Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 141

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 141
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 enjoy similar benefits. 84 In preclinical studies, we have observed CER-1236 to display attractive functional attributes, among which are:

| ● | target-dependent                                                                           
 activation, cytotoxicity, anti-tumor cytokine production, and high proliferative capacity; |

| ● | phagocytosis    
 of tumor cells; |

| ● | distinct                                                                                                                             
 transcriptome, cytokine and chemokine signatures that substantiate the complementary activity of both the innate and adaptive immune 
 response;                                                                                                                            |

| ● | enhanced                                          
 antigen acquisition, processing and presentation; |

| ● | no                                                         
 evidence of T cell exhaustion despite repeated challenges; |

| ● | no                                           
 observed off-target or off-tumor toxicities; |

| ● | expression                                                                                                                                 
 and maintenance of diverse T cell populations, including naïve and memory cells, likely indicative of response persistence and durability; 
 and                                                                                                                                        |

| ● | well                                          
 defined and scalable manufacturing protocols. |

Based on the preclinical data regarding the use of CER-1236 T cells to combat hematologic malignancies, we anticipate beginning clinical trials in the first half of 2025. We anticipate that our initial targets will be relapsed, remitting acute myeloid leukemia (“AML”) patients as well as AML patients with measurable residual disease (“MRD”) and patients with mutations in TP53, a gene mutation associated with aggressive AML. AML is a heterogenous and aggressive hematopoietic malignancy characterized by the rapid buildup of immature myeloid cells in the bone marrow and blood. This process results in the inhibition of normal haematopoiesis, manifesting as neutropenia, anemia, thrombocytopenia, and the clinical features of bone marrow failure. AML accounts for 90% of all acute leukemias in adults, with an estimated 20,800 new cases and 11,220 deaths expected in the United States in 2023. The current treatment has remained largely unchanged over several decades with combination chemotherapy with cytarabine for 7 days and an anthracycline for 3 days (“7+3”). Newer, targeted approaches that include multi-kinase domain inhibitors and antibody-drug conjugates are now available during induction chemotherapy for certain patients. For patients that are sufficiently healthy and at unfavorable risk, allogeneic Hematopoietic Stem Cell Transplants (“HSCTs”) are commonly performed. Despite these interventions, there is significant unmet