Corporate Presentation. Forward Looking Statements. May 2013

Transcription

1 Corporate Presentation May 2013 Forward Looking Statements Today s 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 ed 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

2 Oncolytics Overview Expanding Clinical Program Lead product is REOLYSIN, a broadly active novel cancer therapy Ongoing clinical trials include seven randomized studies: Enrollment complete in first stage of international Phase III study (REO 018) REOLYSIN and carboplatin / paclitaxel in platinumrefractory recurrent e head and neck cancer ce patients ts Six sponsored Phase II studies announced or ongoing in the US and Canada breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers Strong Intellectual Property Portfolio More than 360 patents issued worldwide Manufacturing at Commercial Scale 100L cgmp completed, commercial manufacturing agreement in place 3 REOLYSIN Overview REOLYSIN is a proprietary isolate of the reovirus Reovirus is a replication competent virus and is considered safe to humans REOLYSIN has been safely administered to patients via intravenous, intratumoral and intrathecal injection Mechanism of Action: In Ras-activated cells, one of the key cellular defence mechanisms against doublestranded RNA viral infection, Protein Kinase-R (PKR), is deactivated This specific vulnerability of constitutive Ras-activated cancer cells to the reovirus is the basis of REOLYSIN s activity and specificity Reovirus oncolysis is seen in cancer cells with constitute Ras pathway activation; susceptible cancer cells therefore include those with either: EGFR overexpression or mutation 1 ; or Ras mutation, which includes Kras mutation 2 Both of these mutations lead to activation i 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): The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12):

3 REOLYSIN Mechanism of Action Normal Cells REOLYSIN administered to patients via IV REOLYSIN infects both tumor cells and normal, healthy cells REOLYSIN is a virus whose replication is stopped in a non- Ras-activated cell Ras-Activated Cells Healthy cell remains undamaged REOLYSIN infects both tumor cells and normal, healthy cells REOLYSIN replicates in Rasactivated tumor cells Tumor cells rupture to release progeny virus Replicated viruses repeat cell lysis cycle in nearby tumor cells 5 REO 013: REOLYSIN Induced Tumour Responses Image shows positive (red staining) for reovirus in the metastatic lesions (yellow arrow) and negative for reovirus in the normal cells (red arrow) Nine out of ten patients showed the same pattern, i.e. targeted delivery to metastatic tumor lesions of the liver In addition, two of the ten patients had complete tumor necrosis This demonstrates that REOLYSIN specifically accesses and replicates in metastatic colorectal cancer when delivered as a monotherapy 6

4 Market for Ras Pathway Mediated Cancers Estimated global cancer market was $77 billion in 2011; this is expected to rise to $105 billion in 2016 At least five million new patients per year are expected to develop cancers with a Ras pathway involvement In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized 7 REOLYSIN Clinical Program Overview REOLYSIN has been utilized in studies in over 620 patients In total, nearly thirty ongoing or completed clinical i l trials including: 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 Nine single arm studies in the following indications: Phase II trials: Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma, metastatic melanoma and squamous cell carcinoma Phase I trials: Company sponsored: colorectal cancer and advanced malignancies Investigator t sponsored:multiple l myeloma and relapsed or refractory solid tumors 8

5 Selected REOLYSIN Pipeline: Randomized Studies Indication REO 018: Head & Neck Cancer Combination Therapy Carboplatin + paclitaxel n Preclinical Phase I Phase II Phase III Sponsor 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 Randomized Canadian Studies of REOLYSIN Patients are currently being enrolled in four randomized Phase II studies in Canada: IND 209: Intravenous Administration of REOLYSIN in Combination with Docetaxel for Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer IND 210: Intravenous Administration with REOLYSIN in Combination with FOLFOX-6 Plus Avastin versus FOLFOX-6 Plus Avastin Alone in Patients with Advanced or Metastatic Colorectal Cancer 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 IND 213: Intravenous Administration of REOLYSIN in Combination with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer All four studies are sponsored by the National Cancer Institute of Canada s Clinical Trials Group (NCIC CTG) 10

6 Randomized U.S. Studies of REOLYSIN Patients are currently being enrolled in two randomized Phase II studies in the United States: OSU-10045: Intravenous Administration of REOLYSIN in Combination with Paclitaxel and Carboplatin for Patients with Metastatic Pancreatic Cancer GOG-0186H: Intravenous Administration of REOLYSIN in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Both studies are sponsored by the U.S. National Cancer Institute (NCI), with GOG-0186H being conducted by the Gynecologic Oncology Group (GOG) 11 REO 016: Non-Small Cell Lung Cancer Single-arm (up to 36 patients), open-label, two-stage US Phase II study of intravenously-administered REOLYSIN in combination with carboplatin and paclitaxel For non-small cell lung cancer (NSCLC) patients who have been prescreened for Kras and EGFR mutation status 15-20% of NSCLC is Kras mutated, t while up to 50% is EGFR mutated or overexpressed, all of which cause Ras pathway activation 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 Interim data demonstrated d that, of 30 evaluable patients (all stage 4 on entry), 90% were SD or better (9 PR, 18 SD) by RECIST 12

7 Phase II NSCLC (REO 016): REOLYSIN / Carboplatin / Paclitaxel Combination (EGFR Over-Expression; Partial Response in Lung) Pre-Treatment Post Cycle 2 13 REO 021: Squamous Cell Carcinoma (SCC) of the Lungs Single-arm (up to 36 patients), open-label US Phase II study of intravenously-administered REOLYSIN in combination with carboplatin and paclitaxel l Interim results in first 21 evaluable patients (all with metastatic disease) demonstrated 86% of patients were SD or better (9 PR, 9 SD, 3 PD) by RECIST Of the total 20 patients with evaluable tumours, 95% (n=19) had tumour stabilization (0% growth) or shrinkage from Cycles 2 to 6 14

8 REO 021: Best Overall Percentage Response in Target Lesions (Interim Data) esions) Percent Ch hange (Target Le US Phase II Squamous Cell Carcinoma Lung Cancer (REO 021): REOLYSIN / Carboplatin / Paclitaxel Combination (Partial Response) Right Upper Lung Mass (8.3 cm) Right Upper Lung Mass (4.1 cm) Right Upper Lung Mass (3.6 cm) Right Pleural Met (2.2 2 cm) Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm) Pre-Treatment Post Cycle 2 Post Cycle 4 16

9 Pivotal (Phase III) Program for REOLYSIN Study Overview (REO 018) Randomized, two stage, two-arm, double-blind, multicenter trial examining REOLYSIN in combination with paclitaxel / carboplatin in taxane-naïve patients with platinum-refractory recurrent head and neck cancers Study approved in fourteen countries in North America and Europe Stage 1 enrollment completed Q Principal Investigators: James A. Bonner, MD, University of Alabama at Birmingham, US Kevin Harrington, MBBS MRCP FRCR, The Royal Marsden Hospital, London, UK Jan Vermorken, MD, PhD, University Hospital, Antwerp, Belgium Endpoints Primary Endpoint: Overall survival Secondary Endpoints: Progression-Free Survival (PFS), best response, and tumour specific response Pharmacodynamic Endpoints: Tumor Ras pathway status and HPV status 17 REO 018: Tumor Specific Response Data Data announced December 13, 2012 Endpoint examines initial iti percentage tumor changes between baseline and first post treatment scans in all patients, differentiating between loco-regional tumours and metastatic tumours This is a measure of rate or velocity of response, not magnitude of response The endpoint was introduced to determine if REOLYSIN adds tumor specific differential activity in metastatic and loco-regional disease in a randomized setting Of the total 105 patients with evaluable metastatic tumors, 86% (n=50) of those in the test, and 67% (n=55) in the control arm, arm had tumor stabilization (0% growth) or shrinkage This is a statistically significant difference, with a p-value of

10 REO 018: Percentage Change in Metastatic Lesions at First Post-Treatment Scan (Control vs. Test) Lesions) Change (Target L Percent C p= REOLYSIN and Safety More than 620 patients treated, more than 530 intravenously at doses up to 3x10 10 TCID 50 daily No maximum tolerated dose (MTD) reached to date 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 Transient grade 3 and 4 toxicities included lymphopenia and neutropenia These symptoms were more frequently observed from day 2 of treatment and usually lasted less than 6 hours 20

11 Intellectual Property Approximately 360 patents issued worldwide, including 49 US and 15 Canadian Reovirus issue patent claims 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 Approximately 235 pending applications worldwide 21 Manufacturing Now produced at 100L under cgmp with final formulation Commercial manufacturing agreement with SAFC in place 22

12 Market & Capital Data (all amounts in CAD) Exchanges NASDAQ:ONCY Shares Outstanding (March 31, 2013) Warrants Expiring i Pi Price TSX:ONC 84,758,818 Feb 8, 2014 $ ,945 Options $4.40 (average) 6,076,844 Fully Diluted (March 31, 2013) 91,139,607 Cash/Cash Equivalents (March 31, 2013) $43.9M 23 Oncolytics Summary Expanding Clinical Program Lead product is REOLYSIN, a broadly active novel cancer therapy Ongoing clinical trials include seven randomized studies: Enrollment complete in first stage of international Phase III study (REO 018) REOLYSIN and carboplatin / paclitaxel in platinumrefractory head and neck cancer ce patients ts Six sponsored Phase II studies announced or ongoing in the US and Canada breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers Strong Intellectual Property Portfolio More than 360 patents issued worldwide Manufacturing at Commercial Scale 100L cgmp completed, commercial manufacturing agreement in place 24

13 Corporate Presentation May 2013