Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2595

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2595
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 trials or registrational trials. The FDA or comparable foreign regulatory
authorities may disagree with our trial designs and our interpretation of data from preclinical studies or clinical trials. In addition,
any of these regulatory authorities may change requirements for the approval of a product candidate even after reviewing and providing
comments or advice on a protocol for a pivotal Phase 3 or registrational clinical trial. In addition, any of these regulatory authorities
may also approve a product candidate for fewer or more limited indications than we request or may grant approval contingent on the performance
of costly post-marketing clinical trials. The FDA or comparable foreign regulatory authorities may not approve the labeling claims that
we believe would be necessary or desirable for the successful commercialization of our product candidates, if approved.

We
intend to develop OCX-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,