Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3383

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3383
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 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 roughly 1 in 1,800 in the
northwest region of the island, or an estimated 1,500 patients, accounting for more than 50% of the worldwide HPS population. HPS effects
approximately 1 to 9 people per 1 million individuals worldwide outside of Puerto Rico. The disease onset occurs as early as age 30,
and the lifespan of patients with some of the most severe disease subtypes usually does not exceed 40 to 50 years. HPS is diagnosed through
a combination of identifying signs of albinism, evaluation of patient blood, and/or genetic testing; however, early diagnosis of PF in
HPS patients presents the same challenges as IPF diagnosis.

There
is an unmet need for therapeutics to treat HPS-related