CERO THERAPEUTICS HOLDINGS, INC.

CERO THERAPEUTICS HOLDINGS, INC. is an immunotherapy company focused on developing engineered T cell therapeutics for cancer treatment. The company's approach to T cell engineering integrates characteristics of both innate and adaptive immunity into a single therapeutic construct. This platform is designed to redirect patient-derived T cells to eliminate tumors by employing both cytotoxic and phagocytic mechanisms to destroy cancer cells, creating Chimeric Engulfment Receptor T ("CER-T") cells. The company's lead molecule is CER-1236, an autologous T-cell product that targets the TIM-4 ligand tumor antigen. CER-1236 is intended for use in both hematological malignancies and solid tumors. On November 14, 2024, the FDA cleared the Investigational New Drug Application ("IND") for CER-1236 after a brief clinical hold, which was lifted following additional in vitro experiments addressing off-target toxicity. In May 2025, CERO THERAPEUTICS HOLDINGS, INC. initiated a Phase 1 clinical trial to evaluate the safety, potential therapeutic utility, and applicable dose of CER-1236 in patients with acute myeloid leukemia ("AML"). This first-in-human, multi-center, open-label, Phase 1/1b study is designed for patients with relapsed/refractory AML, AML in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. Additionally, on March 27, 2025, the FDA accepted a second IND application for CER-T cell therapy in non-small cell lung cancer ("NSCLC") and ovarian cancer, with a Phase 1 study anticipated to begin in the first quarter of 2026.