Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 48

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 48
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 difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. Identifying and qualifying patients to participate in clinical trials of our product candidates will be critical to our success. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:

| ● | the patient eligibility criteria 
 defined in the protocol;         |

| ● | the number of patients with             
 the disease or condition being studied; |

| ● | the perceived risks and benefits       
 of the product candidate in the trial; |

| ● | clinicians’ and patients’                                                                                                              
 perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including  
 any new drugs that may be approved for the indications we are investigating or drugs that may be used off-label for these indications; |

| ● | the size and nature of the patient                                               
 population required for analysis of the trial’s primary and secondary endpoints; |

| ● | the proximity of patients to 
 study sites;                 |

| ● | the design of the clinical trial; |

| ● | our ability to recruit clinical                                       
 trial investigators with the appropriate competencies and experience; |

21

| ● | competing clinical trials for                                                         
 similar therapies or other new therapeutics not involving T cell-based immunotherapy; |

| ● | our ability to obtain and maintain 
 patient consents;                  |

| ● | the risk that patients enrolled                                                                   
 in clinical trials will drop out of the clinical trials before completion of their treatment; and |

| ● | other public health factors,                                         
 including the coronavirus pandemic or outbreaks of other infections. |

In particular, some of our clinical trials will look to enroll patients with characteristics which are found in a very small population. For example, our clinical trial for CER-1236 will seek to enroll patients with hematologic malignancies, including AML, MCL, CLL, and other B cell and myeloid neoplasms. Other companies are conducting clinical trials with their engineered T cell therapies in hematologic malignancies and seek to enroll patients in their studies that may otherwise be eligible for our clinical trials, which could lead to slow recruitment and delays in our clinical trials. In addition, since the number of qualified clinical investigators is limited, we expect to conduct