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

  • 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

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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

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Strategy

15Products

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Services

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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

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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

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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.