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GH Research Q1 2025 Earnings Report
GH Research reported its first quarter 2025 financial results, highlighting a significant reduction in MADRS for GH001 in TRD, progress on IND hold submission, and a strong cash position.
Key Takeaways
GH Research PLC reported a net loss of $10.8 million for Q1 2025, or $0.19 per share. The company met its primary endpoint in the Phase 2b trial for GH001 in TRD, showing a -15.5 point placebo-adjusted MADRS reduction. The company also reported a strong cash position of $315.3 million as of March 31, 2025, following a public offering that generated $150.0 million.
GH001 Phase 2b trial in TRD met its primary endpoint with a -15.5 point placebo-adjusted MADRS reduction on Day 8.
57.5% remission rate on Day 8 for GH001 in TRD trial compared to 0% in the placebo group.
Full response to the IND hold for GH001 is on track for submission in mid-2025.
Cash, cash equivalents, other financial assets, and marketable securities totaled $315.3 million as of March 31, 2025.
Forward Guidance
GH Research is focused on advancing its clinical programs for GH001, with key milestones including the submission of the full response to the IND hold and continued data analysis from ongoing trials.
Positive Outlook
- Full response to the IND hold for GH001 is on track for submission in mid-2025.
- Further clinical trial results from the GH001-TRD-201 trial (double-blind and open-label extension) are expected at upcoming scientific conferences.
- Further clinical trial results from GH001 proof-of-concept trials (BDII and PPD) are expected at upcoming scientific conferences.
- Phase 1 clinical pharmacology trial for GH001 with proprietary aerosol delivery device is ongoing in the United Kingdom.
- Strong cash position provides financial flexibility for ongoing operations and development.
Challenges Ahead
- Safety analysis for the OLE of GH001-TRD-201 is not yet completed.
- The IND for GH001 administered using the proprietary aerosol delivery device is currently on clinical hold by the FDA.
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