GH Research: Steady Expenses And $229M Cash Position For 2026 Runway

The clinical-stage psychedelics biotech GH Research PLC GHRS reported its  financial results for Q3 2023 ended September 30, showing:

• Cash, cash equivalents and other financial assets and marketable securities totaled $228.7 million by Sept. 30, compared to $251.7 million by Dec. 31, 2022..

• Cash and cash equivalents for the Europe-based company were $86.5 million by Sept. 30, an almost 11% QoQ decrease from the $96.9 held by June 30 and nearly a 50% cut compared to the $166 million held by Dec. 31, 2022. 

See full Q2 results.

• Three and nine-month R&D expenses of $7.1 million and $21.6 million, compared to $4.6 million and $13.6 million during the comparable quarters in 2022.

• Three and nine months G&A expenses of $2.6 million and $8.5 million, compared to $2.0 million and $7.8 million in the same quarters in 2022.

• Quarterly net loss of $5.6 million (or $0.11 per share) vs. $0.4 million (or $0.01 per share) during the same quarter in 2022.

• Accumulated deficit of $56.7 million by Sept. 30, an over 10% QoQ increase and an almost 75% nine-month increase as of Dec. 31, 2022’s deficit at $32.5 million.

The company has stated it believes existing cash, cash equivalents and other financial assets -both comprising money market funds, now totaling $55.5 million- and marketable securities -comprising investment-grade bonds, quoted in active markets totaling $86.8 million and acting “as an additional source of liquidity”- will be “sufficient” to fund operating expenses and capital expenditure requirements into 2026.

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• Phase 2b trial of lead drug candidate GH001, a novel inhalable 5-MeO-DMT formulation for Treatment-Resistant Depression (TRD,) got approval in seven European countries. Aiming to recruit around 80 patients across some 20 sites, enrollment is reportedly on schedule completion of the study’s double-blind phase is set for Q3 2024, topline data available in Q3/Q4 2024. In the trial, GH001 is administered using an externally-sourced inhalation device.

• An August-submitted Investigational New Drug Application (IND) for GH001 with the FDA toward approval of a Phase 1 trial assessing administration through the company’s novel aerosol delivery device finally got the IND placed on clinical hold. To remove the hold, GH Research must 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.

The company says it is “working to respond to the FDA’s requests,” initiating the requested nonclinical studies among other actions. The team intends to request a meeting with the federal authority to take place within Q1 2024, to discuss the feedback, provide clarifications, and discuss the company’s plan to address their comments. 

“We intend to provide an update regarding the IND response submission and the planned Phase 1 healthy volunteer clinical pharmacology trial in due course after taking into account the conclusions of that meeting.”

• Phase 2a studies on GH001 in patients with bipolar II disorder with a current depressive episode and in patients with postpartum depression (PDD) are also underway. As the clinical research organization managing one of the two clinical trials sites will soon close, and considering both studies have been recruiting slower than projected, GH Research says it expects a delay in their completion. An updated timeline will be shared in Q1 2024.

• Phase 1 study of GH002, the 5-MeO-DMT IV product candidate, is expected to be completed in Q4 2023.

• Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.