Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 18

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 18
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 are unlikely to be commercially viable products. Our inability to successfully identify additional
new product candidates to advance into clinical trials could have a material adverse effect on our business, financial condition, results
of operations and prospects.

 10 

If we are able to raise sufficient capital and
successfully identify new product candidates, we expect that we will incur significant losses over the next several years and may never
achieve or maintain profitability. 

We have limited our operations in advancing our technology
based on the limited amount of capital we have raised. Since the reverse merger in August 2020, we have not raised any capital other than
$575,000 and $341,632 from the issuance of our convertible notes in May 2021 and February 2022, respectively. Due to our limited operations,
our historical results do not reflect the significant costs required to develop a product candidate. In addition, the products we have
previously developed were in preclinical development and any future product may likely be in preclinical development. Therefore, pending
our ability to raise sufficient capital, we anticipate that our expenses will increase substantially over the next several years, if and
as we:

    ·
    identify and successfully license or acquire new product candidates or technologies;

    ·
    develop product manufacturing processes under the Food and Drug Administration’s (“FDA’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