Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 439

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 439
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 additional clinical trials;

    ●
    our
    relationships with our collaboration partners may suffer;

    ●
    we
    could be sued and held liable for harm caused to patients; or

    ●
    our
    reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed
    for pediatric indications.

We
may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants
or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully
commercialized. Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from
the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death.
To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market.
In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation
of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are
not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants.
Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily
or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects
for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore,
any of these events may result in labeling statements such as warnings or contraindications. In addition, such events or labeling could
prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the
costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products
either by us or by our collaboration partners.

Risks
Related to Our Reliance Upon Third Parties

We
rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties
do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be
able to obtain marketing approval for or commercialize our product candidates, and our business could be