Tuhura Biosciences, Inc. · NASDAQ:HURA
Tuhura Biosciences — Kintara Therapeutics — Merger or Acquisition (April 2024)
28 slides from Tuhura Biosciences's merger presentation, Apr 3, 2024
Slide 1: Enter into Definitive Merger Agreement
Enter into Definitive Merger Agreement Phase 3 Clinical Stage Immuno-Oncology Company Addressing Major Obstacles to Overcoming Resistance to Cancer Immunotherapy
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the futu
Slide 3: Robert E. Hoffman, President, CEO, CFO and Chairman, Kintara
President, CEO, CFO and Chairman of the Board Kintara Therapeutics Robert E. Hoffman
Slide 4: Focused on Bringing Novel Therapies to Treat and Cure Patients with Cancer
Focused on Bringing Novel Therapies to Treat and Cure Patients with Cancer Phase 3 Clinical Stage Company Advancing a Risk-Diversified Product Pipeline to Overcome Primary and Acquired Resistance to Cancer Immunotherapies Personalized Cancer Vaccines IFx Technology Harnesses the Power of the Innate
Slide 5: Transaction Highlights
Transaction Highlights TEXT Combined company will operate under the name TuHURA Biosciences, Inc. and expects to trade on Nasdaq under the ticker HURA Structured as a stock-for-stock transaction whereby at closing, all of TuHURA’s outstanding equity interests expected to be exchanged for shares of K
Slide 6: James A Bianco, MD, President and CEO, TuHURA Biosciences
James A Bianco, MD President and Chief Executive Officer TuHURA Biosciences
Slide 7: Risk Diversified Development Pipeline
Risk Diversified Development Pipeline Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Highlight IFx-3.0 Diffuse Large B-Cell Lymphoma (DLBCL) Expect to initiate IND-enabling studies in 2024 Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Highlight Nal-anti TGIT Myelodysplasia Acute Myeloid
Slide 8: High Value Opportunity: Allowing Checkpoint Inhibitors to Work in More Patients
High Value Opportunity: Allowing Checkpoint Inhibitors to Work in More Patients Standard therapy for more than 20 types of cancer 9 individual checkpoint inhibitors currently on the market Merck’s Keytruda® dominates the CPI market Annual sales to reach $30 billion in 2024 Represents 40% of their an
Slide 9: Designed to Overcome Primary Resistance and Increase Response Rates to Checkpoint Inhibitor Therapy
Designed to Overcome Primary Resistance and Increase Response Rates to Checkpoint Inhibitor Therapy IFx-2.0 Personalized Cancer Vaccine
Slide 10: IFx Personalized Cancer Vaccine Technology
IFx Personalized Cancer Vaccine Technology Checkpoint Inhibitors need an activated immune response to work IFx-2.0 makes patient’s entire tumor appear foreign activating the innate immune response allowing checkpoint inhibitors to work where they previously failed Intra-tumoral injection of pDNA enc
Slide 11: Phase 1b Study in Advanced Skin Cancer
Phase 1b Study in Advanced Skin Cancer (Merkel Cell and Squamous Cell Carcinoma) IFx-2.0: Personalized Cancer Vaccine Advanced MCC (6) Squamous Cell (3) patients Three dosing cohorts: IFx-2.0 weekly for one, two, or three weeks N=9 IFx-2.0 weekly x 3 Targeted enrollment toward patients with 10 resis
Slide 12: Demonstrated Ability to Overcome CPI Resistance Across Multiple Tumor Types
Demonstrated Ability to Overcome CPI Resistance Across Multiple Tumor Types* IFx-2.0: Personalized Cancer Vaccine 1 2 3 4 5 6 7 8 9 10 11 Phase 1/1b Trials in Advanced Merkel Cell, Squamous Cell, Melanoma Patient KEY NR NR NR PD PD PD PD PD PD PD PD PD PD PD CR PR pCR PR PR PR SD PR Merkel Cell 80%
Slide 13: 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) Ongoing 33 Months IFx-2.0 Weekly x3 – Fol
Slide 14: Overcomes Resistance to Keytruda in MCC
Overcomes 10 Resistance to Keytruda® in MCC Progressed through 3 months of Keytruda® Large Sub-dermal Metastatic deposit IFx-2.0 weekly x 2 injected into dermal lesions (blue arrows) Post IFx-2.0 Keytruda ® rechallenge. Cavitation of lesion radiographically a PR when excised demonstrated necrotic ti
Slide 15: Overcomes Resistance to Keytruda in MCC
Progressed through 2 months of Keytruda® Large bulky abdominal masses (blue) IFx-2.0 weekly x 2 injected into dermal lesions (blue arrows) Post IFx-2.0 rechallenged with checkpoint inhibitor, avelumab. Complete disappearance of subcutaneous nodules ~80% reduction (Partial Response) in abdominal mass
Slide 16: Advanced Merkel Cell Carcinoma (MCC)
Advanced Merkel Cell Carcinoma (MCC) Up to 50% of Patients Have Primary Resistance and Don’t Respond to 1st Line Keytruda®1 Increasing Keytruda’s anti-tumor response rate represents an attractive commercial opportunity An aggressive form of skin cancer, driven by polyoma viral oncogene with 5-year s
Slide 17: Single Phase 3 Accelerated Approval Trial Under SPA with FDA
Single Phase 3 Accelerated Approval Trial Conducted under SPA agreement with FDA IFx-2.0: Personalized Cancer Vaccine 1:1 Randomization, Placebo Controlled Trial Enrolling ~118 patients IFx-2.0 x3 weeks + Keytruda® vs Keytruda® + Placebo 20-25 U.S. clinical centers Primary Endpoint Overall Response
Slide 18: Oncology Accelerated Approval Trials Are A Select Group
Oncology Accelerated Approval Trials Are A “Select” Group 54* 12,258 Ongoing Phase 3 cancer trials * Mostly large pharma/biotech
Slide 19: Overcoming Resistance to Checkpoint Inhibitors Large Market Opportunity
Overcoming Resistance to Checkpoint Inhibitors Large Market Opportunity Mechanism of 10 Resistance to Checkpoint Inhibitors is the same irrespective of the type of cancer IFx-2.0 demonstrated ability to overcome 10 resistance to Checkpoint inhibitors is 3 types of cancer “Basket” trial to get underw
Slide 20: IFx-3.0 – Tumor Targeted mRNA Personalized Cancer Vaccine
IFx-3.0 – Tumor Targeted mRNA Personalized Cancer Vaccine Designed to Overcome Primary Resistance to Checkpoint Inhibitors and Cellular Therapies
Slide 21: IFx-3.0: mRNA Tumor Targeted Cancer Vaccine
IFx-3.0: mRNA Tumor Targeted Cancer Vaccine Targeting Start of Human Clinical Trials in 2025 IFx-3.0 (mRNA) First mRNA vaccine to be given intravenously First tumor targeted mRNA cancer vaccine Developed proprietary CD22 targeting antibody fragment (scFv) coupled to mRNA loaded lipid nanoparticle CD
Slide 22: Bi-Functional ADC Inhibitors of MDSC Immune Suppression
Bi-Functional ADC Inhibitors of MDSC Immune Suppression Designed to Overcome Acquired Resistance to Checkpoint Inhibitors and Cellular Therapies
Slide 23: MDSCs are a Major Obstacle for Immunotherapies
Myeloid Derived Suppressor Cells (MDSCs) are a Major Obstacle for Immunotherapies Normally produced during pregnancy populate placenta to create an immune sanctuary to protect fetus from paternal foreign antigens “Hijacked” by tumors to populate tissue where tumor lives (microenvironment). Produce m
Slide 24: Bi-Functional Antibody Drug Conjugates (ADCs)
Bi-Functional Antibody Drug Conjugates (ADCs) Blocks MDSC production of multiple immune suppressing soluble factors while carrying a checkpoint inhibitor to the tissue where the tumor lives Removes the tumor’s “protective” immune sanctuary while checkpoint releasing T cells to attack and eradicate t
Slide 25: Robert E. Hoffman, President, CEO, CFO and Chairman, Kintara
President, CEO, CFO and Chairman of the Board Kintara Therapeutics Robert E. Hoffman
Slide 26: Legacy Kintara Assets Provide Opportunity for Potential Upside
Legacy Kintara Assets Provide Opportunity for Potential Upside REM-001: In Development for the Treatment of Cutaneous Metastatic Breast Cancer (CMBC) Ongoing Open-Label Study Enrolling 15-patents with CMBC Evaluating safety and efficacy Funded by SBIR Grant from NIH FDA Fast Track Designation Potent
Slide 27: Among select group of accelerated approval Phase oncology companies under SPA with FDA for
Among select group of accelerated approval Phase 3 oncology companies under SPA with FDA for novel trial design removing need for confirmatory trial Phase 3 results in Merkel Cell Carcinoma expected to be translatable to majority of cancers where checkpoint inhibitors don’t work Overcoming resistanc
Slide 28: Enter into Definitive Merger Agreement
Enter into Definitive Merger Agreement Phase 3 Clinical Stage Immuno-Oncology Company Addressing Major Obstacles to Overcoming Resistance to Cancer Immunotherapy
Kintara Therapeutics — Merger or Acquisition (April 2024) on 6ix