Clearmind Medicine Announces Successful Completion of Second Cohort Enrollment in Ongoing FDA-Approved Phase I/IIa Trial for CMND-100

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) announced completion of patient enrollment for the second cohort in its FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder on Dec. 16, 2025. The six-patient cohort was recruited rapidly across three clinical sites: Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

The trial is multinational and will assess safety, tolerability, pharmacokinetics, and preliminary efficacy in moderate-to-severe AUD. Dosing for the second cohort is expected to start shortly, and topline results are anticipated in the coming months. The announcement references encouraging topline safety and preliminary efficacy signals from the first cohort.

Positive

• Second cohort enrolled: 6 patients across 3 premier sites
• Rapid enrollment suggesting strong site and patient interest
• First cohort topline showed favorable safety and preliminary efficacy

Negative

• Small cohort size: only 6 patients in cohort two
• Early-stage trial: Phase I/IIa results are preliminary and limited
• Topline results pending: no new efficacy data available yet

Key Figures

Second cohort size 6 patients Second cohort in ongoing FDA-approved Phase I/IIa CMND-100 trial for AUD

Clinical sites 3 sites Johns Hopkins University, Tel Aviv Sourasky Medical Center, Hadassah Medical Center

Market Reality Check

$2.72 Last Close

Volume Volume 359,908 vs 20-day average 582,171 (relative volume 0.62x) shows subdued trading ahead of this news. low

Technical Shares at $2.72 are below the 200-day MA of $35.89 and close to the 52-week low of $2.42, far from the $87.20 52-week high.

Peers on Argus 1 Up

CMND was down 8.48% while peers were mixed: SXTP -3.52%, TTNP -3.96%, KTTA +3.57%, PLRZ -0.59%, SILO -6.54%. Momentum scanner only flagged ADTX at +6.20% (no news), reinforcing a stock-specific move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 12	Expert review	Positive	+3.6%	Peer-reviewed article highlighted MEAI’s potential and favorable safety profile for AUD.
Dec 12	Nasdaq compliance	Positive	+3.6%	Nasdaq confirmed Clearmind regained compliance with minimum stockholders’ equity rule.
Dec 10	Reverse split	Negative	-6.1%	Announced 1-for-40 reverse split to address Nasdaq Minimum Bid Price Rule deficiency.
Dec 05	Bid-price notice	Negative	+2.5%	Nasdaq notified company of noncompliance with the $1.00 minimum bid price requirement.
Dec 02	Trial dosing	Positive	-9.9%	First participant enrolled and dosed with CMND-100 in Phase I/IIa AUD trial at Hadassah.

Pattern Detected

Recent positive clinical and compliance updates have seen mixed price reactions, including selloffs on several favorable CMND-100 trial milestones.

Recent Company History

Over the past few weeks, Clearmind has combined clinical progress with significant listing and capital-structure actions. A 1-for-40 reverse split was approved to address Nasdaq’s bid-price deficiency, while a later notice confirmed regained compliance with the $2,500,000 equity rule. Multiple FDA-approved Phase I/IIa CMND-100 updates, including positive safety data and continued trial enrollment, have alternated between gains and sharp declines, showing inconsistent market responses to broadly constructive clinical news.

Market Pulse Summary

This announcement marks another incremental step in CMND-100’s development, with the second cohort of 6 patients fully enrolled across 3 high-profile sites in the FDA-approved Phase I/IIa AUD trial. It follows earlier updates on dosing and positive safety signals. Investors may watch for upcoming topline data, any changes in Nasdaq listing status, and additional regulatory filings as key markers of both clinical and corporate progress.

Key Terms

alcohol use disorder medical

"drug candidate, 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.

phase i/iia regulatory

"ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100"

An early-stage clinical trial program that combines Phase I (primarily testing safety and finding a tolerable dose) with Phase IIa (initial checks for whether the drug shows signs of working in patients). Think of it as trying a new product with a small group to confirm it’s safe and gives early benefits before a larger rollout. For investors, these studies are major risk/reward checkpoints: positive results can boost value, while failures are common and costly.

clinical trial regulatory

"ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

pharmacokinetics medical

"designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

AI-generated analysis. Not financial advice.

Vancouver, Canada, Dec. 16, 2025 (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 the successful completion of patient enrollment for the second cohort in its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). The cohort consists of six patients, who were recruited rapidly across three premier clinical sites: Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

This milestone follows the recent completion of the first cohort, which demonstrated encouraging top-line safety and efficacy data, including a favorable safety profile and preliminary signals of reduced cravings and withdrawal symptoms.

The swift enrollment of the second cohort—achieved in a remarkably short timeframe—highlights the strong commitment and operational excellence of the collaborating clinical centers, emphasizing their dedication to advancing innovative treatments for AUD, a condition affecting millions worldwide with limited effective options.

“We are thrilled with the accelerated pace of enrollment for our second cohort, which reflects the high level of interest from both patients and leading clinical sites in CMND-100’s potential to transform AUD treatment,” stated Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “Building on the excellent results from the first cohort, we believe that this rapid progress positions us to generate additional valuable data, bringing us closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile.”

The multinational Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Dosing for the second cohort is expected to commence shortly, with topline results anticipated in the coming months.

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 advancing innovative treatments for AUD, the high level of interest from both patients and leading clinical sites in CMND-100, CMND-100’s potential to transform AUD treatment and its belief that that this rapid progress positions it to generate additional valuable data, bringing it closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile. 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, 2024 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 (CMND) announce on December 16, 2025 about CMND-100?

Clearmind announced completion of enrollment for the second cohort (6 patients) in its FDA-approved Phase I/IIa CMND-100 trial for AUD.

Which clinical sites enrolled patients for CMND-100 cohort two?

The six patients were recruited across Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

When will dosing and topline results for CMND-100 cohort two occur?

Dosing for the second cohort is expected to commence shortly, with topline results anticipated in the coming months.

What does the Phase I/IIa CMND-100 trial evaluate for CMND (CMND)?

The trial assesses safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in moderate-to-severe AUD.

How did the first cohort in Clearmind's CMND-100 trial perform?

The first cohort reported encouraging topline findings, including a favorable safety profile and preliminary signals of reduced cravings and withdrawal symptoms.

Does the second cohort completion signal commercial readiness for CMND-100?

No; cohort completion advances clinical development but the trial remains early-stage and results are still required to assess commercial potential.