Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 120

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 120
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 T cells to combat cancer, we intend to commence clinical trials with our initial
treatment target being patients suffering from relapsed, or refractory AML as well as those subsets who are positive for Minimal Residual
Disease and the TP53 mutation. We subsequently intend to expand the clinical development of CER-1236 to include solid tumors such as NSCLC
and ovarian cancer. We expect these clinical trials to evaluate the safety, the potential therapeutic utility and applicable dose of CER-1236.
In addition, we anticipate that these clinical trials may provide insight into the possible use of CER-1236 to treat an array of hematologic
and solid tumors.

We believe this drug candidate
has the potential to be a therapy for the unmet needs of targeted indications, 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.

17

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 $