GH Research PLC GHRS, the clinical-stage biopharma company dedicated to transforming the treatment of psychiatric and neurological disorders through 5-MeO-DMT production, provided a financial and business update for the quarter ended June 30, 2022.
The financial results for the period:
Total cash position of $265.4 million, compared to $276.8 million as of December 31, 2021.
R&D expenses totaled $4.2 million for the period, compared to $2 million for the same quarter in 2021.
Net profit of a total of $0.3 million (or $0.006 earnings per share) for the period, compared to a net loss of $2.1 million (or $0.053 loss per share) for the same quarter in 2021, due to the foreign exchange gain in the quarter.
Regarding management and pipeline news, the company is advancing its lead program on proprietary inhalable 5-MeO-DMT candidate, GH001, for the treatment of Treatment-Resistant Depression (TDR).
GH is set to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 for TRD in the third quarter of 2022, aiming to determine the efficacy of a single-day individualized-dosing regimen (IDR) in improving depressive symptoms as measured by the 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 80 patients can receive treatment with the GH001 IDR as needed, based on the patient’s clinical response.
On US soil, GH Research had a positive pre-IND meeting with the U.S. FDA and expects to submit an IND application for GH001 in TRD by the first quarter of 2023.
Interestingly, GH001 is also set to be tested in Phase 2a clinical trials for the treatment of patients with bipolar II disorder and a current depressive episode (BDII), as well as for the treatment of patients with postpartum depression (PPD). Both studies have received regulatory approvals and site startup activities have begun.
The company is also developing two other compounds: GH002 and GH003.
GH002 is a 5-MeO-DMT candidate dosed via a proprietary injectable approach, which has already completed pre-clinical development and for which GH Research is set to submit a clinical trial application in the fourth quarter of 2022, and GH003 is a currently preclinical 5-MeO-DMT candidate administrable through a proprietary intranasal approach.
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