Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (March 2025)
42 slides from Oncolytics Biotech's investor presentation, March 2025
Slide 1: Unleashing the Power of the Immune System to Fight Cancer
Unleashing the Power of the Immune System to Fight Cancer Investor Presentation March 2025
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 the 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 ~55,000 Addressable Patients
The HR+/HER2- mBC Segment Post Enhertu Represents ~55,000 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: ~55,000 prevalent HR+ HER2- mBC who have progressed
Slide 8: Pelareorep Potential Peak Sales: $2.4 Billion across US + EU5
Pelareorep Potential Peak Sales: $2.4 Billion across US + EU5 Projected U.S. & EU sales of Pelareorep(*) in HR+ mBC (Sales in USD MM) Key Assumptions: $2,438 • Peak penetration across key addressable patient populations $2,500 EU Sales (USD MM) • 1L+ for HER2-null: 20% U.S. Sales (USD MM) • 2L+ for
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: IND-213: Pelareorep-based Therapy Led to Statistically Significant Survival Benefit
IND-213: Pelareorep-based Therapy Led to Statistically Significant Survival Benefit • Randomized Ph2 study in adv/metastatic breast cancer post hormonal therapy and ≥1-line chemotherapy • Treatment groups: Paclitaxel + pelareorep vs. paclitaxel (standard of care control) Phase 2 All Subtypes (n = 74
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: Robust Improvement in Progression-free Survival (PFS) in 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. PTX - 0.39 1.
Slide 13: BRACELET-1: Substantial Improvement in Overall Survival
BRACELET-1: Substantial Improvement in Overall Survival (OS) for in the Pelareorep + Paclitaxel Arm Kaplan-Meier Plot of Overall Survival Paclitaxel PTX + pela + PTX + pela (PTX) avelumab Cohort 2 Cohort 1 Cohort 3 Paclitaxel + pelareorep Not reached Median OS 18.2 21.7 (months) Estimate: 32.1* Pacl
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: Licensure Pathway Plan & FDA Type C Meeting Feedback
Licensure Pathway Plan & FDA Type C Meeting Feedback
Slide 17: Registration-Enabling Phase 2 Study in HR+/HER2- Metastatic Breast Cancer
Registration-Enabling Phase 2 Study in HR+/HER2- in Metastatic Breast Cancer Patients Primary endpoint Paclitaxel alone (N≈60) PFS final PFS IA: OS final analysis: 109 ~180 patients randomized 2:1 ~55 events analysis: 123 events Est. 12 mos events Est. 18 mos Paclitaxel + pelareorep (N≈120) ≥4.3-mon
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 Metastatic Pancreatic Cancer Second-line or Later Anal Cancer Status Phase 1/2 updated data reported October 2023 Phase 1/2 updated data reported January 2025 62% Objective response rate Key 7.2 months Median PFS 33% Objective respons
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: Pelareorep + Gem/Nab-paclitaxel + Atezolizumab Showed 62% ORR
Pelareorep + Gemcitabine/Nab-paclitaxel + Atezolizumab Showed 62% ORR, More Than Double Historical Rate 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%
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 Safety run-in Treatment
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, more than double the response rates recorded in historical Increased ORR control trials1-4 Studies Show Prior studies also showed clinicall
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, Expanding Enrollment
Positive GOBLET Anal Cancer Data Meets Success Criteria, Expanding Enrollment, Highlights Synergy with CPI Updated data presented at ASCO GI January 2025 Patient Population: • Patients with 2L, unresectable squamous cell carcinoma of the anal canal (SCCA) ORR of 33%, with 1 CR • Prior treatments inc
Slide 29: Pelareorep-Atezolizumab Combination in Anal Cancer, ORR Exceeds Historical Rates
Pelareorep-Atezolizumab Combination in Anal Cancer, ORR Exceeds Historical Efficacy Rates of Like Studies ORR of 33%, expanding enrollment to confirm efficacy signal. Of 12 evaluable patients: • 1 CR (ongoing at 15 months) • 3 PR (one at week 8, week 16, and one ongoing at week 80) • ~10-24% Average
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 147 patents issued worldwide, including 12 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 with Strong Immuno-oncology Expertise
Innovative Leadership Team with Strong Immuno-oncology, Business Development, Clinical Trial and Finance Expertise Wayne Pisano Thomas Heineman, M.D., Ph.D. Kirk Look, CA, MSJ Interim Chief Executive Officer Chief Medical Officer Chief Financial Officer Chair of Board Allison Hagerman, PEng, PMP, MB
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*) 411,410 Jason McCarthy Maxim Group Shares Outstanding 86,421,592 Douglas Miehm RBC Capital Markets Market cap1 ~$64 M Douglas Loe Leede Financial Cas
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 First Patient Enrolled Planned Study TBD pela + PTX Preparing protocol for FDA submission H2 2025 GASTROINTESTINA
Slide 35: Value-Driving Milestones
Value-Driving Milestones H1 2025 H2 2025 2026 - 2027 GI Cancer Breast Cancer Breast Cancer Finalize master protocol First patient enrolled in H1 2026: PFS interim for registration-enabling registration-enabling analysis, approx. study with GCAR mBC study 55 events GI Cancer H2 2026: last patient enr
Slide 36: 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 37: 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 38: 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
Slide 39: BRACELET-1 Study Groups are Well-balanced for Key Attributes
BRACELET-1 Study Groups are Well-balanced for Key Attributes PTX Monotherapy PTX + Pelareorep PTX + Pelareorep + Avelumab N=15 N=16 N=17 Age 60 (46-74) 52.5 (38-71) 59 (37-70) Performance status (ECOG score) 0 10 (67%) 11 (69%) 10 (59%) 1 5 (33%) 5 (31%) 7 (41%) White race 12 (80%) 12 (75%) 13 (76%)
Slide 40: Benefit of Pelareorep-based Therapy Compare Favorably to T-DXd
Benefit of Pelareorep-based Therapy Compare Favorably to T-DXd Destiny-Breast04 Destiny-Breast06 BRACELET-1 Chemotherapy vs. T-DXd Chemotherapy vs. T-DXd Pac vs. Pac + Pela Endpoint 1-line prior chemotherapy No prior chemotherapy No prior chemotherapy TPC T-DXd TPC T-DXd Paclitaxel Pac-Pela Confirme
Slide 41: 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 42: 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
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