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TuHURA Biosciences (HURA) investor relations material
TuHURA Biosciences Corporate presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- Merger completed, cash burn persists, and urgent funding needs threaten going concern.HURA
Q3 20249 Jun 2026 - Phase 3 IFx-2.0 trial and Kineta acquisition drive growth, backed by $36M in new funding.HURA
Q4 20249 Jun 2026 - Net loss widened to $6.7M in Q1 2025; pipeline and merger progress drive outlook.HURA
Q1 20259 Jun 2026 - Net loss rose to $7.1M in Q3 2025 as R&D spending increased and liquidity concerns persist.HURA
Q3 20259 Jun 2026 - Q2 2025 net loss rose to $9.5M as costs surged post-Kineta merger; $15.5M in new funding raised.HURA
Q2 20259 Jun 2026 - $50M credit facility and rising R&D spending support clinical milestones through 2028.HURA
Q1 20269 Jun 2026 - Clinical pipeline advanced and financing secured, with key trial milestones expected in 2026-2027.HURA
Q4 20258 Jun 2026
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