Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 19

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 19
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 market and distribute our products commercially in the U.S., Europe and elsewhere. Now, and in the future, an individual
may bring a liability claim against us alleging that Ketamir-2, MIRA-55 or one of our other product candidates caused an injury. While
we continue to take what we believe are appropriate precautions, we may be unable to avoid significant liability if any product liability
lawsuit is brought against us. Large judgments have been awarded in class action or individual lawsuits based on drugs that had unanticipated
side effects. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities. Regardless
of merit or eventual outcome, liability claims may result in:

    ●
    decreased
    demand for Ketamir-2, MIRA-55 or our other product candidates if such product candidates are approved;

32

    ●
    injury
    to our reputation;

    ●
    withdrawal
    of clinical trial participants;

    ●
    costs
    of related litigation;

    ●
    substantial
    monetary awards to patients and others;

    ●
    increased
    cost of liability insurance;

    ●
    loss
    of revenue; and

    ●
    the
    inability to successfully commercialize our products.

Counterfeit
versions of our products could harm our business.

Counterfeiting
activities and the presence of counterfeit products in a number of markets and over the Internet continue to be a challenge for maintaining
a safe drug supply for the pharmaceutical industry. Counterfeit products are frequently unsafe or ineffective and can be life-threatening.
To distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions
to counterfeit drugs along with increased levels of counterfeiting could be mistakenly attributed to the authentic product, affect patient
confidence in the authentic product and harm the business of companies such as ours. If our products were to be the subject of counterfeits,
we could incur reputational and financial harm.

We
depend upon our key personnel and our ability to attract and retain employees.

Our
future growth and success depend on our ability to recruit, retain, manage, and motivate our employees. The inability to hire or retain
experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due
to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific,
technical, and managerial personnel. The competition for qualified personnel in the pharmaceutical