Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3476

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3476
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 below the expectations of analysts or investors or below any forecasts we may provide to the market, or if
the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline
substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

75

Risks
Related to Clinical Development

We
are a biopharmaceutical company with a limited operating history, and many of our development programs are in early stages of development.
This may make it difficult to evaluate our prospects and likelihood of success.

We
are an early-stage biopharmaceutical company with a limited operating history, have no products approved for commercial sale and have
not generated any revenue. All of our product candidates are in the preclinical stages of development and will require additional preclinical
studies or clinical development as well as regulatory review and approval, substantial investment, access to sufficient commercial manufacturing
capacity and significant marketing efforts before we can generate any revenue from product sales. Our operations to date have been limited
to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and performing
research and development of our product candidates. Our approach to the discovery and development of product candidates is unproven,
and we do not know whether we will be able to develop any products of commercial value. In addition, our product candidates will require
substantial additional development and clinical research time and resources before we would be able to apply for or receive regulatory
approvals and begin generating revenue from product sales. We have not yet demonstrated the ability to initiate or progress any product
candidate through clinical trials. We are still in preclinical development and may be unable to obtain regulatory approval, manufacture
a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary
for successful product commercialization. Investment in biopharmaceutical product development is highly speculative because it entails
substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate
efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. In addition, as a business with a
limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors
and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. Consequently, we have no meaningful
history of operations upon which to evaluate our business, and predictions about