Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3420

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3420
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will be priced at a significant premium over competitive generic, including branded generic, products. As a result, obtaining market
acceptance of, and gaining significant share of the market for, any of our product candidates that we successfully introduce to the market
will pose challenges. In addition, many companies are developing new therapeutics, and we cannot predict what the standard of care will
be as our product candidates progress through clinical development.

Oncology

The
most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy
and targeted drug therapy or a combination of such methods. There are a variety of available drug therapies marketed for cancer. In many
cases, these drugs are administered in combination to enhance efficacy. While our product candidates, if any are approved, may compete
with these existing drug and other therapies, to the extent they are ultimately used in combination with or as an adjunct to these therapies,
our product candidates may not be competitive with them.

In
oncology, two of our programs, OCX-253 and OCX-410, are targeting NSCLC as their initial indication. For NSCLC, currently marketed oncology
drugs and therapeutics range from traditional cancer therapies, including chemotherapy, to immune checkpoint inhibitors targeting PD-1/PDL-1,
such as Bristol Myers Squibb’s, or BMS’, Opdivo, Merck’s Keytruda, Genentech’s Tecentriq, Regeneron’s Libtayo,
Astra Zeneca’s Imfinzi, and targeting CTLA- 4, such as BMS’ Yervoy. There are also numerous compounds in clinical development
for the potential treatment of NSCLC including Roche’s tiragolumab which targets TIGIT. Our OCX-909 is targeting GBM, for which
there are no currently approved therapies that are effective in treating this disease.

46

Fibrosis

Our
program OCF-203 in fibrotic diseases is targeting IPF and HPS. For the treatment of IPF, we are aware of two approved products: Esbriet
(pirfenidone), marketed by Roche Holding AG, and Ofev, marketed by Boehringer Ingelheim GmbH. Novartis launched a generic version of
pirfenidone in May 2022. Roche and Boehringer Ingelheim are both developing next-generation IPF therapies. Companies currently developing
product candidates in