First quarter results

Transcription

1 First quarter results 2018 Arming the patient s immune system t fight cancer 1Q 2018 presentatin 3 May

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 Agenda 1Q 2018 Highlights ONCOS-102 Mesthelima update 1Q 2018 Financials 3

4 Highlights frm the first quarter 2018 The safety lead-in chrt f ONCOS-102 in mesthelima was cmpleted withut any cncerns Research & Develpment ONCOS-102 generated immune activatin in the first treated patients in the mesthelima trial ONCOS-102 generated immune activatin in 4/4 patients treated in the checkpint inhibitr refractry melanma trial A new site in Philadelphia was pened fr the melanma trial Crprate Dr. Michael Bgenstätter was appinted Chief Business Officer Dr. Catherine Wheeler was elected new member f the Bard Pst-perid Early signal f efficacy was detected in the ONCOS-102 mesthelima trial, with respnses bserved in 3 ut f 6 patients 4

5 ONCOS Targvax has tw immun-nclgy prgrams in clinical develpment ONCOS Onclytic virus Genetically armed adenvirus Makes cancer antigens visible t immune system Induces T-cells specific t patients tumr RAS neantigen vaccine Shared neantigen, ff-the-shelf cancer vaccine Targets ncgenic, mutated RAS neepitpes Induces T-cells specific t RAS mutatins 5

6 ONCOS-102 ONCOS Overview f Targvax full clinical prgram Interim data Clinical, immune and safety data Cancer Indicatin H1 H2 H1 H2 H Resected Pancreas Ph l/ii Resected Pancreas Planned registratin prgram Planned Phase II (lead-in) Clrectal Phase lb Melanma Phase l Mesthelima Ovarian & Clrectal Cllab. w/cri & MedImmune Prstate Cllab. w/sti Dse escalating Ph I Phase l Phase lb/ii Ph II 6

7 ONCOS ONCOS clinical prgram verview Melanma Phase I 12 patients Cmbinatin with PD-1 CPI in refractry patients Prf-f-cncept Memrial Slan Kettering Cmpassinate use prgram Finland 115 patients Initial Phase I trial Slid tumrs 7 indicatins Mesthelima Phase I/II - cntrlled 30 patients Ovarian / clrectal Phase I/II up t 78 patients Cmbinatin with chem SC Randmized trial Orphan indicatin Cllabratin with Ludwig & CRI Cmbinatin with Medimmune s durvalumab (Imfinzi ) Prstate Phase I 10 patients Cllabratin with SOTIO Cmbinatin with DC therapy 7

8 Agenda 1Q 2018 Highlights ONCOS-102 Mesthelima update 1Q 2018 Financials 8

9 ONCOS ONCOS clinical prgram verview Melanma Phase I 12 patients Cmbinatin with PD-1 CPI in refractry patients Prf-f-cncept Memrial Slan Kettering Cmpassinate use prgram Finland 115 patients Initial Phase I trial Slid tumrs 7 indicatins Mesthelima Phase I/II - cntrlled 30 patients Ovarian / clrectal Phase I/II up t 78 patients Cmbinatin with chem SC Randmized trial Orphan indicatin Cllabratin with Ludwig & CRI Cmbinatin with Medimmune s durvalumab (Imfinzi ) Prstate Phase I 10 patients Cllabratin with SOTIO Cmbinatin with DC therapy 9

10 ONCOS Malignant pleural mesthelima is a difficult-t-treat cancer f the lining f the lung Orphan disease, estimated 15,000 new cases per year (EU, USA, Australia) Often caused by asbests expsure Diagnsis usually t late fr surgery N significant treatment advance in the last decade Median survival 12 mnths with current standard f care (SC), 5 year OS <10% Chemtherapy (pemetrexed / cisplatin) is the SC in nn-resected disease SOURCE: Glbal Data 10

11 ONCOS Mesthelima treatment ptins Surgery Offers best prgnsis, but nly abut 10% f patients are resectable Technically challenging due t lcatin Raditherapy Rarely used as the shape f mesthlima tumrs make them hard t target Mainly palliative care Chemtherapy Pem/Cis nly apprved SC 40% respnse in 1 st line, <10% in 2 nd line 6 mnth PFS and 12 mnth median OS Immuntherapy Mixed signals frm early CPI trials Niv+ipi phase III trial reading ut Currently n/few ther nclytic viruses 1: BMS trial CheckMate

12 Nn-randmized Randmized ONCOS ONCOS-102 in Mesthelima Phase I/II study design Safety lead-in cmpleted Experimental grup (n=14) Patient ppulatin Safety lead-in (n=6) ONCOS-102 (6 administratins) SC (6 cycles) Advanced malignant pleural mesthelima 1 st line / 2 nd line ONCOS-102 plus SC chemtherapy (6 cycles) GO Cntrl grup (n=10) 2:1 SC (6 cycles) 12

13 ONCOS Mesthelima trial: Early signal f clinical efficacy in the 6 patient safety lead-in chrt Safety Phase Ib safety lead-in chrt f six patients cmpleted with n safety cncerns ONCOS-102 first time in cmbinatin with chemtherapy Nw recruiting patients int the randmized phase II part Innate immune activatin Systemic increase f several pr-inflammatry cytkines in 6/6 patients (IL-6, TNFα and IFNγ) Adaptive immune activatin Increase in infiltratin f CD4+ helper and CD8+ cyttxic T cells int lesins (3/4 patients with pre- and pst-bipsies available) Clinical efficacy 3 f 6 patients in the safety lead-in chrt shwed clinical respnse after 6 mnths (50% respnse rate, RECIST 1.1) 13

14 ONCOS Mesthelima trial: Safety chrt patient split and clinical respnses Clinical respnse 2 patients 1 partial repnse 1 stable disease 1 st line treatment 3 patients Safety lead-in chrt 6 patients N previus chemtherapy treatment Prgressin f disease 1 patient Safety & tlerability Immune activatin Clinical repnse rate 2 nd / 3 rd line treatment 3 patients Previus chemtherapy treatment Clinical respnse 1 patient Prgressin f disease 2 patients 1 stable disease 14

15 ONCOS ONCOS-102 pprtunity in malignant mesthelima Ratinale fr ONCOS-102 pprtunity in mesthelima ONCOS-102 has the pprtunity t becme standard f care in 1 st line treatment - In cmbinatin with current SC chemtherapy ONCOS-102 has rphan drug designatin in mesthelima in bth the US and EU - 7 year market exclusivity in the US and 10 years in the EU Few direct IO cmpetitrs in current develpment - CPIs are ptential cmbinatin therapies with ONCOS, rather than cmpetitrs - N/few cmpeting viruses and vaccines in clinical develpment 15

16 Agenda 1Q 2018 Highlights ONCOS-102 Mesthelima update 1Q 2018 Financials 16

17 CORPORATE Targvax has a sund financial psitin, with cash t cmplete the planned clinical prgram well int 2019 Operatins Cash end f Q1 NOK 229m USD 29m Mar 31 st 2018 Net cash flw NOK -32m USD -4m Ttal Q1 Annual run rate NOK 113m USD 15m Last fur quarters The share OSE: TRVX Market Cap NOK 850m USD ~110m At share price NOK ~16 Daily turnver NOK 3m USD 0.4m Rlling 6 mnth avg. Analyst cverage DNB, ABG Sundal Cllier, Arctic, Redeye, Nrske Aksjeanalyser, Edisn 17

18 CORPORATE The increase in run rate ver the last 12 mnths is driven by higher spend n R&D R&D spend (NOK millin) 2Q16-1Q17 R&D 70.0m 61% 45.6m 39% Other 2Q17-1Q18 R&D 80.8m 64% 45.6m 36% Other Ttal: 115.6m Ttal: 126.4m 12 mnths rlling (Amunts in NOK thusands) 2Q Q Q Q 2018 Ttal f which R&D Ttal f which R&D External R&D expenses Payrll and related expenses Other perating expenses Ttal perating expenses

19 CORPORATE Targvax is listed n the Osl Stck Exchange, and included in the OSEBX index as f December 2017 TRVX share turnver (% f share capital, rlling 12 mnth) NOK ~850 m market cap NOK 3m avg. daily turnver in last 6 mnths NOK 213m ttal turnver in 1Q 190k shares avg. daily vlume in 1Q >4,100 wners 52.6m shares* (57.4 fully diluted) 19

20 Crp Read-uts Initiatin News flw Multiple near-term value inflectin pints H H H1 H2 H1 H2 H Melanma ph l/ll OvCa / Cl. ph l Pancreas ph II Clrectal ph Ib Prstate ph I Pancreas 2yr survival Clrectal safety data Pancreas full data Clrectal full data Melanma safety data Melanma interim data Melanma full data Mesthl. safety data Mesthl. interim data Mesthl. full data OSE main list OSEBX index 20

21 Arming the patient s immune system t fight cancer Brad clinical prgram Six shts n gal Several upcming data pints ONCOS Demnstrated ability t increase T-cell cunt Early signal f efficacy in difficult-t-treat tumrs Unique apprach fr targeting RAS mutatins Ptential t benefit up t 1/3 f all cancer patients 21