TuHURA Biosciences (HURA) Corporate presentation summary

Strategic focus and pipeline overview

• Advancing three novel immuno-oncology technologies to address resistance in cancer immunotherapies.

• Lead asset IFx-2.0 is in Phase 3 for first-line Merkel Cell Carcinoma (MCC) with top-line data expected in 2H 2027.

• TBS-2025, a VISTA-inhibiting antibody, targets AML and MDS with Phase 1b/2 initiation planned for 2H 2026.

• Developing first-in-class immune modulating bi-specific ADCs targeting MDSCs and Tregs for blood cancers.

• $50 million non-equity credit facility provides funding runway through Q1 2028.

IFx-2.0 program highlights

• IFx-2.0 designed to overcome primary resistance to checkpoint inhibitors by mimicking bacterial antigens on tumors.

• Phase 1b in advanced MCC showed 66% best overall response in CPI-resistant patients, with durable responses up to 23+ months.

• Phase 3 trial is a randomized, placebo-controlled study in first-line CPI-naïve advanced/metastatic MCC, with ORR as the primary endpoint.

• SPA agreement with FDA; confirmatory trial not expected to be required for approval.

• Addressable market for MCC estimated at 8,167 to 15,262 patients in US, EU4, and UK.

TBS-2025 and VISTA targeting

• VISTA is a novel checkpoint highly expressed in AML and MDS, associated with poor survival and therapy resistance.

• TBS-2025 blocks VISTA, potentially improving survival in mutNPM1 AML models.

• Phase 1b/2 trial in relapsed/refractory mutNPM1 AML planned for 2H 2026, with potential for accelerated approval.

• Synergy with ADC technology targeting MDSCs in blood cancers.