Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 29

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 29
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 a number of
factors. If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have
to curtail the development of a potential product candidate, reduce or delay its development program or one or more of our other potential
development programs, delay its potential development schedule or reduce the scope of research activities, or increase our expenditures
and all development activities at our own expense. If we fail to enter into collaborations and do not have sufficient funds or expertise
to undertake the necessary development activities, we may not be able to further develop any potential future product candidates, and
our business may be materially and adversely affected.

If any future potential collaboration does not result
in the successful development of products or product candidates, product candidates could be delayed, and we may need additional resources
to develop product candidates. All of the risks relating to product development, regulatory approval and commercialization described in
this periodic report also apply to the activities of our collaborators.

We may contract with third parties for the manufacture
of product candidates for preclinical and clinical studies and may expect to continue to do so for commercialization. This potential reliance
on third parties increases the risk that we will not have sufficient quantities of product candidates or products at an acceptable cost
and quality, which could delay, prevent or impair our development or commercialization efforts. 

If we are able to raise sufficient capital and potentially
license or acquire new technologies, then due to our limited operations and no existing manufacturing infrastructure or capabilities,
we may utilize third parties to formulate, manufacture, package, and distribute preclinical and clinical supplies. In addition, these
materials are generally custom-made and available from only a limited number of sources. Despite drug substance and product risk management,
this reliance on third parties presents a risk that we will not have sufficient quantities of these product candidates or products or
such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. Any
performance failure on the part of our future manufacturers of drug substance or drug products could delay clinical development or potential
marketing approval.

 17 

We would also expect to rely on other third parties
to label, store, and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay
clinical development or marketing approval of product candidates or commercialization of products, producing additional losses and depriving
us of potential product revenue.

If we are able to license or acquire new technologies,
we