Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 135

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 135
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 in Human (FIH): HCRC Facility. The TASMC site is led by Prof. David Zeltser, Director of Internal Medicine Department and Deputy Director, R&D and Innovation. The Hadassa site is led by Prof. Yoseph Caraco, M.D., clinical pharmacologist. 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 November 2025 we announced DSMB unanimously approves continuation of Phase I/IIa clinical trial for CMND-100 following positive interim safety review. 82 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 is responsible for the global clinical supply chain of CMND-100 from manufacture to the various clinical sites. IMP is known for its comprehensive, tailor-made clinical supply services that address all study requirements. The array of services to be performed are fully compliant with GMP, GCP, and GDP standards. Clinical drug supply is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply. The Phase I part of the Phase I/IIa clinical study is an open label, randomized study to evaluate the safety and pharmacokinetics of single ascending doses of MEAI oral capsules. In the study we are utilizing a hybrid model where we study the effects of MEAI in healthy volunteers and AUD patients. Single ascending doses will be distributed in up to 4 cohorts, with