- Phase 2b results in TRD published in JAMA Psychiatry
- GH001-HV-106 study enrolment completed; doses selected for the global Phase 3 pivotal program of GH001 in TRD
- GH001-HV-109 US IND-opening study enrolment completed
- Cash, cash equivalents and marketable securities of $267.3 million as of March 31, 2026
- Net cash proceeds of an additional $111.2 million from underwritten offering received in April 2026
DUBLIN, May 14, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the quarter ended March 31, 2026, and provided a business update.
Business Updates
Scientific Presentations and Publications
In March 2026, the results of our Phase 2b trial in TRD (GH001-TRD-201) were published in JAMA Psychiatry. A post-hoc analysis reported alongside the publication demonstrated efficacy independent of the number of prior antidepressant treatment failures, with Day 8 remission rates of 53.9%-63.6% across subgroups.
In January 2026, data from our clinical trials in TRD and bipolar II depression were presented in three posters at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP).
An additional three posters have been accepted to the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2026 in Miami (May 26–29), featuring data from our Phase 2b trial in TRD (GH001-TRD-201), including the post-hoc analysis of efficacy by prior antidepressant failure, secondary endpoints covering anxiety and quality of life, and impact on anhedonia.
Proprietary Aerosol Delivery Device Study and Dose Selection
We have completed enrolment in our Phase 1 clinical pharmacology trial in the UK, evaluating our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106). We have selected the doses for our global Phase 3 pivotal program based on the results from this trial.
IND-Opening Study for GH001 in the United States
We have completed enrolment in our IND-opening Phase 1 trial of GH001 in healthy volunteers (GH001-HV-109) in the United States.
Global Pivotal Program Plans
We are seeking FDA alignment on the global Phase 3 pivotal program, which is intended to replicate the Phase 2b design. We continue to target initiation of our global pivotal program in late 2026.
“The first quarter of 2026 marks progress as planned toward our global GH001 Phase 3 pivotal program,” said Dr. Velichka Valcheva, Chief Executive Officer.
First Quarter 2026 Financial Highlights
Cash position
Cash, cash equivalents and marketable securities were $267.3 million as of March 31, 2026, compared to $280.7 million as of December 31, 2025.
Research and development expenses
R&D expenses were $12.4 million for the quarter ended March 31, 2026, compared to $7.9 million for the same quarter in 2025. The increase is primarily due to increased expenses relating to our technical development and clinical development expenses, as well as employee expenses; partly offset by a decrease in nonclinical expenses.
General and administrative expenses
G&A expenses were $6.4 million for the quarter ended March 31, 2026, compared to $4.9 million for the same quarter in 2025. The increase is primarily due to an increase in professional fees.
Net loss
Net loss was $19.0 million, or $0.31 loss per share, for the quarter ended March 31, 2026, compared to $10.8 million, or $0.19 loss per share, for the same quarter in 2025.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a Montgomery-Åsberg Depression Rating Scale (MADRS) reduction from baseline of -15.5 points compared with placebo on Day 8 (p