Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 33

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 33
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 be significantly harmed.

<div align='center'>12</div>

We have not generated any revenue and may never be profitable.

Our ability to become profitable
depends upon our ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant revenue
unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize,
our product candidates. We do not know when, or if, we will generate any revenue. All of our product candidates, including CER-1236,
are in the preclinical stages of development and will require additional preclinical studies, clinical development regulatory review
and approval, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before
we can generate any revenue from product sales. Our ability to generate revenue depends on a number of factors, including, but not limited
to, our ability to:

| ● | successfully complete preclinical                                  
 studies and clinical trials for our CER-T cell product candidates; |

| ● | timely file and receive                                                                                                 
 acceptance of INDs, and amendments thereto, as applicable, in order to commence our planned and future clinical trials; |

| ● | successfully enroll subjects                                             
 in, and complete, clinical trials for our CER-T cell product candidates; |

| ● | hire additional staff,                                   
 including clinical, scientific and management personnel; |

| ● | timely file BLAs and receive                                                                   
 regulatory approvals for our product candidates from the FDA and other regulatory authorities; |

| ● | initiate and successfully                                                                                                                 
 complete clinical trials and safety studies required to obtain U.S. and applicable foreign marketing approval for our product candidates; |

| ● | establish commercial manufacturing                                                                                                   
 capabilities through third-party manufacturers and CDMOs for clinical supply and commercial manufacturing of our product candidates; |

| ● | obtain and maintain patent                                                        
 and trade secret protection or regulatory exclusivity for our product candidates; |

| ● | launch commercial sales                                                                         
 of our product candidates, if and when approved, whether alone or in collaboration with others; |

| ● | maintain a continued acceptable                              
 safety profile of the product candidates following approval; |

| ● | obtain and maintain acceptance                                                                              
 of the product candidates, if and when approved, by patients, the medical community and third-party payors; |

| ● | position our products to                  
 effectively compete with other therapies; |

| ● | obtain and maintain favorable                                                             
 coverage and adequate reimbursement by third-party payors for our product candidates; and |

|