GH Research PLC (Nasdaq: GHRS) has launched an underwritten public offering in the United States of $150 million of ordinary shares. The company said in its offering document that it intends to use the net proceeds to strategically invest in research, clinical, and technical development of current and/or additional product candidates, working capital, capital expenditures, and general corporate purposes. The stock was falling over 8% on the news of the offering. 

As of September 2024, GH Research had $193 million in cash but expects that by the end of December, the cash will likely be roughly $182 million. The company has an accumulated deficit of $97 million.

GH Research’s focus is on developing novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD). Its portfolio currently includes GH001, a proprietary inhalable mebufotenin product candidate and GH002, its proprietary intravenous mebufotenin product candidate. Mebufotenin, also known as 5-MeO-NMT (5-Methoxy-N-Methyltryptamine), is a naturally occurring tryptamine alkaloid. It is structurally related to 5-MeO-DMT (5-Methoxy-Dimethyltryptamine) but differs in having only one methyl group on the amine rather than two.

GH001 delivers positive results

“While GH001 is currently delivered via a vaporization device produced by a third party, we are developing a proprietary aerosol delivery device, which is currently in clinical investigation,” read the company’s offering document. “We have completed two Phase 1 healthy volunteer clinical trials for GH001 (GH001-HV-101 and GH001-HV-103), in which administration of GH001 via inhalation was observed to be well tolerated at the investigated single dose levels and in an individualized dosing regimen (IDR), with intra-subject dose escalation within a single day. We have also completed a Phase 1/2 clinical trial in patients with TRD (GH001-TRD-102) and have recently completed the double-blind phase of a randomized, double-blind, placebo-controlled phase 2b trial in patients with TRD (GH001-TRD-201). Based on observed clinical activity in these clinical trials, we believe that administration of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS.”

The company reported this week that it met its primary endpoint as GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from a baseline of -15.5 on Day 8 (p<0.0001).

“Patients treated with GH001 experienced a difference of -15.5 points in MADRS score at Day 8 compared to placebo, which is truly remarkable,” said Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania. “Most TRD patients have not benefited from a number of established treatment options and this illness frequently imposes years of insurmountable mental suffering and disabling effects on social and vocational functioning. A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment.”

Psychedelic drug treatment companies are racing to find a cure for alcohol use disorder or alcoholism. This week, atai Life Sciences gave investors an update on its DMT-based drug, while Awakn Life Sciences updated the market on its ketamine-based drug for the same disorder.

The World Health Organization estimates that around 400 million people suffer from AUD worldwide, with around 3 million deaths each year attributed to alcoholism. With such a large patient population, a solution would be a financial home run for these companies – not to mention the benefits to the patients.

Atai’s update

Atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe AUD. The company told investors that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months. Atai said it expects to have the Phase 2b data readout of BPL-003 midyear.

“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” said Dr. Srinivas Rao, CEO and co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders.”

Atai’s BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate which is designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time.

Awakn’s update

Awakn Life Sciences Corp. (CSE: AWKN) (OTC Pink: AWKNF) has two drugs to treat AUD, designated as AWKN-001 and AWKN-002, and both use a ketamine base. AWKN-001 is in Phase 3 in the U.K. The company told investors it is targeting a Regulation 52b hybrid application in the U.K. for AWKN-001.

“If successful, this could provide 8 years of market exclusivity, with an additional 2 years of supplementary protection, preventing competitors from marketing a similar product for the same indication,” the company said in a statement.

Concerning AWKN-002, the company said it completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration, which confirmed that AWKN-002 can be reviewed under the 505(b)(2) NDA pathway. The FDA also further confirmed that no additional clinical data are needed to proceed with a Phase 2b trial in patients with moderate to severe AUD.

Awakn said in a statement that it plans to submit an IND Application for AWKN-002 in the second half of 2025, followed by a Clinical Trial Application for a Phase 2b trial in the first half of 2026. If all goes well, the company will have market exclusivity for five years.

“We are excited about the progress across our key R&D programs, particularly in the areas of Alcohol Use Disorder and PTSD. With the advancements we’ve made in AWKN-001 and AWKN-002, we’re on track to deliver transformative therapies for patients in need of more effective solutions,” Anthony Tennyson, CEO of Awakn said.

Green Market Report wrote in December that Awakn would be bought by Graft Polymer (UK) PLC with Graft acquiring all of the company’s shares in a deal valued at C$8.8 million. That deal is expected to close in the summer of 2025.

Enveric Biosciences Inc. (NASDAQ: ENVB) reported its financial results for the third quarter of 2024 and provided a corporate update yesterday.

Enveric said it made “important progress” in the development of EB-003, its lead neuroplastogenic molecule designed to treat depression, anxiety and addiction disorders without causing the hallucinogenic effects common to DMT and related analogs.

According to the company, studies confirmed EB-003 can potentially be delivered orally and penetrate the brain “at levels expected to elicit the desired therapeutic effect.” Preclinical data also showed EB-003 targets desired serotonergic receptors while minimizing potentially harmful off-target interactions.

“These are clear differentiators for EB-003, which we believe will add to its value potential,” CEO Joseph Tucker said in a statement. The company plans to submit an Investigational New Drug application for EB-003 to the FDA in the second half of 2025.

For the quarter ending Sept. 30, Enveric reported a net loss of $2.1 million, or 24 cents per share, versus a net loss of $2.8 million, or $1.30 per share, a year earlier. The company ended the quarter with cash of $3.1 million.

According to Enveric’s quarterly report filed with the SEC, the company’s operating expenses for the quarter totaled $2.1 million, down from $3.4 million in the same period last year. The reduction was primarily driven by lower G&A expenses and reduced R&D costs.

As of Sept. 30, Enveric had an accumulated deficit of $102.9 million. The company noted in its 10-Q filing that it anticipates further losses as it continues to develop its product candidates. Enveric’s operations have been funded principally through the issuance of equity, and the company stated it will require additional capital to fund additional research and development efforts.

In addition to advancing EB-003, Enveric announced it expanded patent protection for a broad range of molecules in its EVM301 portfolio and granted licenses for two of its drug candidates. The company granted Aries Science & Technology a license to its patented radiation dermatitis topical product. It also licensed its EB-002 drug candidate and EVM201 Program to MycoMedica Life Sciences.

“These agreements not only validate the company’s platform but also generate nondilutive revenue to support the development of EB-003 and further building stockholder value,” Tucker said.

In May, Enveric received a letter from the Nasdaq stating that the company was not in compliance with the minimum bid price requirement for continued listing. The company had until earlier this week to regain compliance and is considering a reverse stock split in 2025 if the bid price does not close above $1 per share for at least 10 consecutive business days before the end of the compliance period. It did not comment on the issue in its earnings release.