Activating the patient s the immune system t fight immune cancer system t Cmpany presentatin fight cancer Cmpany presentatin August Nvember 2018 2018
Imprtant NOTICE AND DISCLAIMER This reprt cntains certain frward-lking statements based n uncertainty, since they relate t events and depend n circumstances that will ccur in future and which, by their nature, will have an impact n the results f peratins and the financial cnditin f Targvax. Such frward-lking statements reflect the current views f Targvax and are based n the infrmatin currently available t the cmpany. Targvax cannt give any assurance as t the crrectness f such statements. There are a number f factrs that culd cause actual results and develpments t differ materially frm thse expressed r implied in these frward-lking statements. These factrs include, amng ther things, risks r uncertainties assciated with the success f future clinical trials; risks relating t persnal injury r death in cnnectin with clinical trials r fllwing cmmercializatin f the cmpany s prducts, and liability in cnnectin therewith; risks relating t the cmpany s freedm t perate (cmpetitrs patents) in respect f the prducts it develps; risks f nn-apprval f patents nt yet granted and the cmpany s ability t adequately prtect its intellectual prperty and knw-hw; risks relating t btaining regulatry apprval and ther regulatry risks relating t the develpment and future cmmercializatin f the cmpany s prducts; risks that research and develpment will nt yield new prducts that achieve cmmercial success; risks relating t the cmpany s ability t successfully cmmercialize and gain market acceptance fr Targvax s prducts; risks relating t the future develpment f the pricing envirnment and/r regulatins fr pharmaceutical prducts; risks relating t the cmpany s ability t secure additinal financing in the future, which may nt be available n favrable terms r at all; risks relating t currency fluctuatins; risks assciated with technlgical develpment, grwth management, general ecnmic and business cnditins; risks relating t the cmpany s ability t retain key persnnel; and risks relating t the impact f cmpetitin. 2
TARGOVAX S POSITION IN THE FUTURE CANCER TREATMENT LANDSCAPE Targvax fcus Immune activatrs Onclytic viruses, vaccines Immune mdulatrs Checkpint inhibitrs Surgery - Radi - Chem Immune bsters CAR-Ts, TCRs Targeted therapy TKIs, PARPs, etc. 3
Tw prgrams in clinical develpment, with an ONCOLYTIC VIRUS LEAD PRODUCT CANDIDATE ONCOS Onclytic virus TG Neantigen vaccine Lead prduct candidate Genetically armed adenvirus Alerts the immune system t recgnize cancer antigens Induces T-cells specific t the patients tumr 4 nging trials Pipeline prduct Shared neantigen, therapeutic cancer vaccine Triggers the immune system t recgnize mutant RAS cancers 1 nging trial Triggers patientspecific respnses N need fr individualizatin 4
ONCOS CLINICAL PROGRAM OVERVIEW Mesthelima Phase I/II - randmized 30 patients Shrtest path-t-market Orphan drug designatin Cmbinatin with SC chem Cmpassinate use prgram 115 patients Phase I trial 12 patients 7 indicatins Melanma Phase I up t 12+12 patients Peritneal cancer Phase I/II up t 78 patients PC in CPI refractry patients Cmbinatin with Keytruda Cmbinatin with Imfinzi Intraperitneal administratin Cllabratin with MedImmune / AZ, CRI, & Ludwig Prstate cancer Phase I up t 15 patients Cmbinatin with dendritic cell vaccine (DCVAC) Cllabratin with Sti 5
ONCOS-102 CLINICAL DATA SUMMARY Patient ppulatin Immune activatin Efficacy Varius slid tumrs Ph I Mntherapy End-stage patients, 3 rd line and beynd 7 different slid tumrs 12 pts Innate: 12/12 Adaptive: 11/12 40% DCR 2 lng-term survivrs Survival crrelated with TIL increase Mesthelima Ph I/II randmized with SC chem Metastatic 1 st and 2 nd /3 rd line 6 pts cmpleted trial t date Innate: 6/6 Adaptive: 3/4 50% DCR 1 PR 2 SD Melanma Ph I Cmb with Keytruda PD-1 refractry advanced melanma 6 pts cmpleted trial t date Innate: 6/6 Adaptive: 4/4 1 CR, w/supprting immune data 3 lcal respnders, but with distal prgressin
ONE PATIENT HAD A COMPLETE RESPONSE fllwing ONCOS-102 and Keytruda cmbinatin treatment Baseline Week 3 Week 9 Prgressin n Keytruda Partial respnse (PR) after 3x ONCOS-102 injectins Cmplete respnse (CR) after 3x ONCOS-102 & 2 Keytruda infusins 7
ONCOS CLINICAL DEVELOPMENT STRATEGY 1 2 3 4 Path-t-market Orphan indicatin Prf-f-cncept Re-activating CPIs Prf-f-cncept New CPI indicatin Next generatin nclytic viruses Target launch indicatin CPI refractry cancers Indicatins with n/ limited effect f CPIs Platfrm expansin with new targets Mesthelima Orphan drug status Cmb with SC chem CPI refractry melanma Cmb w/pd-1 Ovarian and clrectal cancer with spread t peritneum Cmb w/pd-l1 Onging in viv testing Nvel targets and mde-f-actin 8
The RAS gene is mutated in 90% OF PANCREATIC AND 50% OF COLORECTAL CANCERS Frequency f RAS mutatins Glbal cancer incidents per 10,000 (xx) = n. f cancer patients High Med Gallbladder (180,000) Pancreas (340,000) Melanma f skin (230,000) Prstate (1,130,000) Clrectal (1,360,000) Lung (1,820,000) RAS mutatins are ncgenic and result in uncntrlled cell divisin There are n existing therapies targeting RAS mutatins Targvax TG prgram is a unique neantigen vaccine apprach fr mutant RAS cancer Lw 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 9 Fernandez-Medarde; RAS in Cancer and Develpmental Diseases; Genes & Cancer. 2011;2(3)
TG CLINICAL PROGRAM OVERVIEW Phase I/II trial in resected pancreas cancer recently cmpleted Phase I & II - Pancreas Mntherapy >200 patients Phase I/II Resected pancreas Adjuvant, w/chem 32 patients Clrectal - TG02 Phase I 12-20 patients TG in cmbinatin with CPI Phase I Pancreas Bimarker study 2 nd generatin TG vaccine Cmbinatin w/keytruda Currently assessing pprtunities fr new prf-fcncept CPI cmbinatin trials n TG prgram 10
TG01 IN RESECTED PANCREATIC CANCER SIGNAL OF EFFICACY SEEN IN PHASE I/II TRIAL Median verall survival Median disease free survival mutras immune activatin 33.4 vs. 27.6 mnths reprted in the ESPAC4 trial fr gemcitabine alne (frm time f surgery) First chrt: 33.1 mnths Secnd chrt: nt yet reached 16.1 vs. 13.1 mnths reprted in the ESPAC4 trial fr gemcitabine alne (frm time f surgery) First chrt 13.9 mnths Secnd chrt 19.5 mnths 94% (30 ut f 32 patients) had RAS-specific immune activatin Dsing and safety Dsing regimen defined and TG01 is well-tlerated First chrt: 19 pts, Secnd chrt: 13 pts. Ttal 32 pts. 11
DISEASE FREE SURVIVAL FROM SURGERY 2nd chrt (n=13) Median DFS 19.5 mnths ESPAC4 mdfs 13.1 mnths 1st chrt (n=19) Median DFS 13.9 mnths - - - 1 st chrt 2 nd chrt Censred= N prgressin n latest scan cllected 12
PIPELINE OVERVIEW AND MILESTONES Platfrm Prduct candidate Preclinical Phase I Phase II Phase III Next expected event Mesthelima Cmb. w/ pemetrexed/cisplatin 1H 2020 Randmized ORR data ONCOS nclytic adenvirus ONCOS-102 Next-gen ONCOS Melanma Cmb. w/keytruda Peritneal metastasis 1 Cllab: Ludwig, CRI & AZ Cmb. w/imfinzi Prstate Cllab: Sti Cmb. w/dcvac 3 viruses undisclsed 1H 2019 ORR and immune data first chrt Update by cllabratr, expected 2019 Update by cllabratr, expected 2019 2H 2019 Target disclsure and in viv data TG ne-antigen cancer vaccine TG01 TG02 TG02 Pancreatic cancer Cmb. w/gemcitabine Clrectal cancer Prf-f-mechanism Cmb. w/keytruda CPI synergy TG + PD-1 TBD 1H 2019 Immune activatin and mechanistic data (mn) 1H 2019 TG02 + in viv data 1 Patients with advanced peritneal disease, wh have failed prir standard chemtherapy and have histlgically cnfirmed platinum-resistant r refractry epithelial varian r clrectal cancer Onging cllabratr spnsred trials 13 13
Large deals in the last year shw strng INDUSTRY INTEREST IN ONCOLYTIC VIRUSES Acquirer Target Type f deal Deal value M&A Phase I/II nclytic virus USD 250m up-frnt cash M&A Phase I/II nclytic virus USD 400m up-frnt cash M&A Pre-clinical nclytic virus USD 140m up-frnt cash Up t USD 1b ttal value 15 BD partnership Pre-clinical nclytic virus USD 15m milestne payment Up t USD 1b ttal value