Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 175

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 175
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6 showed potent activation and cytotoxicity against AML cells (Below, top and bottom graphs), but limited activation (Below, top graph) and no cytotoxicity (Below, bottom graph) against any of the human cell types tested. These experiments support the lack of off-target responses by CER-1236 T cells. CER-1236 Clinical Development Strategy Based on the extensive preclinical data that we have assembled regarding the use of CER-1236 T cells to combat cancer, we commenced our Phase 1 clinical trial in May 2025 with an initial treatment target being patients suffering from relapsed, or refractory AML as well as those subsets who are positive for Minimal Residual Disease and the TP53 mutation. Analyses of the first two patients treated revealed no dose-limiting toxicities. In addition, expansion of the CER-T cells was observed. We subsequently intend to expand the clinical development of CER-1236 to include solid tumors such as NSCLC and ovarian cancer. We anticipate initiation of the Phase 1 study in NSCLC and ovarian cancer in the first quarter of 2026. We expect these clinical trials to evaluate the safety, the potential therapeutic utility and applicable dose of CER-1236. In addition, we anticipate that these clinical trials may provide insight into the possible use of CER-1236 to treat an array of hematologic and solid tumors. 104 We believe this drug candidate has the potential to be a therapy for the unmet needs of targeted indications, if approved, and by leveraging the innate immune system’s phagocytic capabilities, could be differentiated by its safety, tolerability, efficacy and clinical benefit over current therapeutic approaches, which have been observed in preclinical studies. None of the abovementioned statements regarding any of our products in development are intended to be a prediction or conclusion of efficacy. No clinical trials on our product candidates have been completed so no conclusions relating to such attributes can be made. Disease backgrounds Acute Myeloid Leukemia AML is a cancer of the blood and bone marrow that affects myeloid cells, cells which normally develop into the various types of mature blood cells. It is a fast-progressing and aggressive form of blood cancer, with a median time from diagnosis to death of just 5.5 months. Despite over 20 FDA approved therapeutics for the treatment of AML, the death rate in AML patients has only moderately diminished since the 1990s, with the disease hovering around a