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Clearmind Medicine (Nasdaq: CMND) details neuroplastogen-based response to U.S. addiction RFI

(Neutral)
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Clearmind Medicine Inc., a clinical-stage biotech focused on non-hallucinogenic neuroplastogen therapies for addiction and mental health conditions, reported that it submitted a formal response to a U.S. Department of Health and Human Services Request for Information on addiction treatment innovations under the Great American Recovery Initiative.

The company’s response centers on its proprietary MEAI-based candidate CMND-100, a non-hallucinogenic neuroplastogen being developed for Alcohol Use Disorder (AUD) and binge behaviors, highlighting a potential scalable, at-home treatment model with low abuse potential that targets neural pathways such as 5-HT1A. Clearmind notes that AUD affects roughly 10% of the U.S. population while only 1 in 10 affected individuals receive treatment, and positions MEAI-based therapies as candidates to support moderation and long-term recovery. The company also reiterates that it is a clinical-stage neuroplastogen pharmaceutical biotech with nineteen patent families, including 32 granted patents, and that its shares trade on Nasdaq under the symbol CMND.

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AUD prevalence in U.S. 10% of the U.S. population Approximate share of U.S. population affected by Alcohol Use Disorder cited by the company
Treatment coverage for AUD 1 in 10 Americans receiving treatment Proportion of Americans with Alcohol Use Disorder reported as receiving treatment
Patent families nineteen patent families Size of Clearmind’s intellectual property portfolio as described
Granted patents 32 granted patents Number of granted patents within Clearmind’s nineteen patent families
neuroplastogen medical
"developing novel, non-hallucinogenic, next-generation, neuroplastogen-derived therapeutics to solve major under-treated mental health problems"
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
"with a focus on Alcohol Use Disorder and other addiction related diagnoses"
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.
Request for Information (RFI) regulatory
"submitted a formal response to the U.S. Department of Health and Human Services (HHS) Request for Information (RFI)"
A request for information (RFI) is a formal inquiry a company or government makes to gather basic facts, capabilities, pricing ranges, or timelines from suppliers, partners, or other parties before deciding how to proceed. For investors, an RFI can signal early-stage interest in a contract, product or project that may lead to revenue, spending or regulatory action—think of it as a company asking for quotes and details before committing to a purchase or partnership, which helps assess future business prospects and risks.
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.
abuse liability medical
"offering a differentiated profile with reduced abuse liability and a focus on moderation and resilience"

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

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FAQ

What did Clearmind Medicine (CMND) announce regarding U.S. addiction treatment policy?

Clearmind Medicine announced it submitted a formal response to a U.S. Department of Health and Human Services Request for Information on addiction treatment innovations under the Great American Recovery Initiative, outlining how its MEAI-based CMND-100 may fit emerging treatment models.

How is Clearmind Medicine (CMND) positioning its CMND-100 candidate for Alcohol Use Disorder?

Clearmind is positioning CMND-100, an MEAI-based non-hallucinogenic neuroplastogen, as a potential scalable, clinically effective treatment for Alcohol Use Disorder and binge behaviors, emphasizing at-home use, low abuse potential, and engagement of neural pathways such as 5-HT1A to support moderation and long-term recovery.

What market need does Clearmind Medicine (CMND) highlight for Alcohol Use Disorder treatments?

Clearmind highlights that Alcohol Use Disorder affects approximately 10% of the U.S. population, yet only 1 in 10 affected Americans receive treatment, underscoring a large under-served population that may benefit from new non-hallucinogenic neuroplastogen-based therapies like CMND-100.

What therapeutic focus does Clearmind Medicine (CMND) describe in this update?

Clearmind describes a focus on non-hallucinogenic, second-generation neuroplastogens designed to provide psychedelic-like neuroplasticity benefits without hallucinations or lengthy supervised dosing, aiming to integrate these therapies into broader addiction recovery strategies emphasizing moderation and resilience.

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

Clearmind reports an intellectual property portfolio consisting of nineteen patent families, including 32 granted patents, and indicates it plans to seek additional patents and selectively acquire further intellectual property to support its neuroplastogen-based therapeutic pipeline.

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

Shares of Clearmind Medicine are listed for trading on Nasdaq under the symbol CMND, providing public market access for investors interested in its development of non-hallucinogenic neuroplastogen-derived therapeutics for addiction and related mental health conditions.

 

 

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: July 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 July 10, 2026, titled “Clearmind Medicine Responds to the U.S. Administration’s RFI for Addiction Treatment Innovations as Part of the Great American Recovery Initiative”.

 

1

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “Clearmind Medicine Responds to the U.S. Administration’s RFI for Addiction Treatment Innovations as Part of the Great American Recovery Initiative”

 

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: July 10, 2026 By: /s/ Adi Zuloff-Shani
  Name:  Adi Zuloff-Shani
  Title: Chief Executive Officer

 

3

 

Exhibit 99.1

 

 

Clearmind Medicine Responds to the U.S. Administration’s RFI for Addiction Treatment Innovations as Part of the Great American Recovery Initiative

 

Vancouver, Canada, July 9, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage a biotech company developing novel, non-hallucinogenic, next-generation, neuroplastogen-derived therapeutics to solve major under-treated mental health problems, with a focus on Alcohol Use Disorder and other addiction related diagnoses, today announced that it has submitted a formal response to the U.S. Department of Health and Human Services (HHS) Request for Information (RFI) about MEAI’s potential as an innovative, empirically-evidenced intervention for the treatment of addiction.

 

Clearmind proposes an innovative model to enable inexpensive, scalable, and clinically effective treatment for Americans living with alcohol use disorder (AUD). The Clearmind approach places a focus on FDA-regulated research and development of an emerging class of pharmaceutical agents, non-hallucinogenic neuroplastogens, which promote the neuroplasticity provided by classic psychedelics but without hallucinogenic and the need for hours of costly supervised dosing.

 

In its submission, Clearmind highlights its proprietary MEAI-based candidate CMND-100, an innovative non-hallucinogenic neuroplastogen for AUD and binge behaviors. The document emphasizes that AUD affects approximately 10% of the U.S. population, with only 1 in 10 Americans receiving treatment, and positions MEAI as a potentially leading intervention that may meet many objectives of the U.S. Administration, including through MEAI’s scalable, at-home solution with low abuse potential that is designed to engage neural pathways, such as 5-HT1A, to support moderation and long-term recovery

 

“Clearmind’s submission to the HHS RFI underscores our commitment to supporting the Great American Recovery Initiative with science-driven, non-opioid solutions for addiction,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “We believe that CMND-100 represents a promising new approach that could help millions struggling with alcohol use disorder and binge behaviors. We are proud to contribute our clinical insights and data to this important national effort aimed at enhancing prevention, treatment, and long-term recovery. We are grateful that President Trump and Secretary Kennedy are looking to transform addiction treatment through the expansion of new therapeutic approaches, and our research at Yale and Johns Hopkins indicates that MEAI is well-positioned to lead in these efforts.”

 

This RFI is part of the Administration’s Great American Recovery Initiative. It invites researchers, companies, healthcare providers and the public to submit comments, successful programs, and novel policy ideas aimed at improving prevention, treatment, and recovery from addiction and co-occurring mental health conditions, using existing federal resources.

 

The HHS RFI, issued following President Trump’s Executive Orders on addiction and recovery, seeks public input on successful research, programs, and policies, as well as novel ideas to close gaps using existing funding.

 

With its focus on neuroplastogens, Clearmind is working to offer safe, reproducible delivery across community-based, rural, and underserved settings where until now access to addiction treatment remains constrained, as well as in under-served urban health care systems.

 

Clearmind’s response emphasizes the potential of neuroplastogen-based therapies like CMND-100 to integrate into broader recovery strategies, offering a differentiated profile with reduced abuse liability and a focus on moderation and resilience rather than traditional harm reduction models.

 

 

 

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 MEAI’s potential as an innovative, empirically-evidenced intervention for the treatment of addiction, MEAI’s position as a potentially leading intervention that may meet many objectives of U.S. administration, its commitment to supporting the Great American Recovery Initiative with science-driven, non-opioid solutions for addiction, its belief that CMND-100 represents a promising new approach that could help millions struggling with alcohol use disorder and binge behaviors, transforming addiction treatment through the expansion of new therapeutic approaches, how Clearmind is working to offer safe, reproducible delivery across community-based, rural, and underserved settings and the potential of neuroplastogen-based therapies like CMND-100 to integrate into broader recovery strategies.. 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