Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (September 2023)
61 slides from Oncolytics Biotech's investor presentation, September 2023
Slide 1: Investor Presentation September 2023
Investor Presentation September 2023 1 Website oncolyticsbiotech.com Nasdaq ONCY TSX ONC
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 infor
Slide 3: Oncolytics At-A-Glance
Oncolytics At-A-Glance Exchanges Nasdaq: ONCY / TSX: ONC Market Cap. Approx. $148M Our goal is to improve patient survival by Cash, cash equivalents, & CDN $42.7M (USD $31.7M) developing pelareorep, an marketable securities Based on FX as of Aug. 14, 2023 intravenously-delivered Shares Outstanding 7
Slide 4: Oncology's Most Prevalent Problems
Pelareorep: Immune Platform Molecule Targeting One of Oncology’s Most Prevalent Problems Problem: Inability of the Immune System to Recognize and Infiltrate Tumors Severely blunts the impact of a broad range of drug classes across a spectrum of indications Caused by multiple complex biological mecha
Slide 5: Pelareorep's Immune-mediated MOA Positions it to be a Platform Molecule
Pelareorep’s Immune-mediated MOA Positions it to be a Platform Molecule The Inability of the Immune System to Recognize and Infiltrate Tumors Limits the Impact of Many Drug Classes Pelareorep Offers a Potential Solution to Immunosuppressive Tumor Microenvironments (TMEs) Underlying Characteristics o
Slide 6: Pipeline Includes Two Registration Opportunities
Pipeline Includes Two Registration Opportunities HR+ / HER2- First-line Advanced / Metastatic Breast Cancer Pancreatic Cancer Positive data reported from two randomized phase 2 Status Phase 1/2 data reported November 2022 trials (IND-213 & BRACELET-1) Statistically significant near doubling of media
Slide 7: Pelareorep in HR+ / HER2- Breast Cancer
Pelareorep in HR+ / HER2- Breast Cancer
Slide 8: 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 9: Clinical Data Confirm Pelareorep's Immunotherapeutic Mechanism of Action
Clinical Data Confirm Pelareorep’s Immunotherapeutic Mechanism of Action in HR+ / HER2- Breast Cancer Pre vs. Post Treatment CD8+ T Cell Infiltration AWARE-1 Window-of-opportunity Study Design Cohort 1 (n=10): Letrozole (LTZ) + pelareorep (pela) HR+ / HER2- N = 20 Before Cohort 2 (n=10): Atezolizuma
Slide 10: Phase 2 BRACELET-1 Study Design
Phase 2 BRACELET-1 Study: Designed to Confirm IND-213’s Positive Results and Inform Registrational Trial Design Randomization Treatment Schedule Follow Up 1:1:1 Cohort 1 (n=15): Paclitaxel (PTX) Key Eligibility Criteria • No prior chemo for metastatic disease • Progressed on at least 1 hormone-based
Slide 11: BRACELET-1 Robust Improvements in PFS and ORR
BRACELET-1 Data Show Robust Improvements in PFS and ORR in Pelareorep + Paclitaxel Arm1 Paclitaxel (PTX) PTX + Pelareorep + PTX + Pelareorep Response2 Monotherapy Avelumab (Cohort 2, n=16) (Cohort 1, n=15) (Cohort 3, n=17)3 Confirmed ORR Over 13.3% 37.5% 17.6% Course of Trial 6.3 9.5 6.2 mPFS (month
Slide 12: BRACELET-1 Robust Improvement in PFS
BRACELET-1 Robust Improvement in PFS in Pelareorep + Paclitaxel Arm1 PFS Kaplan-Meier Curve2 PTX + Paclitaxel (PTX) PTX + Pelareorep + Monotherapy Pelareorep Avelumab Median PFS 6.3 9.5 6.2 (months) (95% CI: 3.9, NR) (95% CI: 6.5, NR) (95% CI: 4.0, NR) PFS HR vs. PTX 0.29 1.31 Mono-therapy - (95% CI
Slide 13: BRACELET-1 Translational Data Align with ORR and PFS Endpoints
BRACELET-1 Translational Data Align with ORR and PFS Endpoints Statistically Significant Expansion of T Cell Clones Key Translational Findings with Pelareorep-Paclitaxel Combination Paclitaxel (PTX) PTX + Pelareorep PTX + Pelareorep • Statistically significant expansion of T cell + Avelumab clones s
Slide 14: IND-213 and BRACELET-1 Patient Populations
IND-213 and BRACELET-1 Patient Populations BRACELET-1 Population is Representative of Current Standard-of-care All BRACELET-1 Patients Received Prior Hormone-based Therapy with a CDK 4/6 Inhibitor IND-213 BRACELET-1 PTX PTX + Pela PTX PTX + Pela PTX + Pela + Ave HR+ / HER2- BC n 29 28 15 16 17 Non-H
Slide 15: Pelareorep Displayed a Generally Favorable Safety Profile
Pelareorep Displayed a Generally Favorable Safety Profile Fifteen Most Common Adverse Events1,2 as Attributed to Study Drug(s) Paclitaxel (PTX) PTX + Pelareorep PTX + Pelareorep + (n=12) (n=16) Avelumab (n=17) Grade Any ≥3 Any ≥3 Any ≥3 Alopecia 6 (50%) - 9 (56%) - 8 (47%) - Anemia 7 (58%) - 5 (31%)
Slide 16: BRACELET-1 Summary: Advancing to Registrational Study
BRACELET-1 Summary: Advancing to Registrational Study 31.3% ORR at week 16 with pelareorep + paclitaxel (PTX) vs. 20% with PTX monotherapy Efficacy 37.5% Confirmed ORR Over Course of Trial with pelareorep + paclitaxel (PTX) vs. 13% with PTX monotherapy Data Median PFS of 9.5 months with pelareorep +
Slide 17: Advancing to Registrational Study in HR+/HER2- mBC
Advancing to Registrational Study in HR+/HER2- mBC Monotherapy Study Phase 1 Demonstrated pelareorep’s single agent activity in HR+/HER2- breast cancer Randomized Phase 2 study in mBC comparing pelareorep (pela) + paclitaxel (PTX) vs. PTX alone IND-213 Provided clinical POC by demonstrating a statis
Slide 18: Registration Could Address a Critical Unmet Need
Registration Could Address a Critical Unmet Need Drug Treatable HR+ / HER2- Breast Cancer Cases in Major Markets1 300 290 Patients (Thousands) Significant SOC limitations Incidence projected to rise to ~300,000 patients by 2028 280 Currently approved therapies are unable to produce a meaningful surv
Slide 19: Pelareorep in First-Line Advanced / Metastatic Pancreatic Cancer
Pelareorep in First-Line Advanced / Metastatic Pancreatic Cancer
Slide 20: Effective Therapies For Pancreatic Cancers are an Urgent Unmet Need
Effective Therapies For Pancreatic Cancers are an Urgent Unmet Need Estimates project ~135,000 metastatic, drug-treatable, 1L cases in major markets by 20281 Mono- or Combo-therapies Chemotherapy Provides with ICIs Are Not Effective Poor Prognosis Limited Efficacy for >99% of Patients Historical con
Slide 21: Pelareorep-based Combinations Evaluated in First and Second-line Patients
Several Pelareorep-based Combinations, Including With Checkpoint Inhibitors, Have Been Evaluated in First and Second-line Patients Pelareorep has been administered to 129 PDAC patients in 4 completed and 1 ongoing study: First-line studies Study N CPI Treatment regimen REO 017 34 - pelareorep + gemc
Slide 22: REO 017: Pelareorep + Chemotherapy Median Overall and Landmark Survival
REO 017: Pelareorep + Chemotherapy Generated Median Overall and Landmark Survival Rates Compare Favorably to 3rd – Party Historical Data Design: Single-arm; 34 patients enrolled, 29 evaluable for response REO 017 Population: Metastatic or advanced PDAC; No previous chemotherapy (1L) Treatment: Gemci
Slide 23: 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 Metastatic ORR at week 16 Colorectal Cancer Pelareore
Slide 24: GOBLET Tumor Responses at Weeks 8, 16, and 24
GOBLET Tumor Responses at Weeks 8, 16, and 24 Week 8 Week 16 Week 24 • Numbers indicate the percent change in target lesion size from baseline • Dotted lines represent cut-offs for progressive disease (+20%) or partial response (-30%) • (*) indicates patients with PD 24
Slide 25: Interim Pancreatic Cancer Cohort Showed ORR of 69%
Interim Data from Pancreatic Cancer Cohort Showed ORR of 69% in Evaluable Patients (n = 13) Average ORR of ~25% reported in historical control trials of gemcitabine + Nab-paclitaxel1-4 Baseline Week 8 Week 16 Week 24 Week 32 Week 40 Week 48 Strong Early Efficacy Signal C1-002 Complete response (CR)
Slide 26: Conclusions from Pancreatic Cancer Studies and Pathway to Registration
Conclusions from Pancreatic Cancer Studies and the Pathway to Registration Pelareorep administered to 129 pancreatic cancer patients with no safety concerns, multiple studies show 01 pelareorep infects tumors and modifies the TME to stimulate both innate and adaptive immune responses 02 Pelareorep +
Slide 27: Precision Promise Pivotal Phase 3 Platform Trial
Precision PromiseSM Pivotal Phase 3 Platform Trial is Designed to Reduce the Time and Cost of a Pivotal Trial Precision Promise’sSM Design Potential Benefits: Control Arms ➢ Control arms of mFOLFIRINOX and gemcitabine + nab- mFOLFIRINOX paclitaxel have been enrolling for several years and historical
Slide 28: Pancreatic Cancer Action Network Grant Enables Opportunity
Pancreatic Cancer Action Network Grant Enables Opportunity to Address Both Standard of Care Populations
Slide 29: PanCAN $5M Therapeutic Accelerator Award Grant
PanCAN $5M Therapeutic Accelerator Award Grant Opens Both Standard of Care Markets in Pancreatic Cancer ➢ Currently, mFOLFIRINOX and gemcitabine + nab-paclitaxel are the standards of care for pancreatic cancer patients.1 ➢ With the Precision PromiseSM trial of pelareorep + gemcitabine + nab-paclitax
Slide 30: Clinical Studies Leverage Platform Potential and Collaborations
Clinical Studies Leverage Pelareorep’s Platform Potential and Collaborations With Industry Leaders Program Collaborator Preclinical Phase 1 Phase 2 Phase 3 Milestone BREAST CANCER BRACELET-1 HR+/HER2- mBC ORR and PFS Q2 ’23 ✓ IRENE TNBC Phase 2 Safety Data Q4 ‘21 ✓ GASTRO-INTESTINAL CANCER Precision
Slide 31: Pelareorep as an Enabling Technology for CAR T Cell Therapy
Pelareorep as an Enabling Technology for CAR T Cell Therapy in Solid Tumors
Slide 32: Pelareorep: An Enabling Technology For CAR T Cell Therapy
Pelareorep: An Enabling Technology For CAR T Cell Therapy in Solid Tumors Current Challenges for CAR T Cell Therapy in How Pelareorep May Enable CAR T Cells to Solid Tumors Overcome Traditional Solid Tumor Challenges Early CAR T cell exhaustion: CAR T cells are short lived Pelareorep-loaded CAR T ce
Slide 33: Synergistic Anti-Cancer Activity of Pelareorep With CAR T Cell Therapy
Synergistic Anti-Cancer Activity of Pelareorep Combined With CAR T Cell Therapy in Solid Tumors B16-EGFRviii tumor s.c. Enhanced survival with pelareorep + CAR T Cell combination therapy relative to either monotherapy Day 8 Day 15 CAR T cells or virus i.v. (1x107 Boost i.v. Virus or PBS (1x107 CAR T
Slide 34: Recurring Tumors Treated With Boost of Homologous Virus
Tumors Which Recur Can Be Treated With a Further Boost of Homologous Virus But Not Heterologous Virus B16-EGFRviii tumor s.c. In three mice, tumors recurred Day 8 Day 15 around day 40-50. When CAR T cells or virus i.v. (1x107 Boost i.v. Virus or PBS (1x107 recurrent tumors started to CAR T; Loaded a
Slide 35: CAR T Conclusions and Next Steps
CAR T Conclusions and Next Steps Pelareorep vastly Pelareorep’s synergistic Pelareorep has the Pursuing a partnership improved the persistence effects with CAR T cell potential to broaden the strategy to further and efficacy of CAR T therapy appear to be applicability of CAR T pelareorep’s cell ther
Slide 36: Catalysts & Milestones
Catalysts & Milestones Innately Adaptive’
Slide 37: Catalysts & Milestones
Catalysts & Milestones Upcoming Catalysts & Milestones Collaborator(s) Timing BRACELET-1 mBC study: ORR and PFS data ✓ Preclinical data from the combination of pelareorep and CAR T therapy ✓ GOBLET PDAC cohort updated efficacy data H2 2023 GOBLET metastatic colorectal and advanced anal cohort update
Slide 38: Appendix
Appendix Owco LYTICS BIOTECH INC. Innatel ly Adaptive
Slide 39: Experienced Leadership and Advisory Board
Experienced Leadership and Advisory Board Extensive knowledge of immuno-oncology | Public company experience | Strong business development and commercialization expertise MANAGEMENT NON-EXECUTIVE DIRECTORS SCIENTIFIC ADVISORY BOARD Matt Coffey, PhD, MBA Wayne Pisano, MBA Dr. Martine Piccart, MD, PhD
Slide 40: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio 153 patents issued worldwide, including 19 US and 7 Canadian 17 pending applications worldwide Reovirus issued patent claims cover: Compositions of matter comprising reovirus Patent rights extend to at least the end of 2031 Pharmaceutical use of reoviruses to t
Slide 41: Competitive Advantages
Competitive Advantages Delivered Intravenously Accesses primary and metastatic disease Selective PD-L1 Response in Tumor Cells BSL 2 classification Administered via standard practices, does not require special handling for administration Potentiates multiple immunotherapies Synergistic potential wit
Slide 42: Underlying Biology of Pelareorep's Immunotherapeutic Mechanism of Action
Underlying Biology of Pelareorep’s Immunotherapeutic Mechanism of Action Intravenous administration of pelareorep leads to • Selective replication in cancerous cells with accumulation of dsRNA • Promotion type 1/2 interferon signaling via pattern recognition receptors such as RIG-I and TLR3 • Activa
Slide 43: Pelareorep is Safe and Well-Tolerated
Pelareorep is Safe and Well-Tolerated Intravenous Local • 1,100 patients treated, 1,000+ intravenously Monotherapy Toxicity Symptoms • Toxicities have generally been mild (grade 1 or 2) and included chills, fever, headache, cough, myalgia, runny nose, sore throat, fatigue, lymphopenia or neutropenia
Slide 44: Pelareorep in Breast Cancer
Pelareorep in Breast Cancer Additional studies and data
Slide 45: BRACELET-1 Robust Improvement in ORR
BRACELET-1 - Robust Improvement in ORR in Pelareorep + Paclitaxel Arm1 Paclitaxel (PTX) PTX + Pelareorep + PTX + Pelareorep Response2,3 Monotherapy Avelumab (Cohort 2, n=16) (Cohort 1, n=15) (Cohort 3, n=17)4 ORR at Week 16 20% 31.3% 17.6% Confirmed ORR Over 13.3% 37.5% 17.6% Course of Trial Disease
Slide 46: BRACELET-1 Swimmers Plots: PTX vs. Pelareorep + PTX
BRACELET-1 Swimmers Plots: PTX vs. Pelareorep + PTX Cohort 1 (PTX alone) Cohort 2 (PTX + Pelareorep) Partial response Stable disease Radiologic progression Not evaluable End of treatment (EOT) Patients with arrowheads ( ) remain on study Data cut-off date: March 3, 2023. Numbers presented may change
Slide 47: BRACELET-1 Spider Plots: PTX vs. Pelareorep + PTX
BRACELET-1 Spider Plots: PTX vs. Pelareorep + PTX PTX Monotherapy Pelareorep + PTX 100% 100% On study 80% 80% Tumor Size (% Change From Baseline) Tumor Size (% Change From Baseline) 60% 60% 40% 40% 20% 20% 0% 0% -20% -20% -40% -40% -60% -60% -80% -80% -100% -100% 0 2 4 7 10 13 17 0 2 4 7 10 13 17 Mo
Slide 48: AWARE-1 Achieved Primary Objective
AWARE-1 Achieved Primary Objective CelTIL (Primary Endpoint): A composite measure of tumor Pre vs. Post Treatment Tumor PD-L1 Expression cellularity and immune cell infiltration 175 Cohort Cohort1 (pela 1 w/o atezo) from Baseline to Surgery 150 Cohort Cohort 2 + atezo) 2 (pela Before % change in Cel
Slide 49: TNBC Market: Additional Opportunity
TNBC Market: Additional Opportunity TNBC Collaborator 3,600,000 breast cancer prevalence, U.S. 20171 540,000 TNBC prevalence in the US2 Nearly all patients saw increased 62% PD-L1 expression in the of patient are not eligible for AWARE-1 study following immunotherapy based on low PD-L1 expression3 p
Slide 50: Phase 2 IRENE Study in Metastatic TNBC
Phase 2 IRENE Study Evaluates the Efficacy of Pelareorep- anti-PD-1 Combination Therapy in Metastatic TNBC Primary Endpoints • Safety Treatment Schedule • Objective response rate IRENE Study (n=25): Pelareorep + Anti-PD-1 Secondary Endpoints • PFS • OS • Duration of response Exploratory Endpoints 28
Slide 51: Expanding the Frontiers of Immunotherapy
Expanding the Frontiers of Immunotherapy Gastrointestinal Cancers & Hematologic Malignancies
Slide 52: Improved Therapies For Gastrointestinal Cancers Are Needed
Improved Therapies For Gastrointestinal Cancers Are Needed GI Collaborator 4,800,000 Estimated number of new GI cancer cases worldwide in 20181 26% GI cancers account for 26% of global cancer incidence1 Pela combo therapies have shown: >90% CBR in KRAS-mutated colorectal 180,000 cancer patients3 Est
Slide 53: Pelareorep-Checkpoint Inhibitor Combination Therapy in GI Cancer
Clinical Data Highlight the Potential of Pelareorep-Checkpoint Inhibitor Combination Therapy in GI Cancer Clinical studies evaluating pelareorep-based combination treatments in GI cancer have shown: • A >90% clinical benefit rate in KRAS-mutated colorectal cancer patients1 • 69% objective response r
Slide 54: GOBLET PDAC Patient Profiles: Evaluable Patients
GOBLET PDAC Patient Profiles: Evaluable Patients Target lesion size at Patient # Age (years) Sex ECOG score Metastases (location) baseline (mm) C1-001 72 F 1 None 65 C1-002 54 M 1 Peritoneum 37 C1-004 63 F 1 Lung 13 C1-005 71 M 0 Liver 79.5 C1-007 54 M 0 Liver 63 C1-008 53 M 0 Liver 187 C1-010 67 M
Slide 55: Anti-PD-1 / PD-L1 Have Shown Limited Efficacy in PDAC
Anti-PD-1 / PD-L1 Have Shown Limited Efficacy in PDAC Table 1 | Selected T cell checkpoint-targeted clinical trials in PDAC1 Target (drug) Phase N Population Objective Response Rate PD-L1 (BMS-936559) 1 14 Advanced PDAC, pretreated 0% PD-1 (pembrolizumab + 1 11 Advanced PDAC 18.2%* gemcitabine + nab
Slide 56: NU 18I01: Pelareorep + Pembrolizumab Without Chemotherapy
NU 18I01: Pelareorep + Pembrolizumab Without Chemotherapy Achieved Disease Control in 42% of PDAC Patients Design: Single-arm; 13 patients enrolled, 12 evaluable for efficacy Efficacy results in the absence of Population: Relapsed metastatic PDAC (2L) chemotherapy: Treatment: Pelareorep (Days 1, 2,
Slide 57: Pelareorep's Potential in Liquid Tumors
Clinical Data Show Pelareorep’s Potential in Liquid Tumors Clinical data demonstrate pelareorep’s potential to synergistically combine with proteasome and/or immune checkpoint inhibitors in the treatment of hematologic malignancies Proof-of-Concept Clinical Data PD-L1 expression before Pelareorep ta
Slide 58: Development Strategy
Development Strategy Objective: Pelareorep As An Enabling Technology Across Oncology Drug Classes 1 2 3 Preserve primary focus and Leverage collaborations with Selectively pursue partnership resources on advancing breast industry leaders and academia opportunities to further and pancreatic cancer pr
Slide 59: Additional Potential Immunotherapy Opportunities
Additional Potential Immunotherapy Opportunities Pelareorep combined with CD3-bsAbs increased T cell numbers, induced tumor regression, and Bispecific prolonged survival in solid tumor models Antibodies1 The combination strategy may be effective in the treatment of metastatic disease PARP Pelareorep
Slide 60: Business Development Strategy Anchored By Partnerships With Large Pharma
Business Development Strategy Anchored By Partnerships With Large Pharmaceutical Companies Objective: Joint Development and Co-Development Study Commercialization Partnership • Co-development agreement with Pfizer/EMD • Support of breast and pancreatic cancer Serono to evaluate Bavencio® in 2L mBC r
Slide 61: Website oncolyticsbiotech.com Nasdaq ONCY TSX ONC
61 Website oncolyticsbiotech.com Nasdaq ONCY TSX ONC
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