Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1612

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1612
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 changes to the DNA such as a non-target site gene insertion, a large deletion, or a DNA translocation,
any of which could lead to oncogenesis.

We may not be successful in our efforts
to identify or discover additional product candidates.

The success of our business
depends primarily upon our ability to identify, develop and commercialize products based on our CER-T cell technology. Our research programs
may fail to identify other potential product candidates outside of CER-1236 for clinical development for a number of reasons. We may be
unsuccessful in identifying potential product candidates or our potential product candidates may be shown to have harmful side effects
or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval. Research programs
to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources
on potential programs or product candidates that ultimately prove to be unsuccessful. If any of these events occur, we may be forced to
abandon our research, development or commercialization efforts for a program or programs, which would have a material adverse effect on
our business and could potentially cause us to cease operations.

Even if we obtain regulatory approval of
a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others
in the medical community.

The use of engineered T cells
as a potential cancer treatment is nascent and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers
and others in the medical community. We expect physicians with expertise in immunotherapy to be particularly important to the market acceptance
of our products and we may not be able to educate them on the benefits of using our product candidates for many reasons. For example,
certain of the product candidates that we will be developing may result in unacceptable and unanticipated side effects, including death.
Additional factors will influence whether our product candidates are accepted in the market, including:

●the clinical indications for which our product candidates are approved;

●physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe
and effective treatment;

●the potential and perceived advantages of our product candidates over alternative treatments;

●the prevalence and severity of any side effects;

●product labeling or product insert requirements of the FDA or other regulatory authorities;

●limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities;

●the timing of market introduction of our product candidates as well as competitive products;

42

●the cost of treatment in