Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 324

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 324
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 control, quality assurance and
qualified personnel. If the FDA or any comparable foreign regulatory authority does not approve these facilities for the manufacture
of Telomir-1 or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would
significantly impact our ability to develop, obtain regulatory approval for or market Telomir-1, if approved. Our failure, or the failure
of our third-party manufacturers, to comply with applicable regulations also could result in sanctions being imposed on us, including
clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of Telomir-1
or other future products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies
of our products and our financial position.

Our
or a third party’s failure to execute on our manufacturing requirements on commercially reasonable terms, in a timely manner and
in compliance with cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:

    ●
    an
    inability to initiate or complete clinical trials of Telomir-1 or any future product candidates in a timely manner;

    ●
    delay
    in submitting regulatory applications, or receiving marketing approvals, for Telomir-1 or any future product candidates;

    ●
    subjecting
    third-party manufacturing facilities or our potential future manufacturing facilities to additional inspections by regulatory authorities;

    ●
    requirements
    to cease development or to recall batches of Telomir-1 or any future product candidates; and

    ●
    in
    the event of approval to market and commercialize Telomir-1 or any future product candidates, an inability to meet commercial demands
    for Telomir-1 or any future product candidates.

In
addition, we do not have any long-term commitments or supply agreements with any third-party manufacturers. We may be unable to establish
any long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to
timely obtain sufficient quantities of Telomir-1 or such quantities at an acceptable cost. Even if we are able to establish agreements
with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

    ●
    failure
    of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

    ●
    breach
    of the manufacturing agreement by the third party;

    ●