Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 171

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 171
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 CER-1236 T
cells in peripheral blood displayed robust expansion at Day 7, with or without the concomitant administration of ibrutinib. Animals
that received CER-1236 T cells demonstrated an expansion of over 400-fold as compared to Day 2 levels both in the absence and presence
of ibrutinib. High levels of CER-1236 T cells did not persist in the periphery and animals that received CER-1236 T cells showed a greater
than 95% contraction in cell count from peak numbers by Day 14 with subsequent CER-T cell expansion likely prompted by residual tumor
cell encounters. CER-1236 T cells also maintained robust proliferative capacity despite repeated antigen challenges with no evidence
of T cell exhaustion noted. These findings are illustrated in the following charts.

<div align='center'>99</div>

A single infusion of CER-1236 T cells generated rapid cell expansion across repeated challenges

CER-1236 demonstrates in vivo tumor clearance in NSCLC adenocarcinoma xenograft

We envisioned that the simultaneous
exposure to both osimertinib and CER-1236 would lead to synergistic in vivo anti-tumor responses. HCC827 NSCLC cells were inoculated
into the flanks of NSG mice. Once established, the mice were dosed with a short course of the EGFR inhibitor osimertinib to prime TIM-4-L
antigen on tumors and administered 2.5e6 CER-1236 T cells. Treatment groups that received the EGFR inhibitor alone, after initial tumor
regression, developed progressive disease, as evidenced in the below left graph. In contrast, animals infused with CER-1236 T cells demonstrated
potent anti-tumor responses in the presence of osimertinib. CER-1236 T cells expanded rapidly in the blood, with the highest expansion
observed in the osimertinib-treated cohorts, as observed in the below right graph. Importantly, no evidence of organ toxicity or weight
loss was observed with increases in body weight recorded in all groups over the course of the study. Analysis of the tumors post-infusion
indicated extensive infiltration of T cells compared to untransduced controls.

CER-1236 T cells infused to Osimertinib dosed animals showed tumor elimination and higher levels of T cell expansion

We believe that the preclinical
models