Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 109

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 109
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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.

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;

●no evidence of T cell exhaustion despite repeated challenges;

●no observed off-target or off-tumor toxicities;

●expression and maintenance of diverse T cell populations, including naïve and memory cells, likely
indicative of response persistence and durability; and

●well defined and scalable manufacturing protocols.

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We have designed CER-1236
to align with components included in the current generation of conventional CAR-T configurations by fusing the external domain of TIM-4,
a phagocytic receptor