Corporate presentation (april 8 2014)

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Corporate presentation (april 8 2014)

  1. 1. Corporate Presentation April 8, 2014
  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 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
  3. 3. Oncolytics Overview o Expanding Clinical Program o Lead product is REOLYSIN®, a broadly active novel cancer therapy o Ongoing clinical trials include seven randomized studies: o Enrollment complete randomized international study (REO 018) of REOLYSIN® in combination with carboplatin and paclitaxel in platinum- refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication o Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers 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 3
  4. 4. REOLYSIN® Overview o REOLYSIN® is a proprietary isolate of the reovirus o Reovirus is a replication competent virus and is considered safe to humans o REOLYSIN® has been safely administered to patients via intravenous, intratumoral and intrathecal injection o Mechanism of Action: o In Ras-activated cells, one of the key cellular defence mechanisms against double-stranded RNA viral infection, Protein Kinase-R (PKR), is deactivated o This specific vulnerability of constitutive Ras-activated cancer cells to the reovirus is the basis of REOLYSIN®’s activity and specificity o Reovirus oncolysis is seen in cancer cells with constitute Ras pathway activation; susceptible cancer cells therefore include those with either: o EGFR overexpression or mutation1; or o Ras mutation, which includes Kras mutation2 o Both of these mutations lead to activation of the Ras pathway 1 Evidence that the epidemal growth factor receptor on host cells confers reovirus infection efficiency. Strong et al. Virology 1993; 197(1): 405 2 The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12): 3351 4
  5. 5. REOLYSIN® Mechanism of Action REOLYSIN® infects both tumor cells and normal, healthy cells REOLYSIN® is a virus whose replication is stopped in a non- Ras-activated cell Healthy cell remains undamaged Tumor cells rupture to release progeny virus Replicated viruses repeat cell lysis cycle in nearby tumor cells REOLYSIN® replicates in Ras- activated tumor cells REOLYSIN® infects both tumor cells and normal, healthy cells Normal Cells Ras-Activated Cells REOLYSIN® administered to patients via IV 5
  6. 6. REO 013: REOLYSIN® Induced Tumour Response o Image shows positive (red staining) for reovirus in the metastatic lesions (blue arrow) and negative for reovirus in the normal cells (red arrow) o Nine out of ten patients showed the same pattern, i.e. targeted delivery to metastatic tumor lesions of the liver o In addition, two of the ten patients had complete tumor necrosis o This demonstrates that REOLYSIN® specifically accesses and replicates in metastatic colorectal cancer when delivered as a monotherapy 6
  7. 7. Market for Ras Pathway Mediated Cancers o Estimated global cancer market was US$85 billion in 2013; this is expected to rise to US$109 billion in 2018 o At least five million new patients per year are expected to develop cancers with a Ras pathway involvement o In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized 7
  8. 8. REOLYSIN® Clinical Program Overview REOLYSIN® has been utilized in studies in over 1,000 patients In total, nearly thirty ongoing or completed clinical trials including: o Seven randomized Phase II and Phase III clinical trials, including Phase III head and neck cancer and Phase II trials for ovarian, pancreatic, prostate, colorectal, non-small cell lung and breast cancers o Nine single arm studies in the following indications: o Phase II trials: o Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma, metastatic melanoma and squamous cell carcinoma o Phase I trials: o Company sponsored: colorectal cancer and advanced malignancies o Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors 8
  9. 9. REOLYSIN® Randomized Pipeline Indication Combination Therapy n Preclinical Phase I Phase II Phase III Sponsor REO 018: Head & Neck Cancer Carboplatin + paclitaxel 167 n/a GOG-0186H: Ovarian, Fallopian Tube & Primary Peritoneal Cancers Paclitaxel 110 NCI/ GOG OSU-10045: Pancreatic Cancer Carboplatin + paclitaxel 70 NCI IND 209: Prostate Cancer Docetaxel 80 NCIC IND 210: Colorectal Cancer FOLFOX-6 + Avastin® 100 NCIC IND 211: Non-Small Cell Lung Cancer Docetaxel or pemetrexed 150 NCIC IND 213: Breast Cancer Paclitaxel 100 NCIC 9
  10. 10. 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 10
  11. 11. Phase III (Pivotal) Program for REOLYSIN® in Squamous Cell Head & Neck Cancers o In Q3 2012, Oncolytics completed enrollment in REO 018, a randomized, two stage, two-arm, double-blind, multi-center trial examining REOLYSIN® in combination with carboplatin and paclitaxel in taxane-naïve patients with platinum-refractory recurrent head and neck cancers o The study was approved and run in fourteen countries in North America and Europe o Patients in the REO 018 study were stratified for: o ECOG performance status (0-1 versus 2) o Time of progression/relapse after prior platinum-based chemotherapy o Disease location (patients with locally recurrent disease, with or without distal metastases, versus patients with metastatic disease only) o REO 018 Endpoints: o Primary Endpoint: Overall Survival (OS) o Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response o Pharmacodynamic Endpoints: Tumour Ras pathway status and HPV status o The Company intends to treat REO 018 as a separate supportive study to a planned randomized, follow-on international Phase III head and neck registration study 11
  12. 12. REO 018: Safety o REOLYSIN® was safe and well-tolerated by patients o The side effects experienced by test-arm patients were consistent with those observed in earlier studies of REOLYSIN®; consistent with treatment with a virus, there was a higher incidence of flu-like symptoms in the test arm, most commonly fever, diarrhea, nausea, and fatigue o On a per-cycle basis: o More test (mean=27.2%, median=25.9%) than control (mean=5.3%, median=4.8%) patients with fever at each cycle o More test (mean=87.9%, median=81.7%) than control (mean=47.3%, median=45%) patients exhibiting flu-like symptoms at each cycle o Fewer patients required dose reductions of paclitaxel due to neuropathy or neurotoxicity on the test arm than the control o No test patients versus 6 control patients (p=0.028) 12
  13. 13. REO 018: Tumor-Specific Response Data o The percentage magnitude of initial tumour changes between the baseline and first post-treatment scans (performed at approximately six weeks) was examined for all patients o The endpoint differentiated between patients with loco-regional disease with or without distal metastases and those with metastatic disease only in order to determine whether REOLYSIN® adds tumor-specific activity in loco-regional and/or metastatic disease in a randomized setting o In an analysis of the 118 loco-regional patients, the test arm showed a statistical trend towards better tumour stabilization (defined as 0% growth) or shrinkage (p=0.076) over the control o In an analysis of the 47 patients with metastatic disease only, the test arm demonstrated statistically significantly better tumour stabilization (defined as 0% growth) or shrinkage (p=0.021) over the control 13
  14. 14. REO 018: Percentage Shrinkage of Tumours at First Post-Treatment Scan Patients with Loco-Regional Disease, With or Without Distal Metastases (p = 0.076, n= 118) Patients with Distal Metastases Only (p= 0.021, n= 47) 14 -80 -60 -40 -20 0 20 40 60 80 100 120 0 0.2 0.4 0.6 0.8 1 Control Test -80 -60 -40 -20 0 20 40 60 80 100 120 0 0.2 0.4 0.6 0.8 1 Control Test
  15. 15. REO 018: Progression-Free Survival (PFS) and Overall Survival (OS) Patients with Loco-Regional Disease, With or Without Distal Metastases o There were a total of 118 patients with loco-regional disease, with or without distal metastases o Test arm patients in this group maintained a PFS benefit over those in the control arm through five cycles of therapy o In an intent-to-treat analysis of progression-free survival, the test arm showed a statistically significant improvement in PFS (p=0.0072, hazard ratio=0.5360) over the control o The analysis used Type II censoring from the median PFS of each arm (48 days for the control arm and 95 for the test arm) o In an intent-to-treat analysis of overall survival, the test arm showed a statistically significant improvement in OS (p=0.0146, hazard ratio=0.5099) over the control o The analysis was performed to the median PFS of each arm, censoring any patients who received post- discontinuation therapy at the date at which they commenced the first of these therapies Patients with Distal Metastases Alone o There were a total of 47 patients with distal metastases alone; at the time of the analysis, eight of these patients were still alive o Test arm patients maintained a PFS benefit over those in the control for five cycles of therapy o Ultimately, there are too few patients to power a statistical analysis of the PFS and OS of the metastatic-only patient group 15
  16. 16. REO 016: Non-Small Cell Lung Cancer o Single-arm (up to 36 patients), open-label, two-stage US Phase II study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel o For non-small cell lung cancer (NSCLC) patients who have been pre-screened for Kras and EGFR mutation status o 15-20% of NSCLC is Kras mutated, while up to 50% is EGFR mutated or overexpressed, all of which cause Ras pathway activation o First-line therapy study, i.e. patients will be offered REOLYSIN® / carboplatin / paclitaxel instead of standard of care if they are Kras or EGFR mutated or EGFR overexpressed 16
  17. 17. REO 016: Biomarker Correlations with REOLYSIN® Efficacy o Of 36 evaluable patients, all of whom were Stage IV on entry, 89% exhibited SD or better (11 PR, 21 SD and 4 PD by RECIST) o 20 of these 36 patients (56%) had one year or more of survival o Of 24 patients with at least an EGFR mutation or amplification, 16 (66.7%) had one year or more of survival o Of 13 patients with only an EGFR mutation or amplification, 9 (69.2%) had one year or more of survival o Of 4 patients with BRAF and EGFR amplifications, 4 (100%) had one year or more of survival 17
  18. 18. REO 016: Partial Response in Lung (EGFR Over-Expression) 18 Pre-Treatment Post-Cycle 2
  19. 19. REO 021: Squamous Cell Carcinoma of the Lungs o Single-arm (up to 36 patients), open-label US Phase II study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel o Final results in 25 evaluable patients (all with metastatic disease) demonstrated that 92% (23 patients) exhibited overall tumour shrinkage, with mean shrinkage of 32.7% o Of the 25 evaluable patients who received more than one cycle of therapy, 10 (40%) showed partial responses by RECIST, and a further 12 (48%) showed stable disease by RECIST, for a disease control rate (CR + PR + SD) of 92% 19
  20. 20. REO 021: Partial Response in Lung 20 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)
  21. 21. Randomized Canadian Studies of REOLYSIN® o Patients are currently being enrolled in four randomized Phase II studies in Canada: o IND 209: Intravenous Administration of REOLYSIN® in Combination with Docetaxel for Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer o IND 210: Intravenous Administration of REOLYSIN® in Combination with FOLFOX-6 Plus Avastin® versus FOLFOX-6 Plus Avastin® Alone in Patients with Advanced or Metastatic Colorectal Cancer o IND 211: Intravenous Administration of REOLYSIN® in Combination with Docetaxel or Pemetrexed for Patients with Previously-Treated Advanced or Metastatic Non-Small Cell Lung Cancer o IND 213: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer o All four studies are sponsored by the National Cancer Institute of Canada’s Clinical Trials Group (NCIC CTG) 21
  22. 22. Randomized U.S. Studies of REOLYSIN® o Patients are currently being enrolled in two randomized Phase II studies in the United States: o OSU-10045: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Metastatic Pancreatic Cancer o GOG-0186H: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer o Both studies are sponsored by the U.S. National Cancer Institute (NCI), with GOG-0186H being conducted by the Gynecologic Oncology Group (GOG) 22
  23. 23. Intellectual Property o More than 370 patents issued worldwide, including 51 US and 16 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 23
  24. 24. Manufacturing o Now produced at 100L under cGMP with final formulation o Commercial manufacturing agreement with SAFC in place 24
  25. 25. Market & Capital Data (all amounts in CAD) Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (December 31, 2013) 84,803,818 Price Options $4.32 (weighted average) 5,918,678 Fully Diluted (December 31, 2013) 91,026,441 Cash/Cash Equivalents (December 31, 2013) $25.2M 25
  26. 26. Oncolytics Summary o Expanding Clinical Program o Lead product is REOLYSIN®, a broadly active novel cancer therapy o Ongoing clinical trials include seven randomized studies: o Enrollment complete randomized international study (REO 018) of REOLYSIN® in combination with carboplatin and paclitaxel in platinum- refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication o Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers 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 26
  27. 27. Corporate Presentation April 8, 2014

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