• NDA submission for seralutinib in PAH targeted for September 2026, with potential FDA decision in Q3 2027.

• Regulatory path leverages one pivotal trial (PROSERA) plus confirmatory evidence (TORREY), supported by robust clinical, biomarker, imaging, and long-term data.

• PAH market projected to grow to $13.7 billion by 2034, with high unmet need for therapies addressing disease biology rather than just vasodilation.

• Seralutinib's differentiated mechanism and inhaled delivery position it as a practical add-on to standard care, with blockbuster potential and expansion opportunities in PH-ILD.