Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 153

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 153
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 patients that are sufficiently healthy and at unfavorable risk, allogeneic Hematopoietic Stem Cell Transplants
(“HSCTs”) are commonly performed. Despite these interventions, there is significant unmet medical need for novel therapies,
including cell therapeutic approaches

Our Phase 1 AML clinical
trial is intended to evaluate the safety, potential therapeutic utility and applicable dose of CER-1236. The approved starting dose for
the clinical trial is sufficiently high that we expect begin to see efficacy by the second dose level cohort. Concurrent with a trial
in these hematological malignancies, we intend to expand the clinical development of CER-1236 with an additional IND submission to investigate
solid tumors such as non-small cell lung cancer (“NSCLC”) and ovarian cancer. We believe that CER-1236 has the potential
to address unmet medical needs in the targeted indications, and be differentiated from currently available therapeutics by its safety,
tolerability and efficacy. Since no clinical trials of CER-1236 have commenced, none of the abovementioned statements regarding any of
our products in development are intended to be a prediction or conclusion of efficacy.

Our Strategy

Our intent is to become
a leading biopharmaceutical company focused on the capital-efficient advancement of innovative anti-cancer product candidates targeting
the unmet medical need associated with aggressive and difficult-to-treat hematological malignancies and solid tumors. To accomplish this
objective, the key elements of our strategy include:

| ● | Advance                                                                                         
 the clinical development of CER-1236 for the treatment of AML patients. Based on preclinical    
 data generated to date related to the use of CER-1236 to treat hematological cancers, we        
 intend to initially target relapsed and refractory AML patients for clinical development.       
 These are aggressive cancers with limited treatment options. Moreover, these cancers represent  
 a significant unmet medical need, and to date there are no approved CAR-T cell therapies        
 for patients diagnosed with AML. There are approximately 20,800 cases of AML diagnosed annually 
 in the U.S.                                                                                     |

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| ● | Leverage                                                                                        
 past and current CAR-T product approvals to shorten the regulatory and manufacturing pathway    
 for CER-1236. We have designed our CER-T cells to share similar construction to currently       
 approved CAR-T cell therapies. The processes and protocols used to produce autologous CAR-T     
 cells are well recognized