Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 24

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 24
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 marketing team, either internally or by contract with third parties; |

11

| • |     | establish and maintain patent and trade secret protection or regulatory exclusivity for TuHURA’s product candidates; |

| • |     | develop and implement marketing strategies for successful commercial launch of TuHURA’s product candidates, if, and when, approved; |

| • |     | secure and maintain acceptance of TuHURA’s products, if, and when approved, by patients, from the relevant medical communities and from third-party payors; |

| • |     | compete effectively with other therapies; |

| • |     | establish and maintain adequate health care coverage and reimbursement from third-party payors; |

| • |     | ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any required post-marketing clinical trials or the elements of any post-marketing Risk Evaluation and Mitigation Strategy (“REMS”), that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the product outweigh its risks; |

| • |     | maintain continued acceptable safety profile of the product candidates following approval; and |

| • |     | invest significant additional cash in each of the above activities. |

If TuHURA is unable to address one or more of these factors in a timely manner or at all, it could experience significant delays in the successful commercialization of, or an inability to successfully commercialize, TuHURA’s product candidates, which would materially harm its business. If TuHURA does not receive regulatory approvals for one or more of its product candidates, TuHURA may not be able to continue its operations. Even if TuHURA successfully obtains regulatory approvals to manufacture and market its product candidates, its revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and has commercial rights. If the markets for patient subsets that TuHURA is targeting are not as significant as it estimates, TuHURA may not generate significant revenues from sales of such products, if approved. TuHURA may encounter substantial delays in its clinical trials or may not be able to conduct its trials on the timelines it expects. Clinical testing is expensive, time consuming, and subject to uncertainty. TuHURA cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing, and TuHURA’s future clinical trials may not be successful. Events that may prevent