Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 103

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 103
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 any one of which it may not be able to successfully complete:

| • |     | conduct additional preclinical and clinical development with successful outcomes; |

| • |     | manage preclinical, manufacturing, and clinical activities; |

| • |     | obtain regulatory approval from the FDA and other comparable foreign regulatory authorities; |

| • |     | establish manufacturing relationships for the clinical and post-approval supply of the applicable drug candidate 
 in compliance with all regulatory requirements;                                                                  |

| • |     | build a commercial sales and marketing team, either internally or by contract with third parties; |

| • |     | establish and maintain patent and trade secret protection or regulatory exclusivity for TuHURA’s product 
 candidates;                                                                                              |

| • |     | develop and implement marketing strategies for successful commercial launch of TuHURA’s product candidates, 
 if, and when, approved;                                                                                     |

| • |     | secure and maintain acceptance of TuHURA’s products, if, and when approved, by patients, from the relevant 
 medical communities and from third-party payors;                                                           |

| • |     | compete effectively with other therapies; |

| • |     | establish and maintain adequate health care coverage and reimbursement from third-party payors; |

| • |     | ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any                                                                                                                               
 required post-marketing clinical trials or the elements of any post-marketing Risk Evaluation and Mitigation Strategy (“REMS”), that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the 
 product outweigh its risks;                                                                                                                                                                                                                     |

| • |     | maintain continued acceptable safety profile of the product candidates following approval; and |

| • |     | invest significant additional cash in each of the above activities. |

If TuHURA is unable to address one or more of these factors in a timely manner or at all, it could experience significant delays in the successful commercialization of, or an inability to successfully 61

commercialize, TuHURA’s product candidates, which would materially harm its business. If TuHURA does not receive regulatory approvals for one or more of its product candidates, TuHURA may not be able to continue its operations. Even if TuHURA successfully obtains regulatory approvals to manufacture and market its product candidates, its revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and has commercial rights. If the markets for patient subsets that TuHURA