Slide 1: Liquid biopsy from a simple blood test enabling personalised cancer care
Liquid biopsy from a simple blood test enabling personalised cancer care Interim Results for the six months ended 31 October 2015 Andrew Newland & Ian Griffiths 28 January 2016
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 information and opinions contained in this presentation have not been indepen
Slide 3: Parsortix commercialisation on track
ParsortixTM commercialisation on track Significant progress against key commercial objectives − First sales secured − FDA authorisation − Ovarian cancer clinical application Key Opinion Leaders “The Parsortix system has a unique combination of − Prostate cancer (Barts Cancer Institute) features maki
Slide 4: Precision medicine
Precision medicine Cancer Research UK: “One in two people born after 1960 in the UK will be diagnosed with some form of cancer during their lifetime.” Each patient’s cancer is different Major pharma developing more selective drugs Patient’s cancer changes over time − Colorectal cancer KRAS- Erbitux
Slide 5: Obtaining cancer cells for analysis
Obtaining cancer cells for analysis Existing approach: solid tumour biopsy Clinicians cut out part of the tumour and analyse the cancer cells − Breast cancer mastectomy or lumpectomy − Colorectal cancer colonoscopy tumour biopsy − Prostate cancer fine needle biopsy and prostatectomy Difficulty in ac
Slide 6: ANGLE's patented Parsortix system
ANGLE’s patented Parsortix system Stepped, microscale cell separators Two granted US Patents Patents pending worldwide for fluid flow and cell separation Granted patents in China, European patent expected Canada and Australia © ANGLE plc 2016 Page 6
Slide 7: Market size and drivers
Market size and drivers Total addressable market for liquid biopsy US$14 billion in the United States market alone by 2025 Four key market segments − Diagnostic screening − Therapeutic decision-making − Minimal residual disease − Post treatment monitoring Liquid biopsy comprises ctDNA and CTCs − “Wh
Slide 8: Parsortix and the advantages of CTCs for liquid biopsy
ParsortixTM and the advantages of CTCs for liquid biopsy ANGLE’s ParsortixTM system is a patented product, competitively differentiated in a $ multi-billion market ParsortixTM provides a unique product based solution where others are offering only a laboratory-service based approach ANGLE is offerin
Slide 9: Competitive differentiation in a $ multi-billion market
Competitive differentiation in a $ multi-billion market Captures High purity Able to easily Simple Captures all mesenchymal of Cell viability Technology Name Low cost harvest cells process types of cancer CTCs involved harvested (alive) for analysis in metastasis cells Microfluidic step Parsortix An
Slide 10: Path to commercialisation
Path to commercialisation KOL Concept KOL evaluation Research use Productisation translational development & refinement sales research May 11 – Apr 12 Apr 12 – May 13 Dec 11 – Oct 14 Sep 14 - Ongoing Dec 15 - Ongoing Regulatory Clinical Revenues authorisation applications CE Mark May 13 – Dec 13 Lat
Slide 11: System optimisation
System optimisation Extensive product development and system optimisation successfully completed − address operational requirements of a wide range of KOLs and beta customers Product development work completed to develop, test, optimise and document key operating protocols − enable customers to unde
Slide 12: Research use sales progress
Research use sales progress First sales for research use secured after the period end − sales to multiple customers of both Parsortix instruments and cassettes − customers include both new research users and existing KOLs − growing sales pipeline Supported by multiple third party cancer centre publi
Slide 13: FDA authorisation progress
FDA authorisation progress Seeking to be first FDA authorised system for harvesting cancer cells from blood − appointed full-time FDA experienced clinical studies director − detailed study plans have been developed and reviewed with the FDA Strategic decision to pursue FDA authorisation of the syste
Slide 14: Ovarian cancer clinical application
Ovarian cancer clinical application Medical University of Vienna Highly successful patient study Clinical application in triaging patients − 100% specificity in primary epithelial ovarian with abnormal pelvic mass cancer (no false positives) − to identify those at high risk of ovarian cancer − 78/80
Slide 15: Ovarian cancer clinical application progress
Ovarian cancer clinical application progress Simple blood test to identify ovarian cancer prior to surgery for pelvic mass Successful pilot study expanded − Medical University of Vienna 65-patient study presented at ESMO − unprecedented sensitivity and specificity in identifying ovarian cancer Devel
Slide 16: Other progress: Prostate cancer mesenchymal cells
Other progress : Prostate cancer mesenchymal cells Barts Cancer Institute CTCs harvested in 100% of patients (n=52) Barts study demonstrates Parsortix harvested cells are clinically relevant in prostate cancer Mesenchymal cells (involved in metastasis) as well as epithelial cells Clinically relevant
Slide 17: Other progress: Breast cancer metastatic biopsy comparison
Other progress: Breast cancer metastatic biopsy comparison University of Southern California Norris Comprehensive Cancer Center CTCs harvested for RNA Seq analysis in 100% of patients CTCs from Parsortix liquid biopsy had similar patterns of gene expression to the traditional biopsy of cancer cells
Slide 18: Other progress: Lung cancer out-performs other systems
Other progress: Lung cancer out-performs other systems Cancer Research UK Manchester Institute and Christie Hospital CTCs harvested 100% patients (n=12) − Parsortix harvested >5 cells from 100% of patients compared to 58% by leading competitive system Suitable for at least four days at room temperat
Slide 19: Financial Results for the six months ended October 2015
Financial Results for the six months ended 31 October 2015 Six months ended 31 October 2015 2014 Statement of Comprehensive Income £’000 £’000 Comments Operating costs (2,399) (1,578) Planned investment in Other income 12 7 product development and commercialisation Loss before tax from continuing op
Slide 20: Anticipated Newsflow
Anticipated Newsflow Sales growth − cancer drug trials leading to companion diagnostics Results from KOL patient studies − scientific publications − new clinical applications − growth in sales potential Ovarian cancer clinical study FDA authorisation Commercial collaborations − medtech − pharma © AN
Slide 21: Summary
Summary Liquid biopsy ParsortixTM patented system provides cells for precision medicine changing the paradigm in a $ billion emerging market High performance in ovarian, prostate, breast and lung cancers Growing research use sales with a clear competitive advantage CE Mark authorised. FDA authorisat
Slide 22: Contact details
Contact details Andrew Newland ANGLE plc 3 Frederick Sanger Road 3711 Market Street The Surrey Research Park University Science Center 8th floor Guildford GU2 7YD Philadelphia PA 19104 United Kingdom USA Tel: +44 1483 685830 +1 (267) 265 6761 Email: andrew.newland@ANGLEplc.com © ANGLE plc 2016 Page