Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 139

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 139
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 market opportunity and recent advances signal an increased acceptance of these novel approaches, and we believe we are well positioned to capitalize on this potential opportunity. In May 2021, Nature Medicine published findings from a first Phase 3 clinical trial conducted with psychedelic-assisted therapy. The study found that MDMA combined with psychological counseling yielded “marked relief to patients” with severe PTSD. Based on the Phase 3 clinical trial results, MAPS Public Benefit Corp. recently filed an application with the U.S. FDA to approve the psychedelic drug MDMA — also known as Ecstasy — in combination with therapy to treat PTSD. The filing is a milestone in researchers’ quest to move psychedelic drugs from tightly restricted substances into mainstream medical treatments that are widely accessible to patients. This comes after decades of studies have demonstrated the promise of psychedelics to treat mental health disorders. 84 Esketamine was approved by the FDA on March 5, 2019, for treatment-resistant depression. It is sold under the trade name, Spravato. Esketamine became the first FDA-approved psychedelic treatment for a psychiatric disorder. In addition, recently the FDA extended its approval for esketamine to adults with major depressive disorder with acute suicidal ideation or behavior. In April 2021, the FDA granted psilocybin “breakthrough” therapy designation. In addition, the FDA cleared MAPS (Multidisciplinary Association for Psychedelics Studies) to conduct Phase III trials of MDMA as assisted therapy for PTSD. COVID-19 Pandemic implications AUD is a huge problem that costs billions every year. But the problem was only escalated and more people suffer, partially due to the COVID-19 pandemic. Economists as well as healthcare and addiction specialists agree the pandemic and quarantines of 2020 had a significant impact on nationwide alcohol consumption. For example, the National Center for Drug Abuse Statistics has reported that during the pandemic and quarantines of 2020, year-over-year alcohol sales were up 234%, 34.1% of respondents in a survey conducted by Johns Hopkins University reported binge drinking at least once, with 7.0% of respondents reporting extreme binge drinking and 45.7% of respondents reporting increased stress as a reason for their increased drinking. In addition, it has been estimated that depression symptoms increased by a factor of 3 compared to pre-COVID-19 levels, with severe depression symptoms increasing by a factor of 7.5 compared to pre-COVID-19 levels. Markets Overview and Opportunity The current indications we