Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 38

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 38
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 because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will not successfully undergo or complete necessary clinical trials, fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. 14 We expect that it could take several years until any of our product candidates, which at present is solely CER-1236, receive regulatory and marketing approval and are commercialized, and we may never be successful in obtaining regulatory and marketing approval and commercializing product candidates. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our stockholders’ equity and net assets and may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

| ● | continue our ongoing and planned                                    
 R&D activities for our CER-T cell therapies and product candidates; |

| ● | pursue preclinical studies and                                                      
 initiate clinical trials for our CER-T cell therapies and other product candidates; |

| ● | seek to discover and develop                                           
 additional product candidates and further expand our product pipeline; |

| ● | seek regulatory and marketing                                                    
 approvals for any product candidates that successfully complete clinical trials; |

| ● | establish sales, marketing and                                                                                  
 distribution infrastructure to commercialize any product candidate for which we may obtain regulatory approval; |

| ● | develop and refine the manufacturing 
 process for our product candidates;  |

| ● | change or add additional manufacturers                      
 or suppliers of biological materials or product candidates; |

| ● | establish or supplement relationships                 
 with CDMOs, CROs and other third-party collaborators; |

| ● | develop, maintain, expand and                
 protect our intellectual property portfolio; |

| ● | acquire or in-license other          
 product candidates and technologies; |

| ● | hire clinical, quality control 
 and manufacturing personnel;   |

| ● | add clinical, operational, financial                                                                                                          
 and management information systems and personnel, including personnel to support our product development and planned future commercialization 
 efforts; and                                                                                                                                  |

| ● | incur additional legal, accounting                                
 and other expenses associated with operating as a public company. |

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials for our product candidates, preparing a satisfactory filing package for regulatory authorities, obtaining regulatory approval, manufacturing, marketing and selling any products for which we may