Gossamer Bio, Inc. (GOSS)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 delivered a clean beat versus S&P consensus: revenue $9.89M vs $3.95M*, EPS $(0.16) vs $(0.18)*, driven by collaboration revenue recognition and cost reimbursements from the Chiesi partnership .
• Operationally, management closed new patient screening and expects full enrollment of the registrational PROSERA Phase 3 PAH study in early June, with topline in February 2026; blinded baseline characteristics align with the intended, sicker patient profile to maximize 6MWD signal .
• PH-ILD Phase 3 SERANATA site activations are expected in Q4 2025, with a design targeting dual benefits (hemodynamic and antifibrotic) and a differentiated FVC secondary endpoint, supported by FDA/EMA alignment .
• Cash and marketable securities were $257.9M, with runway into 1H 2027, supporting execution of the PAH and PH-ILD programs and commercial planning with Chiesi .
• Near‑term stock catalysts: formal announcement of full PROSERA enrollment, ongoing baseline disclosures, and PH‑ILD Phase 3 initiation updates; medium‑term catalyst is the February 2026 PROSERA topline readout .

What Went Well and What Went Wrong

What Went Well

• Closed screening and near full enrollment for PROSERA with enriched, sicker baseline characteristics (lower mean 6MWD, higher NT‑proBNP, more FC III), improving probability of detecting 6MWD benefit; “we are more optimistic than ever about the likelihood of achieving positive results” — CEO Faheem Hasnain .
• PH‑ILD Phase 3 SERANATA design finalized with FDA/EMA alignment; dual doses (90mg/120mg BID) and FVC as a key secondary endpoint to capture antifibrotic potential, aiming for differentiated profile vs current therapy .
• Financial execution: collaboration revenue recognized ($9.9M, including $6.6M cost reimbursement) while opex was controlled YoY (G&A down), reducing net loss and EPS year‑over‑year .

What Went Wrong

• PROSERA topline timing shifted to February 2026 (from earlier expectations of late‑2025) to honor strong late screening demand and ensure data quality through full adjudication/cleaning, pushing the pivotal readout beyond initial timelines .
• R&D expenses rose YoY ($38.0M vs $32.4M) reflecting intensified late‑stage development and global trial execution, widening cash burn sequentially, and lowering cash/marketable securities vs year‑end .
• Limited inclusion of background sotatercept patients, reducing immediate combination insights; management notes real‑world non‑linearity and stringent criteria resulted in only “3 or 4” enrolled on stable sotatercept .

Financial Results

Revenue and EPS vs prior periods and estimates

Notes: Consensus values marked with * retrieved from S&P Global.

Income Statement KPIs (document-based)

Balance Sheet KPIs

Segment breakdown: Not applicable; revenue is collaboration and cost reimbursements (no commercial product segments) .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are just weeks away from fully enrolling the PROSERA Phase 3 Study in PAH… baseline characteristics… reinforce our optimism for meaningful results… first‑in‑class therapy” — Faheem Hasnain (CEO) .
• “We achieved alignment on study design and endpoints with FDA and EMA… SERANATA… randomized… dual doses… FVC as key secondary” — Dr. Richard Aranda (CMO) .
• “We ended the quarter with $257.9M… sufficient capital into the first half of 2027” — Bryan Giraudo (CFO/COO) .
• “Patients who are sicker at baseline… tend to have better outcomes, particularly on 6‑minute walk… PROSERA was designed to enroll more of these patients” — Faheem Hasnain .

Q&A Highlights

• Timing trade‑off and quality: Decision to allow the late “bolus” of screened patients to enroll pushed data to Feb 2026, prioritizing database lock and adjudication; last patient out targeted by Q4 2025 .
• Baseline enrichment and powering: Sicker baseline (lower 6MWD, higher NT‑proBNP, more FC III) does not change powering (>90% power; 30m effect, SD 70), with FC stratification to avoid arm imbalance .
• Sotatercept: Very few stable background sotatercept patients met criteria; community views ~20m+ 6MWD improvement as clinically meaningful in context of safety and potential continued improvement beyond week 24 .
• PH‑ILD rationale: Higher dose arm to enhance lung exposure and capture antifibrotic effects; FVC selected as key secondary for differentiation; larger unmet need and EU opportunity noted .
• Commercial positioning: Potential backbone therapy with disease‑modifying profile and favorable tolerability enabling earlier‑line use and combination approaches over time .

Estimates Context

• Q1 2025 revenue beat: Actual $9.89M vs S&P consensus $3.95M*; driven by collaboration revenue ($9.9M including $6.6M cost reimbursements) .
• Q1 2025 EPS beat: Actual $(0.16) vs S&P consensus $(0.18)*; YoY improvement vs $(0.19) in Q1 2024 .
• Future estimate revisions may reflect confidence in execution milestones (screening closure, imminent full enrollment, enriched baseline) and timing push of topline to Feb 2026.
  Notes: Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

• Near‑term execution de‑risks Phase 3: screening closed and full enrollment imminent with enriched baseline, a design feature historically associated with stronger 6MWD signals in PAH .
• Timeline reset reduces event risk: pushing topline to Feb 2026 signals prioritization of comprehensive data quality and adjudication; monitor further baseline disclosures and enrollment completion confirmation .
• PH‑ILD offers a larger market with differentiation: dual‑dose design, antifibrotic potential, and FVC endpoint could unlock a broader opportunity vs Tyvaso, with significant EU unmet need .
• Liquidity is sufficient: $257.9M cash and securities; runway into 1H 2027 supports both pivotal PAH and PH‑ILD programs and commercial build‑out with Chiesi .
• Collaboration revenue supports P&L optics: Q1 beat was largely from cost reimbursements; expect opex to reflect Phase 3 cadence; model cost sharing ramp with Chiesi as SERANATA initiates .
• Trading setup: watch for enrollment completion PR and any additional baseline data; these can serve as catalysts for sentiment into the pivotal window; medium‑term focus is on February 2026 topline .

Appendix: Source Documents

• Q1 2025 8‑K 2.02 and Exhibit 99.1 Press Release .
• Q1 2025 Earnings Call Transcript (May 15, 2025) .
• Q1 2025 Press Release (Business Wire) .
• Prior quarter PRs: Q4/FY 2024 , Q3 2024 .