Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial
Rhea-AI Summary
Clearmind Medicine (Nasdaq: CMND) reported additional positive topline safety results from the second cohort of its FDA‑approved Phase I/IIa trial of CMND‑100 for Alcohol Use Disorder (AUD) on February 9, 2026. The cohort completed treatment across multinational sites, showed no serious adverse events, and maintained good tolerability.
The company said the Data and Safety Monitoring Board gave unanimous clearance to advance the study, and investigators completed dosing at sites including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.
Positive
- DSMB gave unanimous approval to advance the second cohort
- Second cohort showed no serious adverse events
- Full treatment completion achieved across multinational sites including Johns Hopkins and two Israeli centers
- Good tolerability maintained consistent with first cohort
Negative
- None.
News Market Reaction – CMND
In the Feb 9 session, CMND declined 8.15%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.3% during that session. Argus tracked a trough of -20.3% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 14 | Cohort 2 completion | Positive | +0.4% | All six second-cohort patients completed CMND-100 treatment per protocol successfully. |
| Dec 16 | Cohort 2 enrollment | Positive | -3.7% | Completed enrollment of six-patient second cohort across three multinational clinical sites. |
| Dec 02 | Dosing at Hadassah | Positive | -9.9% | First participant enrolled and dosed with CMND-100 at Hadassah in Phase I/IIa AUD trial. |
| Dec 01 | Positive cohort data | Positive | -6.9% | Reported positive first-cohort safety and efficacy signals and unanimous DSMB approval to continue. |
| Nov 25 | New site enrollment | Positive | -19.4% | Tel Aviv Sourasky site activated with first patient enrolled into CMND-100 AUD trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial updates for CMND-100 have generally been positive, yet the stock has more often traded down on these announcements, showing a pattern of negative price reactions to constructive clinical progress.
Over recent months, Clearmind has repeatedly reported progress in its CMND-100 Phase I/IIa Alcohol Use Disorder program, including new site activations, enrollment milestones, dosing initiation, and completion of the second cohort. Despite positive themes such as favorable safety data and unanimous DSMB recommendations to continue, four of the last five clinical trial headlines (since Nov 25, 2025) saw negative next-day moves. Today’s additional positive safety results extend this ongoing development narrative.
Key Terms
phase i/iia medical
pharmacokinetics medical
data and safety monitoring board medical
dsmb medical
alcohol use disorder medical
aud medical
neuroplastogen medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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.
