ANGLE PLC (LON:AGL) has hailed “major progress” in its latest results as it targeted regulatory submission for its Parsortix system to the US Food and Drug Administration (FDA) in the third quarter of 2020.
Parsortix is designed to capture and harvest circulating tumour cells from metastatic breast cancer patients.
In an outlook statement accompanying results for the eight months ended December 31, 2019, the liquid biopsy specialist said its full De Novo FDA submission is in preparation so that it can be “rapidly submitted” once the remaining analytical samples needed to meet requirements identified in a meeting in January were available and analysed.
While the samples had been delayed by restrictions during the coronavirus pandemic, which had prevented the recruitment of volunteer blood donors, ANGLE said work was back in progress and the FDA submission was expected in the third quarter of the year.
The company added that it is also making progress with its ovarian cancer test, with patient enrolment expected to complete by the end of 2020 with the aim of supporting a laboratory-developed test for ovarian cancer in the new year.
In its figures for the eight months, following a change in the company’s accounting reference date to December 31 from April 30, ANGLE reported a pre-tax loss of £7.7mln compared to a £10.9mln loss for the year ended April 30, 2019, while revenues were £581,000 compared to £678,000 in the comparative period.
ANGLE also reported it had raised gross proceeds of £18mln during the year from institutional investors, including new “significant” backers in the US, and as such had ended the year with a cash balance of £18.8mln.
“During the period, we raised further growth capital, expanding our existing UK shareholder base and adding key new US investors. ANGLE has a robust balance sheet with sufficient working capital and liquidity. We remain confident about the Group's long-term prospects", said ANGLE’s non-executive chairman Garth Selvey.
Shares in ANGLE were 0.8% lower at 59p in early deals on Thursday.