Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2583

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2583
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 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;

    ●
    poor
    efficacy of our product candidates during clinical trials;

    ●
    unfavorable
    FDA or other regulatory agency inspection and review of a clinical trial site;

    ●
    failure
    of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations
    in a timely manner, or at all;

    ●
    delays
    related to the impact of recessions, man-made and/or natural disasters, pandemics, and/or any other such events;

    ●
    delays
    and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around
    clinical testing generally or with respect to our technology in particular; or

    ●
    varying
    interpretations of data by the FDA and similar foreign regulatory agencies.

We
do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission
process, potential threats to our intellectual property rights and our manufacturing, marketing, distribution and sales efforts or that
of any future collaborator.

Our
underlying technology is unproven and may not result in marketable products.

Our
approach is designed to discover and develop targeted treatments for non-small cell lung cancer, or NSCLC, glioblastoma, or GBM, and
possibly other visceral cancers, by targeting the prototypic chitinase-like protein Chi3l1 which we have found is induced in human cancers
including in primary lung cancer formation, in pulmonary melanoma metastasis, and in pulmonary breast cancer metastasis. These findings
are the basis for our OCX-253, OCX-410 (PD-1), and OCX-909 (CTLA-4