Clearmind Medicine Inc. (NASDAQ:CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment  of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), announced today the initiation of Phase lla, the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial evaluating CMND-100 for the treatment of AUD, with six patients enrolled to date. Three participants have been enrolled at Tel Aviv Sourasky Medical Center (TASMC) and three at Hadassah Medical Center in Jerusalem, initiating the first multiple-dose treatment phase of Part C (“phase IIa”) following the successful completion of the trial’s initial safety part in healthy volunteers.

The ongoing Phase IIa clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of CMND-100 in individuals with moderate-to-severe AUD. The clinical trial is structured as a four‑part Phase I/IIa study single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and subjects with AUD. CMND-100 is Clearmind’s lead investigational psychedelic-based therapeutic candidate, currently in development as a potential treatment for AUD, a chronic condition characterized by an impaired ability to stop or control alcohol consumption despite significant social, occupational or health consequences. AUD remains a major global health burden, with substantial unmet medical needs and limited effective treatment options.

The Company previously reported that an independent Data and Safety Monitoring Board (“DSMB”) reviewed the clinical data generated during part A of the trial and recommended advancing to the subsequent parts of the study. This positive DSMB assessment supports the continued clinical evaluation of CMND-100 and the simultaneously progression of the program into multiple dosing in healthy volunteers and single dosing in AUD patient population.