Company: CMND
Filing Date: 2025-11-26
Form Type: 424B5
Source: 0001213900-25-115106
Chunk: 6

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-26
Form: 424B5
Chunk 6
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 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 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