Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 440

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 440
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 substantially harmed.

We
are dependent on third parties to conduct our clinical trials and preclinical and nonclinical studies. Specifically, we rely on, and
intend to continue to rely on, medical institutions, clinical investigators, contract research organizations, or CROs, and consultants
to conduct nonclinical studies and clinical trials, in each case in accordance with our study protocols and applicable regulatory requirements.
These CROs, investigators and other third parties play a significant role in the conduct and timing of these studies or trials and the
subsequent collection and analysis of data. Though we expect 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. Further, while we have and will have agreements
governing the activities of our third-party contractors, we have limited influence over their actual performance. Nevertheless, we are
responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory
and scientific standards and requirements, and our reliance on our CROs and other third parties does not relieve us of our regulatory
responsibilities. In addition, we and our CROs are required to comply with GLP and GCP requirements, as applicable, which are regulations
and guidelines enforced by the FDA and comparable foreign regulatory authorities related to the conduct of nonclinical studies and clinical
trials, respectively. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and
trial sites. If we or any of our CROs or trial sites fail to comply with applicable GLP or GCP or other requirements, the collected nonclinical
data or the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities
may require us to perform additional nonclinical studies or clinical trials before approving our marketing applications, if ever. Furthermore,
our clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Failure to comply with these regulations
may require us to repeat clinical trials, which would delay the regulatory approval process.

36

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