Interim Results for the six months ended 30 June 2021
FDA Review Progressing With Response Anticipated in the Second Half of the Year
Successful Launch of Global Pharma Services Business
Ovarian Cancer Clinical Verification Study Nearing Completion
GUILDFORD, UK / ACCESSWIRE / September 30, 2021 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world leading liquid biopsy company, today announces its unaudited interim financial results for the six months ended 30 June 2021.
Operational Highlights
Substantive review by United States Food and Drug Administration (FDA) of the Parsortix® system for capturing and harvesting circulating tumour cells from metastatic breast cancer patients making good progress
comprehensive response made to FDA Additional Information Request
regulatory response anticipated in H2 2021
Global pharma services business launched with clinical laboratories opened in the UK and United States
contracts now in progress with three pharma / biotech customers
discussions ongoing with multiple other potential customers, including large global pharma companies
Ovarian cancer clinical verification study with leading United States cancer centre nearing completion
patient enrolment completed during the period and sample analysis in preparation
study expected to report headline results in Q4 2021 ahead of anticipated launch of the ovarian cancer test as ANGLE's first LDT (laboratory developed test)
Financial Highlights
Revenue for the half-year £0.3 million (H1 2020: £0.2 million)
Loss for the half-year £7.7 million (H1 2020 restated: loss £3.4 million) reflecting planned investment
Cash and cash equivalents and short-term deposits combined balance at 30 June 2021 of £21.0 million (31 December 2020: £28.6 million)
A further £20.0 million (£18.9 million net of expenses) was raised in a placing which was well supported by new and existing institutional investors in both the UK and United States. Proceeds of the placing will be used to support expansion of commercial and management infrastructure and initiation of new studies in prostate cancer
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
"ANGLE continues to make good progress in its aim to achieve the first ever FDA product clearance, the gold standard for medical devices globally, for a system to harvest cancer cells from patient blood for subsequent analysis, initially in metastatic breast cancer.
"At the beginning of June 2021, ANGLE confirmed that it had completed the work required to answer questions raised by FDA in its Additional Information Request and that a comprehensive response was submitted to FDA. Despite FDA resources being under pressure due to the COVID-19 pandemic, the FDA review is progressing, and ANGLE continues to anticipate a regulatory response from FDA during H2 2021.
"The launch of the Company's clinical laboratories and pharma services business was a key highlight of the first half and early signs of demand have been encouraging, with significant contracts already agreed including a Phase III global clinical trial in prostate cancer and the development of bespoke CTC-based assays.
"ANGLE's ovarian cancer detection test which, in trials to date, has shown the potential to out-perform the current standard of care by greatly reducing the level of false positives, is now nearing conclusion. Patient enrolment was 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, addressing a large unmet medical need.
"I was delighted that, shortly after the period end, ANGLE successfully completed fundraising of a further £20.0 million from both new and existing shareholders in both the UK and United States. The funds raised will support ANGLE's commercial plans, particularly in the United States, and enable the Company to initiate a new programme focused on prostate cancer, adding to the Company's programmes in metastatic breast cancer and ovarian cancer."
Details of webcast
A virtual meeting and webcast for analysts will be held at 10:00 am BST today. If you wish to attend, please register in advance and log on to the webcast approximately 5 minutes before 10.00 am. Details of how to attend can be accessed via https://angleplc.com/investor-relations/corporate-presentations/.
For further information ANGLE:
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
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 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.
CHAIRMAN'S STATEMENT
Following ANGLE's FDA Submission in September 2020, the progress in reviewing ANGLE's submission has been encouraging, despite the well-publicised pressures on FDA resources due to the ongoing COVID-19 pandemic. As planned, ANGLE completed the additional analytical work required to provide a comprehensive response to the Additional Information Request and FDA is now continuing its review process.
As previously reported, ANGLE made excellent progress in establishing clinical laboratories in the UK and United States, which were opened ahead of schedule. These laboratories are offering pharma services and, once accredited, will be able to offer validated clinical tests. They will be used as accelerators and demonstrators in support of the Company's established plan for product sales of Parsortix instruments and cassettes and to provide services to pharmaceutical and biotech customers running drug trials.
Initial demand for these services has been encouraging and contracts are now in progress with three different customers. Discussions are ongoing with a number of other potential customers and we are pleased with the level of interest being generated by the commercial teams in the UK and United States.
Patient enrolment for the Company's ovarian cancer assay clinical verification study was completed during the period and headline results are expected in Q4 2021. A laboratory developed test is scheduled for launch pending the results of the study and once the clinical laboratories have received accreditation.
In line with its strategy, ANGLE continues to explore potential new clinical applications for the Parsortix system and identify opportunities to develop additional assays for specific high-risk groups. To this end, ANGLE has initiated discussions with a leading group of urology clinics in the United States to assist in the design and execution of a new study in prostate cancer. We expect to update the market with further details in due course.
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