Clearmind (Nasdaq: CMND) posts more positive CMND-100 safety results

Rhea-AI Filing Summary

Clearmind Medicine Inc. reports additional positive safety topline results from the second cohort of its ongoing FDA-approved Phase I/IIa trial of CMND-100, an oral, non-hallucinogenic MEAI-based drug candidate for treating alcohol use disorder. Another six patients completed treatment with no serious adverse events and overall good tolerability, reinforcing the favorable safety profile seen in the first cohort.

The multinational study evaluates safety, tolerability, pharmacokinetics and preliminary efficacy in patients with moderate to severe alcohol use disorder at sites including Johns Hopkins University and leading Israeli medical centers. Clearmind is a clinical-stage psychedelic pharmaceutical biotech with nineteen patent families and 31 granted patents focused on underserved conditions such as alcohol use disorder.

Insights

Biotech clinical development analyst

Clearmind adds clean safety data for CMND-100 but remains early stage.

Clearmind reports that the second cohort of its Phase I/IIa trial of CMND-100 in moderate to severe alcohol use disorder produced additional positive safety topline results. Six more patients completed treatment with no serious adverse events and maintained good tolerability, echoing the first cohort.

The trial is multinational and multicenter, including Johns Hopkins University and major Israeli hospitals, which can support high-quality clinical execution. The design focuses on safety, tolerability, pharmacokinetics and preliminary efficacy, so current disclosures center on safety rather than clinical benefit.

Management highlights CMND-100 as a potentially safe, non-hallucinogenic treatment that is not adjunct to psychotherapy. Future results on pharmacokinetics and preliminary efficacy from this Phase I/IIa program, and any progression into later-stage studies, will be important to understand CMND-100’s commercial potential in alcohol use disorder.

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: February 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 February 9, 2026, titled “Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial”.

The first four 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, 333-276913 and 333-291817) 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 Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa 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: February 9, 2026	By:	/s/ Adi Zuloff-Shani
	Name:	Adi Zuloff-Shani
	Title:	Chief Executive Officer

3

Exhibit 99.1

Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial

Vancouver, Canada, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced additional positive safety topline results from the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).

These further safety data points, emerging following the successful completion of treatment in another six patients of the second cohort, previously announced January 14, 2026, continue to strengthen the encouraging safety and tolerability profile previously established in the first cohort.

The results reinforce no serious adverse events and overall good tolerability, consistent with the favorable results reported from the first cohort, support the rapid progression enabled by the Company’s Data and Safety Monitoring Board’s (DSMB) unanimous approval to advance for the second cohort.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The second cohort, conducted across leading sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, achieved full treatment completion shortly after DSMB clearance, underscoring continued confidence in CMND-100’s safety profile as a potential innovative therapy for AUD.

“These additional topline safety results from the second cohort further validate and reinforce the positive profile we observed in the first cohort,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “With no serious adverse events emerging and strong tolerability maintained, we are continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in alcohol use disorder.”

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-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” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@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 CMND-100’s safety profile as a potential innovative therapy for alcohol use disorder and how it is continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in alcohol use disorder. 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 (CMND) report about CMND-100 in its latest 6-K?

Clearmind reported additional positive safety topline results from the second cohort of its Phase I/IIa CMND-100 trial. Six more alcohol use disorder patients completed treatment with no serious adverse events and overall good tolerability, reinforcing the favorable safety profile observed in the first cohort.

What is CMND-100 and what condition is Clearmind Medicine (CMND) targeting?

CMND-100 is Clearmind’s proprietary non-hallucinogenic, MEAI-based oral drug candidate. It is being tested in an FDA-approved Phase I/IIa clinical trial for patients with moderate to severe alcohol use disorder, aiming to address significant unmet medical needs in this widespread and underserved condition.

What phase is Clearmind Medicine’s (CMND) CMND-100 trial and what does it measure?

CMND-100 is in an ongoing Phase I/IIa multinational, multicenter clinical trial. The study is designed to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy in patients with moderate to severe alcohol use disorder treated at leading sites in the United States and Israel.

Were there any serious adverse events reported in Clearmind’s CMND-100 second cohort?

Clearmind stated that no serious adverse events emerged among the additional six second-cohort patients. The company reported overall good tolerability, consistent with the first cohort, and said these findings further validate and reinforce CMND-100’s encouraging safety and tolerability profile in alcohol use disorder patients.

What type of company is Clearmind Medicine (CMND) and where are its shares listed?

Clearmind is a clinical-stage psychedelic pharmaceutical biotech focused on novel psychedelic-derived therapeutics for underserved conditions like alcohol use disorder. Its shares trade on Nasdaq under the symbol CMND and on the Frankfurt Stock Exchange under the symbol CWY0, reflecting its international investor base.

How extensive is Clearmind Medicine’s (CMND) intellectual property portfolio?

Clearmind reports that its intellectual property portfolio includes nineteen patent families and 31 granted patents. The company intends to seek additional patents for its compounds when appropriate and may acquire more intellectual property to expand protection around its psychedelic-derived therapeutic candidates, including CMND-100.