Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 33

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 33
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 from product sales. In addition, because our other product candidates are based on similar technology as our lead product candidate, if the lead product candidate encounters additional safety issues, efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed. 12 We have not generated any revenue and may never be profitable. Our ability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, our product candidates. We do not know when, or if, we will generate any revenue. All of our product candidates, including CER-1236, are in the preclinical stages of development and will require additional preclinical studies, clinical development regulatory review and approval, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Our ability to generate revenue depends on a number of factors, including, but not limited to, 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; |

| ● | 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