Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 174

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 174
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 positive clinical data and Kineta may not receive marketing approval from the FDA, European Commission, or other regulatory authorities for its product candidate. Kineta has limited experience
submitting INDs to the FDA. KVA12123 is in clinical development. There can be no assurance that the FDA will permit any of Kineta’s future INDs to go into effect in a timely manner or at all. Without an IND for a product candidate, Kineta will
not be permitted to conduct clinical trials in the United States of such product candidate.

Biopharmaceutical development is a difficult,
long, time-consuming, expensive and uncertain process, and delay or failure can occur at any stage of any of Kineta’s clinical trials. Failure to obtain regulatory approval for

106

Kineta’s product candidate will prevent it from commercializing and marketing its product candidate. The success in the development of Kineta’s product candidate will depend on many factors, including:

| • |     | timely and successful completion of preclinical studies; |

| • |     | sufficiency of Kineta’s financial and other resources to complete the necessary preclinical studies and 
 clinical trials;                                                                                        |

| • |     | obtaining and maintaining patent, trademark and trade secret protection and regulator exclusivity for   
 Kineta’s product candidates and otherwise protecting its rights in its intellectual property portfolio; |

| • |     | submission of INDs and Clinical Trial Applications for and receipt of allowance to proceed with Kineta’s 
 planned clinical trials or other future clinical trials;                                                 |

| • |     | initiating, enrolling, and successfully completing clinical trials; |

| • |     | obtaining positive results from Kineta’s preclinical studies and clinical trials that support a 
 demonstration of efficacy, safety, and durability of effect for its product candidates;         |

| • |     | receiving approvals for commercialization of Kineta’s product candidates from applicable regulatory 
 authorities;                                                                                        |

| • |     | the outcome, timing and cost of meeting regulatory requirements established by the FDA, European Commission 
 (based on recommendation from the EMA), and other regulatory authorities;                                   |

| • |     | establishing sales, marketing and distribution capabilities and successfully launching commercial sales of 
 Kineta’s products, if and when approved, whether alone or in collaboration with others;                    |

| • |     | maintaining a continued acceptable safety, tolerability and efficacy profile of any approved products; |

| • |     | setting acceptable prices for Kineta’s product and obtaining coverage and adequate reimbursement from 
 third-party pay