Clearmind starts Phase IIa AUD trial of CMND-100

Rhea-AI Filing Summary

Clearmind Medicine Inc. (CMND), a clinical-stage biopharmaceutical company focused on non-hallucinogenic psychedelic-derived neuroplastogens for neuropsychiatric, metabolic and addiction disorders, reported that Phase IIa of its double-blind, placebo-controlled Phase I/IIa trial of CMND-100 for Alcohol Use Disorder (AUD) is now underway, with six patients enrolled in the multiple-dose Part C stage.

Three participants have been enrolled at Tel Aviv Sourasky Medical Center and three at Hadassah Medical Center in Jerusalem, following successful completion of the initial safety part in healthy volunteers. The study is designed to assess safety, tolerability and preliminary efficacy of CMND-100 in moderate-to-severe AUD. Clearmind notes support from an independent Data and Safety Monitoring Board to advance the program and highlights an intellectual property portfolio of nineteen patent families, including 32 granted patents.

Filing Explained

The filing also states that the press release’s first two paragraphs are incorporated by reference into six specified Form F-3 registration statements and one Form S-8, making those paragraphs part of those registration statements from September 1, 2026.

Key Figures

Phase IIa Enrollment: 6 patients Site Enrollment – Tel Aviv Sourasky Medical Center: 3 patients Site Enrollment – Hadassah Medical Center: 3 patients +3 more

6 metrics

Phase IIa Enrollment 6 patients Patients enrolled to date in CMND-100 Phase IIa AUD trial Part C

Site Enrollment – Tel Aviv Sourasky Medical Center 3 patients Participants enrolled at Tel Aviv Sourasky Medical Center in Phase IIa

Site Enrollment – Hadassah Medical Center 3 patients Participants enrolled at Hadassah Medical Center in Phase IIa

Patent Families 19 patent families Clearmind’s intellectual property portfolio

Granted Patents 32 granted patents Granted patents within Clearmind’s intellectual property portfolio

Form Type Form 6-K Report of Foreign Private Issuer for September 2026

Key Terms

Phase I/IIa, placebo-controlled, neuroplastogens, Data and Safety Monitoring Board, +1 more

5 terms

Phase I/IIa medical

"the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial"

An early-stage clinical trial program that combines Phase I (primarily testing safety and finding a tolerable dose) with Phase IIa (initial checks for whether the drug shows signs of working in patients). Think of it as trying a new product with a small group to confirm it’s safe and gives early benefits before a larger rollout. For investors, these studies are major risk/reward checkpoints: positive results can boost value, while failures are common and costly.

placebo-controlled medical

"the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

neuroplastogens medical

"non-hallucinogenic, next-generation, psychedelic-derived neuroplastogens for the scalable treatment"

Neuroplastogens are drugs or molecules designed to boost the brain’s ability to reorganize and form new connections—think of them as medicines that help the brain ‘rewire’ itself after damage or during therapy. Investors watch them because successful neuroplastogens could become treatments for conditions like depression, Alzheimer’s, or brain injury, creating large markets and sharp changes in company value as trials, approvals, or setbacks occur.

Data and Safety Monitoring Board medical

"an independent Data and Safety Monitoring Board (“DSMB”) reviewed the clinical data"

An independent panel of experts that watches over a clinical trial to protect participants and ensure the data are reliable, acting like an impartial referee who can recommend pausing or stopping the study if safety problems or clear benefits emerge. Investors care because the board’s findings can change a drug or device’s timeline, cost, and odds of regulatory approval, directly affecting a company’s value and risk profile.

Alcohol Use Disorder medical

"evaluating CMND-100 for the treatment of AUD, a chronic condition characterized by"

A chronic medical condition characterized by an inability to control or stop drinking despite negative effects on health, work, relationships or safety; it ranges from mild to severe based on frequency, loss of control, and withdrawal symptoms. Investors care because its prevalence and treatment options affect markets for pharmaceuticals, medical services and health-related productivity—think of it like a long-running equipment fault in a factory that reduces output and creates demand for repairs and preventive solutions.

FAQ

What milestone did Clearmind Medicine (CMND) announce regarding CMND-100?

Clearmind announced that Phase IIa of its double-blind, placebo-controlled Phase I/IIa clinical trial of CMND-100 for Alcohol Use Disorder is now underway, marking the start of the first multiple-dose treatment phase in AUD patients after completion of the initial safety stage in healthy volunteers.

How many patients are enrolled in Clearmind’s CMND-100 Phase IIa AUD trial?

The company reports that six patients are enrolled in the CMND-100 Phase IIa trial for Alcohol Use Disorder, with three at Tel Aviv Sourasky Medical Center and three at Hadassah Medical Center in Jerusalem, all participating in the multiple-dose Part C of the study.

What is the design of Clearmind (CMND)’s CMND-100 Phase I/IIa study?

The CMND-100 program is a four-part Phase I/IIa clinical study designed as a single- and multiple-dose tolerability, safety and pharmacokinetic trial in healthy volunteers and subjects with Alcohol Use Disorder, with Phase IIa focusing on safety, tolerability and preliminary efficacy in moderate-to-severe AUD.

What role did the DSMB play in Clearmind’s CMND-100 trial progression?

An independent Data and Safety Monitoring Board (DSMB) reviewed clinical data from part A of the trial and recommended advancing to subsequent parts. Clearmind states this positive assessment supports continued clinical evaluation of CMND-100, including progression into multiple dosing in healthy volunteers and single dosing in AUD patients.

What is the scope of Clearmind Medicine (CMND)’s intellectual property portfolio?

Clearmind reports an intellectual property portfolio of nineteen patent families, including 32 granted patents. The company’s primary objective is to research and develop psychedelic-based compounds and seek to commercialize them as regulated medicines, foods or supplements, while pursuing additional patent protection when warranted.

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Available on EDGAR 09/01/2026 - 08:02 AM Accepted by SEC EDGAR 09/01/2026 - 08:01 AM Learn about SEC filing dates

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: September 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 September 1, 2026, titled “Clearmind Reaches Key Milestone: CMND-100 Phase IIa Underway for Alcohol Use Disorder Trial, One-Third of Part C Enrolled”.

The first two 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 Reaches Key Milestone: CMND-100 Phase IIa Underway for Alcohol Use Disorder Trial, One-Third of Part C Enrolled”

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: September 1, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Reaches Key Milestone: CMND-100 Phase IIa now Underway for Alcohol Use Disorder Trial, One-Third of Part C Enrolled

Vancouver, Canada, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment  of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), announced today the initiation of Phase lla, the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial evaluating CMND-100 for the treatment of AUD, with six patients enrolled to date. Three participants have been enrolled at Tel Aviv Sourasky Medical Center (TASMC) and three at Hadassah Medical Center in Jerusalem, initiating the first multiple-dose treatment phase of Part C (“phase IIa”) following the successful completion of the trial’s initial safety part in healthy volunteers.

The ongoing Phase IIa clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of CMND-100 in individuals with moderate-to-severe AUD. The clinical trial is structured as a four-part Phase I/IIa study single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and subjects with AUD. CMND-100 is Clearmind’s lead investigational psychedelic-based therapeutic candidate, currently in development as a potential treatment for AUD, a chronic condition characterized by an impaired ability to stop or control alcohol consumption despite significant social, occupational or health consequences. AUD remains a major global health burden, with substantial unmet medical needs and limited effective treatment options.

The Company previously reported that an independent Data and Safety Monitoring Board (“DSMB”) reviewed the clinical data generated during part A of the trial and recommended advancing to the subsequent parts of the study. This positive DSMB assessment supports the continued clinical evaluation of CMND-100 and the simultaneously progression of the program into multiple dosing in healthy volunteers and single dosing in AUD patient population.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage biopharmaceutical company advancing the discovery and development of non-hallucinogenic, next-generation, psychedelic-derived neuroplastogens for the scalable treatment of widespread and underserved health problems  of neuropsychiatric, metabolic, and addiction disorders, including alcohol use disorder. 

The Company’s intellectual portfolio currently consists of nineteen patent families, including 32 granted patents. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements. 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

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 ongoing conduct of its Phase I/IIa clinical trial evaluating CMND-100 for the treatment of alcohol use disorder (AUD), anticipated patient enrollment activities, the continued clinical development of CMND-100, the potential of CMND-100 as a treatment for AUD, and the Company’s plans to provide additional updates regarding the study and related clinical activities. 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

Press Releases

• EX-99.1 PRESS RELEASE TITLED: "CLEARMIND REACHES KEY MILESTONE: CMND-100 PHASE IIA UNDER 10.1 KB