COMPANY:

ANGLE

"ANGLE plc...is pleased to announce the presentation of two posters at the San Antonio Breast Cancer Symposium (SABCS), in San Antonio, Texas, United States, between 06-10 December 2022. The studies demonstrated the successful isolation and subsequent analysis of circulating tumour cells (CTCs) from Metastatic Breast Cancer (MBC) patient blood samples using the Parsortix® PC1 Clinical System."

"ANGLE plc...announce the publication of results from a multi-centre clinical study undertaken with The University of Texas MD Anderson Cancer Center, TX, Wilmot Cancer Institute, University of Rochester, NY, Robert H Lurie Comprehensive Cancer Center, Northwestern University, IL, and Norris Comprehensive Cancer Center, University of Southern California, CA, US. The Parsortix® system was used to enrich circulating tumour cells (CTCs) from 207 patients with metastatic breast cancer (MBC) with each patient providing two blood tubes allowing for testing of multiple downstream analytical techniques."

"ANGLE plc...is pleased to announce it presented results from a proof of concept study at the International Society of Liquid Biopsy meeting in Miami, Florida on 20-22 October 2022...The results show that removal of plasma from blood samples for circulating tumour DNA (ctDNA) analysis does not impact on the number or quality of circulating tumour cells (CTCs) which can be successfully isolated from the same sample using the Parsortix® system."

"ANGLE plc...is pleased to announce it has signed a distribution agreement with Promedeus s.r.o to enable and support the roll out of the FDA cleared and CE marked Parsortix® PC1 system across the Czech Republic for its intended use in metastatic breast cancer."

"ANGLE plc...is delighted to announce 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."

"ANGLE plc...is pleased to announce that the University of Birmingham has published the results of a study undertaken in head and neck squamous cell carcinoma (HNSCC) which characterised the epithelial-mesenchymal transition (EMT) status of circulating tumour cells (CTCs)...The study used the Parsortix® system to harvest CTCs from peripheral blood samples from 20 treatment-naïve HNSCC patients at baseline prior to surgery."

"ANGLE plc...is delighted to announce that its United States clinical laboratory team presented a new poster at the 100th American Society for Clinical Pathology (ASCP) meeting in Chicago, Illinois, USA between 7-9 September 2022. The poster, which describes the novel use of Papanicolaou (Pap) staining procedures with cells harvested from blood samples using the Parsortix® system, was selected as a finalist for a prestigious Blue Ribbon award for laboratory practice by ASCP judges."

"ANGLE plc...is delighted to announce the publication of results from a clinical study undertaken in partnership with the Wilmot Cancer Institute, University of Rochester, NY, US. The Parsortix® system was utilised for cancer detection in 183 women with a pelvic mass who had a range of benign and malignant conditions. The results have been published in the respected, high impact, journal Obstetrics & Gynecology ('The Green Journal')."

"ANGLE plc...is pleased to announce details of a new separate study...The study used the Parsortix® system to harvest CTCs from whole blood samples from 46 early-stage non-small cell lung cancer (NSCLC) patients, to analyse the expression of Metabolism-Related Genes (MRGs). Use of the biomarker-independent Parsortix system also allowed the researchers to investigate the association of MRG expression with epithelial and epithelial to mesenchymal transition (EMT) markers."

"ANGLE plc...is pleased to announce that the world-class research team led by Prof. Evi Lianidou at the National and Kapodistrian University of Athens, Greece, has recently published results of a study undertaken in early-stage non-small cell lung cancer (NSCLC), which demonstrates the benefit of analysing epigenetic alterations in circulating tumour cells (CTCs) to assess patient prognosis...The researchers used the Parsortix® system to isolate CTCs from 42 early-stage NSCLC patients for DNA methylation analysis."

"ANGLE plc...announce ground-breaking research by the world-class team at the Molecular Oncology Laboratory at the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland. The study utilised the Parsortix® system to investigate the impact of sleep on the release of CTCs in preclinical models and 30 patients with breast cancer (21 with early stage and 9 with metastatic disease)...The Parsortix system provided biomarker-independent isolation and harvest of CTCs, CTC clusters and CTC-white blood cell (WBC) clusters."

"ANGLE plc...is delighted to announce that the Company has secured an additional contract with its first large-scale pharma services customer. The customer, a pharma company with numerous cancer drugs under development and revenues exceeding US$1 billion per annum, has again selected ANGLE's Parsortix® system to undertake longitudinal monitoring (i.e. before, during and after drug intervention) of patients with certain unresectable solid tumours in a new Phase Ib dose-escalation study using its investigational drug in combination with immuno-oncology agents."

"ANGLE plc ...is pleased to announce that the Edith Cowan University, Perth, Australia, has published results from a study in small cell lung cancer (SCLC) patients using the Parsortix® system. The primary aim of this study was to demonstrate the ability to evaluate the PD-L1 status of isolated circulating tumour cells (CTCs), providing an alternative sample than solid tissue in SCLC, which may help to predict response to immunotherapy."

"ANGLE plc...is pleased to announce that researchers at King's College London, UK, have published data investigating the role of invasive cellular protrusion, known as invadopodia, activity in prostate cancer, and a potential role in the formation of circulating tumour cells (CTCs). This novel finding has the potential to provide a new target, within the metastatic process, for the development of novel therapeutics in the prostate cancer setting...the researchers used ANGLE's marker-independent Parsortix® system to isolate CTCs from prostate cancer patients with a Gleason score ≥7 (medium to high grade cancer)."

"ANGLE plc...is delighted to announce it has signed a master clinical study agreement with Solaris Health Holdings, LLC (Solaris) and joinder agreements with MidLantic Urology LLC, to collaborate and conduct clinical studies in prostate cancer and as a potential route to market in the United States...Together with MidLantic Urology, ANGLE will initiate clinical studies aimed at investigating the use of the Parsortix® system for the detection of prostate cancer and prediction of its severity in patients who present with an elevated prostate specific antigen (PSA) level and/or abnormal digital rectal exam."

"ANGLE plc...is pleased to announce that a leading cancer research institute, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, has published results of work undertaken in advanced non-small cell lung cancer (NSCLC) and sarcoma patients. The institute demonstrated that the Parsortix® system could successfully isolate circulating tumour cells (CTCs) from frozen peripheral blood mononuclear cell (PBMC) samples."

"ANGLE plc...is absolutely delighted to announce that the US Food and Drug Administration (FDA) has cleared the Parsortix® system for its intended use with metastatic breast cancer (MBC) patients...This ground-breaking FDA clearance is the first ever FDA product clearance to harvest cancer cells from a patient blood sample for subsequent analysis and offers the prospect of a new era of personalised cancer care."

"ANGLE plc...is pleased to announce that Prostate Cancer UK has approved funding for a significant clinical study at Barts Cancer Institute, Queen Mary University of London. The study will investigate the use of the Parsortix® system to isolate circulating tumour cells (CTCs) as a predictor of future disease recurrence. Assessment of whether prostate cancer is likely to progress, if this can be done reliably, may have a major bearing on whether radical prostatectomy surgery is the most appropriate treatment choice...The trial is being funded by a £750,000 grant from Prostate Cancer UK and will follow 200 men with localised prostate cancer over five years."

"ANGLE plc...is pleased to announce that the Company has presented a poster showcasing the Parsortix® system at the American Association for Cancer Research Conference (AACR) 2022, held in New Orleans, United States on 8-13 April 2022...The research presented related to the use of the Parsortix system with triple negative breast cancer (TNBC) patients."

"ANGLE plc...is pleased to announce that the Molecular Oncology Laboratory at the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, has published results of work undertaken in preclinical models of metastatic breast cancer (MBC), where they have identified specific genes involved in various steps of the metastatic process...This study adds to the growing body of evidence demonstrating the ability of the Parsortix system to isolate single CTCs and CTC clusters, enabling the identification of actionable targets involved in the metastatic spread of cancer. This research has potential clinical applicability in discovering and testing, new and existing, targeted therapies."

"ANGLE plc...is pleased to announce that the University of Maryland Marlene and Stewart Greenebaum NCI Comprehensive Cancer Institute, Baltimore, Maryland, USA, has published results of work undertaken in preclinical models of triple-negative breast cancer (TNBC), showing that isolation of live circulating tumour cells (CTCs) from a simple blood draw, using the Parsortix® system, can provide rapid information on patient response to existing chemotherapy treatments that can target metastasis more effectively than tumour growth."

"ANGLE plc...announce that a leading cancer research institute, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, has published results of a study undertaken in early stage triple negative breast cancer (TNBC) patients undergoing neoadjuvant chemotherapy (NAC; chemotherapy administered before surgery)...This study demonstrates how CNA analysis of CTCs harvested by the Parsortix system, from early stage TNBC patients pre- and post-NAC treatment, has the potential to provide information on tumour evolution and identify actionable therapeutic targets that could help determine future treatment options for patients with chemotherapy-resistant disease."

"ANGLE plc...provides an update on the accreditation of its clinical laboratory in the United States to allow Parsortix® tests to be offered for patient management...The Centers for Medicare and Medicaid Services (CMS) has issued a Certificate of Registration, under the Clinical Laboratory Improvement Amendments (CLIA), to the Company's United States clinical laboratory. This is a key step towards achieving CLIA accreditation of the laboratory."

"ANGLE plc...is pleased to announce that the Edith Cowan University, Perth, Australia, has published results from a study in ovarian cancer patients using the Parsortix® system. The primary aim of this study was to demonstrate the ability to evaluate the expression of both epithelial and mesenchymal markers, as well as PD-L1 status, of circulating tumour cells (CTCs) isolated using the Parsortix system, which may help to predict whether patients will respond to immunotherapy drugs."

"ANGLE plc...is delighted to announce the publication of breakthrough research undertaken by the world-class team at the University of Southern California Norris Cancer Center. The research demonstrates the potential of circulating tumour cells (CTCs) harvested from a simple blood draw using the Company's Parsortix® system to be used as an alternative to invasive metastatic tissue biopsy for metastatic breast cancer (MBC) patients."

"ANGLE plc...provides an update on its plans for accreditation of its clinical laboratories and on its ovarian cancer study...First submissions have been made in relation to CLIA and UKAS accreditation of the Company's United States and UK clinical laboratories respectively. In the United States, these processes are in hand pending results of the ovarian cancer study evaluating the combined use of ANGLE's Parsortix® and HyCEAD™ platforms as a simple blood test to detect the presence of ovarian cancer in women with an abnormal pelvic mass, which is nearing completion."

"ANGLE plc...is pleased to announce that the world-class research team led by Prof. Evi Lianidou at the National and Kapodistrian University of Athens (Greece), has published results of a further study undertaken in non-small cell lung cancer (NSCLC) patients with...Osimertinib (AstraZeneca's Tagrisso®), which demonstrates the benefit of longitudinal analysis of epigenetic alterations in circulating tumour cells (CTCs), in addition to circulating tumour DNA (ctDNA), to assess possible drug resistance mechanisms in patients...The study used the Parsortix® system to harvest CTCs in blood samples from 42 metastatic NSCLC patients before treatment with Osimertinib and again at disease progression."

"ANGLE plc...announce the publication of new clinical research undertaken by the world-class team at the Medical University of Vienna, Austria. The study in Non-Small Cell Lung Cancer (NSCLC) patients utilised ANGLE's Parsortix® system to isolate circulating tumour cells (CTCs) for enumeration and gene expression analysis (RNA). The Parsortix system was selected by researchers for the study due to its ability to provide unbiased CTC enrichment enabling the isolation of non-epithelial cancer cells together with exceptional depletion of white blood cells, which is key for molecular analysis."

"ANGLE plc...is pleased to announce that a poster presentation showcasing the Parsortix® system was presented yesterday at the National Cancer Research Institute (NCRI) Festival, being held 8-12 November 2021. The poster showcases findings from a Barts Cancer Institute study in metastatic prostate cancer which undertook circulating tumour cell (CTC) analysis to evaluate docetaxel drug treatment response and resistance markers...This study concludes that longitudinal analysis of CTCs isolated using the Parsortix system can predict whether a patient is resistant or developing resistance to treatment with docetaxel."

"ANGLE plc...announce that the Molecular Oncology Group at the Medical University of Vienna, presented results of three studies at the 5th Advances in Circulating Tumour Cells (ACTC) conference, held 22-25 September in Kalamata, Greece...The largest study, a Phase II drug trial including 133 ovarian cancer patients, explored longitudinal gene expression of CTCs isolated using the Parsortix system in platinum-resistant patients enrolled on the GANNET53 trial over a five year period with an average four time points for each patient."

"ANGLE plc...is pleased to announce that the Health Research Institute of Santiago (IDIS), Spain, has published results of a study in patients with metastatic non-small cell lung cancer (NSCLC) undergoing treatment with the immune checkpoint inhibitor (ICI), pembrolizumab...IDIS's study was limited to investigating epithelial CTCs in patient blood and demonstrated that the Parsortix system could be used to recover CTCs from NSCLC patient blood for investigation of their PD-L1 status prior to receiving immunotherapy targeting this pathway. All patients where the Parsortix system recovered epithelial CTCs had at least some PD-L1-expressing epithelial CTCs."

"ANGLE plc...is pleased to announce that the Medical University of Innsbruck, Austria has published results from a study in metastatic prostate cancer (mPCa) patients. A key aim of this study was to demonstrate the ability to analyse gene expression in circulating tumour cells (CTCs), which may help guide treatment decision-making for a diverse range of mPCa patients with differing tumour burdens and various prior therapies...Despite the study not investigating mesenchymal CTCs...and the capture of which is a particular strength of the Parsortix system, epithelial CTCs were recovered using the Parsortix system which could then be analysed for gene expression in 80% of patients."

"ANGLE plc...is pleased to announce that the Institute of Oncology, Ljubljana, Slovenia has published favourable results from a preliminary study in metastatic breast cancer (MBC) patients. The study compared ANGLE's Parsortix® system to an alternative antibody-based approach for the isolation of circulating tumour cells (CTCs) to determine whether these systems could be integrated into routine laboratory use." "

"ANGLE plc...is delighted to announce that it has agreed a pharma services contract with another new customer for its recently established pharma services business. ANGLE has been selected to develop immunofluorescence (IF) assays using its Parsortix® system to detect two specific protein markers expressed by circulating tumour cells (CTCs) and implicated in DNA damage repair (DDR), an increasing area of focus for oncology drug development...As part of the contract, ANGLE will develop the two assays to detect the target proteins in four hard-to-treat cancers: triple negative breast cancer, prostate cancer (including metastatic and/or castration resistant), ovarian cancer (including high grade) and pancreatic cancer."

"ANGLE plc...is pleased to announce that University Medical Centre Hamburg-Eppendorf has published results of new work undertaken in patients with brain metastasis demonstrating use of ANGLE's Parsortix® system in the isolation of circulating tumour cells (CTCs). In addition, the research investigated the role of two proteins, CD74 and CD44, in the development of brain metastasis."

"ANGLE plc...has published results of a new study undertaken in non-small cell lung cancer (NSCLC) which demonstrates the benefit of analysing circulating tumour cells (CTCs), in addition to circulating tumour DNA (ctDNA), to inform treatment decisions. The aim of the study was to detect Epithelial Growth Factor Receptor (EGFR) mutations, a key target for therapy selection, in ctDNA and matched CTCs from a single blood sample. The study used the Parsortix® system to harvest CTCs in blood samples from 48 metastatic NSCLC patients, with known EGFR mutations, before treatment with a targeted therapy and again at disease progression."

"ANGLE plc...is pleased to announce that the University Hospital Ghent, Belgium has published results of research undertaken in oesophageal cancer, using ANGLE's Parsortix® system. These are the first published results in this cancer type, with the Parsortix system now validated in 24 cancer types in 28 independent cancer research centres located across 11 countries."

"ANGLE plc...is pleased to announce that a leading cancer research institute, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, has published results of new work undertaken in triple negative breast cancer (TNBC) patients. Researchers used ANGLE's Parsortix® system to isolate circulating tumour cells (CTCs) in patients with recurrent disease and analysed these concurrently with circulating tumour DNA (ctDNA, fragments of tumor derived DNA) in the blood...This study demonstrates how analysis of CTCs harvested by the Parsortix system, as a liquid biopsy, have significant potential for non-invasive, real-time monitoring of cancer patients, giving insight into druggable targets for next line therapy at disease recurrence."

"ANGLE plc…is delighted to announce that the company has secured its first large-scale pharma services contract. The customer, a pharma company with numerous cancer drugs under development and revenues exceeding US$1 billion per annum, has selected ANGLE's Parsortix® system to undertake longitudinal monitoring (i.e. before, during and after drug intervention) of patients in three separate global clinical trials in prostate cancer and other locally advanced and metastatic solid tumours. The contract is expected to be worth up to US$1.2 million over some 18 months. The work relates to a large Phase III prostate cancer study and two smaller Phase I studies. The Phase I studies, if successful, could progress to larger Phase II studies and, if successful, much larger Phase III studies."

"ANGLE plc...is pleased to announce that two poster presentations showcasing the Parsortix® system are being presented at the American Association for Cancer Research Conference (AACR) 2021, being held as a virtual meeting on 10-15 April 2021 and then 17-21 May 2021. These posters present findings from key studies undertaken as part of ANGLE's clinical development programme…The first poster, ‘Mesenchymal markers: the new avenue for circulating tumour cells detection’, reports on the performance of ANGLE's new epithelial-to-mesenchymal transition (EMT) assay to isolate and identify both epithelial and mesenchymal circulating tumor cells (CTCs) in 47 metastatic breast cancer (MBC) and 48 non-small cell lung cancer (NSCLC) patients…The second poster ‘Investigation of PD-L1 expression in circulating tumour cells isolated using the Parsortix system in metastatic lung and breast cancer patients’ showcases ANGLE's programmed death-ligand 1 (PD-L1) assay."

"ANGLE…is delighted to announce that it has completed the fitout and staffing of its clinical services laboratories in Guildford UK, and Plymouth Meeting PA, United States…Together, these laboratories will allow ANGLE to accelerate the commercial deployment of the Parsortix® system by offering services to pharmaceutical and biotech customers for use in cancer drug clinical trials and, once the laboratories are accredited and tests validated, through the provision of Laboratory Developed Tests (LDTs) for patient care…ANGLE is targeting future clinical studies for adoption of the Parsortix system and has developed service capabilities in the United Kingdom and the United States to process samples on a commercial scale as part of global pharma trials."

"ANGLE plc...announces that, following substantive review of ANGLE's FDA submission requesting De Novo clearance of the Parsortix® PC1 system, FDA has provided a written response in the form of an Additional Information Request (AIR). Receipt of an AIR was expected and is in line with typical De Novo clearance processes. ANGLE is confident of being able to provide a full response to all the information requests raised...In its communication with FDA, ANGLE has been advised that, due to unprecedented allocation of resources to COVID-19 priorities, it is currently unclear how quickly FDA will be able to review ANGLE's response to the AIR once it has been submitted. Whilst there has not been a delay to date, taking into account the possibility that FDA processes are delayed, it is now more likely that FDA clearance, if granted, would occur in the second half of 2021 rather than the previous guidance of the 'earliest prospect of FDA clearance being Q2 CY21.'"