Company: HURA
Filing Date: 2025-08-12
Form Type: S-1
Source: 0001193125-25-179009
Chunk: 55

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-08-12
Form: S-1
Chunk 55
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S program as a condition of approval of TuHURA’s product candidates, which could entail requirements for long-term patient follow-up, amedication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves TuHURA’s product candidates, TuHURA will have to comply with requirements including submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs, cGTP and cGCPs for any clinical trials that TuHURA conducts post-approval. Later discovery of previously unknown problems with TuHURA’s product candidates, including adverse events of unanticipated severity or frequency, or with TuHURA’s third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following among other things:

| • |     | restrictions on the manufacturing of the product, the approved manufacturers or the manufacturing process; |

| • |     | restrictions on the labeling or marketing of a product; |

| • |     | restrictions on product distribution or use; |

| • |     | requirements to conduct post-marketing studies or clinical trials; |

| • |     | withdrawal of the product from the market; |

| • |     | product recalls; |

| • |     | warning or untitled letters from the FDA or comparable notice of violations from foreign regulatory authorities; |

| • |     | refusal of the FDA or other applicable regulatory authority to approve pending applications or supplements to approved applications; |

| • |     | fines, restitution or disgorgement of profits or revenues; |

| • |     | suspension or withdrawal of marketing approvals; |

| • |     | suspension of any of TuHURA’s ongoing clinical trials; |

| • |     | product seizure or detention or refusal to permit the import or export of products; and |

| • |     | consent decrees, injunctions or the imposition of civil or criminal penalties. |

The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses,and a company that is found to have improperly promoted off-label usesmay be subject to significant liability. Non-compliance withEuropean Union requirements regarding safety monitoring or pharmacov