Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 97

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 97
---
Item 1. Business.

Overview

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 active in both hematological
malignancies and solid tumors.

On November 14, 2024, we received notice from the FDA that the Investigational
New Drug Application (“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. We submitted
a second IND application for the investigation of CER-T cell therapy in non-small cell lung cancer (“NSCLC”) and ovarian cancer,
which was accepted by the FDA on March 27, 2025.

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 hematological malignancies with approved CAR-T cell therapies