Clearmind Medicine (Nasdaq: CMND) wins DSMB nod to advance AUD trial

Rhea-AI Filing Summary

Clearmind Medicine Inc. reports a key milestone in its CMND-100 program for Alcohol Use Disorder (AUD) after its independent Data and Safety Monitoring Board (DSMB) unanimously approved advancing an ongoing FDA-regulated Phase I/II trial to Parts B and C. Part A, conducted in healthy participants, met its primary safety endpoint, with CMND-100 showing a favorable safety and tolerability profile across all planned dose levels.

Part B will, for the first time, evaluate CMND-100 in human patients with moderate to severe AUD in two sequential cohorts of six patients each at 80 mg and 160 mg doses, assessing safety, tolerability and early signals of clinical activity, including potential reductions in alcohol consumption and craving. Part C will run concurrently in healthy participants at a fixed 160 mg daily dose over five consecutive days in a double-blind, placebo-controlled design to further characterize safety and tolerability.

The multicenter trial, focused on safety, tolerability, pharmacokinetics and preliminary efficacy in AUD, is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. Clearmind describes CMND-100 as a proprietary, non-hallucinogenic neuroplastogen-derived oral formulation and notes an intellectual property portfolio of nineteen patent families, including 32 granted patents.

Filing Explained

As a foreign private issuer’s interim report, this Form 6-K furnishes the August 6 press release and incorporates specified paragraphs by reference into the listed Form F-3 registration statements and Form S-8; that filing action is not itself a disclosed share issuance.

Key Figures

Trial phase: Phase I/II Part B cohort size: Two cohorts of six patients Part B doses: 80 mg and 160 mg +3 more

6 metrics

Trial phase Phase I/II FDA-regulated clinical trial of CMND-100 for Alcohol Use Disorder

Part B cohort size Two cohorts of six patients Moderate to severe AUD patients receiving 80 mg and 160 mg doses

Part B doses 80 mg and 160 mg Sequential dosing cohorts in AUD patients in Part B

Part C dosing duration Five consecutive days 160 mg daily CMND-100 in healthy participants in Part C

Patent families Nineteen Clearmind’s intellectual property portfolio structure

Granted patents 32 Granted patents within Clearmind’s nineteen patent families

Key Terms

Data and Safety Monitoring Board, Phase I/II clinical trial, Alcohol Use Disorder, neuroplastogen, +1 more

5 terms

Data and Safety Monitoring Board regulatory

"Clearmind Medicine has received Independent Data and Safety Monitoring Board (DSMB) approval"

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.

Phase I/II clinical trial regulatory

"ongoing FDA-regulated Phase I/II clinical trial to parts B and C"

A Phase I/II clinical trial is a combined early-stage study that first checks whether a new drug or treatment is safe for people and then looks for initial signs that it works. Think of it as a safety inspection followed by a short test drive: researchers monitor side effects, appropriate dosing, and early effectiveness. For investors, results from these trials matter because they reduce scientific uncertainty and can significantly change a development program’s value and the likelihood of later regulatory approval.

Alcohol Use Disorder medical

"clinical evaluation of CMND-100 in patients with Alcohol Use Disorder (AUD)"

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.

neuroplastogen medical

"nonhallucinogenic neuroplastogenderived treatments for AUD, addictions, and weight management"

A neuroplastogen is a drug or compound designed to boost the brain’s ability to rewire and form new connections, enhancing recovery or adaptation after injury, stress, or disease. For investors, these molecules matter because they target underlying brain repair processes rather than just masking symptoms, offering the potential for durable benefits in conditions like depression, neurodegeneration, or cognitive decline—akin to giving a tired garden fresh tools to regrow and reshape itself.

pharmacokinetics medical

"designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

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FAQ

What clinical milestone did Clearmind Medicine (CMND) report for CMND-100?

Clearmind reported that an independent DSMB unanimously approved advancing its FDA-regulated Phase I/II trial of CMND-100 for Alcohol Use Disorder to Parts B and C, after Part A met its primary safety endpoint in healthy participants with a favorable tolerability profile.

What does Part B of Clearmind Medicine (CMND)’s CMND-100 trial involve?

Part B will test CMND-100 for the first time in human patients with moderate to severe Alcohol Use Disorder, using two sequential cohorts of six patients at 80 mg and 160 mg doses, assessing safety, tolerability and early signs of reduced alcohol use and craving.

How is Part C of Clearmind Medicine (CMND)’s CMND-100 study designed?

Part C will be conducted in healthy participants with 160 mg of CMND-100 administered daily over five consecutive days in a double-blind, placebo-controlled format, aiming to further define the treatment’s safety and tolerability profile alongside pharmacokinetic characteristics.

Which institutions are running Clearmind Medicine (CMND)’s CMND-100 Phase I/II trial?

The multicenter CMND-100 Phase I/II trial is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center, focusing on safety, tolerability, pharmacokinetics and preliminary efficacy in Alcohol Use Disorder.

What is CMND-100 and Clearmind Medicine (CMND)’s neuroplastogen approach?

CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane), described as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity and enable scalable treatment models without the intensive supervision often associated with classical psychedelic therapies.

What intellectual property position does Clearmind Medicine (CMND) report?

Clearmind states that its intellectual property portfolio consists of nineteen patent families, including 32 granted patents, and indicates an intention to seek additional patents and opportunistically acquire further intellectual property to expand and strengthen its therapeutic pipeline.

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 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 August 6, 2026, titled “Clearmind Reaches Key Clinical Trial Milestone as DSMB Unanimously Clears Progression in AUD Study”.

The first, second, fourth and fifth 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 Clinical Trial Milestone as DSMB Unanimously Clears Progression in AUD Study”

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: August 6, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

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Exhibit 99.1

Clearmind Reaches Key Clinical Trial Milestone as DSMB Unanimously Clears Progression in AUD Study

Clearmind Medicine has received Independent Data and Safety Monitoring Board (DSMB) approval to advance its clinical evaluation of CMND-100 in patients with Alcohol Use Disorder (AUD) - a key milestone in the progression of the Company’s clinical development program.

Vancouver, Canada, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biotechnology company pioneering nonhallucinogenic neuroplastogenderived treatments for AUD, addictions, and weight management, today announced that its independent DSMB has unanimously approved advancing the Company’s ongoing FDA-regulated Phase I/II clinical trial to parts B and C (the two of the remaining 3 parts) of the clinical trial, evaluating CMND-100 in patients actively suffering from AUD and in healthy participants, respectively. The DSMB’s approval follows the successful completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participates. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol.

Part B marks a key clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients with moderate to severe AUD, unlike Part A that included only healthy participants This phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100’s potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND-100 at a fixed daily dose of 160 mg administered over five consecutive days. This double-blind, placebo-controlled segment will further characterize the safety and tolerability profile of CMND-100.

“Receiving DSMB approval to advance our clinical trial to patients with AUD marks an important milestone for Clearmind,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “ With the successful demonstration of safety and tolerability throughout the dose-escalation phase of the study, we are now positioned to evaluate CMND-100 in the population it is designated to help. This transition represents a meaningful step toward advancing a potential new treatment option for individuals living with AUD.”

The multicenter Phase I/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in reducing drinking patterns and alcohol craving in individuals with moderate to severe AUD of CMND-100. The study is being conducted at leading clinical sites, including Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center.

The Company expects to provide additional updates as patient enrollment progresses the clinical program advances.

About CMND-100 and Neuroplastogen Approach

CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane). The Company is developing it as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity while avoiding the perceptual effects associated with classical psychedelics. This profile aims to support scalable treatment models that do not require intensive clinical supervision or prolonged monitored sessions.

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 32 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

www.Clearmindmedicine.com

2

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 trial, advancing a potential new treatment option for individuals living with AUD and the Company’s expectation to provide additional updates as patient enrollment progresses the clinical program advances. 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.

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Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE TITLED: "CLEARMIND REACHES KEY CLINICAL TRIAL MILESTONE AS DSMB UN 17.7 KB