Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 57

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 57
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 its product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community. TuHURA’s products may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, and others in the medical community. Several factors will influence whether TuHURA’s product candidates are accepted in the market, including:

| • |     | the clinical indications for which TuHURA’s product candidates are approved; |

| • |     | physicians, hospitals, cancer treatment centers, and patients considering TuHURA’s product candidates as a safe and effective treatment; |

| • |     | the potential and perceived advantages of TuHURA’s product candidates over alternative treatments; |

| • |     | the prevalence and severity of any side effects; |

| • |     | any restrictions on concomitant TuHURA of other medications; |

| • |     | product labeling or product insert requirements of the FDA or other regulatory authorities; |

| • |     | limitations or warnings contained in the labeling approved by the FDA; |

| • |     | the size of the market for such drug candidate, based on the size 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