GH Research: This European Biotech Company Reports Full Year 2023 Financial Results And Business Updates

Nasdaq-listed, GH Research GHRS is a clinical-stage biopharma business developing novel 5-MeO-DMT therapies as transformative treatment of psychiatric and neurological disorders.

Its reported yearly financial results show:

• Cash position of $ 222.7 million by December 31, 2023, an 11.5% decrease as compared to that held by December 31, 2022.
• Yearly R&D expenses totaled $29.8 million, a 45% increase as compared to the $20.5 million spent in 2022. 
• Yearly G&A expenses totaled $11.4 million, a 12.8% increase as compared to the $10.1 million spent in 2022. 
• Yearly net loss of $35.6 million (or $0.68 loss per share), a 58% rise from the 2022 net loss ($22.5 million, or $0.43 loss per share.)

Additional financial assets held during the fiscal year 2023 include money market funds and marketable securities (held both in 2022 and 2023) involving investment-grade bonds. 

The GH Research team stated its existing cash, cash equivalents, additional financial assets and marketable securities "will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026."

Clinical Pipeline & IP Portfolio In Development

GH Research portfolio focuses on three mebufotenin (or 5-MeO-DMT) assets: lead product candidate GH001, a proprietary inhalation formulation in Phase 2 clinical trials; GH002, a proprietary intravenous formulation in Phase 1 clinical-stage; and GH003, a proprietary intranasal formulation undergoing preclinical development.

GH001 has passed two Phase 1 clinical trials on healthy volunteers, as well as a Phase 1/2 clinical trial in patients with Treatment-Resistant Depression (TRD) with strong positive outcomes: 87.5% of TRD patients were brought into an ultra-rapid remission with a single-day dosing regimen. 

The company's lead compound is now being assessed in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in 80 patients with TRD, and in two Phase 2a trials: one in patients with bipolar II disorder and a current depressive episode (BDII,) and another in patients with postpartum depression (PPD.)

The Phase 2b trial is recruiting participants in about 20 European sites. Its double-blind phase is expected to be completed in Q3 2024, delivering topline data in Q3 or Q4, 2024. In the trial, GH001 is administered via an externally-sourced inhalation device, on a single initial-dosing day without additional required psychotherapy or psychological support visits before or after dosing.

GH001's assessment in patients with PPD and BDII is also at the recruiting stage. The PPD trial is now expecting completion and availability of topline data in Q3 2024, while the BDII trial's updated timeline is still to be determined.

Meanwhile, the company's Investigational New Drug Application (IND) for GH001 administered via its proprietary aerosol device was placed on clinical hold by the FDA. 

The federal agency requested that GH Research provide: an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, additional device design verification information, and updates to its investigator brochure to resolve the hold.

The company reported it is working to respond to the FDA's requests, initiating the nonclinical studies and preparing the device design verification information. 

"In addition, we have recently requested a meeting with the FDA to discuss certain aspects of the FDA's feedback," the company wrote in a press release. "We intend to provide an update regarding the IND response submission and the planned Phase 1 healthy volunteer clinical pharmacology trial in Q2 2024. In parallel, to mitigate a potential delay to the GH001 program, we are also progressing preparations to potentially conduct the Phase 1 healthy volunteer clinical pharmacology trial in Europe."

As for intellectual property, the European Patent Office (EPO)'s January grant enables the company to claim mebufotenin (5-MeO-DMT) or "a pharmaceutically acceptable salt thereof" for use in treating patients diagnosed with Major Depressive Disorder (MDD) and treatment-resistant forms of MDD, including TRD. 

The patent is now effective, with an expiry date of no earlier than 2040, and is expected to cover all mebufotenin and mebufotenin salt products marketed to treat MDD and TRD, including but not limited to products administered through pulmonary inhalation, intravenous and intranasal routes.

More recently, the EPO granted the company two more patents. One, covering "crystalline hydrobromide salt" of mebufotenin (effective date March 13, 2024 and expiry date no earlier than 2043;) and another directed to "a specific method of purifying mebufotenin" (effective date March 13, 2024 and expiry date no earlier than 2040.)

Photo: Benzinga edit with photo by Pexels.