Jefferies 2014 Global Healthcare Conference. June 3, 2014

Transcription

1 Jefferies 2014 Glbal Healthcare Cnference June 3, 2014

2 Frward Lking Statements This presentatin cntains certain frward lking statements relating t the cmpany s financial results, business prspects and the develpment and cmmercializatin f REOLYSIN, a therapeutic revirus. These statements are based n management s current expectatins and beliefs and are subject t a number f factrs which invlve knwn and unknwn risks, delays, uncertainties and ther factrs nt under the cmpany s cntrl which may cause actual results, perfrmance r achievements f the cmpany t be materially different frm the results, perfrmance r ther expectatins implied by these frward lking statements. In any frward lking statement in which Onclytics Bitech Inc. expresses an expectatin r belief as t future results, such expectatins r beliefs are expressed in gd faith and are believed t have a reasnable basis, but there can be n assurance that the statement r expectatin r belief will be achieved. These factrs include results f current r pending clinical trials, risks assciated with intellectual prperty prtectin, financial prjectins, market prjectins, actins by the FDA/HPB/MHRA and thse ther factrs detailed in the cmpany s filings with SEDAR and the Securities and Exchange Cmmissin. Onclytics des nt undertake an bligatin t update the frward lking statements, except as required by applicable laws. 2

3 Onclytics Overview Expanding Clinical Prgram Lead prduct is REOLYSIN, a bradly active nvel cancer therapy Onging clinical trials include six randmized studies: Phase II studies nging in the US and Canada breast, nn-small cell lung, clrectal, prstate, pancreatic and varian cancers Strng Intellectual Prperty Prtfli Mre than 370 patents issued wrldwide Manufacturing at Cmmercial Scale 100L cgmp cmpleted, cmmercial manufacturing agreement in place 3

4 REOLYSIN Overview REOLYSIN is a prprietary islate f the revirus Revirus is a replicatin cmpetent virus and is cnsidered safe t humans REOLYSIN has been safely administered t patients via intravenus, intratumral and intrathecal injectin Mechanism f Actin (MA): Primary MA is as a selective cyttxin, where selectivity is based n whether cancer cells have cnstituative Ras pathway activatin; susceptible cancer cells therefre include thse with either: EGFR verexpressin r mutatin; r Ras mutatin, which includes Kras mutatin Secndary MAs may include interfern up regulatin in target tissues, and tumur directed immune respnse 4

5 Market fr Ras Pathway Mediated Cancers Estimated glbal cancer market was US$85 billin in 2013; this is expected t rise t US$109 billin in 2018 At least five millin new patients per year are expected t develp cancers with a Ras pathway invlvement In the develped wrld alne, at least 2.6 millin patients per year die f cancers that have metastasized 5

6 REO 003: REOLYSIN Intratumural Mntherapy Anaplastic Astrcytma Early Cyttxic Activity Fllwed by Late Stage Immune-Mediated Respnse Against the Residual Tumur Days after REOLYSIN administratin: (Pst Debulking) 6

7 REO 013: REOLYSIN Intravenus Mntherapy Metastatic Liver Lesin Image shws psitive (red staining) fr revirus in the metastatic lesins (blue arrw) and negative fr revirus in the nrmal cells (red arrw) Nine ut f ten patients shwed the same pattern, i.e. targeted delivery t metastatic tumr lesins f the liver 7

8 REOLYSIN Clinical Prgram Overview REOLYSIN has been utilized in studies in ver 1,000 patients In ttal, nearly thirty nging r cmpleted clinical trials including: Seven randmized Phase II and Phase III clinical trials, including Phase III head and neck cancer and Phase II trials fr varian, pancreatic, prstate, clrectal, nn-small cell lung and breast cancers Nine single arm studies in the fllwing indicatins: Phase II trials: Cmpany spnsred: pancreatic cancer, nn-small cell lung cancer, head and neck carcinma, metastatic melanma and squamus cell carcinma Phase I trials: Cmpany spnsred: clrectal cancer and advanced malignancies Investigatr spnsred: multiple myelma and relapsed r refractry slid tumrs 8

9 Key Clinical Endpints in Onclgy Tumur shrinkage r remval Safety Time t prgressin Overall survival 9

10 REO 011: Head & Neck Cancer Patient with Partial Respnse in Liver Metastases Pre-Treatment Pst-Cycle 6 Prir treatment: radiatin Respnse maintained thrugh 8 cycles 10

11 REO 016: Nn-Small Cell Lung Cancer Single-arm (up t 36 patients), pen-label, tw-stage US Phase II study f intravenusly-administered REOLYSIN in cmbinatin with carbplatin and paclitaxel Fr nn-small cell lung cancer (NSCLC) patients wh have been pre-screened fr Kras and EGFR mutatin status 15-20% f NSCLC is Kras mutated, while up t 50% is EGFR mutated r verexpressed, all f which cause Ras pathway activatin First-line therapy study, i.e. patients will be ffered REOLYSIN / carbplatin / paclitaxel instead f standard f care if they are Kras r EGFR mutated r EGFR verexpressed 11

12 REO 016: Bimarker Crrelatins with REOLYSIN Efficacy Of 36 evaluable patients, all f whm were Stage IV n entry, 89% exhibited SD r better (11 PR, 21 SD and 4 PD by RECIST) 20 f these 36 patients (56%) had ne year r mre f survival Of 24 patients with at least an EGFR mutatin r amplificatin, 16 (66.7%) had ne year r mre f survival Of 13 patients with nly an EGFR mutatin r amplificatin, 9 (69.2%) had ne year r mre f survival Of 4 patients with BRAF and EGFR amplificatins, 4 (100%) had ne year r mre f survival 12

13 REO 016: Partial Respnse in Lung Pre-Treatment Pst-Cycle 2 13

14 REO 021: Squamus Cell Carcinma f the Lungs Single-arm (up t 36 patients), pen-label US Phase II study f intravenusly-administered REOLYSIN in cmbinatin with carbplatin and paclitaxel Final results in 25 evaluable patients (all with metastatic disease) demnstrated that 92% (23 patients) exhibited verall tumur shrinkage, with mean shrinkage f 32.7% Of the 25 evaluable patients wh received mre than ne cycle f therapy, 10 (40%) shwed partial respnses by RECIST, and a further 12 (48%) shwed stable disease by RECIST, fr a disease cntrl rate (CR + PR + SD) f 92% 14

15 REO 021: Partial Respnse in Lung 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 cm) Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm) Pre-Treatment Pst-Cycle 2 Pst-Cycle 4 15

16 REOLYSIN and Safety Mre than 1,000 patients treated, mre than 900 intravenusly at dses up t 3x10 10 TCID 50 daily N maximum tlerated dse (MTD) reached t date Mntherapy txicities have generally been mild (grade 1 r 2) and included chills, fever, headache, cugh, myalgia, runny nse, sre thrat, fatigue and grade 1 r 2 lymphpenia and neutrpenia Transient grade 3 and 4 txicities included lymphpenia and neutrpenia These symptms were mre frequently bserved frm day 2 f treatment and usually lasted less than 6 hurs 16

17 Phase III (Pivtal) Prgram fr REOLYSIN in Squamus Cell Head & Neck Cancers In Q3 2012, Onclytics cmpleted enrllment in REO 018, a randmized, tw stage, tw-arm, duble-blind, multi-center trial examining REOLYSIN in cmbinatin with carbplatin and paclitaxel in taxane-naïve patients with platinum-refractry recurrent head and neck cancers The study was apprved and run in furteen cuntries in Nrth America and Eurpe Patients in the REO 018 study were stratified fr: ECOG perfrmance status (0-1 versus 2) Time f prgressin/relapse after prir platinum-based chemtherapy Disease lcatin (patients with lcally recurrent disease, with r withut distal metastases, versus patients with metastatic disease nly) REO 018 Endpints: Primary Endpint: Overall Survival (OS) Secndary Endpints: Prgressin-Free Survival (PFS), best respnse and tumur-specific respnse Pharmacdynamic Endpints: Tumur Ras pathway status and HPV status The Cmpany intends t treat REO 018 as a separate supprtive study t a planned randmized, fllw-n internatinal Phase III head and neck registratin study in patients with lc-reginal head and neck cancer 17

18 REO 018: Tumr Specific Respnse Data Data annunced December 13, 2012 Endpint examines initial percentage tumr changes between baseline and first pst treatment scans in all patients, differentiating between lc-reginal tumurs and metastatic tumurs This is a measure f rate r velcity f respnse, nt magnitude f respnse The endpint was intrduced t determine if REOLYSIN adds tumr specific differential activity in metastatic and lc-reginal disease in a randmized setting Of the ttal 105 patients with evaluable metastatic tumrs, 86% (n=50) f thse in the test, and 67% (n=55) in the cntrl arm, arm had tumr stabilizatin (0% grwth) r shrinkage This is a statistically significant difference, with a p-value f

19 Head and Neck: Percentage Shrinkage f Tumurs at First Pst-Treatment Scan Grup Test 0 Grup Cntrl 1 20 Grup Test 0 Grup Cntrl Patients with Lc-Reginal Disease, With r Withut Distal Metastases (p=0.076, n=118) Patients With Distal Metastases Only (p=0.021, n=47) 19

20 REO 018: Tp-Line Safety Data Data annunced Nvember 21, 2013 fr all 167 patients enrlled REOLYSIN was safe and well-tlerated by patients Patients n the test arm f the study experienced a higher incidence f flu-like symptms cnsistent with earlier clinical trials f REOLYSIN and treatment with a virus Mst cmmnly mild fever, chills, nausea and diarrhea Fewer patients required dse reductins f paclitaxel due t neurpathy r neurtxicity n the test arm than the cntrl arm (zer in the test arm versus six in the cntrl; p=0.028) On this basis, Onclytics intends t explre the ptential chemprtective and neurprtective prperties f REOLYSIN in future clinical studies 20

21 REO 018: Tp-Line Efficacy Data Data annunced Nvember 21, 2013 and April 8, 2014 Patients with lcreginal disease plus r minus distal metastases in the test arm (n=62) shwed a median PFS f 94 days (13.4 weeks), versus 50 days (7.1 weeks) in the cntrl arm (n=56) Patients wh received REOLYSIN had increased benefit thrugh five cycles f therapy An intent t treat analysis f the 118 lcreginal patients using Type II censring frm the median PFS f each arm shwed a statistically significant imprvement in PFS f the test arm versus the cntrl arm (p=0.0072, hazard rati= ) An intent t treat analysis f the 118 lcreginal patients perfrmed n all patients t the median PFS in each arm, censring any patients wh received pst-discntinuatin therapy at the date at which they cmmenced the first f these therapies shwed a statistically significant imprvement in OS f the test arm versus the cntrl arm (p=0.0146, hazard rati=0.5099) 21

22 REOLYSIN : Randmized Pipeline Indicatin REO 018: Head & Neck Cancer Cmbinatin Therapy Carbplatin + paclitaxel n Preclinical Phase I Phase II Phase III Spnsr 167 n/a GOG-0186H: Ovarian, Fallpian Tube & Primary Peritneal Cancers Paclitaxel 110 NCI/ GOG OSU-10045: Pancreatic Cancer Carbplatin + paclitaxel 70 NCI IND 209: Prstate Cancer Dcetaxel 80 NCIC IND 210: Clrectal Cancer FOLFOX-6 + Avastin 100 NCIC IND 211: Nn-Small Cell Lung Cancer Dcetaxel r pemetrexed 150 NCIC IND 213: Breast Cancer Paclitaxel 100 NCIC 22

23 Intellectual Prperty Mre than 370 patents issued wrldwide, including 56 US and 20 Canadian Revirus issue patent claims cver: Cmpsitins f matter cmprising revirus Pharmaceutical use f reviruses t treat neplasia and cellular prliferative diseases Cmbinatin therapy with radiatin, chemtherapy and/r immune suppressants Methds fr manufacturing revirus and screening fr susceptibility t revirus Pharmaceutical use f reviruses in transplantatin prcedures Apprximately 235 pending applicatins wrldwide 23

24 Manufacturing Nw prduced at 100L under cgmp with final frmulatin Cmmercial manufacturing agreement with SAFC in place 24

25 Market & Capital Data (all amunts in CAD) Exchanges Shares Outstanding (March 31, 2014) NASDAQ:ONCY TSX:ONC 85,810,718 Optins Outstanding (March 31, 2014) Price $3.65 (weighted average) 6,065,344 Fully Diluted (March 31, 2014) 91,876,062 Cash/Cash Equivalents (March 31, 2014) $22.2M 25

26 Onclytics Summary Expanding Clinical Prgram Lead prduct is REOLYSIN, a bradly active nvel cancer therapy Onging clinical trials include six randmized studies: Phase II studies nging in the US and Canada breast, nn-small cell lung, clrectal, prstate, pancreatic and varian cancers Strng Intellectual Prperty Prtfli Mre than 370 patents issued wrldwide Manufacturing at Cmmercial Scale 100L cgmp cmpleted, cmmercial manufacturing agreement in place 26

27 Jefferies 2014 Glbal Healthcare Cnference June 3, 2014