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 accelerated approval pathway and SPA agreement with FDA.

• TBS-2025, a VISTA-inhibiting monoclonal 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 credit facility and royalty transaction provide non-equity capital, extending runway through Q1 2028.

IFX-2.0 clinical development and results

• IFX-2.0 uses intra-tumoral pDNA to express bacterial proteins, making tumors appear as bacteria and activating innate and adaptive immunity.

• Phase 1b in advanced skin cancers showed durable responses in CPI-resistant MCC, with ongoing CRs and PRs beyond 19-23 months.

• Phase 3 trial in first-line MCC is enrolling ~118 patients, with ORR as the primary endpoint and PFS as a key secondary endpoint.

• Top-line Phase 3 data expected in 2H 2027; confirmatory trial not expected to be required.

• Addressable market for MCC estimated at ~3,000 patients, with significant unmet need for those failing first-line therapy.

TBS-2025 and ADC platform

• TBS-2025 targets VISTA, a checkpoint highly expressed in AML and MDS, associated with poor survival and immune evasion.

• Phase 1b/2 trial in mutNPM1 r/r AML to initiate in 2H 2026, with potential for accelerated approval if MLFS or better responses are achieved.

• Bi-specific ADCs combine anti-VISTA mAb and DOR inhibition to overcome acquired resistance by targeting MDSCs and Tregs.

• ADCs are designed to be non-cytotoxic, non-internalizing, and modulate immune suppression in blood cancers.

• In vivo proof-of-concept studies for ADCs expected in 2H 2026.