corporate presentation-february18-2015
TRANSCRIPT
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.
2
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 Q1 2016 (at current burn rates)
3
Randomized Clinical Trial Program for REOLYSIN®: Active Studies
4
Trial Phase Sponsor n Enrollment Status
IND 213: Intravenous REOLYSIN® in Combination with Paclitaxel in Patients with Advanced or Metastatic
Breast CancerII 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 CancerII NCIC CTG 100 complete
IND 209: Intravenous REOLYSIN® in Combination with Docetaxel in Patients with Recurrent or Metastatic
Castration-Resistant Prostate CancerII NCIC CTG 80 >80% 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 cellsand 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 and induce an anti-tumour specific immune response mediated by NK and T cells
Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® IntratumouralMonotherapy 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
Ras Pathway Specific Biomarkers and Cancer
BreastHER-2 (an EGFR variant)
GlioblastomaEGFR, BRAF
Head & NeckEGFR
PancreasKRAS
MelanomaBRAF, S100
ColorectalKRAS, EGFR
Non-Small Cell LungEGFR, BRAF, KRAS
Biomarkers are increasingly used to assess risk, diagnose, and identify treatment options
7
REO 016: Single-Arm Non-Small Cell Lung Cancer (NSCLC) Study Demonstrates Biomarker Utility
8
Molecular AbnormalityNumber of
PatientsNumber 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 1,000 patients have been treated with REOLYSIN®, which has been shown to be safe and well-tolerated
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
9
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
11
REO 021: Partial Response in Lung
12
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 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)
14
Randomized Top-Line Survival Data
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 therapyo An intent-to-treat analysis of all 118 loco-regional patients performed on all
patients showed a statistically significant improvement in OS of the test arm versus the control arm (p=0.0146, hazard ratio=0.5099)o OS was measured to the median PFS in each arm, censoring any patients who
received post-discontinuation therapy at the date at which they commenced the first of these therapies
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 was 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%
16
Enhancing Immune Responses to Improve Survival
o Ongoing preclinical research has led to two clinical candidate programs:
1. GM-CSF in combination with REOLYSIN®; or
2. A checkpoint inhibitor in combination with REOLYSIN®
21
GM-CSF + REOLYSIN®: Effect on Overall Survival
22
0
20
40
60
80
100
0 20 40 60Days
Perc
ent
Surv
ival
IL2 + REO
IL2 alone
G-CSF + REO
G-CSF alone
GM-CSF + REO
GM-CSF
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 survival, as measured by progression-free survival (EU) and overall survival (US) endpoints.
20
REOLYSIN® and Safety
o More than 1,000 patients treated, more than 900 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
21
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 reoviruso Pharmaceutical use of reoviruses to treat neoplasia and cellular
proliferative diseaseso Combination therapy with radiation, chemotherapy and/or
immune suppressantso Methods for manufacturing reovirus and screening for
susceptibility to reoviruso Pharmaceutical use of reoviruses in transplantation procedures
o Approximately 235 pending applications worldwide
22
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)
23
Market & Capital Data
(all amounts in CAD)
Exchanges NASDAQ:ONCY
TSX:ONC
Shares Outstanding (September 30, 2014)
89,566,597
Price
Options Outstanding (September 30, 2014)
$3.49 (weighted average)
5,987,844
Fully Diluted (September 30, 2014) 96,410,358
Cash/Cash Equivalents (September 30, 2014)
$17.04M
24
Investment Highlightso Five ongoing randomized Phase II studies, with
data readouts anticipated in 2015o Indications: ovarian, colorectal, non-small
cell lung, prostate and breast cancers
o Preparing for registration study
o Safety data for 1,000+ patients
o Strong intellectual property portfolio
o More than 370 patents issued worldwide
o Manufacturing at commercial scale
2525