DUBLIN, Ireland, May 18, 2022 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the first quarter ended March 31, 2022 and gave updates on its business.
First Quarter 2022 Financial Highlights
Cash position
Cash was $270.8 million as of March 31, 2022, compared to $276.8 million as of December 31, 2021. We believe that our existing cash will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2025.
Research and development expenses
R&D expenses were $4.7 million for the quarter ended March 31, 2022, compared to $692 thousand for the same quarter in 2021. The increase was primarily due to increased activities relating to our technical development and clinical trials and increases in employee expenses to support these activities.
General and administrative expenses
G&A expenses were $3.3 million for the quarter ended March 31, 2022, compared to $448 thousand for the same quarter in 2021. The increase was primarily due to higher legal, professional and compliance fees, as well as increased employee expenses.
Net loss
Net loss was $5.8 million, or $0.111 loss per share, for the quarter ended March 31, 2022, compared to $1.1 million, or $0.038 loss per share, for the same quarter in 2021.
Business Updates
GH001 for the treatment of TRD
GH001 is our proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate.
We recently announced our plan to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201) in the third quarter of 2022. Preparation of those submissions is ongoing.
On May 11, 2022, we held a pre-IND meeting with the U.S. Food and Drug Administration (FDA), the planning of which had been previously announced. In preparation for this meeting, we had provided the FDA with a detailed description of the development status and plans for GH001 including clinical, non-clinical, and chemistry, manufacturing and controls activities. The outcome of the meeting was positive and positions us for an anticipated IND submission not later than the first quarter of 2023. The planned IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).
The data from our previously reported Phase 1/2 clinical trial of GH001 in patients with TRD (GH001-TRD-102) has been recently accepted for oral presentation at the American Society of Clinical Psychopharmacology 2022 Annual Meeting in Scottsdale, AZ, and will be presented during the Pharmaceutical Pipelines session on May 31, 2022. The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Asberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p