Angle PLC Announces Preliminary Results
ANGLE plc has reported its preliminary results for the year ending December 31, 2020, highlighting significant operational and financial developments. The company made a full De Novo FDA submission for the Parsortix system aimed at capturing circulating tumor cells. Key achievements include the completion of patient enrollment for an ovarian cancer study and the signing of a large-scale contract with a pharmaceutical customer, potentially generating up to US$1.2 million in revenue. Financially, revenue increased to £0.8 million, while losses rose to £11.6 million.
- Full De Novo Submission made for FDA clearance of Parsortix system.
- First large-scale pharma services contract signed with potential revenue of up to US$1.2 million over 18 months.
- Patient enrollment completed in ovarian cancer clinical verification study with results expected in Q4 2021.
- Revenue increased to £0.8 million from £0.6 million year-on-year.
- Cash balance rose to £28.6 million from £18.8 million year-on-year.
- Loss for the year increased to £11.6 million from £7.6 million year-on-year.
- Potential delays in FDA review processes indicated in recent communications.
ANGLE plc
("ANGLE" or "the Company")
Preliminary Results for the year ended 31 December 2020
FDA SUBSTANTIVE REVIEW PROGRESSING
LAUNCH OF CLINICAL LABORATORY SERVICES
FIRST LARGE-SCALE CONTRACT WITH PHARMA CUSTOMER USING THE PARSORTIX SYSTEM IN CLINICAL TRIALS
PATIENT ENROLMENT COMPLETED IN OVARIAN CANCER CLINICAL VERIFICATION STUDY
SURREY, UK / ACCESSWIRE / April 29, 2021 / ANGLE plc (AIM: AGL OTCQX: ANPCY), a world-leading liquid biopsy company, today announces audited preliminary results for the year ended 31 December 2020.
Operational Highlights
- Full De Novo Submission made in September 2020 for US Food and Drug Administration (FDA) clearance of the Parsortix® system for capturing and harvesting circulating tumour cells from metastatic breast cancer patients
- FDA Administrative Review complete and Substantive Review in progress
- FDA Additional Information Request (AIR) received and response planned for submission in May 2021
- Ovarian cancer clinical verification study in progress with leading US cancer centre
- patient enrolment completed after the year end
- surgical procedures in progress and sample analysis in preparation
- study expected to report headline results in Q4 2021
- targeting launch as an LDT (laboratory developed test) around the end of the year
- Planning, recruitment and the development of facilities progressed during the year and, post year end, ANGLE launched clinical laboratories in the UK and United States and initiated a global pharma services business
- Post year end, first large-scale pharma services contract signed with an oncology focused pharma customer utilising the Parsortix system for longitudinal monitoring of patients in a Phase III drug trial with revenue potential of up to US
$1.2 million over 18 months - Over 22,000 samples processed during the year and a further 11 peer-reviewed publications from internationally recognised cancer centres with key developments in breast, head and neck, melanoma, non-small cell lung, prostate and renal cancers
Financial Highlights
- Revenue £0.8 million (eight months ended 31 December 2019: £0.6 million)
- Loss for the year £11.6 million reflecting planned investment (eight months ended 31 December 2019 restated: loss £7.6 million)
- Fundraising from institutional investors, including existing and new US institutional investors, raising gross proceeds of £19.6 million (£18.5 million net of expenses)
- Cash and cash equivalents and short-term deposits combined balance at 31 December 2020 of £28.6 million (31 December 2019: £18.8 million)
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
"ANGLE adapted to COVID-19 related disruption and successfully completed the work required to make the full De Novo FDA Submission for the Parsortix system. This marked a watershed moment for ANGLE in its goal to achieve the first ever FDA clearance for a system to harvest cancer cells from patient blood for subsequent analysis, initially in metastatic breast cancer. It was encouraging that FDA's Additional Information Request was received without undue delay despite the ongoing pressure on FDA resources as a result of COVID-19. Whilst recent communication with FDA indicates a potential delay to their review processes, our response, which will be comprehensive, is expected to be submitted in May 2021, with a regulatory decision from FDA anticipated during H2 2021.
Towards the end of the year, we successfully raised further capital in a fundraising that was well supported by new and existing shareholders, particularly in the United States. As planned, the funds raised supported the launch of our clinical laboratories and pharma services business and I am delighted that, post year end, ANGLE has already announced its first large-scale contract with an oncology focused pharma customer.
ANGLE is making progress with the development of its ovarian cancer detection test, which in trials to date has shown the potential to outperform current standard of care by greatly reducing the level of false positives. Patient enrolment has been completed in the pivotal clinical verification study, and headline results are expected to be reported in Q4 2021, with the aim of supporting the establishment of a laboratory developed test for ovarian cancer around the end of the year, addressing a large unmet medical need.
ANGLE continues to gather momentum and, through its new services business, has begun to accelerate commercialisation of its unique liquid biopsy platform to support personalised cancer care. I look forward to the coming year with confidence."
For further information:
ANGLE plc | +44 (0) 1483 343434 |
Andrew Newland, Chief Executive Ian Griffiths, Finance Director Andrew Holder, Head of Investor Relations | |
finnCap Ltd (NOMAD and Joint Broker) Corporate Finance - Carl Holmes, Simon Hicks, Teddy Whiley ECM - Alice Lane, Sunila de Silva | +44 (0)20 7220 0500 |
WG Partners (Joint Broker) Nigel Barnes, Nigel Birks, Andrew Craig | +44 (0) 203 705 9330 |
FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US) | +44 (0) 203 727 1000 +1 (212) 850 5624 |
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 and commercialisation strategies, the uncertainties related to regulatory clearance and the acceptance of the Group's products by customers.
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SOURCE: ANGLE plc
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