Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 137

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 137
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 24-hour post last drug administration |

The primary objective of the study is the evaluation of tolerability, safety and pharmacokinetics of CMND-100 in both healthy and subjects with binge drinking/AUD. Safety will be assessed from randomization of subjects until the last follow-up visit. The primary safety endpoint will therefore consist of evaluation of incidence of adverse events, changes in vital signs, clinical significant abnormal laboratory data, clinical significant abnormal physical examination and ECG following subject randomization. Additional safety assessments include, among others, abuse liability measured by Visual Analogue Scale (VAS) and suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS). The primary PK endpoint parameters will be evaluated in all subjects: Tmax, Cmax, AUC0-∞, t1/2, Cl, Vd. Treating Unmet Mental Health Disorders We believe that AUD is not being addressed by most of the psychedelic industry. Global spending necessitated by the implications of AUD is sky-rocketing; in 2010 there was an estimated cost of nearly $250 billion in the United States, comprised of costs due to productivity losses, healthcare expenditures, crime, and traffic crashes among other things. A 2020 survey in the United States conducted by the National Survey on Drug Use and Health showed that 28.3 million people aged 12 years and older reported having AUD, with 2.1 million of this group having reported receiving treatment for alcohol use. Despite the pressing need to address AUD, psychedelic industry is mostly focusing on research and development on other areas of health. We believe that these unmet needs exist across efficacy, safety and time to onset of current treatment options. 83 Tackling a Social Burden to Improve the Lives of Patients and People Surrounding Them Alcoholism and binge drinking are a huge social burden in terms of costs by direct and indirect implications. These health problems impact a wide range of social cycles surrounding the alcoholic/ binge drinkers life – especially when it is a parent, life partner, sibling or co-worker. According to the National Council on Alcoholism and Drug Dependence: The time, effort, and resources formerly dedicated to life-sustaining activities, such as working and spending time with the family, are disrupted. Initially, a person may think that abusing alcohol will help them deal with these stressors, but as they continue to drink a lot, over time, this use can turn into dependence on the substance. Once individuals become psychologically addicted, alcohol abuse can become all-consuming. As individuals