Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 48

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 48
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 or manage adverse side effects of our product candidates and such medicines may be difficult to source or costly or may not adequately 
 control the side effects or may have other safety risks or a detrimental impact on the efficacy of the treatment;                      |

| ● | conditioning patients with cyclophosphamide and fludarabine in advance                                                                 
 of administering our product candidates, which may be difficult to source, costly or increase the risk of infections and other adverse 
 side effects;                                                                                                                          |

| ● | obtaining regulatory approval,                                                                                           
 as the FDA and other regulatory authorities have limited experience with development of CER T cell therapies for cancer; |

| ● | establishing sales and marketing                                                                      
 capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and |

| ● | obtaining acceptance and approval                                                                 
 by physicians, patients, hospitals, cancer treatment centers and others in the medical community. |

Our current product candidates are in early clinical or preclinical development and have never been tested in humans. One or all of our current product candidates may fail in clinical development or suffer delays that materially and adversely affect their commercial viability. Our current product candidates are in early clinical and preclinical development and we are subject to the risks of failure inherent in the development of product candidates based on novel approaches, targets and mechanisms of action. Although we received IND clearance for CER-1236 from the FDA in November 2024 and for additional indications in March 2025, and we anticipate beginning clinical trials in the first half of 2025, there is no guarantee that we will be able to proceed with clinical development of CER-1236 or any of our other product candidates or that any product candidate will demonstrate a clinical benefit once we advance these candidates to testing in patients. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by early clinical stage biotechnology companies such as ours. Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials. Results from preclinical studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results. Our product candidates may ultimately fail to show the desired safety and efficacy in clinical settings despite positive results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidates. 20 Manufacturing genetically engineered products is complex and we, or our third-party manufacturers, may encounter difficulties