Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 497

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 497
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5 if the results of the mixing studies and potency assay qualifications are acceptable to the FDA. Components of TuHURA’s Results of Operations Revenue TuHURA did not generate any revenue and does not expect to generate any revenue from the sale of products in the near future. Research and Development Expenses To date, TuHURA’s research and development expenses have related primarily to development of IFx-Hu2.0,manufacturing, clinical studies, and other early pre-clinicalactivities related to TuHURA’s portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Research and development expenses include:

| • |     | salaries, payroll taxes, employee benefits |

| • |     | external research and development expenses incurred under agreements with contract research organizations (“CROs”), and consultants to conduct TuHURA’s clinical studies; |

| • |     | laboratory supplies; |

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| • |     | costs related to manufacturing product candidates, including fees paid to third-party manufacturers and raw material suppliers; |

| • |     | stock-based compensation charges for those individuals involved in research and development efforts; and |

| • |     | facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent. |

Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. TuHURA outsources a substantial portion of its clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party service providers to assist it with the execution of its clinical trials. TuHURA plans to substantially increase its research and development expenses for the foreseeable future as it continues the development of its product candidates and seeks to discover and develop new product candidates. Due to the inherently unpredictable nature of preclinical and clinical development, TuHURA 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. TuHURA anticipates that it 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 TuHURA’s ongoing assessments as to each product candidate’s commercial potential. In addition