TuHURA Biosciences, Inc. has released its third-quarter financial report for 2025, revealing a company focused on overcoming cancer immunotherapy resistance. The company is currently conducting a Phase 3 accelerated approval trial for IFx-2.0, a potential breakthrough in treating advanced and metastatic Merkel cell carcinoma (MCC). This trial, conducted under a Special Protocol Assessment (SPA) agreement with the FDA, aims to establish IFx-2.0 as an adjunctive therapy with Keytruda® (pembrolizumab) as a first-line treatment.
But here's where it gets exciting: TuHURA's DeltaOpioid Receptor (DOR) technology has been selected for an oral presentation at the 67th Annual American Society of Hematology (ASH) Meeting. This prestigious event, held in Orlando, Florida, from December 6-9, 2025, will also feature two poster presentations by TuHURA.
The company's President and CEO, Dr. James Bianco, emphasized their commitment to clinical development, particularly the Phase 3 pivotal trial of IFx-2.0. This trial, if successful, could eliminate the need for a post-approval confirmatory trial, expediting the approval process. Simultaneously, TuHURA is designing a Phase 2 study for TBS-2025, a VISTA inhibiting antibody, in patients with NPM1 mutated AML.
And this is the part most people miss: TuHURA's DOR technology has the potential to reprogram immune-suppressing cells like MDSCs and TAMs, which are responsible for acquired resistance to cancer immunotherapies. Their oral presentation at ASH 2025 will unveil data supporting DOR as a novel target in this context.
Corporate highlights include the acceptance of TuHURA's oral and poster presentations at ASH 2025, strengthening their team with the appointment of Dr. Michael Turner as Vice President of Immunology, and filing a $50 million At-The-Market (ATM) facility. Upcoming milestones include preliminary results from Phase 1b/2a trials and the completion of enrollment in Phase 3 trials for IFx-2.0, as well as the initiation of a Phase 2 trial for TBS-2025 in combination with a menin inhibitor.
Financial details for the third quarter of 2025 show research and development expenses of $4.9 million, and net cash outflows from operating activities of ($22.1) million. As of September 30, 2025, TuHURA had approximately 51.2 million total shares outstanding.
TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company dedicated to developing innovative solutions for cancer immunotherapy resistance. Their lead innate immune agonist, IFx-2.0, targets primary resistance to checkpoint inhibitors, while TBS-2025, acquired through a merger, is a VISTA inhibiting mAb. TuHURA is also pioneering first-in-class bi-specific antibody drug conjugates and antibody peptide conjugates to inhibit immune-suppressing cells and prevent T cell exhaustion.
This press release includes forward-looking statements, subject to risks and uncertainties. Investors are cautioned that actual results may differ significantly from these statements due to various factors. For more information, visit TuHURA's website and the SEC's website.
