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: July 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 incorporatedherein is the Registrant’s press release issued on July 3, 2025, titled “Clearmind Medicine Announces IRB Approval for Phase1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center”.

 

The first, second, third,fourth and sixth 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extentnot superseded by documents or reports subsequently filed or furnished.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 Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky 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: July 3, 2025 By: /s/ Adi Zuloff-Shani
  Name:  Adi Zuloff-Shani
  Title: Chief Executive Officer

 

 

3

 

Exhibit 99.1

 

 

Clearmind Medicine Announces IRB Approval for Phase 1/2a ClinicalTrial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center

 

Vancouver, Canada, July 03, 2025 (GLOBE NEWSWIRE) -- Clearmind MedicineInc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discoveryand development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has receivedInstitutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2aclinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). Thisapproval will enable patient enrollment at TASMC, a leading clinical site in Israel, prior to commencing this first-in-human trial atthe 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 Hadassah-University Medical Centerin Jerusalem, Israel. The study at TASMC will be led by Dr. David Zeltser, Director of the Emergency Medicine Department and Deputy DirectorR&D and Innovation.

 

Clearmind recently announced the dosing of the first participant inthe trial, marking a historic step toward developing a novel therapy for the millions affected by AUD worldwide.

 

IRB approval from TASMC follows Clearmind’s prior regulatorymilestones, including U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application and IRB approvalsfrom other clinical sites.

 

“We are pleased to receive IRB approval from Tel Aviv SouraskyMedical Center, a renowned institution, for our Phase 1/2a clinical trial,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine.“This milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a conditionthat devastates millions of lives. With TASMC’s participation, alongside leading centers like Yale and Johns Hopkins, we believethat we are well-positioned to advance our mission of developing safe, effective, and innovative psychedelic-derived therapies.”

 

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 potentially offering a transformative treatment for individuals struggling with Alcohol UseDisorder, its belief that it is well-positioned to advance its mission of developing safe, effective, and innovative psychedelic-derivedtherapies and its anticipation of further progress in patient enrollment and data collection across its clinical sites, with the goalof delivering a breakthrough solution for those affected by AUD and their families. 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’sexpectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicatedby the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performanceor results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks anduncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securitiesand Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report onForm 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak onlyas 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 tothe extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference shouldbe drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. Referencesand links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by referenceinto this press release. Clearmind is not responsible for the contents of third-party websites.