Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 290

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 290
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 the reporting of ongoing clinical trials and completed clinical trial results
to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov
website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects
of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results
of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years
after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress
of development programs. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined.

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    ●
    Phase
    I clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to
    a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism,
    pharmacologic action, side effect tolerability and safety of the drug.

    ●
    Phase
    II clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At
    the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety
    risks are identified, and a preliminary evaluation of efficacy is conducted.

    ●
    
    Phase
    III clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary
    to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk
    relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo
    and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.

Post-approval
trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to
gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow
up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics
License Application (“BLA”).

Progress
reports detailing the results of the clinical trials must be submitted at least annually