Company: OCEA
Filing Date: 2025-01-13
Form Type: 10-Q
Source: 0001493152-25-001880
Chunk: 179

Company: Ocean Biomedical, Inc.
Filing Date: 2025-01-13
Form: 10-Q
Item: Item 8
Chunk 179
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 across multiple programs and, therefore, we do not track their costs by program.

Research
and development activities are key to our business model. Product candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage
clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next 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.

39

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;

    ●