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TuHURA Biosciences Provides Corporate Update Following Recent Financing

TAMPA, Fla., Dec. 11, 2025 - TuHURA Biosciences, Inc. (NASDAQ: HURA), a leading immune-oncology company, has shared crucial updates on its portfolio following a recent financing initiative. This includes significant advancements in their Phase 3 program for IFx-2.0 as an adjunctive therapy alongside Keytruda® (pembrolizumab) for patients suffering from advanced Merkel cell carcinoma (MCC).

Overview of Latest Developments

The company’s clinical journey has gained momentum, particularly with its lead product, IFx-2.0, entering Phase 3 trials under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). This trial is positioned to be completed by the fourth quarter of 2026. A recent financing round raised $15.6 million, enhancing TuHURA’s financial standing and enabling the completion of key milestones across its multiple development programs.

In an insightful mini symposium held on December 5, 2025, before the 57th ASH Annual Meeting, TuHURA focused on addressing the potential of targeting VISTA in acute myeloid leukemia (AML). Notable key opinion leaders actively discussed the implications of combining VISTA inhibitors with menin inhibitors for patients with NPM1 mutated relapsed/refractory AML.

Encouraging Insights from Recent Research

At the recent ASH conference, presentations highlighted the Delta Opioid Receptor (DOR) as a promising target in the realm of bi-functional and bi-specific immune-modulating antibody drug conjugates (ADCs). This is viewed as a significant advancement toward addressing resistance to checkpoint inhibitors, a pressing challenge in oncology today.

Dr. James Bianco, President and CEO of TuHURA, expressed enthusiasm over the company's trajectory in 2025, marking it as transformative. “With substantial initiatives including the start of the Phase 3 trial for IFx-2.0, the merger with Kineta, and our strategies targeting DOR, we are ideally placed to take on the challenges in cancer treatment,” he stated. The successful equity financing efforts earlier in June 2025, yielding $15 million, set the stage for this latest $15.6 million funding round, ensuring adequate financial resources for ongoing projects.

Future Plans and Expectations for 2026

Looking ahead to 2026, the company anticipates the enrollment completion for its pivotal Phase 3 study of IFx-2.0 in MCC as well as FDA clearance to initiate a new randomized Phase 2 trial comparing menin inhibitor versus a combination of menin inhibitor and TBS-2025, a novel VISTA inhibiting antibody targeting AML. Preliminary data presentations and proof-of-concept results are also expected at various scientific forums, further showcasing the advancements in their clinical programs.

During the mini symposium, leading experts expressed profound interest in the VISTA inhibiting antibody, TBS-2025. The discussions underscored the existing medical need within the AML landscape, particularly among high-risk patients unresponsive to conventional therapies. The consensus indicated a significant unmet need stemming from low complete response rates associated with current treatment methodologies.

Insights from Key Opinion Leaders

Prominent figures in the symposium included Geoffrey Uy, MD, from Washington University who affirmed the urgency of improving treatments for high-risk AML patients, emphasizing the fundamental role VISTA plays in therapeutic resistance.

Dr. Kevin Lin, along with Dr. Tae Kon Kim, presented compelling findings suggesting that inhibition of VISTA might alleviate the poor clinical outcomes seen within this patient population. Their studies reveal that VISTA expression considerably contributes to low response rates and thus targeting it may yield notable improvements.

Conference Call and Additional Information

Management will be hosting a conference call today, December 11, 2025, at 8:30 AM ET. This session aims to delve into the corporate updates and recent financing events, providing investors with a clearer picture of the company’s direction. Those unable to join the live discussion can access a replay on the investor relations section of TuHURA’s website.

In summary, TuHURA Biosciences is firmly stepping into 2026 with a wealth of initiatives designed to tackle the intricacies of cancer treatment and resistance, driven by innovative science and robust financing strategies. For further information, please visit TuHURA's website and follow us on social media platforms.