Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 204

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 204
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 |     | product labeling or product insert requirements of the FDA, European Commission, EMA or other comparable foreign 
 regulatory authorities;                                                                                          |

| • |     | limitations or warnings contained in the labeling approved by the FDA, European Commission, EMA or other 
 comparable foreign regulatory authorities;                                                               |

| • |     | the timing of market introduction of Kineta’s product candidates as well as competitive products; |

| • |     | the cost of treatment in relation to alternative treatments; |

| • |     | the amount of upfront costs or training required for physicians to administer Kineta’s product candidates; |

125

| • |     | the availability of coverage, adequate reimbursement from, and Kineta’s ability to negotiate pricing with, 
 third-party payors and government authorities;                                                             |

| • |     | the willingness of patients to pay                                                                                         
 out-of-pocket in the absence of comprehensive coverage and reimbursement by third-party payors and government authorities; |

| • |     | relative convenience and ease of administration, including as compared to alternative treatments and competitive 
 therapies; and                                                                                                   |

| • |     | the effectiveness of Kineta’s sales and marketing efforts and distribution support. |

Kineta’s efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of Kineta’s product candidates, if approved, may require significant resources and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness of Kineta’s product candidates. Because Kineta expects sales of its product candidates, if approved, to generate substantially all of Kineta’s product revenue for the foreseeable future, the failure of Kineta’s product candidates to find market acceptance would harm Kineta’s business and could require Kineta to seek additional financing. Even if Kineta’s product candidates, if approved, achieve market acceptance, Kineta may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than Kineta’s products, are more cost effective or render Kineta’s products obsolete. Kineta may not be able to successfully commercialize its product candidates, if approved, due to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could make it difficult for Kineta to sell its product candidates profitably. Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process, with uncertain results, that could require Kineta to provide supporting scientific, clinical and cost