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Clearmind Medicine Announces Johns Hopkins IRB Approval to Advance CMND-100 Phase I/II Clinical Trial to the Next Parts

(Positive)

Clearmind Medicine (Nasdaq: CMND) received Johns Hopkins Medicine IRB approval to advance its ongoing Phase I/II CMND-100 trial. The multicenter study in healthy volunteers and Alcohol Use Disorder (AUD) subjects can now proceed to Parts B and C, following successful completion of earlier stages.

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Positive

  • Johns Hopkins IRB approval to proceed CMND-100 Phase I/II Parts B and C
  • Multicenter trial targets healthy volunteers and Alcohol Use Disorder subjects
  • Progress follows successful completion of earlier CMND-100 study stages
  • CMND-100 described as non-hallucinogenic MEAI-based candidate for AUD

Negative

  • None.

News Market Reaction – CMND

+14.60%
10 alerts
+14.60% Session close to close
+24.4% Peak in 7 hr 24 min
$2.75M Market Cap
0.6x Rel. Volume

In the May 26 session, CMND gained 14.60%, reflecting a significant positive market reaction. Argus tracked a peak move of +24.4% during that session. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +14.6% in the session following this news. A strong positive reaction aligns with C...
Analysis

The stock surged +14.6% in the session following this news. A strong positive reaction aligns with CMND-100’s ongoing clinical momentum at leading sites such as Johns Hopkins. Investors previously saw mixed moves around similar trial updates, with an average clinical-news move of -1.65%. The presence of an effective Form F-3 registering up to 22,626,988 resale shares tied to convertible notes adds structural overhang that could influence how long enthusiasm for IRB-driven milestones persists.

Previous Clinical trial Reports

5 past events · Latest: 2026-05-12 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
2026-05-12 Clinical milestone update Positive +3.8% Reported 20 participants treated and higher 160 mg cohort in ongoing trial.
2026-05-11 Clinical webinar notice Positive -5.6% Announced webinar to review latest Phase I/IIa CMND-100 data and updates.
2026-04-20 Top-line safety data Positive +58.4% Reported CMND-100 met primary safety endpoint with high safety and tolerability.
2026-04-15 DSMB recommendation Positive -28.6% DSMB gave positive recommendation to continue trial and escalate to 160 mg.
2026-04-14 Primary endpoint met Positive -36.4% Announced CMND-100 met primary safety and tolerability endpoint in AUD trial.

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 are mostly positive in tone, but price reactions have skewed negative, with more downside than upside on such news.

Recent Company History

Over recent months, CMND has issued several CMND-100 clinical updates, including primary safety endpoint success with no serious adverse events on Apr 14 and a positive DSMB recommendation on Apr 15. A further milestone on May 12 noted 20 participants treated and a higher 160 mg dose. These announcements generally support continued development, yet price reactions have been mixed to negative, framing today’s Johns Hopkins IRB approval as a continuation of incremental trial progress.

Key Terms

institutional review board, phase i/ii, pharmacokinetic, alcohol use disorder, +1 more
5 terms
institutional review board regulatory
"Johns Hopkins Medicine Institutional Review Board (JHM-IRB) has granted approval"
An institutional review board is an independent committee that reviews and approves research involving people to make sure studies are safe, ethical, and protect participants’ rights and privacy. For investors, IRB approval is a gatekeeper: it can determine whether a clinical trial can start or continue, affecting timelines, regulatory risk, cost and the credibility of trial results—similar to a safety inspector whose sign-off is required before work can proceed.
phase i/ii medical
"ongoing Phase I/II clinical trial of 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.
pharmacokinetic medical
"Tolerability, Safety and Pharmacokinetic Study of CMND-100"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
alcohol use disorder medical
"Alcohol Use Disorder (AUD) Subjects: Parts A, B, and C"
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.
irb regulatory
"This IRB approval represents another important step forward"
An Institutional Review Board (IRB) is an independent committee that reviews and approves medical and behavioral research involving people to ensure safety, informed consent, and ethical treatment—think of it as a safety inspector for studies. For investors, IRB decisions matter because their approval or requests for changes can speed up, delay, or halt clinical trials and other studies, directly affecting timelines, costs, and the value of companies developing treatments.

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

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Vancouver, Canada, May 26, 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 that the Johns Hopkins Medicine Institutional Review Board (JHM-IRB) has granted approval for its ongoing Phase I/II clinical trial of CMND-100.

The approval advances the multicenter study titled “A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Alcohol Use Disorder (AUD) Subjects: Parts A, B, and C” and permits the Company to proceed with Parts B and C.

This milestone follows successful completion of earlier stages and reflects continued positive momentum at one of the world’s leading clinical research institutions.

Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine, commented, “This IRB approval represents another important step forward in our clinical development program for CMND-100. We are grateful to the Johns Hopkins team for their continued support and look forward to further demonstrating the potential of our non-hallucinogenic MEAI-based candidate for patients suffering from Alcohol Use Disorder.”

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 trials and how it looks forward to further demonstrating the potential of its non-hallucinogenic MEAI-based candidate for patients suffering from 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 Johns Hopkins IRB approval did Clearmind Medicine (NASDAQ: CMND) receive in May 2026?

Clearmind Medicine received Johns Hopkins Medicine IRB approval to advance its CMND-100 Phase I/II trial. According to Clearmind, this approval allows the multicenter study to move into Parts B and C in healthy volunteers and Alcohol Use Disorder subjects.

What is the CMND-100 Phase I/II clinical trial studying for Clearmind Medicine (CMND)?

The CMND-100 Phase I/II trial evaluates tolerability, safety and pharmacokinetics in healthy volunteers and Alcohol Use Disorder subjects. According to Clearmind, the multicenter study includes single and multiple dose parts labeled A, B and C under Johns Hopkins IRB oversight.

How does the Johns Hopkins IRB decision impact Clearmind Medicine’s CMND-100 development?

The Johns Hopkins IRB decision enables Clearmind to proceed with Parts B and C of the CMND-100 Phase I/II trial. According to Clearmind, this follows earlier successful stages and supports continued clinical development of CMND-100 for Alcohol Use Disorder.

What condition is Clearmind Medicine’s CMND-100 targeting in the current Phase I/II trial?

CMND-100 is being investigated for Alcohol Use Disorder in a Phase I/II tolerability, safety and pharmacokinetic trial. According to Clearmind, the study includes both healthy volunteers and AUD subjects as it advances through Parts A, B and C.

How does Clearmind Medicine describe its CMND-100 drug candidate for AUD?

Clearmind describes CMND-100 as a non-hallucinogenic, MEAI-based, second-generation neuroplastogen-derived candidate. According to Clearmind, the therapy is being developed to address Alcohol Use Disorder as part of a broader program aimed at under-treated health problems.