STOCK TITAN
  1. Home
  2. Sec-filings
  3. CMND
  4. [6-K] Clearmind Medicine Inc. Current Report (Foreign Issuer)

Clearmind Medicine (NASDAQ: CMND) finishes Part A dosing in CMND-100 Alcohol Use Disorder trial

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Clearmind Medicine Inc. reports completion of dosing for all 24 participants in Cohorts 1–4 of Part A of its FDA-regulated Phase I/II clinical trial of CMND-100 for Alcohol Use Disorder. Healthy volunteers received escalating dose levels of the company’s proprietary, non-hallucinogenic drug candidate.

The multicenter trial is being conducted under FDA oversight as a randomized, double-blind, placebo-controlled study at leading sites including Yale and Johns Hopkins. Interim results from the first three cohorts continue to show a strong safety profile, supporting further advancement of the program. Clearmind also highlights an intellectual property portfolio of nineteen patent families with 31 granted patents.

Positive

  • None.

Negative

  • None.

Insights

Clearmind hits an early clinical milestone with favorable safety signals.

Clearmind Medicine has finished dosing 24 healthy participants in Part A of its Phase I/II CMND-100 trial for Alcohol Use Disorder. This stage used escalating doses under an FDA Investigational New Drug framework across multiple prominent medical centers.

Interim data from the first three cohorts are described as showing a strong safety profile, which is important at this early phase focused on safety and tolerability rather than efficacy. The trial’s randomized, double-blind, placebo-controlled design supports more rigorous future readouts.

The company also emphasizes its intellectual property position with nineteen patent families and 31 granted patents, which can matter if CMND-100 progresses. Future disclosures in company filings may provide more detail on later-stage cohorts, efficacy outcomes, and any resulting regulatory interactions.

Participants dosed Part A 24 participants Cohorts 1–4 of Phase I/II CMND-100 trial
Trial phase Phase I/II CMND-100 for Alcohol Use Disorder
Cohorts completed 4 cohorts Part A of CMND-100 trial
Patent families 19 patent families Clearmind intellectual property portfolio
Granted patents 31 granted patents Clearmind intellectual property portfolio
Phase I/II clinical trial medical
"ongoing Phase I/II clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder"
A Phase I/II clinical trial is a combined early-stage study that first checks whether a new drug or treatment is safe for people and then looks for initial signs that it works. Think of it as a safety inspection followed by a short test drive: researchers monitor side effects, appropriate dosing, and early effectiveness. For investors, results from these trials matter because they reduce scientific uncertainty and can significantly change a development program’s value and the likelihood of later regulatory approval.
Alcohol Use Disorder (AUD) medical
"Phase I/II clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD)"
A chronic medical condition in which a person repeatedly drinks alcohol in a way that they cannot control, continuing despite harm to their health, work or relationships; it ranges from risky drinking to severe dependence. Investors should care because AUD drives demand for treatments, public health spending, workplace productivity losses and regulatory attention—similar to how a persistent mechanical problem increases repair and operating costs, it creates long-term market and policy implications for healthcare, insurers and employers.
neuroplastogen-derived therapeutics medical
"development of 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.
randomized, double-blind, placebo-controlled medical
"a multicenter, randomized, double-blind, placebo-controlled study"
A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.
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.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Form 6-K: How Foreign Companies Report to the SEC →

FAQ

What did Clearmind Medicine (CMND) announce in this Form 6-K?
Clearmind Medicine announced it completed dosing all 24 participants in Part A of its FDA-regulated Phase I/II clinical trial of CMND-100 for Alcohol Use Disorder, marking an early clinical milestone with reported strong safety signals in the first three cohorts.

What is CMND-100 in Clearmind Medicine’s Phase I/II trial for CMND?
CMND-100 is Clearmind’s proprietary, non-hallucinogenic, second generation neuroplastogen-derived drug candidate being tested for Alcohol Use Disorder. In this Phase I/II trial, healthy participants received escalating doses to evaluate safety and tolerability under a randomized, double-blind, placebo-controlled design with FDA oversight.

How many participants were dosed in Clearmind Medicine’s Part A trial segment?
Clearmind completed dosing 24 healthy participants across Cohorts 1 through 4 in Part A of its Phase I/II clinical trial. These participants received escalating dose levels of CMND-100, providing initial safety data before moving further into the broader Alcohol Use Disorder program.

What safety information did Clearmind Medicine report from the CMND-100 study?
Clearmind stated that interim results from the first three cohorts continue to show a strong safety profile for CMND-100. This early-stage safety information is important because Phase I/II trials primarily assess tolerability and adverse events before expanding into larger Alcohol Use Disorder patient populations.

Which clinical sites are involved in Clearmind Medicine’s CMND-100 trial?
The CMND-100 Phase I/II trial includes Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. Clearmind highlighted rapid patient recruitment and efficient treatment timelines across these leading Israeli and U.S. clinical research centers.

What does Clearmind Medicine’s intellectual property portfolio include for CMND?
Clearmind reports an intellectual property portfolio of nineteen patent families and 31 granted patents. The company plans to seek additional patents where warranted and may opportunistically acquire more IP assets, aiming to support long-term protection around its neuroplastogen-derived therapeutic candidates, including CMND-100.

 

 

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: June 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 June 16, 2026, titled “Clearmind Medicine Completes Dosing for Part A of its of FDA-Regulated Phase I/II Clinical Trial”.

 

The first, second and fourth 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 Medicine Completes Dosing for Part A of its of FDA-Regulated Phase I/II Clinical Trial”

 

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: June 16, 2026 By: /s/ Adi Zuloff-Shani
  Name:  Adi Zuloff-Shani
  Title: Chief Executive Officer

 

 

3

 

 

Exhibit 99.1

 

 

Clearmind Medicine Completes Dosing for Part A of its of FDA-Regulated Phase I/II Clinical Trial

 

Vancouver, Canada, June 16, 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 the successful completion of dosing for all 24 participants in Cohorts 1 through 4 of Part A of its ongoing Phase I/II clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD).

 

All healthy participants in the first stage of the trial have been treated with escalating  dose levels of the Company’s proprietary drug candidate, CMND-100. All trial sites, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, demonstrated rapid patient recruitment and efficient treatment timelines.

 

“We are very pleased to have completed dosing of all 24 participants in the first four cohorts marking the completion of Part A of the clinical trial, supported by the rapid enrollment and excellent execution across our leading clinical sites in Israel and the United States,” said Adi Zuloff-Shani, PhD, CEO of Clearmind Medicine. “The interim results from the first three cohorts continue to show a strong safety profile, which is encouraging as we advance this important program under FDA oversight.”

 

The ongoing Phase I/II trial is being conducted under FDA oversight (IND) as a multicenter, randomized, double-blind, placebo-controlled study

 

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 the timing and progress of its clinical trial and how interim results from the first three cohorts continue to show a strong safety profile, which is encouraging as it advances its clinical study under FDA oversight. 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.

 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

1 document

Press Releases