Corporate Presentation April 2015
Jul 17, 2015
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 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, market 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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Oncolytics Overview
o Broad Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include five sponsored, randomized Phase II studies in the US and Canada
o Conducted over 30 clinical studies in 13 indications to date
o Strong Intellectual Property Portfolio
o More than 370 patents issued worldwide
o Manufacturing at Commercial Scale
o 100L cGMP completed, commercial manufacturing agreement in place
o Cash Until End of Q1, 2017 (at current burn rates)
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Randomized Clinical Trial Program for REOLYSIN®: Active Studies
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Trial Phase Sponsor n Enrollment Status
IND 213: Intravenous REOLYSIN® in Combination with Paclitaxel in Patients with Advanced or Metastatic
Breast Cancer II NCIC CTG 100 >60% complete
IND 211: Intravenous REOLYSIN® in Combination with Docetaxel or Pemetrexed in Patients with Previously-Treated Advanced or Metastatic Non-Small Cell Lung
Cancer (NSCLC)
II NCIC CTG 150 >90% complete
IND 210: Intravenous REOLYSIN® in Combination with FOLFOX-6 Plus Bevacizumab (Avastin®) in Patients
with Advanced or Metastatic Colorectal Cancer II NCIC CTG 100 complete
IND 209: Intravenous REOLYSIN® in Combination with Docetaxel in Patients with Recurrent or Metastatic
Castration-Resistant Prostate Cancer II NCIC CTG 80 >90% complete
GOG-0186H: Intravenous REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary
Peritoneal Cancer
II NCI/GOG 110 complete
REOLYSIN® Mechanism of Action
REOLYSIN®
infects both tumour cells and normal healthy cells
REOLYSIN® does not replicate in cells that are not Ras activated
Healthy cells remain undamaged
REOLYSIN®
Administered to patients
prescreened for RAS, EGFR, BRAF
and others
Normal Cells
REOLYSIN® infects both tumour cells and normal healthy cells
REOLYSIN® replicates in Ras activated tumour cells
Tumour cells rupture to release progeny virus
Progeny viruses repeat cell infection cycle in nearby tumour cells
Ras–Activated Cells
Productively infected cells upregulate interferon, and others including PD-1 and PD-L1 and induce an anti-tumour specific immune response mediated by NK and T cells
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Ras Pathway Specific Biomarkers and Cancer Breast
HER-2 (an EGFR variant)
Glioblastoma EGFR, BRAF
Head & Neck EGFR
Pancreas KRAS
Melanoma BRAF, S100
Colorectal KRAS, EGFR
Non-Small Cell Lung EGFR, BRAF, KRAS
Biomarkers are increasingly used to assess risk, diagnose, and identify treatment options
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REO 016: Single-Arm Non-Small Cell Lung Cancer (NSCLC) Study Demonstrates Biomarker Utility
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Molecular Abnormality Number of
Patients Number of Patients Surviving One Year
Percentage of Patients Surviving One Year
BRAF mutation + EGFR amplification 4 4 100%
EGFR amplification 10 7 70%
EGFR mutation + EGFR amplification 3 2 67%
KRAS mutation + EGFR amplification 7 3 43%
KRAS mutation 12 4 33%
Total 36 20 56%
15-20% of NSCLC is KRAS mutated, while up to 50% is EGFR mutated or overexpressed. Each of these result in Ras pathway activation.
REOLYSIN®: Clinical History
o To date, over 1,100 patients have been treated with REOLYSIN®, which has been shown to be safe and well-tolerated by patients
o Over 30 ongoing and completed studies of REOLYSIN® in North America and Europe, examining a variety of: o Modes of administration
o Therapeutic combinations
o Cancer indications and patient populations
o Ongoing preclinical and clinical research bolsters clinical program strategy, trial design, intellectual property portfolio and supports regulatory submissions
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Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® Intratumoural Monotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated
Response Against the Residual Tumour
Viral replication mediated tumour response
Post debulking Immune mediated tumour response
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REO 011: Head & Neck Cancer Patient with Partial Response in Liver Metastases
The patient had been previously been treated with radiation. The response to REOLYSIN® was maintained through 8 cycles.
Pre-Treatment Post-Cycle 6
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REO 021: Squamous Cell Carcinoma (SCC), Partial Response in Lung
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Pre-Treatment Post-Cycle 2 Post-Cycle 4
Right Upper Lung Mass (8.3 cm)
Right Pleural Met (2.2 cm)
Right Upper Lung Mass (4.1 cm)
Right Pleural Met (0.8 cm)
Right Upper Lung Mass (3.6 cm)
Right Pleural Met (0.4 cm)
REO 016: Non-Small Cell Lung Cancer (NSCLC), Partial Response in Lung (EGFR Over-Expression)
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Pre-Treatment Post-Cycle 2
REO 016 (NSCLC): Best Overall Responses by Tumour Shrinkage
-100
-80
-60
-40
-20
0
20
40
60
80
100
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
-100
-80
-60
-40
-20
0
20
40
60
80
100
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
Best Overall Percentage Tumour Shrinkage by Longest Dimension
Best Overall Percentage Tumour Shrinkage by Volume
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REO 018 Head and Neck Cancer: Randomized Tumour-Specific Response Data
o This study demonstrated that REOLYSIN® increases both the magnitude and velocity of tumour shrinkage
o The first endpoint examined initial percentage tumour changes between baseline and first post treatment scans in all patients, differentiating between loco-regional tumours and metastatic tumours (a measure of velocity)
o Of the total 105 patients with evaluable metastatic tumours, 86% (n=50) of those in the test, and 67% (n=55) in the control arm, arm had tumour stabilization (0% growth) or shrinkage
o This is a statistically significant difference, with a p-value of 0.025
o The second endpoint compared percentage tumour shrinkage at the same time points
o Patients with loco-regional disease with or without distal metastases on the test arm had a decrease in tumour volume of an average of 23% over control (p=0.076, n=118)
o Patients with distal metastases only on the test arm had a decrease in tumour volume of an average of 30% over control (p=0.021, n=47)
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Top-Line Progression Free Survival (PFS) Results REO 018 (Head and Neck Cancer):
o An analysis of patients with loco-regional disease with or without distal metastases showed a median PFS of 94 days (13.4 weeks) in the test arm (n=62), versus a PFS of 50 days (7.1 weeks) in the control arm (n=56)
o Patients who received REOLYSIN® demonstrated increased benefit through five cycles of therapy
NCI-8601 (Pancreatic Cancer):
o An interim analysis of 44 patients with KRAS mutated pancreatic cancer
showed a median progression free survival in the test arm of 5.72 months (95% CI = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI = 1.938 to 6.176) – an improvement of 39%
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Top-Line Overall Survival (OS) Results REO 018 (Head and Neck Cancer):
An intent-to-treat analysis performed on all 118 loco-regional patients showed a statistically significant improvement in the OS of the test arm versus that of the control arm (p=0.0146, hazard ratio=0.5099)
OS was measured to the median PFS in each arm, censoring any patients who received post-discontinuation therapy from the date on which they commenced the first of these therapies
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
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Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® Intratumoural Monotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated
Response Against the Residual Tumour
Viral replication mediated tumour response
Post debulking Immune mediated tumour response
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Immune Preclinical Research
In melanoma models in mice, the combination of GM-CSF with REOLYSIN® improved overall survival
In brain cancer models in mice, the combination of a checkpoint inhibitor (anti PD-1) with REOLYSIN® improved overall survival
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GM-CSF + REOLYSIN®: Effect on Overall Survival
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0
20
40
60
80
100
0 20 40 60 Days
Perc
ent
Surv
ival
IL2 + REO
IL2 alone
G-CSF + REO
G-CSF alone
GM-CSF + REO
GM-CSF
Enhancing Immune Responses to Improve Survival
o Ongoing preclinical and clinical research has led to three clinical candidate programs:
1. Gemcitabine in combination with REOLYSIN®;
2. GM-CSF in combination with REOLYSIN®; or
3. A checkpoint inhibitor in combination with REOLYSIN®
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Possible Registration Pathways for REOLYSIN® I. Studies using REOLYSIN® therapy prior to standard efficacy-
based therapies (surgery, radical radiotherapy and chemotherapy) in order to reduce tumour burden, as measured by histopathology, scans, or tumour specific markers; and/or
II. Studies using REOLYSIN® in combination with chemotherapy and/or radiotherapy and immune enhancing agents to improve overall survival.
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REOLYSIN® and Safety
o More than 1,100 patients treated, more than 1,000 intravenously at doses up to 3x1010 TCID50 daily
o No maximum tolerated dose (MTD) reached to date
o Monotherapy 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 and neutropenia
o Transient Grade 3 and 4 toxicities included lymphopenia and neutropenia
o These symptoms were more frequently observed from Day 2 of treatment and usually lasted less than 6 hours
o Safety profile has been confirmed in a randomized setting in Oncolytics’ REO 018 study of head and neck cancer patients
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Intellectual Property
o More than 370 patents issued worldwide, including 56 US and 20 Canadian
o 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, chemotherapy and/or
immune suppressants o Methods for manufacturing reovirus and screening for
susceptibility to reovirus o Pharmaceutical use of reoviruses in transplantation procedures
o Approximately 235 pending applications worldwide
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Orphan Drug Designations
Orphan Drug Designations obtained for REOLYSIN®: From the US FDA: ovarian, primary peritoneal, fallopian tube and
pancreatic cancers and malignant gliomas From the EMA: ovarian cancer
Potential benefits of Orphan Drug Designation in the US: A period of market exclusivity if regulatory approval is ultimately
received in the designated indication Potential tax credits for certain activities Eligibility for orphan drug grants Waiver of certain administrative fees
Potential benefits of Orphan Designation in the EU: Protocol assistance Market exclusivity for a ten-year period following regulatory approval
if it is ultimately received in the designated indication Potential fee reductions
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Manufacturing
o Now produced at 100L (commercial scale) under cGMP with final formulation
o Commercial manufacturing agreement in place with Sigma-Aldrich® Fine Chemicals (SAFC)
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Market & Capital Data
(all amounts in CAD)
Exchanges NASDAQ:ONCY
TSX:ONC
Shares Outstanding (March 13, 2015) 107,372,669
Price
Options Outstanding (March 13, 2015) $3.49 (weighted average)
5,446,394
Fully Diluted (March 13, 2015) 112,819,063
Cash/Cash Equivalents (March 13, 2015) $27.5M
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Financial runway extends well into 2017 with ATM and Equity Line facilities.
Investment Highlights o Five ongoing randomized Phase II studies, with
data readouts anticipated in 2015 o Indications: ovarian, colorectal, non-small
cell lung, prostate and breast cancers
o Preparing for registration study
o Safety data for 1,100+ patients
o Strong intellectual property portfolio
o More than 370 patents issued worldwide
o Manufacturing at commercial scale
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