Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 169

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 169
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 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 commenced 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 approvals for AML, the death rate in AML patients has only moderately diminished since the 1990s, with the disease hovering around a 32% 5-year overall survival rate according to the National Cancer Institute. AML was diagnosed in 21,000 Americans in 2019, and there were 11,000 AML-related deaths in the same year, according to the Leukemia and Lymphoma Society. Like most cancers, it is a terrifying diagnosis for patients which often leads to many rounds of treatment and a complete disruption of their lives. Figure 1: Rate of new cases of AML and associated mortality in the United States 1992-2020 Source: NIH, National Cancer Institute According to Alliance Global Partners, the total AML therapeutic market is estimated to be approximately USD $1B-$1.5B as of 2023 and projected to grow at a compound annual growth rate (CAGR) of ~9% based on the historical growth rate, the anticipated approval of new therapeutics, and an increase in the number of total patients to be diagnosed in the coming years. According to estimates, by 2028, the AML therapeutic market will likely grow to over $2B+, highlighting the significant economic upside associated with any improvements to the standard of care from the current pipeline therapeutics. 96 Current therapies and their limitations Currently, there are over 20 FDA approved therapeutics in the AML space, with eight approvals having come in just two years from 2017-2019. Before then, AML was treated with decades-old combination chemotherapy regimens, including cytarabine and anthracycline. This regimen has about a 70-80