ANGLE Peliminary Results 2013 31jul13

Parsortix PR1 System successfully developed

Moving into regulatory authorisation and market launch phase

Andrew Newland and Ian Griffiths

31 July 2013

© 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, directlyor indirectly, to any other person or published in whole or in part for any purpose. This document is being provided to recipients onthe basis that they keep confidential any information contained herein or otherwise made available, whether orally or in writing, inconnection with the Company. Neither this document or any part of this document nor any copy of it may be sent to or taken intothe United States of America, Canada, Australia, Japan, the Republic of South Africa or the Republic of Ireland, nor may it bedistributed to, directly or indirectly, to any US person (within the meaning of regulation S promulgated under the United StatesSecurities Act of 1933, (as amended) (the “US Securities Act”)). This document does not constitute an offer to buy or to subscribefor, or the solicitation of an offer to buy or to subscribe for securities in the Company. To the extent this document is received orused in jurisdictions outside the UK, any such recipient or user should inform themselves about and observe any applicable legalrequirements. 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 anycitizens, residents or nationals thereof, or to any corporation, partnership or other entity created or organised under the laws thereofor in any other country outside the United Kingdom where such distribution may lead to a breach of any law or regulatoryrequirement. 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 purchaseany securities in the Company and does not constitute or form part of a prospectus. No reliance may be placed for any purposewhatsoever 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 independentassessment 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, analysisand 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 theaccuracy, completeness or fairness of the information and opinions contained in this document, nor does the Company accept anyresponsibility or liability whatsoever for any loss howsoever arising from any use of this document or its contents or otherwise arisingin connection therewith.

Forward-Looking StatementsThis 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 currentlyavailable to the Company; and actual results could differ materially from those stated or implied, due to risks and uncertaintiesassociated with its business. Forward-looking statements include statements regarding expectations, beliefs, intentions or strategiesregarding 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 theinformation included in this presentation, whether as a result of new information, future events or otherwise.


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

© 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


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


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

© 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


Parsortix GEN3 Cassette successfully developed


Parsortix PR1 Machine successfully developed


CE Marked for electrical compliance


Batch of PR1 Machines on Cogent Technology line


Parsortix PR1 System set for automated harvesting


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


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


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


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


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 cellSCLC = small cell lung cancer


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


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


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: [email protected]

Website: www.ANGLEplc.com

Contact details

Date post:	02-Dec-2014
Category:	Health & Medicine
Upload:	angle-plc
View:	185 times
Download:	1 times

ANGLE Peliminary Results 2013 31jul13

Health & Medicine