Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3398

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3398
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DA-579 will likely begin with a SAD study, and an additional MAD
may be added depending on the pharmacokinetics observed. Both drugs are expected to proceed into a Phase 1b trial that will likely consist
of a small number of volunteers testing the efficacy of the product candidates following a challenge with P. falciparum. This design
is intended to allow us to observe any early signs of efficacy on a preliminary basis that could help guide future development and further
refine the dosing strategy. The Phase 2 clinical trials of ODA-611 and ODA-579 are modeled after that of Novartis’ KAE607 (NCT03334747).
This trial design allows for assessment of the impact of different dose levels and treatment regimens of the molecules in the treatment
of P. falciparum infected patients in a region where malaria is endemic. The registration trials of ODA-611 and ODA-579 are aimed at
assessing the safety and efficacy of these treatments in combination with standard of care and are modeled after the National Institute
of Allergy and Infectious Diseases’, or NIAID, past work exploring combinations with chloroquine (NCT00379821). While the NIAID’s
chloroquine trial was primarily focused on children, we anticipate recruiting both adults and children because we believe this may maximize
the treatable population should our therapeutic candidate receive regulatory approval.

Intellectual
Property

We
seek to protect the intellectual property (“IP”) and proprietary technology that we consider important to our business, including
by pursuing patent applications that cover our product candidates and methods of using the same, as well as any other relevant inventions
and improvements that are considered commercially important to the development of our business. We likewise seek to protect the IP to
which we obtain rights through direct and indirect licenses (e.g., from universities and research institutions) and work collaboratively
with our licensors to ensure (and if possible be the driver of) patent prosecution and protection. We also rely on trade secrets, know-how
and continuing technological innovation to develop and maintain our proprietary and IP positions. Our commercial success depends, in
part, on our ability to obtain, maintain, enforce and protect our intellectual property and other proprietary rights for the technology,
inventions and improvements we consider important to our business, and to defend any patents we may own or in-license in the future,
prevent others from infringing any patents we may own or in-license in the future,