Clearmind CMND-100 Hits Primary Endpoint in AUD Trial

Clearmind Medicine Inc. reported that its oral drug candidate CMND-100, a non-hallucinogenic MEAI-based therapy for alcohol use disorder, met the primary safety and tolerability endpoint in an FDA-approved Phase I/IIa clinical trial.

Rhea-AI Filing Summary

Clearmind Medicine Inc. reported that its oral drug candidate CMND-100, a non-hallucinogenic MEAI-based therapy for alcohol use disorder, met the primary safety and tolerability endpoint in an FDA-approved Phase I/IIa clinical trial.

Data from the trial’s third cohort showed CMND-100 was well tolerated at the highest dose tested so far, with no serious adverse events and a high safety profile consistent with earlier cohorts. The multinational, multicenter study is also assessing pharmacokinetics and preliminary efficacy in patients with moderate to severe alcohol use disorder. The company highlights this milestone as supporting continued development of CMND-100 as a potential novel treatment option.

Positive

• CMND-100 met its primary safety and tolerability endpoint in an FDA-approved Phase I/IIa trial for alcohol use disorder, including at the highest dose tested in the third cohort with no serious adverse events reported.
• Early clinical data support continued advancement of a non-hallucinogenic MEAI-based therapy for alcohol use disorder, addressing a large, underserved condition where treatment innovation has historically been limited.

Negative

• None.

Insights

Biotech clinical development analyst

Clearmind achieved a key safety milestone for CMND-100, supporting continued AUD development.

Clearmind Medicine announced that CMND-100, its non-hallucinogenic MEAI-based candidate for alcohol use disorder, met the primary safety and tolerability endpoint in an FDA-approved Phase I/IIa trial. The third cohort, using the highest dose to date, reported no serious adverse events and good tolerability.

This outcome reduces early-stage safety risk and supports advancing development, particularly because alcohol use disorder patients often have comorbidities that heighten safety concerns. The study is multinational and multicenter, which can enhance data robustness across different clinical environments.

The company emphasizes CMND-100’s non-hallucinogenic profile and positions it as a potential novel option in an underserved indication. Future disclosures from later-stage trials will be important to understand efficacy and durability of response beyond the current preliminary data focus.

Key Figures

Trial phase: Phase I/IIa Cohort level: Third cohort Patent families: 19 patent families +3 more

6 metrics

Trial phase Phase I/IIa Clinical trial stage for CMND-100 in alcohol use disorder

Cohort level Third cohort Highest CMND-100 dose tested so far showed high safety

Patent families 19 patent families Size of Clearmind’s intellectual property portfolio

Granted patents 31 granted patents Granted patents within Clearmind’s IP portfolio

Listing Nasdaq: CMND Clearmind’s shares listed on Nasdaq under symbol CMND

Fiscal year end October 31, 2025 Year-end date referenced for Form 20-F risk factors

Key Terms

Phase I/IIa clinical trial, Alcohol Use Disorder, neuroplastogen-derived therapeutics, MEAI-based, +1 more

5 terms

Phase I/IIa clinical trial medical

"FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder"

An early-stage clinical study that combines initial safety testing (Phase I) with a first look at whether a treatment shows signs of working in patients (Phase IIa). Investors watch these trials because they move a therapy from lab research toward proof that it can help people; successful results reduce technical risk and can unlock bigger trials, partnerships, regulatory attention, or increases in a company’s value — like a prototype test that determines whether a product should go into full production.

Alcohol Use Disorder medical

"oral drug candidate, for the treatment of 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-derived therapeutics medical

"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.

MEAI-based medical

"proprietary non-hallucinogenic MEAI-based oral drug candidate"

MEAI-based describes products or research built around MEAI, a synthetic small-molecule compound developed as a potential alcohol alternative and mood-affecting ingredient. For investors it matters because these offerings face a mix of upside and risk: they can tap large beverage and wellness markets if shown safe and effective, but they also carry regulatory scrutiny, clinical and safety data risk, and potential liability—similar to backing a new drug or novel food ingredient.

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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Clearmind Medicine (CMND) announce about CMND-100 in this filing?

Clearmind Medicine reported that CMND-100 met the primary safety and tolerability endpoint in its FDA-approved Phase I/IIa trial for alcohol use disorder. The third cohort showed the highest dose so far was well tolerated, with no serious adverse events observed in participants.

What is CMND-100 and what condition is Clearmind Medicine targeting?

CMND-100 is Clearmind’s proprietary, non-hallucinogenic, MEAI-based oral drug candidate developed to treat alcohol use disorder. The company focuses on second-generation neuroplastogen-derived therapeutics aimed at widespread, underserved health problems, with alcohol use disorder being a primary indication in this program.

What were the key safety results from the CMND-100 Phase I/IIa trial?

In the third cohort of the Phase I/IIa study, CMND-100 demonstrated a high safety profile and was well tolerated at the highest dosage administered to date. No serious adverse events were reported, and tolerability was consistent with earlier cohorts’ favorable safety outcomes in the same trial.

What is the design and goal of Clearmind’s Phase I/IIa trial for CMND-100?

The Phase I/IIa trial is a multinational, multicenter study in patients with moderate to severe alcohol use disorder. It is designed to evaluate CMND-100’s safety, tolerability, pharmacokinetics, and preliminary efficacy, with the primary endpoint focused on safety and tolerability in a dose-escalation framework.

How does this CMND-100 milestone affect Clearmind Medicine’s development plans?

Meeting the primary safety and tolerability endpoint, including at a higher dose in the third cohort, supports Clearmind’s continued advancement of CMND-100. The company presents this as reinforcing CMND-100’s potential as a novel, non-hallucinogenic treatment option for alcohol use disorder in future studies.

What intellectual property position does Clearmind Medicine report in this document?

Clearmind states that its intellectual property portfolio currently includes nineteen patent families and 31 granted patents. The company intends to seek additional patents when appropriate and may opportunistically acquire more intellectual property to further build and protect its therapeutic pipeline.

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

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Accepted by SEC EDGAR 04/14/2026 - 08:23 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: April 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 April 14, 2026, titled “Clearmind Medicine’s CMND-100 Meets Primary Endpoint in FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder”.

1

EXHIBIT INDEX

Exhibit No.
99.1		Press release titled: “Clearmind Medicine’s CMND-100 Meets Primary Endpoint in FDA-Approved Phase I/IIa Clinical Trial 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: April 14, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine’s CMND-100 Meets Primary Endpoint in FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder

Vancouver, Canada, April 14, 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 CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD) has met the primary endpoint in its FDA-approved Phase I/IIa clinical trial.

Results from the third cohort of the trial indicated a high safety profile for CMND-100, even at the higher dosage administered to date. The data demonstrated that the drug candidate was well tolerated, with no serious adverse events reported in the third cohort and continued favorable overall tolerability, consistent with the safety outcomes observed in prior cohorts.

The Phase I/IIa clinical 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. Meeting the primary safety and tolerability endpoint in this dose-escalation stage, including at the higher dosage in the third cohort, supports continued advancement of CMND-100 as a potential novel, non-hallucinogenic treatment option for AUD.

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 its clinical trials. 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'S CMND-100 MEETS PRIMARY ENDPOINT IN F 9.0 KB