Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 481

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 481
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. The Merger Agreement also provides that Kineta may request the extension of up to $2,000,000 in working capital loans from TuHURA, $1,750,000 of which will be contingent on the completion of a financing transaction by TuHURA. Special Protocol Assessment Agreement On January 25, 2024, TuHURA entered into a Special Protocol Assessment Agreement for a single registration directed, randomized, placebo controlled Phase 3 trial for IFx-Hu2.0 as adjunctive therapy to pembrolizumab (Keytruda ®) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naive. The trial utilizes a novel design recommended by the FDA which incorporates Objective Response Rate (ORR) as the primary endpoint for accelerated approval. The trial also includes Progression Free Survival (PFS) as a key secondary endpoint which, if achieved, without demonstrating a detriment to Overall Survival, could allow conversion from accelerated approval to full approval satisfying the requirement for a post marketing trial. Before initiating this Phase 3 trial TUHURA is required to complete certain CMC activities as noted in a partial clinical hold correspondence from FDA. TuHURA has reached agreement with FDA on the requirements for lifting the partial clinical hold and believes that TuHURA will meet the requirements and consequently expect to receive a complete response letter, or CRL, lifting the partial clinical hold in the second quarter of 2025. TuHURA may be in position to initiate the Phase 3 study in the second quarter of 2025 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;