Slide 1: Parsortix Liquid Biopsy Preliminary Results for the year ended 30 April 2018
Parsortix Liquid Biopsy Preliminary Results for the year ended 30 April 2018 Andrew Newland and Ian Griffiths 25 July 2018 © ANGLE plc 2018 Page 1
Slide 2: Legal disclaimer
Legal disclaimer LSE AIM: AGL OTCQX: ANPCY This presentation has been prepared by ANGLE plc (the “Company”). By attending this presentation and/or reviewing the slides you agree to be bound by the following conditions. The presentation slides which follow this notice and the oral presentation of whi
Slide 3: Highlights
Highlights Liquid biopsy FDA clinical study set up and in progress Large scale clinical studies in ovarian cancer out-perform standard of care Acquisition of downstream analysis technology enables ‘sample to answer’ Collaborative agreements with QIAGEN, Philips and Abbott Installed base increased to
Slide 4: Financial Results for the year ended April 2018 (unaudited)
Financial Results for the year ended 30 April 2018 (unaudited) Year ended 30 April 2018 2017 Statement of Comprehensive Income £’000 £’000 Comments Revenue and grant income 680 498 Revenue and grant income up 36% Cost of sales (169) (123) Gross profit 511 375 >70% gross margin Operating costs (9,444
Slide 5: FDA clearance
FDA clearance ANG-002 STUDY START-UP STATUS (1 June 2018) Site 01: Site 02: Site 03: Site 04: Tasks MD North- USC URMC Seeking to be the first company ever to receive an FDA Institution/Investigator Check (FDA restrictions, Anderson western clearance for harvesting cancer cells from blood for analys
Slide 6: Business growth post FDA clearance
Business growth post FDA clearance FDA clearance would be a major validation − generating increased interest from third parties to utilise Parsortix − widening the market − increasing third party investment in developing Parsortix applications Revenues from clinical applications will be possible wit
Slide 7: Driving commercialisation in a $ multi-billion market
Driving commercialisation in a $ multi-billion market © ANGLE plc 2018 Page 7
Slide 8: Clinical application: Ovarian cancer pelvic mass triage test
Clinical application Increased value captured with Ziplex Ovarian cancer pelvic mass triage test US $1 billion p.a. market potential 400 patient clinical studies completed Potential to significantly out-perform current clinical care in discriminating malignant from benign − up to 95% sensitivity and
Slide 9: Ziplex high performance multiplex downstream analysis solution
Ziplex® high performance multiplex downstream analysis solution Ziplex system − benchtop laboratory platform designed for routine and focused multiplex analysis of DNA, RNA and protein biomarkers − sample to answer solution for distributed testing under development HyCEAD chemistry − enables simulta
Slide 10: Regulatory clearance for clinical use
Regulatory clearance for clinical use Breast cancer FDA clearance progress 400 patient study Analytical studies progressing well − precision and reproducibility − limits of quantification and detection − accuracy and linearity − interferents and carryover ANG-002 clinical study in progress − 200 met
Slide 11: Non-invasive metastatic breast cancer biopsy
Clinical application Non-invasive metastatic breast cancer biopsy £1 billion p.a. market potential CTCs harvested and RNA-Seq analysis successful for 100% of patients (21 patient study) CTCs from Parsortix liquid biopsy had similar patterns of expression for 192 genes to the traditional biopsy of ca
Slide 12: Collaboration with Abbott for HER-2 FISH application
Collaboration with Abbott for HER-2 FISH application Abbott is the global leader for FISH testing in solid tissue biopsies Physicians use the FISH HER-2 result to determine whether a patient should receive Herceptin (Trastuzumab) − about 1 in 5 breast cancer patients have a positive HER-2 result − F
Slide 13: Non-invasive prostate biopsy
Clinical application under consideration Non-invasive prostate biopsy £3 billion p.a. market potential Barts Cancer Institute pilot studies − harvested CTCs in 100% of patients (52 patient study) − number of mesenchymal CTCs showed good correlation to Gleason score (80 patient study) Simple blood te
Slide 14: Prostate cancer aggressiveness – the key question
Clinical application under consideration Prostate cancer aggressiveness – the key question Kaplan-Meier curve: 40 patient study Patients classified as high risk using the Parsortix system 10x more likely to die than those classified as low risk Source: “The novel association of circulating tumor cel
Slide 15: Co-marketing agreement with leading molecular testing company, QIAGEN
Co-marketing agreement with leading molecular testing company, QIAGEN QIAGEN leading molecular testing company − 500,000 customers and $1.3bn revenues − NGS (next generation sequencing), PCR (polymerase chain reaction), single cell analysis products and bioinformatics capabilities Selected Parsortix
Slide 16: Research use - growing body of evidence – becoming the CTC system of choice
Research use - growing body of evidence – becoming the CTC system of choice Growing user base (in-house, KOLs, customers and evaluations) Instrument Cassette − over 200 Parsortix instruments in active use (30Apr17: 145) Price 1 £40,000 £100 − over 49,000 blood separations performed (30Apr17: 30,000)
Slide 17: Strengthening a leading position in emerging $ multi-billion liquid biopsy market
Strengthening a leading position in emerging $ multi-billion liquid biopsy market Providing the Complete Picture - viable, intact CTCs for DNA, RNA, and protein analysis (not just ctDNA) Clinical study in progress to support first ever FDA clearance in metastatic breast cancer expected to complete i
Slide 18: ANGLE plc
ANGLE plc ANGLE Europe Ltd ANGLE North America Inc ANGLE Biosciences Inc 10 Nugent Road 3711 Market Street 50 Ronson Drive, Suite 105 The Surrey Research Park University Science Center 8th floor Toronto Guildford GU2 7AF Philadelphia PA 19104 Ontario M9W 1B3 United Kingdom USA Canada www.ANGLEplc.co