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September 2016 Corporate Presentation


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September 2016 Corporate Presentation

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September 2016 Corporate Presentation

  1. 1. Corporate Presentation September 2016
  2. 2. 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. 2
  3. 3. 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 scale 100L cGMP completed 3
  4. 4. What is REOLYSIN®?  A proprietary isolate of wild-type reovirus Serotype 3 Dearing  Non-pathogenic  Most humans show evidence of exposure by adulthood 4
  5. 5. 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 5
  6. 6. 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 6
  7. 7. Clinical Data: Progression Free Survival (PFS) & Overall Survival (OS)
  8. 8. 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 8
  9. 9. Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211 9
  10. 10. 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 10
  11. 11. Randomized PFS and OS by Gender in NSCLC Patients: IND 211 11
  12. 12. Clinical Data: Tumour Responses
  13. 13. 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 13
  14. 14. 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; and 3. Genetics of metastases 14
  15. 15. 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 15
  16. 16. Post-Cycle 2 16 Post-Cycle 6 Partial Response in Liver Metastases Pre-Treatment o Patient was diagnosed with sinu-nasal carcinoma o Study participants were treated with REOLYSIN® in combination with carboplatin and paclitaxel (Phase 1)
  17. 17. Pre-Treatment Post-Cycle 3 o Patient was diagnosed with metastatic nasopharyngeal cancer o 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% reduction 17 Partial Response in Liver Metastases
  18. 18. 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) 18
  19. 19. 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) 19
  20. 20. 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) 20
  21. 21. 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 21
  22. 22. 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 22
  23. 23. REOLYSIN® Combination Therapy with Carfilzomib in Multiple Myeloma Variable Mean (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) 23 Data supplied by Dr. G. Nuovo • Each value is number of positive cells/200X field • * = significant difference from pretreatment at p = 0.001
  24. 24. 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 24
  25. 25. Manufacturing & Intellectual Property
  26. 26. Manufacturing  Now produced at commercial scale (100L) under cGMP with final formulation  Commercial manufacturing agreement in place with Sigma-Aldrich® Fine Chemicals (SAFC) 26
  27. 27. 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 27
  28. 28. Corporate & Financial
  29. 29. Market & Capital Data 29
  30. 30. 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 30
  31. 31. Corporate Presentation September 2016