GH Research PLC, a clinical-stage biopharmaceutical company, has reported its financial results for the first quarter of 2024 and provided updates on its business operations. The company is making significant progress in its clinical trials, particularly with GH001, its proprietary inhaled mebufotenin (5-MeO-DMT) product candidate, aimed at treating psychiatric and neurological disorders.
Clinical Trials Progress:
- GH001 in Treatment-Resistant Depression (TRD): The Phase 2b clinical trial is on track, with the double-blind phase expected to complete in Q3 2024 and the 6-month open-label extension phase in Q1 2025. The trial involves approximately 80 patients across 20 sites in seven European countries.
- GH001 in Postpartum Depression (PPD): The Phase 2a clinical trial is also progressing, with completion expected in Q3 2024. However, recruitment for the bipolar II disorder (BDII) trial is slower than anticipated, prompting additional measures to support recruitment.
Financial Highlights:
- The company reported a cash position of $214.0 million as of March 31, 2024, expected to fund operations into 2026.
- Research and development expenses increased to $8.7 million for the quarter, up from $7.3 million in the same period last year, primarily due to increased nonclinical and clinical trial activities.
- General and administrative expenses slightly decreased to $2.9 million from $3.1 million in the previous year.
- Net loss for the quarter was $7.7 million, or $0.15 per share, compared to a net loss of $10.9 million, or $0.21 per share, in the first quarter of 2023.
Regulatory Updates:
- The U.S. FDA has placed a clinical hold on the Investigational New Drug Application (IND) for GH001, requesting additional studies and information. GH Research is actively working to address these requests and has initiated the necessary nonclinical studies.
GH Research PLC continues to focus on developing innovative treatments for psychiatric and neurological disorders, with GH001 leading its pipeline. The company remains committed to advancing its clinical trials and addressing the regulatory requirements to bring its therapies to patients in need.
