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Dec 31, 2025
GH Research Q4 2025 Earnings Report
Key Takeaways
GH Research, a clinical-stage biopharmaceutical company, reported a net loss of $48.3 million for the full year 2025. The company successfully completed its Phase 2b trial for GH001 in treatment-resistant depression, meeting its primary endpoint with significant MADRS reduction. The company maintains a strong cash position of $280.7 million to fund its upcoming Phase 3 pivotal program.
Phase 2b trial of GH001 met primary endpoint with a placebo-adjusted MADRS reduction of -15.5 points at Day 8 (p<0.0001).
GH001 achieved a 57.5% remission rate at Day 8 in the double-blind portion and 73% at six months in open-label extension.
FDA cleared GH001 for U.S. clinical investigation, enabling U.S. subject enrollment for the upcoming Phase 3 program.
Cash and marketable securities increased to $280.7 million following a successful capital raise during the year.
Forward Guidance
GH Research is focused on transitioning to a global Phase 3 pivotal program for GH001 and advancing its proprietary aerosol delivery device.
Positive Outlook
- Targeting initiation of global Phase 3 program in 2026.
- Actively seeking FDA alignment on Phase 3 pivotal program design.
- Proprietary aerosol delivery device Phase 1 trial ongoing to support bridging to pivotal trials.
- Strong cash runway with $280.7 million in liquid assets.
- GH001 cleared by FDA for U.S. clinical investigation.
Challenges Ahead
- Risk of delays in obtaining FDA alignment on pivotal program design.
- Potential for future clinical holds by the FDA on GH001 or GH002.
- Increasing R&D and G&A expenses as programs advance.
- Uncertainty regarding the timeline for submitting an IND for GH002.
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