Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3622

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3622
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 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.

150

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 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 include direct and allocated facility-related costs as well as insurance costs and professional
fees for accounting and audit services, legal, patent, consulting, investor and public relations.

General
and administrative expenses for the fiscal years ended December 31,