Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2082

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2082
---
atively planned to follow the example of Merck’s CENTRIC trial of Cilengitide (NCT00689221).
The CENTRIC trial used overall survival as the approval endpoint leading to a study duration over five years. We intend to continue to
work with the oncology community to develop novel validated biomarkers, which could allow for accelerated trials in GBM. We are optimistic
that these novel tools may allow for accelerated trials in the GBM space which could speed the transition of OCX-909 to the market. We
intend to seek orphan drug designation for OCX-909 in GBM and may also request priority review.

Fibrosis
Product Candidate for IPF and HPS:

    ●
    OCF-203
    anti-Chit1 Small Molecule

Overview
of Fibrotic Diseases

An
important protective mechanism for tissue regeneration and wound healing is the formation of extracellular matrix, or ECM, a non-cellular
portion of a tissue produced and secreted by cells and functions mainly to provide support for tissues.

Fibrosis
is a pathologic condition where an excessive accumulation of ECM leads to organ disfunction and failure. Fibrotic diseases constitute
a major health problem worldwide and encompass a wide spectrum of clinical entities including systemic fibrotic diseases such as systemic
sclerosis, or SSc, scleroderma and nephrogenic systemic fibrosis, as well as numerous organ-specific disorders including pulmonary, cardiac,
liver and kidney fibrosis.

24

The
United States government estimates that 45% of deaths in the United States can be attributed to fibrotic disorders. Fibrosis is a factor
in various tissue and organ diseases as shown in the figure below.

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