Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3475

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3475
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 to complete preclinical studies and successfully submit Investigational New Drug, or IND, applications or comparable applications
    for our product candidates;

    ●
    the
    timing and success or failure of preclinical studies and clinical trials for our product candidates or competing product candidates,
    or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;

    ●
    whether
    we are required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond
    those planned to support the approval and commercialization of our product candidates or any future product candidates;

    ●
    our
    ability to successfully recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;

    ●
    our
    ability to obtain marketing approval for our product candidates, and the timing and scope of any such approvals we may receive;

    ●
    the
    timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may
    change from time to time;

    ●
    the
    cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements
    with manufacturers;

    ●
    our
    ability to attract, hire and retain qualified personnel;

    ●
    expenditures
    that we will or may incur to develop additional product candidates;

    ●
    the
    level of demand for our product candidates should they receive approval, which may vary significantly;

    ●
    the
    risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential
    future therapeutics that compete with our product candidates;

    ●
    general
    market conditions or extraordinary external events, such as recessions, natural disasters, and/or the conflict between Russia and
    Ukraine;

    ●
    the
    changing and volatile U.S. and global socio-economic and political environments; and

    ●
    future
    accounting pronouncements or changes in our accounting policies or changes in tax laws.

The
cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability
could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue
or operating results fall