Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2587

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2587
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 regulatory approvals for our trials may prevent
us from completing our clinical trials or commercializing our products on a timely basis, if at all.

Preclinical
and clinical development involves a lengthy, complex and expensive process, with an uncertain outcome and results of earlier studies
and trials may not be predictive of future preclinical studies or clinical trial results.

To
obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical
studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take
many years to complete, and its outcome is inherently uncertain. In particular, the general approach for FDA approval of a new product
is dispositive data from two well-controlled, Phase 3 clinical trials of the relevant drug in the relevant patient population. Phase
3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete. A product candidate can
fail at any stage of testing, even after observing promising signals of activity in earlier preclinical studies or clinical trials. The
results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage
clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed.
There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product
candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through
preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks
in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed
their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing
approval of their product candidates. Most product candidates that commence clinical trials are never approved as products and there
can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development in any of our
product candidates. Product candidates that appear promising in the early phases of development may fail to reach the market for several
reasons, including but not limited to:

    ●
    preclinical
    studies or clinical trials may show the product candidates to be less effective than expected (e.g., a clinical trial could fail
    to meet its