Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 35

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 35
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, 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, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete. Data from our preclinical studies is limited and may change as patient data become available or may not be validated in any future or advanced clinical trial. Data from preclinical studies and any clinical trials that we may complete is subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data becomes available. For example, preclinical and Phase 1 results are preliminary in nature and should not be viewed as predictive of ultimate success. It is possible that such results will not continue or may not