Company: HURA
Filing Date: 2025-05-15
Form Type: 425
Source: 0000950170-25-072703
Chunk: 4

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-15
Form: 425
Chunk 4
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 requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

| Date: | May 15, 2025 | By: | TUHURA BIOSCIENCES, INC.       
 /s/ Dan Dearborn               |
|:------|:-------------|:----|:-------------------------------|
|       |              |     | Name: Dan Dearborn             
 Title: Chief Financial Officer |

<div align='center'>TuHURA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides a Corporate Update

Anticipates initiating the Company’s Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda®(pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), in Q2 2025

Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP)

Targeting to close the acquisition of Kineta, Inc. in Q2 2025 and initiate a Phase 2 trial of Kineta’s VISTA inhibiting monoclonal antibody (mAb) in NPM1-mutated acute myeloid leukemia (AML) in Q3 2025</div>

TAMPA, Fla., May 15, 2025 - TuHURA Biosciences, Inc.(NASDAQ:HURA) (“TuHURA”), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported financial results for the Company’s first quarter ended March 31, 2025, and provided a corporate update.

“TuHURA has had an impressive start to 2025, and we continue to execute our corporate strategy as we drive towards TuHURA’s four major clinical data readouts anticipated over the next 24 months. We recently initiated our Phase 1b/2a study of IFx-Hu2.0 in combination with pembrolizumab in checkpoint-naïve MCCUP patients. Evaluating IFx-Hu2.0 in MCCUP patients is an important component of our overall strategy for the program, as the Phase 1b/2a trial