Clearmind Medicine Charges Forward in Alcoholism Treatment: Positive Cohort Data, Full DSMB Approval, and New Elite Site Joins the Clinical Trial

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) announced three clinical milestones for its MEAI-based oral therapy CMND-100 targeting Alcohol Use Disorder: positive top-line safety and preliminary efficacy data from the trial's first cohort of six participants (reported Nov 18, 2025); a unanimous independent DSMB recommendation to continue following an unblinded safety review (Nov 24, 2025); and activation of a new Israeli site, Tel Aviv Sourasky Medical Center, with first patient enrolled (Nov 25, 2025), joining Yale, Johns Hopkins and Hadassah sites. The Phase I/IIa trial evaluates safety, tolerability, pharmacokinetics and preliminary efficacy and the new site may accelerate multinational recruitment for subsequent phases.

Positive

• Top-line positive safety and preliminary efficacy in a 6-patient cohort (Nov 18, 2025)
• Unanimous DSMB recommendation to continue after unblinded review (Nov 24, 2025)
• Tel Aviv Sourasky Medical Center site activated with first patient enrolled (Nov 25, 2025)
• Multiple elite investigator sites active: Yale, Johns Hopkins, Hadassah, TASMC

Negative

• Initial cohort size was only 6 participants, limiting statistical strength

News Market Reaction

-6.92%

37 alerts

-6.92% News Effect

+44.8% Peak Tracked

-19.2% Trough Tracked

-$473K Valuation Impact

$6M Market Cap

0.7x Rel. Volume

On the day this news was published, CMND declined 6.92%, reflecting a notable negative market reaction. Argus tracked a peak move of +44.8% during that session. Argus tracked a trough of -19.2% from its starting point during tracking. Our momentum scanner triggered 37 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $473K from the company's valuation, bringing the market cap to $6M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

First cohort size: 6 participants AUD prevalence: over 28 million adults AUD economic cost: over $249 billion annually +5 more

8 metrics

First cohort size 6 participants Initial CMND-100 Phase I/IIa cohort at Johns Hopkins and Yale

AUD prevalence over 28 million adults Adults affected by Alcohol Use Disorder in the U.S.

AUD economic cost over $249 billion annually Estimated yearly societal and economic costs in the U.S.

Registered direct shares 7,944,868 common shares Nov 26, 2025 registered direct offering at $0.12 per share

Pre-funded warrants 2,865,960 warrants Nov 26, 2025 offering, exercisable at $0.0001 per share

Gross proceeds $1,297,012.76 Total gross proceeds from Nov 26, 2025 offering

Primary offering size 10,925,000 shares Nov 19, 2025 primary offering at $0.20 per share

Stockholders’ equity $1,065,668 Reported vs Nasdaq $2.5 million minimum equity requirement

Market Reality Check

Price: $1.76 Vol: Volume 15,267,357 vs 20-d...

low vol

$1.76 Last Close

Volume Volume 15,267,357 vs 20-day average 38,613,643 (relative volume 0.4x) ahead of this positive trial update. low

Technical Shares at $0.0717 are trading below the 200-day MA of $0.91, reflecting a longer-term downtrend.

Peers on Argus

CMND was down 6.08% while small-cap biotech peers were mixed: SXTP -10.82%, TTNP...

1 Up 2 Down

CMND was down 6.08% while small-cap biotech peers were mixed: SXTP -10.82%, TTNP -3.96%, KTTA -2.61%, PLRZ +13.7%, SILO -1.83%. Momentum scanner shows 1 peer up and 2 down (median -4.8%), suggesting broader volatility but not a clean sector-wide move in one direction.

Historical Context

5 past events · Latest: Dec 10 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 10	Reverse split	Negative	-6.1%	1-for-40 reverse share split to regain Nasdaq minimum bid compliance.
Dec 05	Listing compliance	Negative	+2.5%	Nasdaq notice for $1.00 minimum bid deficiency with 180-day cure period.
Dec 02	Clinical trial update	Positive	-9.9%	First participant dosed at Hadassah in Phase I/IIa CMND-100 AUD trial.
Dec 01	Clinical milestones	Positive	-6.9%	Positive cohort data, DSMB green light, and new Israeli site activation.
Nov 25	Site activation	Positive	-19.4%	TASMC enrolls first patient, expanding Phase I/IIa AUD trial footprint.

Pattern Detected

Clinical and compliance updates with positive implications often coincided with negative 24h price moves, while a Nasdaq deficiency notice saw a positive reaction, indicating frequent divergence between news tone and price.

Recent Company History

Over recent weeks, Clearmind reported multiple milestones for CMND-100, including site activations at Hadassah and Tel Aviv Sourasky, a unanimous DSMB continuation recommendation, and positive top-line data from the first six-patient cohort. Despite these favorable clinical updates, 24-hour moves around them were mostly negative, while a Nasdaq minimum bid price deficiency notice on Dec 5, 2025 produced a modest gain. A 1-for-40 reverse split was then announced to address listing compliance, also drawing a negative price reaction.

Market Pulse Summary

The stock moved -6.9% in the session following this news. A negative reaction despite positive clini...

Analysis

The stock moved -6.9% in the session following this news. A negative reaction despite positive clinical milestones fits recent patterns where favorable CMND-100 updates coincided with weak price action. The company had conducted several equity offerings at $0.20 and $0.12, increasing outstanding shares while stockholders’ equity remained below Nasdaq’s $2.5 million minimum. These capital and listing pressures, combined with a long-term downtrend well below the 200-day MA, have historically weighed on sentiment around otherwise encouraging trial news.

Key Terms

neuroplastogen-derived therapeutics, Alcohol Use Disorder (AUD), Data and Safety Monitoring Board (DSMB), pharmacokinetics, +4 more

8 terms

neuroplastogen-derived therapeutics medical

"a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics"

Neuroplastogen-derived therapeutics are drugs or biological treatments developed from compounds that promote neuroplasticity — the brain’s ability to rewire and form new connections after injury or in response to learning. For investors, they matter because these therapies target underlying brain repair mechanisms rather than only masking symptoms, offering the potential for durable benefits in conditions like depression, stroke recovery, or neurodegeneration; if effective, they can create large, high-value markets similar to replacing a faulty bridge with a stronger one.

Alcohol Use Disorder (AUD) medical

"oral therapy targeting Alcohol Use Disorder (AUD). These achievements include"

A chronic medical condition in which a person repeatedly drinks alcohol in a way that they cannot control, continuing despite harm to their health, work or relationships; it ranges from risky drinking to severe dependence. Investors should care because AUD drives demand for treatments, public health spending, workplace productivity losses and regulatory attention—similar to how a persistent mechanical problem increases repair and operating costs, it creates long-term market and policy implications for healthcare, insurers and employers.

Data and Safety Monitoring Board (DSMB) medical

"unanimous approval from the independent Data and Safety Monitoring Board (DSMB) to continue"

An independent panel of medical, statistical and ethical experts who regularly review the safety and results coming from a clinical trial and can recommend changes, pauses or early stop if risks or benefits become clear. Think of it as an impartial referee watching a game to protect participants and ensure the score is reliable; its decisions can materially affect trial timing, regulatory approval prospects and therefore investor value.

pharmacokinetics medical

"a single- and multiple-dose evaluation of 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.

pre-funded warrants financial

"pre-funded warrants to purchase up to 2,865,960 common shares at $0.1199 per warrant"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

Nasdaq Minimum Bid Price Rule regulatory

"reverse share split effective December 15, 2025 to regain compliance with the Nasdaq Minimum Bid Price Rule"

A NASDAQ minimum bid price rule requires a stock to trade above a set minimum price per share for a specified period to remain listed. Think of it like a shop that won’t carry items that sell too cheaply: if a share’s trading price stays below the threshold, the company can get a warning and eventually be removed from the exchange. Investors care because falling below the rule can reduce liquidity, limit where the stock can be bought or sold, and often signals financial stress or weak market confidence.

Form F-3 regulatory

"incorporated by reference into Clearmind’s existing Form F-3 and Form S-8 registration statements"

Form F-3 is a U.S. securities filing that lets eligible foreign companies pre-register and then quickly sell shares or other securities to raise money, because they already meet ongoing reporting and size tests. For investors it signals that the company is up-to-date with regulatory disclosure and has an efficient way to issue new securities — similar to a pre-approved credit line — which can mean faster capital raises but also potential dilution of existing holdings.

Form S-8 regulatory

"incorporated by reference into its existing shelf registration statements on Form F-3 and its equity compensation registration on Form S-8"

A Form S-8 is a U.S. Securities and Exchange Commission registration that lets a public company set aside shares for employee benefit plans and stock-based compensation. Think of it as opening a dedicated account that authorizes the company to issue or reserve stock for workers and directors; it matters to investors because it enables share dilution when those awards are granted or exercised and signals how management is compensated and incentivized.

AI-generated analysis. Not financial advice.

Vancouver, Canada, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, recently announced three transformative milestones in its FDA-approved Phase I/IIa clinical trial for CMND-100—the Company's proprietary, non-hallucinogenic, MEAI-based oral therapy targeting Alcohol Use Disorder (AUD). 

These achievements include positive top-line results from the first cohort, unanimous approval from the independent Data and Safety Monitoring Board (DSMB) to continue Phase I/IIa clinical trial and the commencement of enrollment at another clinical site in Israel, propelling the multinational study toward potential accelerated patient recruitment.

AUD impacts over 28 million adults in the U.S. alone, driving staggering societal and economic costs exceeding $249 billion annually, yet current treatments fall short in efficacy and accessibility. Clearmind's CMND-100, designed to safely and effectively diminish alcohol cravings and consumption through innovative neuroplasticity mechanisms. The ongoing trial—a single- and multiple-dose evaluation of safety, tolerability, pharmacokinetics, and preliminary efficacy—spans world-renowned institutions.

Positive Safety and Efficacy Results from First Cohort

In an announcement on November 18, the Company reported compelling top-line data from the trial's initial cohort of six participants Who were dosed across elite sites including Johns Hopkins University School of Medicine (two participants) and Yale School of Medicine’s Department of Psychiatry (four participants).

DSMB's Resounding Green Light Fuels Momentum

Building on this momentum, Clearmind's independent DSMB conducted a meticulous, unblinded interim safety review on November 24. The board unanimously recommended that the clinical trial continue.

Global Network Expands with Elite Israeli Site Activation

Just one day later, on November 25, Clearmind activated enrollment at another clinical site in its international consortium: Tel Aviv Sourasky Medical Center (TASMC), one of Israel's leading medical centers. Under the leadership of Principal Investigator Prof. David Zeltser, Director of Internal Medicine and Deputy Director of R&D and Innovation, TASMC welcomed its first patient—marking seamless site initiation and injecting fresh velocity into recruitment efforts. This joins an elite lineup of active centers, including Yale School of Medicine, Johns Hopkins University School of Medicine, and Hadassah Medical Center, enabling diverse, high-quality data accrual to power the trial's next phases.

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 potential accelerated patient recruitment in its Phase I/IIa clinical trial and the timing and progress of its clinical trial. 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) report about the first cohort of CMND-100 on November 18, 2025?

Clearmind reported positive top-line safety and preliminary efficacy from the trial's first cohort of six participants on Nov 18, 2025.

What did the DSMB conclude about Clearmind's Phase I/IIa trial on November 24, 2025?

An independent DSMB conducted an unblinded safety review and issued a unanimous recommendation to continue the trial on Nov 24, 2025.

Which new clinical site did Clearmind activate for CMND-100 and when was the first patient enrolled?

Clearmind activated Tel Aviv Sourasky Medical Center and enrolled its first patient on Nov 25, 2025.

How might the new TASMC site affect CMND-100 clinical trial recruitment for CMND?

The TASMC activation is intended to accelerate multinational recruitment by expanding the trial's international site network.

What endpoints is the Phase I/IIa CMND-100 trial evaluating for CMND?

The trial evaluates safety, tolerability, pharmacokinetics, and preliminary efficacy in single- and multiple-dose cohorts.

Which leading institutions are participating in the CMND-100 trial for CMND?

Active sites include Yale School of Medicine, Johns Hopkins University School of Medicine, Hadassah Medical Center, and TASMC.