Core Insights - GH Research PLC reported financial results for the year ended December 31, 2024, and provided updates on its clinical programs and financial position [1] Business Updates - GH001, an inhalable mebufotenin product candidate, is in a Phase 2b trial for treatment-resistant depression (TRD) involving approximately 80 patients [2] - The trial met its primary endpoint with a significant placebo-adjusted reduction of -15.5 in the Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 8 (p<0.0001) [3] - A 57.5% remission rate was observed in patients treated with GH001 on Day 8 compared to 0% in the placebo group (p<0.0001) [3] - Safety analysis for the ongoing open-label extension (OLE) has not been completed, but as of January 22, 2025, 77.8% of OLE completers were in remission at the 6-month visit [4] - The Phase 1 trial for the proprietary aerosol delivery device is ongoing in the UK [5] Regulatory Updates - The Investigational New Drug Application (IND) for GH001 was placed on clinical hold by the FDA, which requested additional inhalation toxicology studies and device design verification [6] - The company has completed the requested inhalation toxicology studies, showing no adverse findings in the respiratory tract of dogs [7][9] - A full response to the IND hold is on track for submission in mid-2025 [10] Clinical Trials - Two Phase 2a proof-of-concept trials for GH001 in postpartum depression (PPD) and bipolar II disorder (BDII) have been completed [11] - The PPD trial met its primary endpoint with a MADRS reduction of -35.4 points (96.3%) on Day 8, with 100% of patients in remission [12] - The BDII trial also met its primary endpoint with a MADRS reduction of -16.8 points (51.9%) on Day 8, with 33.3% of patients in remission [13] Financial Highlights - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $182.6 million, down from $222.7 million in 2023 [14] - Research and development expenses increased to $35.0 million in 2024 from $29.8 million in 2023, primarily due to clinical development activities [15] - General and administrative expenses rose to $15.3 million in 2024 from $11.4 million in 2023, driven by higher professional fees and increased headcount [16] - The net loss for 2024 was $39.0 million, or $0.75 loss per share, compared to a net loss of $35.6 million, or $0.68 loss per share, in 2023 [17]