Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 323

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 323
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, there is a natural transition period when a
new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance
that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact
on our business, financial condition and prospects.

We
currently rely on a third party for the manufacture of Telomir-1 for clinical development and expect to continue to rely on third parties
for the foreseeable future. This reliance on third parties increases the risk that supplies of our product may not be manufactured in
accordance with specifications or that we will not have sufficient quantities of Telomir-1 or such quantities at an acceptable cost,
which could delay, prevent or impair our development or potential commercialization efforts.

We
do not own or operate manufacturing facilities and have no plans to develop our own clinical or commercial-scale manufacturing capabilities.
We rely on a third party and expect to continue to rely on third parties for the manufacture of Telomir-1 and related raw materials
for clinical development, as well as for commercial manufacture if Telomir-1 receives marketing approval. There is a risk that supplies
of our product for use in pre-clinical or clinical testing will not be manufactured in accordance with our specifications, which could
render our trial data useless or lead to the creation of compounds which are novel and for which we do not have intellectual property
protection. Based on the terms of our contracts with our manufacturers, we may have no recourse against them in the case of such errors.

Further,
the facilities used by third-party manufacturers to manufacture Telomir-1 must be approved by the FDA and any comparable foreign regulatory
authority pursuant to inspections that will be conducted after we submit an NDA to the FDA or make any comparable submission to a foreign
regulatory authority. We do not control the manufacturing process of, and are completely dependent on, third-party manufacturers for
compliance with cGMP requirements for manufacture of products. If these third-party manufacturers cannot successfully manufacture material
that conforms to our specifications and the strict regulatory requirements of the FDA or any comparable foreign regulatory authority,
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.

37

In
addition, we have no control over the ability of third-party manufacturers to maintain adequate quality