Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 11

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 11
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 for approval. The FDA
could approve the BLA with a Risk Evaluation and Mitigation Strategy (“REMS”) plan to mitigate risks, which could include medication
guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and
other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling, development of
adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials. Such post-market
testing may include Phase IV clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness
after commercialization.

 6 

Foreign Regulation

In addition to regulations in the United States, we
could be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of product candidates
we plan to potentially secure and develop, and products being marketed outside of the United States. We must obtain approval by the comparable
regulatory authorities of foreign countries before we can commence clinical trials or marketing of any products in those countries. The
approval process varies from country to country, and the time may be longer or shorter than that required by the FDA for BLA licensure.
The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

Manufacturing

We currently do not possess any internal manufacturing
infrastructure or capabilities. Pending our ability to raise sufficient capital and successfully identify new product candidates and license
or acquire those rights, for any new product candidates, we would plan to rely on internal manufacturing and development capabilities,
as capital resources become available and capabilities are developed, in addition to third-party contract manufacturing and development
organizations, or CDMOs, to manufacture biological product candidates for clinical testing, as well as for commercial manufacture if any
product candidates receive marketing approval. We believe that this hybrid strategy would enable us to control and manage preclinical
and early-stage clinical manufacturing while outsourcing other aspects of manufacturing and later-stage clinical manufacturing that would
likely require higher infrastructure cost to build and operate. As with any supply program, obtaining pre-clinical and clinical materials
of sufficient quality and quantity to meet the requirements of our development programs cannot be guaranteed and we cannot ensure that
we will be successful in this endeavor. To date, we have not manufactured any products candidates due to our limited capital resources.

Sales and
Marketing

None of our historical product candidates has been
approved for sale. If and when a product candidate advances