Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2489

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2489
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 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 pulmonary fibrosis, or HPS-PF, patients. There is no approved drug therapy, and
no treatment except potential lung transplantation. The only pharmacological option for patients is off-label use of Esbriet, which may
slow disease progression but only in patients who retain significant residual lung function. Published clinical studies of Esbriet and
Ofev suggest that bleeding is more likely with Ofev, so its use is generally avoided in the HPS patient population.

We
believe that OCF-203, if approved, has potential to address the need for a HPS therapeutic due to its novel therapeutic approach. It
is also our belief that developing this product candidate for HPS may allow us to enter the broader fibrotic disease space in an expedited
manner by pursuing an ultra-rare disease indication before potentially broadening to adjacent indications.

The
Chitinase Biology Behind Our Fibrosis Product Candidate

Previously,
we described Dr. Elias’ research on chitinase enzymes and CLP, and his discovery of the key role that a CLP called Chi3l1 plays
in cancer. Dr. Elias also discovered that a chitinase called Chit1, also known as chitotriosidase, plays a central role in inflammation
and in fibrotic diseases such as IPF and HPS. Chit1 is expressed in an exaggerated manner in IPF where it correlates inversely with Smad
7. Chit1 is also a critical biomarker and therapeutic target in Scleroderma-associated interstitial lung disease. This finding is the
basis for our anti-Chit1 small molecule therapeutic product candidate, OCF-203.

OCF-203—Small