Company: HURA
Filing Date: 2025-08-12
Form Type: S-1
Source: 0001193125-25-179009
Chunk: 23

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-08-12
Form: S-1
Chunk 23
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 intends to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before it can generate any revenue from product sales. Additionally, TuHURA is investigating TBS-2025in a randomized Phase 2 trial and will require additional capital before it can generate any revenue from product sales. Before obtaining marketing approval from regulatory authorities for the sale of TuHURA’s product candidates, TuHURA must conduct extensive clinical trials to demonstrate the safety, purity, and potency of the product candidates in humans. TuHURA cannot be certain that any of its product candidates will be successful in clinical trials and they may not receive regulatory approval even if they are successful in clinical trials. Before TuHURA can generate any revenues from sales of its lead product candidates, it must complete the following activities for each of them, any one of which it may not be able to successfully complete:

| • |     | conduct additional preclinical and clinical development with successful outcomes; |

| • |     | manage preclinical, manufacturing, and clinical activities; |

| • |     | obtain regulatory approval from the FDA and other comparable foreign regulatory authorities; |

| • |     | establish manufacturing relationships for the clinical and post-approval supply of the applicable drug candidate in compliance with all regulatory requirements; |

| • |     | build a commercial sales and 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