Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 161

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 161
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 related to the rapid proliferation and activation of T cells upon detection of a target antigen, severe or life-threatening CRS
was noted in a significant number of patients who participated in the registrational trials of FDA-approved CAR-T therapies. These SAEs
can result in patients requiring longer hospitalizations and more intensive medical care. The frequency and severity of observed SAEs
is one of the primary 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 ligand 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.

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