Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 45

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 45
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 trials, which would delay the regulatory approval process.

47

There
is a risk that our CROs, investigators or other third parties will be unable to devote adequate time and resources to such trials or
studies or perform as contractually required. If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols
or meet regulatory requirements, or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated.
In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our
competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position.
In addition, principal investigators for our clinical trials are expected to serve as scientific advisors or consultants to us from time
to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation
result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation
of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical
trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA we submit. Any such delay or rejection
could prevent us from receiving regulatory approval for, or commercializing, TELOIR-1 and any future product candidates.

Our
CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third
parties on commercially reasonable terms, in a timely manner or at all. Switching or adding CROs, investigators and other third parties
involves additional cost and requires our management’s time and focus. In addition, there is a natural transition period when a
new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance
that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact
on our business, financial condition and prospects.

Risks
Related to Our Intellectual Property

We
may not be able to adequately protect our product candidates or our proprietary technology