Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 36

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 36
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. Manufacturing these products
requires facilities specifically designed for and validated for this purpose and sophisticated quality assurance and quality control
procedures are necessary. Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage and
shipping and quality control and testing, may result in failures, product recalls or spoilage. When changes are made to the manufacturing
process, we may be required to provide preclinical and clinical data showing the comparable identity, strength, quality, purity or potency
of the products before and after such changes. If microbial, viral or other contaminations are discovered at manufacturing facilities,
such facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical
trials and adversely harm our business. The use of biologically derived ingredients can also lead to allegations of harm, including infections
or allergic reactions, or closure of product facilities due to possible contamination.

In addition, there are risks
associated with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems
with process scale-up, process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timely
availability of raw materials. Even if we obtain marketing approval for any of our product candidates, there is no assurance that we
or our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA, the EMA or other comparable
foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch of
the product or to meet potential future demand. If we or our manufacturers are unable to produce sufficient quantities for clinical trials
or for commercialization, our development and commercialization efforts would be impaired, which would have an adverse effect on our
business, financial condition, results of operations and growth prospects.

Genetic engineering of T cells to create CER-T cells is a relatively new technology, and if we are unable to use this technology in our intended product candidates, our revenue opportunities will be materially limited.

Our technology involves
a relatively new approach to T cell gene therapy. This technology may also not be shown to be effective in clinical studies that we may
conduct, or may be associated with safety issues that may negatively affect the development of our product candidates. For instance,
lentiviral gene transduction may create unintended 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