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

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 25
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 successful or timely completion of clinical development include:

| • |     | inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials; |

| • |     | delays in reaching a consensus with regulatory agencies on trial design; |

| • |     | the FDA may not allow TuHURA to use the clinical trial data from a research institution to support an investigational 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; |

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| • |     | 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;