Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2197

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2197
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 development;

87

    ●
    delay
    in submitting regulatory applications, or receiving regulatory approvals, for product candidates;

    ●
    loss
    of the cooperation of an existing or future collaborator;

    ●
    subjecting
    third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;

    ●
    requirements
    to cease distribution or to recall batches of our product candidates; and

    ●
    in
    the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.

Changes
in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As
product candidates progress through preclinical to late stage clinical trials to marketing approval and commercialization, it is common
that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort
to optimize yield, manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that
they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect
the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion
of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical
trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates and generate
revenue.

In
addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,
cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing
practices, lot consistency and timely availability of raw materials. Even if we obtain marketing approval for any of our product candidates,
there is no assurance that our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA
or other comparable foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential
commercial launch of the product or to meet potential future demand. Additionally, if we advance a biological candidate into IND-enabling
studies, the manufacturing processes for biological products is more complex and expensive than with small molecule products and additional
manufacturing suppliers may be needed to manufacture clinical supplies for these programs. If our manufacturers are unable to produce
sufficient quantities for clinical trials or for commercialization, our development and commercialization efforts would be impaired,
which would have