DMT drug company GH Research PLC (Nasdaq: GHRS) reported financial results for the full year ending December 31, 2022, and gave updates on its business with no revenue at this time. The company delivered a net loss of $22.5 million, or $0.432 loss per share versus $9.2 million, or $0.211 loss per share, for the full year 2021.
R&D expenses were $20.5 million for the year versus $8.6 million in 2021. GH Research attributed the jump to increased activities relating to our technical development, clinical trials and increased employee expenses to support these activities. G&A expenses were $10.1 million for 2022 versus $6.5 million for 2021. The company said the increase was primarily due to higher insurance costs, an increase in professional costs as well as increased employee expenses.
GH Research said that it recently initiated our multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). In a statement the company said, “GH001 is our proprietary inhalable mebufotenin (5-MeO-DMT) product candidate. We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective will be 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. The double-blind phase will be followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status.”
January was also a big month for the company. It reported development progress in respect of its proprietary aerosol delivery device and the expectation that it will submit an IND for GH001, delivered with this proprietary device, in the third quarter of 2023. “The IND-opening study is expected to be a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-106), designed to support bridging to the clinical data generated with the third-party device we currently use in our clinical trials.”
In addition to the spray, the company initiated a randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002 in healthy volunteers (GH002-HV-105). GH002 is its mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. The company said it expects to complete this trial in the fourth quarter of 2023.
GH Research is flush with cash sitting on a cushion of cash equivalents and marketable securities of $251.7 million at the end of 2022. Marketable securities are comprised of investment grade bonds. “We believe that our existing cash, cash equivalents and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026.”