Company: OCEA
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001641172-25-011080
Chunk: 5

Company: Ocean Biomedical, Inc.
Filing Date: 2025-05-15
Form: 10-Q
Item: Item 2
Chunk 5
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    employee-related expenses, including salaries and benefits, and stock-based compensation expense for employees engaged in research and development functions; and

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    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:

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    scope, progress, outcome and costs of our preclinical development activities, clinical trials and other research and development activities;

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    ability to successfully in-license attractive product candidates from our partners;

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    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;

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    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;

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

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    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.