Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 12

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 12
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 closer to marketing approval, we may commercialize them on our own in the
United States and potentially with pharmaceutical or biotechnology partners in other geographies. We currently have no sales, marketing
or commercialization capabilities and have no experience as a company doing such activities. However, we may build the necessary capabilities
and infrastructure over time following the advancement of our product candidates. Clinical data, the size of the opportunity and the size
of the commercial infrastructure required will influence our commercialization plans and decision making.

Competition

Competition in the pharmaceutical and biotechnology
industry is intense and characterized by aggressive research and development and rapidly evolving science, technology, and standards of
medical care throughout the world. Pending our ability to raise sufficient capital and successfully identify new product candidates and
license or acquire those rights, the competitive position in the industry and our focus on immunotherapies for the treatment of cancer,
we would face competition with all other immuno-oncology products either in development or already approved. Many of the companies against
which we may compete in the future, such as biotechnology and pharmaceutical companies focused on cancer immunotherapies, including but
not limited to, Amgen, Inc., AstraZeneca plc, Bristol-Myers Squibb Company (“BMS”), Genentech, Inc., GlaxoSmithKline PLC,
Merck & Co., Inc., Novartis AG, Pfizer Inc., Roche Holding Ltd and Sanofi S.A., all have significantly greater financial resources
and expertise in research and development, manufacturing, conducting preclinical studies, conducting clinical trials, obtaining regulatory
approvals and marketing approved products than we do. Oncology drugs and therapeutics on the market range from traditional cancer therapies,
including chemotherapy, to immune checkpoint inhibitors targeting CTLA-4, such as BMS’ YERVOY, and PD-1/PD-L1, such as BMS’
OPDIVO, Merck & Co.’s KEYTRUDA and Genentech’s TECENTRIQ, to T cell-engager immunotherapies, such as Amgen’s
BLINCYTO.

Moreover, mergers and acquisitions in the pharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and
other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and
established companies. Potential competitors also include academic institutions, government agencies and other public and private research