Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 120

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 120
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in the value of the Company could also cause stockholders to lose all or part of their investment.

Our development efforts have historically been
with product candidates in early-stage preclinical development. 

We currently do not have any products that have gained
regulatory approval and our development efforts have historically been focused on product candidates in early-stage preclinical development.
Our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on the successful
development and eventual commercialization of new product candidates. As a result, our business is substantially dependent on our ability
to successfully license or acquire new technologies and complete the development of and obtain regulatory approval for these product candidates.

If we are unsuccessful in accomplishing the numerous
and complex objectives in developing product candidates, we may not be able to successfully develop and commercialize new product candidates,
and our business will suffer.

 11 

Our short operating history may make it difficult
to evaluate the success of our business to date and to assess our future viability. 

We are an early development stage biotechnology company
formed on March 30, 2020. Our ongoing operations to date have been limited to organizing the Company, business planning, acquiring rights
to technologies, and identifying potential product candidates. In addition, we have limited human resources to help us achieve our goals.
Consequently, any predictions made about our future success or viability based on our short operating history to date may not be as accurate
as they could be if we had a longer and more established operating history. In addition, as an early-stage business, we may encounter
unforeseen expenses, difficulties, complications, delays and other known and unknown factors.

Business interruptions resulting from the coronavirus
disease (COVID-19) outbreak or similar public health crises could cause a disruption of the development of product candidates and adversely
impact our business.

In March 2020, the World Health Organization declared
the novel coronavirus disease (COVID-19) outbreak a global pandemic. To limit the spread of COVID-19, governments have taken various actions
including the issuance of stay-at-home orders and physical distancing guidelines. Accordingly, businesses have adjusted, reduced or suspended
operating activities. We may experience disruptions as a result of COVID-19, any variants of COVID-19, or any other pandemic that could
severely impact our business and planned clinical trials, including:

    ·
    delays or difficulties in planned clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site