Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 565

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 565
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 any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on Kineta. The process required by the FDA before a drug may be marketed in the U.S. generally involves the following:

| • |     | completion of preclinical laboratory tests, animal studies and formulation studies in accordance with GLP 
 regulations and other applicable regulations;                                                             |

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| • |     | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |

| • |     | approval by an independent institutional review board (“IRB”) at each clinical site before each trial 
 may be initiated;                                                                                     |

| • |     | performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice 
 (“GCP”) regulations to establish the safety and efficacy of the proposed drug for its intended use;         |

| • |     | submission to the FDA of an NDA or a biologics license application (“BLA”); |

| • |     | a determination by the FDA within 60 days of its receipt of an NDA or BLA to accept the filing for review; |

| • |     | satisfactory completion of an FDA advisory committee review, if applicable; |

| • |     | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is                                                                                        
 produced to assess compliance with current GMP (“cGMP”) requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |

| • |     | satisfactory completion of other studies required by the FDA, including immunogenicity, carcinogenicity, 
 genotoxicity and stability studies;                                                                      |

| • |     | FDA review and approval of the NDA or BLA to permit commercial marketing and sales of the product for particular 
 indications for use in the U.S.; and                                                                             |

| • |     | compliance with any post-approval requirements, including the potential requirement to implement a risk     
 evaluation and mitigation strategy (“REMS”) and the potential requirement to conduct post-approval studies. |

Once a