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Investor Presentation
March 2017
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF
Forward Looking Statements
This presentation contains certain forward looking statements relating to the company’s business prospects and the development and commercialization of REOLYSIN®, a therapeutic reovirus. These statements are based on management’s current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company’s control which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward looking statements.
In any forward looking statement in which Oncolytics Biotech® Inc. expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by the FDA/HPB/MHRA and those other factors detailed in the company’s filings with SEDAR and the Securities and Exchange Commission. Oncolytics does not undertake an obligation to update the forward looking statements, except as required by applicable laws.
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Investment Highlights
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Novel immuno-oncology (I/O) viral-agent for systemic administration exploiting dual activity by cancer cell lysis and anti-tumor immunity
Additional randomized Ph 2 studies to generate OS data in 2017 Pending data in Breast, Ovarian, NSCLC & Colorectal
Near-term focus on chemo-combos for late-stage clinical development
Potential to establish REOLYSIN® as a backbone I/O agent in combination with checkpoint inhibitors and IMiDs
Extensive patient safety data showing no added significant toxicity when used as combination with chemotherapy
Manufacturing at scale with sufficient supplies on hand to support late/ stage development and early commercialization
The Landscape
4
AZ / Medimmune
Omnis Pharma Undisclosed
Combine IO portfolio with oncolytic virus
programme
Valeant
Dendreon $495M
Metastatic prostate cancer
Amgen
BioVEx Upfront $425M
Milestones $575M
Ph 3 oncolytic vaccine for H&N and
melanoma
Bristol-Myers Squibb
PsiOxus Upfront $50M
Milestones $886M
NG-348, a pre-clinical oncolytic virus for
solid tumors – plus royalties on net sales
Boehringer Ingelheim
ViraTherapeutics up to €210M
Pre-clinical oncolytic virus
Amgen
Onyx $10.4B
Kyprolis – approved for multiple myeloma
Pfizer
Medivation $14B
XTANDI – approved for advanced
metastatic prostate cancer
Pfizer
Western Oncolytics Undisclosed
Novel oncolytic vaccinia virus
Ipsen
Merrimack Upfront $575M
Milestones $450M
ONIVYDE – approved for pancreatic cancer
DOXIL – approved for ovarian cancer
Oncolytics Overview
Defined clinical program and potential registration pathway
Final formulation produced
• 100L scale under cGMP
900+ patients treated systemically
• Strong safety profile
New class of immuno-oncology viral agent
5
What is REOLYSIN®
First in class systemically administered immuno-oncology viral agent for solid tumors and heme malignancies
Proprietary isolate of the unmodified reovirus
Non-pathogenic
6
The Future of REOLYSIN® as an Immuno-Oncology Viral Agent
REO
LYSI
N®
C
linic
al D
evel
op
men
t P
lan
Chemo Combinations
Immunotherapy Combinations
Targeted / IMiDCombinations
Continuing positive benefit-risk profile
7
Conceptual data
What’s New and Lessons Learned
• Strong OS data trumps Progression Free Survival (PFS)• Emerging OS results support mechanism of action (MOA)
o Pancreatic, Lung & Colorectal
1 Hodi, NEJM 2010, 363:711; 2 Borghaei, NEJM 2015,371:1627; 3 Ferris, NEJM 2016, 375:1856
Emerging paradigm from immune checkpoint inhibition studies1. Chemo impacts the overall response rate (ORR) and PFS because of its rapid
antitumor response, yet OS is not always improved2. Immunotherapies (e.g., immune checkpoint inhibitors (ICI)), by contrast, may not
improve ORR or PFS but survival rates are consistently better than with chemotherapy in certain cancers 1-3
Melanomatreated with ICI
vs. chemoIpilimumab
SOC
Hodi et.al., NEJM 2010
Ipilimumab
SOC
Overall SurvivalProgression Free Survival
8
REOLYSIN® & Mechanism of Action
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF
REOLYSIN® Mechanism of Action
1. Direct tumor lysis 1-15, 24
Selective viral replication in permissive cancer cells leading to tumor cell lysis.
2. Innate immunity 2,16-21, 27
Viral replication resulting in a cascade of chemokines/cytokines causingNK (natural killer) cells to recognize and attack cancer cells.
3. Adaptive immunity 17-27
Viral replication and resulting cell lysis releasing TAA (tumor associated antigens – “biological shrapnel”). The fragments of the tumor cell and virus are epitopes or antigenic determinants that educate T-cells to recognize and destroy cancer cells.
1 Adair, Sci Transl Med 2012,4:138; 2 Adair, Int J Cancer, 2013, 132:2327; 3 Chakrabarty, Invest New Drugs 2015, 33:761; 4 Gong, Frontiers in Oncology 2014; 4:1; 5 Garant, Oncogene 2016, 35:771; 6
Pan, PLosOne 2013, 8:e54006; 7 Kelly, Oncogene. 2012, 31:3023; 8 Mahalingam BMC Cancer 2015, 15:513; 9 Nuovo Mod Pathol 2012, 25:1333; 10 Roulstone, Clin Cancer Res 2015, 21:1305; 11
Roulstone, Gene Ther 2013, 20:521; 12 Sei, Mol Cancer 2009, 8:47; 13 Strong, EMBO J 1998, 17:3351; 14 Villalona Calero, Cancer 2016, 122:875; 15 Wadler, Eur J Cancer Suppl, 2004, 2:135; 16 El-Sherbiny, Clin Exp Immunol 2014, 180:98; 17 Gujar., Mol Cancer Ther 2010 9:2924; 18 Gujar, Mol Ther 2011, 19:797; 19 Rajani, Mol Ther 2016, 24:166;20 Steele, Mol Cancer 2011, 10:20; 21 White, Gene Ther 2008, 15:911; 22 Gujar Br J Cancer 2014, 110:83; 23 Gujar, Mol Ther 2013, 21:338; 24 Gujar, Frontiers in Oncology 2014, 4:1; 25 Shashi, Front Oncol. 2014; 4: 77;. 26 Kim, Viruses 2015, 7, 6506; 27 Noonan, Mol Ther 2016, 24:1150
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REOLYSIN® Mechanism of Action
11
Clinical Development Plan
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF
Clinical Development Plan: Pathways
The clinical development plan addresses drug combinations that can potentially boost each response of the MOA
1. Chemo combinations (direct cell lysis): The basis of the first registration pathway
2. Immunotherapy combinations (adaptive immune response): Approaches with checkpoint inhibitors embodied in the ongoing REOLYSIN® + pembrolizumab study and possible future collaborations
3. Combination with IMiDs / targeted therapy (innate immune response):The proposed approach to be used in collaboration with Myeloma UK where we expect enhancement of innate immunity
13
Path 1: Chemotherapy Combinations
Metastatic Pancreatic Cancer (1st Line)o Regulatory Status
o Orphan Drug Designation Granted (FDA / EMA) o Seeking scientific advice - potential for
Fast-Track Designation o Preparing for End of Phase 2 Meeting
14
Path 1: Chemotherapy Combinations
15
Metastatic Pancreatic Cancer (1st Line)o Excellent safety and encouraging benefit in 2-year survival in single arm Ph 2 studies:
Randomized Intent To Treat (NCI-8601)o Carbotax + REO (n=36)o Carbotax (n=37)
Randomized Excluding Crossovero Carbotax + REO (n=36)o Carbotax (n=20)
Single Arm (REO 017)o REO + Gemcitabine
(n=34)
Reo + gem2y-OS = 24 %
Path 1: Chemotherapy Combinations
Metastatic Pancreatic Cancer (1st Line)o REO 017 vs historical controls:
16
Median OS (months)
1-year survival 1.5-year survival 2-year survival
Burris et al., 1997
Gemcitabine (n=63) 5.65 18% NR NR
5-Fluorauracil (n=63) 4.41 2% NR NR
Conroy et al., 2011
Gemcitabine (n=171) 6.8 (5.5-7.6) NR 6% NR
Folfirinox (n=171) 11.1 (9.0-13.1) NR 19% NR
Von Hoff et al., 2013
Gemcitabine (n=430) 6.7 (6.0-7.2) 22% NR 4% (2%-7%)
Gem + nab paclitaxel (n=431) 8.5 (7.9-9.5) 35% NR 9% (6%-13%)
REO 017
REOLYSIN® + Gemcitabine (n=34) 10.2 46% NR 24%
Path 1: Chemotherapy Combinations
Pending survival data expected to read out in 2017Study Phase Tumor Type Enrollment Timeline
NCI-GOG 0186H(REO + paclitaxel) 2
Ovarian Epithelial, Fallopian Tube, Primary Peritoneal Cancer
n=100 1H 2017
NCIC-CTG IND.213(REO + paclitaxel) 2
Advanced or Metastatic Breast Cancer
n=74 1H 2017
NCIC-CTG IND.209 (REO + docetaxel) 2
Recurrent or Metastatic Castration Resistant Prostate Cancer
n=85 2H 2017
NCIC-CTG IND.210 (REO + FOLFOX6 + Avastin) 2 Recurrent Colorectal Cancer n=109 2H 2017
NCIC-CTG IND.211 (REO + docetaxel or pemetrexed)
2Previously Treated Advanced or
Metastatic NSCLCn=90 2H 2017
17
Path 2: Immunotherapy Combinations
REO + Pembrolizumab (anti-PD-1 antibody) in pancreatic cancer (REO 024)
o Establish safety profileo Final analysis in 2017
Future potential collaborations pending
Rajani, Viruses 2015, 7:588; Noonan, Mol Ther 2016; Rajani, Mol Ther 2016,24:166
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Path 3: Targeted/IMiD Combinations
REO + Pomalidomide in multiple myelomao Establish safety profileo Ongoing collaboration with Myeloma UK
Enhancement of Innate
Immune Response:
REOLYSIN® + IMiDs
REOLYSIN® alone
REOLYSIN® + IMiDs
Release of
inflammatory
cytokines
Increased
activation of
NK cells
Release of
inflammatory
cytokines
Activation
of NK
cells
+ IMiDs
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Safety, Manufacturing & Intellectual Property
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF
REOLYSIN® and Safety
1,100+ patients treated, 900+ intravenously
No maximum tolerated dose (MTD) reached to date
Monotherapy Toxicity Symptoms
Symptoms frequently observed from day 2 of treatment and usually lasted < 6 hours
Intravenous local
Toxicities have generally been mild (grade 1 or 2) and included chills, fever, headache, cough, myalgia, runny nose, sore throat, fatigue, and grade 1 or 2 lymphopenia or neutropenia
Transient grade 3 and 4 toxicities included lymphopenia or neutropenia
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Manufacturing
Final formulation produced at 100L scale under cGMP
Commercial scale manufacturing agreement with SAFC
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Patent Portfolio
More than 440 patents issued worldwide, including 61 US and20 Canadian
Reovirus issue patent claims cover:• Compositions of matter comprising reovirus
• Pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases
• Combination therapy with radiation, chemotherapy and/or immune suppressants
• Methods for manufacturing reovirus and screening for susceptibility to reovirus
• Pharmaceutical use of reoviruses in transplantation procedures
Over 60 pending applications worldwide
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Corporate & Financial
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF
Experienced Leadership
25
Matt Coffey, PhD, MBA
Co-founder, Director,
President & CEO
Kirk Look, CA
Chief Financial Officer
Ernst & Young
Andres Gutierrez, MD, PhD
Chief Medical Officer
Bristol-Myers Squibb
Wayne Pisano, MBA
Chairman of the Board, Oncolytics
Former President, Sanofi Pasteur
Angela Holtham, MBA, ICD.D
Nabisco
Hospital for Sick Children
J. Mark Lievonen, CA
Former President, Sanofi Pasteur
Ontario Institute for Cancer Research
William G. Rice, PhD
President & CEO, Aptose Biosciences
President, CEO & Director of Achillion
Bernd R. Seizinger, MD, PhD
Former President & CEO of GPC Biotech
VP of Oncology Drug Discovery, BMS
Non-Executive Directors
Extensive knowledge of oncology/immunotherapy | Public company experience
Strong commercialization expertise
Management
Market and Capital Data
ExchangesOTCQX: ONCYF
TSX: ONC
Shares Outstanding (December 31, 2016)
121,258,222
OptionsRestricted/performance share units(December 31, 2016)
7,974,2271,612,829
Fully Diluted (December 31, 2016)
130,845,278
Cash / Cash Equivalents / Short Term Investments (November 2, 2016)
CDN $17.7 millionUSD $13.2 million*
Cash runway Into 2018
26
* Based on FX on November 2, 2016
Investment Highlights
27
Novel immuno-oncology viral-agent for systemic administration exploiting dual activity by cancer cell lysis and anti-tumor immunity
Additional randomized Ph 2 studies to generate OS data in 2017 Pending data in Breast, Ovarian, NSCLC & Colorectal
Near-term focus on chemo-combos for late-stage clinical development
Potential to establish REOLYSIN® as a backbone I/O agent in combination with checkpoint inhibitors and IMiDs
Extensive patient safety data showing no added significant toxicity when used as combination with chemotherapy
Manufacturing at scale with sufficient supplies on hand to support late/ stage development and early commercialization
Investor Presentation
www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF