Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 99

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 99
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 cells, such as CAR-NK and CAR-M therapies, are unlikely to enjoy similar benefits.

1

In preclinical studies, we have observed CER-1236
to display attractive functional attributes, among which are:

●target-dependent activation, cytotoxicity, anti-tumor cytokine production, and high proliferative capacity;

●phagocytosis of tumor cells;

●distinct transcriptome, cytokine and chemokine signatures that substantiate the complementary activity of both the innate and adaptive
immune response;

●enhanced antigen acquisition, processing and presentation;

●no evidence of T cell exhaustion despite repeated challenges;

●no observed off-target or off-tumor toxicities;

●expression and maintenance of diverse T cell populations, including naïve and memory cells, likely indicative of response persistence
and durability; and

●well defined and scalable manufacturing protocols.

Based on the
preclinical data regarding the use of CER-1236 T cells to combat hematologic malignancies, we anticipate beginning clinical trials
in the first half of 2025. We anticipate that our initial targets will be relapsed, remitting acute myeloid leukemia
(“AML”) patients as well as AML patients with measurable residual disease (“MRD”) and patients with
mutations in TP53, a gene mutation associated with aggressive AML. AML is a heterogenous and aggressive hematopoietic malignancy
characterized by the rapid buildup of immature myeloid cells in the bone marrow and blood. This process results in the inhibition of
normal hematopoiesis, manifesting as neutropenia, anemia, thrombocytopenia, and the clinical features of bone marrow failure.
According to the American Cancer Society, AML accounts for 90% of all acute leukemias in adults, with an estimated 22,010 new cases
and 11,090 deaths expected in the United States in 2025. The current treatment has remained largely unchanged over several decades
with combination chemotherapy with cytarabine for 7 days and an anthracycline for 3 days (“7+3”). Newer, targeted
approaches that include multi-kinase domain inhibitors and antibody-drug conjugates are now available during induction chemotherapy
for certain patients. For patients that are sufficiently healthy and at unfavorable risk, allogeneic Hematopoietic Stem Cell
Transplants (“HSCTs”) are commonly performed. Despite these interventions, there is significant unmet medical need for
novel