Tuhura Biosciences, Inc. · NASDAQ:HURA
Tuhura Biosciences — Investor Presentation (March 2025)
28 slides from Tuhura Biosciences's investor presentation, Mar 18, 2025
Slide 1: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy Presentation | March 2025 tuhurabio.com Filed by TuHURA Biosciences, Inc. Pursuant to Rule 425 under the Securities Act of 1933 and deemed filed pursuant to Rule 14a-12 under the Securities Act of 1934 Filer: TuHURA Biosciences, Inc. Commission File No.:
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: Investment Summary
Investment Summary * Trial currently subject to partial clinical hold relating to completion of certain CMC requirements for initiation of Phase 3 registration trial MCC = Merkel cell carcinoma Business Highlights Tumor Microenvironment Modulators Innate Immune Agonists Single Phase 3 registration d
Slide 4: 2024 Highlights and Looking Ahead 2025
Successful SPA agreement with FDA Single Phase 3 Accelerated Approval Trial1 Key 20 endpoint (PFS) may satisfy post approval confirmatory trial requirement Acquired Phase 2 ready VISTA inhibitor in clinical partnership with Merck Advanced first-in-class bi-specific immune modulating ADCs/APCs patent
Slide 5: Diversified Immuno-Oncology Pipeline
Diversified Immuno-Oncology Pipeline Program Drug Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Highlight Innate Immune Agonists IFx-2.0 Tumor-targeted pDNA 1st Line Merkel Cell Cancer Keytruda® + IFx-2.0 or placebo Phase 3 registration study initiation expected in 1H 20252 IFx-Hu2.0 Prim
Slide 6: IFx Technology: Innate Immune Agonists
IFx Technology Innate Immune Agonists Designed to Overcome Primary Resistance to Checkpoint Inhibitors
Slide 7: IFx-2.0: Mechanism of Action
3 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 Intra-tumoral injection of pDNA results in expression bacterial protein on surface of tumor – making tumor look like a bacterium Molecular patterns on bact
Slide 8: Increasing Keytruda's Response Rate is an Attractive Commercial Opportunity
Sources N Engl J Med 2016; 374:2542-2552 DOI: 10.1056/NEJMoa1603702 *DelveInsight Merkel Cell Carcinoma (MCC) -- Market Insight, Epidemiology, and Market Forecast – 2034 Increasing Keytruda’s Response Rate is an Attractive Commercial Opportunity Probability of disease progression at two years is 26%
Slide 9: Phase 1b Study in Advanced Skin Cancer
Phase 1b Study in Advanced Skin Cancer (Merkel Cell and Cutaneous Squamous Cell Carcinoma) Advanced MCC (6) Squamous Cell (3) patients Three dosing cohorts: IFx-2.0 weekly for one, two or three weeks Up to 3 accessible lesions injected N=9 IFx-Hu2.0 Biopsy/Blood Cohort 1 N=3 Cohort 2 N=3 Cohort 3 N=
Slide 10: IFx-2.0 MCC Phase 1b Results Suggest Encouraging Efficacy
IFx-2.0 MCC Phase 1b Results Suggest Encouraging Efficacy with Durable Responses Phase 1b Dose/Schedule trial N (%) Total 7 CR 2 (29%) PR 3 (43%) ORR 5 (71%) DOR (median) 21 months+ SAFETY (n=21) Grade 1 8 (38%) Grade 3 1(5%) Phase 1b Results: Merkel cell carcinoma n=7 7 patients (primary resistance
Slide 11: Overcomes Resistance to Checkpoint Inhibitors in Merkel Cell Carcinoma
Overcomes 10 Resistance Checkpoint Inhibitors in Merkel Cell Carcinoma Progression Three months on avelumab, a checkpoint inhibitor IFx-2.0 Weekly x3 Injected Lesion Not Shown Checkpoint Inhibitor Keytruda® Rechallenge Following IFx-2.0 Partial Response (PR) 33 Months IFx-2.0 Weekly x3 – Followed by
Slide 12: IFx-2.0 Overcomes Resistance to Anti-PD-(L)1 Therapy in MCC
IFx-2.0 MCC Phase 1b trial Overcomes 10 Resistance to Anti-PD-(L)1 Therapy (pembrolizumab or avelumab) in MCC Progressed through 3 months of Keytruda® (pembrolizumab). Large sub-dermal metastatic deposit IFx-2.0 weekly x2 injected into dermal lesions (blue arrows) Post IFx-2.0 Keytruda® (pembrolizum
Slide 13: Single Phase 3 Accelerated Approval Trial Designed with OCE
Oncology Center of Excellence Trial currently subject to partial clinical hold relating to completion of certain CMC requirements for initiation of Phase 3 registration trial Single Phase 3 Accelerated Approval Trial Designed with OCE1 - Project Front Runner FPI – first patient in LPI - last patient
Slide 14: Potential Commercial Opportunity – Keytruda + IFx-2.0
Potential Commercial Opportunity – Keytruda® + IFx-2.0 Assumptions 2034 Peak Market Size (patients) Total - 15,262 US – 5,973 7MM+UK – 9,289 US product launch 2027, EU 2028 Adoption rate ( years 1-3) 50% to 70% peak penetration $150,000 per patient COGS 10% Peak Sales US only - $627mm *Source – Delv
Slide 15: Attractive Commercial Opportunity: Overcoming Resistance to CPIs
Sources Zhao B, et al. Ther Ady Med Oncol. 2020;12:1-22; 2. Sun JY, et al. Biomark Res. 2020;8:35; 3. Zhang T, et al. Oncotarget. 2016:7(45):73068-73079. Attractive Commercial Opportunity: Overcoming Resistance to CPIs On average only 20% of patients respond to CPIs Head and Neck Cancer (15%) Lung C
Slide 16: IFx-2.0 Demonstrated Ability to Overcome CPI Resistance Across Tumor Types
IFx-2.0 Demonstrated Ability to Overcome CPI Resistance Across Multiple Tumor Types Phase 1/1b Trials in Advanced Merkel Cell, Squamous Cell, Melanoma KEY Response POST IFx-Hu2.0 + CPI rechallenge Response to CPI PRE IFx-Hu2.0 No Response NR MELANOMA TRIAL OVERVIEW Phase 1*: (N=7) Advanced Melanoma,
Slide 17: Tumor Microenvironment Modulators
Tumor Microenvironment Modulators Novel Targets for Intervention Negative Immune Regulators (VISTA) MDSCs and M2 macrophages (DOR inhibitors*) *DOR – Delta Opioid Receptor
Slide 18: Targeting VISTA to Overcome Resistance to Immunotherapy
* Formerly KVA12123 Targeting VISTA to Overcome Resistance to Immunotherapy Broader Potential as a Target Than Other Checkpoints Only checkpoint highly expressed on “quiescent” T cells and myeloid (MDSC, M2 macrophages ) cells Other checkpoints (CTLA-4, PD-(L)1, LAG3) are only expressed on activated
Slide 19: VISTA-101 Phase 1b Clinical Trial
*As of 11-21-24 VISTA-101 Phase 1b Clinical Trial Modified BOIN Design with Accelerated Titration 3 patients KVA12123 3 mg Q2W KVA12123 10 mg Q2W KVA12123 30 mg Q2W KVA12123 100 mg Q2W KVA12123 300 mg Q2W KVA12123 1000 mg Q2W 2 patients 5 patients 4 patients 6 patients 4 patients 6 patients Monother
Slide 20: Rational Phase 2 Trial: mutNPM1 AML Menin +/- VISTA Antibody
RATIONAL PHASE 2 mutNPM1 AML – MENIN +/- VISTA INHIBITING ANTIBODY VSIR overexpression (encoding VISTA) associated with mutNPM1 and VISTA overexpression on AML blasts mutNPM1 interact with Menin to drive downstream gene expression linked to leukemogenesis Menin inhibitors can salvage 25% of patients
Slide 21: VISTA: Potential Accelerated Approval Pathway in NPM1 mutAML
VISTA : Potential Accelerated Approval Pathway in NPM1 mutAML NPM1,most common gene mutation in leukemia (AML), produces a protein, menin, which “drives” leukemia NPM1 also “drives” VISTA expression on AML cells which leads to evasion of immune attack Menin inhibitors are standard of care inr/r NPM1
Slide 22: Tumor Microenvironment Modulators
Tumor Microenvironment Modulators Novel Targets for Intervention Negative Immune Regulators (VISTA) MDSCs and M2 Macrophages (DOR inhibitors*) *DOR – Delta Opioid Receptor
Slide 23: MDSCs Create Immune Sanctuary for Tumors
MDSCs are normally produced during pregnancy; provide immune sanctuary for fetus Hijacked by tumors, responsible for immunosuppression in TME Produce multiple immune suppressing factors (Arg-1, iNOS, TGFb,) Inhibit T cell proliferation and activation TuHURA and Moffitt scientists first to report exp
Slide 24: Delta Opioid Receptor (DOR)
Delta Opioid Receptor (DOR) Well characterized class of G-protein-coupled receptors (GPCRs) TuHURA and Moffitt Cancer Center scientists first to report over expression on tumor associated MDSCs and tumor polarized M2 macrophages Decreases MDSC and M2 macrophage production of multiple immunosuppressi
Slide 25: Corporate Highlights
fHuRA biosciences Corporate Highlights ~~’
Slide 26: Upcoming Anticipated Milestones
Program 2025 2026 1st Half 2nd Half 1st Half 2nd Half IFx-2.0 IFx-3.0 VISTA Inhibiting mAb* MDSC Inhibitors Upcoming Anticipated Milestones 1H25: Initiate Phase 3 trial 1H25: Phase 1 VISTA inhibitor + pembrolizumab results 1H25: Initiate “basket” trial 2H25: Initiate Phase 2 trials (VISTA + AML, End
Slide 27: Investment Summary
Investment Summary * Trial currently subject to partial clinical hold relating to completion of certain CMC requirements for initiation of Phase 3 registration trial MCC = Merkel cell carcinoma Business Highlights Tumor Microenvironment Modulators Innate Immune Agonists Single Phase 3 registration d
Slide 28: Overcoming Resistance to Cancer Immunotherapy
Overcoming Resistance to Cancer Immunotherapy tuhurabio.com
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