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: August 2025

 

Commission file number: 001-41557

 

CLEARMINDMEDICINE 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 annualreports under cover of Form 20-F or Form 40-F.

 

Form 20-F    Form 40-F 

 

 

 

 

 

CONTENTS

 

Attached hereto and incorporated herein is theRegistrant’s press release issued on August 5, 2025, titled “Clearmind Medicine Receives IRB Approval for Phase 1/2a ClinicalTrial for Alcohol Use Disorder at Hadassah Medical Center”.

 

The first, second, third andfifth paragraphs of the press release attached to this Form 6-K as Exhibit 99.1 are incorporated by reference into the Registrant’sRegistration Statements on Form F-3 (File Nos. 333-275991333-270859333-273293)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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extentnot superseded by documents or reports subsequently filed or furnished.

 

1

 

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “Clearmind Medicine Receives IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Hadassah Medical Center”

 

2

 

 

SIGNATURES

 

Pursuant to the requirementsof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereuntoduly authorized.

 

  Clearmind Medicine, Inc.
  (Registrant)
     
Date: August 5, 2025 By: /s/ Adi Zuloff-Shani
  Name:  Adi Zuloff-Shani
  Title: Chief Executive Officer

 

3

 

Exhibit 99.1 

 

 

 

Clearmind Medicine Receives IRB Approval for Phase 1/2a Clinical Trialfor Alcohol Use Disorder at Hadassah Medical Center

 

IRB Approval from Hadassah Medical Center FollowsFDA IND Clearance and Prior Approvals from Additional Clinical Sites

 

Vancouver, Canada, Aug. 05, 2025 (GLOBENEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), aclinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve majorunder-treated health problems, today announced that it has received Institutional Review Board (IRB) approval from Hadassah MedicalCenter, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drugcandidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable patient enrollment at Hadassah Medical Center,a leading clinical site in Israel, prior to commencing this first-in-human trial at the site.

 

The trial includes other first-in-class institutions, such as YaleSchool of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine and Tel Aviv Sourasky Medical Center,Israel. The study at Hadassah-University Medical Center will be led by Prof. Joseph Caraco, Director of Clinical Pharmacology Unit inthe Department of Medicine.

 

IRB approval from Hadassah Medical Center follows Clearmind’sprior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) applicationand IRB approvals from other clinical sites.

 

“Securing IRB approval from Hadassah-University Medical Center,a globally respected institution, marks another important step in our journey to address the deep unmet need in Alcohol Use Disorder,”said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “The addition of Hadassah to our growing network of top-tier research centers— including Yale and Johns Hopkins — reflects the strong momentum behind our clinical program and reinforces our commitmentto pioneering next-generation psychedelic-based therapies that can truly change lives.”

 

Clearmind’s clinical trial is a critical step in addressing theglobal burden of AUD, which accounts for 4.7% of all deaths worldwide, according to the World Health Organization. The Company anticipatesfurther progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solutionfor those affected by AUD and their families. The Phase 1/2a clinical trial, a multinational, multi-center study, is designed to assessthe safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcoholcravings and consumption in patients with AUD.

 

About Clearmind Medicine Inc.

 

Clearmind is a clinical-stage psychedelic pharmaceutical biotech companyfocused 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 commercializethem as regulated medicines, foods or supplements.

 

The Company’s intellectual portfolio currently consists of nineteenpatent families including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted andwill 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” and the Frankfurt Stock Exchange under the symbol “CWY0.”

 

For further information visit: https://www.clearmindmedicine.com orcontact:

 

Investor Relations
invest@clearmindmedicine.com

 

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

 

GeneralInquiries
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 usingforward-looking statements when it discusses commencing this first-in-human trial at Hadassah Medical Center, its journey to address thedeep unmet need in Alcohol Use Disorder, its commitment to pioneering next-generation psychedelic-based therapies that can truly changelives and its anticipation of further progress in patient enrollment and data collection across its clinical sites, with the goal of deliveringa breakthrough solution for those affected by AUD and their families. Forward-looking statements are not historical facts, and are basedupon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Suchexpectations, 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-lookingstatements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differmaterially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affectingthe 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 fiscalyear ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statementsare 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 securitieslaws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additionalupdates with respect thereto or with respect to other forward-looking statements. References and links to websites have been providedas a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind isnot responsible for the contents of third-party websites.