Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 444

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 444
---
 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 our pre-clinical development activities.

Our
existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect
our ability to develop and commercialize our product candidates.

We
have existing, and will likely continue to seek additional collaboration arrangements with pharmaceutical or biotechnology companies
for the manufacturing, testing, development or commercialization of our product candidates. We may, with respect to our product candidates,
enter into new arrangements on a selective basis depending on the merits of retaining commercialization rights for ourselves as compared
to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate,
both in the U.S. and internationally. To the extent that we decide to enter into collaboration agreements, we will face significant competition
in seeking appropriate collaborators and the terms of any collaboration or other arrangements that we may establish may not be favorable
to us.

Any
existing or future collaboration entered into