Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2195

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2195
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 to name a few. For additional information on our competitors please see Item 1 of this Annual
Report on Form 10-K.

86

Many
of our current or potential competitors, either alone or with their strategic partners, have significantly greater financial resources
and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals,
and marketing approved products than we do.

Mergers
and acquisitions in the biopharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller
number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific
and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring
technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors
develop and commercialize products that are safer, more effective, more convenient, or less expensive than any products that we may develop.
Furthermore, products currently approved for other indications could be discovered to be effective treatments of fibrosis as well, which
could give such products significant regulatory and market timing advantages over our product candidates. Our competitors also may obtain
FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors
establishing a strong market position before we are able to enter the market. Additionally, products or technologies developed by our
competitors may render our potential product candidates uneconomical or obsolete and we may not be successful in marketing any product
candidates we may develop against competitors. The availability of competitive products could limit the demand, and the price we are
able to charge, for any products that we may develop and commercialize.

Risks
Related to Manufacturing

Because
we rely on third-party manufacturing and supply vendors, our supply of research and development, preclinical and clinical development
materials may become limited or interrupted or may not be of satisfactory quantity or quality.

We
rely on third-party contract manufacturers to manufacture our product candidates for preclinical studies and clinical trials. We do not
own manufacturing facilities for producing any clinical trial product supplies. There can be no assurance that our preclinical and clinical
development product supplies will not be limited, interrupted, or of satisfactory quality or continue to be available at acceptable prices.
In particular, any replacement of a contract manufacturer could require significant