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

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-08-12
Form: S-1
Chunk 25
---
 extensive negotiation and may vary significantly among different CROs and clinical trial sites; |

12

| • |     | delays in obtaining required Institutional Review Board (“IRB”) approval at each clinical trial site; |

| • |     | imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of TuHURA’s clinical trial operations or trial sites; developments on clinical trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; |

| • |     | delays in recruiting suitable patients to participate in TuHURA’s clinical trials; |

| • |     | failure by TuHURA’s CROs, other third parties, or TuHURA to adhere to clinical trial requirements; |

| • |     | failure to perform in accordance with the FDA’s current good clinical practice regulations (“cGCPs”), requirements, or similar applicable regulatory guidelines in other countries; |

| • |     | delays in patients completing participation in a trial or returning for post-treatment follow-up; |

| • |     | patients dropping out of a trial; |

| • |     | occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; |

| • |     | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |

| • |     | changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; |

| • |     | the cost of clinical trials of TuHURA’s product candidates being greater than TuHURA anticipates; |

| • |     | clinical trials of TuHURA’s product candidates producing negative or inconclusive results, which may result in TuHURA deciding, or regulators requiring it, to conduct additional clinical trials or abandon product development programs; |

| • |     | delays in developing TuHURA’s manufacturing processes and transferring to new third-party facilities to support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and |

| • |     | delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of TuHURA’s