GH Research (GHRS) Q3 2025 earnings summary

Executive summary

• Full Phase 2b clinical trial dataset for GH001 in treatment-resistant depression (TRD) reported, meeting primary endpoint with significant MADRS reduction at Day 8 (p<0.0001).

• Long-term safety and efficacy data from open-label extension showed 73% remission at 6 months, with no serious adverse events or suicidal behavior.

• Engagement with FDA on GH001 IND clinical hold ongoing, with only one hold topic remaining.

• Global pivotal program for GH001 expected to initiate in 2026.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $293.9 million as of September 30, 2025, up from $182.6 million at December 31, 2024.

• Research and development expenses were $10.6 million for Q3 2025, up from $8.4 million in Q3 2024, mainly due to increased technical development and employee expenses.

• General and administrative expenses were $6.0 million for Q3 2025, up from $4.2 million in Q3 2024, primarily due to higher professional fees and employee expenses.

• Net loss for Q3 2025 was $14.0 million ($0.23 per share), compared to $12.1 million ($0.23 per share) in Q3 2024.

• Total comprehensive loss for Q3 2025 was $14.1 million.

Outlook and guidance

• Ongoing engagement with FDA to resolve the remaining clinical hold topic for GH001 IND.

• Global pivotal program for GH001 in TRD planned to start in 2026.