Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 158

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 158
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ER-1236 for the treatment of AML patients. We began dosing the cohort in our Phase 1 AML clinical trial of CER-1236 in May 2025. As of November 24, 2025, four patients have had product successfully manufactured and were treated. No patients had any dose-limiting toxicities during the 28 day observation window, and the cell therapies in the first three patients were observed to expand during the first 14 days period post infusion. The fourth patient’s cell expansion is still under analysis. Based on preclinical data generated to date related to the use of CER-1236 to treat hematological cancers, we intend to initially target relapsed and refractory AML patients for clinical development. These are aggressive cancers with limited treatment options. Moreover, these cancers represent a significant unmet medical need, and to date there are no approved CAR-T cell therapies for patients diagnosed with AML. There are approximately 20,800 cases of AML diagnosed annually in the U.S. |

| ● | Leverage past and current CAR-T product approvals to shorten the regulatory and manufacturing pathway for CER-1236. We have designed our CER-T cells to share similar construction to currently approved CAR-T cell therapies. The processes and protocols used to produce autologous CAR-T cells are well recognized, and we expect to benefit from the well-defined regulatory guidelines established by both U.S. and European regulatory authorities related to CAR-T cell therapy manufacture. Accordingly, we have configured CER-T cell manufacturing processes to share similarities with those employed in the production of CAR-T cells. |

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| ● | Expand CER-1236 development activities to target solid tumors. We intend to expand the clinical development of CER-1236 to include solid tumors. To this end, we plan on evaluating the potential therapeutic utility of CER-1236 to treat NSCLC and ovarian cancer, indications for which efficacious treatments have proven elusive. We believe CER-1236’s differentiated mechanism of action enables the enhanced activity of a broader contingent of immune effector cells, which may allow CER-1236 to achieve success treating cancers for which currently approved CAR-T cell therapies have demonstrated little clinical benefit. We anticipate initiation of a Phase 1 study in NSCLC and ovarian cancer in the first quarter of 2026. |

The Immune System and its Function The immune system is a host defense system comprising multiple structures and processes within an organism that protects against disease. As with other mamm