Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 123

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 123
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% more likely to develop lung cancer than White men. The rate is about 16% lower
in Black women than in White women.

●Black and White women have lower rates than men, but the gap is closing. The lung cancer rate has been
dropping among men over the past few decades, but only for about the past decade in women.

●Despite their overall risk of lung cancer being higher, Black men are less likely to develop SCLC than
White men.

Statistics on survival in
people with lung cancer vary depending on the type of lung cancer, the stage (extent) of the cancer when it is diagnosed, and other factors.

5-year relative survival rates for non-small
cell lung cancer

These numbers are based on people diagnosed
with NSCLC between 2012 and 2018.

    SEER stage 
    5-year relative
 survival rate 
  
    Localized 
     65%
  
    Regional 
     37%
  
    Distant 
     9%
  
    All SEER stages combined 
     28%

19

Our therapeutic approach and development program

We anticipate the design
of the clinical development program for CER-1236 to enable our evaluation of its therapeutic utility in treating both hematologic and
solid tumors, as the capacity of a single therapeutic construct to provide clinical benefit across this diversity of tumor types would
represent a significant advance in cancer immunotherapy. Due to the therapy’s novel mechanism of action, engaging both the innate
and the adaptive immune response, and the broad expression profile of PS on a variety of hematologic and solid tumors, we intend to employ
an adaptive Phase 1 trial design to evaluate patient response to CER-1236. As such, the dosing protocol will emphasize a gradual increase
in the delivered dose with the objective of achieving a clinical signal, while ensuring patient safety. We also intend our Phase 1 trial
design to enable an evaluation of appropriate dosing strategies to optimize CER-T engagement and proliferation.

We believe, subject to discussions
with the FDA and other regulatory authorities, that there may be a full development path to registration and use in the larger AML patient
populations on achieving positive safety data along with indications of therapeutic benefit in these initial trial cohorts. We believe
CER-1236 may provide significant treatment advantages over currently available therapeutics, including CAR-T therapy as a result of its
potential to enhance objective response rates and the duration of response related to the comprehensive, coordinated engagement of