Clearmind Medicine Evaluates Lead Candidate, CMND-100 (MEAI), For Eligibility For FDA's Breakthrough Therapy Designation

Positive clinical results from Alcohol Use Disorder clinical trial may strengthen potential for eligibility for Breakthrough Therapy Designation

Vancouver, Canada, April 27, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ:CMND) ("Clearmind" or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced that it is evaluating its lead candidate, CMND-100 (MEAI), for eligibility for the U.S. Food and Drug Administration's (FDA) Breakthrough Therapy Designation (BTD).

The FDA's Breakthrough Therapy Designation is granted to drugs intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential for substantial improvement over existing therapies on at least one clinically significant endpoints. Alcohol Use Disorder represents a life-threating with a significant unmet medical need, affecting millions worldwide with limited effective treatment options.

Clearmind Medicine remains committed to science-driven development and looks forward to continued engagement with the FDA as it advances CMND-100 toward providing safe, effective, and scalable non-hallucinogenic treatment options for patients.

As of the date hereof, the Company has not submitted a request for Breakthrough Therapy Designation for MEAI, and the FDA has not granted such designation.