Psychedelic: Clearmind enrolls last patient in first cohort of CMND-100 trial

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on an enrollment update, price target raises and an interest acquisition.

CLEARMIND ENROLLS LAST PATIENT IN FIRST COHORT OF TRIAL: Clearmind Medicine (CMND) announced on Tuesday the enrollment of the last patient for the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the company’s proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder. To date, six patients have been enrolled into the trial. Of these, two patients were enrolled at Johns Hopkins University School of Medicine and four at Yale School of Medicine’s Department of Psychiatry. The multinational, multicenter Phase I/IIa trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking.

“With the enrollment of the last patient in our first cohort, we are thrilled to reach this key inflection point in our CMND-100 trial, within an excellent timeline” said Adi Zuloff-Shani, CEO. “Building on the momentum from our first cohort enrollment and site activations at world-class institutions like Yale and Johns Hopkins, this progress underscores the growing interest in MEAI-based therapeutics and our commitment to delivering safe, effective solutions for the underserved AUD community. We look forward to sharing topline data from the first cohort as we continue to accelerate this groundbreaking program. Enrollment was completed within excellent and efficient timelines, and we hope that with the activation of the two additional sites based in Israel to the trial, we will be able to maintain, and perhaps even improve, this excellent pace of enrollment.”

Clearmind also announced on Monday the publication of a U.S. patent application by the United States Patent and Trademark Office for its combination therapy of 5-methoxy-2-aminoindane and N-Acylethanolamines, such as Palmitoylethanolamide, addressing binge behavior disorders. The patent application stems from Clearmind’s ongoing collaboration with SciSparc (SPRC). This therapy targets multiple binge behaviors, including excessive alcohol consumption, binge eating, smoking, compulsive shopping, and problematic sexual conduct. The combination leverages MEAI’s neuroplastic properties to reduce impulsivity and reward-seeking behavior, which, together with PEA, has shown a synergistic pharmacological effect.

ATAI PRICE TARGET RAISES: Jefferies raised the firm’s price target on atai Life Sciences (ATAI) to $10 from $7 and kept a Buy rating on the shares. The ATAI-Beckley story “becomes more attractive” with the FDA granting a breakthrough designation to BPL-003, according to the analyst, who expects Atai to meet with the FDA to discuss Phase 3 design and regulatory strategy in Q4. The firm, which views BPL-003 as differentiated from other psychedelics due to single-dose durability and an in-clinic dosing paradigm, noted that its analysis shows a 72%-plus approval rate for drugs with BTD, so it argued the drug’s prospects “could be more favorable” than current Street thinking.

Additionally, Canaccord raised the firm’s price target on atai to $14 from $11 and kept a Buy rating on the shares. The firm noted their merger with privately held Beckley is on track to close in Q4 while recently announcing the FDA granted breakthrough therapy designation to Beckley’s BPL-003, which had solid Phase 2 data for treatment-resistant depression.

HOPE THERAPEUTICS ACQUIRES INTEREST IN COHEN: HOPE Therapeutics, an interventional psychiatry network owned by NRx Pharmaceuticals (NRXP), announced Monday the acquisition of a strategic interest in Cohen and Associates, and its incorporation into the HOPE Network. Additionally, Rebecca Cohen, MD has joined HOPE as Medical Director, overseeing medical standards of care throughout HOPE’s Florida locations. Cohen offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Transcranial Magnetic Stimulation, and medication management.

“We are excited to launch HOPE Therapeutics in Florida with Dr. Cohen’s passionate medical leadership. Her background and training perfectly complement the anesthesia and pain management expertise brought by Stephen Durand, RN, founder of Dura Medical, now a key component of HOPE. Rebecca dedicated her practice to TMS and other neuroplastic therapies when the field was in its infancy and has continued to advance the science of interventional psychiatry. Her extraordinary compassion for patients fits perfectly with our culture of bringing HOPE to life,” said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE.

ENVERIC TO EFFECT 1-FOR-12 REVERSE STOCK SPLIT: Enveric Biosciences (ENVB) announced Thursday that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 12 pre-split shares. The reverse stock split will become effective at 8:00 a.m., New York time, on Tuesday, October 28. Enveric’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol “ENVB” and will begin trading on a split-adjusted basis when the market opens on Tuesday. On October 22, the company received a delisting determination from Nasdaq, and the board determined to effect the reverse stock split and approved the corresponding final form of the certificate of amendment.

SILO PROVIDES UPDATE ON SPC-15 DEVELOPMENT: Silo Pharma (SILO) announced on Thursday an update detailing progress for lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder and stress-induced anxiety, and key achievements under its new digital assets treasury platform. Silo is advancing SPC-15 through the final preparations required prior to submitting an investigational new drug application to the FDA. Recent milestones in its drug discovery program include: Positive bioanalytical and safety/toxicology results for an FDA-requested 7-day large animal safety study of SPC-15; Finalizing drug-device study of the formulation-specific microchip-based nasal spray system used for SPC-15 drug delivery; Completion of an IND-enabling GLP-compliant toxicology and toxicokinetic study of SPC-15 with data expected in early 2026.

“Our team recently executed a strategic corporate initiative to diversify our operations as both a biopharmaceutical developer and a cryptocurrency treasury company. This expansion is aimed at creating long-term, sustainable stockholder value through treasury growth, asset diversification, and a stronger capital foundation to advance our ongoing drug development programs,” said Eric Weisblum, CEO. “Multiple catalysts are on the horizon as we prepare to submit our SPC-15 IND to the FDA. We believe that SPC-15 is well-positioned to proceed into a Phase 1 clinical trial upon FDA approval of our IND, which we plan to submit in 2026. Positive results from the safety/toxicology large animal study further support that SPC-15’s formulation and spray profile will meet the safety standards for clinical trials.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Cybin (CYBN), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Seelos Therapeutics (SEEL).