september 2016 corporate presentation
TRANSCRIPT
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Corporate PresentationSeptember 2016
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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 Oncolytic 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 regulatory authorities including but not limited to the FDA, HPB and MHRA, and those other factors detailed in the Company’s filings with SEDAR and the Securities and Exchange Commission. Oncolytics Biotech® Inc. does not undertake an obligation to update these forward looking statements, except as required by applicable laws.
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Oncolytics Overview
Conducted 30+ clinical studies in 13 indications
400+ issued patents and 70+ pending applications worldwide
1,100+ patients treated; strong safety profile
Developing REOLYSIN®(oncolytic virus) as a cancer therapeutic
$20.41 million cash and cash equivalents as at the end of Q2, 2016
Manufacturing at commercial scale100L cGMP completed
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What is REOLYSIN®?
A proprietary isolate of wild-type reovirus Serotype 3 Dearing
Non-pathogenicMost humans show
evidence of exposure by adulthood
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Safety Profile of REOLYSIN®General Safety 1,100+ patients treated, 1,000+ of these intravenously No maximum tolerated dose (MTD) reached Safety profile confirmed in a randomized setting
Monotherapy Safety Mild toxicities (grade 1 or 2) including:
Transient grade 3 and 4 toxicities included lymphopenia or neutropenia – symptoms usually last less than 6 hours
• Chills• Fever• Headache
• Cough• Myalgia• Runny nose
• Sore throat• Fatigue• Lymphopenia or neutropenia
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REOLYSIN®: Two Mechanisms of Action
1. In cancer cells with Ras pathway activating (BRAF, Kras, Nras, Hras, and EGFR) and/or p53 mutations, REOLYSIN® acts as a directed cytotoxin
2. REOLYSIN® also interacts with the immune system in at least two known ways, thereby functioning as an immune therapy
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Clinical Data: Progression Free Survival (PFS) & Overall Survival (OS)
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Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211
Test Arm (n=38)
Patients without Mutations (months)
Patients with Mutations (month) P-Value
Median PFS 1.51 5.39 0.039
Median OS 4.76 11.53 0.031
Randomized Phase II study of non-squamous non-small cell lung cancer (NSCLC) patients treated with pemetrexed and REOLYSIN®
Test arm patients with Ras pathway activating and/or p53 mutations received greater PFS and OS benefit from treatment with REOLYSIN® than test arm patients without these mutations
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Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211
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Randomized PFS and OS in Female NSCLC Patients: IND 211
Female Patients(n=36)
Control Arm(months)
Test Arm(month) P-Value
Median PFS 3.02 5.39 0.020
Median OS 7.59 10.68 0.145
Female patients on the test arm received greater PFS and OS benefit than female patients on the control arm
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Randomized PFS and OS by Gender in NSCLC Patients: IND 211
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Clinical Data: Tumour Responses
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Cancer and Metastases
Approximately 8.5 million people die from cancer each year, 4 million of them in the developed world
90% of cancer deaths are due to metastatic disease, primarily in the liver, lung, lymph nodes and brain
An agent with specific, demonstrated activity in metastatic disease is necessary
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REOLYSIN® and Metastases
REOLYSIN® should have therapeutic effects on patients’ liver, lymph, lung and brain metastases in based on:
1. Bio distribution patterns;2. Ability to cross the blood brain barrier in
patients with brain metastases; and3. Genetics of metastases
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REOLYSIN® and Liver Metastases
Single-arm drug combination studies in head and neck cancer patients showed REOLYSIN® to markedly reduce liver metastases in an “unusual” manner
However, single arm study responses must be considered to be anecdotal
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Post-Cycle 2
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Post-Cycle 6
Partial Response in Liver Metastases
Pre-Treatment
o Patient was diagnosed with sinu-nasal carcinomao Study participants were treated with REOLYSIN® in combination with
carboplatin and paclitaxel (Phase 1)
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Pre-Treatment Post-Cycle 3
o Patient was diagnosed with metastatic nasopharyngeal cancero Study participants were treated with REOLYSIN® in combination with
carboplatin and paclitaxel (Phase 2)o Liver metastases were reduced from 59.4mm at baseline to 19mm post-Cycle 3
– a 68.01% reduction17
Partial Response in Liver Metastases
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Randomized Tumour Specific Data: Head and Neck Cancer (REO 018)
Patients were treated with REOLYSIN® in combination with carboplatin and paclitaxel
Loco-regional patients with or without distal metastases experienced a 23% increased reduction in median total tumour volume in the test arm versus the control arm (median from Kaplan-Meier curve, p-value 0.076, n=118)
Patients with distal metastases (lymph node, lung, and liver) experienced a 30% increased reduction in median total tumour volume in the test arm versus the control (median from Kaplan-Meier curve, p-value 0.021, n=47)
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Randomized Tumour Specific Data: Colorectal Cancer (IND 210) Patients were treated with FOLFOX-6/Avastin® plus
or minus REOLYSIN® Patients in the test arm had a 53% objective overall
response rate (n=51) versus 35% in the control arm (n=52) (p=0.06)
Patients with liver metastases (with or without other metastases) had a 55% objective overall response rate in the test arm (n=40) versus 28.6% in the control arm (n=42) (p=0.0077)
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Randomized Tumour Specific Data in Female Colorectal Cancer Patients (IND 210)
Female patients with or without metastases on the test arm had a 63.2% objective response rate (n=19) versus 23.8% on the control arm (n=21) (p=0.0054)
These patients also experienced a 51% increased reduction in median total liver metastases volume in the test arm versus the control arm (median from Kaplan-Meier curve, p= 0.0378, n=27)
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Upcoming Colorectal Cancer Study
Oncolytics has filed for a Phase 2 study of REOLYSIN® in combination with FOLFOX-6 and Avastin® in female patients with colorectal cancer that is metastatic to the liver
All patients will be prescreened for mutations in EGFR, Kras, Nras, Hras, BRAF and/or p53
Primary Endpoint: Overall tumour response rate Secondary Endpoint: Liver metastases specific
response rate
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REOLYSIN® and Multiple Myeloma
REOLYSIN® should have tumour effects in multiple myeloma patients based on:
1. Bio distribution patterns;• >90% infectivity of multiple myeloma cells in bone
marrow
2. Replicative induction with proteasome inhibitors; and
3. Immune effects
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REOLYSIN® Combination Therapy with Carfilzomib in Multiple Myeloma
VariableMean (SEM),
Pre-Treatment(N=5)
Mean (SEM), REOLYSIN® +
Carfilzomib (N=5)
Mean (SEM), Carfilzomib Alone
(N=5)
CD8 37.8 (8.5) 84.6* (26.8) 5.2 (1.5)
PD-L1 74.2 (49.5) 208.2* (31.1) 9.4 (12.5)
caspase-3 6.2 (0.8) 24.8 (4.3)* 10.9 (2.9)
NK cells 16.8 (4.3) 20.6 (4.7) 0.9 (0.2)
CD68 199.0 (7.7) 188.9 (10.1) 197.5 (11.1)
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Data supplied by Dr. G. Nuovo
• Each value is number of positive cells/200X field• * = significant difference from pretreatment at p = 0.001
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Multiple Myeloma Registration Study
Oncolytics is preparing to file a Phase III registration study of REOLYSIN® in combination with carfilzomib in patients with multiple myeloma
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Manufacturing & Intellectual Property
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Manufacturing
Now produced at commercial scale (100L) under cGMP with final formulation Commercial manufacturing agreement in place with Sigma-Aldrich® Fine
Chemicals (SAFC)
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Patent Portfolio More than 400 patents issued worldwide,
including 60 US and 20 Canadian
More than 70 pending patent applications worldwide
Issued patent claims for reovirus 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
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Corporate & Financial
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Market & Capital Data
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Investment Highlights
Preparing to file for lead registration study in multiple myeloma
Positive safety data for 1,100+ patients Strong intellectual property portfolio
• More than 400 issued patents worldwide
Manufacturing at commercial scale
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Corporate Presentation
September 2016