Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (September 2016)
31 slides from Oncolytics Biotech's investor presentation, September 2016
Slide 1: Corporate Presentation
Corporate Presentation September 2016
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 an
Slide 3: Oncolytics Overview
Oncolytics Overview Developing REOLYSIN® 400+ issued patents and (oncolytic virus) as a 70+ pending cancer therapeutic applications worldwide Conducted 30+ clinical 1,100+ patients treated; studies in 13 indications strong safety profile Manufacturing $20.41 million cash and at commercial scale cash
Slide 4: What is REOLYSIN?
What is REOLYSIN®? A proprietary isolate of wild-type reovirus Serotype 3 Dearing Non-pathogenic Most humans show evidence of exposure by adulthood 4
Slide 5: Safety Profile of REOLYSIN
Safety Profile of REOLYSIN® General Safety 1,100+ patients treated, 1,000+ of these intravenously No maximum tolerated dose (MTD) reached Safety profile confirmed in a randomized setting Monotherapy Safety Mild toxicities (grade 1 or 2) including: • Chills • Cough • Sore throat • Fever • Mya
Slide 6: REOLYSIN: Two Mechanisms of Action
REOLYSIN®: Two Mechanisms of Action 1. In cancer cells with Ras pathway activating (BRAF, Kras, Nras, Hras, and EGFR) and/or p53 mutations, REOLYSIN® acts as a directed cytotoxin 2. REOLYSIN® also interacts with the immune system in at least two known ways, thereby functioning as an immune therapy 6
Slide 7: Clinical Data: Progression Free Survival (PFS) & Overall Survival (OS)
Clinical Data: Progression Free Survival (PFS) & Overall Survival (OS)
Slide 8: Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211
Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211 Randomized Phase II study of non-squamous non-small cell lung cancer (NSCLC) patients treated with pemetrexed and REOLYSIN® Test Arm Patients without Patients with Mutations P-Value (n=38) Mutations (months) (month) Media
Slide 9: Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211
Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211 9
Slide 10: Randomized PFS and OS in Female NSCLC Patients: IND 211
Randomized PFS and OS in Female NSCLC Patients: IND 211 Female Patients Control Arm Test Arm P-Value (n=36) (months) (month) Median PFS 3.02 5.39 0.020 Median OS 7.59 10.68 0.145 Female patients on the test arm received greater PFS and OS benefit than female patients on the control arm 10
Slide 11: Randomized PFS and OS by Gender in NSCLC Patients: IND 211
Randomized PFS and OS by Gender in NSCLC Patients: IND 211 11
Slide 12: Clinical Data: Tumour Responses
Clinical Data: Tumour Responses
Slide 13: Cancer and Metastases
Cancer and Metastases Approximately 8.5 million people die from cancer each year, 4 million of them in the developed world 90% of cancer deaths are due to metastatic disease, primarily in the liver, lung, lymph nodes and brain An agent with specific, demonstrated activity in metastatic disease
Slide 14: REOLYSIN and Metastases
REOLYSIN® and Metastases REOLYSIN® should have therapeutic effects on patients’ liver, lymph, lung and brain metastases in based on: 1. Bio distribution patterns; 2. Ability to cross the blood brain barrier in patients with brain metastases; and 3. Genetics of metastases 14
Slide 15: REOLYSIN and Liver Metastases
REOLYSIN® and Liver Metastases Single-arm drug combination studies in head and neck cancer patients showed REOLYSIN® to markedly reduce liver metastases in an “unusual” manner However, single arm study responses must be considered to be anecdotal 15
Slide 16: Partial Response in Liver Metastases
Partial Response in Liver Metastases Pre-Treatment Post-Cycle 2 Post-Cycle 6 o Patient was diagnosed with sinu-nasal carcinoma o Study participants were treated with REOLYSIN® in combination with carboplatin and paclitaxel (Phase 1) 16
Slide 17: Partial Response in Liver Metastases
Partial Response in Liver Metastases Pre-Treatment Post-Cycle 3 o Patient was diagnosed with metastatic nasopharyngeal cancer o Study participants were treated with REOLYSIN® in combination with carboplatin and paclitaxel (Phase 2) o Liver metastases were reduced from 59.4mm at baseline to 19mm post
Slide 18: Randomized Tumour Specific Data: Head and Neck Cancer (REO 018)
Randomized Tumour Specific Data: Head and Neck Cancer (REO 018) Patients were treated with REOLYSIN® in combination with carboplatin and paclitaxel Loco-regional patients with or without distal metastases experienced a 23% increased reduction in median total tumour volume in the test arm versus
Slide 19: Randomized Tumour Specific Data: Colorectal Cancer (IND 210)
Randomized Tumour Specific Data: Colorectal Cancer (IND 210) Patients were treated with FOLFOX-6/Avastin® plus or minus REOLYSIN® Patients in the test arm had a 53% objective overall response rate (n=51) versus 35% in the control arm (n=52) (p=0.06) Patients with liver metastases (with or with
Slide 20: Randomized Tumour Specific Data in Female Colorectal Cancer Patients (IND 210)
Randomized Tumour Specific Data in Female Colorectal Cancer Patients (IND 210) Female patients with or without metastases on the test arm had a 63.2% objective response rate (n=19) versus 23.8% on the control arm (n=21) (p=0.0054) These patients also experienced a 51% increased reduction in medi
Slide 21: Upcoming Colorectal Cancer Study
Upcoming Colorectal Cancer Study Oncolytics has filed for a Phase 2 study of REOLYSIN® in combination with FOLFOX-6 and Avastin® in female patients with colorectal cancer that is metastatic to the liver All patients will be prescreened for mutations in EGFR, Kras, Nras, Hras, BRAF and/or p53 P
Slide 22: REOLYSIN and Multiple Myeloma
REOLYSIN® and Multiple Myeloma REOLYSIN® should have tumour effects in multiple myeloma patients based on: 1. Bio distribution patterns; • >90% infectivity of multiple myeloma cells in bone marrow 2. Replicative induction with proteasome inhibitors; and 3. Immune effects 22
Slide 23: REOLYSIN Combination Therapy with Carfilzomib in Multiple Myeloma
REOLYSIN® Combination Therapy with Carfilzomib in Multiple Myeloma Mean (SEM), Mean (SEM), Mean (SEM), Variable Pre-Treatment REOLYSIN® + Carfilzomib Alone (N=5) Carfilzomib (N=5) (N=5) CD8 37.8 (8.5) 84.6* (26.8) 5.2 (1.5) PD-L1 74.2 (49.5) 208.2* (31.1) 9.4 (12.5) caspase-3 6.2 (0.8) 24.8 (4.3)* 1
Slide 24: Multiple Myeloma Registration Study
Multiple Myeloma Registration Study Oncolytics is preparing to file a Phase III registration study of REOLYSIN® in combination with carfilzomib in patients with multiple myeloma 24
Slide 25: Manufacturing & Intellectual Property
Manufacturing & Intellectual Property
Slide 26: Manufacturing
Manufacturing Now produced at commercial scale (100L) under cGMP with final formulation Commercial manufacturing agreement in place with Sigma-Aldrich® Fine Chemicals (SAFC) 26
Slide 27: Patent Portfolio
Patent Portfolio More than 400 patents issued worldwide, including 60 US and 20 Canadian More than 70 pending patent applications worldwide Issued patent claims for reovirus cover: • Compositions of matter comprising reovirus • Pharmaceutical use of reoviruses to treat neoplasia and cellular p
Slide 28: Corporate & Financial
Corporate & Financial C)ncoryrics www.oncolyticsbiotech.com ONC ONCY ONY
Slide 29: Market & Capital Data
Market & Capital Data (all amounts in CAD) Exchanges OTCQX:ONCYF TSX:ONC FRA:ONY Shares Outstanding (June 30, 2016) 120,233,122 Price Options Outstanding (June 30, 2016) $2.04 7,754,727 (weighted average) Fully Diluted (June 30, 2016) 127,987,849 Cash & Cash Equivalents (June 30, $20.41 M 2016)
Slide 30: Investment Highlights
Investment Highlights Preparing to file for lead registration study in multiple myeloma Positive safety data for 1,100+ patients Strong intellectual property portfolio • More than 400 issued patents worldwide Manufacturing at commercial scale 30
Slide 31: Corporate Presentation
Corporate Presentation September 2016
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