Debra Borchardt
Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the first quarter that ended March 31, 2023. The company has no revenue at this time but did state that it has cash, and cash equivalents of $246.1 million down from $251.7 million at the end of 2022. The company said, “We believe that our existing cash, cash equivalents, other financial assets, and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026.”
Expenses
R&D expenses were $7.3 million for the quarter versus $4.7 million for the same quarter in 2022. 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. G&A expenses were $3.1 million for the quarter versus $3.3 million for the same quarter in 2022. The decrease was primarily due to lower insurance costs offset by an increase in professional costs, as well as increased employee expenses.
Drug Pipeline
The company noted that its inhalable mebufotenin (5-MeO-DMT) product candidate GH001 is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). “We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective is to determine the efficacy of our single-day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase,” said the company’s statement.
The company said that its randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002, the mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach, in healthy volunteers (GH002-HV-105) is expected to be completed in the fourth quarter of 2023.
GH Research went on to say, “We have recently filed 19 new international patent applications, which claim priority to earlier filings, further expanding our patent portfolio, which relates to various aspects of mebufotenin (5-MeO-DMT) use in a therapeutic context, including but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes.”
