ANGLE plc announced positive headline results from its ovarian cancer clinical verification study, demonstrating that a Parsortix® blood test can be used to determine if a woman is at risk of a malignant pelvic mass. Following the recent FDA clearance and CE Marking of the Parsortix PC1 system for use in metastatic breast cancer, this achievement marks another important milestone in the Company's commercialisation strategy. The study evaluated blood samples from patients diagnosed with a pelvic mass and was led by Dr Richard Moore at the University of Rochester Medical Centre, Wilmot Cancer Institute in New York, Unites States.

144 patients (48 of which were found to have a malignancy following surgery) had blood samples shipped to ANGLE's laboratory for processing and evaluation. The population of cells captured and harvested using the Parsortix system were evaluated using ANGLE's Landscape+ Ovarian assay to determine the expression levels of 164 different gene transcripts. Analysis of the data produced an algorithm for the prediction of the risk of malignancy that combines the physician's initial cancer risk assessment (benign vs.

malignant), the patient's age, and the RNA expression levels of 23 different genes. The area under the receiver operating characteristic curve (ROC-AUC) for this predictive algorithm was 95.4%, a level which is considered "Excellent"1. Employing a threshold of =40% for the risk probability (a value of between 0 - 100% that is generated by the algorithm using the patient specific inputs) resulted in a sensitivity of 90%, a specificity of 93%, a positive predictive value (PPV) of 86%, a negative predictive value (NPV) of 95%, a false positive rate (FPR) of 7%, a false negative rate (FNR) of 10%, and an accuracy of 92%. Compared to the physician's initial cancer risk assessment for this patient cohort (which had a sensitivity of 75%, a specificity of 86%, a PPV of 74%, a NPV of 87%, a FPR of 14%, a FNR of 25% and an accuracy of 83%), the predictive algorithm would significantly aid the physician in their risk assessment, and in particular, reduced both the FPR and the FNR by 50% or more.

The performance of the Parsortix Landscape+ Ovarian assay in this study was in-line with the high level of accuracy demonstrated in an earlier 200 patient multicentre clinical study reported in 2018 (ROC-AUC 95.1%) and achieved the Company's objective of best in class results with both sensitivity and specificity of 90% or greater. ANGLE believes the clinical data reported provides a clear demonstration of the value of the Parsortix harvest of circulating tumour cells as the "best sample" for subsequent analysis as a liquid biopsy. This is possible because the Parsortix system recovers intact living cancer cells in the patient blood, which contrasts with other tests based on free-floating proteins that can be upregulated for reasons other than cancer.

In contrast to ANGLE's previously reported MAGIC algorithm2, the new algorithm utilises more comprehensive gene expression information derived from blood samples shipped overnight to a central laboratory, uses a lysis buffer that does not require the separate extraction of RNA from the population of cells captured by the Parsortix system, and does not directly rely on the use of serum biomarkers. The clinical results therefore demonstrate the ability to undertake complex molecular analysis of the Parsortix harvest and confirms its suitability for use in both hospital laboratories and central laboratories requiring sample shipping. ANGLE believes that these key findings provide evidence of the potential for widespread use of the Parsortix system for molecular analysis in numerous different cancer applications adding greatly to the value of the FDA cleared Parsortix system.

Following these excellent results, ANGLE is finalising detailed plans for the commercialisation of Parsortix Landscape+ molecular assays including, but not limited to, ovarian cancer and will update the market once these are complete.