Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 47

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 47
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 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 |

| ● | enforce and defend intellectual                                    
 property rights and claims with respect to our product candidates. |

Many of the factors listed above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercializing our product candidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soon after generating product sales, if ever. If we are unable to generate sufficient revenue through the sale of our product candidates or any future product candidates, we will be unable to continue operations without continued funding. Our engineered CER-T cells represent a novel approach to cancer treatment that creates significant challenges for us. We are developing autologous T-cell product candidates that are engineered from healthy donor T-cells to express chimeric engulfment receptors (“CERs”) and are intended for use in patients with certain cancers. Advancing these novel product candidates creates significant challenges for us, including:

| ● | manufacturing our product candidates                                                                                         
 to our regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; |

19

| ● | sourcing clinical and, if approved,                                                   
 commercial supplies for the raw materials used to manufacture our product candidates; |

| ● | understanding and addressing                                                                                                    
 variability in the quality of a donor’s T cells, which could ultimately affect our ability to produce product in a reliable and 
 consistent manner and treat certain patients;                                                                                   |

| ● | educating medical personnel                                                                                                            
 regarding the potential side effect profile of our product candidates, if approved, such as the potential adverse side effects related 
 to cytokine release syndrome (“CRS”), neurotoxicity, prolonged cytopenia, coagulation abnormalities, thrombosis, hypotension,          
 aplastic anemia and neutropenic sepsis;                                                                                                |

| ● | using medicines to preempt