Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 12

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 12
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 to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

    ●
    attract
    and retain enough talented employees;

    ●
    manage
    our clinical trials effectively;

    ●
    manage
    our external manufacturing operations with contract research organizations effectively and in a cost-effective manner;

    ●
    manage
    our development efforts effectively while carrying out our contractual obligations to contractors and other third parties; and

In
addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks
related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.
Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If
we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors,
we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing,
and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.

28

Our
product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate
revenue from new products.

Even
when product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends
on the acceptance of our products by physicians and patients. We cannot assure you that our product candidates will achieve the expected
level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product
depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label.
Market acceptance can also be influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness
to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers,
the price of the product, the nature of any post-approval risk, management activities mandated by regulatory authorities, competition,
and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability
to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of our products could
have a material adverse effect on our business, results of operations and financial condition.

If
the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate
reimbursement