Press Releases April 15, 2026 07:30 AM

Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 clinical trial

Clearmind's DSMB endorses continuation and dose escalation in Phase I/IIa trial of CMND-100 for Alcohol Use Disorder following promising safety data

By Caleb Monroe CMND
Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 clinical trial
CMND

Clearmind Medicine announced a positive safety evaluation by its independent Data and Safety Monitoring Board for its ongoing Phase I/IIa clinical trial of CMND-100, a novel non-hallucinogenic neuroplastogen-based drug candidate aimed at treating Alcohol Use Disorder (AUD). Following successful completion of the third cohort with no serious adverse events, the company plans to advance to the fourth cohort with an increased dose, highlighting the drug's favorable safety profile and potential therapeutic value.

Key Points

  • The DSMB issued a positive recommendation to continue the Phase I/IIa clinical trial of CMND-100 for AUD after reviewing encouraging safety data from the third cohort.
  • No serious adverse events were reported, reinforcing the drug candidate’s favorable safety and tolerability profile.
  • The company will proceed to the fourth cohort with an increased dose of 160mg, aiming to further evaluate CMND-100’s safety and efficacy.
  • The trial is multinational and multicenter, focusing on safety, pharmacokinetics, tolerability, and preliminary efficacy for patients with moderate to severe AUD.

Vancouver, Canada, April 15, 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 its independent Data and Safety Monitoring Board (“DSMB”) has completed its review and issued a positive recommendation to continue the ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder (“AUD”).

The positive DSMB recommendation follows the successful completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. These results reinforce the favorable safety and tolerability profile observed in previous cohorts.

As a result, the Company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, in patients with moderate to severe AUD.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND."

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
[email protected]
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the timing and progress of its clinical trials. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.


Risks

  • As a clinical-stage biotech company, the ultimate success and regulatory approval of CMND-100 remain uncertain, and the drug could fail in later trial phases impacting commercialization prospects.
  • Forward-looking statements indicate inherent uncertainty in trial outcomes, timelines, and market potential, with no guarantee that positive trends will continue.
  • Potential side effects or unforeseen safety issues may emerge with higher doses or larger patient populations in future trial phases, affecting the development trajectory.

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