Company: CMND
Filing Date: 2025-09-15
Form Type: POS AM
Source: 0001213900-25-087398
Chunk: 9

Company: Clearmind Medicine Inc.
Filing Date: 2025-09-15
Form: POS AM
Chunk 9
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 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,
Israel), to study the effect of MEAI on treating obesity and metabolic syndrome, to examine MEAI's metabolic efficacy on appetite regulation,
obesity, and related comorbidities under acute and chronic settings. The results demonstrated that MEAI treatment (i) significantly reduced
diet induced obesity (DIO) and adiposity by preserving lean mass and decreasing fat mass; (ii) exhibited positive effects on glycemic
control by attenu