Angle Regulatory News (AGL)

ANGLE plc ("the Company")

ANGLE'S OVARIAN CANCER RISK ASSESSMENT ACHIEVES THE HIGHEST SENSITIVITY AND SPECIFICITY FOR PREDICTING CANCER

Detailed results of 200 patient study presented at the world's leading gynecologic oncology conference

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that detailed results from its US pelvic mass study (ANG-003) have been presented at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in New Orleans. The results follow the publication of headline data from the ANG-003 study on 4 July 2017.

Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute presented results from the 200 patient prospective study examining the use of ANGLE's Pelvic Mass Triage (PMT) test in combination with multiple serum markers to predict cancer in women with a pelvic mass or ovarian cyst. The predictive assay combines the expression levels of 9 different genes and 4 different serum markers, to detect ovarian cancer in women having surgery for an abnormal pelvic mass. The results from the pilot trial demonstrated a correct prediction of cancer with an ROC-AUC1 of 95.1% for the predictive assay. The novel test utilising gene analysis and serum biomarkers achieved higher sensitivity and specificity than any other test available for the same application.

Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, commented:

"The 200 patient ANG-003 clinical study shows that the next generation ANGLE PMT test has the ability to out-perform current clinical practice in accurately discriminating malignant from benign pelvic masses prior to biopsy or surgery. The improved accuracy of the test results in a high level of sensitivity as well as a substantial reduction in false positives. The test also offers key additional benefits over existing practice through the gene expression information it provides, which may help to further guide choices for targeted therapy in women with ovarian cancer."

The area under the receiver operating characteristic curve (ROC-AUC)1 evaluating the ability of the ANGLE PMT test to differentiate between benign disease and cancer was 95.1%, a level which is considered "Excellent". These results demonstrate the potential for the PMT blood test to substantially out-perform current tests in discriminating between benign and malignant pelvic masses.

The PMT test is in the process of optimisation, with the goal of further improving the assay's performance and potentially removing the need for the serum marker testing results for the assay. The PMT test offers both high sensitivity (correctly identifying cancer) and high specificity (correctly identifying benign).

ANGLE's PMT blood test has the potential to assist in the diagnosis of ovarian cancer prior to a patient undergoing a biopsy or surgery. This will enable women with ovarian cancer to be referred to gynaecologic oncology surgeons and institutions that specialise in the care of women with ovarian cancer, giving them the best possible outcome for the treatment of their disease. At the same time, it will allow patients with a benign tumour to be cared for in their communities and where appropriate to receive minimally invasive surgery. This has the potential to reduce healthcare costs and avoid the unnecessary transfer of patients from their local hospital to specialist referral centres. The test also has the potential to identify gene targets on the tumour that may be used to inform treatment strategies.

The test utilises information from RNA based markers that could not be obtained from analysis of ctDNA (circulating tumor DNA).

Approximately 5 to 10% of women will be diagnosed with a pelvic mass during their lifetime, with 13 to 21% of these women being subsequently diagnosed with ovarian cancer.

Combining its new downstream technology the Ziplex® system with its existing CTC harvesting technology the ParsortixTM system allows ANGLE to capture a larger part of the value chain. ANGLE estimates that the market size for its combined PMT test for this clinical application alone is worth US$1 billion per annum.

Once optimisation of the PMT Test is completed, the next step will be to evaluate performance in a study utilising a separate set of patients.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The results presented at SGO are a major endorsement for ANGLE. The excellent performance of ANGLE's Parsortix system in this large scale clinical study for the detection of ovarian cancer demonstrates the capability of ANGLE's CTC system to out-perform current approaches for the detection of ovarian cancer. ANGLE is now working to bring this clinical application to the market. This study is an exemplar of the level of accuracy that can be achieved with the Parsortix liquid biopsy tests as we simultaneously progress applications in metastatic breast cancer and prostate cancer."

For further information ANGLE:

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

1. The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the y-axis at each possible threshold for a test's results, is a measure of the test's accuracy. The accuracy of the test depends on how well the test separates the two groups being tested into those with the outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Source: University of Cambridge MRC Unit http://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc

About Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute https://www.urmc.rochester.edu/people/29638888-richard-g-moore

Dr. Moore comes to UR Medicine from Brown University and Women & Infants Hospital of Rhode Island. A native of Montreal, Quebec, Canada, Dr. Moore graduated from the University of Alberta Medical School in Edmonton. He completed his residency at Eastern Virginia Graduate School of Medicine, where he also served as Administrative Chief Resident. He completed a fellowship in Gynecologic Oncology and Breast Surgery at Women & Infants Hospital/Brown University. Dr. Moore joined the faculty at Women and Infants/Brown University after leaving fellowship. He served as the Associate Director of the Program in Women's Oncology since 2009 and was the Director of the Center for Biomarkers and Emerging Technology as well as the Molecular Therapeutics laboratory.

Dr. Moore is board-certified in gynecologic oncology and is a fellow of the American College of Obstetricians and Gynecologists and a fellow of the American College of Surgeons.

In addition to his clinical interest in ovarian and endometrial cancers, Dr. Moore is recognized internationally as a leading expert on the use of biomarkers to detect ovarian cancer. He led the team that developed the Risk of Ovarian Malignancy Algorithm (ROMA), a test that is cleared for use in Europe and Asia and was recently cleared by the U.S. Food and Drug Administration to detect ovarian cancer in women who have an ovarian cyst or pelvic mass.

Dr. Moore will see patients at 125 Lattimore Road, Suite 258 and will perform surgeries at Highland Hospital, which has been awarded the Gold Seal of Approval by the Joint Commission and leads the state in the number of minimally invasive, robotic surgeries for gynecologic cancer performed each year.

About ANGLE plc www.angleplc.com

ANGLE is a world leading liquid biopsy company with sample to answer solutions. ANGLE's proven patent protected platforms include an epitope-independent circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

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, India, 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. The Parsortix system has a CE Mark for Europe and FDA clearance is in process for the United States.

ANGLE's analysis technology for proteins and nucleic acids of all types is called Ziplex® and is based on a patented flow through array technology. It provides for highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. These technologies can be combined to provide fully automated, sample to answer results in both centralised laboratory and point of use cartridge formats. It is ideal for measuring gene expression and other markers directly from Parsortix harvests.

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/