Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 121

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 121
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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 do not respond to frontline
therapy with azacitidine or venetoclax, and the subset who do not respond to targeted therapies, e.g., IDH1/2 inhibitors, are candidates
for investigational trials. To date, there are no approved cell