Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 160

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 160
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 diagnosis for patients which often leads to many rounds of treatment and a complete disruption of their lives. 102 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. 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% complete response (“CR”) rates of adults younger than 60 years and 40-60% of fit adults older than 60 years old. For those eligible for the chemotherapy regimen and experiencing a CR, many patients with adverse features (70%) undergo allogeneic HSCT which, in some patients are “curative.” Unfortunately, a significant proportion (up to 50%) of AML patients are over the age of 65 and are “unfit” for intensive chemotherapy, requiring different treatment approaches for medically unfit patients. The treatment landscape for older unfit adults with AML fundamentally changed with the recent availability of new drugs, in particular the oral B-cell lymphoma 2 inhibitor venetoclax. Venetoclax is used in conjunction with azacytidine to treat these patients, with a complete response rate ~65%. However the majority of adult patients with AML experience relapse despite initially attaining CR; a venetoclax-based doublet therapy for medically less-fit adults carries a median survival of ~14.7 months. The prognosis for patients who are refractory to or relapse after frontline azacitidine venetoclax is dismal with median overall survival of 2.4 months, making this an area of high unmet need. Such patients who