Preliminary Results for the year ended 30 April 2019.
BUILDING ON A LEADING POSITION IN THE LIQUID BIOPSY MARKET
FDA SUBMISSION ON TRACK FOLLOWING POSITIVE RESULTS FROM BREAST CANCER CLINICAL STUDY
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world leading liquid biopsy company, today announces unaudited results for the year ended 30 April 2019.
Operational Highlights
- 400 subject FDA clinical study enrolment using the Parsortix® system in metastatic breast cancer completed by four leading US cancer centres with positive primary and exploratory objectives announced post period end, a key milestone for the Company. FDA submission on track and expected early Q4 CY19
- Extensive optimisation of HyCEADTM Ziplex® molecular analysis platform successfully completed, demonstrating exceptionally high sensitivity enabling the detection and characterisation of as low as a single cancer cell
- Ovarian cancer clinical verification study established with leading US cancer centre. Pre-study phase completed successfully; 200 subject study expected to start in Q3 CY19
- Leveraged partnership strategy delivers further validation, new uses and commercial progress with key developments in circulating tumour cell clusters
- 24,000 blood samples processed during the year (2018: 19,000) and an installed base of c.200 Parsortix instruments has led to a growing body of published evidence from internationally recognised cancer centres, with a further 10 peer reviewed publications during the year (2018: 6)
Financial Highlights
- Loss for the year £8.9 million (2018: loss £7.5 million) reflecting planned investment
- Revenue and grant income £0.9 million (2018: £0.7 million)
- Cash balance at 30 April 2019 of £11.0 million (30 April 2018: £7.6 million)
- Post year end fundraising of £18.0 million (£16.9 million net of expenses)
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
“We announced the successful completion of the Company’s 400 subject FDA clinical study, with positive results after the period end, which is a key milestone for the business. Significant progress has also been made with the related analytical studies, such that ANGLE remains on course to submit its regulatory filing to the FDA during the current calendar year. Strong progress has also been made with our test for ovarian cancer in women with an abnormal pelvic mass; a 200 patient clinical verification study is expected to initiate in the third quarter, with completion expected in Q1 CY20.
The recent successful fundraise strengthens the balance sheet and provides us with a cash runway into the next phase of the Company’s development, which will include key product development activities and, for the first time, the establishment of a clinical laboratory offering Parsortix clinical tests.
We expect that the next 12 months will see several key milestones for the Company, with the prospect of FDA clearance in early CY20, and we look forward to updating the market as we progress the FDA clearance process as well as our ovarian cancer clinical verification study.”
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