Company: CERO
Filing Date: 2025-07-21
Form Type: S-1
Source: 0001213900-25-066152
Chunk: 42

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-07-21
Form: S-1
Chunk 42
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 our ability to:

| ● | successfully complete preclinical studies and clinical trials for our CER-T cell product candidates; |

| ● | timely file and receive acceptance of INDs, and amendments thereto, as applicable, in order to commence our planned and future clinical trials; |

| ● | successfully enroll subjects in, and complete, clinical trials for our CER-T cell product candidates; |

| ● | hire additional staff, including clinical, scientific and management personnel; |

| ● | timely file BLAs and receive regulatory approvals for our product candidates from the FDA and other regulatory authorities; |

| ● | initiate and successfully complete clinical trials and safety studies required to obtain U.S. and applicable foreign marketing approval for our product candidates; |

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| ● | establish commercial manufacturing capabilities through third-party manufacturers and CDMOs for clinical supply and commercial manufacturing of our product candidates; |

| ● | obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates; |

| ● | launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; |

| ● | maintain a continued acceptable safety profile of the product candidates following approval; |

| ● | obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; |

| ● | position our products to effectively compete with other therapies; |

| ● | obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidates; and |

| ● | enforce and defend intellectual property rights and claims with respect to our product candidates. |

Many of the factors listed above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercialize our product candidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soon after generating product sales, if ever. If we are unable to generate sufficient revenue through the sale of our product candidates or any future product candidates, we will be unable to continue operations without continued funding. Our engineered CER-T cells represent a novel approach to cancer treatment that creates significant challenges for us. We are developing autologous T-cell product candidates that are engineered from healthy donor T-cells to express chimeric engulfment receptors (“CERs”) and are intended for use in patients with certain cancers. Advancing these novel product candidates creates significant challenges for us, including:

| ● | manufacturing our product candidates to our or regulatory specifications and in a timely manner to