Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 119

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 119
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umor
activity. Additionally, in antigen presentation assays, activated CER-1236 T cells exhibited superior cross-presentation ability relative
to conventional T cells, triggering specific TCR-T cell responses in an MHC class I and TLR-2 dependent manner, overcoming the limited
antigen presentation capabilities of conventional T cells. These results indicate that CER-1236 T cells have the potential to achieve
optimal tumor control by eliciting both cytotoxic effects and cross-priming.

CER-1236 T cells did not elicit safety signals in preclinical safety/toxicology
studies

Importantly, no evidence of toxicity was observed during a safety/toxicology
study conducted in mice, a clinically relevant model that has an identical structure of TIM-4-L as humans. The effects of CER-1236 administration
were evaluated at 2 doses at 3- and 28-day timepoints. No incidence of anemia, thrombocytopenia, neutropenia or coagulation abnormalities
were recorded in any condition. Hematologic indices, including hemoglobin/hematocrit, platelets and neutrophils remained stable throughout
the study. No perturbation of clinical chemistries was noted. None of the animals experienced weight loss, morbidity or unexpected mortality.
No clinically relevant tissue abnormalities were noted at either timepoint at the high dose in any organ evaluated. Overall, these data
demonstrate a lack of on-target off-tumor responses and support the safety profile of CER-1236.

The potential for off-target
toxicity by CER-1236 was also tested against primary human cells or iPSC-derived human cells representing vital organs, including the
CNS, heart, lungs, liver, spleen, kidneys, GI tract, and gonads. CER-1236 was co-cultured with these cells and activation was monitored
by IFNγ secretion or cytotoxic effect. Over the time points tested, CER-1236 showed potent activation and cytotoxicity against AML
cells (Below, top and bottom graphs), but limited activation (Below, top graph) and no cytotoxicity (Below, bottom graph) against any
of the human cell types tested. These experiments support the lack of off-target responses by CER-1236 T cells.

16

CER-1236 Clinical Development Strategy

Based on the extensive preclinical
data that we have assembled regarding the use of CER-1236