Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 173

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 173
---
ity against
AML cells (Below, top and bottom graphs), but limited activation (Below, top graph) and no cytotoxicity (Below, bottom graph) against
any of the human cell types tested. These experiments support the lack of off-target responses by CER-1236 T cells.

<div align='center'>101</div>

CER-1236 Clinical Development Strategy

Based on the extensive preclinical
data that we have assembled regarding the use of CER-1236 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

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