GH Research PLC(GHRS) - 2024 Q4 - Annual Report

GH Research Full Year 2024 Financial Results and Business Updates Business Updates The company reports positive clinical trial results for GH001 across multiple depression indications and is addressing an FDA clinical hold GH001 in Patients with Treatment-Resistant Depression (TRD) - The Phase 2b trial for TRD met its primary endpoint, showing a significant placebo-adjusted reduction of -15.5 on the MADRS on Day 8[3][4] - A high remission rate of 57.5% was observed in patients treated with GH001 by Day 8, compared to 0% in the placebo group[4] - In the ongoing open-label extension, 77.8% of completers were in remission at the 6-month visit, with completion expected in Q1 2025[5][6][7] - GH001 was well tolerated during the double-blind part of the trial, with no serious adverse events reported[4] GH001 Administered with Proprietary Aerosol Delivery Device - A Phase 1 trial is ongoing to evaluate a proprietary aerosol delivery device for GH001 administration in healthy volunteers[7][8] - This trial aims to bridge clinical data from the previous device to support the global program for GH001[8] Update on IND for GH001 - The IND for GH001 remains on clinical hold by the FDA pending additional toxicology and device information[9] - The company has completed the requested additional inhalation toxicology studies, with findings supporting the company's position[10][11] - A full response to the IND hold is on track for submission to the FDA in mid-2025[7][12] Proof-of-Concept (POC) Trials with GH001 - The Phase 2a POC trial in postpartum depression (PPD) met its primary endpoint, with 100% of patients achieving remission on Day 8[13][14] - The Phase 2a POC trial in bipolar II disorder (BDII) also met its primary endpoint, with 33.3% of patients achieving remission on Day 8[15] - In both POC trials, GH001 was well tolerated with no treatment-related serious adverse events reported[14][15] Full Year 2024 Financial Highlights The company's cash position decreased while expenses and net loss increased, though a subsequent public offering bolstered cash reserves Financial Highlights | Financial Metric | Dec 31, 2024 | Dec 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Cash, cash equivalents, other financial assets and marketable securities | $182.6 million | $222.7 million | -$40.1 million | | Research & Development Expenses | $35.0 million | $29.8 million | +$5.2 million | | General & Administrative Expenses | $15.3 million | $11.4 million | +$3.9 million | | Net Loss | $39.0 million | $35.6 million | +$3.4 million | | Loss Per Share | $0.75 | $0.68 | +$0.07 | - The increase in R&D expenses was primarily due to clinical development activities, while the rise in G&A expenses was driven by higher professional fees and increased headcount[18][19] - The company received an additional $139.8 million in net cash proceeds from a public offering in February 2025[7] About the Company and Products GH Research is a clinical-stage biopharmaceutical company developing mebufotenin-based therapies for psychiatric and neurological disorders - GH Research is a clinical-stage biopharmaceutical company focused on novel mebufotenin therapies, initially for Treatment-Resistant Depression (TRD)[21] - The lead product, GH001, is a proprietary inhalable mebufotenin with positive Phase 2b results for TRD treatment[22] - GH002, a secondary candidate formulated for intravenous mebufotenin administration, has completed a Phase 1 trial[23] Consolidated Financial Statements The company's financial statements show a widened net loss of $39.0 million for 2024 and total assets of $188.3 million Consolidated Statement of Comprehensive Loss Statement of Comprehensive Loss | (in thousands, except per share amounts) | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Operating Expenses | | | | Research and development | (35,016) | (29,821) | | General and administration | (15,296) | (11,401) | | Loss from operations | (50,312) | (41,222) | | Finance income | 9,873 | 8,978 | | Foreign exchange gain/(loss) | 2,129 | (2,621) | | Loss for the year | (38,961) | (35,587) | | Total comprehensive loss for the year | (41,188) | (33,154) | | Basic and diluted loss per share (in USD) | (0.75) | (0.68) | Consolidated Balance Sheet Balance Sheet | (in thousands) | At Dec 31, 2024 | At Dec 31, 2023 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | 100,791 | 78,420 | | Other financial assets & Marketable securities | 81,833 | 144,282 | | Total current assets | 154,225 | 164,089 | | Total assets | 188,273 | 226,300 | | LIABILITIES AND EQUITY | | | | Total current liabilities | 8,953 | 6,701 | | Total liabilities | 9,322 | 7,332 | | Total equity | 178,951 | 218,968 | | Total liabilities and equity | 188,273 | 226,300 |