Clearmind Medicine’s CMND-100 Meets Primary Endpoint in FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) reported that its oral candidate CMND-100 met the primary safety and tolerability endpoint in an FDA-approved Phase I/IIa dose-escalation trial for Alcohol Use Disorder on April 14, 2026. The third cohort showed a high safety profile with no serious adverse events and continued favorable tolerability, including at the highest dose tested to date. The multinational, multicenter study assessed safety, tolerability, pharmacokinetics, and preliminary efficacy; meeting the primary endpoint supports continued clinical advancement of CMND-100 as a potential non-hallucinogenic AUD treatment.

Positive

• Primary safety endpoint met in FDA-approved Phase I/IIa trial
• No serious adverse events reported in third cohort
• Favorable tolerability at higher dose in dose-escalation stage
• Supports continued clinical advancement of CMND-100

Negative

• Efficacy readouts not reported in this announcement
• Data limited to Phase I/IIa dose-escalation early-stage cohort

News Market Reaction – CMND

-36.36% 119.6x vol

50 alerts

-36.36% Session close to close

+41.2% Peak Tracked

-62.1% Trough Tracked

$2.99M Market Cap

119.6x Rel. Volume

In the Apr 14 session, CMND declined 36.36%, reflecting a significant negative market reaction. Argus tracked a peak move of +41.2% during that session. Argus tracked a trough of -62.1% from its starting point during tracking. Our momentum scanner triggered 50 alerts that day, indicating high trading interest and price volatility. Trading volume was exceptionally heavy at 119.6x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -36.4% in the session following this news. A negative reaction despite positive sa...

Analysis

The stock dropped -36.4% in the session following this news. A negative reaction despite positive safety and tolerability news would fit a prior pattern: several CMND‑100 clinical updates in 2026 showed declines of between 4.8% and 8.15% even as DSMB approvals and cohort progress were reported. With shares far below the $20.46 200-day MA and 97.27% under the 52-week high, sentiment around dilution, liquidity, or prior financings could still have weighed on responses to good trial news.

Previous Clinical trial Reports

5 past events · Latest: Mar 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 30	Clinical trial update	Positive	+22.7%	Reported completion of treatment and follow-up for 18 CMND‑100 trial participants.
Mar 19	Clinical trial update	Positive	-3.1%	Announced successful ongoing treatment in third cohort with no serious adverse events.
Mar 11	Clinical trial update	Positive	-6.3%	Highlighted continued enrollment for Cohort 3 following positive topline results and DSMB approval.
Mar 04	Clinical trial update	Positive	-4.8%	Disclosed DSMB approval to progress trial and escalate to an 80 mg third cohort dose.
Feb 09	Clinical trial update	Positive	-8.2%	Reported additional positive topline safety results from second cohort with no serious adverse events.

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 have often seen negative price reactions despite positive safety and progression headlines, with only one of five similar past events showing a positive move.

Recent Company History

Over recent months, Clearmind has repeatedly reported progress in its FDA‑approved Phase I/IIa trial of CMND‑100 for Alcohol Use Disorder, including additional positive safety data, DSMB approvals to advance dosing, and successful completion of treatment and follow-up for 18 participants. Price reactions to these clinical updates were mixed, with several declines of between 4.8% and 8.15% despite favorable safety signals, and one strong 22.7% gain on Mar 30, 2026. Today’s primary endpoint success extends that safety-focused narrative.

Key Terms

phase i/iia, pharmacokinetics, alcohol use disorder (aud), non-hallucinogenic, +4 more

8 terms

phase i/iia medical

"FDA-approved Phase I/IIa clinical trial."

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

"study 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.

alcohol use disorder (aud) medical

"for the treatment of Alcohol Use Disorder (AUD) has met the primary endpoint"

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.

non-hallucinogenic medical

"proprietary non-hallucinogenic MEAI-based oral drug candidate"

A non-hallucinogenic substance is one that does not produce hallucinations or significant distortions of perception, mood, or thought; think of a medicine that relieves symptoms without causing vivid sensory experiences or altered reality. For investors, non-hallucinogenic status matters because it can mean fewer safety concerns, simpler regulatory approval, broader patient acceptance, and potentially lower liability and marketing barriers, which affect commercial viability and risk.

neuroplastogen-derived medical

"non-hallucinogenic, second generation, neuroplastogen-derived therapeutics"

Neuroplastogen-derived describes a drug or product made from or based on compounds that promote neuroplasticity — the brain’s ability to rewire and form new connections. For investors, this signals a therapy’s intended mechanism of action and market positioning: such treatments aim to repair or improve brain function in conditions like depression or injury, which can mean high clinical and regulatory risk but also potentially large therapeutic value if proven effective.

adverse events medical

"no serious adverse events reported in the third cohort"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

fda-approved regulatory

"has met the primary endpoint in its FDA-approved Phase I/IIa clinical trial"

FDA-approved means a medical product, drug, device or treatment has passed the U.S. Food and Drug Administration’s review for safety and effectiveness for a specific use. Think of it like a formal safety and performance seal that allows the product to be marketed for that purpose in the U.S.; for investors, approval reduces regulatory uncertainty, enables sales and reimbursement pathways, and can materially affect a company’s revenue prospects and valuation.

dose-escalation medical

"endpoint in this dose-escalation stage, including at the higher dosage"

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.

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

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Vancouver, Canada, April 14, 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 CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD) has met the primary endpoint in its FDA-approved Phase I/IIa clinical trial.

Results from the third cohort of the trial indicated a high safety profile for CMND-100, even at the higher dosage administered to date. The data demonstrated that the drug candidate was well tolerated, with no serious adverse events reported in the third cohort and continued favorable overall tolerability, consistent with the safety outcomes observed in prior cohorts.

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. Meeting the primary safety and tolerability endpoint in this dose-escalation stage, including at the higher dosage in the third cohort, supports continued advancement of CMND-100 as a potential novel, non-hallucinogenic treatment option for AUD.

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. 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 about CMND-100 on April 14, 2026?

CMND announced that CMND-100 met the primary safety and tolerability endpoint in its FDA-approved Phase I/IIa trial. According to the company, the third cohort showed a high safety profile with no serious adverse events at the highest dose tested.

Does the CMND-100 result from CMND mean the drug is effective for AUD?

The announcement reports safety and tolerability endpoints met, not definitive efficacy. According to the company, the trial assessed preliminary efficacy, but specific efficacy readouts were not provided in this release.

Were there any serious adverse events for CMND-100 in the April 2026 update from CMND?

No serious adverse events were reported in the third cohort of the trial. According to the company, CMND-100 was well tolerated, including at the higher dosage administered to date.

What stage is CMND-100 in development after the April 14, 2026 announcement by CMND?

CMND-100 is in an FDA-approved Phase I/IIa multinational, multicenter dose-escalation study. According to the company, meeting the primary safety endpoint supports continued clinical advancement toward later-stage trials.

How will CMND-100 safety results affect Clearmind (CMND) development plans?

Meeting the primary safety endpoint likely enables progression to subsequent development steps. According to the company, the dose-escalation safety outcome supports continued advancement of CMND-100 as a potential non-hallucinogenic AUD treatment.