Tuhura Biosciences, Inc. · NASDAQ:HURA
Tuhura Biosciences — Investor Presentation (August 2026)
24 slides from Tuhura Biosciences's investor presentation, August 2026
Slide 1: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy August 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 developing 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 IFx-2.0 in a Ph3 accelerated approval study in 1st Line Merkel Cell Carcinoma • Top-line data expected 2H 2027 • Confirmatory trial not expected to be required • Special Protocol Assessment (SPA) Agreement with the FDA VISTA inhib
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 2H 2027: Phase 3 Keytruda® +/- IFx-2.0 or / Expected Topline Results placebo1 IFx-2.0 Innate Immune Innate Immune Agonists Agonist Primary Checkpo
Slide 6: IFx-2.0: Mechanism of Action
IFx-2.0: Mechanism of Action Making a Tumor Look Like a Bacterium Initiate an Innate Immune Response Activate Tumor Specific T Cells Allows CPI to work where they previously failed 1 Intra-tumoral injection of 3 4 5 pDNA results in expression bacterial protein on surface of tumor – making tumor look
Slide 7: Merkel Cell Carcinoma
Merkel Cell Carcinoma A rare and aggressive skin cancer
Slide 8: Merkel Cell Carcinoma (MCC)
Merkel Cell Carcinoma (MCC) ~3,800 new cases diagnosed / year 25% with local disease receive adjuvant CPI with Merkel Cell is an curative intent aggressive rare type of skin cancer that 75% have advanced/metastatic disease receive Keytruda 1st line standard of care can progress rapidly and spread ea
Slide 9: 50% of Patients Don't Respond to 1st Line Keytruda
Advanced Metastatic Merkel Cell Carcinoma 50% of Patients Don’t Respond to 1st Line Keytruda® Probability of disease progression at two years is 26%, Increasing Keytruda’s Response Rate 57% and 100% for those with CR, PR and SD, respectively in first-line MCC is an attractive commercial opportunity
Slide 10: IFx-2.0 Technology
IFx-2.0 Technology Innate Immune Agonists Designed to Overcome Primary Resistance to Checkpoint Inhibitors
Slide 11: Phase 1b Study of IFx-2.0 in Advanced Skin Cancer
Phase 1b Study of IFx-2.0 in Advanced Skin Cancer In Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) Trial Design Design Two-Stage Trial Design Endpoint Safety and feasibility of repeated dosing of IFx-2.0 Number of Patients n=23 (13=MCC; 10=SCC) 3+3 trial design using a fix
Slide 12: Phase 1b Results: Encouraging and Durable Responses
Phase 1b Results: Encouraging and Durable Responses Responses in Merkel Cell and CPI resistant 2 PD CR 23 4 pCR PD 23 3 PR PD 33 5 PD PR 19 Patient 11 PD PR 11 15 PD PR 6 7 PD NR 13 PD NR 14 PD NR 0 5 10 15 20 25 30 35 40 Months IFx-2.0 Administration Response to CPI Pre IFx-2.0 Response to CPI Post
Slide 13: Phase 1b Results: IFx-2.0 Overcomes Resistance in MCC
Phase 1b Results: IFx-2.0 Overcomes 10 Resistance in MCC Keytruda® Keytruda® + IFx-2.0 Keytruda® Keytruda® + IFx-2.0 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®.
Slide 14: Phase 3 Trial: Single Accelerated Approval Trial with SPA
Phase 3 Trial: Single Accelerated Approval Trial with SPA 1st line CPI naïve, advanced/metastatic MCC 1:1 Randomization, Placebo, Injection Controlled Trial Primary Endpoint Overall Response Rate (ORR) Key Secondary Endpoint Enrolling ~118 IFx-2.0 weekly x 3 + 21 of 25 U.S. clinical Progression Free
Slide 15: TBS-2025 VISTA Inhibiting mAb
TBS-2025 VISTA Inhibiting mAb
Slide 16: Targeting VISTA: a new checkpoint target in AML, MDS
Broad Potential in Blood Related Targeting VISTA: a new Malignancies checkpoint target in AML, MDS VISTA is a novel negative checkpoint highly expressed on: Myeloid Derived Suppressor Cells Strategic Focus and Technology Synergies (MDSCs) Quiescent T Cells – VISTA maintains resting state, preventing
Slide 17: TBS-2025: A Novel VISTA Inhibitor
TBS-2025: A Novel VISTA Inhibitor Strong Scientific Rational for VISTA in AML • Only checkpoint highly expressed in AML • Expression driven by most common mutations in AML (NPM1, FLT-3) • Presence on leukemic blast in patients correlates with poor survival • Suppression of T cell activity by VISTA o
Slide 18: TBS-2025: Development Plan for VISTA in AML
TBS-2025: Development Plan for VISTA in AML FDA guidance: r/r AML with no effective or approved therapies Abbreviated BOIN* dose escalation for PK and RPD2 • 75% of patients don't respond to or relapse following menin inhibitors Phase 1b mutNPM1 r/r AML: • Represents an unmet medical need patient po
Slide 19: Bi-Specific, Bi-Functional Antibody Drug Conjugates ADCs
Bi-Specific, Bi-Functional Antibody Drug Conjugates ADCs First in class immune modulating ADCs targeting MDSCs and Tregs
Slide 20: First-in-Class Immune Modulating Bi-specific ADC
We Are Developing a First-in-Class Immune Modulating Bi-functional, Bi- specific Antibody Drug Conjugates (ADC) Targeting MDSCs, to overcome acquired resistance to cancer immunotherapies • Non tumor targeting, non internalizing, non Anti-VISTA mAb cytotoxic or cell cycle targeting payloads • Bi-spec
Slide 21: Delta Opioid Receptor controls immune suppressing genes in MDSCs, Tregs
Delta Opioid Receptor controls the expression of multiple immune suppressing genes in MDSCs, Tregs A DOR-VISTA antagonist ADC is an ideal therapeutic candidate for blood related cancers MDSCs • Produce a cascade of immune suppressing factors (iNOS, COX2, IDO) • Attract other immune suppressing cells
Slide 22: Upcoming Milestone Targets
Upcoming Milestone Targets 2026 2027 1H 2026 2H 2026 1H 2027 2H 2027 IFx-2.0 Results IR study IFx-2.0 with Complete Enrollment in Orphan Drug Keytruda® Ph3 IFx-2.0 study Innate Immune Designation MCC For deep seated MCC Agonist Supportive FDA feedback on TBS-2025 Orphan Drug Designation AML VISTA in
Slide 23: Investment Highlights
Investment Highlights Overcoming resistance to cancer immunotherapies IFx-2.0 in a Ph3 accelerated approval study in 1st Line Merkel Cell Carcinoma • Top-line data expected 2H 2027 • Confirmatory trial not expected to be required • Special Protocol Assessment (SPA) Agreement with the FDA VISTA inhib
Slide 24: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy tuhurabio.com
TuHURA Biosciences — Investor Presentation (August 2026) on 6ix