Clearmind Medicine Receives Yale IRB Approval, Enabling Patient Recruitment for Parts B and C of CMND-100 Phase I/II Trial, Following Positive Safety Results

Yale IRB approval and favorable Part A safety data allow Clearmind to broaden and accelerate its Phase I/II CMND-100 trial in Alcohol Use Disorder.

Rhea-AI Summary

Clearmind Medicine (CMND) received Yale University IRB approval to begin recruiting patients for Parts B and C of its Phase I/II CMND-100 trial. This clearance enables immediate expansion of enrollment at Yale School of Medicine’s Department of Psychiatry, joining existing sites at Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center in the multicenter study.

The trial, titled “A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with AUD,” evaluates Clearmind’s proprietary non-hallucinogenic, MEAI-based candidate for Alcohol Use Disorder. Part A of this FDA-regulated trial met its primary endpoint of safety and tolerability, with all 24 participants across four ascending-dose cohorts completing treatment per protocol. CMND-100 showed a consistent safety profile, including at the highest dose, and no serious adverse events were observed.

Positive

• Yale IRB approval enables immediate recruitment for Parts B and C at a major U.S. academic site
• Multicenter expansion now includes Yale, Johns Hopkins, Tel Aviv Sourasky and Hadassah Medical Center
• Part A primary endpoint met: safety and tolerability achieved in the Phase I/II CMND-100 trial
• 24 participants across four ascending-dose cohorts completed treatment per protocol in Part A
• No serious adverse events reported and safety profile remained consistent, including at the highest dose tested

Negative

• None.

Argus 15 min delay

+5.16% vs previous close $1.22 last price 615.1x rel. volume Open Argus

Details

Market reaction after Phase I/II recruitment approval: CMND +5.16%

+15.8% Peak Tracked

-9.0% Trough Tracked

$1.11 $1.39 Day Range

$1.81M Market Cap

Following this news, CMND has gained 5.16%, reflecting a notable positive market reaction. Argus tracked a peak move of +15.8% during the session. Argus tracked a trough of -9.0% from its starting point during tracking. Our momentum scanner has triggered 19 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $1.22. Trading volume is exceptionally heavy at 615.1x the average, suggesting very strong buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

On July 30, CMND gained 10.96% after reporting Part A safety results; the current Yale approval adde...

Analysis

On July 30, CMND gained 10.96% after reporting Part A safety results; the current Yale approval added site-level execution to the same study without reporting new safety outcomes.

Key Figures

Participants treated: 24 participants Dose cohorts: 4 ascending-dose cohorts

Participants treated

24 participants

Part A across four ascending-dose cohorts

Dose cohorts

4 ascending-dose cohorts

Part A of the Phase I/II trial

Previous Clinical trial Reports

2 past events · Latest: Aug 06

Same Type 2 events

1. Aug 06

   Clinical trial progression

   24h Move

   -0.6%

   DSMB approved progression from Part A to Parts B and C

2. Jul 30

   Positive safety results

   24h Move

   +11.0%

   Part A met its primary safety and tolerability endpoint

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

Key Terms

irb, pharmacokinetic, dose-escalation, serious adverse events

4 terms

irb regulatory

"Yale University’s IRB has approved the initiation of patient recruitment"

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.

pharmacokinetic medical

"A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study"

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.

dose-escalation medical

"throughout the dose-escalation phase"

Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.

serious adverse events medical

"No serious adverse events were observed"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

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

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Vancouver, Canada, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company” or “Clearmind”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment  of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), today announced that the Yale University’s IRB has approved the initiation of patient recruitment for Parts B and C of its Phase I/II clinical trial evaluating CMND‑100.

This 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 Subjects with AUDand directly enables the Company to accelerate enrollment at Yale School of Medicine’s Department of Psychiatry.

The Yale site now joins other leading centers already approved and actively recruiting patients for the trial, including Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. The trial at the Yale site is led by Anahita Bassir Nia, MD, a specialist in psychiatry and addiction medicine.

Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind, commented: “Yale IRB approval to proceed with Parts B and C is an important milestone for our CMND-100 clinical program. This clearance allows us to immediately expand and accelerate patient recruitment at another world‑class site, alongside Johns Hopkins and Israeli medical centers, as we continue evaluating our proprietary non-hallucinogenic, MEAI-based candidate for individuals with AUD.”

As previously announced, Clearmind achieved positive safety results from Part A of its ongoing FDA-regulated Phase I/II clinical trial evaluating CMND-100. 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.

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 development, progress, advancement, timing, conduct and results of its clinical trials and research programs, the potential safety, tolerability, efficacy and therapeutic benefits of its product candidates, the enrollment and participation of subjects in its clinical studies, anticipated clinical, regulatory and development milestones, and the Company's plans, objectives, expectations and strategy with respect to the development and commercialization of its product candidates. 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 is CMND-100 and which condition is Clearmind targeting in this trial?

CMND-100 is Clearmind’s proprietary, non-hallucinogenic, MEAI-based psychedelic-derived neuroplastogen. The Phase I/II clinical trial is evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD), in both healthy volunteers and subjects with AUD.

What is the full design focus of the Phase I/II CMND-100 study?

The multicenter trial is titled “A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with AUD.” It is designed to assess tolerability, safety and pharmacokinetics under single and multiple dosing.

Which institutions are currently participating as sites in the CMND-100 Phase I/II trial?

Recruitment is underway at Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center, all of which are participating as clinical sites in the trial.

Who is leading the CMND-100 trial at the Yale study site?

At the Yale site, the trial is led by Anahita Bassir Nia, MD, who is described as a specialist in psychiatry and addiction medicine.

What specific safety outcomes were reported from Part A of the CMND-100 trial?

Part A of the FDA-regulated Phase I/II trial met its primary endpoint of safety and tolerability. All 24 participants in four ascending-dose cohorts completed treatment per protocol. CMND-100 showed a consistent safety profile throughout dose escalation, including at the highest dose, and no serious adverse events were observed, with overall tolerability described as strong and consistent with earlier cohorts.