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Clearmind Medicine Completes Dosing for Part A of its of FDA-Regulated Phase I/II Clinical Trial

(Very High)
(Positive)

Clearmind Medicine (Nasdaq: CMND) reported completion of dosing for all 24 participants in Cohorts 1–4 (Part A) of its FDA-regulated Phase I/II trial of CMND-100 for Alcohol Use Disorder. The multicenter, randomized, double-blind, placebo-controlled study uses escalating doses in healthy participants.

According to Clearmind, interim data from the first three cohorts continue to indicate a strong safety profile, supported by rapid enrollment and efficient execution at Yale, Johns Hopkins, Tel Aviv Sourasky, and Hadassah Medical Center sites.

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Positive

  • Completed dosing of all 24 participants in Part A (Cohorts 1–4)
  • Phase I/II CMND-100 trial conducted under FDA oversight (IND)
  • Multicenter, randomized, double-blind, placebo-controlled study design
  • Rapid enrollment and efficient treatment timelines at four leading sites
  • Interim results from first three cohorts indicate a strong safety profile

Negative

  • None.

News Market Reaction – CMND

-6.82%
17 alerts
-6.82% Session close to close
+21.9% Peak Tracked
-14.5% Trough Tracked
$3.43M Market Cap
0.1x Rel. Volume

In the Jun 16 session, CMND declined 6.82%, reflecting a notable negative market reaction. Argus tracked a peak move of +21.9% during that session. Argus tracked a trough of -14.5% from its starting point during tracking. Our momentum scanner triggered 17 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.8% in the session following this news. A negative reaction despite completion of ...
Analysis

The stock moved -6.8% in the session following this news. A negative reaction despite completion of Part A dosing would contrast with several earlier CMND-100 updates that saw sizeable positive moves averaging 21.61%. Regulatory filings highlight substantial doubt about going concern status and ongoing convertible note activity, along with an effective F-3 registering 22,626,988 shares for resale. Pressure from capital structure and prior reverse splits could amplify downside even when clinical headlines appear constructive.

Key Figures

Participants dosed: 24 participants Trial cohorts: 4 cohorts in Part A Trial phase: Phase I/II
3 metrics
Participants dosed 24 participants Cohorts 1–4, Part A of Phase I/II CMND-100 trial in healthy volunteers
Trial cohorts 4 cohorts in Part A Dose-escalation across Cohorts 1–4 under FDA oversight
Trial phase Phase I/II Ongoing FDA-regulated CMND-100 trial for Alcohol Use Disorder

Previous Clinical trial Reports

5 past events · Latest: Jun 05 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 05 Clinical data webinar Positive +36.8% Webinar to review early Phase I/IIa CMND-100 data with key investigators.
May 26 Trial advancement Positive +14.6% Johns Hopkins IRB approval to proceed CMND-100 trial to Parts B and C.
May 12 Enrollment milestone Positive +3.8% Reported 20 participants treated and high safety profile with no serious AEs.
May 11 Webinar announcement Positive -5.6% Announced upcoming “Inside MEAI” webinar on CMND-100 clinical data.
Apr 20 Top-line safety data Positive +58.4% CMND-100 met primary safety and tolerability endpoint with no serious AEs.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical-trial updates for CMND-100 have often coincided with positive price reactions, though there is at least one instance where positive clinical news was followed by a negative move.

Recent Company History

Over recent months, Clearmind has repeatedly highlighted progress for CMND-100 in Alcohol Use Disorder, including positive top-line safety results on Apr 20, 2026 and advancement of the trial to Parts B and C on May 26, 2026. Subsequent webinar-related updates on May 11 and Jun 5, 2026 reviewed emerging data with investigators at leading centers. The current completion of dosing in Part A continues this sequence of CMND-100 clinical milestones under FDA oversight.

Key Terms

phase i/ii, alcohol use disorder, randomized, double-blind, +1 more
5 terms
phase i/ii medical
"ongoing Phase I/II clinical trial evaluating CMND-100"
"Phase I/II" describes early stages of testing a new medicine or treatment, where researchers first evaluate its safety and then begin to see if it works. For investors, these phases are important because they indicate whether a product is progressing toward potential approval and commercialization, which can impact future value and success prospects. These stages help gauge how close a new treatment is to reaching the market.
alcohol use disorder medical
"clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD)"
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.
randomized medical
"as a multicenter, randomized, double-blind, placebo-controlled study"
Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.
double-blind medical
"as a multicenter, randomized, double-blind, placebo-controlled study"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"as a multicenter, randomized, double-blind, placebo-controlled study"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

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

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Vancouver, Canada, June 16, 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 the successful completion of dosing for all 24 participants in Cohorts 1 through 4 of Part A of its ongoing Phase I/II clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD).

All healthy participants in the first stage of the trial have been treated with escalating  dose levels of the Company’s proprietary drug candidate, CMND-100. All trial sites, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, demonstrated rapid patient recruitment and efficient treatment timelines.

“We are very pleased to have completed dosing of all 24 participants in the first four cohorts marking the completion of Part A of the clinical trial, supported by the rapid enrollment and excellent execution across our leading clinical sites in Israel and the United States,” said Adi Zuloff-Shani, PhD, CEO of Clearmind Medicine. “The interim results from the first three cohorts continue to show a strong safety profile, which is encouraging as we advance this important program under FDA oversight.”

The ongoing Phase I/II trial is being conducted under FDA oversight (IND) as a multicenter, randomized, double-blind, placebo-controlled study

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 trial and how interim results from the first three cohorts continue to show a strong safety profile, which is encouraging as it advances its clinical study under FDA oversight. 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) announce about its CMND-100 Phase I/II trial on June 16, 2026?

Clearmind Medicine announced it completed dosing all 24 participants in Part A of its FDA-regulated Phase I/II CMND-100 trial for Alcohol Use Disorder. According to Clearmind, this milestone covers Cohorts 1–4 with escalating doses in healthy participants.

What is the design of Clearmind Medicine's Phase I/II CMND-100 trial for Alcohol Use Disorder?

The CMND-100 trial is a multicenter, randomized, double-blind, placebo-controlled Phase I/II study under FDA oversight. According to Clearmind, Part A involves escalating doses in healthy participants to assess safety before moving further in Alcohol Use Disorder evaluation.

How many participants were dosed in Part A of Clearmind Medicine's CMND-100 trial?

Part A of Clearmind Medicine's CMND-100 Phase I/II trial dosed 24 healthy participants across Cohorts 1–4. According to Clearmind, all received escalating dose levels of CMND-100 as part of the safety-focused first stage of the Alcohol Use Disorder program.

What safety data has Clearmind Medicine reported so far for CMND-100 in its Phase I/II trial?

Interim results from the first three cohorts reportedly continue to show a strong safety profile for CMND-100. According to Clearmind, these findings support further advancement of the FDA-regulated Phase I/II trial for Alcohol Use Disorder in healthy participants.

Which clinical sites are involved in Clearmind Medicine's CMND-100 Phase I/II trial for Alcohol Use Disorder?

The CMND-100 trial sites include Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. According to Clearmind, these centers achieved rapid patient recruitment and efficient treatment timelines in Part A.

What does the completion of Part A mean for Clearmind Medicine's CMND-100 program for Alcohol Use Disorder?

Completion of Part A means all 24 healthy participants in Cohorts 1–4 have been dosed with CMND-100. According to Clearmind, this marks a key early milestone as the FDA-regulated Phase I/II study progresses under its current clinical protocol.