TuHURA Biosciences Hits Major Milestones: Phase 3 Trial Launch and Kineta Acquisition Signal Aggressive 2025 Push

TAMPA, Aug. 14, 2025 — TuHURA Biosciences, Inc. (NASDAQ: HURA), a Phase 3-stage immuno-oncology player focused on breaking through cancer immunotherapy resistance, wrapped up a landmark first half with two game-changing developments: kicking off a Phase 3 accelerated approval pathway for its lead candidate and absorbing a VISTA-inhibiting antibody through the Kineta acquisition.

Clinical Engine Firing on Multiple Fronts

The headline move came when TuHURA launched its Phase 3 accelerated approval trial of IFx-2.0 paired with Keytruda® (pembrolizumab) for first-line advanced and metastatic Merkel cell carcinoma (MCC). What makes this special: the FDA granted a Special Protocol Assessment (SPA), meaning if the Phase 3 trial hits its marks, TuHURA could potentially satisfy both accelerated and full approval requirements in a single shot—no separate confirmatory trial needed down the road.

“That’s a meaningful time and cost savings,” CEO James Bianco noted, underscoring how the dual approval pathway could compress the path to market.

But the MCC story doesn’t stop there. TuHURA also initiated a Phase 1b/2a study dosing IFx-2.0 via interventional radiology alongside Keytruda in patients with MCC of unknown primary origin (MCCUP)—a subset that makes up roughly 30% of newly diagnosed advanced or metastatic MCC cases. This population typically presents with deep-seated liver, lung, or retroperitoneal tumors, making them ideal candidates for localized delivery approaches.

Kineta Deal Expands Pipeline Depth

The company fortified its pipeline through June’s acquisition of Kineta and its novel VISTA inhibiting monoclonal antibody, now branded as TBS-2025. The strategic rationale is solid: TBS-2025 plays into TuHURA’s core immunotherapy focus while leveraging the company’s existing antibody-peptide conjugate (APC) and antibody-drug conjugate (ADC) technology platforms.

TuHURA is eyeing a randomized Phase 2 trial of TBS-2025 combined with a menin inhibitor for relapsed or refractory NPM1-mutated acute myeloid leukemia (AML) in the second half of 2025—testing whether the VISTA inhibitor can amplify the menin inhibitor’s efficacy in a population that currently lacks robust options.

Capital Raise and Index Recognition

On the capital front, TuHURA closed a $12.5 million equity financing in June, plus pocketed an extra $3 million from warrant exercises tied to February 2025 activity. These funds shore up the balance sheet for the expanded trial slate.

Adding to the validation, TuHURA gained admission to the Russell 3000® and Russell 2000® indexes in June 2025, reflecting its growing market presence.

What’s Next

Investors should mark their calendars for several near-term catalysts:

End of 2025: Enrollment update on the Phase 3 IFx-2.0 MCC trial

Q1 2026: Topline data from the Phase 1b/2a MCCUP study

2H 2026: Final readout from Phase 3

Meanwhile, TBS-2025 Phase 2 initiation is slated for 2H 2025. TuHURA is also pushing forward with its bi-specific ADC/APC candidates targeting the Delta Opioid Receptor on myeloid-derived suppressor cells (MDSCs), with non-clinical data presentations expected this year.

The Bottom Line

TuHURA Biosciences is stacking multiple late-stage assets across distinct oncology indications—IFx-2.0 in solid tumors via the accelerated MCC pathway, TBS-2025 in hematologic malignancies, plus an emerging ADC/APC platform. The Kineta deal adds complementary firepower, while the SPA agreement signals FDA confidence in the IFx-2.0 approach. With cash on hand and catalysts spanning 2025-2026, TuHURA has positioned itself to deliver meaningful data readouts that could reshape its commercial trajectory in immuno-oncology.

As of June 30, 2025, the company had approximately 49.9 million shares outstanding.