Angle Regulatory News (AGL)

ANGLE plc ("the Company")

BUSINESS UPDATE HIGHLIGHTS PROGRESS WITH PARSORTIX LIQUID BIOPSY

Ovarian cancer clinical studies progressing well with patient enrolment completed. Headline data on target for reporting this quarter

MD Anderson Cancer Center signed as the lead cancer centre for the FDA clinical study and related analytical study progressing well

Parsortix user base grows and recognition of utility expands

ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is pleased to provide a business update following the close of its financial year ended 30 April 2017.

Ovarian Cancer Studies

The Company's first clinical application for Parsortix is being progressed with two clinical studies in ovarian cancer: ANG-001 in Europe (200 patients) and ANG-003 in the United States (200 patients). The Company has made good progress in these studies and patient enrolment is now complete in both. A few patients remain to have their abnormal pelvic mass surgically removed and/or the removed tissue to be analysed to confirm the presence or absence of tumour cells. The studies will then be un-blinded and an independent statistical evaluation of the predictive power of the Parsortix clinical application will be undertaken. The headline data is on track for reporting this quarter (Q2 CY17).

FDA Clearance

The Company has successfully completed fundamental aspects of the FDA analytical study and the remaining tasks are in progress. The FDA clinical study, ANG-002 in metastatic breast cancer, has passed formal Scientific Review Committee approval and The University of Texas MD Anderson Cancer Center has been signed as the lead cancer centre for analysis of the primary endpoint and one of the secondary endpoints for the study. ANGLE has engaged with IRBs (institutional review boards) at six US cancer centres to provide patient samples and to process these with Parsortix for subsequent analysis. The studies remain on track for completion by the end of CY17.

Research

Over 30,000 blood separations have now taken place with Parsortix, up from c. 15,000 at 30 April 2016. The installed base of Parsortix instruments is continuing to grow, standing at over 145 at 30 April 2017, up from c. 85 at 30 April 2016. Adoption of Parsortix into the customers' routine laboratory practice is evident from a substantial increase in revenues from cassette sales, which are up over 500% from last year. Overall revenues for the year are up over 40% and sales are expected to be c. £0.5 million for the year. Our sales team continue to focus on supporting our customers as they evaluate Parsortix in their current laboratory procedures, and we have seen a cumulative conversion rate for evaluations to sales of over 75%. However evaluations have taken longer to close than expected generally because of limitations in analytical techniques outside the Parsortix system. At present, there are a further 20 prospective customers evaluating Parsortix systems with a view to purchase. The Directors believe that the conversion rates to date and the number of institutions currently engaged point to a positive profile of growth in research use for Parsortix.

The cash position at 30 April 2017 is c. £5.5 million, which is broadly in line with plans despite having established higher inventory balances than planned and an outstanding payment due to the Company in relation to an R&D tax credit.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are continuing to make good progress against the Company's key milestones. We are delighted that the #1 ranked cancer centre in the United States, MD Anderson Cancer Center, is leading our FDA clinical study. We look forward to the results of our clinical studies in ovarian cancer as clear demonstration of the value of Parsortix in the clinical setting. Success in these clinical studies would mark a major step forward in the validation of the Parsortix technology and for ANGLE as a key participant in the rapidly growing multi-billion dollar liquid biopsy market."

For further information:

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

This announcement contains inside information.

Notes for editors

About ANGLE plc www.angleplc.com

ANGLE is a specialist medtech company commercialising a disruptive platform technology that can capture cells circulating in blood, such as cancer cells, even when they are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.

ANGLE's cell separation technology is called the ParsortixTM system and it enables a liquid biopsy (simple blood test) to be used to provide the cells of interest. Parsortix is the subject of granted patents in Europe, the United States, Canada, China, Japan and Australia and three extensive families of patents are being progressed worldwide. The system is based on a microfluidic device that captures live cells based on a combination of their size and compressibility. Parsortix has a CE Mark for Europe and FDA authorisation is in process for the United States.

ANGLE has established formal collaborations with world-class cancer centres. These Key Opinion Leaders are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. Details are available here http://www.angleplc.com/the-company/collaborators/ 

The analysis of the cells that can be harvested from patient blood with ANGLE's Parsortix system has the potential to help deliver personalised cancer care offering profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.

The global increase in cancer to a 1 in 3 lifetime incidence is set to drive a multi-billion dollar clinical market. The Parsortix system is designed to be compatible with existing major medtech analytical platforms and to act as a companion diagnostic for major pharma in helping to identify patients that will benefit from a particular drug and then monitoring the drug's effectiveness.

As well as cancer, the Parsortix technology has the potential for deployment with several other important cell types in the future.

ANGLE stock trades on the AIM market of the London Stock Exchange under the ticker symbol AGL and in New York on the OTC-QX under the ticker symbol ANPCY. For further information please visit: www.angleplc.com

About MD Anderson Cancer Center

The University of Texas MD Anderson Cancer Center has ranked No. 1 for cancer care by U.S. News & World Report's annual "Best Hospitals" rankings. Since the rankings began in 1990, MD Anderson Cancer Center has been named one of the top two cancer hospitals in the United States every year and has received the top position nine times in the last 10 years.