Company: OCEA
Filing Date: 2025-01-13
Form Type: 10-Q
Source: 0001493152-25-001880
Chunk: 215

Company: Ocean Biomedical, Inc.
Filing Date: 2025-01-13
Form: 10-Q
Item: Item 2
Chunk 215
---
 will be delivered or the services
rendered.

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.

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