Core Insights - GH Research PLC reported financial results for Q1 2025, highlighting significant advancements in its clinical trials for GH001, a treatment for treatment-resistant depression (TRD) [1][9]. Business Updates - The Phase 2b trial of GH001 in 81 patients with TRD has completed, achieving its primary endpoint with a significant placebo-adjusted reduction of -15.5 on the Montgomery-Åsberg Depression Rating Scale (MADRS) by Day 8 [2][3]. - A 57.5% remission rate was observed in patients treated with GH001 on Day 8, compared to 0% in the placebo group [3]. - Safety analysis for the open-label extension (OLE) has not been completed, but as of January 22, 2025, no serious adverse events (SAEs) were reported [4]. - In the OLE, 77.8% of completers were in remission at the 6-month visit, with a 91.7% remission rate for those who achieved remission on Day 8 [4]. - The company is preparing to submit a full response to the FDA regarding the clinical hold on the Investigational New Drug Application (IND) for GH001, with submission expected in mid-2025 [6][7]. Financial Highlights - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $315.3 million, up from $182.6 million as of December 31, 2024 [10]. - Gross proceeds from a public offering in Q1 2025 amounted to $150 million [10]. - Research and development expenses for Q1 2025 were $7.9 million, a decrease from $8.7 million in the same quarter of 2024 [11]. - General and administrative expenses increased to $4.9 million in Q1 2025 from $2.9 million in Q1 2024 [12]. - The net loss for Q1 2025 was $10.8 million, or $0.19 loss per share, compared to a net loss of $7.7 million, or $0.15 loss per share, in Q1 2024 [12]. Clinical Development - GH001 is being developed for various indications, including bipolar II disorder and postpartum depression, with ongoing proof-of-concept trials [5]. - The Phase 1 clinical pharmacology trial for GH001 using a proprietary aerosol delivery device is ongoing in the UK [8].