Clearmind outlines AUD drug at FDA psychedelic hearing

Rhea-AI Filing Summary

Clearmind Medicine Inc. (CMND), a clinical-stage biopharmaceutical company focused on non-hallucinogenic psychedelic-derived neuroplastogens, reported that, following an invitation from the U.S. Food and Drug Administration, it testified at an FDA hearing on September 14, 2026 on “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” Clearmind’s Chief of Global Impact, Mary-Elizabeth Gifford, briefed a federal panel on patient access, sharing insights from the company’s clinical trial being conducted at Yale University Medical School and Johns Hopkins University.

The company highlighted its proprietary candidate MEAI, developed for Alcohol Use Disorder, which is being evaluated in an FDA-approved clinical trial and is among a limited number of non-hallucinogenic, psychedelic-derived neuroplastogens to reach a Phase 2a clinical trial. Clearmind also noted its intellectual property position, with nineteen patent families and 32 granted patents, and emphasized its strategy to develop scalable, potentially more accessible treatments for neuropsychiatric, metabolic, and addiction disorders.

Key Figures

Participants at FDA hearing: 1,800 participants Prevalence of Alcohol Use Disorder: 1 in 10 Americans Patent families: 19 patent families +2 more

5 metrics

Participants at FDA hearing 1,800 participants Approximate number attending the FDA psychedelic hearing in person and virtually

Prevalence of Alcohol Use Disorder 1 in 10 Americans AUD described as affecting one in ten Americans

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

Granted patents 32 granted patents Granted patents within Clearmind’s IP portfolio

Clinical trial phase for MEAI Phase 2a MEAI is among limited non-hallucinogenic psychedelic-derived neuroplastogens to reach Phase 2a

Key Terms

neuroplastogen, Alcohol Use Disorder, Phase 2a clinical trial, forward-looking statements, +1 more

5 terms

neuroplastogen medical

"advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment"

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.

Alcohol Use Disorder medical

"proprietary drug candidate for the treatment of AUD, 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.

Phase 2a clinical trial medical

"among a limited number of neuroplastogen candidates to have advanced to a Phase 2a clinical trial"

A phase 2a clinical trial is an early-stage human study that tests a medical treatment in a small group of patients to learn whether it appears to work, to refine the right dose, and to monitor short-term safety. Investors watch these trials like prototype test drives: positive results reduce uncertainty about a drug’s chances, help estimate remaining development time and cost, and often trigger valuation changes or partnership interest in a drug program.

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.

psychedelic-derived medical

"development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics"

FAQ

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

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

Clearmind Medicine reported that, after an invitation from the FDA, it testified at a federal hearing on potential future therapeutic use of psychedelic drugs, focusing on patient access and insights from its clinical trial at Yale and Johns Hopkins involving its MEAI drug candidate.

What is MEAI and how is Clearmind Medicine (CMND) developing it?

MEAI is Clearmind’s proprietary non-hallucinogenic, psychedelic-derived neuroplastogen drug candidate for Alcohol Use Disorder (AUD). It is being evaluated in an FDA-approved clinical trial at Yale University Medical School and Johns Hopkins University and has advanced to a Phase 2a clinical trial.

How prevalent is Alcohol Use Disorder according to Clearmind Medicine (CMND)?

Clearmind states that its MEAI candidate targets Alcohol Use Disorder, described as a condition that affects one in ten Americans and is considered a leading cause of preventable deaths for working age adults, underscoring the potential public health relevance of its development efforts.

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

Clearmind reports an intellectual property portfolio consisting of nineteen patent families, including 32 granted patents. The company states that it intends to seek additional patents and may acquire more intellectual property to build its portfolio where warranted.

What was the scale and focus of the FDA psychedelic hearing Clearmind (CMND) attended?

The FDA’s psychedelic hearing, which Clearmind describes as history-making, drew approximately 1,800 participants in person and virtually. It focused on issues such as patient access, provider training, patient safety, and data collection and standardization for potential future therapeutic use of psychedelic drugs.

On which exchange are Clearmind Medicine (CMND) shares listed?

Clearmind states that its shares are listed for trading on Nasdaq under the symbol "CMND", reflecting its status as a publicly traded clinical-stage neuroplastogens pharmaceutical biotech company.

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

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Available on EDGAR 09/17/2026 - 04:00 PM Accepted by SEC EDGAR 09/17/2026 - 04:00 PM 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 17, 2026, titled “Clearmind Medicine Delivers Briefing to FDA Following Invitation to Historic Psychedelic Hearing in Washington, D.C.”.

1

EXHIBIT INDEX

Exhibit No.
99.1		Press release titled: “Clearmind Medicine Delivers Briefing to FDA Following Invitation to Historic Psychedelic Hearing in Washington, D.C.”

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 17, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine Delivers Briefing to FDA Following Invitation to Historic Psychedelic Hearing in Washington, D.C.

Mary-Elizabeth Gifford, Chief of Global Impact at Clearmind Medicine, spoke on patient access and shared insights from Clearmind’s clinical trial at Yale and Johns Hopkins

Vancouver, Canada, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company” or “Clearmind”), 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”), today announced that, following an invitation from the U.S. Food and Drug Administration (“FDA”), it testified at the FDA’s history-making psychedelic hearing in the nation’s capital on September 14, 2026. Clearmind’s Chief of Global Impact, Mary-Elizabeth Gifford, briefed a federal panel convened by the FDA to evaluate “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.”

The history-making hearing marked a dedicated federal forum convened by the FDA to gather public input on the potential future therapeutic use of psychedelic drugs, bringing together senior FDA officials and federal partners from Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institutes of Health and the Veterans Health Administration.

Invited to address the question of “Patient Access” Gifford said: “At Clearmind Medicine, our clinical trial at Yale and Johns Hopkins have generated findings suggesting that a next-generation category of psychedelics, neuroplastogenic compounds, which retain the therapeutic benefits of neuroplasticity enhancement while eliminating the hallucinogenic effects of legacy psychedelics, may help mitigate the need for expensive supervised dosing. Our findings have led us to believe that this may represent a scalable treatment model that is a replicable and shareable opportunity for the future of American health.”

In addition to soliciting expertise on patient access, the FDA’s hearing also invited testimony on provider training and credentialing, patient safety, and best practices for data collection and standardization.

Tiffany R. Farchione, M.D., Director, Division of Psychiatry, Center for Drug Evaluation and Research (CDER) Office of New Drugs, sat on the day’s Federal Listening Panel, as did senior leadership from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse (NIDA), the Advanced Research Projects Agency for Health (ARPA-H) and the Veterans Health Administration. Approximately 1,800 participants attended the hearing in person and virtually.

At the hearing, Gifford told the FDA panel that next-generation psychedelic neuroplastogens that do not need expensive supervised dosing may reduce health disparities and achieve patient access for those with intractable substance use disorders and “myriad other diagnoses that could be treated safely under medical care.” 

She concluded: “This secures responsible patient access, not through new expensive frameworks that are yet to be built, but through America’s already existing primary care and VA resources.”

MEAI, Clearmind’s proprietary drug candidate for the treatment of AUD, a condition that affects one in ten Americans, and is considered a leading cause of preventable deaths for working age adults, is currently being evaluated in FDA-approved clinical trial at Yale University Medical School and Johns Hopkins University. MEAI is also among a limited number of non-hallucinogenic, psychedelic-derived neuroplastogen candidates to have advanced to a Phase 2a clinical trial.

“We are grateful to the FDA and federal health officials for leading this important national conversation and for its visionary encouragement of responsible biopharma innovation in addiction treatment, including the treatment of AUD,” said Adi Zuloff-Shani, Ph.D., Chief Executive Officer of Clearmind Medicine. Zuloff-Shani, Ph.D. added, “We appreciate the opportunity to contribute to this emerging technological field, with MEAI representing our commitment to developing innovative treatments that could ultimately be both effective and more accessible to patients. Mary-Elizabeth Gifford speaks for all of us at Clearmind, articulating our collective mission to bridge rigorous evidence-based research with federal policy that could potentially help us to accelerate improved care for patients across the US and globally.”

Gifford, Clearmind’s Chief of Global Impact, anchors the biopharma’s presence in New York City and Washington, D.C., and has been described by Spirituality & Health magazine as “the most quietly influential woman working in psychedelics today.” Her pro-bono contributions to the field of psychedelic medicine include chairing the steering committee for the Psychedelic Medicine Coalition Annual Federal Psychedelic Summit at the National Press Club and heading the non-profit Global Wellness Institute’s Psychedelics & Healing Initiative.

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

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 potential therapeutic profile of neuroplastogenic compounds, the development and clinical advancement of MEAI, the potential benefits of the Company's product candidates, the implications of its participation in the FDA hearing, and the Company's plans, objectives and expectations regarding future research, development and commercialization 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 MEDICINE DELIVERS BRIEFING TO FDA FOLLOWING INV 14.0 KB