Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 433

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 433
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 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 policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies;

    ●
    delays
    or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

    ●
    uncertainty
    regarding proper dosing;

    ●
    delay
    or failure to supply product for use in clinical trials which conforms to regulatory specification;

    ●
    unfavorable
    results from ongoing pre-clinical studies and clinical trials;

    ●
    failure
    of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or
    to perform their services in a timely or acceptable manner;

    ●
    failure
    by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to
    the conduct of clinical trials or the handling, storage, security