Company: HURA
Filing Date: 2025-08-12
Form Type: S-1
Source: 0001193125-25-179009
Chunk: 57

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-08-12
Form: S-1
Chunk 57
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 of the patient subsets that TuHURA is targeting, in their territories for which TuHURA gains regulatory approval and have commercial rights; |

| • |     | the safety of the drug candidate as demonstrated through broad commercial rights; |

| • |     | the adequacy of supply of TuHURA’s product candidates; |

| • |     | the timing of market introduction of TuHURA’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 TuHURA’s product candidates; |

| • |     | the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities; |

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

| • |     | support from patient advocacy groups; |

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

| • |     | the effectiveness of TuHURA’s sales and marketing efforts. |

**TuHURA’s ability to negotiate, secure and maintain third-party coverage and reimbursement for its product candidates may be affected by political, economic and regulatory developments in the United States, the European Union and other jurisdictions. Governments continue to impose cost containment measures, and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. These and other similar developments could significantly limit the degree of market acceptance of any product candidate of ours that receives marketing approval in the future. 33

Even if TuHURA’s products achieve market acceptance, TuHURA may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than its products, are more cost effective or render TuHURA’s products obsolete.

TuHURA is and will be subject to stringent privacy laws, cybersecurity laws, regulations, policies and contractual obligations related to privacy and security, and changes in such laws, regulations, policies or how they are interpreted or changes in related contractual obligations could adversely affect TuHURA’s business.

TuHURA is subject to data privacy and protection laws and regulations that apply to the collection, transmission, processing, storage and use of personally-identifying information including comprehensive regulatory systems in the U.S. and EU, which, among other things, impose certain