Circio Holding ASA · OSL:CRNA
Circio Holding ASA — Targovax — Q1 2021 Earnings Presentation
31 slides from Circio Holding ASA's earnings presentation, May 6, 2021
Slide 1: Activating the Patient's Immune System to Fight Cancer
ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER 1Q 2021 6 May 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. Mesothelioma 3. Melanoma 4. Finance 5. Summary 3
Slide 4: Targovax at a Glance
TARGOVAX AT A GLANCE Lead product candidate o Class-leading data in monotherapy and combinations with chemo and aPD-1 o Powerful immune activation ONCOS-102 o Ideal combination partner to aPD-1 Vision: o Path to market Unlock greater clinical benefits in cancer patients by deploying multifunctional
Slide 5: Early-stage development completed – entering late-stage development
EARLY-STAGE DEVELOPMENT SUCCESSFULLY COMPLETED – ENTERING LATE-STAGE DEVELOPMENT Expansion opportunities Late-stage development Mesothelioma Colorectal cancer Early-stage development PD-1 refractory melanoma Other indications Other IO combinations Clinical efficacy Platform development Immune activa
Slide 6: Clinical and Preclinical Pipeline
CLINICAL AND PRECLINICAL PIPELINE Product candidate Preclinical Phase 1 Phase 2 Collaborator Next expected event Melanoma 1H 2022 Combination w/anti PD1 First patient Colorectal cancer Updates by collaborator ONCOS-102 Combination w/Imfinzi expected 1H22 Mesothelioma 1H 2021 Combination w/pemetrexed
Slide 7: Recent Highlights
RECENT HIGHLIGHTS Received Fast-Track designation from the US FDA for ONCOS-102 in malignant pleural mesothelioma. This opens the potential for expedited Mesothelioma development path and review Continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up Entere
Slide 8: Mesothelioma
Mesothelioma 3. Melanoma 4. Finance 5. Summary 8
Slide 9: Encouraging clinical outcomes in 1st line
ONCOS-102 MESOTHELIOMA PHASE 1/2 COMBINATION WITH SoC CHEMO ENCOURAGING CLINICAL OUTCOMES IN 1ST LINE Trial design Oncos-102 + SoC, n=8 SoC, n=6 Median PFS, months 1st and 2nd (or later) line ONCOS-102: 6 intra-tumoral injections 9.8 7.6 SoC chemo: pemetrexed and cisplatin, 6 cycles Alive after 21 m
Slide 10: First line data are maturing and already competitive
FIRST LINE DATA ARE MATURING AND ALREADY COMPETITIVE - MOS WILL BE 20.5 MONTHS OR MORE ONCOS-102 +Pem/cis mPFS Pem/cis (or carbo) months Checkpoint trials 11 Targovax experimental8 10 Min. 9 8 Targovax control8 Baas6 Zalcman5 7 control Nowak7 Ceresoli3 chemo/durva Scagliotti4 Baas6 6 Vogelzang2 Ipi/
Slide 11: Fast Track designation and evolving survival data provide opportunities
FAST TRACK DESIGNATION AND EVOLVING SURVIVAL DATA PROVIDE OPPORTUNITIES Well tolerated combination therapy Clear clinical activity in 1st line patients Interim survival data promising even without CPI FDA granted Fast Track designation in mesothelioma Next steps Continue follow patients to determine
Slide 12: Melanoma
Melanoma 4. Finance 5. Summary 12
Slide 13: ONCOS-102 trial in anti-PD1 refractory melanoma: 35% ORR and systemic effect
ONCOS-102 TRIAL IN ANTI-PD1 REFRACTORY MELANOMA: 35% ORR AND SYSTEMIC EFFECT Advanced, unresectable melanoma Disease progression despite prior treatment with anti-PD1 Patient population Poor prognosis, with few treatment alternatives 20 patients, 11 stage III and 9 stage IV Part 1: 3 ONCOS-102 injec
Slide 14: Responders typically had reduction in tumor burden at week 9
RESPONDERS TYPICALLY HAD REDUCTION IN TUMOR BURDEN ALREADY AT THE WEEK 9 MEASUREMENT Change in tumor volume through study; normalized to baseline (BL=100) Complete response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) + 20% No change Possible pseudo- progression - 30% 14
Slide 15: Case example 1: patient with complete response
CASE EXAMPLE 1: PATIENT WITH COMPLETE RESPONSE Tumor response, 1 of 1 injected lesion Baseline Week 3 Week 9 Week 18 Week 27 (EoS) Progression on 3x ONCOS-102 only 3x ONCOS-102 & 3x ONCOS-102 & 3x ONCOS-102 & pembrolizumab (no pembrolizumab) 2x pembrolizumab 5x pembrolizumab 8x pembrolizumab Patient
Slide 16: Case example 1: tumor T-cell infiltration
CASE EXAMPLE 1: PATIENT WITH COMPLETE RESPONSE TUMOR T-CELL INFILTRATION T-cell infiltrate, 1 of 1 injected lesion 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 Wk 3
Slide 17: Case example 2: partial response in patient refractory to T-vec and anti-PD1
CASE EXAMPLE 2: PARTIAL RESPONSE IN PATIENT REFRACTORY TO BOTH T-VEC AND ANTI-PD1 Tumor response, 2 of 2 injected lesions Baseline Week 3 Week 9 Week 18 Week 27 (EoS) Lesion 1 of 2 Monotherapy activity Lesion 2 of 2 Monotherapy activity Progression on 3x ONCOS-102 3x ONCOS-102 & 3x ONCOS-102 & 3x ON
Slide 18: Case example 2: T-cell infiltration
CASE EXAMPLE 2: PARTIAL RESPONSE PATIENT REFRACTORY TO T-VEC – T-CELL INFILTRATION T-cell infiltrate, 1 of 2 injected lesions Baseline Week 3 Week 9 Total level of T-cells Wk 9 CD8+ T-cells Wk 3 BL Some CD8+ 3x increase 4.5x increase presence at baseline from baseline from baseline CD4+ T-cells* Wk
Slide 19: Highest increase in tumor T-cell infiltrates observed in melanoma responders
HIGHEST INCREASE IN TUMOR T-CELL INFILTRATES OBSERVED IN MELANOMA RESPONDERS T-cell infiltrate (TIL) for individual patients; tumor mIHC, relative level Average T-cell level per group Baseline Baseline Week 3 Week 3, ONCOS only Week 9 * w/o pseudo-progressor CD8+ T-cells CR PR SD PD CR 1 PR SD PD PD
Slide 20: T-cell sub-populations indicative of pro-inflammatory shift in responders
T-CELL SUB-POPULATIONS INDICATIVE OF PRO- INFLAMMATORY SHIFT IN MELANOMA RESPONDERS T-cell sub-populations; tumor mIHC, relative level Average % of total T-cell population per group Baseline Very high proportion of Highest level of GRB+ cytotoxic T-cells in Week 3 GRB expressing cytotoxic responders
Slide 21: ONCOS-102 is a well-validated program in anti-PD1 refractory melanoma
ONCOS-102 IS A WELL-VALIDATED PROGRAM IN ANTI-PD1 REFRACTORY MELANOMA Clinical benefit Biomarker data ORR in PD-1 Stage of Abscopal Monotherapy Combination Combination TLR-9 Inflammatory T-cell PD-L1 Company Asset Type of molecule Refractory Development effect data w/ aPD1 with chemo signalling resp
Slide 22: ONCOS-102 melanoma immune activation conclusions
ONCOS-102 MELANOMA IMMUNE ACTIVATION CONCLUSIONS ONCOS-102 activates the immune system and counteracts multiple mechanisms of immuno-suppression Multifaceted modulation of the tumor micro-environment induced by ONCOS-102, with a robust shift towards favorable T-cell sub-populations ONCOS-102 induced
Slide 23: Top international KOLs consulted for advice on next steps
TOP INTERNATIONAL KOLs CONSULTED FOR ADVICE ON NEXT STEPS KOLs consulted Q1 2021 KOL feedback and recommendations for next steps Jedd Wolchok o ORR of >30% viewed as positive, uniform MSK, New York, USA recommendation to continue development Mario Sznol o Systemic effect better than would be expecte
Slide 24: Targovax is planning for a study targeting accelerated approval in PD1 refractory melanoma
TARGOVAX IS PLANNING FOR A STUDY TARGETING ACCELERATED APPROVAL IN PD1 REFRACTORY MELANOMA Rationale Study design – current thinking Next steps • Highly competitive • ONCOS-102 + aPD1 • Test concrete study design and clinical data • Single arm, ca. 100 patients enrolment criteria with KOLs • No stan
Slide 25: Finance
Finance 3. Summary ° targovax °
Slide 26: First quarter opex in line with previous quarters
FIRST QUARTER OPEX IN LINE WITH PREVIOUS QUARTERS NOK m 1Q20 2Q20 3Q20 4Q20 1Q21 Total revenue 0 0 0 0 0 External R&D expenses 1 -13 -14 -9 -8 - -9 Payroll and related expenses -11 -11 -9 -12 -11 Other operating expenses 2 -5 -5 -4 -3 -2 Total operating expenses -30 -30 -22 -23 -23 Operating loss -2
Slide 27: Key Figures
KEY FIGURES The company Share liquidity Cash at end of 1Q 150% of shares traded last 12 month 95 11 Share turnover per month1 NOK million USD million Million shares Net cash flow - total 1Q -27 -3.2 NOK million USD million Market cap 700 84 NOK million USD million Daily value traded Average last 12
Slide 28: TG + chemo patent maintained as granted after opposition in European Patent Office
TG + CHEMO PATENT MAINTAINED AS GRANTED AFTER OPPOSITION IN EUROPEAN PATENT OFFICE An undisclosed party opposed to the granted patent EP 3140320, claiming: – Lack of novelty (not new) – Lack of inventive step (obviousness) – The patent does not disclose the invention in a sufficiently clear and Back
Slide 29: Summary
Summary ° targovax °
Slide 30: In Summary
IN SUMMARY Lead product ONCOS-102 directed to the $25 billion market for checkpoint inhibitors Entering late-stage development in refractory melanoma with class-leading data Powerful and comprehensive immune activation supporting IO-combinations Pipeline with multiple additional value-creating oppor
Slide 31: Upcoming conferences, data milestones and financial calendar
Upcoming conferences / events 12 May 2021: Radium podcast (Norwegian) 25 May 2021: ABGSC Life Science Summit – investor presentation 25 May 2021: Oncolytic Viruses Symposium – scientific presentation Upcoming data milestones 1H 2021: ONCOS-102 Phase 1/2 trial in unresectable malignant pleural mesoth