GH Research (GHRS) Q1 2025 earnings summary

Executive summary

• Phase 2b trial of GH001 in treatment-resistant depression (TRD) met primary endpoint with a -15.5 point placebo-adjusted MADRS reduction and 57.5% remission rate at Day 8; no serious adverse events reported.

• IND hold for GH001 aerosol device addressed; full response to FDA on track for mid-2025 submission.

• Cash and equivalents totaled $315.3 million as of March 31, 2025, up from $182.6 million at year-end 2024, bolstered by $150 million public offering.

Financial highlights

• Net loss was $10.8 million ($0.19 per share) for Q1 2025, compared to $7.7 million ($0.15 per share) in Q1 2024.

• R&D expenses decreased to $7.9 million from $8.7 million year-over-year, mainly due to lower clinical and technical development costs and a tax credit.

• G&A expenses rose to $4.9 million from $2.9 million year-over-year, driven by higher professional fees and employee costs.

• Finance income was $2.8 million, with total comprehensive loss for the period at $10.2 million.

Outlook and guidance

• Further clinical trial results for GH001 in TRD, bipolar II disorder, and postpartum depression expected at upcoming scientific conferences.

• Full IND response for GH001 aerosol device planned for mid-2025 submission to FDA.