TuHURA Biosciences, Inc.

We are a phase 3 clinical stage immuno-oncology company focused on developing new treatments to overcome resistance to cancer immunotherapies. Our proprietary Immune Fx™ technology platform, or IFx, is an innate immune agonist technology designed to make tumor cells appear like bacteria, prompting the body's immune system to attack them. Our main product candidate, IFx2.0, is an innate immune agonist aimed at overcoming initial resistance to checkpoint inhibitors. In June 2025, we started a single randomized placebo-controlled Phase 3 registration trial for IFx2.0 as an add-on therapy to Keytruda® (pembrolizumab) for first-line treatment in patients with advanced or metastatic Merkel cell carcinoma who have not previously received checkpoint inhibitors, using the FDA's accelerated approval pathway. In June 2025, we also acquired the rights to TBS-2025, a VISTA-inhibiting monoclonal antibody previously known as KVA1213, through our acquisition of Kineta, Inc. on June 30, 2025. VISTA is an immune checkpoint found on myeloid cells, believed to drive immunosuppression in tumors and contribute to low response rates and high recurrence in acute myeloid leukemia (AML). We plan to investigate TBS-2025 in a Phase 1b/2 trial for patients with relapsed/refractory mutant NPM1 AML. Additionally, we are using our Delta Opioid Receptor (DOR) technology to create first-in-class bi-functional, bi-specific antibody-drug conjugates (ADCs). These ADCs target the DOR on Myeloid Derived Suppressor Cells (MDSCs) to reduce their immunosuppressive effect in the bone marrow and tumor environment, aiming to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. We were originally formed as a Nevada corporation on June 24, 2009, under the name Berry Only Inc.