Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2590

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2590
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, the ultimate approval and commercial marketing
of any product candidates. We may experience negative or inconclusive results, which may result in our deciding, or our being required
by regulators, to conduct additional clinical studies or trials or abandon some or all of our product development programs, which could
have a material adverse effect on our business.

We
may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of any of our product
candidates.

80

We
may experience delays in initiating or completing clinical trials. Clinical trials can be delayed or terminated for a variety of reasons,
including:

    ●
    regulators
    or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial
    or conduct a clinical trial at a prospective trial site;

    ●
    the
    FDA or other comparable regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels
    administered in our planned clinical trials, which may delay or prevent us from initiating our clinical trials with our originally
    intended trial design;

    ●
    we
    may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract
    research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and
    trial sites;

    ●
    the
    number of subjects required for clinical trials of any product candidates may be larger than we anticipate or subjects may drop out
    of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;

    ●
    our
    third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,
    or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial
    sites or investigators;

    ●
    we
    may need to address any subject safety concerns that arise during the course of a clinical trial;

    ●
    we
    may experience delays and interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail
    to reach, agreement on acceptable terms with third-party service providers on whom we rely;

    ●
    the
    cost of clinical trials of our product candidates may be greater than we anticipate;

    ●
    logistical
    issues relating to any