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Overview of Angle Plc
Angle Plc (ANPCY) is a world-class liquid biopsy company that specializes in the innovative capture and analysis of circulating tumour cells (CTCs) from a simple blood sample. Emphasizing technical precision and validated methodologies, the company has established itself in the fields of clinical oncology, research, and pharmaceutical drug development. Using its patent-protected Parsortix system and complementary diagnostic assays, Angle Plc addresses a critical need in cancer diagnostics by enabling comprehensive downstream analysis—including whole cell imaging, proteomic, genomic, and transcriptomic analyses.
Core Technologies and Business Model
At the heart of Angle Plc's operations is the Parsortix system, an innovative cell harvesting technology designed to capture intact CTCs based on their size and deformability. This method overcomes the limitations of traditional EpCAM-based enrichment techniques by preserving the morphology and viability of harvested cells. The company has further enhanced its technology portfolio with developments such as the proprietary CellKeep slide, which significantly reduces cell loss during microscopy preparation, and specialized assays including DNA Damage Response (DDR) and Androgen Receptor detection assays.
Clinical and Research Applications
Angle Plc's technology is integral to both clinical diagnostics and research-oriented environments. Its robust system facilitates the identification and characterization of rare CTCs, thereby supporting:
- Drug Development: Custom assay development and clinical trial testing enhance the precision of targeted therapies.
- Clinical Oncology: Advanced CTC profiling offers longitudinal, minimally invasive monitoring of molecular markers tied to cancer progression and treatment response.
- Pharma Services: Strategic partnerships with major pharmaceutical companies underscore the application of the Parsortix system in assessing novel cancer therapeutics, thereby enabling more efficient patient stratification.
Market Position and Competitive Landscape
Angle Plc occupies a distinctive niche within the liquid biopsy market by combining multifunctional technologies with comprehensive clinical service offerings. While there are competitors in the broader liquid biopsy and diagnostic space, Angle Plc differentiates itself through its focus on harvesting complete, intact cells rather than fragmented DNA alone. This capability underpins their growing portfolio of peer-reviewed publications and strategic collaborations that collectively enhance the company's credibility and position in the competitive landscape.
Expertise and Technological Advancements
Deep industry expertise is evident in Angle Plc's continuous innovation in assay development and technology refinement. The company has achieved several milestones, including securing intellectual property rights in major jurisdictions and demonstrating superior performance in multiple, independent clinical studies. Its pioneering work in combining CTC analysis with next generation sequencing (NGS) further reinforces its status as a key player in the advancement of liquid biopsy technology for precision oncology.
Operational Excellence
Angle Plc operates a dual business model with a focus on both diagnostic products and custom clinical services. The diagnostic product suite emphasizes high-sensitivity, patented systems and consumables, while its clinical services include assay development and standardized testing in GCP/GCLP compliant laboratories. This integrated approach allows the company to offer comprehensive solutions to research institutions, drug developers, and clinical trial sponsors globally.
Significance in the Oncological Landscape
By enabling the detailed analysis of CTCs, Angle Plc significantly contributes to the paradigm shift towards personalized and precision medicine in oncology. Its methodologies not only increase assay sensitivity but also provide a deeper understanding of cancer biology, ultimately helping to bridge the gap between laboratory research and clinical application. The company’s commitment to extracting high-quality, actionable insights from liquid biopsy samples sets it apart as an innovator in the diagnostic field.
In Summary
Angle Plc is a testament to the evolving nature of cancer diagnostics and research. With its expertise in liquid biopsy technology, particularly in the innovative capture and analysis of circulating tumour cells, the company is well-equipped to support clinical oncology, pharmaceutical research, and drug development. Its comprehensive and continually refined portfolio of diagnostic tools and clinical services provides invaluable insights for advancing personalized cancer therapy.
ANGLE plc (OTCQX:ANPCY), a leader in liquid biopsy technology, will release its preliminary results for the year ending December 31, 2020, on April 29, 2021. A virtual meeting for analysts will occur at 10:00 am BST on the same day. The Parsortix system, their flagship technology, allows for non-invasive cancer analysis and has demonstrated a high accuracy in clinical studies. ANGLE's ongoing advancements include FDA submissions for regulatory clearance and collaborations with major healthcare entities to expand its market presence.
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.