Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 174

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 174
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,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.

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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