Clearmind (NASDAQ: CMND) explores FDA breakthrough path for CMND-100 in AUD

Rhea-AI Filing Summary

Clearmind Medicine Inc. furnished a report describing its evaluation of lead candidate CMND-100 (MEAI) for potential U.S. FDA Breakthrough Therapy Designation to treat Alcohol Use Disorder. The company cites positive results so far from its ongoing FDA-approved Phase I/IIa clinical trial in this indication.

Clearmind develops non-hallucinogenic, second-generation neuroplastogen-derived therapeutics for under-treated conditions and holds a growing patent portfolio. The company stresses that it has not yet submitted a Breakthrough Therapy Designation request for MEAI and that the FDA has not granted any such designation.

Key Figures

Patent families: 19 patent families Granted patents: 31 granted patents Clinical phase: Phase I/IIa

3 metrics

Patent families 19 patent families Company intellectual property portfolio

Granted patents 31 granted patents Company intellectual property portfolio

Clinical phase Phase I/IIa Ongoing FDA-approved CMND-100 trial in Alcohol Use Disorder

Key Terms

Breakthrough Therapy Designation, Phase I/IIa clinical trial, Alcohol Use Disorder, neuroplastogen-derived therapeutics, +1 more

5 terms

Breakthrough Therapy Designation regulatory

"evaluating its lead candidate, CMND-100 (MEAI), for eligibility for the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

Phase I/IIa clinical trial medical

"positive results demonstrated to date throughout our ongoing 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

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

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

"novel, 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.

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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Form 6-K: How Foreign Companies Report to the SEC →

Accepted by SEC EDGAR 04/27/2026 - 07:45 AM Learn about SEC filing dates

FAQ

What did Clearmind Medicine (CMND) announce in its latest 6-K filing?

Clearmind Medicine reported it is evaluating CMND-100 (MEAI) for potential FDA Breakthrough Therapy Designation in Alcohol Use Disorder. The update is based on positive results from its ongoing FDA-approved Phase I/IIa clinical trial but does not include any regulatory submission or approval.

Has Clearmind Medicine (CMND) applied for FDA Breakthrough Therapy Designation for CMND-100?

No, Clearmind states it has not yet submitted a Breakthrough Therapy Designation request for MEAI, and the FDA has not granted such status. The company is currently assessing eligibility based on positive preliminary clinical results in its Phase I/IIa Alcohol Use Disorder trial.

What condition is Clearmind Medicine (CMND) targeting with CMND-100 (MEAI)?

CMND-100 is being developed to treat Alcohol Use Disorder, a serious and life-threatening condition with significant unmet medical need. Clearmind references positive data from an ongoing FDA-approved Phase I/IIa trial in this indication as part of its evaluation for potential Breakthrough Therapy Designation.

How does Clearmind Medicine (CMND) describe its therapeutic approach?

Clearmind focuses on non-hallucinogenic, second-generation neuroplastogen-derived therapeutics aimed at under-treated health problems such as Alcohol Use Disorder. The company is a clinical-stage biotech seeking to commercialize psychedelic-based compounds as regulated medicines, foods, or supplements, subject to regulatory approvals and successful trials.

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

Clearmind reports an intellectual property portfolio of nineteen patent families and 31 granted patents. The company plans to seek additional patents for its compounds when appropriate and may opportunistically acquire further intellectual property to expand and strengthen its patent portfolio over time.

What forward-looking statements does Clearmind Medicine (CMND) highlight?

Clearmind flags statements about evaluating Breakthrough Therapy Designation, clinical trial timing and progress, and advancing CMND-100 as forward-looking. It notes these are based on current expectations and subject to risks and uncertainties detailed in its SEC filings, including its annual report on Form 20-F.

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 27, 2026, titled “Clearmind Medicine Announces Evaluation of its Psychedelic-Based Treatment (MEAI) for Potential FDA Breakthrough Therapy Designation”.

1

EXHIBIT INDEX

Exhibit No.
99.1		Press release titled: “Clearmind Medicine Announces Evaluation of its Psychedelic-Based Treatment (MEAI) for Potential FDA Breakthrough Therapy Designation”

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 27, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine Announces Evaluation of its Psychedelic-Based Treatment (MEAI) for Potential FDA Breakthrough Therapy Designation

Positive clinical results from Alcohol Use Disorder clinical trial may strengthen potential for eligibility for Breakthrough Therapy Designation

Vancouver, Canada, April 27, 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 it is evaluating its lead candidate, CMND-100 (MEAI), for eligibility for the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD).

“We are encouraged by the recognition and positive developments in the space and are evaluating the suitability for potential Breakthrough Therapy Designation for CMND-100 based on the positive results demonstrated to date throughout our ongoing FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder,” said Dr. Adi Zuloff-Shani, Ph.D., Chief Executive Officer of Clearmind Medicine. “These data, combined with the recent Executive Order signed by President Trump, which accelerates FDA review processes for certain psychedelic and neuroplastogen therapies designated as breakthrough treatments, further support our belief that CMND-100 may meet the rigorous criteria for this important designation.”

The FDA’s Breakthrough Therapy Designation is granted to drugs intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential for substantial improvement over existing therapies on at least one clinically significant endpoints. Alcohol Use Disorder represents a life-threating with a significant unmet medical need, affecting millions worldwide with limited effective treatment options.

Clearmind Medicine remains committed to science-driven development and looks forward to continued engagement with the FDA as it advances CMND-100 toward providing safe, effective, and scalable non-hallucinogenic treatment options for patients.

As of the date hereof, the Company has not submitted a request for Breakthrough Therapy Designation for MEAI, and the FDA has not granted such designation.

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 its evaluation of the suitability for potential Breakthrough Therapy Designation for CMND-100, the timing and progress of its clinical trials, its belief that CMND-100 may meet the rigorous criteria for Breakthrough Therapy Designation, its commitment to science-driven development, and its continued engagement with the FDA as it advances CMND-100 toward providing safe, effective, and scalable non-hallucinogenic treatment options for patients. 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 ANNOUNCES EVALUATION OF ITS PSYCHEDELI 10.9 KB