Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 110

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 110
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 not agree that the requirements for such conditional marketing authorization have been satisfied. 65

TuHURA’s clinical trial results may also not support approval, whether accelerated approval, conditional marketing authorizations, or regular approval. The results of preclinical studies and clinical trials may not be predictive of the results of later-stage clinical trials, and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through preclinical studies and initial clinical trials. In addition, TuHURA’s product candidates could fail to receive regulatory approval for many reasons, including the following:

| • |     | the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of 
 TuHURA’s clinical trials;                                                                              |

| • |     | the population studied in the clinical program may not be sufficiently broad or representative to assure safety 
 in the full population for which TuHURA seeks approval;                                                         |

| • |     | TuHURA may be unable to demonstrate that its product candidates’ risk-benefit ratios for their proposed 
 indications are acceptable;                                                                             |

| • |     | the results of clinical trials may not meet the level of statistical significance required by the FDA or 
 comparable foreign regulatory authorities for approval;                                                  |

| • |     | TuHURA may be unable to demonstrate that the clinical and other benefits of its product candidates outweigh their 
 safety risks;                                                                                                     |

| • |     | the FDA or comparable foreign regulatory authorities may disagree with TuHURA’s interpretation of data from 
 preclinical studies or clinical trials;                                                                     |

| • |     | the data collected from clinical trials of TuHURA’s product candidates may not be sufficient to the                                                                                                                                 
 satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; |

| • |     | the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes,                                                   
 TuHURA’s own manufacturing facilities, or a third-party manufacturer’s facilities with which TuHURA contracts for clinical and commercial supplies; and |

| • |     | the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly 
 change in a manner rendering TuHURA’s clinical data insufficient for approval.                                 |

Further, failure to obtain approval for any of the above reasons may be made more likely due to the novel nature of TuHURA’s technology. Failure to obtain regulatory approval to market any of TuHURA’s product candidates would