Company: HURA
Filing Date: 2025-04-01
Form Type: 425
Source: 0001193125-25-069713
Chunk: 8

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-04-01
Form: 425
Chunk 8
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 advanced or metastatic MCC. The data from the Company’s Phase 1b trial in patients with advanced or metastatic MCC who exhibited primary resistance to CPI was used to support a potential single registration directed trial. Consistent with the FDA’s Project Front Runner Initiative, the FDA’s Oncology Center of Excellence (OCE) recommended investigating IFx-2.0in the first line setting rather than in patients progressing on first line therapy. Project Front Runner is an FDA OCE initiative to encourage drug sponsors to consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. The FDA also requested the Company to consider designing the trial to include a key secondary endpoint shown to be of clinical benefit like PFS allowing this accelerated approval trial to potentially satisfy both the requirements for accelerated approval based on ORR, while satisfying the requirement for a post-approval confirmatory trial if the secondary PFS endpoint is achieved. The trial will be conducted under an SPA agreement with the FDA.

| 1 | Trial currently subject to partial clinical hold relating to completion of certain CMC requirements for 
 initiation of Phase 3 registration trial                                                                |

Tumor Microenvironment Modulators:Leveraging its delta opioid receptor technology, TuHURA is developing the first class of non-tumortargeting bi-specificimmune modulating Antibody Drug Conjugates or Antibody Peptide Conjugates targeting MDSCs to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Potential Acquisition of Novel Anti-VISTA Checkpoint Inhibitor:As previously announced, the Company entered into a definitive merger agreement in which TuHURA would acquire Kineta, Inc. (OTC Pink: KATN) including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction. The merger is currently targeted to close in Q2 2025 pending the satisfaction of funding conditions and other closing conditions. 2025 Milestone Targets

| • |     | IFx-2.0 |

| • |     | Q2: FDA complete response letter lifting partial clinical hold |

| • |     | Q2: Initiating enrollment in IFx-2.0 Phase 3 accelerated approval