Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2593

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2593
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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 and the process for identifying patients;

    ●
    the
    willingness or availability of patients to participate in our trials;

    ●
    the
    proximity of patients to trial sites;

    ●
    the
    design of the trial;

    ●
    our
    ability to recruit clinical trial investigators with the appropriate competencies and experience;

82

    ●
    clinicians’
    and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other
    available therapies, including any new products that may be approved for the indications we are investigating;

    ●
    reporting
    of the preliminary results of any of our clinical trials;

    ●
    the
    availability of competing commercially available therapies and other competing product candidates’ clinical trials;

    ●
    our
    ability to obtain and maintain patient informed consents;

    ●
    the
    risk that patients enrolled in clinical trials will drop out of the trials before completion; and

    ●
    factors
    we may not be able to control, such as potential pandemics that may limit patients, principal investigators or staff or
    clinical site availability.

For
example, we are initially developing OCF-203 for the treatment of IPF, a rare disease. In the United States, IPF is estimated to affect
approximately 160,000 patients. As a result, we may encounter difficulties enrolling subjects in our clinical trials of OCF-203 due in
part to the small size of the patient population. In addition, our clinical trials will compete with other clinical trials for product
candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and