GH Research: Q1 2023 Financials And Businesses For European 5-MeO-DMT Depression Treatment Developer

GH Research PLC GHRS, a Dublin-based clinical-stage biotech company reported financial results for the first quarter ended March 31, 2023. The company is developing a proprietary 5-MeO-DMT formulation primarily targeting Treatment-Resistant Depression (TRD).

Numbers show:

• Total cash position (cash, cash equivalents, other financial assets and marketable securities) of $246.1 million as of March 31, 2023, compared to $251.7 million as of Dec. 31, 2022. 

• Net loss of $10.9 million, or $0.210 loss per share, for the quarter ended March 31, 2023, compared to $5.8 million, or $0.111 loss per share, for the same quarter in 2022

• Quarterly R&D and G&A expenses of $7.3 million and $3.1 million respectively, compared to $4.7 million and $3.3 million for the same quarter in 2022.

The company believes the current cash position will successfully fund its operating expenses and capital expenditure requirements into 2026.

Operational Highlights

GH’s novel inhalable mebufotenin (5-MeO-DMT) drug candidate, GH001, is currently being assessed in a multi-center Phase 2b trial on TRD following a Phase 1/2 outstandingly high (87.5%) number of patients with TRD brought into an ultra-rapid remission.

With a recruitment goal of some 80 participants from several European countries, the new study aims to first determine the efficacy of a single-day, individualized dosing regimen of GH001 compared to a placebo in improving depressive symptoms from baseline to day 7. 

This double-blind phase is followed by a 6-month open-label extension phase, in which all patients can receive treatment with the psychedelic as needed. 

GH expects to submit an Investigational New Drug (IND) application for GH001 in TRD, delivered with the company’s proprietary aerosol delivery device, in the third quarter of this year.

Meanwhile, the company’s ongoing Phase 2a trials on GH001 for bipolar II disorder and a current depressive episode and for postpartum depression would be completed in the fourth quarter of 2023.

The second drug candidate is GH002, a proprietary IV-administered mebufotenin (5-MeO-DMT) drug, currently being assessed in a Phase 1 dose-ranging clinical trial in healthy volunteers which would also be completed within the year’s fourth quarter.

The company recently filed 19 international patent applications claiming protection from earlier filings and further expanding its patent portfolio focused on 5-MeO-DMT’s therapeutical use via inhalation or through nasal, buccal, sublingual, intravenous (IV), intramuscular (IM) or subcutaneous routes.

Photo: Benzinga edit with photo by PopTika on Shutterstock and Harbin on Wikimedia Commons.