Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 172

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 172
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 8 after administration of GH001, compared with +0.3 points in the placebo group (difference of -15.5 points, p<0.0001). 99 Table of Contents All secondary endpoints in the trial were met, with results consistent with the primary endpoint .The majority of the patients treated with GH001 achieved remission (MADRS≤10) and were responders (MADRS reduction ≥50%) at 2 hours, Day 2 and Day 8. Remission and response rates with GH001 were significantly greater than placebo at all timepoints(p<0.0001). Treatment with GH001 led to clinically and statistically significant improvements on the Clinical Global Impression Severity, or CGI-S, and Hamilton Anxiety Rating, or HAM-A, scales, and the Quality of Life Enjoyment and Satisfaction Questionnaire, or Q-LES-Q-SF Questionnaire, on Day 8, compared with placebo. 100 Table of Contents 101 Table of Contents As of January 22, 2025, 9 patients are ongoing in the trial, while 54 patients have completed the full 6-month follow-up of the OLE and 18 patients discontinued, with one patient’s discontinuation due to an adverse event. Of the 54 patients who completed the OLE as of January 22, 2025:

| • | 77.8% of patients were in remission (MADRS≤10) at the 6 month visit and 81.5% were responders(MADRS reduction ≥50%); |

| • | Mean MADRS total score at 6 months was 8.6; |

| • | 63.0% (n=34) received 1-4 treatments with GH001; |

102 Table of Contents 103 Table of Contents Safety analysis has not yet been completed for the OLE as it remains ongoing, but as of January 22, 2025, no serious adverse events have been reported throughout the OLE. Our Phase 2b clinical trial of GH001 in patients with TRD is subject to certain risks and uncertainties, as is the case with our other clinical trials. See “Item 3. Key Information – D. Risk Factors”. Phase 1: Clinical Trial with GH001 aerosol delivery device in healthy subjects (GH001-HV-106, NCT06511947) We are also currently recruiting an open-label Phase 1 trial to determine the pharmacokinetic, pharmacodynamics, and safety