Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2500

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2500
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icides which has led to the search for ever more lethal, and ecologically damaging, insecticides. Nevertheless,
application of insecticides remains an important component of many national malaria control programs.

Bed
nets have seen widespread distribution over the past 15 years based on data demonstrating that sleeping under an insecticide-impregnated
bed net results in a low, but still significant, 16% reduction in child mortality. Bed nets suffer from issues of cost, maintenance (they
must be repaired and re-dipped in insecticide), and compliance.

Given
the low efficacy of bed nets and insecticides, the cornerstone of malaria control programs remains the treatment of symptomatic cases
with anti-malarial drugs. Unfortunately, malaria parasites are particularly good at developing resistance to anti-malarial drugs and
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