march 2017 corporate presentation

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Investor Presentation March 2017 www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

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Page 1: March 2017 Corporate Presentation

Investor Presentation

March 2017

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Page 2: March 2017 Corporate Presentation

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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Page 3: March 2017 Corporate Presentation

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

Page 4: March 2017 Corporate Presentation

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

Page 5: March 2017 Corporate Presentation

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

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Page 6: March 2017 Corporate Presentation

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

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Page 7: March 2017 Corporate Presentation

The Future of REOLYSIN® as an Immuno-Oncology Viral Agent

REO

LYSI

C

linic

al D

evel

op

men

t P

lan

Chemo Combinations

Immunotherapy Combinations

Targeted / IMiDCombinations

Continuing positive benefit-risk profile

7

Conceptual data

Page 8: March 2017 Corporate Presentation

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

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Page 9: March 2017 Corporate Presentation

REOLYSIN® & Mechanism of Action

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Page 10: March 2017 Corporate Presentation

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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Page 11: March 2017 Corporate Presentation

REOLYSIN® Mechanism of Action

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Page 12: March 2017 Corporate Presentation

Clinical Development Plan

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Page 13: March 2017 Corporate Presentation

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

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Page 14: March 2017 Corporate Presentation

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

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Page 15: March 2017 Corporate Presentation

Path 1: Chemotherapy Combinations

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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 %

Page 16: March 2017 Corporate Presentation

Path 1: Chemotherapy Combinations

Metastatic Pancreatic Cancer (1st Line)o REO 017 vs historical controls:

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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%

Page 17: March 2017 Corporate Presentation

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

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Page 18: March 2017 Corporate Presentation

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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Page 19: March 2017 Corporate Presentation

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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Page 20: March 2017 Corporate Presentation

Safety, Manufacturing & Intellectual Property

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Page 21: March 2017 Corporate Presentation

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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Page 22: March 2017 Corporate Presentation

Manufacturing

Final formulation produced at 100L scale under cGMP

Commercial scale manufacturing agreement with SAFC

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Page 23: March 2017 Corporate Presentation

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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Page 24: March 2017 Corporate Presentation

Corporate & Financial

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Page 25: March 2017 Corporate Presentation

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

Page 26: March 2017 Corporate Presentation

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

Page 27: March 2017 Corporate Presentation

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

Page 28: March 2017 Corporate Presentation

Investor Presentation

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF