Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 21

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 21
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stances, it will be prevented from being prescribed,
marketed or sold in the United States.

Currently in the United States, MEAI has not been
officially evaluated for its status as a controlled substance. It is currently unknown how it will be scheduled, and it is not currently
found in Schedule II of the U. S. Schedules of Controlled Substances. However, if the molecule is considered to be similar to amphetamines,
then it may fall under this schedule as a stimulant, under which amphetamines are listed. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a
stimulant effect on the central nervous system are in this schedule: Amphetamine, its salts, optical isomers, and salts of its optical
isomers. This molecule also does not exist on the U. S. Toxic Substances Control Act Chemical Substance Inventory List.

In Canada, Health Canada has stated that MEAI is
a controlled substance due to its structure being similar to amphetamines, which are on Health Canada’s Controlled Substances List.
However, at this point in time, the molecule MEAI itself is not listed in Schedule I of Health Canada’s Controlled Substances List,
which includes: amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues.

In Israel, the Israeli Ministry of Health has stated
that 2 - Aminoindane, including derivatives and isomers, is a controlled substance. Since, MEAI is a derivative of 2 - Aminoindane,
it is considered a controlled substance.

Our product candidates contain potentially controlled substances,
the use of which may generate public controversy. Adverse publicity or public perception regarding our current or future product candidates
may negatively influence the success of these therapies.

Our therapies containing potentially controlled
substances may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval of,
and increased expenses for our current product candidates and any future therapeutic candidates we may develop. Opponents of these therapies
may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative
publicity in an effort to persuade the medical community to reject these therapies. Adverse publicity from misuse may adversely affect
the commercial success or market penetration achievable by our product candidates. Anti-psychedelic protests have historically occurred
and may occur in the future and generate media