Company: CMND
Filing Date: 2025-11-17
Form Type: 424B5
Source: 0001213900-25-111233
Chunk: 8

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-17
Form: 424B5
Chunk 8
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ing 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 attenuating
DIO-induced hyperglycemia, glucose