Clearmind Medicine CEO Issues Letter to Shareholders

Vancouver, Canada, April 09, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq:CMND), (FSE: CWY0) (“Clearmind” or the “company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today provided the following letter to shareholders from the Company’s CEO, Dr. Adi Zuloff-Shani:

“In 2023, Clearmind made significant advances on its groundbreaking journey, propelling our flagship compound, CMND-100, through critical stages with a goal of revolutionizing the treatment of alcohol use disorder (AUD) as well as other addictive disorders and mental health conditions. Recently, our efforts reached a key inflection point as the Israeli Ministry of Health approved our Phase I/IIa clinical trial for CMND-100 for AUD. CMND-100, a pioneering MEAI-based (5-methoxy-2-aminoindane) formula, has exhibited encouraging results in pre-clinical studies. Notably, it has shown the ability to disrupt the destructive cycle of binge drinking without inducing hallucinations—a common concern with existing treatments. This distinction is vital as it ensures both safety and efficacy in addressing AUD. It uniquely targets the neural pathways to reduce impulsivity and promote reasoned behavior, positioning it as an innovative solution in the battle against addictions.

2023 was marked by an array of significant milestones aimed at initiating our Phase I/IIa clinical trial of CMND-100 in AUD, including:

• Completing Type A meeting with the FDA. Forming a Data and Safety Monitoring Board for oversight of our first-in-human clinical trial;
• Strengthening our clinical trial readiness through key partnerships for manufacturing and contract research organization (CRO) support.
• Securing IRB Approval for our Phase I/IIa clinical trial in Israel, a critical step towards our clinical endeavors.
• Announcing Johns Hopkins University and Yale School of Medicine’s Department of Psychiatry as the first U.S. sites for our Phase I/IIa clinical trial.

Other key developments during the year, included:

• Unveiling promising pre-clinical outcomes in obesity and metabolic disorders, suggesting MEAI may be a potentially better and safer option compared to other weight-loss drugs currently on the market.
• Forging a collaboration agreement with CTS Ltd., a pharmaceutical leader in Israel.
• Advancing our IP with patent filings in the U.S., including the treatment of depression and dyskinesia, bringing our patent portfolio, to 27 granted patents and 24 pending patent applications across 15 patent families.

Looking ahead, we believe that we are poised to achieve significant milestones that we hope to substantially enhance shareholder value through 2024. These include the initiation of the Phase I/IIa trial of CMND-100 for AUD, expanding our strategic alliances, advancing our obesity research and trials, as well as progressing our MEAI-based alcohol substitute for the consumer market. We stand on the threshold of a new era in psychedelic-based medical treatment, driven by innovation and a commitment to transforming lives. The journey ahead is filled with potential, and we eagerly anticipate sharing impactful updates with our shareholders."