Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 138

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 138
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 or terminated for a variety of reasons, including delays or failures related to:

| • |     | obtaining regulatory approval to begin a trial, if applicable; |

| • |     | the availability of financial resources to begin and complete the planned trials; |

| • |     | reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |

| • |     | obtaining approval at each clinical trial site by an IRB; |

| • |     | recruiting suitable patients to participate in a trial in a timely manner; |

| • |     | having patients complete a trial or return for post-treatment follow-up; |

| • |     | clinical trial sites deviating from trial protocol, not complying with GCP, or dropping out of a trial; |

| • |     | addressing any patient safety concerns that arise during the course of a trial; |

| • |     | addressing any conflicts with new or existing laws or regulations; |

| • |     | adding new clinical trial sites; or |

| • |     | manufacturing qualified materials under cGMP for use in clinical trials. |

TuHURA’s third-party research institution collaborators may also experience similar difficulties in completing ongoing clinical trials and conducting future clinical trials of product candidates. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of TuHURA’s product candidates. Obtaining and maintaining regulatory approval of TuHURA’s product candidates in one jurisdiction does not mean that TuHURA will be successful in obtaining regulatory approval of its product candidates in other jurisdictions. Obtaining and maintaining regulatory approval of TuHURA’s product candidates in one jurisdiction does not guarantee that TuHURA will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate