Clearmind Medicine (Nasdaq: CMND) posts encouraging CMND-100 Phase I/II safety data
Rhea-AI Filing Summary
Clearmind Medicine Inc. reported positive safety results from Part A of its FDA-regulated Phase I/II trial of CMND-100, an MEAI-based, non-hallucinogenic oral candidate for Alcohol Use Disorder. All 24 healthy volunteers across four ascending-dose cohorts completed treatment per protocol, and the primary safety and tolerability endpoint was achieved.
CMND-100 showed a consistent safety profile up to the highest tested dose of 160 mg, with no serious adverse events observed and strong overall tolerability. The company, assuming continued favorable findings from Part A, intends to progress the clinical program to subsequent stages, including dosing patients with Alcohol Use Disorder.
Positive
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Filing Explained
The next clinical step remains conditional on completing the Part A assessment; no new share issuance or sale is disclosed.
Form 6-K is an interim report used by a foreign private issuer to furnish material information published in its home market. In this July 30 report, Clearmind Medicine reports positive safety findings from Part A of its CMND-100 trial, while stating that the full Part A dataset is still being assessed.
The positive findings therefore support continued development, but patient dosing in later stages remains an intended next step conditional on continued favorable findings, not a completed transition. The filing also incorporates the first three paragraphs of the release into six Form F-3 registration statements and one Form S-8 registration statement.
That incorporation makes the specified release text part of those registration statements from the submission date, to the extent it is not later superseded. It updates the registration documents' incorporated information but does not state that shares were offered, sold, or issued in this filing.
The named resolution point is the company's completion of its full Part A dataset assessment and a subsequent disclosure about advancing to stages that would dose patients with Alcohol Use Disorder.
Key Figures
Key Terms
Phase I/II clinical trial medical
single-ascending-dose medical
non-hallucinogenic neuroplastogen-derived medical
Alcohol Use Disorder (AUD) medical
forward-looking statements regulatory
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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: July 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 July 30, 2026, titled “Clearmind Announces Positive Safety Findings for CMND 100, Demonstrating Consistent Tolerability Throughout Full Dose Escalation in Part A of its FDA-Regulated Clinical Trial”.
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 Announces Positive Safety Findings for CMND 100, Demonstrating Consistent Tolerability Throughout Full Dose Escalation in Part A of its FDA-Regulated 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: July 30, 2026 | By: | /s/ Adi Zuloff-Shani |
| Name: | Adi Zuloff-Shani | |
| Title: | Chief Executive Officer | |
3
Exhibit 99.1
Clearmind Announces Positive Safety Findings for CMND 100, Demonstrating Consistent Tolerability Throughout Full Dose Escalation in Part A of its FDA-Regulated Clinical Trial
Vancouver, Canada, July 30, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biotechnology company pioneering nonhallucinogenic neuroplastogenderived treatments for Alcohol Use Disorder (AUD), addictions, and weight management, today announced positive safety results from Part A of its ongoing FDA-regulated Phase I/II clinical trial evaluating CMND-100, the Company’s proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).
Clearmind reported that all 24 participants enrolled across four ascending-dose cohorts successfully completed treatment as planned per-protocol, reinforcing the strength of its proprietary drug candidate, CMND-100. The study achieved its primary endpoint of safety and tolerability. CMND-100 demonstrated a consistent safety profile throughout the dose-escalation phase, including at the highest dose evaluated in the fourth cohort. No serious adverse events were observed, and overall tolerability remained strong and consistent with earlier cohorts, further supporting the compound’s continued clinical advancement.
Clearmind noted that Part A of the study employed a sequential single-ascending- dose of approximately 20 mg, 40 mg, 80 mg, and 160 mg of CMND-100 in healthy volunteers (six participants per cohort). Successfully advancing through all planned dose levels while maintaining a favorable safety profile marks a meaningful milestone for a non-hallucinogenic neuroplastogen-derived therapeutic. Unlike classical psychedelic approaches, which often encounter practical and regulatory limitations due to perceptual effects; CMND-100’s safety and tolerability findings, including at the highest dose tested, - support its continued development as a potentially accessible treatment option. These results further support the program’s differentiated clinical profile and reduce key early-stage development risks as the asset progresses toward subsequent phases.
“These results further strengthen the safety foundation we have established for CMND-100,” said Adi Zuloff-Shani, PhD, CEO of Clearmind Medicine. “Successfully completing the full dose-escalation sequence in Part A with a consistently favorable safety and tolerability profile—including at the highest dose level-represent a significant milestone for the program. The data reinforce our confidence as we advance CMND-100 and evaluate the next stages of development for patients with Alcohol Use Disorder.”
The multicenter trial is being conducted under FDA oversight at leading sites in the United States and Israel, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The Company is completing its assessment of the full Part A dataset and, assuming continued favorable findings, intends to progress to the subsequent stages of the clinical program including dosing AUD patients.
About CMND-100 and Neuroplastogen Approach
CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane). The Company is developing it as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity while avoiding the perceptual effects associated with classical psychedelics. This profile aims to support scalable treatment models that do not require intensive clinical supervision or prolonged monitored sessions.
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 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 continued clinical development of CMND-100, the potential benefits and characteristics of CMND-100, its plans to advance the clinical program and initiate dosing in patients with Alcohol Use Disorder, and expectations regarding future clinical findings and development activities. 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.