ANGLE PLC (LON:AGL, OTCQX:ANPCY) chairman Garth Selvey said the med-tech group is now making “strong progress” towards commercialising its breakthrough liquid biopsy.
ANGLE used its interim results to restate plans outlined earlier in the week as it raised £19.6mln to fund its ambitious blueprint.
The cash injection will be invested to create clinical laboratories in the US and UK and to underwrite the development of a pharma service business that will tap into the huge market potential of its Parsortix cancer cell detection technology.
Much of the work carried out in the six months ended June 30, 2020, was devoted to collating the data required for a De Novo submission to the US Food & Drug Administration for the use of Parsortix in analysing metastatic breast cancer.
The information was formally handed over to the American regulator in late September, and ANGLE said the “earliest prospect for clearance” was the second quarter of next year.
“This marked a watershed moment for ANGLE in its goal to achieve the first-ever FDA 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,” said chairman Selvey in the results statement.
Clinically, the company’s scientific team is focused on a US ovarian cancer clinical verification study with patient enrolment expected to be complete in the second three months of 2021.
Financially, ANGLE did what most R&D companies are expected to do – it burned cash and made a loss. That first-half loss was flat at £4.8mln.
More importantly, it exited the period with £13.8mln in the bank, and it added a ‘net’ £18.5mln from this week’s fundraising activities.