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HURA biotech catalysts & pipeline

TUHURA BIOSCIENCES INC · Data as of 2026-09-08

Upcoming catalysts

ADC — Initial data

2H 2026

2H 2026 : Anticipate POC data in humanized model of AML
Source filing

IFx-2.0 — Interim data

2H 2026

2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)
Source filing

IFx-2.0 — Regulatory decision

2H 2026

• 2H 2026: Expect to receive orphan drug designation in MCC
Source filing

immune modulating ADC — Initial data

Q3 2026

• Q3 2026 : Anticipates first proof of concept in-vivo results from its lead immune modulating ADC.
Source filing

TBS-2025 — Regulatory decision

2H 2026

• 2H 2026: Expect to receive orphan drug designation in AML
Source filing

VISTA — FDA meeting

H2 2026

In the second half, we anticipate receiving safe-to-proceed feedback from FDA and to initiating our Phase 1b/2 trial of VISTA in mut NPM1 r/r AML, initiating our in vivo POC studies for MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)), potentially receiving orphan drug designation in Merkel cell carcinoma (MCC) for IFx-2.0, and potentially receiving orphan drug designation in AML for TBS-2025.
Source filing

IFx-2.0 — Initial data

1H2027

• 1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda® for deep seated MCC
Source filing

TBS-2025 — Initial data

1H 2027

• 1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML
Source filing

VISTA — Initial data

1H 2027

1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML
Source filing

IFx-2.0 — Topline data

H2 2027

We anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 in the second half of 2027.
Source filing

MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)) — Conference presentation

2H 2026

• 2H 2026 : Presentations at key scientific meetings
Source filing

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