Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 129

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 129
---
 and biotechnology sector is likely to result in greater resource concentration among a smaller number of our competitors.
Smaller or early-stage companies may also prove to be significant competitors, particularly through sizeable collaborative arrangements
with established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel,
establishing clinical trial sites and patient registration for clinical trials, and acquiring technologies complementary to, or necessary
for, our programs.

22

Our commercial opportunity
could be reduced or eliminated if one or more of our competitors develop and commercialize products that are safer, more effective, better
tolerated, or of greater convenience or economic benefit than our proposed product offering. Our competitors also may be in a position
to obtain FDA or other regulatory approval for their products more rapidly, resulting in a stronger or dominant market position before
we are able to enter the market. The key competitive factors affecting the success of all of our programs are likely to be product safety,
efficacy, convenience, and treatment cost.

In the event we receive regulatory
approval for any of our product candidates, we will likely compete with other cost-effective and reimbursable treatments used to treat
cancer. The most common treatment modalities for patients with cancer are surgery, radiation, and drug therapy, including chemotherapy,
hormone therapy, biologic therapy, such as monoclonal and bispecific antibodies, immunotherapy, and cell-based therapy, used alone or
in combination to enhance efficacy. Our CER-T cell therapy candidates, if any are approved, may not be competitive with them. Some of
these 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. As a result, obtaining market acceptance of any of
our CER-T cell therapies that we successfully introduce to the market may pose challenges.

Government Regulation

In the United States, biological
products are licensed by the FDA for marketing under the Public Health Service Act (“PHS Act”) and regulated under the Federal
Food, Drug, and Cosmetic Act (“FDCA”). Both the FDCA and the PHS Act and their corresponding regulations govern, among other
things, the testing, manufacturing, safety, purity, potency, efficacy, labeling, packaging, storage, recordkeeping, distribution, marketing,
sales, import, export, reporting, advertising, and other promotional practices involving biological products. FDA clearance of an IND
application must be obtained before