Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 122

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 122
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and clinical sites will have an impact on recruitment and retention for our planned clinical trials. In addition, our future clinical
trial sites could experience delays in collecting, receiving and analyzing data from patients enrolled in our planned clinical trial due
to limited staff at such sites, limitation or suspension of on-site visits by patients, or patients’ reluctance to visit the clinical
trial sites during the pandemic. As a result, research and development expenses and general and administrative expenses may vary significantly
if there is an increased impact from any pandemic on the costs and timing associated with the conduct of our panned clinical trial and
other related business activities.

To the extent the any pandemic adversely affects our
business, financial condition and operating results, it may also have the effect of heightening many of the risks described in this “Risk
Factors” section.

The Company and its subsidiaries have limited insurance
for their operations and are subject to various risks of loss.

The Company and its subsidiaries carry limited directors’
and officers’ insurance. In addition, we do not carry general business liability insurance or other insurance applicable to our
business. Successful claims against the Company would likely render us insolvent. The Company has not reserved any amounts 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.