TIDMAGL
RNS Number : 1356I
Angle PLC
31 March 2020
For immediate release 31 March 2020
ANGLE plc ("the Company")
COVID-19 BUSINESS IMPACT UPDATE
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(R) 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.
Ovarian Cancer
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(R) and HyCEAD(TM) Ziplex(R)
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.
Other matters
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 GBP15.5 million, an R&D tax credit due from
HMRC of GBP1.9 million and a further R&D tax credit of c.
GBP1.5 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:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
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(R)
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 HyCEAD(TM) Ziplex(R)
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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END
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