Company: CMND
Filing Date: 2025-09-15
Form Type: POS AM
Source: 0001213900-25-087398
Chunk: 7

Company: Clearmind Medicine Inc.
Filing Date: 2025-09-15
Form: POS AM
Chunk 7
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indane, or 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 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 2024, 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.
After Phase I/IIa study initiation in Israel in March 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 in April 2025. In June 2025, we announced the addition of Tel Aviv
Sourasky Medical Center (TASMC) in Tel Aviv, Israel and Hadassah-University Medical Center
in Jerusalem