Clearmind gets positive safety review for CMND-100

Clearmind Medicine, a clinical-stage biotech, reported a positive safety review from its independent Data and Safety Monitoring Board for its ongoing FDA-approved Phase I/IIa trial of CMND-100 in Alcohol Use Disorder.

Rhea-AI Filing Summary

Clearmind Medicine, a clinical-stage biotech, reported a positive safety review from its independent Data and Safety Monitoring Board for its ongoing FDA-approved Phase I/IIa trial of CMND-100 in Alcohol Use Disorder.

The DSMB recommendation followed completion of the third patient cohort and was based on top-line safety data showing CMND-100 was well tolerated with no serious adverse events. This supports a favorable safety and tolerability profile seen in earlier cohorts.

The company will now advance to the fourth cohort and increase the CMND-100 dose to 160mg. The multinational, multicenter study evaluates safety, tolerability, pharmacokinetics and preliminary efficacy of this non-hallucinogenic, MEAI-based oral drug candidate in patients with moderate to severe Alcohol Use Disorder.

Insights

Biotech clinical development analyst

Positive safety review lets Clearmind escalate CMND-100 dosing in its AUD trial.

Clearmind Medicine received a favorable recommendation from an independent Data and Safety Monitoring Board after completing the third cohort in its Phase I/IIa CMND-100 trial for Alcohol Use Disorder. Top-line data indicated CMND-100 was well tolerated with no serious adverse events.

This type of DSMB review is a key checkpoint in early-stage development. The green light to continue, combined with the absence of serious safety issues, supports the drug’s current safety profile but does not yet speak to efficacy. The study also examines pharmacokinetics and preliminary efficacy in moderate to severe AUD.

Clearmind will proceed to a fourth cohort and increase the CMND-100 dose to 160mg. How patients tolerate this higher dose and any future preliminary efficacy readouts will be important for understanding CMND-100’s potential, though specific timing beyond the ongoing trial is not detailed here.

Key Figures

Next cohort dose: 160mg Patent families: 19 Granted patents: 31

3 metrics

Next cohort dose 160mg Planned dose for fourth cohort of CMND-100 trial

Patent families 19 Company intellectual property portfolio

Granted patents 31 Part of Clearmind’s IP portfolio

Key Terms

Data and Safety Monitoring Board, Phase I/IIa clinical trial, Alcohol Use Disorder, pharmacokinetics, +2 more

6 terms

Data and Safety Monitoring Board medical

"its independent Data and Safety Monitoring Board (“DSMB”) has completed its review"

An independent panel of experts that watches over a clinical trial to protect participants and ensure the data are reliable, acting like an impartial referee who can recommend pausing or stopping the study if safety problems or clear benefits emerge. Investors care because the board’s findings can change a drug or device’s timeline, cost, and odds of regulatory approval, directly affecting a company’s value and risk profile.

Phase I/IIa clinical trial medical

"ongoing FDA-approved Phase I/IIa clinical trial of CMND-100"

An early-stage clinical study that combines initial safety testing (Phase I) with a first look at whether a treatment shows signs of working in patients (Phase IIa). Investors watch these trials because they move a therapy from lab research toward proof that it can help people; successful results reduce technical risk and can unlock bigger trials, partnerships, regulatory attention, or increases in a company’s value — like a prototype test that determines whether a product should go into full production.

Alcohol Use Disorder medical

"clinical trial of CMND-100 for the treatment of 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.

pharmacokinetics medical

"designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

neuroplastogen-derived therapeutics medical

"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.

forward-looking statements regulatory

"This press release contains “forward-looking statements” within the meaning"

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.

FAQ

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

What did Clearmind Medicine (CMND) announce about its CMND-100 trial?

Clearmind Medicine announced that an independent Data and Safety Monitoring Board issued a positive recommendation to continue the Phase I/IIa CMND-100 trial in Alcohol Use Disorder, based on safety data showing the drug was well tolerated with no serious adverse events reported so far.

What stage is Clearmind Medicine’s CMND-100 Alcohol Use Disorder trial?

CMND-100 is in an FDA-approved Phase I/IIa clinical trial. This early-stage, multinational, multicenter study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with moderate to severe Alcohol Use Disorder, following multiple dose-escalating patient cohorts.

How did CMND-100 perform in terms of safety in Clearmind’s trial?

After completion of the third cohort, top-line safety data showed CMND-100 was well tolerated with no serious adverse events. These findings supported a positive Data and Safety Monitoring Board recommendation and reinforced the favorable safety and tolerability profile observed in previous trial cohorts.

What is the next step in Clearmind’s CMND-100 clinical trial after the DSMB review?

Following the positive Data and Safety Monitoring Board recommendation, Clearmind will proceed to the fourth cohort of its CMND-100 Phase I/IIa trial and increase the tested dose of its proprietary oral drug candidate to 160mg in patients with moderate to severe Alcohol Use Disorder.

What kind of drug is CMND-100 being developed by Clearmind Medicine?

CMND-100 is Clearmind’s proprietary, non-hallucinogenic, MEAI-based oral drug candidate. It is part of the company’s focus on second generation, neuroplastogen-derived therapeutics aimed at addressing widespread and under-treated conditions, particularly Alcohol Use Disorder in this clinical program.

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

Clearmind reports an intellectual property portfolio of nineteen patent families, including 31 granted patents. The company intends to seek additional patents where warranted and may opportunistically acquire further intellectual property to expand and strengthen its portfolio around its therapeutic pipeline.

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

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Accepted by SEC EDGAR 04/15/2026 - 09:15 AM EDT 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: April 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 April 15, 2026, titled “Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 clinical trial”.

1

EXHIBIT INDEX

Exhibit No.
99.1		Press release titled: “Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 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: April 15, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 clinical trial

Vancouver, Canada, April 15, 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 that its independent Data and Safety Monitoring Board (“DSMB”) has completed its review and issued a positive recommendation to continue the ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder (“AUD”).

The positive DSMB recommendation follows the successful completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. These results reinforce the favorable safety and tolerability profile observed in previous cohorts.

As a result, the Company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, in patients with moderate to severe AUD.

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 trials. 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 ANNOUNCES POSITIVE DATA SAFETY MONITOR 8.9 KB