Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3490

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3490
---
-253 and potentially other product candidates in combination with other therapies, which exposes us to additional
risks.

83

We
intend to develop OCX-253 and potentially other product candidates in combination with one or more approved or unapproved therapies to
treat cancer or other diseases. Even if any product candidate we develop were to receive marketing approval for use in combination with
other approved therapies, the FDA or comparable foreign regulatory authorities outside of the United States could still revoke approval
of the therapy used in combination with our product. If the therapies used in combination with our product candidates are replaced as
the standard of care for the indications we choose for any of our product candidates, the FDA or comparable foreign regulatory authorities
may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved,
being removed from the market or being less successful commercially.

Further,
we will not be able to market and sell any product candidate we develop in combination with an unapproved cancer therapy for a combination
indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product.
In addition, unapproved cancer therapies face the same risks described with respect to our product candidates currently in development
and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDA approval.

If
the FDA or comparable foreign regulatory authorities do not approve these other products or revoke their approval of, or if safety, efficacy,
quality, manufacturing or supply issues arise with, the products we choose to evaluate in combination with our product candidate we develop,
we may be unable to obtain approval of or market such combination therapy.

If
we are unable to successfully validate, 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