Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3481

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3481
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 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 regulatory approvals for our trials may prevent
us from completing our clinical trials or commercializing our products on a timely basis, if at all.

Preclinical
and clinical development involves a lengthy, complex and expensive process, with an uncertain outcome and results of earlier studies
and trials may not be predictive of future preclinical studies or clinical trial results.

To
obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical
studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take
many years to complete, and its outcome is inherently uncertain. In particular, the general approach for FDA approval of a new product
is dispositive data from two well-controlled, Phase 3 clinical trials of the relevant drug