Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 325

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 325
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    failure
    to manufacture our product candidates according to our specifications;

    ●
    failure
    to obtain adequate raw materials and other materials required for manufacturing;

    ●
    failure
    to manufacture our product according to our schedule or at all;

    ●
    failure
    to successfully scale up manufacturing capacity, if required;

    ●
    misappropriation
    of our proprietary information, including any potential trade secrets and know-how; and

    ●
    termination
    or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

38

Any
performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval or jeopardize
our ability to commence or continue commercialization of Telomir-1 or any future product candidates, and any related remedial measures
may be costly or time consuming to implement. We do not currently have arrangements in place for redundant supply or a second source
for all required raw materials used in the manufacture of our product candidates. If our existing or future third-party manufacturers
cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or
at all. Without additional suppliers of required raw materials, we may also be unable to meet the commercial needs of a commercial launch
of any future product candidates.

In
addition, our current and anticipated future dependence upon others for the manufacture of Telomir-1 and any future product candidates
may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely
and competitive basis.

We
expect to rely on third parties to conduct our pre-clinical trials and those third parties may not perform satisfactorily, including
failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements or our pre-clinical protocols.

We
currently rely on Contract Research Organizations (“CROs”) to conduct our pre-clinical trials, as we currently do not plan
to independently conduct pre-clinical trials of any of our product candidates. Our agreements with these CROs, and other third parties
might terminate for a variety of reasons, including a failure to perform by the third parties to such agreements. If we were ever to
need to enter into alternative arrangements or if we were to need to change a CRO for an ongoing pre-clinical trial, we might experience
delays in