Clearmind Medicine disclosed that the first cohort of its FDA‑approved Phase I/IIa trial of CMND‑100, an oral MEAI‑based therapy for alcohol use disorder, produced positive top‑line results. The cohort comprised six patients—two treated at Johns Hopkins University School of Medicine and four at Yale School of Medicine’s Department of Psychiatry—and dosing was completed on October 30 2025. The data show a favorable safety profile, with no serious adverse events and a tolerability rate that met expectations across all participants. High treatment observance was also noted, indicating strong adherence to the dosing regimen and protocol requirements.
The article’s reference to a “study completion” date of June 30 2025 refers to an earlier milestone in the overall trial program; the first‑cohort dosing, which generated the top‑line data, concluded on October 30 2025. This clarification resolves the apparent contradiction and confirms that the most recent data are from the October dosing period.
The positive safety and tolerability profile supports the next phase of development, positioning CMND‑100 as a potential breakthrough therapy in a market projected to exceed $20 billion by 2032. The non‑hallucinogenic MEAI mechanism offers a favorable safety profile and reduced misuse liability compared to other monoamine‑releasing agents, strengthening the therapeutic promise of the candidate.
Clearmind remains a pre‑revenue company and has received a Nasdaq notification for non‑compliance with the minimum stockholders’ equity requirement. The company’s financial health is a concern, and additional financing will be required to fund the progression of CMND‑100 through larger efficacy studies and eventual regulatory approval. The lack of revenue and the listing deficiency underscore the financial headwinds that accompany the clinical milestones.
Dr. Adi Zuloff‑Shani, Chief Executive Officer, said, “We are thrilled with these initial top‑line results from the first cohort, which indicate an encouraging safety profile and excellent treatment observance of CMND‑100. Building on our recent milestone of completing dosing at premier institutions like Johns Hopkins and Yale, these data provide strong momentum as we advance toward full data readout and subsequent cohorts. Our goal remains to pioneer neuroplastogen‑derived therapies that offer real hope to those battling addiction, and these results bring us one step closer to that vision.”
Investor reaction to the announcement has been muted, with market focus remaining on the company’s financial position and Nasdaq listing status. The positive clinical data are viewed as a long‑term catalyst, but short‑term attention is dominated by the need for additional capital to sustain the development program.
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