Company: OCEA
Filing Date: 2025-01-13
Form Type: 10-Q
Source: 0001493152-25-001880
Chunk: 216

Company: Ocean Biomedical, Inc.
Filing Date: 2025-01-13
Form: 10-Q
Item: Item 2
Chunk 216
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, 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 commercial launch;

    ●
    launching commercial sales
    of our product candidates, if and when approved, whether alone or in collaboration with others;

    ●
    maintaining a continued
    acceptable safety protocol of our product candidates following any approval; and

    ●
    significant and potential
    changing government regulations.

Any
changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical
development could mean a significant change in the costs and timing associated with the development of these product candidates, such
as if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct other clinical
trials or testing beyond those that we currently expect or if significant delays in enrollment in any of our planned clinical trials
occurred. Such delays or changes may require us to expend significant additional financial resources and time on the completion of clinical
development of that product candidate.

General
and Administrative Expenses

General
and administrative expenses consist, or will consist, primarily of salaries and benefits, travel and stock-based compensation expense
for personnel in executive, business development, finance, legal, human resources, information technology, pre-commercial and support
personnel functions. General and administrative expenses also