Core Insights - GH Research PLC is focused on developing innovative treatments for depression, particularly treatment-resistant depression (TRD) [15][16] - The company reported significant progress in its clinical trials, particularly with its lead product candidate GH001, which demonstrated a substantial reduction in depression scores [4][16] Business Updates - The FDA has communicated regarding the clinical hold on the Investigational New Drug Application (IND) for GH001, with only one topic remaining to be addressed [2] - A Phase 1 clinical trial for GH001 using a proprietary aerosol delivery device is ongoing in the UK, aimed at supporting the global program for GH001 [3] - The Phase 2b trial for GH001 in TRD met its primary endpoint with a significant placebo-adjusted reduction of -15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) [4][16] - An open-label extension analysis confirmed a 73% remission rate at 6 months with no serious adverse events reported [5][6][8] Financial Highlights - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $308.7 million, an increase from $182.6 million at the end of 2024 [11] - Research and development expenses for Q2 2025 were $9.0 million, a decrease from $9.8 million in the same quarter of 2024 [12] - General and administrative expenses rose to $5.7 million in Q2 2025 from $3.5 million in Q2 2024, primarily due to increased professional fees and employee expenses [13] - The net loss for Q2 2025 was $9.3 million, or $0.15 loss per share, compared to a net loss of $10.4 million, or $0.20 loss per share, in Q2 2024 [14] Future Plans - The company is on track to initiate its global pivotal program for GH001 in 2026 [10][8] - Plans for submitting an IND for GH002, another product candidate, are expected in Q4 2025 following a successful Phase 1 trial [9]

DUBLIN, July 23, 2025 (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 provided updates on its business and key upcoming milestones. GH001 Update We have recently announced that we submitted a complete response to the previously announced clinical hold on our Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administrati ...

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].

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]