Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2586

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2586
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 there can be no assurance
that we will be able to in-license them or otherwise acquire rights to them on terms that are beneficial to us. Furthermore, we could
face competition for such opportunities from other companies and from venture capital firms.

Our
research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical
development for a number of reasons, such as:

    ●
    our
    inability to design such product candidates with the pharmacological properties that we desire or attractive pharmacokinetics; or

    ●
    potential
    product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they
    are unlikely to be medicines that will receive marketing approval and achieve market acceptance.

Research
programs to identify new product candidates require substantial technical, financial and human resources. If we are unable to identify
suitable compounds for preclinical and clinical development, we will not be able to obtain product revenue in future periods, which likely
would result in significant harm to our financial position and adversely impact our stock price.

78

We
may not be able to file INDs or IND amendments or comparable applications to commence clinical trials on the timelines we expect, and
even if we are able to, the FDA or other regulatory authorities may not permit us to proceed.

We
may not be able to file INDs or other comparable applications for our product candidates on the timelines we expect. For example, we
or our third party collaborators may experience manufacturing delays or other delays with preclinical studies or FDA or other regulatory
authorities may require additional preclinical studies that we did not anticipate. Moreover, we cannot be sure that submission of an
IND or other comparable application will result in the FDA or other regulatory authorities allowing clinical trials to begin, or that,
once begun, issues will not arise that result in a decision by us, by institutional review boards or independent ethics committees, or
by the FDA or other regulatory authorities to suspend or terminate clinical trials, including as a result of a clinical hold. Additionally,
even if FDA or other regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or comparable
application, we cannot guarantee that they will not change their requirements or expectations in the future. These considerations also
apply to new clinical trials we may submit as amendments to existing INDs or to a new IND or other comparable application. Any failure
to file INDs or other comparable applications on the timelines we expect or to obtain