Psychedelic: Clearmind completes treatment, follow-up for CMND-100 trial

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on treatment completion, a publication of study results and an analyst initiation.

CLEARMIND COMPLETES TREATMENT, FOLLOW-UP IN CMND-100 TRIAL: Clearmind Medicine (CMND) announced Monday the completion of treatment and follow-up of 18 participants in its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. The company also announced that four additional participants have been treated at the clinical center in Tel Aviv, further expanding enrollment and demonstrating the operational strength of the Israeli sites in the trial.

“We are very encouraged by the successful completion of treatment and follow-up for these 18 participants, alongside the rapid addition of four more patients at our Tel Aviv center,” said Dr. Adi Zuloff-Shani, CEO. “This steady progress across our sites underscores the favorable safety and tolerability profile of CMND-100 and brings us closer to potentially delivering a much-needed innovative therapy for Alcohol Use Disorder.”

Additionally on Friday, Clearmind announced the filing of a patent application in India covering next-generation psychedelic-based compounds for the treatment of mental health disorders and addiction. The patent application, filed with the Indian Patent Office, forms part of the company’s expanding global intellectual property portfolio and builds upon its exclusive worldwide licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem. It protects novel new compounds designed to overcome the limitations of classical psychedelics, offering potentially safer, more effective, and scalable treatment options for underserved mental health conditions and addictive disorders.

DEFINIUM ANNOUNCES PUBLICATION OF GAD STUDY: Definium Therapeutics (DFTX) announced results on Tuesday from a retrospective, longitudinal study published in the Journal of Mood and Anxiety Disorders examining the real-world prevalence, incidence, and burden of Generalized Anxiety Disorder in the United States healthcare system from 2020 to 2023. These findings show a steadily increasing diagnosed prevalence of GAD and highlight a substantial and growing burden affecting more than 1 in 10 adults in the U.S. Together, these results underscore the need for improved access to care, including identification, diagnosis, and treatment options for patients living with GAD. This study, based on a large U.S. healthcare claims database, found that the diagnosed prevalence of GAD increased from 5.4% in 2020 to 6.6% in 2023, while the three-year cumulative prevalence reached 10.3%. Annual incidence rates remained consistently high, ranging from 2.1% to 2.3%, indicating a steady influx of newly diagnosed patients. Results also show that GAD disproportionately affects women and is highly associated with major depressive disorder. These findings meet or exceed previously reported prevalence estimates, which range from approximately 5% to 8%.

“Importantly, these data emphasize the urgency of advancing more effective and accessible treatment options for patients living with GAD,” said Erin Ferries, lead author and Senior Director, Healthcare Economics Outcomes Research at Definium. “The high rate of comorbidity of GAD and MDD, both among the most prevalent mental health disorders, highlights the complex overlapping burden between these conditions and reinforces the need for more integrated approaches that address them concurrently.”

ATAIBECKLEY INITIATED WITH BUY RATING: Deutsche Bank initiated coverage of AtaiBeckley (ATAI) with a Buy rating and $12 price target. The company is well positioned for the psychedelic “renaissance,” the analyst said. The firm believes AtaiBeckley will become a leader in the “nascent field” of psychedelic medicine for mental health conditions. Deutsche thinks psychedelic therapies will become increasingly mainstream over the next several years, and views AtaiBeckley as well positioned among its competitors. The company’s lead program, BPL-003, and second program, VLS-01, are being developed for treatment-resistant depression, where unmet need remains high, the firm contended.

HOPE THERAPEUTICS PARTNERS WITH EMOBOT: Hope Therapeutics, a subsidiary of NRx Pharmaceuticals (NRXP), announced Monday a strategic partnership with Emobot Health to deploy its AI-driven emotional monitoring platform across Hope’s network of interventional psychiatry clinics. This roll-out represents the first large-scale clinical integration of Emobot’s “Depression Thermometer,” a passive monitoring tool designed to detect early treatment response and prevent relapse in patients with Treatment-Resistant Depression.

“Precision medicine requires real-time data to be effective,” said Jonathan Javitt, CEO of Hope Therapeutics. “In psychiatry, the period between clinic visits has traditionally been a ‘blind spot.’ Emobot’s 100% passive, multimodal AI provides us with a continuous stream of objective biomarkers—effectively a ‘360-degree view’ of a patient’s emotional state. We believe this is the new gold standard for care; in fact, we expect every patient to be on Emobot. Our team has 15+ years of experience in supporting digital health applications of this nature, having developed the first cellular-enabled medical device for monitoring of diabetes.”

ALGERNON PROPOSES NAME CHANGE TO GREY MATTERS HEALTH: Algernon Health (AGNPF) announced Tuesday that it intends to change its corporate name from “Algernon Health Inc.” to “Grey Matters Health Inc.” The company has reserved the new name and new symbol “GREY” with the Canadian Securities Exchange. The new symbols for the OTCQB and Frankfurt exchange will be provided shortly.

The company said, “Grey Matter is a biological term defined as the darker tissue of the brain and spinal cord, consisting mainly of nerve cell bodies and branching dendrites. The addition of an ‘s’ to the name is a play on words underscoring the importance of cognitive health, and the company’s interest in brain related healthcare programming. Principally, the planned name change reflects the company’s expanding focus on the Alzheimer’s Disease diagnostic market and our plans to establish specialized brain PET scanning clinics across the United States under the brand name NovaScan Neuroimaging Clinics, with the first clinic recently announced to be located at the HCA University Medical Office Building, on the campus of the HCA Florida University Hospital in Davie…Additionally, the new name has a legacy connection to the company’s long-standing drug development programs including N,N-Dimethyltryptamine for ischemic brain stroke and traumatic brain injury, which are serious neurological conditions, as well as its program for Repirinast, a repurposed drug for CKD, which is a mast cell inhibitor, a mechanism shown preclinically to reduce inflammation and cognitive decline in AD.”

Concurrently with the name change, the company will be consolidating its Class A common shares on a ten to one basis. The company currently has 54,182,431 common shares issued and outstanding. Following the proposed consolidation, the company will have approximately 5,418,243 common shares issued and outstanding without accounting for rounding for fractional shares.

ENVERIC SECURES PATENT FOR EVM301 SERIES: Enveric Biosciences (ENVB) announced Tuesday that on March 17, it received U.S. Patent No. 12,577,232 from the United States Patent and Trademark Office pertaining to its EVM301 Series of molecules. The EVM301 Series includes lead candidate, EB-003, being developed as potential treatments for mental health disorders. Entitled, “N-heterocycle substituted tryptamine derivatives and methods of using,” the patent adds to the portfolio covering Enveric’s EVM301 Series of molecules. The issued patent claims chemical compounds, pharmaceutical drug formulations, and methods for treating brain neurological disorders. The ‘232 patent enhances the patent claim coverage of Enveric’s N-heterocycle substituted tryptamine derivative molecules which are also the subject of previously issued U.S. Patent No. 12,338,231. Enveric’s EVM301 Series of molecules include potential neuroplastogenic non-hallucinogenic molecules intended to target neuropsychiatric and addiction disorders for patients with limited options.

“We are very pleased with this new U.S. patent issuance as we continue to work diligently to reinforce our EVM301 Series intellectual property estate and generate additional value for Enveric stockholders,” said Joseph Tucker, CEO. “Our company remains focused on advancing EB-003 toward submitting an IND application to the FDA and initiating a first-in-human Phase 1 clinical trial.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Filament Health (FLHLF), GH Research (GHRS), Helus Pharma (HELP), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla Biotech (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO).