[6-K] Clearmind Medicine Inc. Current Report (Foreign Issuer)
Rhea-AI Filing Summary
Clearmind Medicine Inc. reported continued progress in the third cohort of its FDA-approved Phase I/IIa trial of CMND-100, a non-hallucinogenic MEAI-based oral drug candidate for treating Alcohol Use Disorder. Patients at Yale University and Johns Hopkins University are moving through treatment with no serious adverse events reported to date, supporting the drug’s early safety and tolerability profile.
The multinational, multicenter study is designed to assess safety, tolerability, pharmacokinetics, and preliminary efficacy in moderate to severe Alcohol Use Disorder. Clearmind describes itself as a clinical-stage neuroplastogens-focused biotech with an intellectual property portfolio of nineteen patent families, including 31 granted patents.
Positive
- None.
Negative
- None.
Insights
Early CMND-100 safety signals remain encouraging but still preliminary.
Clearmind Medicine highlights that patients in the third cohort of its Phase I/IIa CMND-100 trial for Alcohol Use Disorder continue treatment at Yale and Johns Hopkins with no serious adverse events reported. This supports the candidate’s early safety and tolerability in a real-world clinical setting.
The trial is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in moderate to severe Alcohol Use Disorder, so current updates focus mainly on clinical execution, not yet on robust efficacy outcomes. As a clinical-stage company with nineteen patent families and 31 granted patents, future data readouts from this program will be important to demonstrate whether CMND-100 can translate these early safety findings into meaningful therapeutic benefit.
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 19, 2026, titled “Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder”.
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EXHIBIT INDEX
| Exhibit No. | ||
| 99.1 | Press release titled: “Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder” |
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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 19, 2026 | By: | /s/ Adi Zuloff-Shani |
| Name: | Adi Zuloff-Shani | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
Clearmind Medicine Reports Successful Ongoing Treatment of Participants at US Sites in its FDA-approved CMND-100 Phase I/IIa Clinical Trial for Alcohol Use Disorder
Vancouver, Canada, March 19, 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 successful continuation of treatment of participants in 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).
This positive progress follows the Company’s recent announcement on March 11, 2026, regarding the advancement of participant enrollment for the third cohort at Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center. Patients at the prestigious U.S. institutions – Yale University and Johns Hopkins University – continue to progress successfully through their treatment protocol, demonstrating continued safety and tolerability with no serious adverse events reported to date.
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. The successful ongoing treatment at these leading U.S. medical centers reflects strong momentum and confidence in CMND-100 as a potential breakthrough therapy for AUD.
“Building on the encouraging recruitment momentum and positive topline results from prior cohorts, we are pleased with the successful continuation of treatment in our U.S. clinical sites,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.
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
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. 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.
Filing Exhibits & Attachments
1 document