Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 104

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 104
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 alcohol consumption and
increased cancer risk, which is in addition to other common risks associated with excessive alcohol consumption. Apart from potentially
changing people’s lives, we believe that our treatment could potentially reduce the amount currently being spent on the consequences
of AUD in the United States, Europe, India, China and other countries around the world. We also believe that our treatment may address
binge drinking. 178,000 people die every year in the United States alone due to binge drinking.

We are currently focusing our research programs
on the uses of MEAI for the treatment of AUD, weight loss and metabolic disorders and as an alcohol substitute consumer products. On the
consumer side, we are developing an alcohol substitute which may offer a solution that adults can enjoy without the extensive damage that
comes with alcohol, such as higher risk to get cancer and other wide range of adverse effects on almost every part of the body, including
the brain, liver, pancreas and the immune system. We have completed a series of pre-clinical, investigational new drug -, or IND -,
enabling studies in the United States and China that are required before we can study our compound for the first time in humans. These
studies include pharmacokinetic and toxicological studies in rats and dogs in order to assess the safety profile of our compound and characterization
of the drug metabolism. We have conducted several metabolism studies designed to better understand the way 5-Methoxy-2-aminoindane, or
MEAI, is digested in several species. In addition, we have conducted a pre-clinical animal model of AUD to characterize the effect of
MEAI on alcohol consumption. This study involved testing the effect of MEAI’s ability to curb alcohol cravings after exposing mice
to prolonged alcohol consumption over a short period, mimicking binge alcohol consumption in humans.

In
February 2024 and in July 2024, we announced that we were granted approval by the Israeli Ministry of Health and by the FDA, respectively
to initiate our first-in-human Phase I/IIa clinical trial with CMND-100 in patients suffering from AUD. Subsequently, in May 2023 we initiated
the CM-CMND-001 clinical trial in both Israel and the United States, including at the Yale School of Medicine’s Department of Psychiatry
and Johns Hopkins University School of Medicine. In October 2024 and December, we announced that we received IRB approvals from Johns
Hopkins University and Yale University, respectively, our clinical