Investor Presentation

Transcription

1 Investr Presentatin August 2018 nclyticsbitech.cm Nasdaq ONCY TSX ONC

2 Frward Lking Statements This presentatin cntains certain frward lking statements relating t the cmpany s business prspects and the develpment and cmmercializatin f pelarerep 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 Crprate & Clinical Prgress Supprts prgress int registratin pathway fr mbc and expansin f I-O & IMiD cmbinatins Nearly dubled verall survival (OS) in HR+/HER2- breast cancer patients Studies with Merck & Celgene Tw Cmb s with Keytruda in MM and pancreatic cancer MM cmb with Revlimid r Imnvid SPA agreement, Granted Fast Track Designatin & psitive feedback frm FDA and EMA Grwing interest in nclytic viruses Merck-Viralytics / BMS-PsiOxus / Jansen-Benevir I-O Data Demnstrated upregulatin f PD-L1 Psitive Keytruda cmb Ptential CI and CAR-T synergies Partnership with Adlai Nrtye Licensing fee and milestnes fr mbc f $21.2M Additinal milestne payments f $65.4M Duble digit ryalty 3

4 What is pelarerep? Nn-pathgenic prprietary islate f the unmdified revirus An unarmed intravenusly (IV) delivered RNA nclytic virus First IV delivered immunnclytic virus t demnstrate verall survival benefit in a randmized study 4

5 Pelarerep Advantages DNA Mst OV s vs RNA pelarerep IT Delivery Specialized delivery Variable dse Assured delivery t tumr Armed Virus IV Delivery Ease f delivery Standard dse Accesses metastatic disease Unarmed Virus Specialized delivery and custmized handling N change t standard practice Bisafety Level 3 Bisafety Level 2 5

6 Pelarerep MOA Synergy with chemtherapies & immuntherapies by prmting: Viral replicatin Activating T cells, NK cells and dendritic cells Recruiting tumr infiltrating lymphcytes Mre than 40 supprting publicatins 6

7 Pelarerep and Safety 1,100+ patients treated, 900+ intravenusly N maximum tlerated dse (MTD) reached t date Bisafety Level 2 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 Addresses drug cmbinatins that can ptentially bst each respnse f the MOA 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. Immuntherapy cmbinatins Pelarerep creates an inflamed phentype highlighting synergies with bth immune checkpint inhibitrs (PD-1/PD-L1) and CAR-T cell therapies. Explring Windw f Opprtunity and phase 1/2 cllabratins. Targeted/IMiD cmbinatins Pelarerep upregulates NK (natural killer cells). Currently in a cmbinatin study with Celgene s Imnvid & Revlimid targeting myelma and explring additinal cllabratins, including cmbinatins with CDK 4/6 and PARP inhibitrs. 9

10 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 Chem-Cmb / Breast Cancer (IND-213) Phase 2 Design Randmized, nn-blinded study, with IV administered pelarerep 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 pelarerep n days 1, 2, 8, 9, 15 and patients; pwered t 90% Endpints: Primary: PFS Secndary: OS Secndary : ORR Secndary: Safety (IND-213) Phase 2 Data 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 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/pelarerep) 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 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/pelarerep) 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 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 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 Immuntherapy Cmbinatins Current checkpint inhibitrs Case 4 pretreatment* Ptential when COLD tumrs turn HOT Case 4 ne week after revirus + Kyprlis* 7-8 days Keytruda Bavenci Opdiv Imfinzi Tecentriq Yervy ~ 20 % f cancers?? % f cancers NCI-9603 (Clinical Trial #NCT ), Dr. Craig Hfmeister 16

17 Immuntherapy Cmbinatins Metastatic Pancreatic Cancer (2 nd Line) REO 024 Keytruda Cmb Tw patients with SD: 126 and 277 day One patient with PR lasting 504 days (35 cycles) On treatment bipsy: infectin in cancer cells and immune infiltrates Pelarerep/Keytruda cmbinatin Primary Endpint: ORR by irecist Secndary Endpints: Bld-based immune bimarker data PFS and mos Additinal I-O cmbinatins being reviewed 17

18 Immuntherapy Cmbinatins Multiple Myelma Pelarerep/Keytruda cmbinatin Primary Endpint: ORR by irecist Secndary Endpints: Bld-based immune bimarker data PFS and mos Additinal I-O cmbinatins being reviewed 18

19 Targeted/IMiD Cmbinatins Pelarerep + 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 19

20 Clinical Pipeline Preclinical Phase I Phase II Phase III REO 026: Paclitaxel ± pelarerep 2/3L mbc Cllabratin SOLTI: Windw f Opprtunity: mbc Subtypes Cmbinatin USC-Merck: Pembr + pelarerep Multiple Myelma Cmbinatin NWU-Merck: Pembr + pelarerep 2L Pancreatic Cmbinatin Celgene-MUK: pm/len + pelarerep in RR Myelma Chem Cmbs Immun Therapy Cmbs Targeted / IMiD Cmbs 20

21 Manufacturing & Intellectual Prperty

22 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 22

23 Strng Patent Prtfli Mre than 396 patents issued wrldwide, including 49 US and 21 Canadian Over 29 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 As f June 30,

24 Crprate

25 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 25

26 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 26

27 Market and Capital Data Exchanges Market Cap (August 2, 2018) Nasdaq: ONCY TSX: ONC USD $80.3 M CDN $103.3M Shares Outstanding (August 2, 2018) 16,531,956 Warrants (August 2, 2018) Optins (August 2, 2018) Restricted/perfrmance share units (August 2, 2018) 1,730, , ,349 Fully Diluted (August 2, 2018) 19,415,930 Cash / Cash Equivalents / (June 30, 2018) CDN $18.7 millin (USD $14.4 millin*) Financial runway End f 2019 * Based n FX n August 2,

28 Achieved & Anticipated Milestnes Event Timing Almst dubled OS in HR+/HER2- mbc patients FDA: Special Prtcl Assessment & Fast Track Designatin Listed n Nasdaq Crprate Update (phase 3, partnering and clinical prgrams) Q Initiate phase 2 Windw f Opprtunity Study in mbc 2H 2018 Initiate phase 2 NWU-Merck study in pancreatic cancer 2H 2018 Initiate phase 1b USC-Merck study in multiple myelma 2H 2018 Data frm Windw f Opprtunity (WOO) Study in mbc 1H 2019 Preliminary Data frm MUK eleven study in multiple myelma Mid-2019* Data frm USC-Merck study in multiple myelma 2H 2019* Preliminary data frm NWU-Merck study in pancreatic cancer 1H 2020* * Guidance prvided by principal investigatrs 28

29 Cmpelling Opprtunity Summary Registratin pathway: Almst dubled OS in HR+/HER2- mbc patients Favrable FDA & EMA feedback SPA agreement Synergies with Immuntherapies Increases NK & T-Cells and enhances antigen presentatin by APC s Ptential synergy with IMiD s (MUK-Celgene study) & CDK 4/6 Increasing expressin f PD-1/L1 n tumr T-Cells Ptential synergy with I-O s (presented Keytruda results) Preparing fr additinal phase 1 and 2 studies Investigating additinal cllabratins with strategic partners Cmpetitive advantages IV administratin (systemic) Bisafety Level 2 & extensive safety database Brad patent prtfli Manufacturing 29

30 Investr Presentatin nclyticsbitech.cm Nasdaq ONCY TSX ONC