GUILDFORD, SURREY / ACCESSWIRE / March 31, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, provides an update in relation to the impact of the Coronavirus (COVID-19) pandemic on its business.
ANGLE's operations and activities in the UK, Canada and the US have all been impacted by the COVID-19 pandemic and resulting Government directives. We take the health, safety and wellbeing of our staff, blood donors and the broader community very seriously. Following the UK Prime Minister's announcement on 23 March 2020 that UK citizens should only leave their homes for certain very limited purposes, we took the decision to temporarily cease operations at the ANGLE UK laboratories and offices. Throughout the medical device and diagnostic industry, the COVID-19 pandemic is severely disrupting clinical trials and research studies due to the temporary cessation of patient enrolment along with associated research activities at clinical sites. These extraordinary measures have been taken in order to allocate resources to healthcare systems and to seek to reduce the spread of COVID-19.
As a response to the domestic and global COVID-19 situation, ANGLE has implemented its business continuity plan and can provide the following update on its ongoing clinical work.
US Food and Drug Administration (FDA) Submission
ANGLE has been following its stated plan and working flat out on the FDA De Novo Submission in metastatic breast cancer for the Parsortix® system. Although this work is very near completion, there are still a small number of analytical samples to be processed, which require healthy volunteer donor blood. The Prime Minister's announcement on 23 March resulted in the immediate loss of availability of healthy volunteer blood donors, which was a key factor in our decision to temporarily close our UK laboratory.
Since the announcement by the UK Government on 23 March, the ANGLE team has investigated how the remaining analytical samples could be completed given the exceptional circumstances and/or whether the submission can be made without these components. Taking into account the current government advice and ANGLE's commitment to the safety of its staff, blood donors and the broader community, ANGLE do not feel it would be advisable or ethical to move forward with the collection of blood samples at this time. In addition, the expert advice we have received recommended that a submission without the remaining analytical studies included would have a high probability of being viewed as incomplete by the FDA, and is consequently not feasible.
We are therefore completing the full write up of the submission with the aim that within a few weeks of the current government restrictions being relaxed we will be able to reinstate healthy volunteer blood collection, process the final analytical samples and make our FDA submission. Given the current circumstances, we cannot be sure of the likely timing for these blood collections, when we might make our submission or how long the FDA will take to review our submission. The outcome and timing of any subsequent FDA regulatory decision is also entirely dependent on the FDA's review and response to the Company's submission. ANGLE will update the market once the submission to the FDA has been made.
ANGLE's ovarian cancer clinical verification study (EMBER2) is in progress, with enrolment by the University of Rochester Medical Center (URMC) Wilmot Cancer Institute, New York, USA to evaluate the use of ANGLE's combined Parsortix® and HyCEAD™ Ziplex® platforms as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass.
A positive outcome from the study will support ANGLE's plans to launch a clinical assay for the detection of ovarian cancer in women with an abnormal pelvic mass, with both high sensitivity (correctly detecting cancer) and high specificity (correctly detecting no cancer with a low false positive rate).
Unfortunately, as with all other major US cancer centres, URMC has temporarily ceased all elective surgeries, patient enrolment, and research laboratory activities to deploy resources towards the prevention and treatment of coronavirus. It is currently unknown when patient enrolment into the EMBER2 study will recommence. Consequently, the study will not now report mid-year. The timing of the US Government lifting restrictions and patient enrolment recommencing is outside of the Company's control. ANGLE will update the market once the ovarian cancer clinical verification study patient enrolment recommences.
Research use sales are currently in the establishment phase and are modest, and therefore do not have a material impact on the Company's short-term cash position, especially in light of the reduced sales and marketing costs during this period.
ANGLE is working on a number of proactive business development programmes that aim to put the Company in the strongest possible position once government restrictions are lifted. These include continued proactive efforts to establish relationships and in-house procedures to drive forward the use of the Parsortix system in contract services for pharmaceutical companies ('Pharma Services') for cancer drug trials; and the development of partnerships with major corporate partners to the benefit of both organisations.
As previously reported, ANGLE has sufficient cash for planned operations until mid-2021. As at 30 March 2020 the Company had a cash balance of £15.5 million, an R&D tax credit due from HMRC of £1.9 million and a further R&D tax credit of c. £1.5 million to be submitted after completion of the audit. Plans are being reviewed and certain expenditures may be reduced and/or deferred to extend this runway further.
Following an announcement to change the Company's year-end, ANGLE previously announced that it would be releasing its preliminary results for the eight month period to 31 December 2019 in April 2020. Under the current circumstances, the Company now plans to release its preliminary results in May, with Accounts posted to shareholders in June and the Annual General Meeting (AGM) held at the end of June or in July, which is anticipated to be a virtual AGM. Given the continued uncertainty as a result of COVID-19, the Board does not believe it appropriate to provide guidance for future financial years at this time.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
'At ANGLE we are committed to the health and well-being of our employees, our clinical study participants, and our healthy volunteer blood donors. We have taken the necessary steps to ensure the safety of all of these groups during the COVID-19 pandemic, which has led us to temporarily pause our FDA submission and ovarian cancer study. I am deeply disappointed for cancer patients and their families, our shareholders, customers, partners and staff that we are having to temporarily pause such important work, but we believe that we have no alternative.
We are fortunate to have a strong cash position and no debt so that we can work through this exceptionally challenging time.
Cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018 with an estimated 18.1 million new cases every year and some 43.8 million living with and after cancer. The need for a simple blood test alternative to tissue biopsies is being even further demonstrated in the current situation as cancer surgeries for critically important metastatic tissue biopsies are being cancelled or postponed. ANGLE offers a unique proprietary solution to address this key medical need.'
For further information:
The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.
For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen, as being a complete cell allows DNA, RNA and protein analysis, and the live cells harvested can also be cultured. The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. The Parsortix system has a CE Mark in Europe for the indicated use and submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has already undertaken two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a 200 patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (ROC-AUC) of 95.1%.
ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 30 peer-reviewed publications and numerous publicly available posters, available on our website.
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