Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 156

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 156
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 produce CAR-T cells are already well recognized, as is the use of lentivirus in the manufacture of these therapies. Accordingly, we have developed CER-T cell manufacturing processes that closely resemble those used to produce existing engineered CAR-T cells. We also expect to benefit from the well-defined and recognized regulatory guidelines established by both U.S. and European regulatory authorities related to CAR-T therapies and their use. In contrast to these attributes, we believe that other emerging CAR-based drug candidates which involve immune effector cells other than T cells, such as CAR-NK and CAR-M therapies, are unlikely to enjoy similar benefits. 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 began our Phase 1 clinical trial in May 2025. Our initial targets are relapsed or refractory 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 hematopoiesis, manifesting as neutropenia, anemia, thrombocytopenia, and the clinical features of bone marrow failure. According to the American Cancer Society, AML accounts for 90% of all acute leukemias in adults, with an estimated 22,010 new cases and 11,090 deaths expected in the United States in 2025. The current treatment