Clearmind Medicine (Nasdaq: CMND) completes second AUD trial cohort
Rhea-AI Filing Summary
Clearmind Medicine Inc. filed a Form 6-K to furnish a press release announcing that treatment is complete for all six patients in the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for alcohol use disorder. This multinational study at sites including Johns Hopkins University and leading Israeli medical centers is designed to assess safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with moderate to severe alcohol use disorder.
The company notes that the first cohort previously showed a favorable safety profile and early signals of benefit, such as reduced cravings and withdrawal symptoms. Clearmind describes this second-cohort completion as steady progress in the program and indicates that topline results from this cohort are anticipated in the coming months.
Positive
- None.
Negative
- None.
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: January 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 January 14, 2026, titled “Clearmind Medicine Announces Successful Completion of Treatment in All Patients of the Second Cohort in Ongoing Phase I/IIa Clinical Trial for CMND-100”.
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) 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 Successful Completion of Treatment in All Patients of the Second Cohort in Ongoing Phase I/IIa Clinical Trial for CMND-100” |
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: January 14, 2026 | By: | /s/ Adi Zuloff-Shani |
| Name: | Adi Zuloff-Shani | |
| Title: | Chief Executive Officer | |
3
Exhibit 99.1
Clearmind Medicine Announces Successful Completion of Treatment in All Patients of the Second Cohort in Ongoing Phase I/IIa Clinical Trial for CMND-100
Vancouver, Canada, Jan. 14, 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 the successful completion of treatment for all patients in the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).
The second cohort, consisting of six patients recruited across premier clinical sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, has now fully completed the treatment per protocol. This milestone builds on the positive results from the first cohort, which demonstrated a favorable safety profile and preliminary efficacy signals, including reduced cravings and withdrawal symptoms.
“We are pleased to announce the successful completion of treatment in the second cohort, within a month after receiving DSMB approval to continue enrollment, marking continued steady progress in our multinational Phase I/IIa trial,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “This achievement reflects the dedication of our clinical sites and the strong interest in CMND-100 as a potential innovative therapy for AUD, a condition with significant unmet medical needs. We look forward to upcoming data readouts and advancing toward subsequent cohorts.”
The Phase I/IIa 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. Topline results from the second cohort are anticipated in the coming months.
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 progress in our multinational Phase I/IIa trial, interest in CMND-100 as a potential innovative therapy for AUD and advancing toward subsequent cohorts. 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, 2024 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 in this Form 6-K?
Clearmind Medicine reported that it has successfully completed treatment for all patients in the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for alcohol use disorder.
What is CMND-100 and what condition is it being tested for?
CMND-100 is Clearmind's proprietary MEAI-based oral drug candidate being evaluated for the treatment of Alcohol Use Disorder (AUD).
How many patients were in Clearmind's second CMND-100 cohort and what is their status?
The second cohort included six patients recruited across premier clinical sites, and Clearmind states that treatment for all patients in this cohort has been fully completed per protocol.
What results were previously observed in the first CMND-100 cohort?
According to Clearmind, the first cohort showed a favorable safety profile and preliminary efficacy signals, including reduced cravings and withdrawal symptoms in patients with alcohol use disorder.
What are the objectives of Clearmind's Phase I/IIa CMND-100 trial?
The Phase I/IIa 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 alcohol use disorder.
When does Clearmind expect topline data from the second cohort?
Clearmind states that topline results from the second cohort are anticipated in the coming months, following the completion of treatment in all six patients.
On which exchanges are Clearmind Medicine shares listed?
Shares of Clearmind Medicine are listed on Nasdaq under the symbol "CMND" and on the Frankfurt Stock Exchange under the symbol "CWY0".
