Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 314

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 314
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 expenses, and may otherwise harm our operations and financial condition

31

Risks
Related to Development and Regulatory Approval of Our Product Candidates

Clinical
trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results
of clinical trials are open to differing interpretations.

Clinical
trials are expensive, time consuming and difficult to design and implement. Regulatory agencies may analyze or interpret the results
differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates
are expected to continue for several years and may take significantly longer to complete. In addition, we, the FDA, or other regulatory
authorities, including state and local authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution,
may suspend, delay or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular
clinical trial to continue for a longer duration than originally planned, require a change to our development plans such that we conduct
clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same
product candidate in parallel. The suspension, delay or termination could be for various reasons, including:

    ●
    lack
    of effectiveness of any product candidate during clinical trials;

    ●
    discovery
    of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions,
    including those which cause confounding changes to the levels of other concomitant medications;

    ●
    slower
    than expected rates of subject recruitment and enrollment rates in clinical trials;

    ●
    difficulty
    in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy,
    insufficient efficacy, fatigue with the clinical trial process or for any other reason;

    ●
    delays
    or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing
    constraints;

    ●
    inadequacy
    of or changes in our manufacturing process or product formulation;

    ●
    delays
    in obtaining regulatory authorization to commence a trial, including “clinical holds” or delays requiring suspension
    or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;

    ●
    changes
    in applicable regulatory