Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 14

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 14
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they will prescribe or administer them, and patients may decline to purchase them. This in turn could affect our ability to successfully
commercialize products we may market, and thereby adversely impact our profitability, results of operations, financial condition, and
future success.

29

In
addition, where we have chosen to collaborate with a third party on product candidate development and commercialization, our partner
may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals. In many countries,
products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12
months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries,
which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may
thereby adversely affect our sales and profitability. In the event that countries impose prices that are not sufficient to allow us or
our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market,
which would adversely affect sales and profitability. Events, such as price decreases, government mandated rebates or unfavorable reimbursement
decisions, could affect the pricing and reimbursement of Ketamir-2 and MIRA-55 and our other product candidates and could have a material
adverse effect on our business, reputation, results of operations and financial condition.

We
expect to face intense competition, often from companies with greater resources and experience than we have. 

Demand
for ketamine analogs like Ketamir-2 and synthetic cannabinoids such as MIRA-55 and will likely be dependent on a number of social, political,
legislative, and economic factors that are beyond our control. While we believe that there will be a demand for such drugs, and that
the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or that our business,
in fact, will ever generate revenues from our drug development programs or become profitable.

The
emerging markets for product candidates like ours and related medical research and development is and will likely remain competitive.
The development and commercialization of drugs and medicines is highly competitive. We compete with a variety of multinational pharmaceutical
companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research
institutions. Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with
our drug candidates.