Company: OCEA
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001641172-25-011080
Chunk: 188

Company: Ocean Biomedical, Inc.
Filing Date: 2025-05-15
Form: 10-Q
Item: Item 8
Chunk 188
---
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.

38

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;