Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 38

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1B
Chunk 38
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 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 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;

    ●
    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