Tuhura Biosciences, Inc. · NASDAQ:HURA
Tuhura Biosciences — Investor Presentation (September 2025)
27 slides from Tuhura Biosciences's investor presentation, September 2025
Slide 1: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy Presentation | September 2025 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: We are a Phase 3 immuno-oncology company
We are a Phase 3 immuno- oncology company developing three distinct novel technologies and therapeutics to overcome primary and acquired resistance to existing cancer immunotherapies 3
Slide 4: Investment Highlights
Investment Highlights: Overcoming resistance to cancer immunotherapies Phase 3 study of IFx-2.0 being conducted under an SPA Agreement with the FDA • Enrollment completion Q4-2026 – currently anticipate no requirement for post approval confirmatory trial IFx-2.0 Phase 1b/2a “basket trial” with topli
Slide 5: Milestones Achieved: 1st Half 2025
Milestones Achieved: 1st Half 2025 ✓ FDA Removed CMC related Partial Clinical Hold ✓ Initiated Phase 3 IFx-2.0 Accelerated Approval Trial ✓ Closed Kineta Acquisition ✓ Raised $15 million 5
Slide 6: Diversified Immuno-Oncology Pipeline
Diversified Immuno-Oncology Pipeline Upcoming Milestone PROGRAM DRUG CANDIDATE INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Targets 1st Line Merkel Cell Cancer Q1 2027: Phase 3 Keytruda® + IFx-2.0 or Topline Results placebo1 Innate Immune IFx-2.0 Tumor-targeted Agonists pDNA Primary Checkpoint Inh
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 1 st 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 Expanded Trial Cohort 1 N=3 (on/off protocol) 21 safety 19 res
Slide 11: IFx-2.0 MCC Phase 1b Results Suggest Encouraging Efficacy with Durable Responses
IFx-2.0 MCC Phase 1b Results 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 Months Response to CPI Pre IFx
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 - Project Front Runner 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 (PFS) Enrolling ~118 IF
Slide 15: Phase 2 Basket Trial Expands Commercial Opportunity Beyond Merkel Cell Carcinoma
Phase 2 Basket Trial Expands Commercial Opportunity Beyond Merkel Cell Carcinoma Only 20% of Patients Respond to CPIs on Average • Biology of 1 0 resistance is common across tumor types (histology agnostic) • MSI-low and MSS tumors are non-immunogenic • Lack activated tumor specific T cells Gastric
Slide 16: Overcoming Resistance to Checkpoint Inhibitors is an Attractive Commercial Opportunity
Overcoming Resistance to Checkpoint Inhibitors is an Attractive Commercial Opportunity Approximately 20% of patients with cancer respond to checkpoint inhibitors like Keytruda® Marketed Class Of 2025 WW Sales FDA Company Name Checkpoint Est. Approval Merck Keytruda1 PD-1 $30.0 Billion 2016 Est. $148
Slide 17: Tumor Microenvironment Modulators
Tumor Microenvironment Modulators Negative Immune Regulators VISTA Inhibiting mAb TBS-2025
Slide 18: Targeting VISTA to Overcome Acquired Resistance to Cancer Immunotherapy
Targeting VISTA to Overcome Broad Potential in Blood Related Malignancies Acquired Resistance to Cancer Immunotherapy VISTA is a novel checkpoint highly expressed on: Strategic Focus and Technology Synergies Leukemic blasts Myeloid Derived Suppressor Cells (MDSCs) Quiescent T Cells – VISTA maintains
Slide 19: TBS-2025 Phase 1b Dose Escalation Trial
TBS-2025 Phase 1b Dose Escalation Trial1 Modified BOIN Design with Accelerated Titration Safety • No DLT, CRS cytokines (IL-6, TBS-2025 TNFα & IL-10) detected at 1000 mg Q2W 1,000mg dose TBS-2025 • 100% VISTA receptor 300 mg Q2W 3 patients Monotherapy TBS-2025 occupancy at 1,000mg dose, PK/PD suppor
Slide 20: Market Opportunity ($B)
VISTA linked to Most Common Mutations in $6.0 AML: VISTA Market Opportunity2 AML & MDS $5.0 ~$2B Market ~$4B Market Primary mechanism for leukemic blasts Market Opportunity ($B) $4.0 to escape immune recognition1 $1B Market • Three mutations that are expressed or co- $3.0 expressed in AML and MDS: N
Slide 21: Tumor Microenvironment Modulators
Tumor Microenvironment Modulators Novel Targets for Intervention MDSCs (DOR inhibitors*) *DOR – Delta Opioid Receptor
Slide 22: MDSCs Create Immune Sanctuary for Tumors
MDSCs Create Immune Sanctuary for Tumors Causing Checkpoint Inhibitors and T Cell Therapies to Stop Working Mechanism of MDSC Derived Immunosuppression • MDSCs are normally produced during pregnancy; provide immune sanctuary for fetus • Hijacked by tumors, responsible for immunosuppression in TME •
Slide 23: First-in-Class Immune Modulating Bi-Specific/Bi-functional Antibody Drug Conjugates
First-in-Class Immune Modulating Bi-Specific/Bi-functional Antibody Drug or Antibody Peptide* Conjugates Single receptor target controls multiple pathways coupled to TME immune suppression Delta Opioid Receptor HUR-009: DOR Specific First-in-Class Immune (DOR) Antagonists** Modulating APCs & ADCs •
Slide 24: DOR-VISTA APC-ADC Design
Anti-VISTA mAb DOR-VISTA APC-ADC Design Multiple Factors to Consider when R* Designing DOR-VISTA ADCs Chemical reactive probe • Bioconjugation site • Bioconjugation method: stochastic vs site- Site of linker specific conjugation attachment • Cleavable or non-cleavable linker • High drug loading (DAR
Slide 25: Upcoming Anticipated Milestones
Upcoming Anticipated Milestones 2025 2026 2027 2H 2025 1H 2026 2H 2026 1H 2027 End of Phase 3; start of Phase 3 topline results IFx-2.0 rolling BLA submission & potential BLA filing Tumor-targeted pDNA TBS-2025 Initiate Phase 2 VISTA Phase 2 results VISTA VISTA Inhibiting mAb trial in NPM1 mut r/r A
Slide 26: Investment Highlights
Investment Highlights: Overcoming resistance to cancer immunotherapies Phase 3 study of IFx-2.0 being conducted under an SPA Agreement with the FDA • Enrollment completion Q4-2026 – currently anticipate no requirement for post approval confirmatory trial IFx-2.0 Phase 1b/2a “basket trial” with topli
Slide 27: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy tuhurabio.com
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