Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2490

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2490
---
Molecule Candidate for IPF and HPS

In
animal models, Dr. Elias and his colleagues showed that Chit1 is a master regulator of transforming growth factor beta 1, an extensively-published
biochemical pathway relevant to inflammation, tissue modeling, and fibrosis, and that it mediated fibrosis response through various mechanisms
described below. Animal models of IPF exhibit similar pathology to that of humans, allowing for relevant testing of molecular mechanisms
and potential therapeutics in these models. Transgenic laboratory animals developed in the Elias laboratory to over-express Chit1 were
shown to be far more susceptible to lung fibrosis than their wild type counterparts, which further demonstrates the role of Chit1 as
a factor in IPF.

Using
high throughput screening, Dr. Elias identified a small molecule candidate for the OCF-203 program that prevented and reduced inflammation
and fibrosis in the bleomycin mouse model of IPF (Fig. 5). Importantly, the molecular mediators of fibrosis, fibronectin, Col1A1, and
Col3A1, were also substantially reduced in the IPF model animals that had received the OCF-203 candidate. Results were similar in a mouse
model of HPS (Fig. 6), suggesting that the OCF-203 molecule could benefit this patient population as well. The biochemical pathways known
to be impacted by Chit1 inhibition imply that there may be benefit of this product candidate for the potential treatment of other fibrotic
diseases such as non-alcoholic-steatohepatitis, or NASH, and lysosomal storage disorders.

26

Figure
6: OCF-203 Lead Candidate Treatment Reduces Observed Markers of Fibrosis in an Animal Model of IPF

Figure
7: OCF-203 Lead Candidate Treatment of the Bleomycin HPS-1 Mouse Model results in Normalized Levels of Fibrotic Markers

No
significant toxicity has been observed at therapeutic doses in the animal studies with the OCF-203 lead to date. This candidate molecule
has been previously evaluated (by unrelated parties) in Japan in the mid-1960s for potential use as an antibiotic – though approval
was never pursued. While the clinical data from these studies is not suitable for current regulatory filings, we believe it may support
the safety observations seen in Dr. Elias’ recent animal studies and also provides invaluable information as to the behavior of
this molecule and its derivatives that we can