Angle PLC Announces Interim Results

• Interim Results for the six months ended 31 October 2019
• SUCCESSFUL COMPLETION OF CLINICAL AND ANALYTICAL STUDIES IN SUPPORT OF FDA CLEARANCE OF PARSORTIX SYSTEM
• OVARIAN CANCER CLINICAL VERIFICATION STUDY IN PROGRESS

GUILDFORD, SURREY / ACCESSSWIRE / January 30, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world leading liquid biopsy company, today announces its unaudited interim financial results for the six months ended 31 October 2019.

Operational Highlights

· Multi-year comprehensive clinical and analytical studies successfully completed in support of FDA clearance of the Parsortix^® system for capturing and harvesting circulating tumour cells from metastatic breast cancer patients

– Q-Submission process completed and full De Novo FDA submission in preparation, targeting Q1 CY20 submission

· Ovarian cancer clinical verification study established with leading US cancer centre. Pre-study phase completed successfully and 200 subject study initiated patient enrolment

· Over 16,000 samples processed during the period (H1 2019: 13,000) and a further six peer reviewed publications from internationally recognised cancer centres (H1 2019: two) with key developments in breast, lung, prostate, melanoma and head and neck cancers

Financial Highlights

· Revenue £0.4 million (H1 2019: £0.3 million)

· Loss for the half-year £5.3 million (H1 2019: loss £4.2 million) reflecting planned investment

·Successful fundraising from institutional investors, including significant new US institutional investors, raising gross proceeds of £18.0 million (£16.9 million net of expenses)

· Cash balance at 31 October 2019 of £20.4 million (30 April 2019: £11.0 million)

· As also announced today, ANGLE’s accounting reference date to be changed to 31 December

Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:

“Major progress was made during the period in the completion of the clinical and analytical studies to support FDA clearance of the Company’s Parsortix system in metastatic breast cancer. Following the Q-Submission meeting earlier this month with FDA, we are now progressing a full De Novo FDA Submission in Q1 CY20 with the prospect of FDA clearance in Q3 CY20, albeit the outcome and timing of the FDA regulatory decision is entirely dependent on the FDA’s review and response to the Company’s submission.

We continue to make progress in other indications with the Company’s ovarian cancer clinical verification study in progress and patient enrolment expected to be completed by the end of Q1 CY20. The aim is to have a clinically verified assay to detect ovarian cancer available for deployment as a laboratory developed test (LDT) in a clinical laboratory in CY20.

During the period, we successfully raised further growth capital, expanding our existing UK shareholder base and adding key new US investors. We have a strong platform of support to drive value and grow the business substantially in the future.”

Details of webcast

Please see https://angleplc.com/investor-relations/regulatory-news/ for details.

For further information:

For Frequently Used Terms, please see the Company’s website on http://www.angleplc.com/the-parsortix-system/glossary/

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the EU Market Abuse Regulation (596/2014). Upon the publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

These Interim Results 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 and commercialisation strategies, the uncertainties related to regulatory clearance and the acceptance of the Group’s products by customers.

CHAIRMAN’S STATEMENT

Introduction

During the period ANGLE completed clinical and analytical studies to support a De Novo FDA submission for its Parsortix^® system for capturing and harvesting circulating tumour cells from metastatic breast cancer patients.

Strong progress was also made with the Company’s ovarian cancer assay and a clinical verification study initiated patient enrolment during the period.

Meanwhile ANGLE’s collaborators and customers continued to demonstrate Parsortix’s versatility in cancer translational research developing important new applications. This work generated six new publications during the period increasing the body of peer-reviewed evidence supporting the platform.

Overview of Financial Results

Revenue of £0.4 million (H1 2019: £0.3 million) came mainly from research use of the Parsortix system. Planned investment in studies to develop and validate the clinical application and commercial use of the Parsortix system increased, resulting in operating costs of £6.7 million (H1 2019: £5.3 million). Thus, the loss for the period increased, in line with expectations, to £5.3 million (H1 2019: £4.2 million).

The cash balance was £20.4 million at 31 October 2019 (30 April 2019: £11.0 million) and there was an R&D Tax Credit due to the Company at 31 October 2019 of £3.0 million (30 April 2019: £1.9 million). The cash position was strengthened during the period with a successful placing of new shares with institutional investors including significant new US investors in July 2019, which raised gross proceeds of £18.0 million. Proceeds net of expenses were £16.9 million.

Strategy

ANGLE has continued with its sustained focus on its four-pronged strategy for achieving widespread adoption of its Parsortix system in the emerging multi-billion dollar liquid biopsy market:

1) Completion of rigorous large-scale clinical studies run by leading cancer centres, demonstrating the effectiveness of different applications of the system in cancer patient care

2) Securing regulatory approval of the system with the emphasis on FDA clearance as the de facto global gold standard. ANGLE is seeking to be the first company ever to gain FDA clearance for a system which harvests circulating tumour cells (CTCs) from the blood of patients (initially metastatic breast cancer patients) for subsequent analysis

3) Establishing a body of published evidence from leading cancer centres showing the utility of the system through peer reviewed publications, scientific data and clinical research evidence, highlighting a wide range of potential applications

4) Establishing partnerships with large healthcare companies for market deployment and development of multiple other clinical applications incorporating the Parsortix system.

Following the successful fundraise during the period, ANGLE intends to establish an independent accredited clinical laboratory that will have the capability of offering validated clinical tests. This clinical laboratory will be used as an accelerator and demonstrator in support of the Company’s established plan for product sales of Parsortix instruments and cassettes.

Progress towards FDA clearance

ANGLE is seeking to become the first ever company to receive FDA clearance for a medical device that harvests intact circulating tumour cells from the blood of metastatic breast cancer patients for subsequent analysis.

During the period, clinical and analytical studies demonstrating the performance of the Parsortix system for the capture and harvesting of circulating tumour cells in metastatic breast cancer were completed. These studies have been technically and logistically extremely challenging, requiring over 10,000 samples to be processed with Parsortix.

The FDA clinical studies were undertaken by four of the leading US cancer centres (University of Texas MD Anderson Cancer Center, University of Rochester Wilmot Cancer Center, University of Southern California Norris Comprehensive Cancer Center, and Robert H Lurie Comprehensive Cancer Center Northwestern University).

The analytical studies demonstrated the performance of the Parsortix system in key aspects including precision and reproducibility, limits of quantification and detection, accuracy and linearity, and interferents and carryover. These studies have required resolution of numerous technical challenges to meet FDA requirements, giving ANGLE a thoroughly characterised platform and consequent competitive advantage.

On 29 October 2019, ANGLE made a substantial Q-Submission (a “pre-submission” used to request formal comment from FDA on key questions) to FDA. The Q-Submission responded to a number of questions and suggestions previously made by FDA on ANGLE’s study plans and set out headline data from both the clinical and analytical studies. ANGLE also requested FDA formally respond to a series of questions, including whether our responses to specific questions which FDA had previously raised, were acceptable. ANGLE’s intention in making this Q-Submission was to reduce the risk that the full FDA De Novo Submission might be rejected.

FDA provided a written response to the Q-Submission and held a formal face-to-face meeting with ANGLE in January to discuss their response, as announced on 22 January 2020. As a result of this meeting, ANGLE will prepare and submit a full De Novo Submission to FDA requesting clearance for the Parsortix PC1 system for capturing and harvesting circulating tumour cells from metastatic breast cancer patients.

The intention is to file with FDA in Q1 CY20 with the prospect of FDA clearance in Q3 CY20 (unchanged). The outcome and timing of the FDA regulatory decision is entirely dependent on the FDA’s review and response to the Company’s submission. US regulatory clearance by FDA is considered the global standard for approval of medical devices and diagnostics.

Large scale clinical studies

Ovarian cancer clinical application: triaging abnormal pelvic mass

During the period, following further successful optimisation of the combination of ANGLE’s Parsortix CTC system with its proprietary HyCEAD^TM Ziplex^® downstream molecular analysis process, an ovarian cancer clinical verification study was established with University of Rochester Wilmot Cancer Center.

Following the successful completion of the initial testing phase, the blinded, independently controlled 200 subject verification study of the targeted population of pelvic mass patients prior to surgery initiated patient enrolment on 29 August 2019. The study has been designed to evaluate performance of the predictive ovarian cancer detection assay developed using the results from the previous 200 subject study in a new patient cohort and is expected to complete patient enrolment in Q1 CY20 with reporting mid-year CY20.

Once the new performance data is available and, assuming comparable results to the previous study, ANGLE intends to establish this test as a laboratory developed test (LDT) in an accredited clinical laboratory setting. The test has the potential to significantly improve patient outcomes whilst at the same time reducing overall healthcare costs.

Establishing a body of published evidence

The Company’s strategy to secure research use adoption of the Parsortix system by leading cancer research centres, in order to get independent third parties driving development of new clinical applications, is working very well.

Over 90,000 samples have now been processed using the Parsortix system, with over 16,000 samples in the period (H1 2019: 13,000). There are now 26 peer-reviewed publications with six new publications announced during the period (see

https://angleplc.com/library/publications/) including:

· the University Medical Centre Hamburg-Eppendorf (UKE), demonstrating the use of Parsortix as a liquid biopsy to investigate a key immunotherapy target in lung cancer

· the Disseminated Cancer Cell Network (DCCNet), Duesseldorf, developing a single cell analysis workflow for breast cancer

· the Medical University of Vienna demonstrating the use of Parsortix for neuroendocrine analysis (corresponding to poor overall survival) in small cell lung cancer

· Queen Mary University of London’s Barts Cancer Institute demonstrating the potential for Parsortix to be used to avoid unnecessary biopsies in prostate cancer without missing clinically significant prostate cancer

· the University of Birmingham publishing a review showing key benefits of Parsortix in head and neck cancer

· the University Medical Centre Hamburg-Eppendorf (UKE), demonstrating Parsortix use in prediction and monitoring of therapy responses for melanoma patients

To date, 23 separate cancer centres from around the world have published uniformly positive reports on their use of the Parsortix system. Leading independent cancer centres throughout Europe and North America using ANGLE’s Parsortix system are working on developments in 23 different cancer types.

Progressing partnerships with large healthcare companies

Large scale deployment of the Parsortix system across numerous cancer types and application areas requires ANGLE to partner with large, global healthcare companies to take advantage of their distribution and sales channels and economic resources. Discussions are ongoing with companies in relevant fields: medtech companies, pharma companies, contract research organisations and reference laboratories (laboratories offering clinical tests). We expect to see our partnership programme accelerate once FDA clearance for the system has been achieved.

During the period, ANGLE has progressed its three key partnerships with the large healthcare companies Abbott, QIAGEN and Philips, and is continuing to seek a corporate partner to progress the use of Parsortix in non-invasive prenatal testing (NIPT).

Outlook

Major progress was made during the period in the completion of the clinical and analytical studies to support FDA clearance of the Company’s Parsortix system in metastatic breast cancer. Following the Q-Submission meeting earlier this month with FDA, we are now progressing a full De Novo FDA Submission with the prospect of FDA clearance in Q3 CY20, albeit the outcome and timing of the FDA regulatory decision is entirely dependent on the FDA’s review and response to the Company’s submission.

We continue to make progress in other indications with the Company’s ovarian cancer clinical verification study in progress and patient enrolment expected to be completed by the end of Q1 CY20. The aim is to have a clinically verified assay to detect ovarian cancer available for deployment as a laboratory developed test (LDT) in a clinical laboratory in CY20.

During the period, we successfully raised further growth capital, expanding our existing UK shareholder base and adding new US investors. We have a strong platform of support to drive value and grow the business substantially in the future.

Garth Selvey

Chairman

29 January 2020

ANGLE plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 31 OCTOBER 2019

All activity arose from continuing operations

ANGLE plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 OCTOBER 2019

ANGLE plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE SIX MONTHS ENDED 31 OCTOBER 2019

ANGLE plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 31 OCTOBER 2019

ANGLE plc

NOTES TO THE INTERIM FINANCIAL INFORMATION

FOR THE SIX MONTHS ENDED 31 OCTOBER 2019

1 Basis of preparation and accounting policies

This Condensed Interim Financial Information is the unaudited interim consolidated financial information (the “Condensed Interim Financial Information”) of ANGLE plc, a company incorporated in Great Britain and registered in England and Wales, and its subsidiaries (together referred to as the “Group”) for the six month period ended 31 October 2019 (the “interim period”).

The Condensed Interim Financial Information should be read in conjunction with the Financial Statements of the Group for the year ended 30 April 2019, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union (EU). New and revised IFRS and interpretations recently adopted by the EU and that became effective in the period did not have or are not expected to have a significant impact on the Group, with the exception of IFRS 16 Leases, the impact of which is described below. Where necessary, comparative information has been reclassified or expanded from the previously reported Condensed Interim Financial Information to take into account any presentational changes which were made in the Annual Report and Accounts to 30 April 2019 and which may be made in the Annual Report and Accounts to 31 December 2019.

The accounting policies used in the preparation of the Condensed Interim Financial Information for the six months ended 31 October 2019 are in accordance with the recognition and measurement criteria of IFRS, as adopted by the EU, and are consistent with those which will be adopted in the Financial Statements for the period ended 31 December 2019. While the Condensed Interim Financial Information has been prepared in accordance with the recognition and measurement criteria of IFRS, as adopted by the EU, these Financial Statements do not contain sufficient information to comply with IFRS.

This Condensed Interim Financial Information does not constitute statutory financial statements as defined in section 434 of the Companies Act 2006 and is unaudited and has not been reviewed. The comparative information for the six months ended 31 October 2018 is also unaudited. The comparative figures for the year ended 30 April 2019 have been extracted from the Group Financial Statements as filed with the Registrar of Companies. The report of the auditors on those accounts was unqualified and did not contain statements under sections 498(2) or (3) of the Companies Act 2006.

The Condensed Interim Financial Information was approved by the Board and authorised for issue on 30 January 2020.

Adoption of new and revised standards

IFRS 16 Leases came into effect for accounting periods commencing on or after 1 January 2019. The Group has adopted the standard and included relevant transactions in these Interim Financial Statements. The Group has not restated comparatives for the previous reporting period, as permitted under the specific transitional provisions in the standard.

The Group has recognised right-of-use assets representing its occupation rights under various property leases, and the corresponding lease liabilities representing its obligations to make lease payments over the remaining lease terms.

The effect of IFRS 16 was to recognise right-of-use assets and corresponding lease liabilities of £1.7 million at 1 May 2019 (the date of initial application). The right-of-use assets are included in Property, plant and equipment and the corresponding Lease liabilities are shown separately on the Statement of Financial Position. There is no impact on reserves as at 1 May 2019.

The impact on the Consolidated Statement of Comprehensive Income in the reporting period has been to increase the depreciation charge and reduce the leasing cost by £0.2 million, both presented within ‘Operating costs’.

Going concern

The Financial Information has been prepared on a going concern basis which assumes that the Group will be able to continue its operations for the foreseeable future.

The Directors have prepared and reviewed financial projections for the 12 month period from the date of approval of this Condensed Interim Financial Information. Based on the level of existing cash and the projected income and expenditure (the timing of some of which is at the Group’s discretion), the Directors have a reasonable expectation that the Company and Group have adequate resources to continue in business for the foreseeable future. Accordingly the going concern basis has been used in preparing the Condensed Interim Financial Information.

Critical accounting estimates and judgements

The preparation of the Condensed Interim Financial Information requires the use of estimates, assumptions and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Information and the reported amounts of revenues and expenses during the reporting period. Although these estimates, assumptions and judgements are based on the Directors’ best knowledge of the amounts, events or actions, and are believed to be reasonable, actual results ultimately may differ from those estimates.

The estimates, assumptions and judgements that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities relate to 1) the valuation and amortisation of internally generated intangible assets 2) impairment of intangible assets 3) share-based payments 4) research and development tax credit and 5) IFRS 16 recognition of right-of-use asset and lease liabilities.

2 Operating segment and revenue analysis

The Group’s principal trading activity is undertaken in relation to the commercialisation of its Parsortix cell separation system and its HyCEAD Ziplex multiplex analysis system. There are separate work streams on the Parsortix and HyCEAD Ziplex systems however the HyCEAD Ziplex system is used primarily in combination with Parsortix in the Ovarian cancer clinical application. There is significant overlap of work between the teams involved in R&D and commercial activities and as a result the Directors believe that these activities are best shown as one operating segment. All significant decisions are made by the Board of Directors with implementation of those decisions on a Group-wide basis. The Group manages all overseas R&D and commercial activities from the UK.

3 Tax

The Group undertakes research and development activities. In the UK these activities qualify for tax relief resulting in research and development tax credits.

4 Earnings/(loss) per share

The basic and diluted earnings/(loss) per share is calculated by dividing the after tax loss for the period attributable to the owners of the parent of £5.3 million (six months to 31 October 2018: loss £4.3 million, year to 30 April 2019: loss £8.9 million) by the weighted average number of shares in the period.

In accordance with IAS 33 Earnings per share 1) the “basic” weighted average number of Ordinary shares calculation excludes shares held by the Employee Share Ownership Trust (ESOT) as these are treated as treasury shares and 2) the “diluted” weighted average number of Ordinary shares calculation considers potentially dilutive Ordinary shares from instruments that could be converted. Share options are potentially dilutive where the exercise price is less than the average market price during the period. Due to the losses in the periods, share options are non-dilutive for the respective periods as adding them would have the effect of reducing the loss per share and therefore the diluted loss per share is equal to the basic loss per share.

The basic and diluted earnings/(loss) per share are based on 160,552,479 weighted average Ordinary £0.10 shares (six months to 31 October 2018: 129,580,872; year to 30 April 2019: 136,398,468).

5 Intangible assets

“Goodwill” relates to the acquisition of the assets of Axela Inc. on 1 November 2017. Goodwill is deemed to have an indefinite useful life, is carried at fair value and is reviewed for impairment annually or more frequently if events or changes in circumstances indicate a potential impairment.

6 Share capital

The Company has one class of Ordinary shares which carry no right to fixed income and at 31 October 2019 had 172,754,816 Ordinary shares of £0.10 each allotted, called up and fully paid.

During the period the Company issued 29,268,294 new Ordinary shares with a nominal value of £0.10 at an issue price of £0.615 per share in a subscription of shares realising gross proceeds of £18.0 million. Shares were admitted to trading on AIM in July 2019.

7 Post reporting date events

As explained in the Chairman’s Statement, subsequent to the reporting date the Company has made continued strong progress with Parsortix and made further announcements in relation to FDA clearance studies progress.

Shareholder communications

The announcement is being sent to all shareholders on the register at 30 January 2020. Copies of this announcement are posted on the Company’s website www.ANGLEplc.com and are available from the Company’s registered office: 10 Nugent Road, Surrey Research Park, Guildford, Surrey, GU2 7AF.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

SOURCE: Angle PLC

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