Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 79

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 79
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 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 sufficient product                                                                              
 supply of product candidate for use in preclinical studies or clinical trials from third-party suppliers; |

| ● | the FDA’s or the applicable                                                                                                         
 foreign regulatory agency’s findings of deficiencies or failure to approve the manufacturing processes or facilities of third-party 
 manufacturers upon which we rely; or                                                                                                |

| ● | the approval policies or regulations                                                                                                  
 of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient 
 for approval.                                                                                                                         |

We may experience numerous adverse or unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including:

| ● | we may receive feedback from                                                         
 regulatory authorities that requires us to modify the design of our clinical trials; |

| ● | we may obtain a result from                                                                                                              
 preclinical studies such as a binder specificity study or a safety toxicology study that require us to modify the design of our clinical 
 trials, abandon our research efforts for product candidates, or result in delays;                                                        |

| ● | clinical trials of our product                                                                                                          
 candidates may produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional clinical 
 trials or abandon our research efforts for our other product candidates;                                                                |

| ● | the number of patients required                                                                                                        
 for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than 
 we anticipate or participants may drop out of our clinical trials at a higher rate than we anticipate;                                 |

| ● | our third-party contractors                                                                                                            
 may fail to comply with regulatory requirements, fail to maintain adequate quality controls or be unable to provide us with sufficient 
 product supply to conduct and complete preclinical studies or clinical trials of our product candidates in a timely manner, or at all; |

| ● | we or our investigators might                                                                                                           
 have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory    
 requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics or a finding that 
 the participants are being exposed to unacceptable health risks;                                                                        |

| ● | the cost of clinical trials                                  
 of our product candidates may