Clearmind Medicine (NASDAQ: CMND) moves CMND-100 Alcohol Use Disorder trial into third cohort
Rhea-AI Filing Summary
Clearmind Medicine Inc. is advancing its CMND-100 program for Alcohol Use Disorder by continuing enrollment for the third cohort of its ongoing FDA-approved Phase I/IIa clinical trial. This step follows positive topline results from the second cohort, which showed continued safety and tolerability.
The company’s Data and Safety Monitoring Board unanimously approved proceeding, allowing recruitment at leading centers including Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center. CMND-100 is a proprietary, non-hallucinogenic, MEAI-based oral candidate designed to treat moderate to severe Alcohol Use Disorder without requiring adjunct psychotherapy.
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Insights
Clearmind moves CMND-100 into a new trial cohort after favorable safety data.
Clearmind Medicine reports that CMND-100, a non-hallucinogenic MEAI-based oral drug for Alcohol Use Disorder, is progressing into the third cohort of an FDA-approved Phase I/IIa trial after positive topline results from the second cohort showing continued safety and tolerability.
The unanimous approval from the Data and Safety Monitoring Board suggests no major safety concerns at tested doses so far, which is crucial in early-stage neuropsychiatric drug development. The trial is multinational and multicenter, evaluating safety, pharmacokinetics, and preliminary efficacy in moderate to severe Alcohol Use Disorder.
Enrollment at prominent sites such as Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center may support robust data collection. Future disclosures on efficacy outcomes and progression to later-phase studies will be key to understanding CMND-100’s potential as a treatment option.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: March 2026
Commission file number: 001-41557
CLEARMIND MEDICINE INC.
(Translation of registrant’s name into English)
101 – 1220 West 6th Avenue
Vancouver, British Columbia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
CONTENTS
Attached hereto and incorporated herein is the Registrant’s press release issued on March 11, 2026, titled “Clearmind Medicine Advances Recruitment for CMND-100 Trial’s Third Cohort at Yale, Johns Hopkins and Tel Aviv Sites Following Recent Positive Topline Results”.
The first three paragraphs of the press release attached to this Form 6-K as Exhibit 99.1 are incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File Nos. 333-275991, 333-270859, 333-273293, and 333-290404) and Form S-8 (File No. 333-283695), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
1
EXHIBIT INDEX
| Exhibit No. | ||
| 99.1 | Press release titled: “Clearmind Medicine Advances Recruitment for CMND-100 Trial’s Third Cohort at Yale, Johns Hopkins and Tel Aviv Sites Following Recent Positive Topline Results” |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Clearmind Medicine, Inc. | ||
| (Registrant) | ||
| Date: March 11, 2026 | By: | /s/ Adi Zuloff-Shani |
| Name: | Adi Zuloff-Shani | |
| Title: | Chief Executive Officer | |
3
Exhibit 99.1
Clearmind Medicine Advances Recruitment for CMND-100 Trial’s Third Cohort at Yale, Johns Hopkins and Tel Aviv Sites Following Recent Positive Topline Results
Vancouver, Canada, March 11, 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 the continuation of participant enrollment for the third cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).
The recruitment follows the positive topline results recently reported from the second cohort, which demonstrated continued safety and tolerability, building on the favorable outcomes from prior cohorts. The Company’s Data and Safety Monitoring Board (DSMB) has reviewed the data and provided unanimous approval to proceed, enabling enrollment in this next phase.
The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Participant recruitment for the third cohort at leading sites, including Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center, reflecting strong momentum and confidence in CMND-100 as a potential breakthrough therapy for AUD.
“Building on the encouraging results from our first and second cohort, we are excited on progressing with the clinical trial at these prestigious institutions,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “The positive data we continue to receive from our clinical trial, reinforce CMND-100’s potential as a safe and well tolerated, non-hallucinogenic treatment option that addresses the critical unmet needs in alcohol use disorder, without requiring adjunct psychotherapy, making this treatment accessible and discrete. We remain committed to progressing this trial to bring innovative, safe and affordable solutions to patients in need.”
About Clearmind Medicine Inc.
Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of novel psychedelic-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
invest@clearmindmedicine.com
Telephone:
(604) 260-1566
US: CMND@crescendo-ir.com
General
Inquiries
Info@Clearmindmedicine.com
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, advancing to patient enrollment for the fourth cohort, CMND-100’s potential as a safe, non-hallucinogenic treatment option that addresses the critical unmet needs in alcohol use disorder, without requiring adjunct psychotherapy and its commitment to progressing its clinical trial to bring innovative, safe and affordable solutions to patients in need. 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.
FAQ
What did Clearmind Medicine (CMND) announce about the CMND-100 trial?
What is CMND-100 in Clearmind Medicine’s (CMND) clinical program?
Which sites are participating in Clearmind Medicine’s CMND-100 third cohort?
What role did the Data and Safety Monitoring Board play in CMND-100’s progress?
How does CMND-100 differ from other Alcohol Use Disorder treatments?
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Filing Exhibits & Attachments
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