Arming the immune system to fight cancer
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1 Arming the immune system t fight cancer June
2 Imprtant ntice 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
3 IMMUNOTHERAPY Targvax is develping tw nvel prprietary immuntherapy platfrms, with prmising phase I/II data ONCOS-102 Onclytic virus Genetically tailred Adenvirus Selectively infects and lyses cancer cells Releases cancer antigens Triggers immune respnse 01 Peptide vaccine Ccktail f 7 synthetic peptides mimicking clinically relevant RAS mutatins Generates RAS-specific T-cells T-cells kill cancer cells displaying mutated RAS antigens n their surface 3
4 ONCOS ONCOS-102 wrks by making cancer antigens visible t the immune system, thus generating tumr specific T-cells Activate immune system: Virus injected directly int the tumr / peritneum Infected cells lyse and release cancer-specific antigens Immune system picks up antigens Train T-cells: APCs present tumr specific antigens at lymph ndes Prductin f tumr specific T-cells Attack the cancer: Tumr specific T-cells circulate in the bdy Identify lesins and kill the cancer cells Lymph nde 4
5 ONCOS Mst patients d nt respnd t check pint inhibitrs (CPIs), due t lack f T-cells in the tumr micrenvirnment Respnse rate t checkpint inhibitrs (CPIs) Melanma ~40% Renal Cell carcinma ~70% Triple Negative Breast Lung Carcinma (NSCLC) ~70%-80% ~80% Cmplimentary immune priming medicines may make tumrs respnd better t checkpint inhibitrs Head and Neck ~80% Bladder ~84% Respnders Nn-respnders 5
6 FI1-06 FI1-04 FI1-18 FI1-02 FI1-15 FI1-08 FI1-13 FI1-09 FI1-17 FI1-01 FI1-14 FI1-19 Fld-change frm baseline ONCOS ONCOS-102 phase I: Increased tumr infiltrating CD8+ T-cells in 11 f 12 cancer patients with a range f slid tumrs ,1 Only 1 patient shwed n respnse 6 patients shwed 2- t 5- fld increase 5 patients shwed >8-fld increase Ranki et al., Jurnal fr Immuntherapy f Cancer 2016, 4(17) 6
7 Increase in CD68+ cells pst-treatment ONCOS In the initial Phase I ONCOS-102 trial tumr specific and systemic immune respnse was bserved Evidence that immune system recgnizes tumr threat Evidence that T-cells find the tumr and are cell killing Evidence f prductin f tumr antigen specific T-cells Innate Immune System (bipsy) Adaptive immune system (bipsy) Anti-tumr immune respnse (bld) Inductin f prinflammatry cytkines + fever (all patients) Infiltratin f innate immune cells int tumrs in 11 ut f 12 patients Scatterplt f ranks Overall survival p=0.0004, R=0.86 Increase in T-cell infiltratin int tumrs (including CD8+ killer T-cells) in 11 ut f 12 patients Observatin in ne nn-injected distant metastasis OvCa. patient (FI1-19) Systemic inductin f tumr-specific CD8+ T-cells Ovarian patient: NY-ESO-1, MAGE-A1, MAGE-A3, and Mesthelin specific CD8+ cells Mesthelima patient: MAGE-A3 specific CD8+ cells Crrelatin between pst-treatment increase in innate immune cells and OS Crrelatin between pst-treatment increase in CD8+ T-cells and OS Assciated with clinical benefit 7
8 ONCOS The encuraging Phase I results have triggered the initiatin f a brad ONCOS-102 clinical prgram cnsisting f fur new trials Melanma Phase I 12 patients Cmbinatin with PD-1 CPI in refractry patients Prf-f-cncept Memrial Slan Kettering Initial Phase I trial Slid tumrs 7 indicatins 12 treatment refractry patients ONCOS-102 mntherapy Crrelatin between level f immune activatin and survival Mesthelima Phase I/II - cntrlled 30 patients Ovarian / clrectal Phase I/II - cntrlled 78 patients Prstate Phase I 10 patients Cmbinatin with chem SC Randmized cntrlled trial Ultra-rphan indicatin Cllabratin with Ludwig & CRI Cmbinatin with Medimmune PD-L1 CPI Randmized cntrlled trial Partnered with Sti Cmbinatin with DC therapy 8
9 ONCOS Melanma trial will CPI refractry patients start respnding after immune-priming with ONCOS-102? Setting Advanced malignant melanma patients nt respnsing t CPIs Immune activate patients with ONCOS-102, then re-challenge with a CPI ) Site 12 patients Memrial Slan Kettering Cancer Centre Key endpints Safety Immune activatin Clinical respnse data Sequence ONCOS weeks Keytruda 5 mnths Prf-fcncept Will CPI refractry melanma patients start respnding t Keytruda after challenge by ONCOS-102? 9
10 Agenda Intrductin t immuntherapy ONCOS-102 nclytic virus platfrm RAS-peptide vaccine platfrm Targvax clinical prgram verview Financial highlights 10
11 ONCOS RAS is a key regulatr f cell cycle that is mutated in 20-30% f all cancer patients, and >85% f pancreatic cancers Incidence f RAS mutatins One f the mst cmmn mutatins in cancer RAS is ne f the mst well-defined neantigens Results in cell divisin permanently switched n N existing therapies targeting RAS Occurs in >85% f pancreatic cancer patients 11
12 ONCOS The peptides prime the immune system t recgnize and destry RAS mutated cancer cells Activate immune system: Train T-cells: Attack the cancer: peptides injected int the skin with GM-CSF adjuvant APCs pick up the RAS antigens APCs migrate t lymph ndes and present RAS specific antigens Prductin f RAS specific T-cells RAS specific T-cells identify mutated RAS antigens n cancer cell surface Killer T-cells destry the cancer cells Ccktail f 7 peptides cvering all relevant RAS mutatins in pancreas 12
13 ONCOS A Phase I/II trial with 01 in Resected Pancreatic Cancer is currently being cmpleted 32 patients in ttal, 2 chrts Dsage regimen with/withut chem Fllw-up bsters
14 ONCOS Key results frm 01 Phase I/II trial in resected pancreatic cancer: Signal f clinical efficacy 2 year OS Median survival Immune respnse Resectin status 13 f 19 patients (68%) alive 2 years after surgery Histrical cntrl 2 year OS range frm 30-53% mnths 27.6 mnths fr SC (Gemcitabine) in ESPAC-4 study 2 16/18 patients (89%) shwed specific immune sensitivity (DTH) (analysis lacking fr ne patient) R0: 32 % (6/19 patients) R1: 68% (13/19 patients) Histrical cmparisns range frm ca % R1 patients Safety Treatment regimen generally well-tlerated Sme manageable allergic reactins were seen 1: Relevant histrical cntrl trials, nt including ESPAC-4, which did nt reprt 2 year OS 2: Based n ESPAC-4 reprted 25.5 mnths median OS frm randmisatin, adding median time frm surgery t randmizatin f 64 days (2.1 mnths) 14
15 Survival (%) ONCOS These results are backed by encuraging 10 year survival data and immune respnse crrelatin frm earlier trials Lng-term data frm earlier mn-therapy trials resected pancreatic cancer Mnths frm resectin 4/20 (20%) patients > 10 years survival (resected patients) Histrical cntrl: 7.7% 10 year survival 3 Advanced pancreatic cancer 01/GM-CSF (mn-therapy) Evaluable patients Median survival (frm 1 st vaccinatin) 1 year survival (frm 1 st vaccinatin) Detected immune respnse 14 / 25 (56%) 156 days 3 (21%) Nt detected Immune respnse 11 / 25 (44%) 109 days 1 ( 9%) (Clinical study reprt CTN RAS n file) Significantly better utcme fr patients with immune respnse (nn-resected) 1 Wedén et al., Oettle H et al., JAMA 2007, vl 297, n 3 3 Oettle H et al., JAMA 2013, vl 310, n
16 ONCOS-102 ONCOS Tw platfrms and six clinical trials in ttal ensures a diversified prgram with frequent data readuts Cancer indicatin Cmbined with H1 H2 H1 H H1 Melanma CPI Phase l Mesthelima Chem * Orphan ind. Phase lb/ll Ovarian & Clrectal CPI Orphan ind. Spnsr: Ludwig Phase l/ll Prstate DC therapy Spnsr: Sti Phase l Resected Pancreatic Chem * Orphan ind. Phase I/II Clrectal CPI Phase Ib Interim data Clinical, immune and safety data 4 readuts readuts
17 FINANCIALS Financial summary end f Q Operatins Cash NOK 147m USD 17m End f Q Net cash flw NOK -24m USD -3m Ttal Q1 Annual run rate NOK 104m USD 12m Last fur quarters Annual pex NOK 116m USD 13m Last fur quarters The share OSE: TRVX Market Cap NOK ~1bn USD ~120m At share price NOK ~24 Daily turnver NOK 14m USD 1.6m Last three mnths avg. Debt NOK 43m USD 5m EUR 6m cnditinal N. f shares 42.2m 46.0m fully diluted per April 18 Analysts DNB, ABG Sundal Cllier, Arctic, Redeye, Nrske Aksjeanalyser 17
18 FINANCIALS TRVX was upgraded t the main list n OSE in March, and has shwed a psitive trend in share turnver in 2017 Develpment in daily average share turnver (NOK millin / day) Jul '16 Aug '16 Sep '16 Oct '16 Nv '16 Dec '16 Jan '17 Feb '17 Mar '17 NOK ~1.2b market cap NOK 14m NOK avg. daily turnver in last 3 mnths NOK 850m ttal turnver in Q1 560k shares avg. daily vlume in Q1 >3,500 wners 42.2m shares (46.0 fully diluted) 18
19 FINANCIALS Strng sharehlder base as per April 2017 Sharehlder Estimated wnership Shares m Relative HealthCap Sweden 11,2 26,4 % RadFrsk Nrway 4,1 9,7 % Nrdea Nrway 3,0 7,2 % KLP Nrway 1,6 3,7 % Nrdnet Livsfrsikring Nrway 1,4 3,3 % Statil Nrway 0,9 2,2 % Danske Bank (nm.) Denmark 0,8 1,8 % Timmun AS Nrway 0,7 1,7 % Prieta AS Nrway 0,7 1,7 % Rasmussengruppen Nrway 0,7 1,7 % Nrdnet Bank AB (nm.) Sweden 0,7 1,5 % Sundt AS Nrway 0,3 0,7 % DNB Nrway 0,3 0,6 % Avanza Bank AB (nm.) Sweden 0,3 0,6 % Threndahl Invest AS Nrway 0,3 0,6 % The Bank f NY Melln (nm. Belgium 0,2 0,5 % Netfnds Livsfrsikring AS Nrway 0,2 0,5 % Tbech Invest AS Nrway 0,2 0,5 % Istvan Mlnar Nrway 0,2 0,4 % Danske Bank (nm.) Denmark 0,2 0,4 % Tp 20 27,8 65,9 % Other sharehlders (3566) 14,4 34,1 % Ttal 42,2 100,0 % 42.2m rdinary shares Management wnership: 2.1% 3,586 sharehlders 46.0m 1 shares fully diluted Average strike price n ptins ~NOK 21 Ttal dilutive effect f ptins is 7.9% 1 Includes utstanding ptins (3,634,263) and Restricted Stck Units (169,128) t Bard members 19
20 FINANCIALS Multiple near term value inflectin pints ONCOS-102 Initiate phase l Ovarian/clrectal ONCOS-102 Initiate phase l/ll melanma 02 Initiate phase Ib in clrectal 01 ONCOS-102 Osl Stck Exchange ONCOS-102 phase ll initiated Initiate phase l/ll mesthelima Listing n OSE main list Initiate phase l prstate H H2 H H2 ONCOS (1 st chrt) 01 (1 st chrt) ONCOS (2 nd chrt) ONCOS-102 Immune activatin and MA dem Interim data pancreas 2-year survival pancreas Interim data melanma 2-year survival pancreas phase l/ll data melanma 01 (2 nd chrt) ONCOS-102 ONCOS-102 ONCOS-102 Immune activatin pancreas Interim data mesthelima Interim data varian /clrectal Interim data prstate 02 (mn) 02 (cmb) Interim data clrectal phase I data/ clrectal 20
21 ONCOS Arming the patient s immune system t fight cancer 1 2 ONCOS Encuraging median survival and tp line tw-year OS data in resected pancreatic cancer Imprtant prf-f-cncept trial in CPI refractry melanma 3 Clinical trials Six shts n gal, and steady news flw 21
22 Appendix 22
23 ONCOS ONCOS-102: An adenvirus armed with different immune stimulating transgenes Selective replicatin in cancer cells inducing immungenic cancer cell death Enhanced immune system activatin Virus capsid is mdified fr enhanced cancer cell infectin 24 bp 6.7K/gp19K Ad5 knb E1A E3 Fiber knb ITR Transgene Ad3 knb ITR A transgene enhances stimulatin f the immune system GM-CSF transgene in ONCOS
24 PBMC PBMC PBMC PBMC PBMC ONCOS ONCOS-102: CPI refractry melanma trial details Open-label Phase I trial ONCOS-102: 3 injectins at day 1, 4 & 8 CPI (Keytruda) at day 22, then every 3 weeks fr 5 mnths 3 bipsies per patient Baseline DAY 22 DAY 64 CT CT CT CT Days Weeks ONCOS-102 Checkpint inhibitr (Keytruda) 24
25 ONCOS ONCOS-102 in Mesthelima Phase I/II study design (NCT ) PATIENT POPULATION STUDY TREATMENT Advanced refractry malignant pleural mesthelima 1st line/prgressing after 1st line Nn-randmised Safety lead-in (n=6) ONCOS-102 plus SC chemtherapy GO Randmized 2:1 Experimental grup (n=14) ONCOS-102 (6 administratins) SC (6 cycles) Cntrl grup (n=10) SC (6 cycles) Chem (every 3 weeks fr 6 cycles) With ONCOS-102 treatment fr 5 mnths Fllw-up frm 6 mnths 1 year
26 ONCOS Resected pancreatic cancer patients nly have chemtherapy as a treatment ptin, and lng term survival is pr N statistical difference fr 2yr verall survival Lwer verall hazard rati fr cmbinatin Significantly imprved lng-term survival >10% ESPAC-4 data; Neptlems et al., The Lancet
27 ONCOS 01 in Resected Pancreatic Cancer Phase I/II study design (NCT ) PATIENT POPULATION STUDY TREATMENT 1 st chrt, main grup (n=15) Patients with resected adencarcinma f the pancreas and candidates fr adjuvant chemtherapy Safety chrt (n=6) 01 (26 vaccinatins) Gemcitabine (6 cycles) GO Nn-randmized 01 (26 vaccinatins) Gemcitabine (6 cycles) 1 st chrt, cncmitant grup (n=4) 01 (26 vaccinatins) Gemcitabine (6 cycles) Mdified vaccinatin chrt (n=13) 01 (15 vaccinatins) Gemcitabine (6 cycles) Chem ± vaccinatin Inductin treatment 8 weeks 2 years
28 ONCOS 02 in Clrectal Cancer Phase I study design (NCT ) PATIENT POPULATION STUDY TREATMENT Patients with lcally recurrent resectable RAS mutated rectal cancer Nn-randmized PART I n=10* 02 treatment GO / NO- GO Nn-randmized PART II n=10* 02 treatment + pembrlizumab * A patient can nly be enrlled int either Part I r int Part II f the study. Part II will start after Part I has been cmpleted. Study plan 1. Baseline bipsy and immune assay when patients enter the clinical trial. Inductin treatment with 02 fr the patients in Part I Inductin treatment with 02 in cmbinatin with pembrlizumab fr the patients in Part II 2. Surgery 8 t 14 weeks after initiatin f treatment. Immune assay f resected tumr.
29 ONCOS The results are being supprted by 10 year lng-term survival data frm earlier trials Histrical data Lng-term data available frm previus trials 4 ut f 20 patients (20%) alive after 10 years in similar trial n resected pancreatic cancer Crrelatin between immune respnse and clinical utcme RAS target Highly specific and well-understd target RAS mutatins are well-characterized neantigens Exclusively fund in cancer cells, and >85% f pancreatic cancers Antigen targeting Peptide design ensures full immune respnse 17 amin acid chain length activate bth CD4+ and CD8+ T cells T-cells recgnize mutated RAS antigens presented n the surface f cancer cells, with n need fr intra-cellular targeting 1 Wedén et al, 2011 and Clinical trial reprts 29
30 Investment highlights Cre fcus n immun-nclgy Prprietary platfrms and pipeline Multiple near term value inflectin pints Crprate Tw differentiated prduct platfrms, nclytic adenvirus (ONCOS-102) and RAS-peptide cancer vaccine () Targeting refractry slid tumrs with cmbinatin trials Prmising Phase I/II data frm bth prprietary platfrm technlgies, with clinically demnstrated immune activatin and signal f efficacy Six cmbinatin trials started r abut t start (phase I & II) All six trials read ut in TRVX transferred t the OSE main list in Q Strng increase in share turnver Cash at apprx. NOK 147m (USD 17m) 30
31 Highly experienced senir management team Øystein Sug, CEO Jined as CFO in April 2015 befre being appinted CEO in Nvember Befre jining Targvax Oystein was CFO at Algeta, where he built up the functins f Finance, IR, Cmpliance, IT and HR, and versaw its ultimate sale t Bayer fr USDbn 2.9 Erik Digman Wiklund, CFO Frmer cnsultant in the Pharma & Healthcare practice f McKinsey & Cmpany, cmbined with a PhD in cancer research. Experience frm management cnsulting, as well as cmmercial and peratinal rles in the bitechnlgy industry Berit Iversen, VP, CMC Mre than 25 years f experience within Research & Develpment in the pharmaceutical and bitech industry. Berit is a Chemist by training Anne-Kirsti Aksnes, VP, Clinical Develpment Mre than 20 years f experience within clinical research and develpment in the pharmaceutical and bitech industry and 10 years f experience wrking in clinical physilgy. Dr. Magnus Jaderberg, CMO Mre than 25 years in varius R&D functins and previusly CMO at Bristl Meyers Squibb (Eurpe). Led develpment f Yervy. Jn Amund Eriksen, CTIO 35 years f R&D experience frm pharmaceutical and bitech industry, 25 years within immun-nclgy. Cfunder f Targvax Tina Madsen, VP, Quality Assurance Mre than 20 years f experience within Research & Develpment and cmmercial manufacturing in the pharmaceutical and bitech industry, including quality assurance, prcess develpment and frmulatin Tiina Haknen, Site Manager Helsinki Mre than 20 years f experience within clinical research and develpment in the pharmaceutical and bitech industry. Tiina has a Master f Science (Statistics) degree frm the University f Oulu, Finland Peter Skrpil, VP, Business Develpment Extensive experience in licensing, cmmercial assessments, business intelligence and partnering and previusly Cmmercial Directr at Prnva BiPharma
32 Bard f Directrs Jónas Einarssn, MD CEO f Radiumhspitalets Frskningsstiftelse On the bard f several Nrwegian Bitech cmpanies, and was ne f the initiatrs behind Osl Cancer Cluster and the Osl Cancer Cluster Innvatin Jhan Christensn, MD, PhD Partner f HealthCap Previusly supervised the healthcare prtfli f SEB Företagsinvest Senir management experience frm Astra Pain Cntrl and AstraZeneca PhD in basic neurscience Authr f 17 scientific articles Per Samuelssn Partner f HealthCap Prir t jining HealthCap in 2000, he gained ver 15 years f investment banking experience, mainly with Ars Securities in Sweden Prir t this Mr. Samuelssn was head f Research, als at Ars Securities Eva-Ltta Allan Currently Chief Business Officer at Immuncre Mre than 25 years f experience frm the bitechnlgy and life science industry in bth private and public cmpanies Has held senir psitins at e.g. Ablynx, Vertex Pharmaceuticals and Oxfrd Asymmetry (Evtec) Lars Lund-Rland CEO f Bringwell AB Previusly MD f MSD Nrway (Merck & C Inc. subsidiary) and has mre than twenty-five years experience frm varius executive psitins within marketing and sales Chairman f the Bard f PI Innvatin and has served as bard member f Infdc and Health Tech Bente-Lill Rmøren Bard member f Radiumhspitalets Frskningsstiftelse and chairman f Farmastat and Phtcure Previusly emplyed by Nv Nrdisk Scandinavia ( ) in varius psitins, including psitin as CEO f the Nrwegian unit ( , ). Bard member at Nrdic Nanvectr ( ) Rbert Burns, PhD Cnsultant and advisr t cmpanies develping immune based therapies in cancer Extensive experience in building bitechnlgy cmpanies, previusly CEO f 4-Antibdy, Affitech and Celldex Therapeutics Previusly Directr at the Ludwig Cancer Research Diane Mellett Cnsultant t bitech and medical device cmpanies Qualified in bth UK and US law Frmerly General Cunsel fr Cambridge Antibdy Technlgy (CAT) Led successful defence fr CAT cncerning a cntractual dispute n Humira 32
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