Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 165

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 165
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 begin clinical trials for the treatment of AML and we submitted a second IND application for the investigation
of CER-T cell therapy in NSCLC and ovarian cancer, which was accepted by the FDA on March 27, 2025, but there are no assurances regarding
the acceptance of any amendments or future INDs, which may impact the timelines we expect. For example, we may experience manufacturing
delays or other delays with future IND-enabling studies. Moreover, there can be no assurances that once trials begin, issues will not
arise that suspend or terminate such clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation
of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in
the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs.

Clinical trials are difficult to design
and implement, involve uncertain outcomes and may not be successful.

Human clinical trials are difficult to design and implement, in part
because they are subject to rigorous regulatory requirements. The design of a clinical trial can determine whether its results will support
approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced.
We may be unable to design and execute a clinical trial that will be successful to achieve regulatory approval. There is a high failure
rate for biological products proceeding through clinical trials, which may be higher for our product candidates because they are based
on new technology and engineered on a patient-by-patient basis. Many companies in the pharmaceutical and biotechnology industries have
suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage
clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit
or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including
changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our business,
financial condition, results of operations and prospects.

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We will depend on enrollment of patients
in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical
development activities could be delayed or otherwise adversely affected.

Identifying and qualifying
patients to participate in clinical trials of our product candidates will be critical to our success. We may experience difficulties in
patient enrollment in our clinical trials