Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 118

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 118
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 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 in vitro antigen challenges with no evidence of T cell
exhaustion noted. These findings are illustrated in the following charts.

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.

15

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 of AML, MCL, ovarian cancer and EGFR-mutation positive NSCLC demonstrate the ability of CER-1236 T cells to induce collaborative
innate-adaptive anti-tumor immune responses in both in vitro and in vivo studies. Moreover, concurrent treatment with standard-of-care
therapeutics for each of these indications increases target ligand, conditionally bolstering CER-1236 T cell function to augment anti-t