Company: CMND
Filing Date: 2025-06-12
Form Type: POS AM
Source: 0001213900-25-053898
Chunk: 8

Company: Clearmind Medicine Inc.
Filing Date: 2025-06-12
Form: POS AM
Chunk 8
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 interact with the serotonergic receptors 5-HT1A
and 5-HT2B and the adrenergic receptors α2A, α2B and α2C receptors. Studies conducted in animals and humans have demonstrated
the role of 5-HT1A receptors in alcohol-drinking behavior. Several 5-HT1A receptor agonists have been tested in animal models to demonstrate
the role of this receptor in alcohol dependence. These preclinical studies suggest that 5-HT1A receptor agonists may play a role in reducing
alcohol intake. In addition, evidence suggests that α2-adrenergic receptor agonist signaling may play a role in mediating alcohol-drinking
behavior in both rodents and humans.

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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 psychoactive 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