Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 108

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 108
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 reasons that administration of currently approved CAR-T therapy is restricted to a select number of treatment
centers. Moreover, aside from the low-level expression of certain cancer specific neoantigens, most tumor associated antigens are also
found on normal cells which may lead to serious, if not life threatening, “on-target, off-tumor” toxicities.

We believe that the preferential
attributes engineered into our CER-T cell therapies have the potential to represent a next-generation adoptive cellular immunotherapy
approach and enable us to overcome many of the limitations which hinder the wider application of current CAR-T technology. The prophagocytic
and immunomodulatory properties of CER-T cells are designed to overcome some of the immunosuppressive elements in many solid tumors. In
addition, their anticipated superior antigen presentation properties may enhance a patient’s ongoing immune response against tumor
antigens. Lastly, healthy cells have minimal expression of TIM-4-L as compared to tumor cells, reducing the potential for on-target off-tumor
effects. In consequence, we envision CER-1236 as having a differentiated mechanism for tumor clearance that enables the potential for
enhanced activity across a broad array of hematological malignancies and solid tumors.

6

CER-T Cell Therapy Technology

Distinguishing our CER-1236
cell therapy candidate is the integration into a single therapeutic construct of many of the anti-tumor capabilities resident in both
the innate and the adaptive immune systems. We believe the coupling of these functions better emulates normal immune system activity which
may promote enhanced T cell activation, proliferation and durability for more robust elimination of cancerous cells and reduction in tumor
burden.

We have designed our CER-T
constructs to embrace many of the components found in conventional CAR-T cell therapies. The processes and protocols used to genetically
modify a patient’s T cells to produce CAR-T cells are well recognized, as is the use of lentivirus in the manufacture of these therapies.
Accordingly, we have constructed CER-1236 cell manufacturing processes to be similar to those of CAR-T cells. We expect to benefit from
the well-defined regulatory guidelines established by both U.S. and European regulatory authorities related to CAR-T cell therapy and
its use.

The biological foundations for CER-T cell therapy

PS, or TIM-4 ligand, is a
component of a cell’s plasma membrane and has a key role in cell removal. Under normal physiological conditions, TIM-4-L is restricted