Company: CMND
Filing Date: 2025-11-26
Form Type: 424B5
Source: 0001213900-25-115106
Chunk: 4

Company: Clearmind Medicine Inc.
Filing Date: 2025-11-26
Form: 424B5
Chunk 4
---
 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, Israel as additional clinical sites for our ongoing Phase I/IIa clinical trial. In addition, also in June 2025, we announced that the first patient was enrolled and dosed in our Phase I/IIa clinical trial at Yale School of Medicine’s Department of Psychiatry. In July 2025, we announced that we received IRB approval from TASMC for our Phase I/IIa clinical trial , and in August