Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3488

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3488
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 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 types of
patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being
conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our
clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available
for our clinical trials in such clinical trial site. If any of our product candidates is shown to have undesirable side effects, some
patients may decline or drop out of our clinical trials. Additionally, certain of our planned clinical trials may also involve invasive
procedures which may lead some patients to decline or to drop out of trials.

Further,
timely enrollment in clinical trials is reliant on clinical