Clearmind Medicine Inc.
(Note: This is NOT an IPO. This is a NASDAQ uplisting – a micro-cap unit public offering of stock and warrants – from the Canadian Securities Exchange and the Frankfurt Stock Exchange. Clearmind Medicine Inc. filed its F-1 on June 29, 2022; the Canadian company had filed confidential IPO paperwork on Dec. 23, 2021.)
We are a pre-clinical pharmaceutical company approaching phase 1 clinical trials, that develops novel psychedelic medicines to solve widespread, yet under-served, health problems. Our goal is to develop and provide a new type of treatment for alcohol use disorders (AUDs), including binge drinking and eating disorders, where there is significant unmet need and lack of innovation. We see psychedelic therapies, which previously may have been overlooked or underused, as the future of treatment for a variety of indications. We believe that our solution for AUDs can help solve one of the world’s biggest health problems, which costs the United States alone $250 billion each year. Our other therapeutic programs also target verticals with significant potential market opportunities, if approved.
Our flagship treatment and focus for the short term is on AUDs, which are incredibly common. It varies from mild to excessive and describes a person’s inability to restrict their alcohol consumption, despite negative social, occupational, or health consequences. Apart from potentially changing people’s lives, we believe that our treatment could potentially reduce the amount currently being spent on the consequences of AUDs in the United States, Europe India, China and other countries around the world. We also believe that our treatment may address binge drinking.
Note: 95,000 people die every year in the United States alone due to binge drinking.
We are currently in the process of conducting a series of pre-clinical, Investigational New Drug application, or IND, enabling studies 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 will conduct several metabolism studies designed to better understand the way 5-Methoxy-2-aminoindane, or 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.
We intend to submit our IND request in the fourth quarter of 2022 and to initiate the Phase I/IIa clinical study by the end of the 2022. As part of this strategy, we requested a pre-IND meeting with the FDA, and we were granted a meeting in May 2022. We plan to submit applications to conduct a Phase I study in Europe, Australia and Israel.
Upon completion of the Phase I/IIa clinical studies, if successful, we will be required to conduct additional clinical trials, which will be subject to securing additional financing.
In addition to our research with MEAI, we have plans to conduct 12 other research programs on different molecules, which are to be led by our highly skilled, focused team, with deep expertise in their respective fields. A majority of these programs remain in the pre-discovery phase. For more information, please see “Business –Future Research Programs.”
With respect to our AUD programs, we developed MEAI as a new chemical entity (NCE) drug candidate. We intend to seek regulatory approval through the FDA’s 505(b)(1) regulatory path. The FDA’s 505(b)(1) regulatory path is typically used for novel drugs that have not previously been studied or approved, and drug development pursuant to this path requires drug developers to conduct all studies needed to demonstrate the safety and efficacy of the drug. Given its nature, this type of submission requires extensive research, including both clinical and nonclinical studies, to prove the product’s safety and efficacy for the indication being sought.
In addition, we asked the FDA at our pre-IND meeting to allow us to move directly to conduct a Phase I/IIa study in our target population, which if granted will allow us to accelerate our clinical development. While we cannot guarantee that the FDA will approve our request, if approved, such special accommodation would allow us to start the first in-human study with the target population rather than with healthy volunteers.
|Address||101 – 1220 West 6th Avenue Vancouver, British Columbia V6H1A5|
|Phone Number||(973) 536-1016|
|View Prospectus:||Clearmind Medicine Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-3.72 mil (last 12 months)|
|Price range||$0.00 - $0.00|
|Est. $ Volume||$0.0 mil|
|Manager / Joint Managers||Aegis Capital Corp.|
|Expected To Trade:|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|