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

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Clearmind Medicine (Nasdaq: CMND) submitted a formal response to a U.S. Department of Health and Human Services Request for Information under the Great American Recovery Initiative, outlining MEAI’s potential as an empirically supported, non-hallucinogenic treatment for addiction, especially Alcohol Use Disorder (AUD).

The company highlights CMND-100, its proprietary MEAI-based neuroplastogen candidate for AUD and binge behaviors, designed as a scalable, at-home, FDA-regulated therapy with low abuse potential. Clearmind notes AUD affects about 10% of Americans, with only 1 in 10 receiving treatment, and positions neuroplastogen-based therapies as compatible with community, rural, and underserved settings.

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Positive

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Negative

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News Market Reaction – CMND

-1.93%
-1.93% Session close to close

In the Jul 10 session, CMND declined 1.93%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Clearmind’s response to the HHS addiction-treatment RFI spotlights CMND-100 and MEAI-based neuroplas...
Analysis

Clearmind’s response to the HHS addiction-treatment RFI spotlights CMND-100 and MEAI-based neuroplastogens for AUD, building on recent trial and patent progress. Investors face ongoing overhang from an effective resale shelf and elevated short interest, making regulatory and clinical milestones key to monitor.

Key Figures

AUD prevalence: 10% of U.S. population Treatment rate: 1 in 10 Americans Neural pathway target: 5-HT1A
3 metrics
AUD prevalence 10% of U.S. population Alcohol Use Disorder burden cited in HHS RFI response
Treatment rate 1 in 10 Americans Portion of people with AUD reported as receiving treatment
Neural pathway target 5-HT1A Pathway MEAI is designed to engage for moderation and recovery

Historical Context

5 past events · Latest: Jul 07 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 07 Formulation study update Positive -9.4% Reported successful feasibility for intranasal MEAI formulation for AUD treatment.
Jun 29 U.S. patent grant Positive -3.4% Announced new U.S. patent expanding IP around MEAI for binge behaviors.
Jun 22 Trial milestone Positive -4.6% Completed treatment for all 24 participants in Part A of Phase I/II trial.
Jun 18 U.S. patent grant Positive -2.9% Received U.S. patent covering MEAI compositions for regulating binge behaviors.
Jun 16 Trial dosing update Positive -6.8% Reported completion of dosing in Part A cohorts with strong interim safety profile.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive clinical and IP updates have tended to coincide with negative next‑day price reactions.

Key Terms

neuroplastogens, 5-ht1a, alcohol use disorder
3 terms
neuroplastogens medical
"an emerging class of pharmaceutical agents, non-hallucinogenic neuroplastogens, which promote"
Neuroplastogens are drugs or molecules designed to boost the brain’s ability to reorganize and form new connections—think of them as medicines that help the brain ‘rewire’ itself after damage or during therapy. Investors watch them because successful neuroplastogens could become treatments for conditions like depression, Alzheimer’s, or brain injury, creating large markets and sharp changes in company value as trials, approvals, or setbacks occur.
5-ht1a medical
"designed to engage neural pathways, such as 5-HT1A, to support moderation"
5-HT1A is a specific protein on nerve cells that responds to serotonin, a brain chemical involved in mood, anxiety and other functions. Investors care because drugs that activate or block this receptor can change symptoms, side effects and how well a medicine works, so success or failure of such drugs can strongly affect a biotech’s prospects — think of the receptor as a lock and a drug as the key that can turn symptoms up or down.
alcohol use disorder medical
"enable inexpensive, scalable, and clinically effective treatment for Americans living with 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.

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

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Vancouver, Canada, July 10, 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


FAQ

What did Clearmind Medicine (NASDAQ: CMND) submit to the HHS addiction treatment RFI in July 2026?

Clearmind Medicine submitted a formal response to the U.S. HHS Request for Information on addiction treatment, focused on its MEAI-based candidate CMND-100. According to Clearmind, the submission outlines a scalable, non-hallucinogenic neuroplastogen approach for Alcohol Use Disorder and binge behaviors.

What is Clearmind Medicine’s CMND-100 and how is it intended to treat Alcohol Use Disorder (CMND)?

CMND-100 is Clearmind’s proprietary MEAI-based, non-hallucinogenic neuroplastogen candidate for Alcohol Use Disorder and binge behaviors. According to Clearmind, it is designed to enhance neuroplasticity, target pathways such as 5-HT1A, and support moderation and long-term recovery through scalable, at-home treatment.

How does Clearmind Medicine’s MEAI approach differ from classic psychedelic treatments for addiction?

Clearmind’s MEAI approach aims to deliver neuroplasticity benefits similar to classic psychedelics without hallucinations or lengthy supervised dosing. According to Clearmind, its non-hallucinogenic neuroplastogens seek to enable inexpensive, scalable, FDA-regulated treatment suitable for broad community, rural, and underserved healthcare settings.

What addiction and mental health needs is Clearmind Medicine targeting with CMND-100 (NASDAQ: CMND)?

Clearmind is targeting Alcohol Use Disorder and binge behaviors, noting AUD affects about 10% of Americans and few receive treatment. According to Clearmind, CMND-100 is positioned as a non-opioid, low-abuse-potential option integrated into broader recovery strategies emphasizing moderation and resilience.

How is Clearmind Medicine supporting the Great American Recovery Initiative on addiction?

Clearmind is contributing clinical insights and data on MEAI-based CMND-100 in response to the HHS RFI under the Great American Recovery Initiative. According to Clearmind, its work aligns with federal goals to expand innovative, non-opioid, empirically evidenced treatments using existing federal resources.