Slide 1: Transforming cancer care with a liquid biopsy based on a simple blood test
Transforming cancer care with a liquid biopsy based on a simple blood test Presentation to Biotech Showcase Andrew Newland January 2021 Analysis of circulating tumor cells (CTCs) can revolutionize cancer care addressing flaws in patient care exposed by COVID-19
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: Liquid biopsy - improving patient outcomes and reducing healthcare costs
Liquid biopsy - improving patient outcomes and reducing healthcare costs Parsortix® cassette “ANGLE’s mission is to enable personalised cancer care by providing the complete picture of the patient’s cancer from a simple blood test. Product-based solution for simple, effective, affordable repeat test
Slide 4: Leading CTC liquid biopsy solution
Leading CTC liquid biopsy solution Strong progress over the last year Why invest now? • Patent protected product-based platform drives leveraged • “Liquid biopsies have multiple applications and mark R&D approach. 36 peer-reviewed publications with 24 a mega-trend for at least the next decade” cance
Slide 5: Parsortix liquid biopsy addresses flaws in standard of care
Parsortix liquid biopsy addresses flaws in standard of care • Existing approach: solid tissue biopsy – clinicians cut out tumor and analyse the cancer cells – difficulty in accessing some tumors such as pancreatic, lung, brain, liver and bone cancers – repeat tissue biopsy problematic, expensive and
Slide 6: Total addressable market > US $100 billion p.a.
Total addressable market > US $100 billion p.a. Current focus Medium term Longer term Detection of Therapy Assessing Remission Early screening “Successful validation of our approach in future clinical studies cancer in high selection treatment monitoring for cancer could revolutionize clinical manag
Slide 7: CTCs provide the complete picture for repeat biopsies
CTCs provide the complete picture for repeat biopsies Tissue ctDNA CTCs CTC clusters CTC cultures Clinicians cut out Fragments of dead Harvest intact 80x greater Growth of cancer part of the tumor cells living cancer cells metastatic outside patient and analyse cancer (CTCs) potential in a cells Par
Slide 8: Parsortix capturing and harvesting living cancer cells
Parsortix capturing and harvesting living cancer cells Plan view Platform technology The Parsortix system harvests cancer cells from blood based on their larger size and lack of deformability. Inlet Outlet Other cells can be captured: • megakaryocytes (frequency may relate to cancer) • fetal cells f
Slide 9: Parsortix system patent protected worldwide
Parsortix® system patent protected worldwide • Stepped, microscale cell separators for fluid flow and cell separation • Manufactured under ISO 13485:2016 quality control • Scalable business with third party manufacture • 26 granted patents: United States, Europe, China, Australia, Canada, Japan, Mex
Slide 10: Animation showing operation of Parsortix cassette
Animation showing operation of Parsortix cassette © ANGLE plc 2021 10
Slide 11: Patient blood flowing in Parsortix cassette
Patient blood flowing in Parsortix cassette © ANGLE plc 2021 11
Slide 12: Growing body of evidence; leveraged R&D strategy identifying new applications
Growing body of evidence Leveraged R&D strategy identifying new applications Research use pricing Instrument Cassette • Translational research market US $50 million p.a. Price1 $50,000 $100 • FDA clearance expected to help Parsortix become the CTC system of choice Cost $15,6002 $15 Margin 69% 85% •
Slide 13: FDA substantive review in process for MBC
FDA substantive review in process for MBC Seeking first ever FDA clearance for a device to harvest Four leading US cancer centres participated cancer cells from patient blood for subsequent analysis • ahead of known competition with five years of clinical • University of Texas MD Anderson Cancer Cen
Slide 14: Prospect of FDA clearance earliest Q2 CY21
Prospect of FDA clearance earliest Q2 CY21 • FDA De Novo Submission for Class II clearance in metastatic breast cancer submitted 25 September 2020 – over 15,000 samples and 400 reports and technical documents • Q-Submission process followed to de-risk process • Successful FDA administrative review a
Slide 15: Commercial pathways open up post FDA clearance
Commercial pathways open up post FDA clearance • Existing research use only (RUO) sales to leading translational researchers is expected to accelerate with Research Pharma LDTs Clinical products FDA clearance and expand with sample-to answer solutions Leveraged R&D Large scale Laboratory Product sal
Slide 16: Clinical laboratories
Clinical laboratories Accredited clinical laboratories being established in US and UK as accelerator and demonstrator • Pharma services and initial clinical services • Offer new tests: – epithelial, EMTing, mesenchymal CTCs and clusters – ER/PR/HER2 application – PD-L1 immunotherapy – ovarian cancer
Slide 17: Pharma services immunotherapy PD-L1 testing >US $1 billion p.a. global market
Pharma services immunotherapy PD-L1 testing >US $1 billion p.a. global market Number of Addressable Addressable Price per sample Number of Number Number of repeat samples number of market per Target market PD-L1 Drug Trials (US$) patients per trial of trials patients in trials per patient samples an
Slide 18: Breast cancer clinical tests c. US $4 billion p.a. market (United States only)
Breast cancer clinical tests c. US $4 billion p.a. market (United States only) Application Reimbursement Number of Number of tests Addressable Addressable Target market potential (US$) patients p.a. (US) per patient p.a. number of tests market per entry per annum annum 1a MBC CTC harvesting (initial
Slide 19: Ovarian cancer pelvic mass triage test clinical study in progress
Ovarian cancer pelvic mass triage test clinical study in progress • 5-10% of women suffer from abnormal pelvic mass • 295,000 women diagnosed globally with ovarian cancer in 2018 • Two 200 patient studies already completed with best in class results AUC >95% accuracy achieved. Potential for high sen
Slide 20: Ovarian cancer clinical tests c. US $1.8 billion p.a. market (United States only)
Ovarian cancer clinical tests c. US $1.8 billion p.a. market (United States only) Addressable Addressable Reimbursement Number of patients Number of tests number of tests market per Target market Application potential (US$) p.a. (US) per patient p.a. per annum annum entry 1 Pelvic mass surgery triag
Slide 21: Partnership potential to enable entire industry
Partnership potential to enable entire industry Wide variety of partnerships possible due to product-based approach with: • Medtech companies to expand revenue opportunities for installed base – expand from one-off tissue biopsy to repeat liquid biopsy tests – Abbott breast cancer FISH HER2 • Pharma
Slide 22: Building on a leading position in the liquid biopsy market
Building on a leading position in the liquid biopsy market Leading cancer centres with original research and peer-reviewed publications using ANGLE’s Parsortix system (selection) • Highly differentiated solution for the emerging multi US$ billion liquid biopsy market • Prospect of FDA clearance earl
Slide 23: Please contact us directly for more information
Please contact us directly for more information on investor@angleplc.com ANGLE plc ANGLE Europe Ltd 10 Nugent Road Surrey Research Park Guildford GU2 7AF United Kingdom ANGLE North America Inc 1150 First Avenue, Suite 1010 Parkview Tower King of Prussia PA 19406 USA ANGLE Biosciences Inc 50 Ronson D