Clearmind Medicine Announces Positive Data Safety Monitoring Board Recommendation in ongoing CMND-100 clinical trial

Clearmind Medicine (Nasdaq: CMND) said an independent Data and Safety Monitoring Board gave a positive recommendation to continue its FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder after the third cohort.

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) said an independent Data and Safety Monitoring Board gave a positive recommendation to continue its FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder after the third cohort.

The DSMB found CMND-100 well tolerated with no serious adverse events, and the company will advance to a fourth cohort testing an increased 160mg dose.

Positive

• DSMB positive recommendation to continue trial after third cohort
• No serious adverse events reported in third cohort
• Dose escalation to 160mg for fourth cohort
• Multinational Phase I/IIa design evaluating safety and preliminary efficacy

Argus Apr 15 session

-28.57% close to close Open Argus

Details

News Market Reaction – CMND

On Apr 15, the day this news came out, CMND closed 28.57% below the previous close.

Data tracked by StockTitan Argus for the Apr 15 session.

Market Context

On Apr 15, the day this news came out, the stock closed 28.6% below the previous close. A negative r...

Analysis

On Apr 15, the day this news came out, the stock closed 28.6% below the previous close. A negative reaction despite favorable DSMB feedback and dose escalation could fit the recent pattern where several positive CMND-100 updates were followed by declines, including a -36.36% move after the primary-endpoint news. Investors have also faced dilution overhang from convertible note financing and registered resale shares. If selling deepens, it may reflect sensitivity to capital structure and past volatility rather than the safety profile alone.

Key Figures

Next cohort dose: 160 mg Participants completed: 18 participants Additional participants: 4 participants +5 more

Next cohort dose

160 mg

Planned dose for fourth cohort of CMND-100 Phase I/IIa AUD trial

Participants completed

18 participants

Completed treatment and follow-up in CMND-100 Phase I/IIa trial (Mar 30, 2026)

Additional participants

4 participants

Additional CMND-100 trial participants treated at Tel Aviv site

Convertible notes principal

$1,750,000

Aggregate principal of new convertible promissory notes

Cash proceeds

$1,575,000

Cash received from sale of new convertible notes at 90% of principal

Converted notes

$875,000

Portion of promissory notes converted into common shares

Note facility size

$10,000,000

Aggregate principal capacity under broader convertible note facility

Registered resale shares

331,949 shares

Common shares registered for resale from January 2024 PIPE warrants

Previous Clinical trial Reports

5 past events · Latest: Apr 14

Same Type 5 events

1. Apr 14

   Primary endpoint met

   24h Move

   -36.4%

   CMND-100 met primary safety and tolerability endpoint in Phase I/IIa trial.

2. Mar 30

   Cohort treatment complete

   24h Move

   +22.7%

   Completed treatment and follow-up for 18 CMND-100 trial participants.

3. Mar 19

   Ongoing cohort treatment

   24h Move

   -3.1%

   Reported successful ongoing treatment in third cohort with no serious adverse events.

4. Mar 11

   Recruitment expansion

   24h Move

   -6.3%

   Advanced recruitment for third cohort after positive topline results and DSMB approval.

5. Mar 04

   DSMB approval

   24h Move

   -4.8%

   DSMB cleared progression after second interim review and endorsed dosing at 80 mg.

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

Key Terms

data and safety monitoring board, phase i/iia, pharmacokinetics, alcohol use disorder, +4 more

8 terms

data and safety monitoring board medical

"its independent Data and Safety Monitoring Board (“DSMB”) has completed its review"

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.

phase i/iia medical

"ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder"

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 of CMND-100"

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 medical

"clinical trial of CMND-100 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.

convertible promissory notes financial

"issue and sell new convertible promissory notes with an aggregate principal of $1,750,000"

A convertible promissory note is a loan a company takes that can later be turned into shares instead of being paid back in cash; think of lending money now in exchange for a voucher that can become ownership later. Investors care because it mixes credit risk and potential ownership upside—it can protect lenders if a company struggles while also diluting existing shareholders when converted, affecting future share value and investor returns.

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 Clearmind’s existing Form F-3 and Form S-8 registration statements"

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.

pipe warrants financial

"shares issuable upon exercise of January 2024 PIPE Warrants"

Pipe warrants are option-like securities issued together with a private investment in a publicly traded company that give the holder the right to buy a set number of shares at a fixed price for a limited time. They matter to investors because if holders exercise them the company receives new cash but the total number of shares increases, which can reduce each existing shareholder’s ownership and earnings per share and potentially pressure the stock price—like redeeming coupons that create more pieces of the same pie.

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

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Vancouver, Canada, April 15, 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 its independent Data and Safety Monitoring Board (“DSMB”) has completed its review and issued a positive recommendation to continue the ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder (“AUD”).

The positive DSMB recommendation follows the successful completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. These results reinforce the favorable safety and tolerability profile observed in previous cohorts.

As a result, the Company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.

The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, in patients with moderate to severe 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Clearmind (CMND) announce about the CMND-100 trial on April 15, 2026?

The company announced a DSMB positive recommendation to continue the Phase I/IIa CMND-100 trial. According to the company, the decision followed completion of the third cohort with top-line safety data showing no serious adverse events, allowing progression to a higher dose cohort.

Why is the DSMB recommendation important for Clearmind (CMND) CMND-100 development?

A positive DSMB recommendation supports continued clinical development and participant safety. According to the company, the DSMB found CMND-100 well tolerated in the third cohort, enabling dose escalation and continued study of safety, pharmacokinetics, and preliminary efficacy.

What dose will Clearmind (CMND) test next for CMND-100 and when does escalation occur?

Clearmind will increase the tested CMND-100 dose to 160mg for the fourth cohort. According to the company, escalation follows the DSMB review of the third cohort’s safety data and will occur as the multinational Phase I/IIa trial advances.

Were there any serious adverse events reported in the CMND-100 Phase I/IIa trial for CMND (CMND)?

No serious adverse events were reported in the third cohort of the CMND-100 trial. According to the company, top-line safety data showed the drug was well tolerated, reinforcing the safety profile observed in earlier cohorts.

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

The trial is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in moderate to severe AUD patients. According to the company, the multinational, multicenter study addresses these endpoints across multiple dose cohorts.