Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 21

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 21
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 |     | failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis, or preparation of Biologics License Application (“BLA”), discussions with the FDA, an FDA request for additional preclinical or clinical data, or unexpected safety or manufacturing issues; |

| • |     | manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical; and |

| • |     | the proprietary rights of others and their competing products and technologies that may prevent the immunotherapy from being commercialized. |

Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit, or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to the next and may be difficult to predict. The evidence of clinical response rates received to date for IFx-2.0,TuHURA’s principal product candidate, as well as the other clinical activity and results described in this prospectus, does not mean that IFx-2.0 orany other product candidate has demonstrated, or that such clinical response data will predict, sufficient clinical efficacy and prove the required level of safety in order to receive FDA approval or any other required regulatory approval. In addition, we have entered into a Special Protocol Assessment (“SPA”) with the FDA for a single Phase 3 randomized placebo and injection controlled trial for IFx-2.0, ourlead innate immune agonist, as an adjunctive therapy to pembrolizumab (Keytruda ®) in the first line treatment of patients with advanced or metastatic Merkel cell carcinoma, who are checkpoint inhibitor-naïve utilizingthe FDA’s accelerated approval pathway. A Special Protocol Assessment agreement is a binding written agreement between the FDA and a trial sponsor that indicates the study’s design and analysis are adequate to support an application submission. A Special Protocol Assessment agreement does not increase the likelihood of marketing approval for the product and may not lead to a faster or less costly development, review, or approval process. We initiated the Phase 3 trial in June 2025. Even if TuHURA is successful in getting market approval, commercial success of any of its product candidates will also depend in large part on