Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2185

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2185
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 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 future clinical trials we may operate in developing countries;

    ●
    we
    may elect to, or regulators, IRBs, Data Safety Monitoring Boards, or DSMBs, or ethics committees may require that we or our investigators,
    suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding
    that the participants are being exposed to unacceptable health risks;

    ●
    we
    may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product
    candidates may be greater than we anticipate;

    ●
    the
    supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may
    be insufficient or inadequate to initiate or