Gossamer Bio (GOSS) Q1 2026 earnings summary

Executive summary

• Reported positive topline results from the Phase III PROSERA study in PAH, with a clinically meaningful placebo-adjusted improvement in 6-minute walk distance at week 24, though the primary endpoint narrowly missed the pre-specified alpha threshold.

• PROSERA CT-FRI substudy generated the largest controlled vascular imaging dataset in PAH, showing statistically significant multi-compartment structural reverse remodeling and imaging signals correlated with clinical outcomes.

• Confirmed in-person FDA Type B pre-NDA meeting for mid-June to discuss regulatory path, targeting NDA submission for seralutinib in September 2026.

• Implemented significant cost reductions, including a workforce reduction affecting nearly half the company and pausing other development activities to extend cash runway and focus on NDA execution.

• Entered a global collaboration with Chiesi for development and commercialization, including a $160 million upfront payment and eligibility for milestones and royalties.

Financial highlights

• Revenue for Q1 2026 was $17.0 million, up from $9.9 million in Q1 2025, driven by the Chiesi agreement.

• Net loss for Q1 2026 was $46.7 million ($0.20 per share), compared to $36.6 million ($0.16 per share) in Q1 2025, reflecting higher R&D and G&A expenses.

• Cash, cash equivalents, and marketable securities totaled $99.2 million as of March 31, 2026.

• Cash runway expected to extend into Q1 2027, with lower quarterly burn rates due to cost containment.

• Accumulated deficit reached $1.49 billion as of March 31, 2026.

Outlook and guidance

• NDA submission for seralutinib targeted for September 2026, pending outcome of the pre-NDA FDA meeting in June.

• Cash resources are expected to fund operations into Q1 2027, but ongoing need for additional capital remains.

• Potential FDA approval could follow in Q3 2027, with updates expected after FDA meeting minutes in the summer.