Parsortix PR1 System successfully developed
Moving into regulatory authorisation and
market launch phase
Andrew Newland an...
© ANGLE plc 2013 Page 2
Legal disclaimer
The information and opinions contained in this presentation are provided as at th...
© ANGLE plc 2013 Page 3
Highly successful year
Completed the key development phase for the Parsortix
system for capturing ...
© ANGLE plc 2013
Page 4
Financial Results for the year ended 30 April 2013
2013 2012
Statement of Comprehensive Income £’0...
© ANGLE plc 2013 Page 5
Medtech capability strengthened
Brian Howlett appointed to the Board in January 2013
−more than 20...
© ANGLE plc 2013 Page 6
Patented micro-fluidic based particle separation technology
Origins in micro-electronics industry ...
© ANGLE plc 2013
Parsortix Cell Capture
Page 7
Inlet
Outlet
Patented
Separation Step
Plan View
Cross Section
Captured CTCs...
© ANGLE plc 2013 Page 8
Parsortix GEN3 Cassette successfully developed
© ANGLE plc 2013 Page 9
Parsortix PR1 Machine successfully developed
© ANGLE plc 2013 Page 10
CE Marked for electrical compliance
© ANGLE plc 2013 Page 11
Batch of PR1 Machines on Cogent Technology line
© ANGLE plc 2013 Page 12
Parsortix PR1 System set for automated harvesting
© ANGLE plc 2013 Page 13
GEN3 cassette: captured PC-3 prostate cancer cells
Lines are the Parsortix cell
separation steps
...
© ANGLE plc 2013 Page 14
System specification
Captures CTCs in cancer patient blood including epithelial,
mesenchymal and ...
© ANGLE plc 2013 Page 15
Applications under development
Presence
−Microscope slide capture device enables the morphologica...
© ANGLE plc 2013 Page 16
Colorectal cancer patient data (Source: University of Surrey)
3rd Party confirmation working well...
© ANGLE plc 2013 Page 17
Cancer Research UK’s Paterson Institute for Cancer Research
Positive evaluation
Key advantages of...
© ANGLE plc 2013 Page 18
Market entry
Major areas of current work
Regulatory compliance and documentation (complete)
ISO13...
© ANGLE plc 2013 Page 19
Moving into regulatory authorisation and market launch phase
Objectives for current financial yea...
© ANGLE plc 2013 Page 20
Andrew Newland
ANGLE plc
3 Frederick Sanger Road
The Surrey Research Park
Guildford GU2 7YD
Unite...
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ANGLE Peliminary Results 2013 31jul13

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ANGLE Peliminary Results 2013 31jul13

  1. 1. Parsortix PR1 System successfully developed Moving into regulatory authorisation and market launch phase Andrew Newland and Ian Griffiths 31 July 2013
  2. 2. © ANGLE plc 2013 Page 2 Legal disclaimer The information and opinions contained in this presentation are provided as at the date hereof and are subject to amendment (without notice), verification and completeness. This document is being supplied to you solely for your information and may not be reproduced, redistributed or passed on, directly or indirectly, to any other person or published in whole or in part for any purpose. This document is being provided to recipients on the basis that they keep confidential any information contained herein or otherwise made available, whether orally or in writing, in connection with the Company. Neither this document or any part of this document nor any copy of it may be sent to or taken into the United States of America, Canada, Australia, Japan, the Republic of South Africa or the Republic of Ireland, nor may it be distributed to, directly or indirectly, to any US person (within the meaning of regulation S promulgated under the United States Securities Act of 1933, (as amended) (the “US Securities Act”)). This document does not constitute an offer to buy or to subscribe for, or the solicitation of an offer to buy or to subscribe for securities in the Company. To the extent this document is received or used in jurisdictions outside the UK, any such recipient or user should inform themselves about and observe any applicable legal requirements. Neither this document nor any part of this document should be copied or distributed by recipients and, in particular, should not be distributed by any means, including electronic transmission, to persons with addresses in the United States of America (or any of its territories or possessions) Canada, Australia, Japan, the Republic of South Africa or the Republic of Ireland or to any citizens, residents or nationals thereof, or to any corporation, partnership or other entity created or organised under the laws thereof or in any other country outside the United Kingdom where such distribution may lead to a breach of any law or regulatory requirement. Any such distribution could result in violation of the laws of such countries. This document does not constitute or form any part of any offer or invitation or other solicitation or recommendation to purchase any securities in the Company and does not constitute or form part of a prospectus. No reliance may be placed for any purpose whatsoever on the information, representation or opinions. This document should not be considered as the giving of investment advice by the Company or any of its shareholders, directors, officers, agents, employees or advisers. Each party to whom this document is made available must make its own independent assessment of the Company after making such investigations and taking such advice as may be deemed necessary. In particular, any estimates or projections or opinions contained herein necessarily involve significant elements of subjective judgment, analysis and assumptions and each recipient should satisfy itself in relation to such matters. Neither the Company nor any other person makes any guarantee, representation or warranty, express or implied, as to the accuracy, completeness or fairness of the information and opinions contained in this document, nor does the Company accept any responsibility or liability whatsoever for any loss howsoever arising from any use of this document or its contents or otherwise arising in connection therewith. Forward-Looking Statements This presentation and the associated commentary contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve significant risks and uncertainties. These statements are based on information currently available to the Company; and actual results could differ materially from those stated or implied, due to risks and uncertainties associated with its business. Forward-looking statements include statements regarding expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “potential”, “target”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “should”, “will”, and “would” or similar words. ANGLE assumes no obligation to update the information included in this presentation, whether as a result of new information, future events or otherwise.
  3. 3. © ANGLE plc 2013 Page 3 Highly successful year Completed the key development phase for the Parsortix system for capturing circulating tumour cells (CTCs) Developed a new capability to harvest intact CTCs from patient blood for DNA analysis Parsortix system well received by research partners, University of Surrey Oncology Group and Cancer Research UK’s Paterson Institute for Cancer Research Now being evaluated by key opinion leaders in the fields of cancer diagnosis and treatment ANGLE is now focused on securing regulatory authorisation to allow it to address the multi billion pound clinical market for the treatment of cancer patients
  4. 4. © ANGLE plc 2013 Page 4 Financial Results for the year ended 30 April 2013 2013 2012 Statement of Comprehensive Income £’000 £’000 Turnover 969 1,407 Investments portfolio gain 514 (1,346) 1,483 61 Management services (976) (1,229) Operating costs (1,580) (1,666) Other income 42 125 Loss before tax (1,031) (2,709) Statement of Financial Position Investments 3,961 3,104 Trade and other receivables 453 533 Inventories 63 0 Cash 1,828 1,121 Property, plant and equipment 138 17 Intangible assets 1,080 411 Total assets 7,523 5,186 Comments Increased investment principally in Parsortix of £2.5m up from £1.7m • Operating costs £1.6m • Capitalised expenditure £0.9m Geomerics non-core investment £4.0m • Held for sale • Investment during year £0.3m • Fair value gain £0.5m Cash balance strengthened to £1.8m Net assets increased 45% to £7.5m Equity issues £3.3m
  5. 5. © ANGLE plc 2013 Page 5 Medtech capability strengthened Brian Howlett appointed to the Board in January 2013 −more than 20 years’ experience of building and managing medical device and diagnostic businesses −CEO of AIM-quoted Lombard Medical Technologies PLC from 2005 to 2010 −1999 to 2005, UK Country Leader at Boston Scientific Corporation −Since 2010, Non-Executive Chairman of two privately held medtech companies, Michelson Diagnostics Limited and Vascular Flow Technologies Limited Two world-leading Scientific Advisers appointed −Professor Adrian Newland CBE (no relation to ANGLE’s Chief Executive) Professor of Haematology at Barts Health NHS Trust and Queen Mary University of London. Director of Pathology for Barts and Clinical Director of the North East London Cancer Network −Professor Ashok Venkitaraman Ursula Zoellner Professor of Cancer Research at the University of Cambridge. Director of the Medical Research Council’s Cancer Cell Unit and Joint Director of the Medical Research Council Hutchison Cancer Research Centre
  6. 6. © ANGLE plc 2013 Page 6 Patented micro-fluidic based particle separation technology Origins in micro-electronics industry – plastics fabrication to sub-micron tolerances Separation structures with ‘step’ configurations Suspended particles flow along a series of channels whose height progressively decreases at each ‘stair-step’ Particles separated on the basis of their size and skeletal structure Parsortix Cell Separation Technology
  7. 7. © ANGLE plc 2013 Parsortix Cell Capture Page 7 Inlet Outlet Patented Separation Step Plan View Cross Section Captured CTCs White blood cells Red blood cells pass through Blood Flow
  8. 8. © ANGLE plc 2013 Page 8 Parsortix GEN3 Cassette successfully developed
  9. 9. © ANGLE plc 2013 Page 9 Parsortix PR1 Machine successfully developed
  10. 10. © ANGLE plc 2013 Page 10 CE Marked for electrical compliance
  11. 11. © ANGLE plc 2013 Page 11 Batch of PR1 Machines on Cogent Technology line
  12. 12. © ANGLE plc 2013 Page 12 Parsortix PR1 System set for automated harvesting
  13. 13. © ANGLE plc 2013 Page 13 GEN3 cassette: captured PC-3 prostate cancer cells Lines are the Parsortix cell separation steps Two outer Steps (RHS) are 20µm apart. The inner Steps are 10µm apart Large PC3 cells are shown captured on the outer Steps The PC3 cells are 15 to 25µm in diameter The image shows a clean capture without the presence of WBC or RBC In the cassette more widely, there will only be a very low level of WBC and RBC PC3 cells captured in GEN3 cassette prior to fluorescent staining Blood flow
  14. 14. © ANGLE plc 2013 Page 14 System specification Captures CTCs in cancer patient blood including epithelial, mesenchymal and clumps of cells −Runs whole blood automatically without the need for user intervention −2ml to 4ml blood is typically sufficient. System has capability to run volumes from 50µl to 50ml Works with variety of cancers including prostate, breast, colorectal, lung and renal −High capture sensitivity. Has successfully captured 9 out of 10 cultured cancer cells spiked in 8ml of whole blood −Captures intact, undamaged, viable cells Does not require the use of antibodies Simple, Effective, Affordable
  15. 15. © ANGLE plc 2013 Page 15 Applications under development Presence −Microscope slide capture device enables the morphological examination of captured cells with clear visibility of cell structure −Step separation of 20µm allows easy visual sizing of cells −Automated cell identification possible in situ within the cassette with a choice of up to 7 reagents e.g. CK18+, DAPI+ and CD45- Counting −Microscope slide format enables the user to view and count captured cells −Indication of disease status and progression Harvesting −Automated recovery of intact, undamaged, viable cells allows DNA analysis −High level of cell purity with only 10 to 100 other cells for each captured CTC Simple, Effective, Affordable
  16. 16. © ANGLE plc 2013 Page 16 Colorectal cancer patient data (Source: University of Surrey) 3rd Party confirmation working well with patient blood n=20 patient samples High positive ID of CTCs in 75% of patients – more than double CellSearch system (Sources: 1. Allard WJ, Matera J, Miller MC et al. Clin Cancer Res 2004; 10: 6897-6904 found 30% of colorectal cancer patients positive for CTCs and 2. Sastre J, Maestro ML, Puente J et al. Annals of Oncology 19: 935-938, 2008 found 36.2% colorectal cancer patients positive for CTCs.) Only 2ml blood run. Increased blood volume will lead to increased CTC capture High capture rate of up to 45 CTCs in 2ml patient blood Merged fluorescent images of colorectal CTCs on Parsortix step White blood cell next to a colorectal CTC • Red stain for nucleus (PI) identifies WBC and CTC • Green stain for cancer (CK20) • Merged red and green image identifies CTC
  17. 17. © ANGLE plc 2013 Page 17 Cancer Research UK’s Paterson Institute for Cancer Research Positive evaluation Key advantages of Parsortix system identified: −Cell marker (epitope) independent −“Plug and play” −Operationally versatile −Biomarker compatible Parsortix included in Paterson Institute’s ongoing efforts to deliver personalised medicine Use of system with mouse model −Widely used research approach with biopsied cancer cells from the patient cultured in vivo in a mouse model −Existing FDA system needs 7.5ml blood and cannot be used Automated imaging of DEP Array showing captured SCLC CTC CTC = circulating tumour cell SCLC = small cell lung cancer
  18. 18. © ANGLE plc 2013 Page 18 Market entry Major areas of current work Regulatory compliance and documentation (complete) ISO13485 quality control system Volume manufacture, supply chain and stock control Customer support and service processes including technical support systems Sales and marketing processes Sales collateral Financial control and administration: credit checks, invoicing, collection, CRM database Distribution and shipping
  19. 19. © ANGLE plc 2013 Page 19 Moving into regulatory authorisation and market launch phase Objectives for current financial year Placing the Parsortix system with Key Opinion Leaders 3rd party independent validation of the Parsortix system Selecting a manufacturing partner and establishing quality control systems Plan for regulatory authorisation for the product to be used in the clinical market CE Mark authorisation for clinical sales in the European Union Application to the FDA for authorisation for clinical sales in the United States Market entry plan for Parsortix
  20. 20. © ANGLE plc 2013 Page 20 Andrew Newland ANGLE plc 3 Frederick Sanger Road The Surrey Research Park Guildford GU2 7YD United Kingdom Tel: +44 1483 685830 Fax: +44 1483 685836 Email: andrew.newland@ANGLEplc.com Website: www.ANGLEplc.com Contact details
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