Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 121

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 121
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 staff;

    ·
    delays or difficulties in enrolling patients in our planned clinical trials and further incurrence of additional costs as a result of preclinical study and clinical trial delays and adjustments;

    ·
    challenges related to ongoing and increased operational expenses related to any pandemic;

    ·
    diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical trials;

    ·
    interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

    ·
    limitations in resources that would otherwise be focused on the conduct of our business or our clinical trials, including because of sickness or the desire to avoid contact with large groups of people or as a result of government-imposed “Stay-at-Home” orders or similar working restrictions;

    ·
    delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;

    ·
    delays in preclinical and clinical sites receiving the supplies and materials needed to conduct our planned clinical trials;

    ·
    interruption in global shipping that may affect the 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.

 12 

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