Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 134

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 134
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 previous responses to inspection observations. Accordingly, TuHURA and others with whom it works must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control. Any regulatory approvals that TuHURA receives for its product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS program as a condition of approval of TuHURA’s product candidates, which could entail requirements for long-term patient follow-up,a medication 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 |

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| • |     | 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