Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 442

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 442
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 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 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