Company: CMND
Filing Date: 2025-11-19
Form Type: 424B5
Source: 0001213900-25-112329
Chunk: 7

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-19
Form: 424B5
Chunk 7
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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 intolerance, and hyperinsulinemia; (iii) reduced DIO-induced hepatic steatosis by decreasing hepatic
lipid accumulation and lowered liver triglyceride and cholesterol levels, primarily by inhibiting de novo lipid synthesis, and demonstrating
that metabolic phenotyping revealed that MEAI increased energy expenditure and fat utilization while maintaining food consumption similar
to that of the vehicle-treated group; and (iv) normalized voluntary locomotion actions without any over stimulatory effects. These findings
provided compelling evidence for the anti-obesity effects of MEAI treatment and highlighted the potential of MEAI as a novel therapeutic
approach for treating obesity and its associated metabolic disorders, offering hope for the development of new treatment options for this
global health challenge.

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‍Additionally, we have
engaged Professor Gal Yadid from