TIDMAGL

RNS Number : 8326T

Angle PLC

23 July 2015

 
   23 July 2015 
 

ANGLE plc

("ANGLE" or "the Company")

Preliminary Results for the year ended 30 April 2015

HIGHLY ENCOURAGING PATIENT RESULTS IN OVARIAN CANCER

ANGLE plc (AIM: AGL OTCQX: ANPCY), the specialist medtech company with pioneering products for cancer diagnostics, today announces audited preliminary results for the year ended 30 April 2015.

Highlights

-- First clinical application for Parsortix cell separation system determined in ovarian cancer following compelling 65-patient study published by the Medical University of Vienna demonstrating high sensitivity and specificity in detecting ovarian cancer and certain other women's cancers

-- Key Opinion Leader platform strengthened with the addition of six further world-class cancer centres making a total of nine Key Opinion Leaders

-- Uniformly positive results published by five Key Opinion Leaders of performance of Parsortix system

   --     Initiation of first two corporate collaborations 

-- Commercial strategy on track with first sales for research use to commence in the current financial year

-- Intellectual property further enhanced; second US patent granted and patents granted in China and Australia

   --     Continuing investment to advance and drive adoption of Parsortix 

- Financial position strengthened following successful fundraising of GBP8.2 million net of expenses

- Loss from continuing operations of GBP3.9 million (2014: GBP2.2 million) reflecting planned investment

   -    Cash balance at 30 April 2015 of GBP8.4 million (30 April 2014: GBP3.9 million) 

Post year end highlights

-- Prostate cancer 52-patient study published by Barts Cancer Institute indicating capture of cancer cells from Parsortix liquid biopsy in 100% of patients

-- Eminent scientific advisors, Jim Reuben from MD Anderson Cancer Center and Daniel Danila from Memorial Sloan Kettering Cancer Center join Scientific Advisory Board

Garth Selvey, Chairman, commented:

"We have made strong progress advancing our strategy this year through the validation of the Parsortix cell separation system by world class cancer centres. We have identified ovarian cancer for the first clinical application for the Parsortix system following a successful patient study with the Medical University of Vienna which demonstrated Parsortix's potential to identify ovarian cancer with high sensitivity and specificity where traditional techniques fail. In the coming year, we are well funded to focus on the development of research use sales, and advance a large scale study in ovarian cancer to establish Parsortix as a diagnostic tool to enable clinicians to choose the most appropriate treatment thereby improving patient outcomes."

Details of webcast

Please see http://www.angleplc.com/investor-information/investor-centre/ for details.

For further information:

 
 ANGLE plc                                01483 685830 
 Andrew Newland, Chief Executive 
  Ian Griffiths, Finance Director 
 
 Cenkos Securities 
  Stephen Keys, Dr Christopher Golden 
  (Nominated adviser) 
  Russell Kerr, Olly Baxendale (Sales)    020 7397 8900 
 
 FTI Consulting 
  Simon Conway, Mo Noonan                  020 3727 1000 
  Kimberly Ha (US)                          001 212 850 5612 
 

These Preliminary Results may contain forward-looking statements. These statements reflect the Board's current view, are subject to a number of material risks and uncertainties and could change in the future. Factors that could cause or contribute to such changes include, but are not limited to, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development and commercialisation strategies, the uncertainties related to regulatory clearance and the acceptance of the Group's products by customers.

CHAIRMAN' S STATEMENT

Introduction

ANGLE made solid progress during the year, laying the foundations to support the future growth of the Company. It secured positive evaluations from its growing network of Key Opinion Leaders from world-class cancer centres, providing further evidence to support the use of the technology in cancer diagnosis and, following a successful patient study, determined the first clinical application for its Parsortix system in ovarian cancer. The Company has also attracted additional scientific advisors for its Scientific Advisory Board, established corporate collaborations and is set to secure first sales in the research market for Parsortix.

Results

ANGLE has completed its transformation to a specialist medtech company focused exclusively on its innovative Parsortix system providing cells for precision medicine from a simple blood test - a repeatable, non-invasive liquid biopsy. Previous activities in relation to Management services, Geomerics and, subsequent to the year end, Novocellus have been discontinued.

As planned, investment in additional studies to validate the clinical application and commercial use of Parsortix was increased, resulting in operating costs of GBP3.9 million (2014: GBP2.2 million).

The loss for the year from continuing operations correspondingly increased to GBP3.9 million (2014: GBP2.2 million).

Following a successful fundraising during the year raising GBP8.2 million net of costs, the cash balance was GBP8.4 million at 30 April 2015 (30 April 2014: GBP3.9 million).

Expansion of Key Opinion Leader platform

The Parsortix cell separation system is a platform technology that can be applied across multiple cancer indications. The system captures and harvests very rare, clinically relevant circulating tumour cells (CTCs) from patients' blood, enabling accurate diagnosis and the potential for use in precision medicine.

Endorsement of the Parsortix system by Key Opinion Leaders from world leading cancer research centres is crucial in identifying and proving clinical applications, and providing validation and credentials for potential customers.

To ensure that we garner this important endorsement across key territories and disease indications, we have established a robust core platform of Key Opinion Leaders to support the adoption of Parsortix. During the year we added six world class cancer centres to the platform in the UK, Europe and the United States making a total of nine Key Opinion Leaders working with the Parsortix system. The new Key Opinion Leaders are:

   --     Barts Cancer Institute, Queen Mary University of London (BCI) 
   --     University Medical Center Hamburg-Eppendorf (Hamburg) 
   --     University of Texas MD Anderson Cancer Center (MD Anderson) 
   --     Medical University of Vienna (Vienna) 
   --     University of Southern California Norris Comprehensive Cancer Center (USC) 
   --     Sidney Kimmel Cancer Center at Thomas Jefferson University (TJU) 

Our Key Opinion Leader platform is evaluating the adoption of the Parsortix system in multiple different cancer types including ovarian, prostate, breast, lung, colorectal and pancreatic cancers and is providing evidence to support the further development of the technology into new indications.

Five Key Opinion Leaders reported uniformly positive results from their evaluation of the Parsortix system capability to harvest cancer cells from patient blood as a liquid biopsy. Key differentiating benefits of the Parsortix system were identified, including:

   --     Ease of use 
   --     Epitope independence i.e. does not use antibodies and harvests all types of cancer cells 
   --     Easy harvest of viable cells allowing a wide range of molecular analysis 
   --     High purity of harvested cells i.e. low residual white blood cell contamination 
   --     High sensitivity and specificity 
   --     Cost efficiency 

In line with our strategy, the third party evaluation phase is now complete and the focus of our work with Key Opinion Leaders has moved to "translational research" that identifies potential indications where the system can be used to benefit patients.

Ovarian cancer determined as first clinical application

Major progress was achieved during the year as the Medical University of Vienna published patient study results demonstrating high sensitivity and specificity of the Parsortix system in detecting ovarian cancer and certain other women's cancers.

The study evaluated a total of 65 patients, comprising 42 cancer patients and 23 healthy normal volunteers. The cancer patients consisted of 24 ovarian cancer, 6 cervical cancer, 5 endometrial cancer and 7 breast cancer cases.

Currently the only way to diagnose ovarian cancer definitively is invasively through surgical investigation by means of a biopsy. Consequently there is no way to know in advance of surgery whether an abnormal pelvic mass identified by ultrasound or CT-scan is likely to be benign or malignant and thus determine the appropriate course of action. If the mass is found to be malignant, a specialist oncological surgeon is required for an operation frequently lasting more than five hours and the patient will subsequently need intensive care. However, if the mass is benign, the surgery is relatively straight forward and can be handled by a general surgeon.

In the United States alone, an estimated 200,000 women have operations to remove abnormal pelvic masses each year and of these an estimated 21,000 have ovarian cancer.

The clinical application of Parsortix would be a simple blood test prior to surgery to triage the patients between high and low risk of ovarian cancer so that they can receive appropriate treatment. Such a blood test would not only improve patient care but would also reduce healthcare costs by targeting necessary resources to those patients at high risk.

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