GH Research Reports Full Year 2025 Financial Results and Provides Business Update

Core Viewpoint - GH Research PLC has reported significant progress in its clinical development of GH001 for treatment-resistant depression (TRD), with promising Phase 2b trial results and a strong financial position as of the end of 2025 [1][2][5]. Business Update - The company completed its Phase 2b trial of GH001 in TRD and presented the full dataset at major conferences in 2025 [2]. - GH Research is seeking FDA alignment for its global Phase 3 pivotal program, which aims to replicate the Phase 2b study [2]. Clinical Trial Results - The Phase 2b trial achieved its primary endpoint with a placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS) reduction of -15.5 points at Day 8 (p<0.0001) [3]. - 57.5% of patients on GH001 achieved remission (MADRS ≤10) at Day 8 compared to 0% on placebo [3]. - The open-label extension showed a 73% remission rate at six months with infrequent retreatment visits and no mandated psychotherapy [3]. - Safety results were favorable, with no treatment-related serious adverse events reported [3]. Financial Highlights - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $280.7 million, up from $182.6 million in 2024 [5]. - Research and development expenses increased to $38.8 million in 2025 from $35.0 million in 2024, primarily due to technical development and employee expenses [6]. - General and administrative expenses rose to $22.0 million in 2025 from $15.3 million in 2024, driven by increased professional fees and employee expenses [7]. - The net loss for 2025 was $48.3 million, or $0.79 per share, compared to a net loss of $39.0 million, or $0.75 per share, in 2024 [8]. Product Development - GH001 is formulated for mebufotenin administration via a proprietary inhalation approach, with the potential to change TRD treatment [10]. - The company is also developing GH002, a mebufotenin product candidate for intravenous administration, having completed a Phase 1 trial in healthy volunteers [11].