Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3395

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3395
---

have done so for every anti-malarial drug ever developed. Currently, the most effective antimalarial drug is artemisinin and its derivatives.
The recent development of artemisinin resistance in south east Asia, coupled with its detection in sub-Saharan Africa, threatens to reverse
the reductions in malaria-attributed mortality seen in the past decade. Given the socio-ecological context of malaria, delayed access
to drug treatment, with its consequent increased mortality, remains a major challenge to control programs.

The
world continues to experience a high burden of malaria and we believe this calls for the development of new drugs and vaccines.

35

Current
Landscape of Malaria Vaccines

A
broadly effective malaria vaccine represents the “holy grail” of malaria control efforts and has been pursued by
scientists for decades without success. The most advanced malaria vaccine candidate, RTS,S, has publicly reported relatively low
efficacy (17% and 32% protection from severe malaria in infants and young children, respectively). More concerning, RTS,S reports
two significant safety signals: a ten-fold increased risk of bacterial meningitis and two-fold increased risk of mortality in girls.
These safety signals had resulted in a decision in 2016 by the European Medicines Agency, or EMA, under recommendation by the World
Health Organization, or WHO, to limit release of the RTS,S vaccine to a pilot introduction in three African countries (Kenya,
Malawi, and Ghana) with detailed follow-up of safety outcomes that would then be used to decide whether to proceed with broad
release. In October 2021 the WHO recommended broader roll-out of the RTS,S / Mosquirix vaccine after concluding it was safe 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