Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2605

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2605
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 size and effectiveness of our sales, marketing and distribution support.

If
government and other third-party payors do not provide coverage and adequate reimbursement levels for any products we commercialize,
market acceptance and commercial success would be reduced.

The
market opportunities for our product candidates may be relatively small since the patients who may potentially be treated with our product
candidates are those who are ineligible for or have failed prior treatments, and our estimates of the prevalence of our target patient
populations may be inaccurate.

Cancer
therapies are sometimes characterized by line of therapy (first line, second line, third line, fourth line, etc.), and the FDA often
approves new therapies initially only for a particular line or lines of use. When cancer is detected early enough, first line therapy
is sometimes adequate to cure the cancer or prolong life without a cure. Whenever first line therapy, usually chemotherapy, antibody
drugs, tumor-targeted small molecules, hormone therapy, radiation therapy, surgery, or a combination of these, proves unsuccessful, second
line therapy may be administered. Second line therapies often consist of more chemotherapy, radiation, antibody drugs, tumor-targeted
small molecules, or a combination of these. Third line therapies can include chemotherapy, antibody drugs and small molecule tumor-targeted
therapies, more invasive forms of surgery and new technologies. In our oncology program, we may initially seek approval of certain of
our product candidates as a second or third line therapy, for use in patients with relapsed or refractory metastatic cancer. Subsequently,
for those product candidates that prove to be sufficiently safe and beneficial, if any, we would expect to seek approval as a second
line therapy and potentially as a first line therapy, but there is no guarantee that our product candidates, even if approved as a second
or subsequent line of therapy, would be approved for an earlier line of therapy, and, prior to any such approvals, we may have to conduct
additional clinical trials.

89

Our
projections of both the number of people who have the cancers we are targeting, who may have their tumors genetically sequenced, as well
as the subset of people with these cancers in a position to receive a particular line of therapy and who have the potential to benefit
from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety
of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect.
Further, new therapies