Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 150

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 150
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| Legacy CERo options                                     |     |             |      48,339 |   |     |              |         483 |   |

<div align='center'>83

BUSINESS</div>

We are an innovative immunotherapy
company advancing the development of next-generation engineered T cell therapeutics for the treatment of cancer. Our proprietary approach
to T cell engineering, which enables us to integrate certain desirable characteristics of both innate and adaptive immunity into a single
therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. Our novel cellular
immunotherapy platform is designed to redirect patient-derived T cells to eliminate tumors by building in pathways that employ both cytotoxic
and phagocytic mechanisms to destroy cancer cells, creating what we refer to as CER-T cells. Our lead molecule is CER-1236, an autologous
T-cell product that targets a novel tumor antigen, TIM-4 ligand. Unlike currently approved chimeric antigen receptor (“CAR-T”)
therapies which have largely been active in hematological B cell malignancies, we believe CER-1236 will be efficacious in both hematological
malignancies and solid tumors.

On November 14, 2024, the
company received notice from the FDA that the IND was cleared after being put on a brief clinical hold due to insufficient nonclinical
data to adequately judge off target toxicity. The clinical hold was lifted after additional in vitro experiments were performed which
allayed the agency’s concerns.

The ability to enhance the
activity of T cells against human cancers through genetic engineering has been among the most significant advances in cancer therapy
in the last decade. One of the more promising therapeutic uses of T cells to emerge has been CAR-T cell technology. However promising
CAR-T cell therapy has been, its use has been largely limited to the treatment of certain hematological cancers due to lack of specific
tumor-associated antigens and CAR-T cells’ limited ability to proliferate, traffic, and circulate in solid tumors. Curative cell
therapies for solid tumors currently do not exist, and the significance of this limitation is underscored by the prevalence of solid
tumor malignancies. The American Cancer Society estimates that solid tumor cancers accounted for more than 1.7 million of the 1.9 million
people newly diagnosed with cancer in 2022. Even in hemat