Cellbxhealth Plc · LSE:CLBX
Cellbxhealth — ANGLE — Jefferies London Healthcare Conference 2022
47 slides from Cellbxhealth's conference presentation, Nov 15, 2022
Slide 1: Transforming cancer care
Transforming cancer care Jefferies London Healthcare Conference 15-17 November 2022 Andrew Newland & Ian Griffiths
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 healthcare
Slide 4: FDA clearance recognized as the gold standard
FDA clearance recognized as the gold standard First ever FDA clearance for a device to harvest INTENDED USE cancer cells from blood for subsequent analysis The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in
Slide 5: Parsortix system could address flaws in standard of care
Parsortix system could address flaws in standard of care • NCCN Guidelines recommend biopsies for all metastatic breast cancer patients (MBC) – tissue biopsies from the primary tumor are out-of-date – up-to-date information is needed to select treatment for personalized care – only samples a single
Slide 6: 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 7: Total addressable market > US $100 billion p.a.
Total addressable market > US $100 billion p.a. Current focus Medium term Longer term Detection of Therapy Assessing Remission Early cancer cancer in high selection treatment monitoring detection risk groups All cancer liquid biopsy emerging multi-US$ billion market: estimates Cowen1 $30-130 billion
Slide 8: CTCs provide the complete picture for repeat biopsies
CTCs provide the complete picture for repeat biopsies Current practice Generic lab process Patent-protected Parsortix® system product solution Tissue ctDNA CTCs CTC clusters CTC cultures Clinicians cut out part of Fragments of dead cells Intact living cancer 80x greater Cancer cells grown in the tum
Slide 9: CTCs and ctDNA analysis with a single blood draw
CTCs and ctDNA analysis with a single blood draw • Poster presented at International Society for Liquid Biopsy Congress, Miami, October 2022 • No cancer cell / CTC loss when pre-processing blood samples by centrifugation and plasma removal before Parsortix separation • Workflow opens up possibility
Slide 10: Growing body of evidence: Leveraged R&D strategy identifying new applications
Growing body of evidence Leveraged R&D strategy identifying new applications • Translational research market $50 million p.a. • FDA clearance expected to help CTC clusters CTC culturing 61 published in Parsortix become the CTC system Metastatic of choice brain cancer Biomarkers for 11 high impact jo
Slide 11: Multi-pronged commercialisation strategy
Multi-pronged commercialisation strategy Business areas Key commercialisation drivers • Regulatory clearance FDA and CE mark in • Pharma services clinical trials business and place potential for CDx fully funded business model • Clinical studies run in real world conditions • Medtech partnership see
Slide 12: Differentiated pharma services offering
Differentiated pharma services offering • Customer base established and growing – four customers secured to date, repeat business with two early customers – numerous others in discussion – anticipated to be the first significant revenue generator for ANGLE • Significant revenue and profitability pot
Slide 13: Pharma services – multi-US$bn growth opportunity in multiple cancers
Pharma services – multi-US$bn growth opportunity in multiple cancers Targeted cancer treatment Cancer type: Breast cancer Prostate cancer Ovarian cancer NSCLC ANGLE 26 publications 11 publications 3 publications supporting data: 14 publications 2 clinical trials 2 planned clinical trials 2 clinical
Slide 14: FDA product clearance provides first mover advantage
FDA product clearance provides first mover advantage Post FDA clearance momentum Professor Dr. Naoto T. Ueno MD Anderson Cancer Center • Enhanced engagement post FDA with discussions “Liquid biopsy to collect circulating live cancer cells is initiated with two medtech companies, more than an essenti
Slide 15: Sales and distribution network being established
Sales and distribution network being established • 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 quality systems – technical expertise and s
Slide 16: Real world clinical validity study: Ovarian cancer – positive headline results
Real world clinical validity 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% maintaining best in class “The next generation ANGLE pelvic mass performance tria
Slide 17: Real world clinical validity study: Prostate cancer with Solaris Health
Real world clinical validity 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
Slide 18: Products under development to drive adoption
Products under development to drive adoption • Pap staining solution • Portrait+ IF stained cells for epithelial, EMTing and mesenchymal cell identification • Portrait+ PD-L1 assessing PD-L1 status key target for immunotherapy • Portrait+ DNA damage assessing DNA damage on cells with application in
Slide 19: ANGLE positioned for commercial growth
ANGLE positioned for commercial growth • FDA clearance a major breakthrough bringing global recognition • First mover advantage in a very large market with high barriers to entry • ANGLE now in position to capitalise with multiple corporate partnerships with leading medtech and pharma companies in d
Slide 20: ANGLE plc contact addresses
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 ANGLE Biosciences Inc 50 Ronson Drive, Suite 105 Toronto Ontario M9W 1B3 Canada www.angleplc.com 20
Slide 21: Additional information
Additional information 21
Slide 22: ANGLE – in numbers
ANGLE – in numbers • 8+ years focused on development of the Parsortix system • May 2022 FDA product clearance • 26 granted patents in all major markets with coverage to 2034 • 3 extensive patent families being progressed worldwide UK clinical services laboratory • 70+ KOL peer-reviewed publications
Slide 23: Targeting large-scale pharma, medtech and clinical laboratories to drive adoption world-wide
Targeting large-scale pharma, medtech and clinical laboratories to drive adoption world-wide Large scale adoption driven by medtech and pharma Seeking to be the Stages of Commercialization industry standard Early adoption in Stage 1: Achieved ANGLE labs Engine room • Revenue Stage 2: Established and
Slide 24: Parsortix system: capturing and harvesting living cancer cells
Parsortix system: 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 Other cells can be captured: Outlet • white blood cells associated with the tumor microenviro
Slide 25: Animation showing operation of Parsortix cassette
Animation showing operation of Parsortix cassette https://www.youtube.com/watch?v=MJNkr81k2Nw © ANGLE plc 2022 25
Slide 26: Patient blood flowing in Parsortix cassette
Patient blood flowing in Parsortix cassette https://www.youtube.com/watch?v=6mLcVIoJ4Zk&t=6s © ANGLE plc 2022 26
Slide 27: Benefits of Parsortix system CTC solution
Benefits of Parsortix system CTC solution Liquid biopsy denotes analysis of cancer material obtained from blood as opposed to tissue Solid tissue biopsy Liquid biopsy Source Primary tumor Metastatic site CTCs1 ctDNA2 1. CTCs (circulating tumor cells) are live Sample type Intact cells Intact cells In
Slide 28: Parsortix - key competitive differentiation
Parsortix - key competitive differentiation Captures Captures many Easily harvests cells Harvest suitable for Cell Simple Low mesenchymal CTC FDA Serviced Technology Product Name Company Name types of cancer for downstream multiple downstream viability Product process cost CTCs involved in Clusters
Slide 29: NIH recognises proteome as critical for the future of precision medicine
NIH recognises proteome as critical for the future of precision medicine • Cancer genome atlas has transformed the development of targeted treatment, however many patients who are matched to therapy based on their DNA do not respond. For example, only 13-36% of THE head and neck cancer patients resp
Slide 30: CTC clusters: breakthrough research using Parsortix system
CTC clusters: breakthrough research using Parsortix system • Dissociation of CTC clusters in mouse model reduced metastatic spread of disease by 80x • CTC clusters incorporate MDSCs (immune suppressor cells) to avoid immune system • Repeat testing with Parsortix system may enable a new approach to c
Slide 31: Circulating Tumor Cell (CTC) clusters
Circulating Tumor Cell (CTC) clusters • Large CTC cluster of c.90 cells harvested from the peripheral blood of a metastatic breast cancer patient using ANGLE’s Parsortix system • Cluster comprises epithelial, mesenchymal and EMTing CTCs as well as white blood cells on the periphery • Clusters are kn
Slide 32: Pap stain assay
Pap stain assay • Simple, low cost CTC test designed to fit into existing pathology workflows • Utilises Pap staining process widely used for cervical smears • Test based on expertise of qualified cyto-technologist fast tracks potential use in clinical laboratories • Presented at the 100th American
Slide 33: Uniformly positive results from key opinion leaders
Uniformly positive results from key opinion leaders • Capture efficiency • Effective for both • 30x purer than a • Captured CTCs in • Parsortix system comparable to epithelial and leading antibody- twice as many results “sensational” CellSearch when mesenchymal cells based system patients as would b
Slide 34: First medtech collaboration under development with Abbott for HER-2 FISH application
First medtech collaboration under development with Abbott for HER-2 FISH application • Abbott is the global leader for FISH testing in solid tissue biopsies − FISH HER-2 to determine whether a patient should receive Herceptin (Trastuzumab) − about 1 in 5 breast cancer patients have a positive HER-2
Slide 35: Clinical management of MBC using the FDA cleared Parsortix system
Clinical management of MBC using the FDA cleared Parsortix system FDA clearance granted for metastatic breast cancer ‘Circulating Tumor Cell Transcriptomics as Biopsy Surrogates in Metastatic Breast Cancer’ published January 2022 – study first of its kind to directly compare molecular analysis of ma
Slide 36: US Ovarian cancer clinical tests c.US$1.3 billion p.a.
US Ovarian cancer clinical tests c.US$1.3 billion p.a. • 500,000 p.a. diagnosed with abnormal pelvic mass, c.200,000 surgery with c.20,000 ovarian cancer • Critical unmet medical need to ensure suspected ovarian cancer patients referred to specialist • Remission monitoring for 234,000 cancer survivo
Slide 37: Prostate cancer LDT – clinical studies initiated to address major unmet need
Prostate cancer LDT – clinical studies initiated to address major unmet need • 1 in 8 men will be diagnosed with prostate cancer – in the United States alone, estimated 270,000 new cases (2022) and 3.2 million (2019) men living with prostate cancer • 1 million prostate biopsies undertaken each year
Slide 38: Non-invasive prostate biopsy
Non-invasive prostate biopsy • Barts Cancer Institute pilot studies – CTC score plus PSA predicts clinically significant prostate cancer – mesenchymal CTCs correlated with disease burden, tumor aggressiveness, and poorer survival • Simple blood test ahead of a standard tissue biopsy test to reduce u
Slide 39: Prostate cancer aggressiveness – the key question
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 Proportion Surviving Source: Xu, L., et al. "The Novel Association of Circulating Tumor Cell
Slide 40: US prostate cancer clinical tests c.US$6.8 billion p.a.
US prostate cancer clinical tests c.US$6.8 billion p.a. • 11 million men have a PSA test in the US each year – c.1.2 million will have an abnormal result • Remission monitoring for c.2 million cancer survivors with 24%-48% risk of recurrence Reimbursement Number of Number of tests Addressable Applic
Slide 41: Growing burden of cancer in the United States
Growing burden of cancer in the United States Selected solid tumor cancers Risk of Recurrence1 (*Tested with Parsortix system = 89%) Incidence Mortality Cancer survivors • In 2022 an estimated 1.9 million new cases of Breast* 287,850 43250 3,771,795 30% cancer will be diagnosed. This is predicted to
Slide 42: Financial Results for six months ended 30 June 2022
Financial Results for six months ended 30 June 2022 Six months ended Six months ended Comments 30 June 2022 30 June 2021 Statement of Comprehensive Income £’000 £’000 • Revenue increased by Revenue 419 296 42% Cost of sales (160) (77) • Gross margin at 62% Gross profit 259 219 Operating costs (net o
Slide 43: Board
Board Non-executive Chairman Chief Executive Finance Director Non-executive director Non-executive director Garth Selvey Andrew Newland Ian Griffiths Jan Groen Brian Howlett BSc in Physics and Electronic MA Engineering from BSc Mathematics with CEO Intravacc BV Lombard Medical Engineering. Cambridge
Slide 44: Senior management 1/2
Senior management 1/2 Associate Commercial Head of R&D Head of Clinical Director Manufacturing Clinical Studies Director Director Anne-Sophie Pailhes- Laboratories and Regulatory Craig Miller Jimenez Madeline I. Repollet Martin Cooke Ghada Abuali Anne-Sophie has over 13 Madeline I. Repollet, PhD, ha
Slide 45: Senior management 2/2
Senior management 2/2 Vice President Business Development Senior Group Leader – Head of Investor Relations Deputy Finance Director Commercial Operations Director Product and Technology Andrew Holder Sinéad Armstrong Nick Claxton Michael O’Brien Development Stefan Peter Andrew Holder BSc. Nick Claxto
Slide 46: Scientific Advisers 1/2
Scientific Advisers 1/2 Dr Daniel Danila Dr George Hvichia Dr Joseph Khoury Dr Adrian Newland Dr James M Reuben Asspciate attending physician Inventor of the Parsortix Professor of Pathology and Professor of Haematology at Professor in the Department at Memorial Hospital Cancer technology trained in
Slide 47: Scientific Advisers 2/2
Scientific Advisers 2/2 Mr Greg L Shaw Dr Clive Stanway Dr Harold Swerdlow Dr Ashok Venkitaraman Consultant Urological Surgeon Former Chief Scientific Officer A freelance consultant. Director, Cancer Science at University College Hospital of CRUK’s Cancer Research Formerly: Special Projects Institut