Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2189

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2189
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 trial sites which may be adversely affected by global health matters, including,
among other things, pandemics. If patients are unable to follow the trial protocols or if our trial results are otherwise disrupted due
to the effects of a pandemic or actions taken to mitigate its spread, the integrity of data from our trials may be compromised or not
accepted by the FDA or other regulatory authorities, which would represent a significant setback for the applicable program.

The
design or execution of our clinical trials may not support marketing approval.

The
design or execution of a clinical trial can determine whether its results will support marketing approval, and flaws in the design or
execution of a clinical trial may not become apparent until the clinical trial is well advanced. It is possible that we may need to amend
our clinical trial designs, which would require us to resubmit our clinical trial protocols to IRBs and FDA for reexamination and approval,
and may impact the costs, timing or successful completion of such clinical trials.

Additionally,
in some instances, there can be significant variability in safety or efficacy results between different trials with the same product
candidate due to numerous factors, including differences in trial protocols, size and type of the patient populations, variable adherence
to the dosing regimen or other protocol requirements and the rate of dropout among clinical trial participants. We do not know whether
any clinical trials we conduct will demonstrate consistent or adequate efficacy and safety to obtain marketing approval to market our
product candidates.

Further,
the FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining when or
whether marketing approval will be obtained for any of our product candidates. Our product candidates may not be approved even if they
achieve their primary endpoints in future Phase 3 clinical 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