Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 69

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 69
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 in obtaining the FDA’s authorization to initiate clinical trials under future INDs and completing ongoing clinical studies of our product candidates due to a variety of factors. Additionally, we cannot be certain that preclinical studies or clinical trials for our product candidates will begin on time, not require redesign, enroll an adequate number of subjects on time, or be completed on schedule, if at all. Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:

| ● | the availability of financial resources to commence and complete the planned trials |

| ● | the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials; |

| ● | delays in obtaining regulatory approval to commence a clinical trial; |

| ● | our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory authority that any of our product candidates are safe, potent and pure; |

| ● | the FDA’s or the applicable foreign regulatory agency’s disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials; |

| ● | our inability to demonstrate that the clinical and other benefits of any of our product candidates outweigh any safety or other perceived risks; |

| ● | the FDA’s or the applicable foreign regulatory agency’s requirement for additional preclinical studies or clinical trials; |

| ● | the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for licensure; |

| ● | the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain licensure of our product candidates in the United States or elsewhere; |

| ● | reaching agreement on acceptable terms with prospective CDMOs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CDMOs and clinical trial sites; |

| ● | obtaining IRB or ethics committee approval at each clinical trial site; |

| ● | recruiting an adequate number of suitable patients to participate in a clinical trial; |

| ● | having subjects complete a clinical trial or return for post-treatment follow-up; |

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| ● | clinical trial sites deviating from clinical trial protocol or dropping out of a clinical trial; |

| ● | addressing subject safety concerns that arise during the course of a clinical trial; |

| ● | adding a sufficient number of clinical trial sites; |

| ● | obtaining