Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 37

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 37
---
 our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval. Research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful. If any of these events occur, we may be forced to abandon our research, development or commercialization efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations. 15 Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community. The use of engineered T cells as a potential cancer treatment is nascent and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community. We expect physicians with expertise in immunotherapy to be particularly important to the market acceptance of our products and we may not be able to educate them on the benefits of using our product candidates for many reasons. For example, certain of the product candidates that we will be developing may result in unacceptable and unanticipated side effects, including death. Additional factors will influence whether our product candidates are accepted in the market, including:

| ● | the clinical indications for which our product candidates are approved; |

| ● | physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment; |

| ● | the potential and perceived advantages of our product candidates over alternative treatments; |

| ● | the prevalence and severity of any side effects; |

| ● | product labeling or product insert requirements of the FDA or other regulatory authorities; |

| ● | limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities; |

| ● | the timing of market introduction of our product candidates as well as competitive products; |

| ● | the cost of treatment in relation to alternative treatments; |

| ● | the availability of coverage and adequate reimbursement by third-party payors and government authorities; |

| ● | the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors and government authorities; |

| ● | relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and |

| ● | the effectiveness of our sales and marketing efforts. |

If our product candidates are approved but fail to achieve market acceptance among physicians, patients,