Angle Regulatory News (AGL)

ANGLE plc ("the Company")

ANGLE STRENGTHENS MANAGEMENT TEAM WITH SENIOR APPOINTMENTS

Brett Swansiger joins as Chief Commercial Officer

Karen Miller PhD joins as Chief Scientific Officer

ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid biopsy company, is delighted to announce the appointments of Brett Swansiger as Chief Commercial Officer (CCO) and Karen Miller PhD as Chief Scientific Officer (CSO). The addition of these highly skilled and experienced leaders will further enhance ANGLE's management team and support the Company in realising its commercial potential.

Brett brings over 20 years of commercial leadership, international business development, business-to-business sales and US managed care contracting experience within the molecular diagnostic and pharmaceutical industries. Most recently, Brett was CCO at DxTerity Diagnostics where he built out the commercial organisation, established new business relationships and initiated payer strategies. Brett began his life sciences career at Bristol Myers Squibb before moving into senior commercial positions at Prometheus Laboratories, Agendia Inc, and MDxHealth. Brett is based in the United States and is responsible for managing pharma and clinical services sales, building corporate partnerships globally, and for guiding US research and clinical product sales and payer engagement. He also supports the products business teams responsible for direct sales of products and sales through ANGLE's growing distributor network.

Karen has over 30 years of experience in the pharmaceutical industry with an extensive background in drug discovery and clinical development as well as in-depth knowledge of molecular analysis techniques used for cancer analysis in a wide range of indications with multiple modalities. She brings a strong network of relationships within the pharmaceutical and companion diagnostic industries. Karen was most recently CSO at Ixaka where she led research strategy, guided major projects through to the clinic and participated in partnership and licensing activities. Previous experience includes senior executive positions with Vertex Pharmaceuticals, UCB Pharma, GlaxoSmithKline and Adaptimmune. At ANGLE, Karen is responsible for external interactions with pharma customers, medtech partner companies and laboratory customers to drive the widespread adoption of the Parsortix system as well as providing overall scientific leadership for the Company.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"I am delighted to be able to welcome these two highly accomplished individuals to the ANGLE management team. Brett and Karen bring valuable skills and networks that will play a key role in helping us deliver on our strategic and commercial objectives. I look forward to working closely with them as we continue to build commercial momentum."

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For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/glossary/

Notes for editors

About ANGLE plc www.angleplc.com 

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system.

ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

Intended use

The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

The Parsortix PC1 system enables a liquid biopsy (a simple blood test) to be used to provide the circulating tumor cells from metastatic breast cancer patients to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient.

The Parsortix technology is the subject of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide.

In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe.

ANGLE has also completed three separate 200 subject clinical studies under a programme designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.4% with sensitivity of 90% and specificity of 93%. This excellent clinical result demonstrates the utility of cells harvested by the Parsortix system, which the Company believes is the "best sample" for liquid biopsy analysis as it recovers intact, living cancer cells that are involved in the progression of the disease providing prospective information.

ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 80 peer-reviewed publications and numerous publicly available posters from 35 independent cancer centres, available on our website.

ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.