Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 140

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 140
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 liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If TuHURA cannot successfully defend itself against product liability claims, TuHURA may incur substantial liabilities or be required to limit commercialization of its product candidates. Even successful defense would require significant financial and management resources. Product liability claims could delay or prevent completion of TuHURA’s development programs. If TuHURA succeeds in marketing any approved products, these claims could result in an FDA investigation of the safety and effectiveness of its products, its manufacturing processes and facilities (or the manufacturing processes and facilities of TuHURA’s third-party manufacturer) or its marketing programs, a recall of TuHURA’s products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in:

| • |     | decreased demand for TuHURA’s products; |

| • |     | injury to TuHURA’s reputation; |

| • |     | withdrawal of clinical trial participants and inability to continue clinical trials; |

| • |     | initiation of investigations by regulators; |

| • |     | costs to defend the related litigation; |

| • |     | a diversion of management’s time and TuHURA’s resources; |

| • |     | substantial monetary awards to trial participants or patients; |

| • |     | substantial monetary awards to trial participants or patients; |

| • |     | product recalls, withdrawals or labeling, marketing or promotional restrictions; |

| • |     | loss of revenue; |

| • |     | exhaustion of any available insurance and TuHURA’s capital resources; |

| • |     | the inability to commercialize any product candidate; and |

| • |     | a decline in TuHURA’s share price. |

TuHURA’s Risks Relating to Government Regulation The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and TuHURA may experience significant delays in the clinical development and regulatory approval, if any, of its product candidates. The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States.