Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 11

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 11
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 any products approved for sale in the United States or in any other country.

The
commercial success of our product candidates will not even be possible for the foreseeable future and will depend on a number of factors
beyond our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability
to pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners
to generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities
necessary to successfully commercialize Ketamir-2 and MIRA-55 or any product candidate approved by the FDA in the future. If we fail
to establish or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements
with third parties, our product revenues may suffer.

Should
we later determine if it is in our best interest to develop a sales force, we may be unable to effectively train and equip our sales
force, therefore our ability to successfully commercialize our products may be harmed.

We
will be required to expend significant time and resources to train our sales force to be credible, persuasive and compliant with applicable
laws in marketing Ketamir-2 and MIRA-55 or our other product candidates to physicians for their approved uses. In addition, we must continue
to train our sales force to ensure that a consistent and appropriate message about Ketamir-2 and MIRA-55 or our other product candidates
are being delivered to our potential customers. If we are unable to effectively train our sales force and equip them with effective materials,
including medical and sales literature, to help them inform and educate potential customers about the benefits of Ketamir-2 and MIRA-55
and our product candidates and its proper administration, our efforts to successfully commercialize Ketamir-2 and MIRA-55 and our product
candidates could be jeopardized, which would negatively impact our ability to generate product revenues.

We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
our growth and executing our growth strategy.

Our
management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth.
As a result, we may need to further expand certain areas of our organization.

Our
need to effectively manage our operations, growth and various projects requires that we:

    ●
    continue