Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 46

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 46
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 product candidates, and significantly influence physicians’ and regulators’ opinions with regard to the viability of our entire pipeline of autologous T cell therapies. All of our product candidates, including our lead product candidate, will require additional preclinical, clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. In addition, because our other product candidates are based on similar technology as our lead product candidate, if the lead product candidate encounters additional safety issues, efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed. 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. We received clearance of our IND for our first product candidate, CER-1236, and the rest of our product candidates are in the preclinical stages of development. Our product candidates 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; |

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| ● | 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