Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 108

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 108
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 the United States in their previous respective roles and are also key members of our scientific advisory board who have participated
in numerous clinical trials in the areas of alcoholism and addiction. We are currently focusing our research programs on the uses of MEAI
for the treatment of AUD, obesity and metabolic disorders and as an alcohol substitute consumer product.

In our research program aimed at treating depression
and treatment resistant depression, or TRD, we studied the effects of administering 2-fluorodeschloroketamine, or 2-FDCK and we investigated
2-FDCK in a pre-clinical proof-of-concept study. Following the completion of the study, while we do not have any immediate plans to further
investigate this now, we may in the future further investigate the effect of depression and the mechanisms of action around it.

In our two research programs aimed at finding substances
that can be utilized for the same therapeutic purposes as MDMA, we studied 1-(Benzofuran-5-yl)-N-methylpropan-2-amine, or 5-MAPB and 1-Benzofuran-6-yl
propan-2-amine, or 6-APB. We believe these treatments may be beneficial for fail-safes for MDMA based on a September 2016 article from
Naunyn-Schmiedeberg’s Archives of Pharmacology, which reported the receptor binding profiles of 5-MAPB and 6-APB are different enough
from MDMA to effectively perform a substitute role in the therapy while being similar enough so as not to have to change the therapeutic
protocol. We currently hold patents with respect to the compounds, but we do not have any immediate research plans.

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.

Phase I/IIa Clinical Study

In
February 2024, we announced that we had submitted