Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 56

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 56
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     | 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 pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions. The policies of the FDA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of TuHURA’s product candidates. TuHURA cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If TuHURA is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if TuHURA is not able to maintain regulatory compliance, TuHURA may lose any marketing approval that it may have obtained and it may not achieve or sustain profitability. 32

In addition, if TuHURA was able to obtain accelerated approval of any of TuHURA’s product candidates, the FDA would require TuHURA to conduct a confirmatory study to verify the predicted clinical benefit and additional safety studies. The results from the confirmatory study may not support the clinical benefit, which would result in the approval being withdrawn. While operating under accelerated approval, TuHURA will be subject to certain restrictions that it would not be subject to upon receiving regular approval. Even if TuHURA obtains regulatory approval of