Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 162

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 162
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 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
to the inner leaflet of the phospholipid bilayer which makes up the plasma membrane of a cell. However, cellular stresses cause the externalization
of TIM-4-L to the cell surface. Exposure of TIM-4-L on the outer surface acts as an “eat-me” signal and marks abnormal, stressed
and dying or dead cells for phagocytic clearance. A variety of tumors have been shown to have constitutively increased surface TIM-4-L
as a result of altered plasma membrane regulation. Among hematologic tumors, loss-of-function mutations in the flippase chaperone transmembrane
protein 30A (“TMEM30A”), have been identified in approximately 11% of patients with diffuse large B cell lymphoma (“DLBCL”),
and this mutation was correlated with improved response to the standard therapeutic regimen suggesting the host’s immune elimination
of TIM-4-L positive tumor cells enhances tumor clearance. We are seeking to exploit the presence of TIM-4-L expressed on the outer cell
surface of both hematological malignancies and solid tumors.

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CER-1236: Our Lead Development Candidate

As externally oriented TIM-4-L
is present on many cancerous cells regardless of tumor type, we believe a single CER construct may demonstrate clinical utility in treating
an array of cancers. To that end, we have focused our development activities on optimizing the cancer killing capabilities of a specific
CER-T therapeutic design. These efforts have resulted in our lead clinical candidate, CER-1236. In preclinical studies, we have observed
CER-1236 to display attractive functional capabilities and product characteristics, among which are:

| ● | target-dependent                                                                           
 activation, cytotoxicity, anti-tumor cytokine production, and high proliferative capacity; |

| ● | tumor              
 cell phagocytosis; |

| ● | distinct                                                                                      
 transcriptome, cytokine and chemokine signatures that substantiate the complementary activity 
 of both the innate and adaptive immune response;                                              |

| ● | enhanced                                          
 antigen acquisition, processing and presentation;