Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 113

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 113
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HURA may be required to change the way such products are distributed or administered, or change the labeling of 
 the products;                                                                                                     |

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| • |     | the FDA or a comparable foreign regulatory authority may require TuHURA to conduct additional clinical trials or 
 costly post-marketing testing and surveillance to monitor the safety and efficacy of the products;               |

| • |     | TuHURA may decide to recall such products from the marketplace after they are approved; |

| • |     | TuHURA could be sued and held liable for harm caused to individuals exposed to or taking its products; and |

| • |     | TuHURA’s reputation may suffer. |

In addition, adverse side effects caused by any therapeutics that may be similar in nature to TuHURA’s product candidates could delay or prevent regulatory approval of TuHURA’s product candidates, limit the commercial profile of an approved label for TuHURA’s product candidates, or result in significant negative consequences for its product candidates following marketing approval. TuHURA believes that any of these events could prevent it from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing TuHURA’s product candidates, if approved, and significantly impact TuHURA’s ability to successfully commercialize its product candidates and generate revenues. If TuHURA encounters difficulties enrolling patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected. The timely completion of clinical trials in accordance with their protocols depends, among other things, on TuHURA’s ability to enroll a sufficient number of patients who remain in the trial until its conclusion. TuHURA may experience difficulties in patient enrollment in its clinical trials for a variety of reasons, including:

| • |     | the size and nature of the patient population; |

| • |     | the patient eligibility criteria defined in the protocol; |

| • |     | the size of the study population required for analysis of the trial’s primary endpoints; |

| • |     | the proximity of patients to trial sites; |

| • |     | the design of the trial; |

| • |     | TuHURA’s ability to recruit clinical trial investigators with the appropriate competencies and experience; |

| • |     | clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product                                                                      
 candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications TuHURA is investigating; |

| •