Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3486

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3486
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 complete a given clinical trial; and

    ●
    the
    FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies,
    or impose other requirements before permitting us to initiate a clinical trial.

We
could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ethics committees of the institutions
in which such clinical trials are being conducted, or by the FDA or other regulatory authorities. Such authorities may suspend or terminate
a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements
or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from
the product candidates, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical
trial.

81

Moreover,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation
in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or
comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship
between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA
or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial
site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our
marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial
of marketing approval of one or more of our product candidates.

Our
product development costs will increase if we experience additional delays in preclinical or clinical testing or in obtaining marketing
approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed
on schedule, or at all. If we do not achieve our product development goals in the time frames we announce and expect, the approval and
commercialization of our product candidates may be delayed or prevented entirely. Significant clinical trial delays also could shorten
any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring
products to market before we do