GH Research (GHRS) Q4 2025 earnings summary

Executive summary

• Completed Phase 2b trial of GH001 in treatment-resistant depression (TRD), meeting primary endpoint and showing strong efficacy and safety results.

• Presented full Phase 2b dataset at major scientific congresses and received FDA clearance for U.S. clinical investigation of GH001.

• Actively seeking FDA alignment for a global Phase 3 pivotal program, with initiation targeted for 2026.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $280.7 million as of December 31, 2025, up from $182.6 million at year-end 2024.

• Research and development expenses were $38.8 million for 2025, compared to $35.0 million in 2024.

• General and administrative expenses rose to $22.0 million in 2025 from $15.3 million in 2024.

• Net loss for 2025 was $48.3 million ($0.79 per share), compared to $39.0 million ($0.75 per share) in 2024.

Outlook and guidance

• Plans to initiate a global Phase 3 pivotal program for GH001 in 2026, pending FDA alignment.

• Intends to use a proprietary aerosol delivery device in pivotal trials.

• Forward-looking statements highlight risks related to clinical trial timelines, regulatory alignment, and future financial performance.