Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 114

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 114
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 new drug (“IND”) application if TuHURA cannot demonstrate the comparability of its product candidates with the product candidate used by the relevant research institution in its clinical trials; |

| • |     | TuHURA’s INDs have been approved in a timely manner thus far, however, the FDA may not agree with TuHURA’s approach and strategy, which could result in potential delays and changes to its regulatory strategy; |

| • |     | TuHURA may be required to complete additional preclinical studies in human leukocyte antigens before it can proceed with its INDs; |

| • |     | delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; |

| • |     | 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; |

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| • |     | 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