Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2178

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2178
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    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) programs. However, although multiple preclinical studies are currently
underway, to date, our approach has not been tested in clinical trials for the treatment of NSCLC, GBM or other cancers.

Our
approach to drug discovery and development in the area of fibrosis, with initial focus on targeting chitinase 1, or Chit1, is unproven
and may not result in marketable products. Our approach is designed to discover and develop targeted treatments for idiopathic pulmonary
fibrosis, or IPF, Hermansky-Pudlak Syndrome, or HPS, and possibly other fibrotic diseases, by targeting Chit1 which we have found to
be a master regulator of the TGF-ß1 mediated fibrosis response through various mechanisms