Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 131

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 131
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 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. TuHURA is not permitted to market any biological drug product in the United States until TuHURA receives a Biologics License from the FDA. TuHURA has not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. However, A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe, pure, potent, and effective for each desired indication. The BLA must also include significant information regarding the chemistry, manufacturing,