Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2501

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2501
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 based on
studies from its pilot introduction, though of note these studies were not clinical trials and did not include a control
group.

The
RTS,S vaccine seeks to generate antibodies that prevent the sporozoite from entering the liver cell, a process that takes less than five
minutes. The high antibody levels necessary to block this rapid event are very difficult to achieve and even harder to maintain. Parasites
which escape the RTS,S antibodies and invade a liver cell will give rise to a full-blown malaria infection as the vaccine has no impact
on the red blood cell stages of the malaria life cycle. These fundamental properties of the RTS,S vaccine result in the vaccine’s
poor efficacy and create a significant unmet medical need that our vaccine will endeavor to address.

Indications
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