Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 212

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 2
Chunk 212
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 delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services
rendered.

149

Our
direct external research and development expenses consist (or are expected to consist) primarily of external costs, such as fees paid
to outside consultants, CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing
and clinical development activities. Our direct research and development expenses also include fees incurred under license agreements.
We have not allocated and do not expect to allocate employee costs, costs associated with our discovery efforts, laboratory supplies,
and facilities, including depreciation or other indirect costs, to specific programs because these costs are or will be deployed across
multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research and discovery
as well as for managing our preclinical development, process development, manufacturing and clinical development activities. These employees
work 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.

At
this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will