january 2017 corporate presentation
TRANSCRIPT
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) therapy exploiting both adaptive and
innate immunity
� Emerging evidence that REOLYSIN® has meaningful impact on overall
survival (OS)
� Six randomized Ph 2 studies with potential to generate OS data in 2017 � Ovarian, Breast, Prostate, Pancreatic, NSCLC & Colorectal
� Supports potential additional registration pathways
� 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 IMiD’s
� Extensive patient safety data showing little to no additional toxicity
when used as combination therapy
� Manufacturing at scale with sufficient supplies on hand to support late
stage development and early commercialization
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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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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The Future of REOLYSIN® as an Immuno-
Oncology Viral AgentR
EO
LYSI
N®
C
linic
al D
eve
lop
me
nt
Pla
n
Chemo Combos
Immuno Therapy Combos
Targeted / IMiDCombos
Continuing positive benefit-risk profile
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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 improved
2. 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
Melanoma
treated with ICI
vs. chemo
Ipilimumab
SOC
Hodi et.al., NEJM 2010
Ipilimumab
SOC
Overall SurvivalProgression Free Survival
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REOLYSIN® Mechanism of Action
1. Replication and lysis in permissive cancer cells 1-15, 24
Alerts the immune system resulting in immunological recognition
of cancer cells.
2. Innate immunity 2,16-21, 27
Viral replication resulting in a cascade of chemokines/cytokines causing
NK (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® Combination Therapy
Enhances the Mechanism of Action
T-cells are recruited to cancer cells due to thepresence of viral and tumor antigens ( ).However, T-cells can be prevented fromattacking cancer cells due to the presence ofimmune checkpoint ligands ( ).
Enhancement of Cell Lysis: REOLYSIN® + Chemotherapy
REOLYSIN®
alone
REOLYSIN® + Chemotherapy
More cancer cells aresusceptible to REOLYSIN®
when cancer cells are stressedwith chemo and/or radiationtherapy
Enhancement of Innate Immune Response: REOLYSIN® + IMiDs
Enhancement of Adaptive Immune Response: REOLYSIN®
+ immune checkpoint inhibition
REOLYSIN® alone
REOLYSIN® + IMiDs
Inhibiting the function of immune checkpointligands enhances REOLYSIN® induced T-celltargeting. REOLYSIN® also induces PD-1 andPD-L1 expression on T- and tumor-cells,respectively
REOLYSIN® alone
REOLYSIN® + αPD-L1
Activated T-cell
Release of inflammatory cytokines
Increased activation of NK cells
Release of inflammatory
cytokines
Activation of NK cells
Activated T-cell
+ IMiDs
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Clinical Development Plan: Key Points
1. Critical analysis of maturing data from relevant studies to
streamline our clinical development plan
2. Focus on the registration pathway with REO-chemo
(based on data emerging from NCI and NCIC randomized Phase
2 studies)
3. Establish REOLYSIN® as a backbone I/O agent for combo with
checkpoint inhibitors & IMiD’s / targeted therapy
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Clinical Development Plan: Pathways
The clinical development plan addresses drug combinations that
can potentially boost each response of the MOA
1. Chemo combos (direct cell lysis):
The basis of the first registration pathway
2. Immuno therapy combos (adaptive immune response):
Approaches with checkpoint inhibitors embodied in the ongoing
REOLYSIN® + pembrolizumab study and possible future collaborations
3. Combo 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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Path 1: Chemotherapy Combo’s
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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Path 1: Chemotherapy Combo’s
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Metastatic Pancreatic Cancer (1st Line)o Excellent safety and encouraging benefit in 2y-survival in single arm Ph 2 studies:
Randomized Intent To Treat (NCI-8601)
o Carbotax + REO (n=36)
o Carbotax (n=37)
Randomized Excluding Crossover
o Carbotax + REO (n=36)
o Carbotax (n=20)
Single Arm (REO 017)
o REO + Gemcitabine
(n=34)
Reo + gem
2y-OS = 24 %
Path 1: Chemotherapy Combo’s
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%
Path 1: Chemotherapy Combo’s
Pending survival data expected to read out in 2017
Study Phase Tumor Type Enrollment Timeline
NCI-GOG 0186H(REO + paclitaxel)
2Ovarian Epithelial, Fallopian Tube,
Primary Peritoneal Cancern=100 1H 2017
NCI-8601
(REO + paclitaxel +
carboplatin)
2 Metastatic Pancreatic Cancer n=73 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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Path 2: Immunotherapy Combo’s
REO + Pembrolizumab
(anti-PD-1 antibody) in pancreatic cancero Establish safety profile
o 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 Combo’s
REO + Pomalidomide in multiple myelomao Establish safety profile
o 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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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 and
20 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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Market and Capital Data
ExchangesOTCQX: ONCYF
TSX: ONC
Shares Outstanding (December 31, 2016)
121,258,222
Options
Restricted/performance share units(December 31, 2016)
7,974,227
1,612,829
Fully Diluted (December 31, 2016)
130,845,278
Cash / Cash Equivalents /
Short Term Investments (November 2, 2016)
$17.7 million
Cash runway Into 2018
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Investment Highlights
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� Novel I/O therapy exploiting both adaptive and innate immunity
� Emerging evidence that REOLYSIN® has meaningful impact on OS
� Six randomized Ph 2 studies with potential to generate OS data in 2017 � Ovarian, Breast, Prostate, Pancreatic, NSCLC & Colorectal
� Supports potential additional registration pathways
� 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 IMiD’s
� Extensive patient safety data showing little to no additional toxicity
when used as combination therapy
� Manufacturing at scale with sufficient supplies on hand to support late
stage development and early commercialization