Company: HURA
Filing Date: 2025-05-13
Form Type: 425
Source: 0000950170-25-069822
Chunk: 1

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-13
Form: 425
Chunk 1
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, 2025. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain closing conditions.

About TuHURA Biosciences, Inc.

TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer

immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.

TuHURA’s lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda®(pembrolizumab) compared to Keytruda®plus placebo in first line treatment for advanced or metastatic Merkel Cell Carcinoma. This accelerated approval trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Recent scientific reports have demonstrated that NPM1, the most common mutation in Acute Myeloid Leukemia (AML), drives the expression of VISTA on leukemic blasts and is the purported mechanism by which AML escapes immune recognition and attack leading to the high rate of treatment failure and relapse. Subject to the completion of the acquisition of Kineta, the Company plans to initiate in Q3 2025 a randomized trial of menin inhibitor +/- VISTA inhibiting antibody in relapsed or refractory AML where menin inhibitors have become standard of care in NPM1 mutated AML.

TuHURA is also leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific immune modulating antibody drug conjugates (ADCs) and antibody peptide conjugates (APCs) targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visitwww.tuhurabio.comand connect with TuHURA onFacebook,X, andLinkedIn.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934,