Circio Holding Asa · OSL:CRNA
Circio Holding Asa — Targovax — Q2 2021 Earnings Presentation
26 slides from Circio Holding Asa's earnings presentation, Aug 18, 2021
Slide 1: Activating the Patient's Immune System to Fight Cancer
ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER 2Q 2021 18 August 2021
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: Introduction and highlights
Introduction and highlights 2. Melanoma 3. Finance 4. Summary 3
Slide 4: Targovax at a Glance
TARGOVAX AT A GLANCE ONCOS-102: Novel immune activator with clinical efficacy in several solid tumors in monotherapy and in combination with anti-PD1 and chemotherapy ONCOS-102 is MoA confirmed in multiple indications: Broad local and systemic immune activation associated with clinical outcome the b
Slide 5: First Half 2021 Highlights
FIRST HALF 2021 HIGHLIGHTS Reported class-leading median overall survival in Targovax’s ONCOS-102 trial in mesothelioma at the 24-month follow-up Trials Completed enrollment of the phase 1/2 trial with ONCOS-102 in combination with durvalumab in patients with advanced colorectal cancer Entered a res
Slide 6: Fast Track Designation
FAST TRACK DESIGNATION Fast track designation is given for new treatments that: Requirements Are aimed at serious medical conditions Have demonstrated potential to address the unmet medical need FDA commits to expedite development and review by: Giving opportunities for frequent interactions with th
Slide 7: Melanoma
Melanoma 3. Finance 4. Summary 7
Slide 8: ONCOS-102 Has Demonstrated Class-Leading Efficacy in PD1-Refractory Melanoma
ONCOS-102 HAS DEMONSTRATED CLASS-LEADING EFFICACY IN PD1-REFRACTORY MELANOMA CR PR Comment 35% ORR o Adenovirus expressing GM-CSF ONCOS-102 5% 30% (7/20 pts.) 35% ORR o Four melanoma antigens, mRNA BNT111 0 35% (6/17 pts.) retreatment Anti-PD1 6% 25% 31% ORR o Herpes virus expressing GM-CSF RP1 (5/1
Slide 9: What Characterizes a Great Immune Activator?
WHAT CHARACTERIZES A GREAT IMMUNE ACTIVATOR? Activate pro-inflammatory signalling pathways o Trigger danger signalling, e.g. through TLR9 activation o Stimulate release of cytokines and chemokines Drive increased tumor immune cell infiltrate o Break down tumor entry barriers o Recruit T-cells, NK-ce
Slide 10: ONCOS-102 Increases Tumor T-Cell Infiltration
ONCOS-102 INCREASES TUMOR T-CELL INFILTRATION COMPLETE RESPONSE MELANOMA PATIENT CASE EXAMPLE T-cell tumor infiltrate Baseline Week 3 Week 9 Total level of T-cells Wk 3 CD8+ T-cells Wk 9 Low CD8+ 15x increase CR, mainly necrotic tissue; BL level at baseline from baseline some T-cells still present W
Slide 11: Increased T-Cell Infiltration Consistent with Melanoma Patient Outcomes
INCREASED T-CELL INFILTRATION FOLLOWING ONCOS-102 MONOTHERAPY IS CONSISTENT WITH MELANOMA PATIENT OUTCOMES CD8+ T-cell infiltration CD4+ helper T-cell infiltration Average level by tumor response Average level by tumor response Baseline Week 3 CR: Complete response PR: Partial response SD: Stable di
Slide 12: High Ratio of Active Cytotoxic CD8+ T-Cells Indicate a Hot Tumor Microenvironment
HIGH RATIO OF ACTIVE CYTOTOXIC CD8+ T-CELLS INDICATE A “HOT” TUMOR MICROENVIRONMENT GRB+ CD8+ T-cell infiltration; % of total CD8+ population Baseline Week 3 CR: Complete response PR: Partial response SD: Stable disease PD: Progressive disease CR PR SD PD PD* 12 * w/o pseudo-progressor who was SD by
Slide 13: Inhibitory Tregs Down-Regulated in Responding Melanoma Patients
CONVERSELY, INHIBITORY TREGS ARE DOWN-REGULATED IN RESPONDING MELANOMA PATIENTS Regulatory T-cell infiltration; FOXP3+ % of total CD4+ population Baseline Week 3 CR: Complete response PR: Partial response SD: Stable disease PD: Progressive disease CR PR SD PD PD* 13 * w/o pseudo-progressor who was S
Slide 14: Gene Expression Data Confirms IHC Observations
GENE EXPRESSION DATA CONFIRMS IHC* OBSERVATIONS AND DETAILS BROAD PRO-INFLAMMATORY TUMOR RE-PROGRAMING Change week 9 vs. baseline RNAseq gene expression provides further insights: o Pro-inflammatory “hot” tumor remodeling through multiple pathways and molecular mechanisms o Increased expression of c
Slide 15: Observations Consistent Across Tumor Types – Mesothelioma Example
IMPORTANTLY, THESE OBSERVATIONS ARE CONSISTENT ACROSS TUMOR TYPES – MESOTHELIOMA EXAMPLE CD8+ T-cell infiltrate (TIL) for individual patients; tumor mIHC Avg. CD8+ TILs Day 36 vs. BL Baseline Day 36 Only PD patient with high baseline CD8+ TILs had decrease by Day 36 CR PR SD PD CR/PR SD PD Baseline
Slide 16: Immune Marker Data Build Strong Biological Rationale for New Combinations
IMMUNE MARKER DATA BUILD STRONG BIOLOGICAL RATIONALE FOR SEVERAL NEW COMBINATIONS WITH ONCOS-102 Immuno-modulation in tumor tissue; Mesothelioma, Day 36 vs. baseline 16
Slide 17: Immune Marker Data Build Strong Biological Rationale for New Combinations
IMMUNE MARKER DATA BUILD STRONG BIOLOGICAL RATIONALE FOR SEVERAL NEW COMBINATIONS WITH ONCOS-102 Immuno-modulation in tumor tissue; Mesothelioma, Day 36 vs. baseline Co-stims: Help T-cells expand, survive and kill Anti-PD1: T-cell engagers: Block the tumor´s “don´t Exploit T-cell cytotoxic machinery
Slide 18: Strength and Breadth of ONCOS-102 Clinical Data Package
STRENGTH AND BREADTH OF ONCOS-102 CLINICAL DATA PACKAGE OPENS BROAD OPPORTUNITIES Class-leading ONCOS-102 drives meaningful clinical benefit, efficacy competitive with leading drug candidates ONCOS-102 data package is highly consistent Highly across tumor types, survival, clinical response, consiste
Slide 19: Planning a Melanoma Phase 2 Platform Trial
PLANNING A MELANOMA PHASE 2 PLATFORM TRIAL TO EXPLORE MULTIPLE ONCOS-102 COMBINATIONS Part 1 – run-in Part 2 – multi-cohort extension Population: Anti-PD1 refractory melanoma 3 ONCOS-102 + o Additional cohorts to explore ONCOS-102 PD1 + aCTLA4 novel combinations 1 o Assess monotherapy contribution o
Slide 20: Clinical and Preclinical Pipeline
CLINICAL AND PRECLINICAL PIPELINE Product candidate Preclinical Phase 1 Phase 2 Phase 3 Next expected event Refractory Melanoma 1H 2022 Platform trial First patient in Mesothelioma 2H 2021 ONCOS-102 Combination w/pemetrexed/cisplatin Survival update Metastatic Colorectal cancer 1H 2022 Combination w
Slide 21: Finance
Finance 4. Summary ° targovax °
Slide 22: 2Q Financial Snapshot
2Q FINANCIAL SNAPSHOT Key figures Shareholder base1 Net cash flow in 2Q Ownership by professional -24 -2.7 institutions, e.g. NOK million USD million • HealthCap, Nordea, Radforsk, AP4, Arctic 31% Cash at end of 2Q Aurora, MP Pension 71 8.4 NOK million USD million Largest shareholder • HealthCap 14%
Slide 23: Second Quarter Opex in Line with Previous Quarters
SECOND QUARTER OPEX IN LINE WITH PREVIOUS QUARTERS NOK m 2Q20 3Q20 4Q20 1Q21 2Q21 Total revenue 0 0 0 0 0 External R&D expenses 1 -14 -9 -8 - -9 - -9 Payroll and related expenses -11 -9 -12 -11 -13 Other operating expenses 2 -5 -4 -3 -2 -3 Total operating expenses -30 -22 -23 -23 -25 Operating loss
Slide 24: Summary
Summary ° targovax °
Slide 25: Targovax at a Glance
TARGOVAX AT A GLANCE ONCOS-102: Novel immune activator with clinical efficacy in several solid tumors in monotherapy and in combination with anti-PD1 and chemotherapy ONCOS-102 is MoA confirmed in multiple indications: Broad local and systemic immune activation associated with clinical outcome the b
Slide 26: Upcoming Conferences, Data Milestones and Financial Calendar
Upcoming conferences / events 7 Sep 2021: Next Gen Cancer Vaccine Development Summit 17-21 Sep 2021: European Society for Medical Oncology (ESMO) 26 Oct 2021: Oncolytic Virotherapy Summit 26-29 Oct 2021: 5th Annual Next Gen IO Conference EU edition Upcoming data milestones 2H 2021: ONCOS-102 in comb