Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2592

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2592
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 authority, as the case may be, and may ultimately lead to the denial
of marketing approval of one or more of our product candidates.

Our
product development costs will increase if we experience additional delays in preclinical or clinical testing or in obtaining marketing
approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed
on schedule, or at all. If we do not achieve our product development goals in the time frames we announce and expect, the approval and
commercialization of our product candidates may be delayed or prevented entirely. Significant clinical trial delays also could shorten
any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring
products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our
business and results of operations. Any delays in our clinical development programs may harm our business, financial condition and results
of operations significantly.

Our
clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may
result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.

If
significant adverse events or other side effects are observed in our clinical trials, we may be required to abandon the trials or our
development efforts altogether. In addition, we may encounter unexpected drug-drug interactions in our planned trials, and may be required
to further test those candidates, including in drug-drug interaction studies, which may be expensive, time-consuming and result in delays
to our programs. Some potential therapeutics developed in the biopharmaceutical industry that initially showed therapeutic promise in
early stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do
not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance
of the approved product due to its tolerability versus other therapies.

If
we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.

Identifying
and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of completion
of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates,
and we may experience delays in our clinical trials if we encounter difficulties in enrollment. We may not be able to initiate or