Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2596

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2596
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 develop and obtain regulatory approval for any required companion diagnostic tests for our product
candidates or experience significant delays in doing so, we may fail to obtain approval or may not realize the full commercial potential
of these product candidates.

In
connection with the clinical development of our product candidates for certain indications, we intend to engage third parties to develop
or obtain access to in vitro companion diagnostic tests to identify patient subsets within a disease category who may derive benefit
from our product candidates, as we are targeting certain genetically defined populations for our treatments. For example, in the OCX-253
program, we may develop a diagnostic tool for measuring the circulating Chi3l1 as a method of stratifying patients for particular clinical
studies. Such companion diagnostics may be used during our clinical trials and may be required in connection with the FDA approval of
our product candidates. To be successful, we or our collaborators will need to address a number of scientific, technical, regulatory
and logistical challenges. Companion diagnostics are subject to regulation by the FDA and other regulatory authorities as medical devices
and require separate regulatory approval prior to commercialization.

Given
our limited experience in developing and commercializing diagnostics, we intend to rely on third parties for the design, development
and manufacture of companion diagnostic tests for our therapeutic product candidates that may require such tests. If we enter into such
collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and
obtaining approval for these companion diagnostics. We and our future collaborators may encounter difficulties in developing and obtaining
approval for the companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility,
or clinical validation of companion diagnostics. We and our future collaborators also may encounter difficulties in developing, obtaining
regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our therapeutic
product candidates themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities
at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop
companion diagnostics for these therapeutic product candidates, or experience delays in doing so, the development of these therapeutic
product candidates may be adversely affected, these therapeutic product candidates may not obtain marketing approval or such approval
may be delayed, and we may not realize the full commercial potential of any of these therapeutics that obtain marketing approval. As
a result, our business, results of operations and financial condition could be materially harmed. In addition