Company: CMND
Filing Date: 2025-09-19
Form Type: F-1
Source: 0001213900-25-089545
Chunk: 10

Company: Clearmind Medicine Inc.
Filing Date: 2025-09-19
Form: F-1
Chunk 10
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 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 the Gonda Multidisciplinary Brain Research Center located at Bar Ilan University
(Ramat