Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2525

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2525
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In
addition, we may likely need to develop certain of our product candidates in collaboration with diagnostic companies, and we will face
competition from other companies in establishing these collaborations. Our competitors will also compete with us in recruiting and retaining
qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials,
as well as in acquiring technologies complementary to, or necessary for, our programs.

Furthermore,
we also face competition more broadly across the market for cost-effective and reimbursable treatments. Some of these competitive drugs
are branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party payors may
also encourage the use of generic products or specific branded products. We expect that if our product candidates are approved, they
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 NS