Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (September 2024)
37 slides from Oncolytics Biotech's investor presentation, September 2024
Slide 1: Unleashing the Power of the Immune System to Fight Cancer
Unleashing the Power of the Immune System to Fight Cancer Investor Presentation September 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking inform
Slide 3: Pelareorep in Breast & Pancreatic Cancer: Overview & Highlights
Pelareorep in Breast & Pancreatic Cancer: Overview & Highlights Non-pathogenic, unmodified immunotherapy Clear registration path in two indications • Targets cancer cells, but not normal cells • Strong efficacy signal in breast and pancreatic cancer • Administered IV, delivers dsRNA into tumors • Fa
Slide 4: Pelareorep is a First in Class Immunotherapeutic Agent
Pelareorep is a First in Class Immunotherapeutic Agent ➢ Non-genetically modified, non-pathogenic reovirus ➢ IV administration allows direct targeting of both primary and metastatic tumors ➢ Manufactured at commercial scale; requires no special handling Selectively replicates in cancer cells Leads t
Slide 5: Pelareorep in HR+ / HER2- Breast Cancer
Pelareorep in HR+ / HER2- Breast Cancer
Slide 6: Pelareorep Offers New Options in Evolving HR+/HER2- Breast Cancer Treatment Pathway
Pelareorep Offers New Options in the Evolving HR+/HER2- Advanced/Metastatic Breast Cancer Treatment Pathway Hormonal and targeted treatment lines Post-hormonal treatment lines First-line Second-line Third-line Fourth-line treatment treatment treatments treatments Antibody-drug conjugate therapy, e.g
Slide 7: The HR+/HER2- mBC Segment Post Enhertu Represents ~55K Addressable Patients
The HR+/HER2- mBC Segment Post Enhertu Represents ~55K Addressable Patients Projected 2027 HR+ mBC Treated Prevalence Across Lines of Therapy in U.S. (# of patients in 1,000s, Not Mutually Exclusive) HER2-low HER2-ultralow Addressable Patients: ~55k prevalent HR+ HER2- mBC who have progressed on ET
Slide 8: Pelareorep Potential Peak Sales: $2.4 Billion
Pelareorep Potential Peak Sales: $2.4 Billion Projected U.S. & EU sales of Pelareorep in HR+ mBC (Sales in USD MM) $2,438 $2,500 EU Sales (USD MM) $2,000 U.S. Sales (USD MM) $760 $1,500 $1,000 $1,679 $500 $0 2028 2029 2030 2031 2032 2033 Treated patients Total U.S Pela Patients 966 3,414 5,577 7,200
Slide 9: Pelareorep-Based Therapy Provides Clinical Benefit in Breast Cancer
Pelareorep-Based Therapy Provides Clinical Benefit in Breast Cancer Phase 1 study of pelareorep in advanced breast cancer Phase 1 Pelareorep has single agent activity in HR+/HER2- breast cancer Phase 2 study in metastatic breast cancer (mBC): Paclitaxel vs. pelareorep + paclitaxel IND-213 Pelareorep
Slide 10: Statistically Significant Improvement in mOS in Phase 2 Trial IND-213
Pelareorep Treatment Led to a Statistically Significant Improvement in mOS in Phase 2 Breast Cancer Trial IND-213 Phase 2 All Subtypes (n = 74) Overall survival for the HR+/HER2- patients in IND-213 HR 0.65 study of metastatic breast cancer (n = 57) p 0.1 (powered to 90%) 100% mOS 17.4 months vs. 10
Slide 11: BRACELET-1 Study Design
BRACELET-1 Study Design Key Eligibility Criteria Randomized 28-day cycles 1:1:1 • No prior chemo for metastatic disease Cohort 1 (n=15): Paclitaxel (PTX) • Progressed on at least 1 hormone-based therapy with a CDK 4/6 inhibitor Primary Endpoint HR+ / HER2- • Overall response rate (ORR) at week 16 R
Slide 12: BRACELET-1 Robust Improvement in Progression-free Survival
BRACELET-1 Study Showed Robust Improvement in Progression-free Survival (PFS) for the Pelareorep + Paclitaxel Arm Kaplan-Meier Plot of Progression-Free Survival* PTX + Paclitaxel PTX + b pelareorep + (PTX) pelareorep avelumab Median PFS 6.4 12.1 6.4 (months) Paclitaxel + pelareorep Hazard ratio vs.
Slide 13: BRACELET-1 Meaningful Improvement in Overall Survival
BRACELET-1 Study Showed Meaningful Improvement in Overall Survival (OS) for the Pelareorep + Paclitaxel Arm Kaplan-Meier Plot of Overall Survival Paclitaxel PTX + pela + (PTX) PTX + pela avelumab Cohort 1 Cohort 2 Cohort 3 Paclitaxel + pelareorep Not reached Median OS 18.2 21.7 (months) Estimate: 32
Slide 14: BRACELET-1: Data Show Benefits in Pelareorep + Paclitaxel Arm
BRACELET-1: Data Show Benefits in Pelareorep + Paclitaxel Arm PTX Monotherapy PTX + Pelareorep PTX + Pelareorep + Response Measures1 (n=15) (n=16) Avelumab (n=17) Confirmed ORR 13.3% 37.5% 17.6% Median PFS (months) 6.4 12.1 6.4 Not Reached Median OS (months) 18.2 21.7 Estimate: 32.1* Hazard Ratio fo
Slide 15: Pelareorep’s Favorable Overall Safety Highlighted by BRACELET-1
Pelareorep’s Favorable Overall Safety Highlighted by BRACELET-1 Safety Summary Fifteen Most Common Adverse Events1,2 as Attributed to Study Drug(s) Paclitaxel (PTX) (n=12) PTX + Pelareorep (n=16) PTX + Pelareorep + Avelumab (n=17) Grade Any ≥3 Any ≥3 Any ≥3 Alopecia 6 (50%) - 9 (56%) - 8 (47%) - Ane
Slide 16: Efficient Path to Registration Through Large Phase 2 Study
Efficient Path to Registration Through Large Phase 2 Study Study design Total study size: • Expected to be ≤200 patients Paclitaxel alone Primary endpoint Key secondary endpoint Target population: PFS final OS final • Advanced or metastatic breast Randomized 2:1 analysis analysis cancer • HR+/HER2-l
Slide 17: FDA Type C Meeting Outcome – May 2024: Alignment on Key Elements
FDA Type C Meeting Outcome – May 2024: Alignment on Key Elements of the Planned Registration-Enabling Study Summary of key outcomes • FDA agreed that the proposed study population is appropriate (i.e., patients who failed hormonal therapy and received either 0 or 1 line of ADC therapy) • FDA agreed
Slide 18: Pelareorep in Gastrointestinal Cancer
Pelareorep in Gastrointestinal Cancer
Slide 19: GOBLET Study Design
GOBLET Study Design Phase 1/2 multiple indication biomarker, safety & efficacy study Advanced / Metastatic Pancreatic Cancer Pelareorep + Atezolizumab + Gemcitabine + Nab-paclitaxel Success Criteria ≥ 3 responses 1L n=12 Primary Endpoints: Safety ORR Newly Diagnosed Secondary Endpoints: Pancreatic C
Slide 20: Efficacy Signals Shown in Two Gastrointestinal Cancers
Efficacy Signals Shown in Two Gastrointestinal Cancers First-line Advanced / Metastatic Second-line or Later Anal Cancer Pancreatic Cancer Status Phase 1/2 updated data reported October 2023 Phase 1/2 initial data reported November 2023 62% Objective response rate Key 7.2 months Median PFS 37.5% Obj
Slide 21: Pelareorep in Metastatic Pancreatic Cancer
Pelareorep in Metastatic Pancreatic Cancer
Slide 22: Advanced/metastatic pancreatic ductal adenocarcinoma market
Advanced/metastatic pancreatic ductal adenocarcinoma market Pelareorep could Legacy treatments target first-line or Proposed treatment regimens chemo failure Chemotherapies (2L) Immuno-chemotherapy gemcitabine + nab-paclitaxel pelareorep + gemcitabine + nab-paclitaxel + atezolizumab mFOLFIRINOX pela
Slide 23: PDAC GOBLET Results Showing 62% ORR
PDAC GOBLET Results Showing 62% ORR, Nearly Triple The Rate Seen in Prior Studies Tumor Responses as of Sep. 18, 2023 cut off; All Tumor Responses Over Time; Evaluable Patients/n=11 Patients/n=13 60% 50% 40% Maximum % change from baseline 30% 20% 10% 0% -10% -20% -30% -40% -50% -60% -70% -80% -90% -
Slide 24: Next Steps: Finalize GCAR PDAC Registrational Trial Protocol and Initiate Study
Next Steps: Finalize GCAR PDAC Registrational Trial Protocol and Initiate Study Patient Population: • Patients receiving 1L treatment for PDAC • Prior Treatments: None • Adaptive trial design to be based on positive GOBLET cohort 1 results Treatment Regimen: Trial plan to include • Randomized trial
Slide 25: mFOLFIRINOX Cohort Design
mFOLFIRINOX Cohort Design Strategic rationale: to investigate the use of pelareorep with another commonly used treatment regimen Patient Population: • Newly diagnosed metastatic PDAC patients (as defined by RECIST 1.1) • To be supported by PanCAN Therapeutic Accelerator Grant Treatment Regimen: • Ph
Slide 26: Pancreatic Cancer Opportunity Driven by Promising GOBLET Phase 1/2 Data
Pancreatic Cancer Opportunity Driven by Promising GOBLET Phase 1/2 Data & Supported by FDA Fast Track Designation GOBLET Study Shows An ORR of 62% was observed, representing a near doubling from historical controls compared Increased ORR to historical control trials1-4 Studies Show Prior studies als
Slide 27: Pelareorep in ≥ Second-Line Unresectable Anal Cancer
Pelareorep in ≥ Second-Line Unresectable Anal Cancer
Slide 28: Positive GOBLET Anal Cancer Data Meets Success Criteria
Positive GOBLET Anal Cancer Data Meets Success Criteria, Expanding Enrollment, Highlights Synergy with CPI Presented November 9, 2023 at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) Patient Population: • Patients with 2L, unresectable squamous cell carcinoma of the anal can
Slide 29: Pelareorep-Atezolizumab in Anal Cancer, ORR Exceeds Historical Rates
Pelareorep-Atezolizumab Combination in Anal Cancer, ORR Exceeds Historical Efficacy Rates of Like Studies ORR of 37.5% meets the pre-specified efficacy success criteria. Of 8 evaluable patients: • 1 CR (ongoing at 12 months) • 2 PR (one at week 8 and one ongoing at week 16) • ~11% Average ORR report
Slide 30: Intellectual Property, Management Team, Financials, Pipeline, Additional Information
Intellectual Property, Management Team, Financials, Pipeline, Additional Information
Slide 31: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio 149 patents issued worldwide, including 13 US and 7 Canadian 14 pending applications worldwide Pelareorep issued patent claims cover: • Compositions of matter comprising pelareorep • Patent rights extend to at least the end of 2031 • Pharmaceutical use of pelar
Slide 32: Innovative Leadership Team
Innovative Leadership Team with Strong Immuno-oncology, Business Development, Clinical Trial and Finance Expertise Matt Coffey, Ph.D., MBA Kirk Look, CA, MSJ Thomas Heineman, M.D., Ph.D. President and CEO Chief Financial Officer Chief Medical Officer Allison Hagerman, PEng, PMP, MBT Christophe Degoi
Slide 33: Financials Overview
Financials Overview Financial Overview Research Coverage ONCY: NASDAQ Ticker Patrick Trucchio H.C. Wainwright & Co. ONC: TSX Avg. Daily Volume (1 mo*) 143,061 John Newman Canaccord Genuity Shares Outstanding 76,986,033 Jason McCarthy Maxim Group Market cap1 ~$79 M Douglas Miehm RBC Capital Markets C
Slide 34: Pelareorep Has Expansive Potential, Starting with Breast and Gastrointestinal Cancers
Pelareorep Has Expansive Potential, Starting with Breast and Gastrointestinal Cancers Registration-Enabling Program Collaborator Combination Phase 1 Phase 2 Study Milestone BREAST CANCER BRACELET-1 OS data reported in pela + PTX HR+/HER2- mBC Q3 2024 Registrational Study Planned Study TBD pela + PTX
Slide 35: Why Did Avelumab Eliminate the Benefit of Pelareorep?
Why Did Avelumab Eliminate the Benefit of Pelareorep? Avelumab is the only licensed anti- PD-L1 Ab with a native Fc region NKcell Dendritic/ CD8 cell that retains FcγR binding Avelumab binding to the FcγR on NK cells may Hypothesis: induce ADCC-mediated killing of T cells Binding of avelumab to Fc r
Slide 36: T Cell Expansion in BRACELET Patients Blocked by Avelumab
T Cell Expansion in BRACELET Patients Blocked by Avelumab Pelareorep + paclitaxel: Statistically significant expansion of T cell clones at Cycle 4 Day 1 (*) Pelareorep + paclitaxel + avelumab : ǂ No T cell expansion at Cycle 4 Day 1 (ǂ) * Pac = paclitaxel; Pela = pelareorep; Avel = avelumab C = cycl
Slide 37: Pelareorep Expected to be Efficacious Following Progression on Enhertu (T-DXd)
Pelareorep Expected to be Efficacious Following Progression on Enhertu (T-DXd) • Pelareorep is efficacious in heavily pre-treated breast cancer patients • T-DXd failure results from reduced HER2 expression or deruxtecan resistance – neither should affect pelareorep’s efficacy1 • T-DXd has no known i
Oncolytics Biotech — Investor Presentation (September 2024) on 6ix