Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 71

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 71
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 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