Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2488

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2488
---
Figure
4

Idiopathic
Pulmonary Fibrosis

IPF
is a chronic, progressive, and fibrotic interstitial lung disease of unknown cause, which occurs primarily in older adults. It results
in irreversible loss of lung function with high morbidity and mortality rates. Median survival is three-to-five years following diagnosis.

IPF
is a rare disease with an estimated prevalence ranging from 10-to-60 per 100,000 in the United States and 1.3 to 32.5 per 100,000 in
Europe depending on country, age, and risk factors. There is an estimated prevalence of approximately 160,000 in the United States, with
most cases occurring in individuals over the age of 50 years. The United States incidence rate is approximately 55,000 cases per year,
and the incidence is rising due to a growing elderly population and increased disease awareness and detection.

In
practice, patients are diagnosed and categorized into three categories, as shown below, based on disease severity: mild, moderate, and
severe. Their disease may be characterized based on two lung function measures: FVC, or forced vital capacity, and diffusing capacity
of the lung for carbon monoxide, or DLCO,

Figure
5

25

Current
therapeutic standard-of-care utilizes Roche’s Esbriet (pirfenidone) or Boehringer’s Ofev (nintedanib). Pirfenidone and nintedanib
slow pulmonary function loss with only modest deceleration of disease progression and no reversal, and their severe side effects (e.g.,
nausea, vomiting, diarrhea) cause many patients to avoid or discontinue these therapies. These drugs are primarily used in the moderate
patient segment—both mild and severe patients view the negative side effect profile as outweighing the benefits. Despite the side
effects, it is estimated that approximately 58% of patients diagnosed with IPF take one of these therapeutics and, together, they generated
global sales of approximately $3.0 billion in 2019. We believe that a therapy with even a modest improvement in side effect profile would
likely see more utilization.

Hermansky-Pudlak
Syndrome

HPS
is a rare, inherited genetic disorder which occurs when a child inherits defective genes from both parents. Although HPS is ultra-rare
from a worldwide perspective, it has a much higher prevalence in Puerto Rico – where the prevalence is