Company: CMND
Filing Date: 2025-11-19
Form Type: 424B5
Source: 0001213900-25-112329
Chunk: 36

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-19
Form: 424B5
Chunk 36
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 each year globally and is the third most common preventable cause of death in the United States. 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. 95,000 people die every year in the United States alone due to binge drinking.

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 March 2023, we announced
that we had submitted an IND application with the FDA, requesting approval 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.

The CM-CMND-001 clinical trial
is designed to be a multinational, multi-center, Phase I/IIa single- and multiple-dose tolerability, safety and pharmacokinetic study
in healthy volunteers and AUD subjects. Upon completion of the Phase I/IIa studies, if successful, we will be required to conduct additional
clinical trials subject to securing additional financing.

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About MEAI

MEAI is a synthetic molecule.
Its mechanism of action has been studied and published in past scientific papers. It was found to interact with the serotonergic receptors
5-HT1A and 5-HT2B and the adrenergic receptors α