Interim report
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RNS Number : 4550N Angle PLC 30 September 2021 For Immediate Release 30 September 2021 ANGLE plc ( " ANGLE " or " the Company " ) 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 . 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/ . Page 1 of 9