Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 78

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 78
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 experience delays 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; |

39

| ● | 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; |

| ● | clinical trial sites deviating                                    
 from clinical trial protocol or dropping