Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 60

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 60
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 manufacturing. 30 If we or our contractors fail to comply with applicable regulatory requirements following approval of CER-1236 or our other product candidates, a regulatory authority may:

| ● | issue a warning letter, untitled letter, or Form 483, asserting that we are in violation of the law; |

| ● | request voluntary product recalls; |

| ● | seek an injunction or impose administrative, civil, or criminal penalties or monetary fines; |

| ● | suspend or withdraw regulatory approval; |

| ● | suspend any ongoing clinical trials; |

| ● | refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto); |

| ● | restrict the marketing or manufacturing of the product; |

| ● | seize or detain the product or otherwise require the withdrawal of the product from the market; |

| ● | refuse to permit the import or export of product candidates; or |

| ● | refuse to allow us to enter into supply contracts, including government contracts. |

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize CER-1236 or other product candidates and adversely affect our business, financial condition, results of operations, and prospects. Prior treatments can alter the cancer or target of CER-T cell therapy and negatively impact chances for achieving clinical activity with our programmed T cells. Patients with hematological cancers receive highly toxic lympho-depleting chemotherapy as their initial treatment. These therapies can impact the viability of the T cells collected from the patient and can contribute to highly variable responses to programmed T cell therapies. Patients could also have received prior therapies that target the same target antigen on the cancer cells as our intended programmed T cell product candidate and thereby lead to a selection of cancer cells with low or no expression of the target. Cancers also naturally evolve and select clones with low or no expression of the target. As a result, our programmed T cell product candidates may not recognize the cancer cell and may fail to achieve clinical activity. If any of our product candidates do not achieve a sufficient level of clinical activity, we may discontinue the development of that product candidate, which could adversely affect our business, financial condition, results of operations, and prospects. 31 Risks Related to Reliance on Third-Parties We will rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet