Transforming cancer care with the first FDA cleared medical device for the capture and harvest of circulating tumor cells
Annual Report and Financial Statements 31 December 2022
Introduction
We are ANGLE plc
WHO WE ARE
ANGLE plc is a world-leading liquid biopsy company that has developed the revolutionary Parsortix® PC1 Clinical System, the first ever FDA cleared* platform for harvesting CTCs (intact cancer cells) from a metastatic breast cancer patient's blood for subsequent analysis.
Our purpose
To revolutionise cancer diagnosis and treatment
Mission
To enable personalised cancer care by providing intact cancer cells as the best sample for a complete picture of the patient's cancer from a simple blood test
By enabling repeat liquid biopsies to assess cancer status, ANGLE's Parsortix® system has the potential to deliver profound improvements in clinical and health economic outcomes in the diagnosis and treatment of cancer.
Visit our website for more information at: www.angleplc.com
@parsortix
ANGLEplc
angleplcParsortix
The Annual Report and Financial Statements may contain forward- looking statements. These statements reflect the Board's current view, are subject to a number of material risks and uncertainties and could change in the future. Factors that could cause or contribute to such changes include, but are not limited to, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development activities, commercialisation strategies, the uncertainties related to clinical study outcomes and regulatory clearance, obtaining reimbursement and payor coverage, acceptance into national guidelines and the acceptance of the Group's products by customers.
Vision
To make precision medicine a reality
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Any reference to regulatory authorisations such as FDA clearance, CE marking or UK MHRA registration of the Parsortix® PC1 Clinical System shall be read in conjunction with the full intended use of the product:
The Parsortix® PC1 Clinical 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 Clinical 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.
Any other product or services offered are for research use only and not for use in diagnostic procedures.
Strategic Report
ANGLE plc Annual Report and Financial Statements 2022
01
Strategic Report
Overview | 02 |
Chairman's Statement | 04 |
Chief Executive's Statement | 06 |
Business Strategy | 10 |
Market Opportunity | 14 |
Strategy | 15 |
Strategic Aims in Action | 16 |
Key Performance Indicators | 30 |
Principal Risks and Uncertainties | 33 |
Corporate Responsibility Report | 42 |
Financial Review | 50 |
Governance
Board of Directors | 52 |
Scientific Advisory Board | 54 |
Directors' Report | 56 |
Corporate Governance Report | 59 |
Remuneration Report | 67 |
Financial Statements
Independent Auditors' Report | 71 |
Consolidated Statement of Comprehensive Income | 77 |
Consolidated Statement of Financial Position | 78 |
Consolidated Statement of Cash Flows | 79 |
Consolidated Statement of Changes in Equity | 80 |
Notes to the Consolidated Financial Statements | 81 |
Company Statement of Financial Position | 106 |
Company Statement of Cash Flows | 107 |
Company Statement of Changes in Equity | 108 |
Notes to the Company Financial Statements | 109 |
Notice of Annual General Meeting
Notice of Annual General Meeting | 112 |
General Information for Shareholders in | 118 |
respect of the Annual General Meeting |
Additional Information
Cancer, Liquid Biopsy, CTCs and the Parsortix system | 119 |
Explanation of Frequently Used Terms | 131 |
Company Information | 140 |
02 | Strategic Report |
ANGLE plc Annual Report and Financial Statements 2022 | |
OVERVIEW
ANGLE plc content highlights
04
Chairman's Statement
Hear from our Chairman on how the ground-breaking FDA product clearance for the Parsortix PC1 Clinical System in metastatic breast cancer heralds a new era for personalised cancer care.
The Group promotes a values-based corporate culture. ISO 15189* (quality) accreditation received in the year.
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Corporate Responsibility Report
Read more on how ANGLE
is committed to adopting best practice with respect to its impact on society and the environment.
* The ANGLE US laboratory ISO 15189 accreditation is specific for the CTC Pap Stain Assay.
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Financial Statements
Consolidated Statement of Comprehensive Income | 77 |
Consolidated Statement of Financial Position | 78 |
Consolidated Statement of Cash Flows | 79 |
Consolidated Statement of Changes in Equity | 80 |
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Read more on pages 42 to 49
Read more in the Financial Review on pages 50 and 51
Strategic Report
ANGLE plc Annual Report and Financial Statements 2022
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Corporate Governance Report
The Board is committed to high standards of corporate governance and adheres to the QCA Corporate Governance Code.
Read more on pages 59 to 66
03
Strategy | |
15Products | 16 |
Services | 18 |
Strategic partnerships | 19 |
Assay development: imaging solutions | 20 |
Assay development: molecular solutions | 22 |
Clinical validity studies: ovarian cancer | 24 |
Clinical studies: prostate cancer | 26 |
Translational research | 28 |
119
Learn more about cancer, liquid biopsy, CTCs and the Parsortix system
Cancer diagnostics: The challenge | 120 |
Liquid biopsy: At a glance | 121 |
Liquid biopsy: Which sample? | 122 |
Parsortix system: The solution | 124 |
Parsortix system: How it works | 126 |
Parsortix system: FDA clearance | 128 |
Parsortix system: The potential | 130 |
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Disclaimer
ANGLE plc published this content on 26 May 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2023 10:06:09 UTC.