Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) reported additional positive topline safety results from the second cohort of its FDA‑approved Phase I/IIa trial of CMND‑100 for Alcohol Use Disorder (AUD) on February 9, 2026. The cohort completed treatment across multinational sites, showed no serious adverse events, and maintained good tolerability.

The company said the Data and Safety Monitoring Board gave unanimous clearance to advance the study, and investigators completed dosing at sites including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

Positive

• DSMB gave unanimous approval to advance the second cohort
• Second cohort showed no serious adverse events
• Full treatment completion achieved across multinational sites including Johns Hopkins and two Israeli centers
• Good tolerability maintained consistent with first cohort

Negative

• None.

News Market Reaction

-8.15%

11 alerts

-8.15% News Effect

+5.3% Peak Tracked

-20.3% Trough Tracked

-$180K Valuation Impact

$2M Market Cap

0.7x Rel. Volume

On the day this news was published, CMND declined 8.15%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.3% during that session. Argus tracked a trough of -20.3% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $180K from the company's valuation, bringing the market cap to $2M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Second cohort size: 6 patients Trial phase: Phase I/IIa

2 metrics

Second cohort size 6 patients Additional safety data from second cohort in Phase I/IIa CMND-100 trial

Trial phase Phase I/IIa Ongoing CMND-100 trial for moderate to severe Alcohol Use Disorder

Market Reality Check

Price: $1.16 Vol: Volume 7,210,769 is 14.96...

high vol

$1.16 Last Close

Volume Volume 7,210,769 is 14.96x the 20-day average of 481,954, indicating unusually elevated trading activity before this safety update. high

Technical Shares at $1.345 are trading well below the 200-day MA of $28.64 and hovering just above the 52-week low of $1.31, far from the $59.60 52-week high.

Peers on Argus

CMND fell 6.9% while peers showed mixed moves: SXTP up 10.05%, TTNP down 3.96%, ...

1 Up 1 Down

CMND fell 6.9% while peers showed mixed moves: SXTP up 10.05%, TTNP down 3.96%, KTTA down 3.9%, PLRZ up 2.6%, SILO up 2.96%. Momentum scanner also flagged ARTL up 7.48% and SXTP down 4.33%, with only one peer in each direction, supporting a stock-specific move rather than a coordinated sector rotation.

Previous Clinical trial Reports

5 past events · Latest: Jan 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	Cohort 2 completion	Positive	+0.4%	All six second-cohort patients completed CMND-100 treatment per protocol successfully.
Dec 16	Cohort 2 enrollment	Positive	-3.7%	Completed enrollment of six-patient second cohort across three multinational clinical sites.
Dec 02	Dosing at Hadassah	Positive	-9.9%	First participant enrolled and dosed with CMND-100 at Hadassah in Phase I/IIa AUD trial.
Dec 01	Positive cohort data	Positive	-6.9%	Reported positive first-cohort safety and efficacy signals and unanimous DSMB approval to continue.
Nov 25	New site enrollment	Positive	-19.4%	Tel Aviv Sourasky site activated with first patient enrolled into CMND-100 AUD trial.

Pattern Detected

Clinical trial updates for CMND-100 have generally been positive, yet the stock has more often traded down on these announcements, showing a pattern of negative price reactions to constructive clinical progress.

Recent Company History

Over recent months, Clearmind has repeatedly reported progress in its CMND-100 Phase I/IIa Alcohol Use Disorder program, including new site activations, enrollment milestones, dosing initiation, and completion of the second cohort. Despite positive themes such as favorable safety data and unanimous DSMB recommendations to continue, four of the last five clinical trial headlines (since Nov 25, 2025) saw negative next-day moves. Today’s additional positive safety results extend this ongoing development narrative.

Historical Comparison

clinical trial

-7.9 %

Average Historical Move

Historical Analysis

Over the last five clinical trial updates, CMND moved an average of -7.91%. Today’s -6.9% reaction to additional positive CMND-100 safety data falls broadly in line with this historically negative skew.

Typical Pattern

Clinical updates trace a steady CMND-100 trajectory from new site activations and first dosing through second-cohort enrollment, treatment completion, and now reinforced safety findings in moderate-to-severe Alcohol Use Disorder.

Market Pulse Summary

The stock moved -8.2% in the session following this news. A negative reaction despite positive safet...

Analysis

The stock moved -8.2% in the session following this news. A negative reaction despite positive safety results fits the pattern seen in prior CMND-100 clinical updates, where average next-day moves have been around -7.91%. The stock already traded near its $1.31 52-week low and far below the $28.64 200-day MA, suggesting fragile sentiment. Continued operating losses and ongoing financing activity from recent filings may have amplified risk perceptions around otherwise encouraging clinical data.

Key Terms

phase i/iia, pharmacokinetics, data and safety monitoring board, dsmb, +3 more

7 terms

phase i/iia medical

"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.

pharmacokinetics medical

"designed to evaluate 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.

data and safety monitoring board medical

"the Company’s Data and Safety Monitoring Board’s (DSMB) unanimous approval"

An independent panel of experts that watches over a clinical trial to protect participants and ensure the data are reliable, acting like an impartial referee who can recommend pausing or stopping the study if safety problems or clear benefits emerge. Investors care because the board’s findings can change a drug or device’s timeline, cost, and odds of regulatory approval, directly affecting a company’s value and risk profile.

dsmb medical

"DSMB’s unanimous approval to advance for the second cohort"

A DSMB (Data and Safety Monitoring Board) is an independent group of medical and statistical experts that watches over clinical trials to protect participants and ensure the study’s data are reliable. Think of it as an impartial referee who can pause, change, or stop a trial if safety problems, clear benefits, or data flaws appear; its decisions can quickly alter a biotech company’s regulatory path, market value, and investor outlook.

alcohol use disorder medical

"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.

aud medical

"for the treatment of Alcohol Use Disorder (AUD)"

AUD is the international currency code for the Australian dollar, the official money used in Australia and several nearby territories. Investors watch AUD because changes in its value act like a price tag or thermometer for assets and transactions denominated in that currency — affecting export revenues, import costs, commodity prices, and the value of overseas investments. Movements in AUD can change returns and risk for portfolios with exposure to Australia or Australian-dollar contracts.

neuroplastogen medical

"development of novel neuroplastogen-derived therapeutics to solve major"

A neuroplastogen is a drug or compound designed to boost the brain’s ability to rewire and form new connections, enhancing recovery or adaptation after injury, stress, or disease. For investors, these molecules matter because they target underlying brain repair processes rather than just masking symptoms, offering the potential for durable benefits in conditions like depression, neurodegeneration, or cognitive decline—akin to giving a tired garden fresh tools to regrow and reshape itself.

AI-generated analysis. Not financial advice.

Vancouver, Canada, Feb. 09, 2026 (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 additional positive safety topline results from the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).

These further safety data points, emerging following the successful completion of treatment in another six patients of the second cohort, previously announced January 14, 2026, continue to strengthen the encouraging safety and tolerability profile previously established in the first cohort.

The results reinforce no serious adverse events and overall good tolerability, consistent with the favorable results reported from the first cohort, support the rapid progression enabled by the Company’s Data and Safety Monitoring Board’s (DSMB) unanimous approval to advance for the second cohort.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The second cohort, conducted across leading sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, achieved full treatment completion shortly after DSMB clearance, underscoring continued confidence in CMND-100’s safety profile as a potential innovative therapy for AUD.

“These additional topline safety results from the second cohort further validate and reinforce the positive profile we observed in the first cohort,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “With no serious adverse events emerging and strong tolerability maintained, we are continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in alcohol use disorder.”

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 CMND-100’s safety profile as a potential innovative therapy for alcohol use disorder and how it is continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in 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 did Clearmind (CMND) announce on February 9, 2026 about CMND-100 safety?

The company announced additional topline safety results showing no serious adverse events and maintained tolerability. According to Clearmind, the second cohort completed treatment after DSMB unanimous clearance across multiple trial sites, reinforcing the favorable safety profile seen in cohort one.

Does the Phase I/IIa trial of CMND-100 have regulatory oversight for safety?

Yes. The trial is FDA‑approved and overseen by a Data and Safety Monitoring Board. According to Clearmind, the DSMB gave unanimous approval for progression after reviewing safety data from the second cohort.

Which clinical sites participated in CMND-100 second cohort for CMND (Nasdaq: CMND)?

The second cohort was conducted at multinational leading centers including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. According to Clearmind, these sites achieved full treatment completion after DSMB clearance.

What does 'no serious adverse events' mean for CMND-100 trial progress?

It means the safety profile allowed continued dosing and cohort completion without major safety stops. According to Clearmind, absence of serious adverse events supported the DSMB's unanimous decision to advance the study.

How does Clearmind describe CMND-100 as a treatment for alcohol use disorder (AUD)?

Clearmind describes CMND-100 as a non‑hallucinogenic, oral MEAI‑based candidate with encouraging tolerability. According to Clearmind, ongoing Phase I/IIa safety data reinforce its potential as a novel treatment option for moderate to severe AUD.