TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate Update
Clinical Trials Update: TuHURA Biosciences is conducting a Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda for advanced Merkel cell carcinoma, aiming for accelerated approval from the FDA without a post-approval trial.
ASH 2025 Presentations: The company has been selected to present its Delta Opioid Receptor (DOR) technology at the 67th Annual ASH Meeting, highlighting its potential to overcome resistance to cancer immunotherapies.
Corporate Developments: Dr. Michael Turner has been appointed as Vice President of Immunology, bringing over 20 years of experience in the field, while TuHURA has filed for a $50 million At-The-Market facility to support its operations.
Financial Overview: TuHURA reported $4.9 million in research and development expenses for Q3 2025, with significant net cash outflows, and plans to submit a Phase 2 protocol for TBS-2025 targeting NPM1 mutated AML by the end of 2025.
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TuHURA Biosciences Releases 1.54M Shares to Kintara CVR Holders Following Clinical Trial Success
- Clinical Trial Success: TuHURA Biosciences announced that Kintara's REM-001 clinical trial met its primary endpoint in ten metastatic cutaneous breast cancer patients, demonstrating safety and signs of clinical efficacy after eight weeks of follow-up, marking a significant advancement in cancer immunotherapy.
- Stock Release Milestone: Following the terms of the Contingent Value Rights Agreement dated October 18, 2024, TuHURA will release 1,539,958 shares of common stock to legacy Kintara stockholders, reflecting the company's commitment to its shareholders and enhancing market confidence.
- Rapid Distribution Plan: The shares are expected to be distributed to CVR holders within the next ten business days, and this swift allocation is likely to bolster investor confidence in TuHURA's future growth prospects.
- Strategic Development Focus: TuHURA is developing novel immunotherapies to overcome resistance to cancer treatments, with ongoing clinical trials for products like IFx-2.0 and TBS-2025, further solidifying its position in the biopharmaceutical industry.

TuHURA Biosciences Advances Phase 3 Trial of IFx-2.0 for Merkel Cell Carcinoma
- Phase 3 Clinical Progress: TuHURA's IFx-2.0, as an adjunctive therapy to Keytruda®, has initiated its Phase 3 trial under a Special Protocol Assessment with the FDA, targeting enrollment completion by Q4 2026, marking a significant milestone in treating advanced Merkel cell carcinoma.
- Funding Support: The company recently secured $15.6 million in equity financing, providing a cash runway to achieve multiple key milestones across its three development programs, reflecting market confidence in its innovative treatment solutions.
- Symposium Insights: At the mini KOL symposium on December 5, 2025, experts expressed strong support for the potential of combining TBS-2025 with a menin inhibitor in NPM1 mutated relapsed/refractory AML, highlighting significant unmet medical needs in this area.
- Future Outlook: Management anticipates completing enrollment for IFx-2.0 in 2026 and plans to present preliminary data at scientific conferences, further solidifying the company's leadership position in the field of cancer immunotherapy.






