MEAI Compound's First Clinical Trial In US, Clearmind Enters NASDAQ Compliance Period

Clearmind Medicine Inc. CMND, an Israel-based biotech company advancing the clinical stage for an MEAI-based compound targeting Alcohol Use Disorder (AUD,) has selected Yale School of Medicine’s Psychiatry Dept. as the first U.S. site for its Phase 1/2a trial on proprietary CMND-100.

CEO Dr. Adi Zuloff-Shani says the company is honored to partner with the university’s Psychiatry Department, “a global pioneer in psychedelics research,” and sees the collaboration as “further validation” of its innovative drug candidate for the potential treatment of AUD.

Within the newly-announced U.S. site, the study will be led by substance abuse specialist and Yale psychiatry professor Dr. Anahita Bassir Nia, whom Dr. Zuloff-Shani says is ideal for the task considering “her research focuses on addiction and mental health disorders, and she is particularly interested in the biological effects of acute and chronic stress on-developing substance use disorders.”

The Phase 1/2 single and multiple-dose study assessing CMND-100 in both healthy volunteers and participants with an AUD diagnosis will administer daily oral capsules for ten consecutive days, with patients reporting their drinking patterns and alcohol craving during the trial period.

The primary endpoint is to find the compound’s tolerable dose and characterize its safety and pharmacokinetics/pharmacodynamics (PK/PD) in single and repeated doses, while the secondary endpoint is set in evaluating its efficacy in reducing drinking patterns and cravings in individuals with moderate-to-severe AUD.

NASDAQ Issues Minimum Bid Price Note

“We believe that CMND-100 has the potential to be a game-changer in treating addictions and mental health concerns,” said Zuloff-Shani, adding the company’s treatment model “is expected to provide immediate therapeutic benefit, as a self-administered and non-addictive prescription pill that is not dependent on expensive therapies."

Meanwhile, on Friday, May 19 Clearmind received a written notice from the Nasdaq indicating that the company is not in compliance with the minimum bid price requirement of $1.00 per share to continue to be listed under the market’s rules.

While the notice does not immediately affect Clearmind’s listing or trading of its ordinary shares, the company has been granted the usual grace period of 180 calendar days to regain compliance, ending Nov. 13. 

Regaining compliance implies its ordinary shares’ closing bid price achieves $1.00 (or more) during a minimum of ten consecutive business days at any time during this 180-day period. 

See also: Reunion Neuroscience Enters Compliance Period, Struggles To Remain NASDAQ Listed

If that target is obtained, Clearmind will receive written confirmation of compliance and business can go on as usual. 

Should the company not regain compliance after the initial 180-day period, it may be eligible for an additional 180-day period, provided it meets the continued listing requirement for the market value of publicly held shares and all other Nasdaq listing standards (with the exception of the minimum bid price requirement.)

If compliance is still not achieved by the allotted period(s), Clearmind’s ordinary shares will be subject to delisting.

Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and metamorworks on Shutterstock.