Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3374

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3374
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also normally help support nerve cells and carry nutrients to them.

Brain
tumors are graded on an I to IV scale based on how fast they grow. Grade I brain tumors are the least aggressive. They grow very slowly
and rarely spread into nearby tissues. Grade IV are the most aggressive. GBMs are grade IV astrocytomas. They grow quickly and often
spread into nearby brain tissue. They rarely metastasize or spread to other parts of the body.

GBM
is a rare disease, with a prevalence of 1-9 out of 100,000 individuals. The prevalence in the United States is estimated to be approximately
28,000 diagnosed individuals, and the annual incidence is estimated to be between 6,000 and 10,000. Primary GBM accounts for 90% of cases,
mostly occurring in older individuals, while secondary GBM develops more slowly and occurs in relatively younger patients.

No
curative therapies exist for GBM and the treatment landscape has not changed in recent years. A significant proportion, approximately
25%, of the GBM prevalent population is not actively treated due to rapid disease progression and an extremely poor prognosis. Surgery
is standard-of-care followed by radiation and follow-up with chemo. If that does not work, then physicians may try a second line approach,
such as switching chemo monotherapies. However, these second line therapies are rarely effective.

Our
bispecific antibody candidate, OCX-909, is designed to combine the mechanism of actions of OCX-253 with an anti-CTLA-4 component. CTLA-4
is a protein receptor that functions as an immune checkpoint that binds to molecules called B7.1 and B7.2 to suppress antitumor immune
responses in a manner similar to PD-1. We believe OCX-909 may produce antitumor response particularly in GBM because CTLA-4 is expressed
in an exaggerated manner in many GBM tumors. If approved, we envision OCX-909 being potentially utilized as an alternative to surgery,
or in the treatment regimen in both the neoadjuvant (before surgery) and adjuvant (after surgery) settings for patients with GBM.

A
Primer on Antibodies, Antigens and Targeted Therapies

One
way the body’s immune system attacks foreign substances is by making large numbers of antibodies. An antibody is a protein that
binds to a specific antigen. An antigen is a molecule that is foreign to