Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 22

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 22
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 in connection
with self-insuring against any potential claims against the Company or its subsidiaries. Once we are able to raise sufficient funding
to advance our business, we plan to secure additional insurance coverage to better protect our business. There can be no assurance that
we will obtain sufficient insurance coverage to cover all possible risks and potential related losses.

If we successfully identify new product candidates
and license those rights, then drug development will involve a lengthy and expensive process with an uncertain outcome, including failure
to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States. We may
incur additional costs or experience delays in completing, or ultimately be unable to complete, the product manufacturing of any potential
product candidates. 

Ten the risk of failure for products in preclinical
or early stage of development is high, provided we are able to raise sufficient capital and potentially license or acquire new technologies,
which is highly uncertain. Before obtaining marketing approval from regulatory authorities for the sale of any potential product candidate,
we would need to complete formulation development, conduct nonclinical trials, and then conduct extensive clinical trials to demonstrate
the safety and efficacy in humans. In addition, product manufacturing and process development along with preclinical and clinical testing
are all expensive activities, difficult to design and implement, and can take several years to complete. The outcome of preclinical and
clinical trials is inherently uncertain. Failure can occur at any time during the development program, including during the clinical trial
process. Further, the results of preclinical studies and early clinical trials for new product candidates may not be predictive of the
results of later-stage clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses,
and many companies that have believed their product candidates performed satisfactorily in preclinical and clinical trials have nonetheless
failed to obtain marketing approval of their products. It is impossible to predict when or if product candidates will prove effective
and safe in humans or will receive regulatory approval.

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If we are able to raise sufficient capital and potentially
license or acquire new technologies, then we may also experience delays in clinical trials, and we do not know whether any planned clinical
trials will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all. There can be no assurance
that the FDA or any other foreign regulatory body will not put any product candidate on clinical hold in the future. We may experience
numerous unforeseen events during, or as a result of