Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 67

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 67
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 management resources. Regardless of the merits or eventual outcome, liability claims may result in:

| ● | decreased demand for our product            
 candidates or products that we may develop; |

| ● | injury to our reputation; |

| ● | withdrawal of clinical trial 
 participants;                |

| ● | initiation of investigations 
 by regulators;               |

| ● | costs to defend the related 
 litigation;                 |

| ● | a diversion of management’s 
 time and our resources;     |

| ● | substantial monetary awards        
 to trial participants or patients; |

| ● | product recalls, withdrawals                        
 or labeling, marketing or promotional restrictions; |

| ● | loss of revenue; |

| ● | exhaustion of any available          
 insurance and our capital resources; |

| ● | the inability to commercialize 
 any product candidate; and     |

| ● | a decline in our stock price. |

32 Failure to obtain or retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with corporate collaborators. Although we plan on purchasing clinical trial insurance, such insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise. Public opinion and scrutiny of cell-based immune-oncology therapies for treating cancer, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates, may impact public perception of our company and product candidates, or impair our ability to conduct our business. Our autologous cell therapy platforms utilizes a relatively novel technology involving the genetic modification of cells, and no CER-T cell-based immunotherapy has been approved to date. Public perception may be influenced by claims, such as claims that cell-based immunotherapy is unsafe, unethical, or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to cell-based immunotherapy in general, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates, could result in greater government regulation and stricter labeling requirements of cell-based immunotherapy products