Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3479

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3479
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. These findings are the basis for our
OCF-203 program. However, although multiple preclinical studies are currently underway, to date, our approach has not been tested in
clinical trials for the treatment of IPF, HPS, or other fibrotic conditions.

Our
approach to therapeutics discovery and development in the area of malaria, with initial focus on targeting P. falciparum glutamic-acid-rich
protein, or PfGARP, and P. falciparum schizont egress antigen, or PfSEA-1, is unproven and may not result in marketable products. Our
approach is designed to discover and develop therapeutics for the treatment of malaria infections and short-term malaria prophylaxis,
and to develop vaccines for immunization against malaria, by targeting PfGARP and PfSEA-1, as applicable. Our findings regarding PfGARP
and PfSEA-1 form the basis for our ODA-611, ODA-579 and OCF-203 programs. However, although multiple preclinical studies are currently
underway, to date, our approach has not been tested in clinical trials for the treatment of malaria infections, to provide malaria prophylaxis
or to provide immunization against malaria.

77

Our
approach to the discovery and development of product candidates based on our Whole Proteome Differential Screening target discovery platform
represents a novel approach to product candidate development, which creates significant challenges for us.

Our
future success depends on the successful development of our product candidates, some of which may be discovered or developed by our Whole
Proteome Differential Screening target discovery program, or WPDS. WPDS is a new technology, and as such, it is difficult to predict
whether WPDS will enable us to successfully identify or develop product candidates. It is also difficult to accurately predict the developmental
challenges we may incur for our product candidates as they proceed through product discovery or identification, preclinical studies and
clinical trials. It is difficult for us to predict the time and cost of the development of product candidates identified by WPDS, and
we cannot predict whether the application of our technology, or any similar or competitive technologies, will result in the identification,
development, and regulatory approval of any products. There can be no assurance that any development problems we experience in the future
related to our technology or any of our research programs will not cause significant delays or unanticipated costs, or that such development
problems can be solved at all.