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New MDMA combo targets PTSD, anxiety at Clearmind (NASDAQ: CMND)

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(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Clearmind Medicine Inc. (CMND), a clinical-stage biopharmaceutical company, reports a key intellectual property milestone with U.S. publication of its patent application covering a novel combination of MDMA and N-acylethanolamines, such as palmitoylethanolamide (PEA), for treating PTSD, anxiety, and eating disorders. The application, published by the USPTO, arises from Clearmind’s collaboration with NeuroThera Labs Inc., which has already generated thirteen related patent applications globally. The new filing describes embodiments where PEA may enhance MDMA’s therapeutic potency, reduce required dosing, mitigate MDMA-associated side effects, and broaden its therapeutic window. Clearmind notes that this development aligns with growing U.S. federal focus on psychedelic medicines, including the FDA’s July 13, 2026 final guidance on clinical investigation of psychedelic drugs, which explicitly includes MDMA. Clearmind states that its overall IP portfolio now consists of nineteen patent families and 32 granted patents.

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Filing Explained

This Form 6-K reports the U.S. patent application as published—not as an issued patent—and incorporates the press release’s first three paragraphs by reference into the listed Form F-3 registration statements and a Form S-8, making those paragraphs part of those filings without changing the application’s disclosed status.

Collaborative patent applications thirteen patent applications Generated globally through the collaboration between Clearmind and NeuroThera Labs
Patent families nineteen patent families Size of Clearmind’s overall intellectual property portfolio
Granted patents 32 granted patents Granted patents within Clearmind’s intellectual property portfolio
FDA psychedelic guidance date July 13, 2026 Date the FDA finalized its guidance “Psychedelic Drugs: Considerations for Clinical Investigations”
Form types referenced Form F-3 and Form S-8 First three paragraphs of the press release incorporated by reference into multiple Clearmind registration statements
neuroplastogens medical
"advancing non-hallucinogenic, psychedelic-derived neuroplastogens for scalable treatment"
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.
N-acylethanolamines medical
"combination of 3,4-methylenedioxymethamphetamine (MDMA) and N-acylethanolamines"
N-acylethanolamines are a family of naturally occurring fatty molecules that act as small chemical messengers inside the body, helping cells communicate about inflammation, appetite, pain and other processes. Investors care because these molecules can be targets or biomarkers for drugs, diagnostics and wellness products — like a visible readout on a dashboard that indicates whether a treatment is working or a condition is present — which affects clinical development, regulatory approval and market potential.
palmitoylethanolamide (PEA) medical
"N-acylethanolamines, such as palmitoylethanolamide (PEA), in methods of treating"
Palmitoylethanolamide (PEA) is a naturally occurring fatty molecule found in the body and some foods that is used in supplements and experimental medicines for its potential to reduce pain and inflammation. Investors care because clinical evidence, regulatory approval, and consumer demand determine whether PEA-based products can become profitable treatments or wellness products, similar to how a promising ingredient can create new market opportunities or face safety and approval hurdles.
post-traumatic stress disorder (PTSD) medical
"for the treatment of PTSD Amid Rising U.S. Federal Support"
A mental health condition that can develop after exposure to a terrifying or life-threatening event, causing persistent distressing memories, heightened anxiety, sleep disturbance, and avoidance of reminders. For investors, PTSD matters because it drives demand for treatments, shapes regulatory and insurance coverage decisions for new therapies, and can influence workforce productivity and legal or disability costs—essentially acting as a market signal of medical need and potential revenue for related products.
entactogens or empathogens medical
"including classic psychedelics as well as “entactogens or empathogens such as"
Form F-3 regulatory
"incorporated by reference into the Registrant’s Registration Statements on Form F-3"
Form F-3 is a U.S. securities filing that lets eligible foreign companies pre-register and then quickly sell shares or other securities to raise money, because they already meet ongoing reporting and size tests. For investors it signals that the company is up-to-date with regulatory disclosure and has an efficient way to issue new securities — similar to a pre-approved credit line — which can mean faster capital raises but also potential dilution of existing holdings.

FAQ

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

Clearmind Medicine announced U.S. publication of a patent application covering a combination of MDMA and N-acylethanolamines, including PEA, for treating PTSD, anxiety, and eating disorders, expanding the intellectual property generated through its collaboration with NeuroThera Labs.

How does the NeuroThera Labs collaboration affect CMND’s IP portfolio?

The collaboration with NeuroThera Labs has generated thirteen patent applications globally. The newly published U.S. application integrates NeuroThera’s PEA technology into Clearmind’s psychedelic-derived therapeutic programs, contributing to a joint and growing intellectual property portfolio.

What potential benefits does the MDMA-PEA combination describe for CMND’s therapies?

The patent application describes embodiments in which PEA may enhance MDMA’s therapeutic potency, reduce required dosing, mitigate MDMA-associated side effects, and broaden MDMA’s therapeutic window, which could strengthen the clinical and commercial potential of MDMA-based treatments.

What regulatory development is highlighted for CMND’s MDMA-based IP?

Clearmind highlights the FDA’s July 13, 2026 final guidance, “Psychedelic Drugs: Considerations for Clinical Investigations,” which explicitly includes MDMA. The guidance outlines clinical development considerations and provides regulatory context for Clearmind and NeuroThera’s MDMA-PEA intellectual property.

How large is Clearmind Medicine’s current patent portfolio (CMND)?

Clearmind states that its intellectual property portfolio consists of nineteen patent families, including 32 granted patents. The company also indicates it intends to seek additional patents and may acquire further intellectual property to build this portfolio.

On which exchange is Clearmind Medicine (CMND) listed?

Clearmind Medicine’s shares are listed for trading on Nasdaq under the symbol “CMND”, according to the company’s description in the report.

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

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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: August 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 August 24, 2026, titled “Clearmind Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal Support for Psychedelic Innovation”.

 

The first three paragraphs of the press release attached to this Form 6-K as Exhibit 99.1 are incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File Nos. 333-275991, 333-270859, 333-273293, 333-290404, 333-293521 and 333-295455) and Form S-8 (File No. 333-283695), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “Clearmind Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal Support for Psychedelic Innovation”

 

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: August 24, 2026 By: /s/ Adi Z.uloff-Shani
  Name:   Adi Zuloff-Shani
  Title: Chief Executive Officer

 

 

3

 

Exhibit 99.1

 

 

Clearmind Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal
Support for Psychedelic Innovation

 

U.S. publication of the patent application covering the MDMA-N-acylethanolamines combination expands intellectual property generated through the collaboration with Neurothera Labs Inc. as the FDA introduces a dedicated regulatory structure for psychedelic drug development, including MDMA

 

Vancouver, Canada, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biopharmaceutical company advancing non-hallucinogenic, psychedelic-derived neuroplastogens for scalable treatment of neuropsychiatric, metabolic, and addiction disorders, including AUD, today announced an advancement of its IP portfolio with the publication in the United States of its patent application covering a novel combination of 3,4-methylenedioxymethamphetamine (“MDMA”) and N-acylethanolamines, such as palmitoylethanolamide (“PEA”), in methods of treating post-traumatic stress disorder (PTSD), anxiety, and eating disorders. The U.S. patent application was published by the United States Patent and Trademark Office (USPTO).

 

The publication marks a significant intellectual property milestone resulting from the ongoing collaboration between Clearmind and NeuroThera Labs Inc. (TSXV: NTLX) (“NeuroThera”), a clinical-stage biotech. . Through this collaboration, NeuroThera’s PEA technology is integrated into Clearmind’s psychedelic-derived therapeutic programs, contributing to a joint growing intellectual property portfolio that already includes thirteen patent applications generated through this collaboration globally.

 

The newly published application includes novel embodiments in which PEA may enhance MDMA’s therapeutic potency, reduce required dosing, mitigate MDMA associated side effects, and broaden MDMA’s therapeutic window — all of which could materially strengthen the clinical and commercial potential of MDMA based treatments.

 

U.S. Federal Momentum in Psychedelic Medicine

 

FDA Establishes Framework Specifically Addressing MDMA

 

The U.S. patent application publication comes at a time of increasing federal attention to the development of psychedelic medicines and importantly, recent U.S. Food and Drug Administration (“FDA”) guidance addressing the clinical development of psychedelic drugs, including MDMA-based therapies.

On July 13, 2026, the FDA finalized its guidance, “Psychedelic Drugs: Considerations for Clinical Investigations”. The guidance provides considerations for sponsors developing psychedelic drugs for medical conditions, including psychiatric disorders and substance use disorders.

 

The FDA’s final guidance explicitly includes MDMA within its definition of psychedelic drugs, describing the category as including classic psychedelics as well as “entactogens or empathogens such as 3,4-methylenedioxymethamphetamine (MDMA).” The guidance addresses considerations relating to clinical development process including trial design, conduct, data collection, subject safety and new drug application requirements.

 

The FDA also notes that psychedelic drugs can present unique challenges in clinical development due to their psychoactive effects and alterations in mood, cognition and perception. The guidance provides sponsors with the FDA’s current recommendations for addressing these considerations as part of psychedelic drug development.

 

For Clearmind and NeuroThera, the FDA’s explicit inclusion of MDMA in its guidance regarding psychedelic drug development provides regulatory context for the collaboration’s MDMA-PEA intellectual property.

 

 

 

About Clearmind Medicine Inc.

 

Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, next-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.

 

Clearmind is a clinical-stage biopharmaceutical company advancing the discovery and development of non-hallucinogenic, next-generation psychedelic-derived neuroplastogens for the scalable treatment of widespread and underserved health problems of neuropsychiatric, metabolic, and addiction disorders, including AUD.

 

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 benefits, safety, efficacy, advantages and commercial potential of the combination of MDMA and N-acylethanolamines, including PEA; the potential of PEA to enhance MDMA’s therapeutic effects, reduce dosing requirements, mitigate side effects and broaden MDMA’s therapeutic window; the potential application of such combination in the treatment of PTSD, anxiety and eating disorders; the development, scope, value and potential benefits of the Company’s intellectual property portfolio and collaboration with Clearmind; and the potential impact of the FDA’s guidance on the development and regulatory pathway of MDMA-based therapies. Clearmind and NeuroThera cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to Clearmind and NeuroThera.. 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