Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 162

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 162
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 such as CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials. 102

We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and seeks to discover and develop new product candidates. Due to the inherently unpredictable nature of preclinical and clinical development, we cannot determine with certainty the timing of the initiation, duration or costs of future clinical trials and preclinical studies of product candidates. Clinical and preclinical development timelines, the probability of success and the amount of development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates and development programs to pursue and how much funding to direct to each product candidate or program on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. Our future clinical development costs may vary significantly based on factors such as:

| • |     | per-patient trial costs; |

| • |     | the number of trials required for regulatory approval; |

| • |     | the number of sites included in the trials; |

| • |     | the countries in which the trials are conducted; |

| • |     | the length of time required to enroll eligible patients; |

| • |     | the number of patients that participate in the trials; |

| • |     | the number of doses that patients receive; |

| • |     | the drop-out or discontinuation rates of patients; |

| • |     | potential additional safety monitoring requested by regulatory agencies; |

| • |     | the phase of development of the product candidate; and |

| • |     | the efficacy and safety profile of the product candidate. |

| • |     | Acquired In-Process Research and Development (“IPR&D”) |

Acquired in-process researchand development expenses consist of existing research and development projects at the time of the acquisition. Projects that qualify as IPR&D assets represent those that have not yet reached technological feasibility and have no alternative future use. Our acquisitions of assets have included IPR&D assets that had not yet reached technological feasibility and had no alternative future use, which resulted in a write-off ofthese IPR&D assets