Circio Holding Asa · OSL:CRNA
Circio Holding Asa — Targovax — Q4 2019 Earnings Presentation
31 slides from Circio Holding Asa's earnings presentation, Mar 11, 2020
Slide 1: Activating the Patient's Immune System to Fight Cancer
ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER 4Q 2019 11 March 2020
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: Intro & Highlights
Intro & Highlights 2. Mesothelioma 3. Melanoma 4. Financials and IOVaxis deal 5. Newsflow 3
Slide 4: Growing Need for Immune Activators
GROWING NEED FOR IMMUNE ACTIVATORS CPIs are revolutionizing …but not all patients …leading to high medical cancer treatment… respond to CPIs… need for immune activators 22 bn USD Global CPI market1 44 % Patients eligible for CPI2: 10 - 40 % Responders 1 Immune Checkpoint Inhibitors Markets Report, 2
Slide 5: Activating the Immune System to Fight Cancer
ACTIVATING THE IMMUNE SYSTEM TO FIGHT CANCER ONCOS-102 lead clinical asset ONCOS oncolytic adenovirus platform targets hard-to-treat solid tumors One of the furthest developed OVs with >180 patients treated to date Four ongoing combination trials ensuring rich news flow in 2020 Encouraging clinical
Slide 6: ONCOS-102 Mode of Action Makes an Ideal Combination Partner for Checkpoint Inhibitors
ONCOS-102 MODE OF ACTION MAKES AN IDEAL COMBINATION PARTNER FOR CHECKPOINT INHIBITORS 1 Virus injection Local delivery 2 Oncolysis Immune activation 3 Antigen processing T-cell activation 4 T-cell response Anti-tumor immunity Intratumoral or intra- Lysis of tumor cells Antigen processing T-cell tumo
Slide 7: Benefits of ONCOS-102 Adenovirus
BENEFITS OF ONCOS-102 ADENOVIRUS Highly immunogenic, TLR-9 agonist, stimulates inflammation Well-characterized, well-tolerated and few safety concerns Versatile DNA backbone, ability to carry multiple transgenes 7
Slide 8: Several Significant BD Transactions in the Oncolytic Virus Space in 2018-2019
SEVERAL SIGNIFICANT BD TRANSACTIONS IN THE ONCOLYTIC VIRUS SPACE IN 2018-2019 Target Type of deal Deal value Strategic collaboration USD 120m near-term Co-development of multiple USD >900m total value vaccinia viruses, Pre-clinical M&A USD 400m RNA virus, Phase II cash acquisition M&A USD 140m up-fr
Slide 9: ONCOS Development Strategy
ONCOS DEVELOPMENT STRATEGY 1 Establish path-to-market Mesothelioma o ~15.000 patients o Potential for first line, limited competition 2 Activate refractory tumors Anti-PD1 refractory melanoma o Few alternatives for ~50.000 patients o Benchmarking arena for immune activators 3 Expand CPI indications
Slide 10: ONCOS-102 Clinical Development Program
ONCOS-102 CLINICAL DEVELOPMENT PROGRAM o Randomized trial Mesothelioma o Combination with SoC chemo 1 Phase I/II 31 patients o Encouraging first set of clinical and immune data Anti-PD1 refractory o Combination with Keytruda Compassionate use Various tumors o program 115 patients Phase I 12 patients
Slide 11: Recent Highlights
RECENT HIGHLIGHTS Showed encouraging data in mesothelioma trial combining ONCOS-102 and SoC chemo ONCOS Completed enrollment of melanoma trial Presented melanoma data at Society for Immunotherapy of Cancer Entered into an option agreement with IOVaxis Therapeutics for an TG TG mutant RAS vaccine lic
Slide 12: ONCOS-102 Clinical Development Program
ONCOS-102 CLINICAL DEVELOPMENT PROGRAM o Randomized trial Mesothelioma o Combination with SoC chemo 1 Phase I/II 31 patients o Encouraging first set of clinical and immune data Anti-PD1 refractory Compassionate use Various tumors program 115 patients Phase I 12 patients 2 melanoma Phase I up to 21 p
Slide 13: Mesothelioma
Mesothelioma 3. Melanoma 4. Financials and IOVaxis deal 5. Newsflow 13
Slide 14: High Need for New Treatment Approaches
MALIGNANT PLEURAL MESOTHELIOMA HIGH NEED FOR NEW TREATMENT APPROACHES Surgery Radiotherapy Only 10% of patients Rarely effective due to suitable for resection tumor shape Often diagnosed too Hard to focus radiation late for surgery Mainly Technically challenging palliative care Chemotherapy Immunoth
Slide 15: Study Design
ONCOS-102 MESOTHELIOMA PHASE I/II TRIAL IN COMBINATION WITH CHEMO STUDY DESIGN Experimental group n=14 Patient population Safety lead-in ONCOS-102 plus Non- n=6 SoC Chemo (6 cycles) Advanced malignant randomized Randomized pleural mesothelioma ONCOS-102 First and second (or later) plus SoC Chemo (6
Slide 16: Patient Characteristics and Outcomes
ONCOS-102 MESOTHELIOMA PHASE I/II COMBINATION WITH SOC PATIENT CHARACTERISTICS AND OUTCOMES ITT: N = 31 (20+11) Experimental Control Comments PP: N = 30 (19+11) n= 20 n= 11 Tumor and disease characteristics at enrollment - Number of lesions 4.3 3.5 - Tumor burden mm (RECIST 1.1) 87 46 Generally more
Slide 17: First Line ONCOS-102 ORR and Early PFS Data Compare Favorably to Historical Control
FIRST LINE ONCOS-102 ORR AND EARLY PFS DATA COMPARE FAVORABLY TO HISTORICAL CONTROL ORR / BORR • Vogelzang 2003 was the basis for FDA approval of Pemetrexed 50 • FDA review disputed data, reducing confirmed BORR to 21% (Hazarika 2005) 45 Vogelzang 40 2003, BORR 35 Targovax control 30 group, ORR 25 T
Slide 18: Increased T-Cell Infiltration in Experimental Group
ONCOS-102 MESOTHELIOMA IMMUNE ACTIVATION INCREASED T-CELL INFILTRATION IN EXPERIMENTAL GROUP CD8+ T-cell infiltration -fold change from baseline to day 36 (n=201) Partial response (PR) Stable disease (SD) Progressive disease (PD) Average -fold change in CD8+ • 3.3-fold in experimental group • No cha
Slide 19: Summary and Next Steps
ONCOS-102 MESOTHELIOMA PHASE I/II TRIAL SUMMARY AND NEXT STEPS Excellent safety profile ONCOS-102 and SoC chemotherapy combination is well-tolerated Clinical activity observed Emerging data suggest benefit for ONCOS-102 treated patients and compare favorably to historical control Increased T-cell in
Slide 20: Next Step: ONCOS-102 + Anti-PD1/L1 + Chemo Triple Combination in First Line Mesothelioma
NEXT STEP: ONCOS-102 + ANTI-PD1/L1 + CHEMO TRIPLE COMBINATION IN FIRST LINE MESOTHELIOMA Study population – malignant pleural mesothelioma: First line, unresectable, advanced and/or metastatic disease ca. 100 patients Experimental arm ONCOS-102 + anti-PD1/L1 + Chemo Safety lead-in Go / No go ONCOS-1
Slide 21: Melanoma
Melanoma 4. Financials and IOVaxis deal 5. Newsflow 21
Slide 22: ONCOS-102 and Keytruda Combination Part 2: Fully Recruited
ANTI-PD1 REFRACTORY MELANOMA ONCOS-102 AND KEYTRUDA COMBINATION PART 2: FULLY RECRUITED Part 1 Part 2 Patients 9 12 ONCOS-102 3 12 injections Overall response 33% 2H20 rate (ORR) 22
Slide 23: 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.) 25% ORR o Checkmate Pharma, TLR-9 agonist retreatment CMP-001 3% 22% o Data from high dose cohort (21/83 pats.) Anti-PD1 3% 17% 21%ORR o Dynavax, TLR-9 agonist SD-101
Slide 24: Financials and IOVaxis Deal
Financials and IOVaxis deal 5. Newsflow 24
Slide 25: Profit and Loss
PROFIT AND LOSS NOK m 4Q18 1Q19 2Q19 3Q19 4Q19 Total revenue 0 0 0 0 2 External R&D expenses -21 -19 -22 -14 -25 Payroll and related expenses -14 -14 -18 -8 -11 Other operating expenses -7 -7 -5 -5 -5 Total operating expenses -42 -40 -45 -27 -42 Operating loss -42 -40 -45 -27 -39 Net financial items
Slide 26: Sufficiently Funded to Advance Clinical Program Beyond Value Inflection Points
SUFFICIENTLY FUNDED TO ADVANCE CLINICAL PROGRAM BEYOND VALUE INFLECTION POINTS The company The shareholders Cash end of 4Q Estimated ownership1 70 8 Raised NOK 101m / USD 12 in Jan 2020 Shareholder HealthCap Shares million Ownership 12.4 16.3 % NOK million USD million RadForsk 4.4 5.8 % Nordea 4.3 5
Slide 27: TG01/02 IOVaxis Option Agreement
TG01/02 IOVAXIS OPTION AGREEMENT CEO: John Wang HQ: Nantong, China Founded: 2018 R&D focus: Shared and personalized cancer vaccines Description Terms Next steps o Exclusive option to license o US$250.000 option fee o File for China IND TG01/02 vaccines for o US$3m up-front fee upon o Establish full
Slide 28: Newsflow
Newsflow ° targovax °
Slide 29: Pipeline with Rich Near-Term News Flow
PIPELINE WITH RICH NEAR-TERM NEWS FLOW Product candidate Preclinical Phase I Phase II Phase III Next expected event 1H 2020 Mesothelioma Updated clinical and Combination w/ pemetrexed/cisplatin immune data 2H 2020 Melanoma Clinical and immune Combination w/Keytruda activation data ONCOS-102 Peritone
Slide 30: Upcoming Events and Milestones
Upcoming events 19-21 Apr H.C. Wainwright Conference, London, UK Investor presentation 26-29 Apr AACR, San Diego, US Next-gen virus poster 5-6 May Annual Cancer Progress Conference, NYC, US Panel discussion 6 May 1Q presentation, Oslo, Norway 1Q presentation 26 May ABGSC Life Science Summit, Stockho
Slide 31: Activating the Immune System to Fight Cancer
ACTIVATING THE IMMUNE SYSTEM TO FIGHT CANCER CLINICALLY PROVEN INNOVATIVE RICH NEWS FLOW PIPELINE One of the furthest developed Next generation Clinical and immune activation oncolytic viruses virus platform in from mesothelioma and pre-clinical testing melanoma trials Strong single agent data Poten