ANGLE PLC S/ADR - ANPCY STOCK NEWS

ANGLE plc announced its Parsortix system's capabilities showcased at the AACR 2021 conference. Two poster presentations highlighted the efficacy of new assays: one for circulating tumor cells (CTCs) detection in cancer (showing 25-38% of CTCs had mesenchymal markers), and another assessing PD-L1 status in patients, indicating potential for personalized immunotherapy. The global PD-L1 inhibitor market is projected to reach $22 billion, growing over 40% annually. ANGLE is pursuing partnerships for clinical trials and has established labs in the UK and US.

ANGLE plc (OTCQX:ANPCY) has successfully launched its clinical services laboratories in Guildford, UK, and Plymouth Meeting, PA, earlier than planned. These labs will enhance the commercialization of the Parsortix system, allowing for circulating tumor cell (CTC) analysis in cancer drug trials. With over 2,000 relevant interventional trials and 300,000 patients registered, ANGLE aims to be a key player. Both labs seek ISO15189 and CLIA accreditations, with the Ovarian Cancer Pelvic Mass Triage assay being targeted as the first Laboratory Developed Test.

ANGLE plc provides an update on its submission for FDA clearance of the Parsortix PC1 system. The FDA issued an Additional Information Request (AIR), which was anticipated and is part of the De Novo clearance process. ANGLE plans to respond by early May, with no need for new patient samples. However, due to ongoing COVID-19 priorities, FDA review times are slower, pushing expected clearance to the second half of 2021. Despite these challenges, ANGLE continues progress in establishing clinical laboratories and developing a new pharma services business.

ANGLE plc's Parsortix system is showcased as a significant advancement in monitoring non-small cell lung cancer (NSCLC) patient responses to treatment. A study from the National and Kapodistrian University of Athens demonstrated how the system can track changes in circulating tumor cell (CTC) gene expression in patients treated with Osimertinib. Notably, the study revealed that 60% of patients exhibited mesenchymal/epithelial to mesenchymal transition (EMT) biomarkers at baseline, increasing to 80% post-treatment. ANGLE aims to leverage these findings to enhance its new 'pharma services' offering, providing critical insights for cancer drug trials.

ANGLE plc (AIM:AGL) announced its interim results for the six months ending June 30, 2020, reporting revenue of £0.2 million, down from £0.4 million in H1 2019. The loss for the period remained at £4.8 million. The cash balance as of June 30, 2020, was £13.8 million, down from £18.8 million at the end of 2019. The company completed its De Novo FDA submission for the Parsortix system aimed at metastatic breast cancer, with an expected FDA clearance in Q2 2021. Post-period fundraising raised £19.6 million to support ongoing commercialization efforts.

ANGLE plc has successfully completed the FDA's administrative review for its Parsortix system, seeking clearance for use with metastatic breast cancer. The full Class II De Novo submission aims for FDA clearance potentially by Q2 CY21. This submission follows five years of development and extensive documentation. The FDA has 150 days to make a decision post-submission acceptance. ANGLE's technology has the potential to be the first of its kind to capture intact circulating tumor cells from blood for analysis, marking a significant advancement in non-invasive cancer diagnostics.

ANGLE plc (OTCQX: ANPCY) announced the grant of up to 3,000,000 Long-Term Incentive Plan (LTIP) options to executive directors and up to 4,940,000 share options to staff, contingent on performance conditions. The Remuneration Committee highlighted that these awards follow a suspension of the Annual Bonus Plan amid the COVID-19 pandemic. The LTIP aims to enhance shareholder value, with performance tied to FDA clearance for the Parsortix system and share price growth. Post-grant, total options outstanding will reach approximately 26,810,806, representing 13.0% of the issued share capital.

ANGLE plc has submitted a full Class II De Novo FDA Submission for its Parsortix system, aiming for clearance to harvest intact cancer cells from blood specifically for metastatic breast cancer patients. The Submission includes data from over 15,000 clinical samples, demonstrating the system's effectiveness in providing non-invasive, repeatable liquid biopsies. With an estimated market potential of US$2.4 billion annually for MBC, successful FDA clearance could significantly enhance ANGLE's competitive positioning in the liquid biopsy market.