Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 119

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 119
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’s”) current Good Manufacturing Practice regulations (“cGMP”) for product candidates and enter into manufacturing supply agreements to support toxicology studies and clinical trials;

    ·
    contract preclinical toxicology studies to support the safety of product candidates prior to starting any human trial;

    ·
    perform preclinical research and translational studies to enhance our understanding of the mechanism of action of the product candidates;

    ·
    enter into collaboration arrangements with regards to product discovery and product development;

    ·
    pay amounts owed under the former licensing agreement with Case Western Reserve University and potentially acquire rights to other product candidates and technologies;

    ·
    prepare regulatory filings, such as filing IND applications with the FDA that are required prior to starting any human clinical trial;

    ·
    plan, initiate, enroll, and complete clinical trials;

    ·
    maintain, expand and protect intellectual property; and 

    ·
    hire additional personnel to support our research, development, and administrative efforts.

Pending our ability to raise sufficient capital, we
expect that it will be several years, if ever, before we have a product candidate ready for commercialization. If we are unable to license
or acquire new product candidates and advance these product candidates, we may have greater difficulty raising capital on favorable terms,
or at all. In addition, there are many risks associated with our financial position and need for additional capital, as further described
below under the section titled “RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL CAPITAL”.

If we are able to raise sufficient capital, we expect
to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses that we incur may
fluctuate significantly from quarter to quarter and year to year.

To become and remain profitable, we or a potential
partner must develop and eventually commercialize a product or products with significant market potential. This will require us to be
successful in a range of challenging activities, including completing all phases of clinical trials, obtaining marketing approval and
manufacturing, marketing and selling those products for which we obtain marketing approval. We or a potential partner may never succeed
in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. If
we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our development efforts
will take several years and will require significant capital that will dilute the ownership interest of common stockholders. A decline