Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 105

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 105
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 broadly; or if FDA finds that the investigational protocol or 
 plan is clearly deficient to meet its stated objectives;                                                                                                                                                                                                  |

| • |     | delays in recruiting suitable patients to participate in TuHURA’s clinical trials; |

| • |     | failure by TuHURA’s CROs, other third parties, or TuHURA to adhere to clinical trial requirements; |

| • |     | failure to perform in accordance with the FDA’s current good clinical practice regulations 
 (“cGCPs”), requirements, or similar applicable regulatory guidelines in other countries;   |

| • |     | delays in patients completing participation in a trial or returning for post-treatment follow-up; |

| • |     | patients dropping out of a trial; |

| • |     | occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential 
 benefits;                                                                                                    |

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| • |     | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |

| • |     | changes in the standard of care on which a clinical development plan was based, which may require new or 
 additional trials;                                                                                       |

| • |     | the cost of clinical trials of TuHURA’s product candidates being greater than TuHURA anticipates; |

| • |     | clinical trials of TuHURA’s product candidates producing negative or inconclusive results, which may result                    
 in TuHURA deciding, or regulators requiring it, to conduct additional clinical trials or abandon product development programs; |

| • |     | delays in developing TuHURA’s manufacturing processes and transferring to new third-party facilities to                                                                                     
 support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and |

| • |     | delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of 
 TuHURA’s product candidates for use in clinical trials or the inability to do any of the foregoing.             |

For example, TuHURA’s IND for its planned Phase 3 trial for IFx-2.0contemplated by its SPA agreement with the FDA is subject to a partial clinical trial hold as described in a January 2024 letter from the FDA that relates to certain CMC matters for the trial. A partial clinical hold means that the FDA suspends part of the clinical work requested under an IND (i.e., a specific protocol or part of a protocol is not allowed to proceed). The