GH Research Reports Third Quarter 2026 Financial Results and Provides Business Update
Key Highlights
- ➤GH001 ADS trial supports one fixed dose per treatment visit, down from up to three
- ➤FDA gave positive initial feedback; TRD pivotal program targeted shortly after Q1 2027 meeting
- ➤GH001 postpartum depression pivotal program targeted for the second half of 2027
- ➤Cash, cash equivalents and marketable securities reached $350.6 million at September 30, 2026
- ➤Third-quarter net loss narrowed to $12.5 million, or $0.18 per share
Expert Statements
Kristina M. Deligiannidis, MD, Feinstein Institutes for Medical Research at Northwell Health
“Women with postpartum depression need treatments that work quickly and ask little of them at a time when they are caring for a newborn. In the Phase 2a trial, every patient was in remission within hours of a single treatment day. A single dose given in a visit of about an hour would fit the lives of new mothers, and I am glad to see GH001 move toward a pivotal program in postpartum depression”
* Novel GH001 Aerosol Delivery System (ADS) device: final results of the GH001-HV-106 trial support going from 3 → 1 doses per treatment visit * TRD pivotal program — positive initial feedback from FDA, End-of-Phase 2 meeting expected in Q1 2027, initiation shortly after * PPD pivotal program — initiation targeted for H2 2027 * Vanina Popova, MD, appointed Chief Development Officer — Formerly Clinical Development at J&J, lead author of pivotal Spravato® trial publication * Cash, cash equivalents and marketable securities of $350.6 million as of September 30, 2026 DUBLIN, Nov. 13, 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 September 30, 2026, and provided a business update.
The final results of our Phase 1 trial GH001-HV-106 in healthy volunteers support one fixed dose of GH001 per treatment visit with our novel GH001 Aerosol Delivery System (ADS). Our Phase 2b trial, which used a third-party vaporizer, titrated patients to a peak experience with an individualized dosing regimen (IDR) of up to three doses per treatment visit: 23% of patients had reached a peak experience after the 6 mg dose, 62% after the 6 mg and 12 mg doses and 86% after the 6 mg, 12 mg and 18 mg doses (19, 50 and 70 of 81 patients). The ADS delivers a consistent dose through reduced variability (82% to 89% of the loaded dose in bench testing, compared with 55% to 79%). In GH001-HV-106, peak experience rates across increasing single doses showed a consistent dose response, up to 88% of participants (7 of 8) at a dose we plan to take into the pivotal program. We expect the single fixed dose allows for a ~1-hour fixed treatment visit in clinical practice.
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