TuHURA Biosciences develops immuno-oncology therapeutics designed to address resistance to cancer immunotherapies. Company news centers on its clinical-stage pipeline, including IFx-2.0, an innate immune agonist being studied as adjunctive therapy with Keytruda in advanced or metastatic Merkel Cell Carcinoma, and TBS-2025, a VISTA-inhibiting monoclonal antibody for mutNPM1 relapsed or refractory acute myeloid leukemia.
Recurring updates also cover the Delta Opioid Receptor technology used in immune-modulating antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells. Other company developments include financial results, clinical operations leadership, investor-conference communications, financing arrangements and Nasdaq listing compliance matters.
TuHURA Biosciences (HURA) received a new U.S. patent broadening protection for TBS-2025, its antibody designed to inhibit VISTA.
Patent No. 12,760,104 covers antigen-binding fragments, antibody framework and Fc-region modifications, and antibodies targeting two or more targets across all human antibody classes. It also covers treatment with TBS-2025 alone or alongside radiation, chemotherapy, targeted therapies, tyrosine kinase inhibitors and immune checkpoint inhibitors, including PD-1 inhibitors. Treatment-method claims extend beyond cancer to autoimmune disease and infection. The patent term extends to February 18, 2042, before any potential patent term adjustment or regulatory extension.
TuHURA Biosciences (NASDAQ:HURA) received a U.S. patent for its delta opioid receptor technology, issued on September 15, 2026.
U.S. Patent No. 12,734,168 covers administering delta opioid receptor (DOR) antagonists to cancer patients, including those with DOR-expressing myeloid-derived suppressor cells, which suppress immune activity. It also addresses combination therapies for cancer and metastasis. Applications extend beyond antibody-drug conjugates, which link antibodies to drugs, to adoptive cellular immunotherapies using a patient's own cells or donor cells, including CAR-T, Treg and TIL therapies. The patent term runs through 2043 before any patent term extension.
TuHURA Biosciences (HURA) received FDA clearance of its IND and a “Study May Proceed” notice to evaluate TBS-2025, a VISTA-inhibiting antibody, in molecularly defined subsets of Acute Myeloid Leukemia (AML) and other blood-related cancers.
The clearance enables a Phase 1b monotherapy study of TBS-2025 in patients with relapsed/refractory mutNPM1 AML who have failed or relapsed after menin inhibitor therapy. The initial stage will assess safety and potential efficacy at different doses, after which, following FDA safety review, the trial is expected to advance to a dose-optimization stage to identify a safe and biologically effective dose.
TuHURA highlights that r/r mutNPM1 AML patients who fail menin inhibitor therapy currently have no approved or effective treatments. If TBS-2025 shows encouraging response rates during dose optimization, the company plans to discuss potential trial expansion with the FDA in the context of a possible accelerated approval pathway.
TuHURA Biosciences (HURA) will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York on Monday, September 14 at 4:00 p.m. ET.
The presentation will be a fireside chat with associated 1x1 meetings. The company provides online registration for live viewing, and an archived webcast of the fireside chat will be made available on the Events page in the investor section of TuHURA’s website.
TuHURA is a Phase 3 immuno-oncology company focused on overcoming primary and acquired resistance to cancer immunotherapy. Its lead candidate, IFx-2.0, is in a randomized, placebo-controlled Phase 3 registration trial as an adjunct to Keytruda in first-line advanced or metastatic Merkel Cell Carcinoma, and it is also advancing TBS-2025 and Delta Opioid Receptor-based ADC programs.
TuHURA Biosciences (NASDAQ:HURA) reported second quarter 2026 results and a corporate update for the period ended June 30, 2026. The company highlighted progress across its immuno-oncology pipeline, including filing an IND for VISTA-inhibiting antibody TBS-2025 in molecularly defined subsets of AML and other blood cancers, aligned with prior FDA guidance.
TuHURA detailed a $50 million term credit facility and royalty transaction from its largest shareholder, bearing 12% annual interest and maturing on April 21, 2031, which it expects will extend its cash runway into 2028. The company outlined multiple anticipated milestones through 2027 for IFx-2.0, TBS-2025 and its MDSC inhibitor ADCs, including potential orphan drug designations and initiation of a Phase 1b/2 AML trial.
As of June 30, 2026, TuHURA reported $1.0 million in cash and cash equivalents and approximately 63.7 million common shares outstanding. Second quarter 2026 R&D expenses were $6.6 million versus $4.9 million a year earlier, while G&A expenses were $2.1 million versus $1.9 million. Net cash used in operating activities was $13.0 million for the first half of 2026, partly offset by $10.6 million in net cash from financing activities, including ATM and credit facility proceeds.
TuHURA Biosciences (NASDAQ:HURA) announced that President and CEO James A. Bianco, M.D., will present at Canaccord Genuity's 46th Annual Growth Conference in Boston, MA, on Wednesday, August 12, 2026 at 12:30 p.m. ET. A live registration link and an archived webcast will be available via the Investor Section of TuHURA's website, alongside an “Ask Me Anything” interview with Dr. Bianco.
TuHURA Biosciences (NASDAQ:HURA) filed an Investigational New Drug (IND) application with the FDA for TBS-2025, a VISTA inhibiting antibody, in molecularly defined subsets of AML and other blood cancers.
The IND follows FDA guidance, supports a combined Phase 1b/2 design, and targets trial initiation in the second half of 2026, including relapsed/refractory AML and high-risk MDS populations.
TuHURA Biosciences (NASDAQ:HURA) reported first quarter 2026 results and a corporate update. The company secured a $50 million credit facility and royalty transaction, extending its anticipated cash runway into 2028. TuHURA received FDA Orphan Drug Designation for IFx-2.0 in stage IIB–IV cutaneous melanoma and outlined key milestones across IFx-2.0, VISTA antibody TBS-2025, and MDSC-inhibiting ADCs. At March 31, 2026, cash and equivalents were $6.3 million, with R&D expenses of $5.2 million and G&A expenses of $2.3 million for the quarter.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immuno-oncology company, announced that President and CEO James A. Bianco, M.D. will participate in a fireside chat at the 4th Annual H.C. Wainwright BioConnect Investor Conference in New York City.
The session is scheduled for Tuesday, May 19, 2026 at 2:00 pm ET, with live and archived webcasts available on TuHURA's investor relations website.
TuHURA Biosciences (NASDAQ:HURA) entered a $50 million credit facility with an affiliate of its largest stockholder to fund clinical programs, including IFx-2.0 through anticipated Phase 3 top-line results and TBS-2025 milestones, extending cash runway into 2028.
The facility allows monthly draws, bears 12% annual interest with monthly interest payments, principal due April 21, 2031, is secured by company assets, and includes a low- to mid-single-digit royalty on future IFx-2.0 commercial sales.