Circio Holding Asa · OSL:CRNA
Circio Holding Asa — Targovax — Q3 2019 Earnings Presentation
28 slides from Circio Holding Asa's earnings presentation, Nov 7, 2019
Slide 1: Activating the Patient's Immune System to Fight Cancer
ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER 3Q 2019 7 November 2019
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This report contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances that will occur in future and which, by their nature, will have an impact on the results of operations and the financial condition of
Slide 3: Financials & Highlights
Financials & Highlights 2. Melanoma 3. Next generation ONCOS 4. Mesothelioma 5. Newsflow
Slide 4: Targovax at a Glance
TARGOVAX AT A GLANCE Immune activation by oncolytic viruses Addressing the growing need for immune activators to enhance efficacy in combination with other treatments, such as checkpoint inhibitors ONCOS clinical stage adenovirus platform targeting hard-to-treat solid tumors ONCOS-102 lead clinical
Slide 5: ONCOS Development Strategy
ONCOS DEVELOPMENT STRATEGY 1 Path-to-market as orphan drug Mesothelioma o ~15.000 patients1 o Potential as frontline therapy, limited competition o Strong immune activation in monotherapy 2 Activating CPI refractory tumors Anti-PD1 refractory melanoma o No/few alternatives for ~50.000 patients1 o Be
Slide 6: ONCOS-102 Clinical Development Program
ONCOS-102 CLINICAL DEVELOPMENT PROGRAM o Randomized trial Mesothelioma o 1 Phase I/II 31 patients o Combination with SoC chemo Enrollment completed o Data Jan 2020 Anti-PD1 refractory o Combination with Keytruda Compassionate use Phase I trial melanoma o program 115 patients 12 patients 7 indication
Slide 7: 3Q 2019 Highlights
3Q 2019 HIGHLIGHTS Released data from part 1 in melanoma, with clinical responses in three out of nine patients (33% ORR) and immune activation in all nine patients R&D Completed dose escalation in peritoneal malignancies trial in combo with Imfinzi. The expansion part opened for patient enrollment
Slide 8: Profit and Loss
PROFIT AND LOSS NOK m 3Q18 4Q18 1Q19 2Q19 3Q19 Total revenue 0 0 0 0 0 External R&D expenses -17 -21 -19 -22 -14 Payroll and related expenses -12 -14 -14 -18 -8 Other operating expenses -5 -7 -7 -5 -5 Total operating expenses -34 -42 -40 -45 -27 Operating loss -34 -42 -40 -45 -27 Net financial items
Slide 9: Profit and Loss
PROFIT AND LOSS NOK m 3Q18 4Q18 1Q19 2Q19 3Q19 Total revenue 0 0 0 0 0 External R&D expenses -17 -21 -19 -22 -14 Payroll and related expenses -12 -14 -14 -18 -8 Other operating expenses -5 -7 -7 -5 -5 Total operating expenses -34 -42 -40 -45 -27 Operating loss -34 -42 -40 -45 -27 Net financial items
Slide 10: Targovax Financial Position
TARGOVAX FINANCIAL POSITION Operations The share Cash end of 3Q Market Cap - at share price NOK ~5 104 11 320 35 NOK million USD million NOK million USD million Net cash flow - total 3Q Daily turnover - 6 month avg. 31 3 1.1 0.1 0.4% NOK million USD million NOK million USD million Annual run rate -
Slide 11: Melanoma
Melanoma 3. Next generation ONCOS 4. Mesothelioma 5. Newsflow
Slide 12: 33% ORR and Robust Immune Activation
ONCOS-102 ANTI-PD1 REFRACTORY MELANOMA PART 1 33% ORR AND ROBUST IMMUNE ACTIVATION Advanced, unresectable melanoma with disease progression following prior treatment with anti-PD1 Patient population Typically treated with 2-3 immunotherapies prior to inclusion Median age 73 years (40-87) Poor progno
Slide 13: ONCOS-102 + Keytruda Data in Context
ONCOS-102 + KEYTRUDA DATA IN CONTEXT ANTI-PD1 REFRACTORY MELANOMA BENCHMARK DATA CR PR Comment 33% ORR ONCOS-102 11% 22% (3/9 pats.) 22% ORR o Checkmate Pharma, TLR-9 agonist CMP-001 3% 19% retreatment (15/69 pats.) Anti-PD1 21% ORR o Dynavax, TLR-9 agonist SD-101 3% 18% (6/29 pats.) 19% ORR o Synda
Slide 14: Melanoma Part 2 Is Recruiting
MELANOMA PART 2 IS RECRUITING UP TO 12 PATIENTS: 12 ONCOS-102 INJECTIONS COMBINED WITH 5 MONTHS KEYTRUDA Part 1: BL 1 2 3 6 9 12 15 18 21 24 27 Weeks 3 ONCOS-102 injections CPO ONCOS-102 PEMBROLIZUMAB Part 2: BL 1 2 3 6 9 12 15 18 21 24 27 Weeks 12 ONCOS-102 injections CPO ONCOS-102 ONCOS-102 + PEMB
Slide 15: Oral Presentation at SITC by Dr. Shoushtari
ORAL PRESENTATION AT SITC BY DR. SHOUSHTARI SITC (Society for Immunotherapy of Cancer) 2019 Annual Meeting Dr. Alexander Shoushtari, MSKCC, NYC 9 November, 17:30 EST, National Harbor, MD, US Key Opinion Leader event hosted by White & Case and Solebury Trout Dr. Alexander Shoushtari, MSKCC, NYC 15 No
Slide 16: Next Generation ONCOS
Next generation ONCOS 4. Mesothelioma 5. Newsflow
Slide 17: Next Generation ONCOS Viruses Have Double Transgenes and Distinct Modes of Action
NEXT GENERATION ONCOS VIRUSES HAVE DOUBLE TRANSGENES AND DISTINCT MODES OF ACTION Mode of action Target tumors ONCOS-210 & -212 o Interfere with tumor’s ability to o Highly invasive or Inhibition of tumor growth break down surrounding tissue metabolic tumors and vascularization o Induce cell cycle a
Slide 18: Next Generation ONCOS Viruses Have Double Transgenes and Distinct Modes of Action
NEXT GENERATION ONCOS VIRUSES HAVE DOUBLE TRANSGENES AND DISTINCT MODES OF ACTION Mode of action Target tumors ONCOS-210 & -212 o Interfere with tumor’s ability to o Highly invasive or Inhibition of tumor growth break down surrounding tissue metabolic tumors and vascularization o Induce cell cycle a
Slide 19: Tumor Growth Inhibition Confirmed in Immuno-Deficient Mice
TUMOR GROWTH INHIBITION CONFIRMED IN IMMUNO-DEFICIENT MICE, SHOWING SUPERIORITY OF DOUBLE-TRANSGENE VIRUSES Effect on tumor volume, melanoma model ONCOS treatment D1 D2 D3 D12 D19 D26 D1 D2750 D3 D12 D19 D26 750 Mock Mock (PBS) Volume (mm3) ONCOS-210 Mock (PBS) 500 ONCOS-212 Volume (mm3) ** ONCOS-21
Slide 20: ONCOS-210 and -212 Transgenes Act Synergistically
ONCOS-210 AND -212 TRANSGENES ACT SYNERGISTICALLY Tumor volume efficacy ratio1 observed / expected 2.5 2.16 1.97 Synergistic effect Additive effect 1 ONCOS-210 ONCOS-212 Anti-synergistic effect 0 20 1 In vivo tumor volume reduction double vs single transgene
Slide 21: Dose Dependent Tumor Responses and Improved Survival in Immune-Competent Mice
DOSE DEPENDENT TUMOR RESPONSES AND IMPROVED SURVIVAL OBSERVED IN IMMUNE-COMPETENT MICE D1 D3 D5 D12 D19 D26 100 Mock Vehicle 80 ONCOS-210 (low) % of survival ONCOS-212 (low) 60 ONCOS-207 (low) ONCOS-209 (low) Effect on tumor volume Survival curves40 ONCOS-210 (high) ONCOS-212 (high) 20 D1 D3 D5 D12
Slide 22: Next Generation ONCOS Program Status and Plans
NEXT GENERATION ONCOS PROGRAM STATUS AND PLANS Status and conclusions so far: In vivo anti-tumor potency of ONCOS-210 and -212 has been demonstrated in immuno- deficient and immuno-competent mouse models The ONCOS backbone can effectively carry double transgenes Two transgenes seem more potent than
Slide 23: Mesothelioma
Mesothelioma 5. Newsflow
Slide 24: Rationale for ONCOS-102 Go-to-Market Strategy in Mesothelioma
RATIONALE FOR ONCOS-102 GO-TO-MARKET STRATEGY IN MESOTHELIOMA Become frontline therapy Orphan Drug Designation Limited competition o Preclinical data and o High unmet medical o Few other viruses in phase I results indicate need; orphan drug development activity in mesothelioma designation o ONCOS-10
Slide 25: Phase I/II Study Design in Combination with SoC
ONCOS-102 IN MALIGNANT PLEURAL MESOTHELIOMA PHASE I/II STUDY DESIGN IN COMBINATION WITH SOC Experimental group (n=14) Patient population ONCOS-102 plus Safety lead-in (n=6) SoC (6 cycles) Advanced malignant Non-randomized Randomized ONCOS-102 pleural mesothelioma plus SoC chemotherapy 1st - 3rd line
Slide 26: Newsflow
Newsflow ° targovax °
Slide 27: Rich Near-Term News Flow
RICH NEAR-TERM NEWS FLOW ONCOS program pipeline overview Product candidate Preclinical Phase I Phase II Phase III Next expected event Mesothelioma January 2020 Combination w/ pemetrexed/cisplatin Randomized data Melanoma 1H 2020 Combination w/Keytruda Part 2 data ONCOS-102 Peritoneal metastasis Coll
Slide 28: Upcoming Events and Milestones
Upcoming events 9 Nov Society for Immunotherapy of Cancer (SITC), National Harbor, MD, US 11-13 Nov BIO-Europe, Hamburg, Germany 15 Nov KOL event, NYC, US 20-21 Nov Jefferies Healthcare conference, London, UK 3-5 Dec Oncolytic Virotherapy Summit, Boston, US 11-14 Dec ESMO-IO, Geneva, CH 11 Dec DNB H