Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 39

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 39
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, any of which would negatively impact our operating results. Our dependence
on single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries,
raise prices or renegotiate terms; our suppliers may become insolvent or cease trading; we may be unable to locate a suitable replacement
supplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our
customers and cause them to turn to our competitors for future needs.

We
maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions
could adversely affect our ability to pay operational expenses or make other payments.

Our
cash held in non-interest-bearing and interest-bearing accounts can at times exceed the Federal Deposit Insurance Corporation (“FDIC”)
insurance limits. If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance
limitations. In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders’
access to their accounts and assets held in their accounts may be substantially delayed. Any material loss that we may experience in
the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability
to pay our operational expenses or make other payments, which could adversely affect our business.

44

We
rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties
do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be
able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.

We
have agreements with third-party CROs to operationalize, provide monitors for and to manage data for our ongoing clinical trials. We
rely heavily on these parties for the execution of clinical trials and control only certain aspects of their activities. As a result,
we have less direct control over the start-up, conduct, timing and competition of these clinical trials, and the management of data developed
through the clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties
can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. However, we remain responsible
for the conduct of these trials and are subject to enforcement which may include civil