20 patients treated in Clearmind (Nasdaq: CMND) Phase I/IIa AUD study

Rhea-AI Filing Summary

Clearmind Medicine Inc. filed a Form 6-K highlighting a clinical milestone in its Phase I/IIa trial of CMND-100 (MEAI) for moderate to severe alcohol use disorder. The company has now treated 20 participants across all cohorts, after dosing two additional patients in the fourth cohort.

The fourth cohort is receiving a higher 160 mg dose of CMND-100, following a positive recommendation from the Data and Safety Monitoring Board and successful completion of the third cohort in April 2026. The first three cohorts, totaling 18 participants, met the primary safety endpoint with no serious adverse events reported, supporting continued dose escalation.

The ongoing FDA-approved trial is a multinational, multicenter study assessing safety, tolerability, pharmacokinetics and preliminary efficacy at institutions including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. Clearmind describes itself as a clinical-stage neuroplastogens biotech with 19 patent families and 31 granted patents, focused on non-hallucinogenic treatments for under-served conditions such as alcohol use disorder.

Insights

Biotech clinical-trials analyst

Early-stage CMND-100 trial shows clean safety in initial cohorts and advances to higher dosing.

Clearmind Medicine reports that its FDA-approved Phase I/IIa study of CMND-100 for alcohol use disorder has treated 20 participants, including two newly dosed patients in a higher-dose fourth cohort at 160 mg. The first three cohorts, totaling 18 participants, met the primary safety endpoint with no serious adverse events.

Phase I/IIa studies primarily test safety, tolerability and pharmacokinetics, with preliminary efficacy as an exploratory goal. The favorable safety profile across escalating doses supports continuing the trial and helps justify progressing to higher exposure levels while monitoring patients at Yale, Johns Hopkins and Israeli centers.

From an investment perspective, this is a typical early-clinical update rather than a pivotal outcome. Future company disclosures will be important for understanding any signals on efficacy, longer-term safety and how CMND-100, as a non-hallucinogenic neuroplastogen, might fit into the broader treatment landscape for alcohol use disorder.

Key Figures

Participants treated: 20 participants Fourth cohort dose: 160 mg Participants in first three cohorts: 18 participants +2 more

5 metrics

Participants treated 20 participants Total treated to date across all CMND-100 Phase I/IIa cohorts

Fourth cohort dose 160 mg CMND-100 dose level in fourth cohort after DSMB recommendation

Participants in first three cohorts 18 participants Earlier CMND-100 cohorts that met the primary safety endpoint

Patent families 19 patent families Clearmind’s intellectual property portfolio breadth

Granted patents 31 granted patents Granted patents within Clearmind’s 19 patent families

Key Terms

Phase I/IIa, Data and Safety Monitoring Board (DSMB), primary safety endpoint, neuroplastogen-derived therapeutics, +2 more

6 terms

Phase I/IIa medical

"ongoing Phase I/IIa trial of CMND-100 for Alcohol Use Disorder"

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.

Data and Safety Monitoring Board (DSMB) medical

"following the positive Data and Safety Monitoring Board (DSMB) recommendation"

An independent panel of medical, statistical and ethical experts who regularly review the safety and results coming from a clinical trial and can recommend changes, pauses or early stop if risks or benefits become clear. Think of it as an impartial referee watching a game to protect participants and ensure the score is reliable; its decisions can materially affect trial timing, regulatory approval prospects and therefore investor value.

primary safety endpoint medical

"met the primary safety endpoint with no serious adverse events reported"

The primary safety endpoint is the single main measure used in a clinical trial to judge whether a treatment causes unacceptable harm, typically tracking key side effects or serious health problems over a specified time. Investors care because this pre‑specified safety measure is a primary thermometer for regulatory decisions and commercial risk: a negative result can block approval or shrink market value, while a clean result lowers the chance of costly delays or restrictions.

neuroplastogen-derived therapeutics medical

"non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems"

Neuroplastogen-derived therapeutics are drugs or biological treatments developed from compounds that promote neuroplasticity — the brain’s ability to rewire and form new connections after injury or in response to learning. For investors, they matter because these therapies target underlying brain repair mechanisms rather than only masking symptoms, offering the potential for durable benefits in conditions like depression, stroke recovery, or neurodegeneration; if effective, they can create large, high-value markets similar to replacing a faulty bridge with a stronger one.

Alcohol Use Disorder (AUD) medical

"Phase I/IIa clinical trial evaluating CMND-100 (MEAI) for the treatment of moderate to severe Alcohol Use Disorder (AUD)"

A chronic medical condition in which a person repeatedly drinks alcohol in a way that they cannot control, continuing despite harm to their health, work or relationships; it ranges from risky drinking to severe dependence. Investors should care because AUD drives demand for treatments, public health spending, workplace productivity losses and regulatory attention—similar to how a persistent mechanical problem increases repair and operating costs, it creates long-term market and policy implications for healthcare, insurers and employers.

forward-looking statements regulatory

"This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What clinical milestone did Clearmind Medicine (CMND) report in this Form 6-K?

Clearmind Medicine reported treating 20 participants in its ongoing FDA-approved Phase I/IIa trial of CMND-100 for moderate to severe alcohol use disorder. This includes two newly dosed patients in the fourth cohort, marking continued progress in the multinational, multicenter dose-escalation study.

What is CMND-100 in Clearmind Medicine’s (CMND) alcohol use disorder trial?

CMND-100 (also referred to as MEAI) is Clearmind Medicine’s investigational, non-hallucinogenic, second-generation neuroplastogen-derived therapeutic candidate. It is being evaluated in a Phase I/IIa trial to assess safety, tolerability, pharmacokinetics and preliminary efficacy in patients with moderate to severe alcohol use disorder.

What safety results has Clearmind Medicine (CMND) reported so far for CMND-100?

Clearmind states that the first three cohorts in the CMND-100 Phase I/IIa trial, involving 18 participants, met the primary safety endpoint with no serious adverse events reported. These findings supported advancing to a higher 160 mg dose in the fourth cohort within the ongoing study.

Where is Clearmind Medicine’s (CMND) CMND-100 Phase I/IIa trial being conducted?

The CMND-100 Phase I/IIa trial is being run as a multinational, multicenter study at leading institutions including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center, reflecting broad academic involvement in evaluating the candidate.

What stage of development is Clearmind Medicine (CMND) in and what is its focus?

Clearmind describes itself as a clinical-stage neuroplastogens pharmaceutical biotech company. It focuses on discovering and developing non-hallucinogenic, second-generation neuroplastogen-derived therapeutics to address under-treated conditions, including alcohol use disorder, and holds 19 patent families with 31 granted patents in its intellectual property portfolio.

What dose level is being tested in the fourth cohort of Clearmind (CMND)’s CMND-100 trial?

The fourth cohort in Clearmind’s Phase I/IIa CMND-100 trial is testing a 160 mg dose. This higher dose follows a positive recommendation from the Data and Safety Monitoring Board and successful completion of the third cohort, enabling continued escalation within the approved clinical protocol for alcohol use disorder.

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 12, 2026, titled “Clearmind Medicine Reaches Important Clinical Milestone: 20 Participants Now Treated in Ongoing Phase I/IIa Trial of CMND-100 for Alcohol Use Disorder”.

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, 333-293521 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 Reaches Important Clinical Milestone: 20 Participants Now Treated in Ongoing Phase I/IIa Trial of CMND-100 for Alcohol Use Disorder”

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 12, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine Reaches Important Clinical Milestone: 20 Participants Now Treated in Ongoing Phase I/IIa Trial of CMND-100 for Alcohol Use Disorder

Vancouver, Canada, May 12, 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 two additional participants have been successfully dosed in the fourth cohort of its FDA-approved Phase I/IIa clinical trial evaluating CMND-100 (MEAI) for the treatment of moderate to severe Alcohol Use Disorder (AUD).

This milestone brings the total number of participants treated to date across all cohorts to 20, reflecting strong momentum and continued progress in the multinational, multicenter study.

The two newly dosed patients in the fourth cohort were treated at Hadassah-University Medical Center in Jerusalem, Israel, one of the key active trial sites. The fourth cohort features a higher dose of CMND-100 (160 mg), following the positive Data and Safety Monitoring Board (DSMB) recommendation and successful completion of the third cohort in April 2026.

Building on highly encouraging safety and tolerability data from the first three cohorts (which included 18 participants and met the primary safety endpoint with no serious adverse events reported), the Company continues to advance the dose-escalation phase of the trial. Previous cohorts demonstrated a favorable safety profile consistent with earlier results, supporting further evaluation of CMND-100’s potential as a novel, non-hallucinogenic treatment option for AUD.

“Reaching the 20- participants milestone and successfully initiating dosing in the fourth cohort at our Israeli site is an important step forward,” said Dr. Adi Zuloff-Shani, Ph.D., Chief Executive Officer of Clearmind Medicine. “The consistent safety data observed so far across all cohorts reinforces our confidence in CMND-100 and brings us closer to potentially delivering a much-needed new therapeutic option for patients struggling with alcohol use disorder.”

The ongoing FDA-approved Phase I/IIa trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The trial is being conducted at leading institutions including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

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:

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 timing and progress of it clinical trials and potentially delivering a much-needed new therapeutic option for patients struggling with 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.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE TITLED: "CLEARMIND MEDICINE REACHES IMPORTANT CLINICAL MILESTONE: 9.9 KB