Angle PLC Announces Preliminary Results

Preliminary Results for the year ended 31 December 2021

FDA REVIEW PROGRESSING WITH RESPONSE AWAITED

CLINICAL LABORATORIES ESTABLISHED AND GLOBAL PHARMA SERVICES BUSINESS LAUNCHED

OVARIAN CANCER CLINICAL VERIFICATION STUDY ENROLMENT COMPLETED AND ANALYSIS IN PROCESS

GUILDFORD, UK / ACCESSWIRE / April 28, 2022 / ANGLE plc (AIM:AG)(OTCQX:ANPCY), a world-leading liquid biopsy company, today announces audited preliminary results for the year ended 31 December 2021.

Operational Highlights

• US Food and Drug Administration (FDA) substantive review made good progress in the year with a comprehensive response made to FDA's Additional Information Request and continued constructive and supportive dialogue with the Agency throughout
• Clinical laboratories opened in the UK and United States and global pharma services business launched
• contracts in place with three pharma and biotech customers, with two new customers onboarded post year end
• discussions continue with multiple other potential customers, including large global pharma companies
• Clinical Laboratory Improvement Amendments (CLIA) and UKAS accreditation submissions initiated in the United States and UK and, post year end, CLIA Registration Certificate awarded to United States clinical laboratory
• Ovarian cancer clinical verification study with leading United States cancer centre nearing completion
• patient enrolment completed during the year but sample analysis was delayed due to COVID-19 related disruption to supplies of key reagents
• Prostate cancer study design completed and discussions progressed with a major group of United States urology clinics, with a view to partnering in studies and providing access to a significant patient base
• Over 26,000 samples processed during the year and a further 17 peer-reviewed publications from internationally recognised cancer centres with key developments in breast, ovarian, head and neck, non-small cell lung and prostate cancers

Financial Highlights

• Revenue £1.0 million (2020: £0.8 million)
• Loss for the year £15.0 million reflecting planned investment (2020: loss £11.6 million)
• Fundraising from institutional investors, including existing and new US institutional investors, raising gross proceeds of £20.0 million (£18.9 million net of expenses)
• Cash and cash equivalents and short-term deposits combined balance at 31 December 2021 of £31.8 million (2020: £28.6 million)

Outlook

• Regular constructive dialogue continues with FDA and a regulatory response is awaited
• Reagents required to complete the ovarian cancer study analysis have been received and are being validated so that analysis of ovarian samples can be resumed and headline results from the study are anticipated mid-year ahead of potential launch of the ovarian cancer test as ANGLE's first laboratory developed test (LDT)
• The pharma services business continues to build with a total of five independent customers onboarded. Deployment of the Parsortix system in the first contracts with these customers is progressing well and two early customers have already agreed additional contracts for further clinical trials

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

"With the help of our staff, external researchers and investors, in 2021 we made good progress on all our major initiatives. We maintained the momentum on our FDA submission with additional analytical studies, launched our clinical laboratories in the United States and UK and secured our first pharma services contracts, added a further 17 peer-reviewed publications, outlined a new prostate cancer study and completed enrolment on our ovarian cancer clinical verification study.

The strong operational momentum seen in 2021 has continued into 2022. Since the start of the year, we have maintained regular and constructive dialogue with FDA on our De Novo application and our United States laboratory has been registered with CLIA and is progressing towards full accreditation. We look forward to a successful year ahead."

Details of webcast

A meeting for analysts will be held at 10:00 am BST today at the offices of Berenberg, 60 Threadneedle Street, London EC2R 8HP. A live webcast of the analyst meeting can be accessed via ANGLE's Investor Centre page, https://angleplc.com/investor-relations/regulatory-news/, with Q&A participation reserved for analysts only. Please register in advance and log on to the webcast approximately 5 minutes before 10:00 am on the day of the results. A recording of the webcast will be made available on ANGLE's website following the results meeting.

For further information:

For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/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 Preliminary 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 impact of the COVID-19 pandemic, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development, 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.

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SOURCE: ANGLE plc