Clearmind Medicine (Nasdaq: CMND) wins IRB nod to advance CMND-100 trial
Rhea-AI Filing Summary
Clearmind Medicine Inc. filed a Form 6-K highlighting a key clinical step for its lead candidate CMND-100. Johns Hopkins Medicine’s Institutional Review Board has approved advancement of the ongoing Phase I/II trial, allowing the company to proceed to Parts B and C in healthy volunteers and Alcohol Use Disorder subjects. Management describes this as another step forward in CMND-100’s clinical development at a leading research institution. Clearmind is a clinical-stage biotech focused on non-hallucinogenic, second-generation neuroplastogen-derived therapeutics and reports an intellectual property portfolio of nineteen patent families, including 31 granted patents.
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Insights
IRB approval lets Clearmind move CMND-100 into later Phase I/II trial parts.
The Johns Hopkins IRB approval enables Clearmind Medicine to advance its CMND-100 Phase I/II study into Parts B and C in healthy volunteers and Alcohol Use Disorder subjects. This follows earlier stages of the trial that the company describes as successfully completed.
IRB approvals are a required ethical and safety gate for human studies. Progressing within an ongoing Phase I/II trial is an incremental clinical milestone rather than a proof-of-efficacy event, and financial implications are not quantified in the disclosure.
Future clinical updates, including safety, tolerability, and pharmacokinetic findings from Parts B and C of the CMND-100 trial in Alcohol Use Disorder subjects, would provide more clarity on the program’s potential and will appear in subsequent company reports or communications.
Key Figures
Key Terms
Institutional Review Board regulatory
Phase I/II medical
Alcohol Use Disorder medical
neuroplastogen-derived therapeutics medical
forward-looking statements regulatory
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: May 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 May 26, 2026, titled “Clearmind Medicine Announces Johns Hopkins IRB Approval to Advance CMND-100 Phase I/II Clinical Trial to the Next Parts”.
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, 333-290404, 333-293521 and 333-295455) 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 Announces Johns Hopkins IRB Approval to Advance CMND-100 Phase I/II Clinical Trial to the Next Parts” |
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: May 26, 2026 | By: | /s/ Adi Zuloff-Shani |
| Name: | Adi Zuloff-Shani | |
| Title: | Chief Executive Officer | |
3
Exhibit 99.1
Clearmind Medicine Announces Johns Hopkins IRB Approval to Advance CMND-100 Phase I/II Clinical Trial to the Next Parts
Vancouver, Canada, May 26, 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 the Johns Hopkins Medicine Institutional Review Board (JHM-IRB) has granted approval for its ongoing Phase I/II clinical trial of CMND-100.
The approval advances the multicenter study titled “A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Alcohol Use Disorder (AUD) Subjects: Parts A, B, and C” and permits the Company to proceed with Parts B and C.
This milestone follows successful completion of earlier stages and reflects continued positive momentum at one of the world’s leading clinical research institutions.
Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine, commented, “This IRB approval represents another important step forward in our clinical development program for CMND-100. We are grateful to the Johns Hopkins team for their continued support and look forward to further demonstrating the potential of our non-hallucinogenic MEAI-based candidate for patients suffering from Alcohol Use Disorder.”
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:
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invest@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 and how it looks forward to further demonstrating the potential of its non-hallucinogenic MEAI-based candidate for patients suffering from Alcohol Use Disorder . 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.