Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 143

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 143
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emia, 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 medical need for novel therapies, including cell therapeutic approaches Our Phase 1 AML clinical trial is intended to evaluate the safety, potential therapeutic utility and applicable dose of CER-1236. The approved starting dose for the clinical trial is sufficiently high that we expect begin to see efficacy by the second dose level cohort. Concurrent with a trial in these hematological malignancies, we intend to expand the clinical development of CER-1236 with an additional IND submission to investigate solid tumors such as non-small cell lung cancer (“NSCLC”) and ovarian cancer. We believe that CER-1236 has the potential to address unmet medical needs in the targeted indications, and be differentiated from currently available therapeutics by its safety, tolerability and efficacy. Since no clinical trials of CER-1236 have commenced, none of the abovementioned statements regarding any of our products in development are intended to be a prediction or conclusion of efficacy. Our Strategy Our intent is to become a leading biopharmaceutical company focused on the capital-efficient advancement of innovative anti-cancer product candidates targeting the unmet medical need associated with aggressive and difficult-to-treat hematological malignancies and solid tumors. To accomplish this objective, the key elements of our strategy include:

| ● | Advance                                                                                         
 the clinical development of CER-1236 for the treatment of AML patients. 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