Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3396

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3396
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and Addressable Market for Malaria Programs

The
target indication for our malaria vaccine ODA-570, is malaria in all at risk populations. This includes individuals living in malaria-endemic
areas, as well as travelers to these areas. Based on the epidemiology, the addressable market for a malaria vaccine is more than three
billion individuals.

Based
on the immunology of malaria, we expect that the initial course of vaccination would entail three doses over a three-month period, with
subsequent booster doses required every one-to-two years. In the developing world, we expect that our vaccine, if approved for marketing,
will likely be included in the WHO-expanded program in immunization, or EPI, which currently achieves greater than 85% coverage for eligible
children worldwide.

We
believe that our malaria antibody, ODA-611, may have both therapeutic and prophylactic applications. The target indication for ODA-611
is the prevention of malaria in short-term travelers to malaria endemic areas, including tourists, government employees and military
personnel.

We
expect the target indication for our malaria drug, ODA-579, if approved, to be the treatment of mild to moderately severe malaria infection.
There are 200-300 million malaria infections per year. We estimate the addressable market for our anti-malarial drug to be more than
200 million persons per year.

In
addition to this prophylactic indication, we believe that our anti-PfGARP antibody could have therapeutic use in individuals with severe
malaria, who are typically unable to take oral medicines. While data on the incidence of severe malaria is difficult to obtain, more
than 500,000 people die each year due to malaria, each of which, by definition, represented a severe malaria case. Thus we believe this
represents a reasonable estimate of the addressable worldwide market for our anti-PfGARP antibody and small molecule for severe malaria.

Infectious
Disease Programs Clinical Development Plan

The
ODA-570 Plasmodium falciparum vaccine is completing optimization efforts and, when completed, we plan to begin IND-enabling studies with
an expected IND filing date in the second half of 2023. Clinical development will likely be modeled after the GlaxoSmithKline, or GSK,
trials of their RTS, S vaccine (Mosquirix). We plan to conduct the Phase 1 clinical trial in two stages in a population of healthy volunteer