Slide 1: Preliminary Results for the year ended 31 December 2022
Preliminary Results for the year ended 31 December 2022 Transforming cancer care with the first FDA cleared medical device for the capture and harvest of circulating tumour cells Andrew Newland and Ian Griffiths 21 April 2023
Slide 2: Legal disclaimer
LSE AIM: AGL OTCQX: ANPCY Legal disclaimer 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: ANGLE – Transforming cancer care
ANGLE – Transforming cancer care National Cancer Institute United States: An estimated 40% of men and women will be diagnosed with cancer during their lifetime Our Mission: Enable personalized cancer care with a simple blood test to guide treatment, improving patient outcomes and reducing Parsortix®
Slide 4: 2022 Highlights
2022 Highlights A breakthrough year for ANGLE and for liquid biopsy Products Services • US FDA De Novo (Class II) medical device application • Global pharma services business gathering momentum granted • Repeat business secured from early customers • First ever FDA cleared device to harvest circulat
Slide 5: Outlook
Outlook Strong growth in 2023 and beyond • Q1 2023 revenues (unaudited) strongly ahead with both products and services progressing well • New pharma services customers such as Crescendo Biologics, repeat business from existing customers, and a growing pipeline of potential business opportunities • H
Slide 6: Financial Results for the year ended 31 December 2022
Financial Results for the year ended 31 December 2022 2022 2021 £'000 £'000 Comments: Statement of Comprehensive Income • Revenue flat but now growing strongly in Revenue 1,041 1,013 Q1 2023 Cost of sales (428) (302) Gross profit 613 711 • Gross margin 59% Operating costs - cash (19,496) (15,300) Op
Slide 7: Commercial strategy
Commercial strategy Integrated model to maximise potential Business areas Key commercialisation drivers • Regulatory clearance FDA, CE mark and UK • Product business MHRA in place – expanding existing research sales to clinical labs • Assay development to provide end-to-end – setting up distributors
Slide 8: Commercial strategy: Major market opportunities for all business areas
Commercial strategy Major market opportunities for all business areas Growth • Services: Pharma services Near term • Potential annual revenue: c £50 million (5 years) Revenue • Services: Laboratory Developed Tests Mid-term • Potential annual revenue: c £100 million (10 years) • Products: Instruments
Slide 9: Products - FDA clearance recognized as gold standard
Products - FDA clearance recognized as gold standard First ever FDA clearance for a device to harvest INTENDED USE CTCs, intact living cancer cells, from MBC patient The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood col
Slide 10: Products - harnessing KOLs to raise Parsortix profile in clinical community
Products - harnessing KOLs to raise Parsortix profile in clinical community Michael F. Press, MD, PhD Massimo Cristofanilli, MD, FACP Daniel F. Hayes, MD, FACP, FASCO James Reuben, PhD, MBA Parsortix Instruments Placed: Parsortix Instruments Purchased: Parsortix Instruments Planned: Parsortix Instru
Slide 11: Products - sales and distribution network being established
Products - sales and distribution network being established for international penetration • Direct sales team being expanded in United States and UK • Distribution partners selected for other key territories based on: – local knowledge and language – exposure to oncology markets – compliance with qu
Slide 12: Services - clinical laboratories building capacity
Services - clinical laboratories building capacity • In 2021, ANGLE opened clinical laboratories in the US and UK • ANGLE’s US Clinical Laboratory is A2LA accredited to ISO 15189 (certificate number 6569.01) • The ISO 15189 accreditation demonstrates that ANGLE’s clinical laboratory maintains global
Slide 13: Services - differentiated pharma services offering
Services - differentiated pharma services offering • Customer base established and growing – multiple customers secured, repeat business being received – new customers in 2023 and growing pipeline of others in discussion – anticipated to be the first significant revenue generator for ANGLE • Signifi
Slide 14: Content - assay development for products and services
Content - assay development for products and services Product business area Imaging Assays Molecular Assays Product kits, Immunofluorescent Molecular analysis of reagents and Clinical laboratory Distributors staining of CTCs CTCs including: protocols customers including: • Portrait Flex for • Landsc
Slide 15: Content - assay development pipeline for 2023
Content - assay development pipeline for 2023 Portrait™ PDL1 Portrait™ DDR Portrait™ HER2 Portrait™ Flex Q1 2023 Q2 2023 Q3 2023 Q4 2023 Landscape+™ RNA dPCR panels inc for ovarian and Landscape+™ EGFR prostate samples (DNA dPCR ) Landscape+™ KRAS Landscape+™ PIK3CA (DNA dPCR ) (DNA dPCR ) © ANGLE p
Slide 16: Spotlight on Portrait Flex assay
Spotlight on PortraitTM Flex assay Analytical Analytical • ANGLE has developed PortraitTM Flex, an Sensitivity Specificity immunofluorescence assay for the identification of Epithelial 99.1% 95.8% epithelial, mesenchymal and EMTing CTCs Mesenchymal 93.5% 100% • Additionally, this assay offers the po
Slide 17: Spotlight on DDR assays
Spotlight on DDR assays • Tumour progression is strongly correlated with defects in the DDR pathway which result in uncontrolled cell proliferation US$ 3.5bn estimated global market value of DDR therapeutics in 2020 • ANGLE has developed two DNA Damage Repair (DDR) immunofluorescence assays for biom
Slide 18: DDR Assay performance
DDR Assay performance • High analytical sensitivity and specificity (>90%) Patient CTCs showing Analytical Analytical diffuse and foci IF staining Sensitivity Specificity γH2AX 87% >99% pKAP1 82% 100% • Clear dose response observed Dose response of γH2AX positivity Dose response of pKAP1 positivity
Slide 19: Spotlight on Portrait PD-L1 assay
Spotlight on Portrait PD-L1 assay • Because CTCs are live, intact cancer cells, PD-L1 protein expression can be measured on CTCs (something not achievable using ctDNA) US$1.7bn • Eight independent peer-reviewed publications in 373 patients report on the PD-L1 pharma services market value assessment
Slide 20: PD-L1 assay performance
PD-L1 assay performance • High analytical sensitivity and specificity • Easy visualisation of PD-L1 positive CTCs Analytical Analytical Sensitivity Specificity (representative staining of a patient CTC cluster) PD-L1 81% 98% Merge Mesenchymal Epithelial Epithelial markers 98% 99% Mesenchymal markers
Slide 21: HER2 assay – collaboration with BioView
HER2 assay – collaboration with BioView • Breast cancer is highly heterogeneous and HER2 status can change over time • New antibody-drug conjugates (ADCs) to treat patients with low HER2 status, which cannot be assessed by FISH alone, are disrupting the HER2 market 80.2% Predicted increase in global
Slide 22: HER2 assay – proof of concept
HER2 assay – proof of concept Analytical Clinical Evaluation of HER2 amplification by HER2 FISH assay in circulating cancer cells from contrived samples previously stained with ANGLE’s Portrait Flex assay N 16 proved to be highly analytically specific: ~100% of HER2-overexpressing cancer cells showe
Slide 23: Spotlight on Landscape+ molecular assays
Spotlight on Landscape+ molecular assays • Landscape+ DNA digital PCR assay - detection of mutations (e.g. EGFR, KRAS and PIK3CA) in DNA from CTCs and ctDNA • Landscape+ RNA digital PCR assay - gene expression analysis for CTC detection and evaluation (development of panels for prostate and ovarian
Slide 24: Clinical studies supporting commercialisation
Clinical studies supporting commercialisation Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 2025 ANG-006 (EMBER): Pelvic mass – completed with transfer to molecular platform in progress Objective: Verification of Performance Targeted Enrolment: 200 patients ANG-010 (INFORM): Metast
Slide 25: Real-world clinical study: Ovarian cancer – positive headline results
Real-world clinical study Ovarian cancer – positive headline results • Excellent results in ovarian cancer with ROC-AUC 95.4% based on molecular analysis of Parsortix harvest • Sensitivity 90%, Specificity 93% for the prediction of “The next generation ANGLE pelvic malignancy, maintaining best in cl
Slide 26: Real-world clinical study: Prostate cancer in collaboration with Solaris Health
Real-world clinical study Prostate cancer in collaboration with Solaris Health Agreement signed with MidLantic Urology Study design • MidLantic Urology, affiliate of Solaris Health • 100 patients scheduled to undergo prostate Partners tissue biopsy • >500 providers across 179 locations in 9 States •
Slide 27: Near term milestones
Near term milestones • Convert pipeline into new pharma services contracts including major global pharma • Roll out of new assays in 2023 (Portrait Flex, PD-L1, and DDR) for pharma services • Launch Portrait+ product kit alongside instruments and cassettes by year end 2023 • Completion of prostate c
Slide 28: ANGLE plc contact details
ANGLE plc ANGLE Europe Ltd 10 Nugent Road Surrey Research Park Guildford GU2 7AF United Kingdom ANGLE North America Inc 5100 Campus Drive Suite 120 Plymouth Meeting PA 19462 USA www.angleplc.com 28