Company: CMND
Filing Date: 2025-11-26
Form Type: F-1
Source: 0001213900-25-115501
Chunk: 8

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-26
Form: F-1
Chunk 8
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The literature shows that 5-HT1A receptors are
associated with controlling craving behaviors across the board. This indicates that MEAI may have a wide range of applications beyond
AUD and binge drinking. Until today, only pre-clinical studies have been conducted with MEAI, including in-vitro and in-vivo studies.
The studies were conducted in the United States, China, France and Israel.

MEAI is a neuroplastogens non-hallucinogenic molecule,
exerting a euphoric alcohol-like experience, and based on human recreational use testimonials and pre-clinical trials, we believe also
reduces the desire to consume alcoholic beverages. While determinations of safety and efficacy are solely within the authority of the
FDA and comparable regulatory bodies, in pre-clinical studies, MEAI was well-tolerated by the tested animals. Although MEAI remains in
development and is not cleared or approved by the FDA or similar foreign regulatory bodies, we believe that our drug candidate has the
potential to change the lives of millions who struggle to drink in moderation.

We believe that MEAI holds the potential to break
the vicious binge-drinking cycle at the decision point to drink more alcohol, by potentially innervating neural pathways such as 5-HT1A
that lead to “sensible behavior”.

Strategic Focus

With respect to our AUD
programs, we developed MEAI as a new chemical entity (NCE) drug candidate. We intend to seek regulatory approval through the FDA’s
505(b)(1) regulatory path. The FDA’s 505(b)(1) regulatory path is typically used for novel drugs that have not previously been studied
or approved, and drug development pursuant to this path requires drug developers to conduct all studies needed to demonstrate the safety
and efficacy of the drug. Given its nature, this type of submission requires extensive research, including both clinical and nonclinical
studies, to prove the product’s safety and efficacy for the indication being sought.

Markets Overview and Opportunity

The current indications
we are pursuing with our MEAI molecule are focused on two main verticals: (1) AUD and binge drinking (2) obesity and metabolic disorder.

With respect to obesity
and metabolic disorder, we have engaged Professor Joseph (Yossi) Tam, D.M.D., Ph.D.,the Head of the Obesity and Metabolism Laboratory
and the Director of the Multidisciplinary Center for Cannabinoid Research at the Hebrew University of Jerusalem (Jerusalem,