Tuhura Biosciences, Inc. · NASDAQ:HURA
Tuhura Biosciences — Investor Presentation (January 2026)
29 slides from Tuhura Biosciences's investor presentation, January 2026
Slide 1: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy January 2026 tuhurabio.com
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes “forward-looking statements” under the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, and TuHURA’s actual results may differ from its expectations, estimates and projections expressed in its forwa
Slide 3: Phase 3 immuno-oncology company with three novel technologies
We are a Phase 3 immuno- oncology company developing three distinct novel technologies and therapeutics to overcome primary and acquired resistance to cancer immunotherapies 3
Slide 4: Investment Highlights
Investment Highlights Overcoming resistance to cancer immunotherapies Lead asset in a Ph3 Front Line study in Merkel Cell with top-line data expected in 1H 2027 • Being conducted under SPA Agreement with the FDA Second asset moving to a Ph2 study in AML with data expected in 3Q 2026 Third asset to h
Slide 5: Diversified Immuno-Oncology Pipeline
Diversified Immuno-Oncology Pipeline PROGRAM DRUG CANDIDATE INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Upcoming Milestone 1st Line Merkel Cell Cancer Q1 2027: Phase 3 Keytruda® + IFx-2.0 or Topline Results IFx-2.0 placebo1 Innate Immune Tumor-targeted Agonists pDNA Primary Checkpoint Inhibitor Q
Slide 6: Upcoming Milestones
Upcoming Milestones 2026 2027 1H 2026 2H 2026 1H 2027 Phase 2 IR trial data at Phase 3 enrollment Phase 3 topline results IFx-2.0 ASCO completion & potential BLA filing Tumor-targeted pDNA Phase 2 results TBS-2025 Phase 2 initiation VISTA trial in NPM1 mut VISTA trial in NPM1 mut VISTA Inhibiting mA
Slide 7: IFx Technology
IFx Technology Innate Immune Agonists Designed to Overcome Primary Resistance to Checkpoint Inhibitors
Slide 8: IFx-2.0: Mechanism of Action
IFx-2.0: Mechanism of Action Making a Tumor Look Like a Bacterium Initiation of an Innate Immune Response Activation of Tumor Specific T Cells Allows CPI to work where they previously failed 1Intra-tumoral injection of 3 4 5 pDNA results in expression bacterial protein on surface of tumor – making t
Slide 9: Advanced Metastatic Merkel Cell Carcinoma
Advanced Metastatic Merkel Cell Carcinoma 50% of Patients Don’t Respond to 1st Line Keytruda® Keytruda® (pembrolizumab) is the 1st line standard of care for Probability of disease progression at advanced metastatic MCC two years is 26%, 57% and 100% for those with CR, PR and SD, respectively 20% 36%
Slide 10: Phase 1b Study in Advanced Skin Cancer
Phase 1b Study in Advanced Skin Cancer (Merkel Cell and Cutaneous Squamous Cell Carcinoma) Dose & Schedule Design 28-day washout Biopsy/Blood safety evaluation IFx-Hu2.0 period after final IFx-2.0 dose Objectives 23 pts enrolled Phase 1b Cohort 1 N=3 (on/off protocol) 21 safety 19 response • Advance
Slide 11: IFx-2.0 Phase 1b Results in anti-PD(L)-1 resistant MCC
IFx-2.0 Phase 1b Results in 10 anti-PD(L)-1 resistant MCC Suggest Encouraging Efficacy with Durable Responses 2 PD CR 23 4 PD pCR 23 10 PD CR 13 3 PD PR 33 5 PD PR 19 11 PD PR 11 Patient 15 PD PR 6 7 PD NR 13 PD NR 14 PD NR 16 PD NR 8 PD N/A 1 PD N/A 0 5 10 15 20 25 30 35 40 IFx-2.0 Administration M
Slide 12: IFx-2.0 Phase 1b Trial advanced, metastatic Merkel Cell Carcinoma
IFx-2.0 Phase 1b Trial advanced, metastatic Merkel Cell Carcinoma IFx-2.0 Weekly x3 – Followed by Keytruda® (pembrolizumab) Progression Three months on avelumab, a checkpoint Checkpoint Inhibitor IFx-2.0 Weekly x3 Partial Response (PR) inhibitor Keytruda® Rechallenge Injected Lesion Not Shown 33 Mon
Slide 13: IFx-2.0 Phase 1b Trial in Advanced Metastatic Merkel Cell Carcinoma
IFx-2.0 Phase 1b Trial in Advanced Metastatic Merkel Cell Carcinoma Progressed through 3 months of Post IFx-2.0 Keytruda® Progressed through 2 months of Post IFx-2.0 rechallenged with Keytruda® (pembrolizumab). (pembrolizumab) rechallenge. Keytruda®. Large bulky abdominal checkpoint inhibitor, Baven
Slide 14: Single Phase 3 Accelerated Approval Trial
Single Phase 3 Accelerated Approval Trial Designed with OCE1 – Utilized Project Front Runner Initiative 1st line CPI naïve, advanced/metastatic MCC 1:1 Randomization, Placebo, Injection Controlled Trial Primary Endpoint Overall Response Rate (ORR) Key Secondary Endpoint Progression Free Survival (PF
Slide 15: Phase 2 Trial in MSI-low Deep-Seated Tumors Expands Opportunity
Phase 2 trial in MSI-low Deep-Seated Tumors Expands Commercial Opportunity Beyond Merkel Cell Carcinoma Image Guidance for Broader Usage Through Interventional Radiology • Biology of 10 resistance is common across tumor types (histology agnostic) • MSI-low and MSS tumors are non-immunogenic • Lack a
Slide 16: TBS-2025 VISTA Inhibiting mAb
TBS-2025 VISTA Inhibiting mAb In mutNPM1 Acute Myeloid Leukemia (AML)
Slide 17: Targeting VISTA: a new target in AML, MDS
Broad Potential in Blood Related Targeting VISTA: a new target Malignancies in AML, MDS VISTA is a novel checkpoint highly expressed on: Strategic Focus and Technology Synergies Leukemic blasts Myeloid Derived Suppressor Cells (MDSCs) Quiescent T Cells – VISTA maintains resting Synergy with Delta st
Slide 18: Development Landscape
Development Landscape VISTA Inhibiting MAbs in Clinical Development Product Candidate Company Indication Status TBS-2025 TuHURA Biosciences mutNPM1 AML Phase 2 (fka KVA12123) r/r Solid Tumors (+/- Kineta Phase 1 KVA12123 pembrolizumab) (Acquired by TuHURA) Completed (n=44) r/r Solid Tumors (+/- Phas
Slide 19: TBS2025: Scientific Rational for VISTA in AML
TBS2025: Scientific Rational for VISTA in AML Strong Scientific Rational for VISTA in AML • Only checkpoint highly expressed in AML responsible for immune evasion • Expression driven by most common mutations in AML (NPM1, FLT-3, DNMT3A) • Presence on leukemic blast correlates with poor survival • De
Slide 20: TBS-2025: Improving menin inhibitor effectiveness in AML
TBS-2025: Improving menin inhibitor effectiveness in AML • NPM1 mutations (NPM1m) are most Phase 2 Trial Design1 common mutation in AML • 1 in 3 patients with AML have an NPM1 mutation • >50% patients with NMP1m relapse after 1L therapy • Menin inhibitors represent a significant advance in r/r NPM1m
Slide 21: Bi-Specific, Bi-Functional Antibody Drug Conjugates ADCs
Bi-Specific, Bi-Functional Antibody Drug Conjugates ADCs First in class immune modulating ADCs *DOR – Delta Opioid Receptor
Slide 22: Delta Opioid Receptor Expression on MDSCs Represents a Novel Target
Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs) Michael Turner, PhD TuHURA Bioscience December 7, 2025
Slide 23: MDSCs Create Immune Sanctuary for Tumors
MDSCs Create Immune Sanctuary for Tumors • MDSC are normally produced during pregnancy; provide immune sanctuary for fetus MDSC immunosuppressive activities • Hijacked by tumors, responsible for immunosuppression in the TME • Tumor associated MDSCs produce multiple immune suppressing factors (Arg-1,
Slide 24: DOR expression is elevated on myeloid cells isolated from TME
DOR expression is elevated on myeloid cells isolated from TME DOR frequency in B16F10 tumor bearing mice 100 Tumor Spleen Tumor Spleen 80 ✱ Cell 60 DOR+ (%) B16F10 Isolation C57BL/6 Strain Tumor bearing 40 mouse (d14) 20 Flow Cytometry 0 es 4+ 8+ s eg lls s lls Conclusions: SC C ce ce g Tr D D D ha
Slide 25: Selective DOR antagonist TH-31 reduces MDSC suppressive activity
Treatment with selective DOR antagonist TH-31 reduces suppressive factor expression and diminishes MDSC suppressive activity in vitro qPCR assessment of suppressive genes T cell proliferation ns ✱✱✱✱ ✱✱ 1.5 1.5 1.5 ✱ 1.5 ✱ 100 ✱ Fold change of S100A9 Fold change of NOS2 Fold change of COX2 Fold chan
Slide 26: First in Class Bi-functional Immune Modulating ADCs
First in Class Bi-functional Anti-VISTA mAb Immune Modulating ADCs Differences from Current ADC Approaches • Non-tumor targeting • Non-internalizing ADC R* Chemical • Non-cytotoxic payload reactive probe • Novel linker selectively cleavable in TME • Novel potent, highly selective DOR inhibitors Site
Slide 27: Upcoming Milestones
Upcoming Milestones 2026 2027 1H 2026 2H 2026 1H 2027 Phase 2 IR trial data at Phase 3 enrollment Phase 3 topline results IFx-2.0 ASCO completion & potential BLA filing Tumor-targeted pDNA Phase 2 results TBS-2025 Phase 2 initiation VISTA trial in NPM1 mut VISTA trial in NPM1 mut VISTA Inhibiting mA
Slide 28: Investment Summary
Investment Summary Ph3 Front Line study of IFx-2.0 being conducted under an SPA Agreement with the FDA • 18/21 sites initiated/screening patients, all operational end Q1 • Target enrollment completion late Q4-2026 • No requirement for post-approval confirmatory trial saves significant costs in 2026
Slide 29: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy tuhurabio.com
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