Investor Presentation

Transcription

1 Investr Presentatin May 2018 nclyticsbitech.cm TSX ONC OTCQX ONCYF

2 Frward Lking Statements This presentatin cntains certain frward lking statements relating t the cmpany s business prspects and the develpment and cmmercializatin f REOLYSIN, a first-in-class systemically administered immun-nclgy agent fr slid tumrs and heme malignancies. 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, 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 Rapid Recent Prgress supprts bth mbc registratin study and I-O & IMiD prgrams Nearly dubled verall survival (OS) in HR+/HER2- breast cancer patients Partnership with Adlai Nrtye Licensing fee and milestnes fr mbc f $21.2M Additinal milestne payments f $65.4M Duble digit ryalty SPA agreement, Granted Fast Track Designatin & psitive feedback frm FDA and EMA I-O Data Demnstrated upregulatin f PD-L1 Psitive Keytruda cmb Ptential CI and CART-T synergies 154,000+ metastatic breast cancer (mbc) patients > $ Multi Billin Cllabratin with Celgene & Myelma UK Cmb with Revlimid r Imnvid First IMiD cmbinatin study 3

4 What is REOLYSIN? First intravenusly delivered immun-nclytic virus (I-OV) agent t demnstrate verall survival benefit in a randmized study Nn-pathgenic prprietary islate f the unmdified revirus Bisafety Level 2 revirus Des nt require special handling Ptential t increase the efficacy f bth chemtherapeutic and Immun-nclgy (I-O) agents 4

5 REOLYSIN MOA Mre than 40 supprting publicatins 5

6 What des REOLYSIN d? Turns COLD tumrs HOT Tw ways t determine hw well a tumr respnds t I-O s: The number f immune cells in the tumr The extent f mutatins in tumr cells Selective tumr cell lysis kills cancer cells Activates innate immune system: Increases NK cell activatin and prmtes immune cell infiltratin Activates adaptive immune system: Prmtes T-Cell activatin and induces PD-1 & PDL-1 expressin Viral priming culd expand the use f CI s in indicatins frmerly thught t be untreatable Nn-inflamed tumr Partially-inflamed tumr Inflamed tumr Immune desert cld tumr Immune respnsive ht tumr 6

7 REOLYSIN and Safety 1,100+ patients treated, 900+ intravenusly N maximum tlerated dse (MTD) reached t date Mntherapy Txicity Symptms Intravenus lcal Txicities have generally been mild (grade 1 r 2) and included chills, fever, headache, cugh, myalgia, runny nse, sre thrat, fatigue, lymphpenia r neutrpenia Transient txicities (grade 3 r 4) als included lymphpenia r neutrpenia Symptms frequently bserved frm day 2 f treatment and usually lasted < 6 hurs 7

8 Clinical Develpment Plan & Clinical Data

9 Clinical Develpment Plan The clinical develpment plan addresses drug cmbinatins that can ptentially bst each respnse f the MOA 1. Prgram 1 - Chem cmbinatins Chemtherapy assists the escape f the virus frm the vasculature and enhances the distributin f the virus in the tumr. The basis fr ur mbc registratin pathway. 2. Prgram 2 Mdulating the immune system Pelarerep upregulates NK (natural killer cells). Currently in a cmbinatin study with Celgene s Imnvid & Revlimid targeting myelma and explring additinal cllabratins. 3. Prgram 3 - Immuntherapy cmbinatins Pelarerep creates an inflamed phentype highlighting synergies with bth immune checkpint inhibitrs (PD-1/PD-L1) and CAR-T cell therapies. Explring bth Windw f Opprtunity and Basket Study cllabratins. 9

10 Prgram 1: Chemtherapy Cmbinatins Metastatic Breast Cancer (2 nd, 3 rd & 4 th Line) Regulatry Status & Key Learnings Statistically significant phase 2 OS data Regulatry Feedback: Favrable FDA End-f-Phase 2 (EOP2) Meeting Favrable EMA Final Advice Letter (FAL) Special Prtcl Assessment Agreement Fast Track Designatin Preparing fr 450-patient adaptive design registratin study with OS endpint Demnstrated t wrk as I-O therapy 10

11 Prgram 1: Chem-Cmb / Breast Cancer (IND-213) Phase 2 Design (IND-213) Phase 2 Data Randmized, nn-blinded study, with IV administered REOLYSIN given in cmbinatin with paclitaxel versus paclitaxel alne Patients with advanced r metastatic breast cancer Paclitaxel weekly, n days 1, 8 and 15 f a 28-day cycle and test arm with the additin f REOLYSIN n days 1, 2, 8, 9, 15 and patients; pwered t 90% Endpints: Primary: PFS Secndary: OS Secndary : ORR Secndary: Safety Statistically significant imprvement in median OS: 10.4 mnths t 17.4 mnths (ITT) HR =.65 P = 0.1 (pwered t 90%) 10.8 mnths t 21.0 mnths (HR+/HER2-) HR =.6 P = 0.1 (pwered t 90%) First IOV t demnstrate a statistically significant median OS advantage in a randmized clinical study ORR and PFS similar in bth grups 11

12 Prgram 1: Chem-Cmb / Breast Cancer IND-213 randmized phase 2 study frm CCTG Statistically significant imprvement in verall survival ITT Ppulatin 100% 80% 60% 40% 20% 0% + Test Arm (paclitaxel/reolysin) mnths Cntrl Arm (paclitaxel) mnths Time in Mnths Test n=36 Cntrl n=38 HR+/HER2- ~80% TNBC ~18% Prir Chem 100% Prir Anthrac. ~90% Prir Taxanes ~50% HR (hazard rati) 0.65 CI (cnfidence int.) 80% ( ) p-value 0.1 (90% pwer) Bernstein V et.al. Abstract CT131, AACR

13 Prgram 1: Chem-Cmb / Breast Cancer Nearly dubled OS in HR+/HER2- Mre than dubled OS in ER+PR+/HER2- Overall survival fr 57 patients in IND-213 breast cancer study with ER+/HER2- status Overall survival fr 47 patients in IND-213 breast cancer study with PgR+/HER2- status Survival prbability Survival prbability Time in Mnths Time in Mnths HR = 0.60 p = 0.1 (pwered t 90%) Median OS = 10.8 mths vs 21.0 mths Test = 28 Cntrl = 29 Test Arm (paclitaxel/reolysin) Cntrl Arm (paclitaxel) HR = 0.36 p = Median OS = 10.8 mths vs 21.8 mths Test = 26 Cntrl = 21 CCTG: Canadian Cancer Trials Grup 13

14 Prgram 1: Chem-Cmb / Breast Cancer 3,560,570 breast cancer prevalence, US ,885 addressable patients in Nrth America 2,599,216 Patients with HR+/HER2- Subtype 154,885 Patients with HR+/HER2- stage IV breast cancer Mst cmmn cancer in wmen glbally Nearly 1.7 millin new cases diagnsed glbally every year Surce: SEER database & WCRF 14

15 Prgram 1: Chem-Cmb / Breast Cancer New agents are all apprved as adjuvants r in 1L setting Why 2L and 3L HR+/HER2- is a significant unmet need Checkpint inhibitrs have failed N ther meaningful OS advantage in 2L and 3L KISQALI IBRANCE FASLODEX VERZENIO I-O activity fcused n TNBC due t inflamed tumr type TNBC is mst active cmpnent f nging clinical studies in breast cancer Only Halaven has shwn an OS advantage (2.5 mnths) Only PFS ptins in 2L & 3L: Taxtere Taxl Abraxane Gemzar 15

16 Prgram 2: Targeted/IMiD Cmbinatins REOLYSIN + Imnvid r Revlimid in multiple myelma Onging cllabratin with Celgene & Myelma UK Establish safety prfile Rescue treatment in relapsing myelma patients Phase 1b enrlling 44 patients Preliminary data expected mid-2019 Additinal targeted/imid studies currently being reviewed 16

17 Prgram 3: Immuntherapy Cmbinatins Metastatic Pancreatic Cancer (2 nd Line) Regulatry Status Orphan Drug Designatin Granted Ptential fr Fast-Track Designatin Ptential End-f-Phase 2 Meeting REO 024: Secnd Line Pancreatic Cancer in cmbinatin with Keytruda Tw patients with stable disease: 126 and 277 days One patient with partial respnse lasting 504 days (35 cycles) On treatment bipsy: infectin in cancer cells and immune infiltrates Additinal I-O cmbinatins in multiple indicatins are currently being reviewed 17

18 Prgram 3: Immuntherapy Cmbinatins Current Checkpint Inhibitr Market Keytruda Opdiv Tecentriq ~20% f cancers Bavenci Imfinzi What can Checkpint Inhibitrs treat with the ability t turn COLD tumrs HOT Yervy??% 18

19 Clinical Develpment Plan Preclinical Phase I Phase II Phase III Chem Cmbs REO 026: Paclitaxel ± REO 2/3L mbc Immun Therapy Cmbs Targeted / IMiD Cmbs Windw f Opprtunity: mbc Basket CI + REO: HCC, TNBC, MSI-H CRC, NSCLC, Bladder Celgene-MUK: pm/len + REO in RR Myelma NWU-Merck: Pembr + REO 2L Pancreatic 19

20 Manufacturing & Intellectual Prperty

21 Established Manufacturing Capability Final frmulatin prduced at 100 liter-scale under cgmp > 50,000 standard dses per prductin run Cmmercial scale manufacturing agreement with SAFC (part f Merck Millipre Sigma) When stred frzen, liquid frmulatin is stable fr at least five years (stability testing nging) Bisafety Level 2 classificatin requiring n specialized handling requirements Cst f Gds (COGS) are in line with thse f ther prducts made via vaccine manufacturing prcess 21

22 Strng Patent Prtfli Mre than 406 patents issued wrldwide, including 47 US and 22 Canadian Over 35 pending applicatins wrldwide Revirus issued patent claims cver: Cmpsitins f matter cmprising revirus Thrugh 2028 and extendable t 2033 Pharmaceutical use f reviruses t treat neplasia and cellular prliferative diseases Cmbinatin therapy with radiatin, chemtherapy and/r immunesuppressants Methds fr manufacturing revirus and screening fr susceptibility t revirus Pharmaceutical use f reviruses in transplantatin prcedures 22

23 Crprate

24 Adlai Nrtye: USD $86.6 Millin Reginal License Reginal license cvers China, Hng Kng, Macau, Singapre, Suth Krea and Taiwan Upfrnt, licensing fee and milestne payments t supprt phase 3 registratin study f USD $21.2 millin Upfrnt payment f USD $5.3 millin Tw milestne payments ttaling USD $8 millin made up f tw callable cmmn share purchase warrants priced at a premium USD $7.9 millin based n certain regulatry advancements USD $65.4 millin upn achievement f clinical, regulatry and cmmercializatin milestnes Duble digit ryalty payments 24

25 Experienced Leadership Extensive knwledge f nclgy/immuntherapy Public cmpany experience Strng business develpment and cmmercializatin expertise MANAGEMENT NON-EXECUTIVE DIRECTORS SCIENTIFIC ADVISORY BOARD Matt Cffey, PhD, MBA C-funder, Directr, President & CEO Kirk Lk, CA Chief Financial Officer EY LLP Andrew de Guttadaur Glbal Head f Business Develpment Amgen, Bigen, Takeda Allisn Hagerman, PEng, PMP VP f Prduct Develpment Visinary Bimedical Michael Mre VP f IR & Crprate Cmmunicatins Equicm, Atkins + Assciates Wayne Pisan, MBA Chair f the Bard, Onclytics Frmer President, Sanfi Pasteur Angela Hltham, MBA, ICD.D Nabisc Hspital fr Sick Children J. Mark Lievnen, CA Frmer President, Sanfi Pasteur Ontari Institute fr Cancer Research William G. Rice, PhD President & CEO, Aptse Bisciences President, CEO & Directr f Achillin Bernd R. Seizinger, MD, PhD Frmer President & CEO f GPC Bitech VP f Onclgy Drug Discvery, BMS Debrah M. Brwn, BSc, MBA Frmer President, EMD Sern Canada CCTG Dr. Martine Piccart, MD, PhD Prfessr f Onclgy, Université Libre de Bruxelles BCRF Scientific Advisry Bard C-Funder f Breast internatinal Grup (BIG) Dr. Aleix Prat, MD, PhD Head, Medical Onclgy Department, Hspital Clinic f Barcelna SOLTI - Breast Cancer Research Grup Dr. Padmanee Sharma, MD, PhD Prfessr, Department f Geniturinary Medical Onclgy MD Andersn Cancer Center KITE, Amgen & BMS IO Netwrk 25

26 Market and Capital Data Exchanges Market Cap (May 10, 2018) OTCQX: ONCYF TSX: ONC USD $97.3 M CDN $125.3 M Shares Outstanding (March 3, 2018) 142,334,722 Warrants (May 3, 2018) Optins (May 3, 2018) Restricted/perfrmance share units (May 3, 2018) 16,445,000 8,846,067 2,493,541 Fully Diluted (May 3, 2018) 170,119,330 *Cash / Cash Equivalents / Shrt Term Investments (March 31, 2018) CDN $7.7 millin USD $6.0 millin** Financial runway Int 2019 * Des nt include CDN $4.9 M f Adlai Nrtye s upfrnt payment ** Based n FX n May 10,

27 Achieved & Anticipated Milestnes Event Timing Mre than dubled 2 year survival in pancreatic cancer Mre than dubled OS in ER+PR+/HER2- mbc patients FDA: Special Prtcl Assessment (SPA) & Fast Track Designatin Favrable feedback frm FDA & EMA fr mbc phase 3 study Adlai Nrtye reginal partnership Registratin Partnership Update 1H 2018 NASDAQ 1H 2018 Initiate phase 3 in metastatic breast cancer 2H 2018 Initiate phase 2 Windw f Opprtunity Study in mbc 2H 2018 Initiate phase 2 Basket Studies 2H 2018 Initiate phase 2 NWU-Merck study in pancreatic cancer 2H 2018 MUK eleven preliminary data 1H 2019 Data frm I-O cmbinatin studies

28 Cmpelling Opprtunity Summary Turning COLD tumrs HOT Seeking Glbal Partner t c-develp REOLYSIN Phase 3-ready: Nearly dubled OS in HR+/HER2- mbc patients Favrable FDA & EMA feedback Optimized trial design Synergies with Immuntherapies Cmpetitive advantages Increase f NK & T-Cells & enhances antigen presentatin by APC s Ptential synergy with IMiD s (MUK-Celgene study) Increasing expressin f PD-1/L1 n tumr T-Cells Ptential synergy with I-O s (presented Keytruda results) Preparing fr additinal phase 2 studies with strategic partners Investigating additinal cllabratins IV administratin Extensive safety database Brad patent prtfli 28

29 Investr Presentatin nclyticsbitech.cm TSX ONC OTCQX ONCYF