Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 37

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 37
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 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. 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 for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:

| ● | the patient eligibility criteria defined in the protocol; |

| ● | the number of patients with the disease or condition being studied; |

| ● | the perceived risks and benefits of the product candidate in the trial; |

| ● | clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating or drugs that may be used off-label for these indications; |

| ● | the size and nature of the patient population required for analysis of the trial’s primary and secondary endpoints; |

| ● | the proximity of patients to study sites; |

| ● | the design of the clinical trial; |

| ● | our ability to recruit clinical trial investigators with the appropriate competencies and experience; |

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| ● | competing clinical trials for similar therapies or other new therapeutics not involving T cell-based immunotherapy; |

| ● | our ability to obtain and maintain patient consents; |

| ● | the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion of their treatment; and |

| ● | other public health factors, including the coronavirus pandemic or outbreaks of other infections. |

In particular, some of our clinical trials will look to enroll patients with characteristics which are found in a very small population. For example, our