Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 122

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 122
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 deny approval of TuHURA’s product candidates for any or all targeted indications and negative side effects could result in a more restrictive label for any product that is approved. Side effects such as toxicity or other safety issues associated with the use of TuHURA’s product candidates could also require TuHURA or its collaborators to perform additional studies or halt development or sale of these product candidates. If one or more of TuHURA’s product candidates receives marketing approval, and TuHURA or others later identify undesirable side effects caused by such products, including during any long-term follow-upobservation period recommended or required for patients who receive treatment using TuHURA’s products, many potentially significant negative consequences could result, including:

| • |     | regulatory authorities may withdraw or limit their approvals of such products; |

| • |     | regulatory authorities may require the addition of labeling statements, specific warnings or a contraindications; |

| • |     | TuHURA may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use; |

| • |     | TuHURA may be required to change the way such products are distributed or administered, or change the labeling of the products; |

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| • |     | the FDA or a comparable foreign regulatory authority may require TuHURA to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products; |

| • |     | TuHURA may decide to recall such products from the marketplace after they are approved; |

| • |     | TuHURA could be sued and held liable for harm caused to individuals exposed to or taking its products; and |

| • |     | TuHURA’s reputation may suffer. |

In addition, adverse side effects caused by any therapeutics that may be similar in nature to TuHURA’s product candidates could delay or prevent regulatory approval of TuHURA’s product candidates, limit the commercial profile of an approved label for TuHURA’s product candidates, or result in significant negative consequences for its product candidates following marketing approval. TuHURA believes that any of these events could prevent it from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing TuHURA’s product candidates, if approved, and significantly impact TuHURA’s ability to successfully commercialize its product candidates and generate revenues. If TuHURA encounters difficulties