Angle Plc - ANPCY STOCK NEWS

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.

ANGLE plc announced notable research from the University of Basel using its Parsortix system, highlighting how intra-tumour hypoxia influences metastatic breast cancer. Circulating tumour cell (CTC) clusters, found to be significantly more likely to cause metastasis, underscore the need for further exploration of their role in cancer spread. The study suggests that therapies targeting vascularisation, like EphrinB2, could mitigate metastasis by reducing hypoxia. This research supports the Parsortix system's potential in cancer drug discovery, particularly for FDA submissions.

ANGLE plc (OTCQX:ANPCY) announced a change in major shareholder holdings. On September 7, 2020, Legal & General Group Plc crossed below a 3% threshold, down from a previous holding of 6.98%. This reduction signifies a shift in voting rights, as the number of voting rights attached to shares now reflects below 3% of the total 172,796,483 voting rights in issue. The notification highlights the continued management of shares by Legal & General, despite the reduction in direct ownership. This change is crucial for current and prospective investors tracking shareholder dynamics.