Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 560

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 4
Chunk 560
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 several
years, which will include:

    ●
    expenses
    incurred under our licenses and services agreements to conduct the necessary preclinical studies and clinical trials required to
    obtain regulatory approval;

    ●
    expenses
    incurred under agreements with CROs, that are primarily engaged in the oversight and conduct of our drug discovery efforts and preclinical
    studies, clinical trials and CMOs, that are primarily engaged to provide preclinical and clinical product for our research and development
    candidates;

    ●
    other
    costs related to acquiring and manufacturing materials in connection with our drug discovery efforts and preclinical studies and
    clinical trial materials, including manufacturing validation batches, as well as investigative sites and consultants that conduct
    our clinical trials, preclinical studies and other scientific development services;

    ●
    employee-related
    expenses, including salaries and benefits, and stock-based compensation expense for employees engaged in research and development
    functions; and

    ●
    costs
    related to compliance with regulatory requirements.

At
this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical
and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product
candidates. The successful development and commercialization of our product candidates is highly uncertain. This uncertainty is due to
the numerous risks and uncertainties associated with product development and commercialization, including the following:

    ●
    scope,
    progress, outcome and costs of our preclinical development activities, clinical trials and other research and development activities;

    ●
    ability
    to successfully in-license attractive product candidates from our partners;

    ●
    establishing
    an appropriate safety and efficacy profile with Investigational New Drug, or IND, enabling studies;

    ●
    successful
    patient enrollment in and the initiation and completion of clinical trials;

    ●
    the
    timing, receipt and terms of approvals from applicable regulatory authorities including the FDA and other non-U.S. regulators;

    ●
    the
    extent of any required post-marketing approval commitments to applicable regulatory authorities;

    ●
    establishing
    clinical and commercial manufacturing capabilities with third-party manufacturers in order to ensure that we or our third-party manufacturers
    are able to produce product successfully;

    ●
    development
    and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for