GH Research pushes forward with DMT trials, drug approvals

Irish psychedelic biotech firm GH Research PLC (Nasdaq: GHRS), which is still in the pre-revenue stage as of New Year’s Eve, posted a $35.6 million loss for 2023 amid multiple ongoing psychedelic drug studies for potential new products that the company says are promising.

GH Research had $222.7 million in cash left at the end of the year, and spent just $29.8 million on research and development through 2023, up from $20.5 million spent on R&D in 2022. GH Research also spent another $11.4 million on general administrative costs, but still, the company said it’s confident that it has enough capital to last through at least 2025.

Meanwhile, GH Research has two DMT-related drugs undergoing clinical trials that are scheduled to be completed this year, and a third that’s still in pre-clinical development. All are based on mebufotenin, a Schedule I psychedelic that’s still illegal in the U.S. but has shown promising results in helping treat serious depression.

The first of GH Research’s drugs still in trials, an inhaled version of DMT labeled GH001, is currently in its second clinical study with 80 depression patients. The trial is expected to wrap up in the third quarter of this year. The drug is also being tested with patients suffering from postpartum depression and bipolar disorder.

The second drug, an intravenous version of DMT dubbed GH002, finished its first clinical study with 64 patients in the final months of 2023, and results show the drug “produced potent and ultra-rapid psychoactive effects,” and was “well-tolerated with no severe or serious adverse events.”

In the past two months, GH Research obtained three patents from the European Patent Office, all related to varying forms of the company’s DMT products designed to treat major depressive disorder and treatment-resistant depression.

GH Research is also working to get more research to the U.S. Food and Drug Administration on a New Drug Application it filed for one of its two DMT therapies, GH001, after the FDA put it on “clinical hold” until it can provide more info on inhalation toxicology.

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