GH Research Q1 2024 Financial Results and Business Updates

GH Research PLC, a Dublin-based clinical-stage biopharmaceutical company listed on Nasdaq (GHRS), has revealed its first-quarter financial results for 2024 and provided business updates.

Business Developments:

GH001 in Treatment-Resistant Depression (TRD):
GH001, an inhaled form of mebufotenin (5-MeO-DMT), is currently undergoing a Phase 2b clinical trial for patients with treatment-resistant depression (TRD). The trial includes approximately 80 patients across 20 sites in seven European countries. Recruitment is on track, with the double-blind phase expected to conclude by Q3 2024. Top-line results are anticipated for late 2024, and the study's 6-month open-label extension phase is set to finish by Q1 2025. GH001 is administered using a commercially available inhalation device, requiring no additional psychotherapy support before or after dosing.

GH001 in Postpartum Depression (PPD) and Bipolar II Disorder (BDII):
GH001 is also in Phase 2a trials for postpartum depression (PPD) and bipolar II disorder (BDII). The PPD trial is progressing as planned, with completion expected by Q3 2024. Conversely, recruitment for the BDII trial is slower than expected, prompting the initiation of six additional sites across three European countries. Further assessment is needed to update the recruitment timeline.

GH002:
GH002, designed for intravenous administration, has recently completed a Phase 1 clinical pharmacology trial in healthy volunteers (GH002-HV-105). The trial showed that GH002 was well-tolerated and produced rapid, short-duration psychoactive effects. Ongoing analyses of pharmacokinetic (PK) and pharmacodynamic (PD) relationships will guide further clinical development.

Investigational New Drug (IND) Application for GH001:
GH Research's IND for GH001, delivered via a proprietary aerosol device, is currently on clinical hold by the FDA. The FDA has requested additional inhalation toxicology studies in non-rodent species and rats, additional device design verification information, and updates to the investigator brochure. GH Research has initiated these studies and is preparing the requested information. A meeting with the FDA to discuss these requirements is scheduled, with written responses expected soon. Meanwhile, a clinical trial application for a Phase 1 trial (GH001-HV-106) in Europe, utilizing the proprietary aerosol device, has been submitted.

Financial Highlights for Q1 2024:

Cash Position:
As of March 31, 2024, GH Research held $214.0 million in cash, cash equivalents, other financial assets, and marketable securities, down from $222.7 million at the end of 2023. This financial reserve is expected to support the company’s operations into 2026.

Research and Development (R&D) Expenses:
R&D expenses rose to $8.7 million in Q1 2024, up from $7.3 million in Q1 2023. The increase was mainly due to higher costs associated with nonclinical activities, technical development, and clinical trials, partially offset by decreased expenses in device development.

General and Administrative (G&A) Expenses:
G&A expenses saw a slight reduction to $2.9 million in Q1 2024, compared to $3.1 million in Q1 2023. This decrease resulted from reduced professional fees and insurance costs, partly balanced by higher employee expenses.

Net Loss:
The company reported a net loss of $7.7 million, or $0.15 per share, for the quarter ended March 31, 2024, compared to a net loss of $10.9 million, or $0.21 per share, for the same period in the previous year.

Company Overview:
GH Research PLC focuses on developing novel mebufotenin (5-MeO-DMT) therapies for psychiatric and neurological disorders, particularly treatment-resistant depression. Their lead product, GH001, has shown promising results, with a high percentage of patients achieving rapid remission in earlier trials. The company is also advancing GH002 and GH003, targeting intravenous and intranasal delivery methods, respectively.

Financial Statements:
The report includes condensed consolidated interim financial statements, highlighting key financial metrics such as assets, liabilities, equity, and comprehensive income for Q1 2024 and 2023. These statements reflect the company’s current financial health and operational expenditures.

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