Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 109

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 109
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 an IND application with the FDA, requesting approval to initiate our first-in-human
Phase I/IIa clinical trial with CMND-100 in subjects suffering from AUD. Subsequently and after submission of a similar application to
the Israeli Ministry of Health, in May 2023 we initiated the CM-CMND-001 clinical trial in both Israel and the United States. 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.

The Israeli study site is IMCA in Ramat-Gan and
is be led by Prof. Mark Weisser, M. D. Our U. S. sites for the CM-CMND-001 clinical trial are Yale School of Medicine’s Department
of Psychiatry and Johns Hopkins University School of Medicine. The Yale site is led by Anahita Bassir Nia, MD, a specialist in substance
abuse, including alcohol abuse. The Johns Hopkins site will be led by Jennifer Ellis, PhD, Associate Professor of Psychiatry and Behavioral
Sciences as the principal investigator, who will be supported by co-investigators Professor Eric Strain, Director, Behavioral Pharmacology
Research Unit of the Johns Hopkins University School of Medicine.

The CM-CMND-001 clinical trial
is designed to be a double blind, multinational, multi-center, Phase I/IIa single- and multiple-dose tolerability, safety, initial efficacy
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.

In April 2023, we announced that we formed a Data
and Safety Monitoring Board, or DMSB, to oversee the Phase I/IIa clinical study. The DSMB - an independent group of experts - 
includes a specialist in internal medicine, a specialist in psychiatry, and a biostatistician. The DSMB is a committee of experts responsible
for reviewing clinical trial data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data.

In May 2023, we announced that we had entered into
a clinical supply agreement with IMP Clinical Supply Services, or IMP, for the Phase I/IIa clinical study. Pursuant to the clinical supply
agreement, IMP