Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 21

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 21
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 transport of clinical trial materials, such as investigational drug product used in our planned clinical trials;

    ·
    changes in regulations as part of a response to the COVID-19 pandemic or any variants of COVID-19 or any other pandemic which may require us to change the ways in which our planned clinical trials may be conducted, or which may result in unexpected costs;

    ·
    delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and

    ·
    increased competition for contract research organizations (“CROs”), suppliers and vendors.

Should COVID-19 or any variants of COVID-19 or any
other pandemic cases in USA increase, the country or states may institute stricter social distancing protocols.

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Additionally, third parties that we may engage, including
our collaborators, contract organizations, third-party manufacturers, suppliers, clinical trial sites, regulators and other third parties
with whom we conduct business are similarly adjusting their operations and assessing their capacity in light of any pandemic. If these
third parties experience shutdowns or continued business disruptions, our ability to conduct our business in the manner and on the timelines
presently planned could be materially and negatively impacted. It is likely that the disproportionate impact of any pandemic on hospitals
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