Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2182

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2182
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 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 primary and/or secondary endpoint(s)) or to have unacceptable side effects or toxicities, or unexpected adverse drug-drug
    interactions;

    ●
    failure
    to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful;

    ●
    failure
    to execute the clinical trials caused by slow enrollment or subjects dropping out;

    ●
    failure
    to receive the necessary regulatory approvals;

    ●
    manufacturing
    costs, formulation issues, pricing or reimbursement issues, or other factors that make a product candidate uneconomical; and

    ●
    the
    proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being
    commercialized.

79

In
addition, differences in trial design between early-stage clinical