Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 18

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 18
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 the production of our products and product
candidates. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and
financial condition.

Before
we can begin commercial manufacture of any product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product,
which requires a successful FDA inspection of our manufacturing facilities and those of our contract manufacturers, processes, and quality
systems in addition to other product-related approvals. Although we may successfully navigate this pre-approval inspection process as
it relates in the U.S., pharmaceutical manufacturing facilities are continuously subject to post-approval inspection by the FDA and foreign
regulatory authorities. Due to the complexity of the processes used to manufacture our product candidates, we may be unable to initially
or continue to pass federal, state or international regulatory inspections in a cost-effective manner. If we are unable to comply with
manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products,
total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These
possible sanctions would adversely affect our business, results of operations and financial condition.

Business
interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.

Our
research and development activities are conducted through outside contractors and manufacturers. Loss of our contracted manufacturing
facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of our raw material, could have an
adverse effect on our ability to continue product development activities and to conduct our business. Failure to supply our partners
with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply.
We currently do not have insurance coverage to compensate us for such business interruptions. Our contract manufacturers and suppliers
provide that in their separate operations; however, such coverage may prove insufficient to fully compensate us for the damage to our
business resulting from any significant property or casualty loss to those facilities.

If
product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the
commercialization of Ketamir-2 and MIRA-55 and our product candidates.

Although
we have never had any product liability claims or lawsuits brought against us, we face potential product liability exposure related to
the testing of our product candidates in human clinical trials. We may face exposure to claims by an even greater number of persons when
we begin to