Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3487

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3487
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, potentially impairing our ability to successfully commercialize our product candidates and harming our
business and results of operations. Any delays in our clinical development programs may harm our business, financial condition and results
of operations significantly.

Our
clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may
result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.

If
significant adverse events or other side effects are observed in our clinical trials, we may be required to abandon the trials or our
development efforts altogether. In addition, we may encounter unexpected drug-drug interactions in our planned trials, and may be required
to further test those candidates, including in drug-drug interaction studies, which may be expensive, time-consuming and result in delays
to our programs. Some potential therapeutics developed in the biopharmaceutical industry that initially showed therapeutic promise in
early stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do
not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance
of the approved product due to its tolerability versus other therapies.

If
we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.

Identifying
and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of completion
of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates,
and we may experience delays in our clinical trials if we encounter difficulties in enrollment. We may not be able to initiate or continue
clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate
in these trials as required by the FDA or similar regulatory authorities outside the United States, or as needed to provide appropriate
statistical power for a given trial. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.
The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient
number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:

    ●
    the
    patient eligibility and exclusion criteria defined in the protocol;

    ●
    the
    size of the patient population required for analysis of the trial’s primary endpoints