Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (May 2024)
34 slides from Oncolytics Biotech's investor presentation, May 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 May 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: Investment Opportunity Driven by Robust Pelareorep Results
Investment Opportunity Driven by Robust Pelareorep Results Robust Clinical Data in Randomized and Open-Label Phase 1/2 studies demonstrate meaningful improvements in Breast and Pancreatic overall response rate, progression-free survival, and overall survival Cancer Differentiated Approach Systemical
Slide 4: 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 updated data reported October 2023 trials (IND-213 & BRACELET-1) Statistically significant near doubling o
Slide 5: Pelareorep is a 1st in Class, Immunotherapeutic Agent
Pelareorep is a 1st in Class, Immunotherapeutic Agent An unmodified, non-pathogenic reovirus Selectively replicates in cancerous cells Enables the accumulation of double-stranded RNA (dsRNA) that stimulates the immune system Leads to the activation of the Innate and Adaptive Immune System 5 Oncolyti
Slide 6: Pelareorep is a Differentiated Immunotherapy
Pelareorep is a Differentiated Immunotherapy Key differentiators: Activation of the Innate and Adaptive Immune System, tumor microenvironment remodeling Key Immunotherapy Innate Immune System Activation Features Promotes expression of interferons and inflammatory cytokines to promote recruitment and
Slide 7: Pelareorep in HR+ / HER2- Breast Cancer
Pelareorep in HR+ / HER2- Breast Cancer
Slide 8: Breast Cancer Registrational Strategy Supported by Data from Two Randomized Trials
Breast Cancer Registrational Strategy Supported by Data from Two Randomized Trials and a Translational Study Phase 2 Studies Highlight Positive data from BRACELET-1 and IND-213 randomized trials showed meaningful improvements Benefit with Paclitaxel in response rates and survival for patients in the
Slide 9: 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 10: BRACELET-1 Study Showed Robust Improvement in mPFS
BRACELET-1 Study Showed Robust Improvement in mPFS for the Pelareorep + Paclitaxel Arm1 Median 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) mPFS HR vs. PTX 0.29
Slide 11: BRACELET-1 Data Show Benefits in Pelareorep + Paclitaxel Arm
BRACELET-1 Data Show Benefits in Pelareorep + Paclitaxel Arm1 Response Measures/ PTX Monotherapy PTX + Pelareorep PTX + Pelareorep + Study arms2 (n=15) (n=16) Avelumab (n=17)3 Confirmed ORR Over 13.3% 37.5% 17.6% Course of Trial 6.3 9.5 6.2 mPFS (months) (95% CI: 3.9, NR) (95% CI: 6.5, NR) (95% CI:
Slide 12: 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 13: AWARE-1 Translational Data Shows Consistent Impact on CelTIL Score, PD-L1
AWARE-1 Translational Data Shows Consistent Impact on CelTIL Score, PD-L1 Expression Tumor PD-L1 expression CelTIL (cell death & inflammation) Expansion: Improvements associated with better treatment outcomes1 Pre-treatment 175 Cohort Cohort 1 w/o atezo) 1 (pela from Baseline to Surgery 150 Cohort C
Slide 14: Breast Cancer Registrational Trial Update Planned for H1 2024
Breast Cancer Registrational Trial Update Planned for H1 2024 Patient Population HR+/HER2- mBC: • Prior Treatments: hormonal therapy including CDK4/6 inhibitors, and patients who failed or were ineligible for ADC therapy • Design to be based on positive BRACELET-1 Phase 2 results Treatment Regimen:
Slide 15: Pelareorep in First-Line Advanced / Metastatic Pancreatic Cancer
Pelareorep in First-Line Advanced / Metastatic Pancreatic Cancer
Slide 16: Registrational Plan in Pancreatic Cancer Driven by GOBLET Phase 1/2 Data
Registrational Plan in Pancreatic Cancer Driven by Promising GOBLET Phase 1/2 Data & Supported by FDA Fast Track Designation Studies Show Positive Data from pancreatic cancer patients in the GOBLET and REO-017 open-label trials Survival Benefit showed meaningful improvements in survival GOBLET Study
Slide 17: PDAC GOBLET Results Showing 62% ORR
PDAC GOBLET Results Showing 62% ORR 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% -100% -110% Dotted lines represent cut-offs for
Slide 18: Expansion of T cell Clones Correlate with Tumor Shrinkage
Expansion of New/Pre-Existing T cell Clones Correlate with Tumor Shrinkage Provides a Valuable Potential Biomarker 18 Source: ESMO 2023 poster
Slide 19: Next Steps: mFOLFIRINOX Study to Further Explore Combinations
Next Steps: mFOLFIRINOX Study to Further Explore Combinations with the Most Common PDAC Treatment Regimens Strategic rationale: to investigate the use of pelareorep with the most commonly used treatment regimens Patient Population: • Newly diagnosed metastatic PDAC patients (as defined by RECIST 1.1
Slide 20: 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 21: Pelareorep in ≥ Second-Line Unresectable Anal Cancer
Pelareorep in ≥ Second-Line Unresectable Anal Cancer
Slide 22: 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: • Phase 2 Simon Two-Stage Cohort • Patients with 2L, unresectable squamo
Slide 23: 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 24: 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 expected in pela + PTX HR+/HER2- mBC H2 2024 Registrational Study Planned Study TBD pela + PTX
Slide 25: Key Value-Driving Clinical Milestones Ahead in 2024+
Key Value-Driving Clinical Milestones Ahead in 2024+ H1 2024 2024 2025 - 2026 Breast Cancer Pancreatic Cancer Pancreatic Cancer Provide guidance on Expanded data from Initiate GCAR study and the registration path the GOBLET study report interim analysis cohorts 1 & 5 from the adaptive registration-e
Slide 26: Cash Balance Supports Planned Operations Through Key Milestones
Cash Balance Supports Planned Operations Through Key Milestones Financial Overview Research Coverage ONCY: NASDAQ Ticker Patrick Trucchio H.C. Wainwright & Co. ONC: TSX Avg. Daily Volume (1 mo*) 198,559 John Newman Canaccord Genuity Shares Outstanding 75,853,097 Jason McCarthy Maxim Group Market cap
Slide 27: Innovative Leadership Team with Strong Immuno-oncology Expertise
Innovative Leadership Team with Strong Immuno-oncology, 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 Amy Levin, RN, BSN VP, Product Develop
Slide 28: Investment Opportunity Driven by Robust Pelareorep Results
Investment Opportunity Driven by Robust Pelareorep Results Robust Clinical Data in Randomized and Open-Label Phase 1/2 studies demonstrate meaningful improvements in Breast and Pancreatic overall response rate, progression-free survival, and overall survival Cancer Differentiated Approach Systemical
Slide 29: Appendix
NCOLYTICS BIOTECH INC Appendix
Slide 30: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio 147 patents issued worldwide, including 13 US and 7 Canadian 16 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 31: 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: Metastatic Colorectal Cancer Pelareorep + Atezolizumab Safet
Slide 32: REO 017: Pelareorep + Chemotherapy in PDAC Survival Rates
REO 017: Pelareorep + Chemotherapy in PDAC Generated Median Overall and Landmark Survival Rates That 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) Tre
Slide 33: BRACELET-1 Translational Data Align with ORR and PFS Endpoints
BRACELET-1 Translational Data Align with ORR and PFS Endpoints Loss of pelareorep clinical activity in BRACELET-1 Cohort 3 coincided with lack of expansion of pre-existing clones 33 ORR: Overall response rate; PFS: Progression-free survival
Slide 34: Pelareorep's Favorable Overall Safety Highlighted by BRACELET-1 Safety Summary
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
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