Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (September 2015)
35 slides from Oncolytics Biotech's investor presentation, September 2015
Slide 1: Corporate Presentation September 2015
Corporate Presentation September 2015
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains certain forward looking statements relating to the company’s financial results, business prospects and the development and commercialization of REOLYSIN®, a therapeutic reovirus. These statements are based on management’s current expectations and
Slide 3: Oncolytics Overview
Oncolytics Overview Developing REOLYSIN® 400+ issued patents and (oncolytic virus) as a 235 pending cancer therapeutic applications worldwide Conducted 30+ clinical 1,100+ patients treated; studies in 13 indications strong safety profile Manufacturing $32.1 million cash as at at commercial scale the
Slide 4: What is REOLYSIN?
What is REOLYSIN®? Proprietary isolate of the reovirus Widely found Non-pathogenic Widespread human exposure 4
Slide 5: REOLYSIN Mechanism of Action
REOLYSIN® Mechanism of Action Normal Cells REOLYSIN® REOLYSIN® Healthy cells infects both does not remain Progeny viruses repeat cell infection cycle in nearby REOLYSIN® tumour cells replicate in undamaged and normal cells that are tumour cells healthy cells not Ras Administered to activated patient
Slide 6: REOLYSIN and Safety
REOLYSIN® and Safety General Safety 1,100+ patients treated, 1,000+ intravenously No MTD reached Safety profile confirmed in a randomized setting Monotherapy Safety Mild toxicities (grade 1 or 2) including • Chills • Cough • Sore throat • Fever • Myalgia • Fatigue • Headache • Runny nose • L
Slide 7: REOLYSIN Clinical Program
REOLYSIN® Clinical Program Indication Studies REO 003 REO 007 REO 008 NCI (COG-ADVL1014) REO 013 Brain MAY0 (MC-1472) GLIOMA PhaseI/II PhaseI/II PhaseII PhaseI PhaseI PhaseI Orphan Status REO 001 REO 002 IND 209 PROSTATE PhaseI PhaseI PhaseII NCI (OSU-07022) NCI (GOG-0186H) OVARIAN PhaseI/II PhaseII
Slide 8: REOLYSIN Addressable Market
REOLYSIN® Brain 13,710 Addressable Head & Neck 27,468 Market Lung & Bronchus 132,720 Pancreas Breast 29,376 140,514 Soft tissue 7,158 Colon & Rectum Ovarian 79,620 12,774 Prostate 132,480 Melanoma 44,322 1,000,000+ new U.S. cases a year Myeloma in studied indications, 16,110 of which REOLYSIN® conse
Slide 9: Orphan Drug Designations
Orphan Drug Designations Orphan Drug Designations obtained for REOLYSIN®: FDA EMA • ovarian • primary peritoneal • ovarian • pancreatic • fallopian tube • pancreatic • malignant gliomas • gastric Potential benefits of Orphan Drug Designation: A period of market exclusivity (US and EU) Potential
Slide 10: What Does REOLYSIN Do? Reduces Tumour Burden
What Does REOLYSIN® Do? Reduces Tumour Burden
Slide 11: REO 003: Intratumoural Monotherapy Anaplastic Astrocytoma
REO 003: REOLYSIN® Intratumoural Monotherapy Anaplastic Astrocytoma Early Cytotoxic Activity Followed by Late Stage Immune-Mediated Response Against the Residual Tumour Days after REOLYSIN® administration: 0 3 43 88 167 537 Viral replication mediated Post debulking Immune mediated tumour response tu
Slide 12: REO 021: Partial Response in Squamous Cell Carcinoma of the Lung
REO 021: Partial Response in Patient with Squamous Cell Carcinoma of the Lung Right Upper Lung Mass (8.3 cm) Right Upper Lung Mass (4.1 cm) Right Upper Lung Mass (3.6 cm) Right Pleural Met (2.2 cm) Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm) Pre-Treatment Post-Cycle 2 Post-Cycle 4 12
Slide 13: REO 018 Head and Neck Cancer: Randomized Tumour-Specific Response Data
REO 018 Head and Neck Cancer: Randomized Tumour-Specific Response Data First Endpoint: Velocity Second Endpoint: Volume o 105 patients Loco-regional patients with or without o 86% of test arm (n=50) had distal metastases tumour stabilization or shrinkage o 23% improvement in test arm vs. o 67% of co
Slide 14: Registration Program for REOLYSIN
Registration Program for REOLYSIN® Short-Term: Tumour Reduction Endpoints: Neoadjuvant treatment of muscle-invasive bladder cancer Neoadjuvant = therapy used prior to a major therapeutic intervention (usually surgery) in order to improve outcome Next Steps: IND has been filed to conduct a smal
Slide 15: Why Muscle Invasive Bladder Cancer?
Why Muscle Invasive Bladder Cancer? Studies demonstrate that REOLYSIN® increases both the magnitude and velocity of tumor shrinkage Muscle invasive bladder cancer is the only cancer indication in which US regulators have accepted histopathological response as a registration endpoint in a neoadju
Slide 16: What Does REOLYSIN Do? Improves Overall Survival
What Does REOLYSIN® Do? Improves Overall Survival
Slide 17: Top-Line Overall Survival Results: REO 018 (Head and Neck Cancer)
Top-Line Overall Survival (OS) Results: REO 018 (Head and Neck Cancer) An intent-to-treat analysis of 118 patients with loco- regional disease showed a statistically significant improvement in the OS of the test arm versus that of the control arm 1 p=0.0146 hazard ratio=0.5099 1 Overall surviv
Slide 18: Top-Line Overall Survival Results
Top-Line Overall Survival (OS) Results REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies: 18
Slide 19: What Does REOLYSIN Do? Enhances Long-Term Immune Responses
What Does REOLYSIN® Do? Enhances Long-Term Immune Responses
Slide 20: REO 003: Intratumoural Monotherapy Anaplastic Astrocytoma
REO 003: REOLYSIN® Intratumoural Monotherapy Anaplastic Astrocytoma Early Cytotoxic Activity Followed by Late Stage Immune-Mediated Response Against the Residual Tumour Days Post Treatment: 0 3 43 88 167 537 Viral replication mediated Post debulking Immune mediated tumour response tumour response 20
Slide 21: REOLYSIN: Enhancing Immune Response
REOLYSIN®: Enhancing Immune Response REOLYSIN® acts as a selective cytotoxin – killing the tumour cells in which it replicates We now know that administration of REOLYSIN® also: Causes the immune system to recognize and kill tumour cells as well Causes up-regulation of PD-1 and PD-L1 21
Slide 22: REOLYSIN: Immunology & Anti-PD-1 / PD-L1
REOLYSIN®: Immunology & Anti-PD-1 / PD-L1 In some types of cancer (including pancreatic cancer, glioblastoma and metastatic brain lesions), REOLYSIN® has been shown to upregulate PD-1 and PD-L1 (Appendix A) In cancers with low PD-1 and PD-L1 upregulation, this enhances the activity of checkpoint
Slide 23: Immune Preclinical Research
Immune Preclinical Research In ovarian cancer models in mice: Combination of gemcitabine and reovirus type 3 improved overall survival In melanoma models in mice: Combination of GM-CSF with REOLYSIN® improved overall survival In brain cancer models in mice: Combination of a checkpoint in
Slide 24: Enhancing Immune Responses to Improve Overall Survival
Enhancing Immune Responses to Improve Overall Survival Ongoing preclinical and clinical research has led to three clinical programs: 1. Gemcitabine in combination with REOLYSIN® (REO 009 and REO 017); 2. GM-CSF in combination with REOLYSIN® (Mayo (pediatric) and Leeds (adult)); or 3. Checkpoint in
Slide 25: Registration Program for REOLYSIN
Registration Program for REOLYSIN® Medium-Term: intravenous treatment of advanced gliomas Long-Term: to be determined upon receipt of data from ongoing single-arm and randomized studies in a range of indications 25
Slide 26: Registration Program for REOLYSIN: Medium-Term Overall Survival Endpoints
Registration Program for REOLYSIN® Medium-Term – Overall Survival Endpoints A key finding from REO 013 was that REOLYSIN® can cross the blood brain barrier and subsequently infect and kill tumour in the brain, as well as primary gliomas and metastatic lesions from other primary cancers outside bra
Slide 27: Registration Program for REOLYSIN: Next Steps
Registration Program for REOLYSIN® Next Steps A small “run-in” study assessing response in gliomas has been initiated (Mayo Clinic’s MC1472) o Pediatric patients being treated with REOLYSIN® in combination with GM-CSF Second study assessing response in adult patients receiving REOLYSIN® and the
Slide 28: Manufacturing & Intellectual Property
Manufacturing & Intellectual Property
Slide 29: Manufacturing
Manufacturing Now produced at 100L (commercial scale) under cGMP with final formulation Commercial manufacturing agreement in place with Sigma- Aldrich® Fine Chemicals (SAFC) 29
Slide 30: Patent Portfolio
Patent Portfolio More than 400 patents issued worldwide, including 56 US and 20 Canadian Reovirus issue patent claims cover: o Compositions of matter comprising reovirus o Pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases o Combination therapy with radiation
Slide 31: Corporate & Financial
Corporate & | Financial
Slide 32: Market & Capital Data
Market & Capital Data (all amounts in CAD) Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (June 30, 2015) 117,710,372 Price Options Outstanding (June 30, 2015) $3.16 (weighted 5,531,394 average) Fully Diluted (June 30, 2015) 123,241,766 Cash/Cash Equivalents (June 30, 2015) $32.1 M 32
Slide 33: Investment Highlights
Investment Highlights Five ongoing randomized Phase II studies Ovarian, colorectal, non-small cell lung, prostate and breast cancers Preparing for registration study Safety data for 1,100+ patients Strong intellectual portfolio More than 400 patents worldwide Manufacturing at commercia
Slide 34: Corporate Presentation
Corporate Presentation September 2015
Slide 35: Appendix A: Presence of Reoviral Protein, PD-1 & PD-L1 (REO 013b Study)
Appendix A: Presence of Reoviral Protein, PD-1 & PD-1 (REO 013b Study) Case Diagnosis Reoviral Protein PD-L1 PD-1 1 glioblastoma 1+ 2+ 2+ 2 adenocarcinoma (colon metastasis) 1+ 2+ 2+ 3 glioma, grade 3 1+ 2+ 2+ 4 glioma, grade 3 negative 0 1+ 5 melanoma metastasis negative 1+ 2+ 6 glioblastoma 1+ 2+
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