Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3477

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3477
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 our future success or viability may not be as accurate
as they could be if we had a longer operating history or a history of successfully developing and commercializing drug and biological
products.

Our
business is dependent on the success of our product candidates that we advance into the clinic. We currently have no products that are
approved for commercial sale and may never be able to develop marketable products. If one or more of our product candidates encounters
safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and business could be significantly
harmed. Before we can generate any revenue from sales of any of our product candidates, we must undergo additional preclinical and clinical
development, regulatory review and approval in one or more jurisdictions. In addition, if one or more of our product candidates are approved,
we must ensure access to sufficient commercial manufacturing capacity and conduct significant marketing efforts in connection with any
commercial launch. These efforts will require substantial investment, and we may not have the financial resources to continue development
of our product candidates.

We
may experience setbacks that could delay or prevent regulatory approval of, or our ability to commercialize, our product candidates,
including:

    ●
    timely
    completion of our preclinical studies and clinical trials;

    ●
    negative
    or inconclusive results from our preclinical studies or clinical trials or the clinical trials of others for product candidates similar
    to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;

    ●
    the
    prevalence, duration and severity of potential product-related side effects experienced by subjects receiving our product candidates
    in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates;

    ●
    delays
    in submitting INDs or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to
    commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

76

    ●
    conditions
    imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

    ●
    delays
    in enrolling subjects in clinical trials;

    ●
    high
    drop-out rates of subjects from clinical trials;

    ●
    inadequate
    supply or quality of product candidates or other materials necessary for the conduct of our clinical trials;

    ●
    greater
    than anticipated clinical trial costs;

    ●
    inability
    to compete with other therapies;

    ●