Company: CMND
Filing Date: 2025-06-12
Form Type: POS AM
Source: 0001213900-25-053898
Chunk: 7

Company: Clearmind Medicine Inc.
Filing Date: 2025-06-12
Form: POS AM
Chunk 7
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 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 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, 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 sites, for part A of our Phase I/IIa clinical trial in the United States for treating patients suffering from
AUD. In March 2025, we initiated our Phase I/IIa clinical trial at IMCA in Israel, and in April 2025, we initiated our Phase I/IIa clinical
trial at the Johns Hopkins University School of Medicine and Yale School of Medicine’s Department of Psychiatry.

The CM-CMND-001 clinical trial is designed
to be a multinational, multi-center, double blind, 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.

About MEAI

MEAI is a synthetic molecule. Its mechanism
of action has been studied and published in the past in scientific papers. It was found to