SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences (NASDAQ: HURA) has provided a corporate update following a recent $15.6 million equity financing, detailing near-term milestones across its Phase 3 IFx-2.0 program in Merkel cell carcinoma, its VISTA-inhibiting antibody TBS-2025 in AML, and its Delta Opioid Receptor (DOR)-focused conjugate platform aimed at overcoming resistance to cancer immunotherapy.
Financing extends runway to execute near-term milestones
TuHURA said the $15.6 million gross-proceeds equity financing is expected to provide cash runway to accomplish multiple key milestones across all three development programs. The update also referenced earlier 2025 capital activity, noting a June 2025 PIPE financing and warrant exercise. For a clinical-stage immuno-oncology developer, extending runway is strategically important because it enables continuity across trial execution, regulatory interactions, and data generation-particularly when multiple programs are advancing in parallel.
"2025 was a transformational year for us, having initiated our accelerated approval Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda® in front-line MCC, having completed the merger with Kineta bringing a Phase 2 ready VISTA inhibiting antibody to our pipeline and having presented data positioning the DOR as a promising new target in overcoming resistance to checkpoint inhibitors. We were pleased to raise $15 million in our June 2025 PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs" said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.
Phase 3 IFx-2.0 study in MCC targets enrollment completion in 2026
The company's lead program is IFx-2.0, described as an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. TuHURA stated its Phase 3 registration trial evaluates IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) versus Keytruda plus placebo as a first-line therapy for advanced or metastatic Merkel cell carcinoma (MCC), conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA and targeting completion of enrollment in Q4 2026.
VISTA in AML: KOL symposium frames combination strategy with menin inhibitors
TuHURA summarized a mini KOL symposium held on December 5, 2025, focused on the scientific rational for targeting VISTA in AML and clinical applications in combination with a menin inhibitor in NPM1 mutated relapsed/refractory AML. The company said it anticipates receiving FDA clearance to initiate a randomized Phase 2 trial of physician's choice of menin inhibitor versus a menin inhibitor plus TBS-2025 in NPM1 mutated r/r AML.
"In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025 prior to the ASH meeting, several key opinion leaders, provided valuable insights and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML. There was clear enthusiasm for the potential of combining TBS-2025 with a menin inhibitor both in NPM1 r/r/ AML, in high-risk AML and in patients with AML who are unfit for intensive therapies. The KOLs noted that while menin inhibitors have become standard of care in NPM1 mutated AML, there still exists a significant unmet medical need, citing the relatively low CR rate and short duration of response as the two obstacles to improving clinical benefit in these patients."
Dr. Bianco continued, "The VISTA gene is the only checkpoint upregulated in patients with AML, notably among high-risk AML. It has been shown that VISTA expression on leukemic blasts is the primary culprit in the low response rate and short duration of response in AML. Targeting VISTA represents the first potential for immunotherapy to improve the treatment outcomes in AML, not just NPM1 mutated AML was the consensus opinion from the group," concluded Dr. Bianco.
DOR platform and conference visibility shape the 2026 data cadence
TuHURA said oral and poster presentations at the recently concluded 57th ASH Annual Meeting showed DOR to be a compelling target underpinning bi-functional, bi-specific immune modulating ADCs. Looking into 2026, the company outlined expected disclosures and readouts, including:
- Preliminary data from its IFx-2.0 basket trial
- Data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q
- Proof-of-concept data in animal models for its lead ADC at a scientific conference in Q4 2026
"We look forward in 2026 to the expected completion of enrollment for our Phase 3 study of IFx-2.0 in MCC, and anticipate receiving FDA clearance to initiate our randomized Phase 2 trial of physician's choice of menin inhibitor vs a menin inhibitor+TBS-2025, our VISTA inhibiting antibody, in NPM1 mutated r/r AML. We also expect to present preliminary data from our IFx-2.0 basket trial; data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q; and proof-of-concept data in animal models for our lead ADC at a scientific conference in Q4 2026."
For more information about TuHURA and its pipeline, visit https://www.tuhurabio.com/.