GH Research PLC (Nasdaq: GHRS) reported financial results for the second quarter ended June 30, 2022 and gave updates on its business. The company has no revenue at this time and is focused on developing its DMT drugs for mental health issues. The company also said it does not expect to have revenue for several years. GH Research has $265.4 million in cash as of June 30, 2022, compared to $276.8 million as of December 31, 2021. The company said it believes that has enough capital to fund its operating expenses and capital expenditure requirements into 2025.
GH Research reported a net profit of $0.3 million, or $0.006 earnings per share, for the quarter versus a net loss of $2.1 million, or $0.053 loss per share, for the same quarter in 2021. This was due to the foreign exchange gain in the quarter.
In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA) and said it expects to submit the IND for GH001 in TRD no later than the first quarter of 2023. GH001 is the proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate. 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).
R&D expenses were $4.2 million for the quarter versus $2.0 million for the same quarter in 2021. The increase was primarily due to increased activities relating to the company’s technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $2.5 million for the quarter versus $0.7 million for the same quarter in 2021. The increase was primarily due to an increase in insurance costs, as well as increased employee expenses.
In March 2022, GH Research announced its 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). “We plan to submit such applications beginning in the third quarter of 2022. When such applications are approved, we expect to recruit approximately 80 patients for this trial. The primary objective will be to determine the efficacy of a 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.”
In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA), and expects to submit the IND for GH001 in TRD 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).
“Our recently announced Phase 2a proof-of-concept clinical trials of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (BDII) (GH001-BD-202) and for the treatment of patients with postpartum depression (PPD) (GH001-PPD-203) have now received regulatory approvals and site startup activities have commenced. The trials have an open-label, single-arm design with 7 days duration and they are expected to recruit approximately 15 patients each. The primary objective of the trials will be to determine the efficacy of a single day IDR of GH001 in improving depressive symptoms as assessed by mean change in MADRS from baseline to day 7.”
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