TIDMONC
RNS Number : 0893H
Oncimmune Holdings PLC
05 June 2017
5 June 2017
This announcement contains inside information
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Business Update and New Distribution Agreements
Nottingham, UK - 5 June 2017: Oncimmune Holdings plc (AIM:
ONC.L), a leading early cancer detection company developing and
commercialising its proprietary EarlyCDT(R) platform technology,
today provides an update on the business at the end of its first
full financial year post its IPO.
In addition, the Company announces the signing of two further
distribution agreements for its EarlyCDT(R)-Lung test kit in Taiwan
and Hong Kong.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented: "It has
been a highly productive year and one in which we have made
significant progress in delivering on the growth strategy laid out
at the time of our IPO. Our recent CE Mark for the EarlyCDT(R)-Lung
kit and signing of first distribution agreements in Asia highlight
the potential for further expansion into world markets. With
progress also made in the US and in the development of our pipeline
we look forward with confidence to delivering value in the medium
and long term."
Business Update
Having just completed our first full year end since IPO, the
Company can confirm that it has been a successful start to the
commercialisation plans outlined at the IPO. Our strategy remains
to significantly improve the outcomes of cancer patients through
early detection of the disease and enhance treatment pathways.
Detecting early stage disease has two key benefits: better survival
for the patients; and significantly lower cost of treatment as most
of these early stage patients do not need expensive
chemotherapy.
We intend to develop, and make commercially available and widely
accessible, accurate early cancer detection tests for multiple
cancer types. Our three year commercialisation plan has to date
focussed on the recruitment of new senior staff to lead our
activities in Asia, UK and Europe and in the US for Reimbursement
and Sales, which we have now successfully completed. Our R&D
plan proceeds at speed and with the EarlyCDT(R)-Lung test CE marked
kit, a key element in delivering our global commercialisation plan
has become a reality. The Company can now start to execute on its
portfolio revenue proposition with multiple products, generating
revenues in different regions and with different partners. In
addition, we have an emerging companion diagnostics business and a
second generation of the platform, the autoantibody "fingerprint",
that will bring new levels of performance and lead to a pan-cancer
test.
EarlyCDT(R)-Lung
In the US, we proceed with our previously outlined process of
supporting our distributors to test the efficiency of our marketing
approach and ensure that our partners deliver high quality and
long-term sales. We appointed a new sales director at the end of
last year and she has worked diligently testing a number of
approaches to ensure an optimal sales and marketing cycle where a
physician re-orders the EarlyCDT(R)-Lung test without the need (and
expense) of a repeat sales visit. The investment programme related
to this - initially scheduled to be started by the end of the first
quarter - was deferred until we were confident that our approach
was gaining traction, and in light of this and the Company's
general prudent approach to expenditure and cash management, the
Company's year end cash balance is stronger than expected at GBP5
million. However, we are now starting to generate sufficient proof
that this can be achieved and thus we expect to start to invest in
sales support / marketing with confidence of commensurate revenue
growth going forward. We remain, however, unashamedly cautious as
positioning of the test is key to long-term success.
We are, in addition, in discussions with a number of pulmonology
distributors with focus on the second use of the EarlyCDT(R)-Lung
test, namely risk stratification of CT identified nodules. 96% of
CT identified nodules are not cancer, so finding the correct ones
to follow up is a large unmet need which our test can address
effectively.
Outside of the US, we are moving ahead well. Our Asian business
has started to deliver with two contracts announced in April for
Israel and Korea which provide meaningful minimum payment
guarantees of over GBP5m in aggregate over the next five years. We
have since signed two further agreements which we are announcing
today with Acecgt, for Hong Kong, and with Invision Biotech for
Taiwan. These two agreements are for three years and include
aggregate minimum payments of approximately GBP0.6m over that
period.
We expect to sign more distribution contracts in Asia and Europe
during the upcoming months, with a number of these arrangements
also likely to include guaranteed minimum payments that would add
to our confidence in our chosen distributors and enhance revenue
visibility/predictability.
R&D and Trials
Our R&D programme continues to progress. We have laid the
foundations for the commercial panel for the EarlyCDT(R)-Liver
test, which is targeted to be complete in the second half of 2017,
with EarlyCDT(R)-Ovarian thereafter.
The NHS Lung Cancer Screening Trial made a further interim
report at the World Conference for Lung Cancer last December in
Vienna. They announced results similar to those previously reported
on the test performance, as we expected, and perhaps most notably
that over 75% of the patients being diagnosed have early stage
cancers (stage 1 & 2) as opposed to the vast majority in normal
practice presenting with late stage cancer - which is generally
incurable. Now fully recruited with 12,210 patients, this is the
largest randomised control trial using biomarkers ever conducted in
lung cancer. The final study results, including the control arm,
will be published after all patients have had two years of follow
up CT scans and these are expected in 2019.
Personalised Medicine & Companion Diagnostics
In companion diagnostics, we are running a number of studies
alongside drug development programs and we expect to be able to
announce results from these in the next 12 months that we expect
will support development of this area as a separate business
unit.
Finally, in the second half of 2017 we expect to announce
results relating to the second generation of tests from our
autoantibody platform where patients can be their own control and
thus testing is significantly more accurate. We believe this second
generation of test will complement the global vision of some major
companies currently investing heavily in developing personalised
medicine platforms and services.
In conclusion, one year in to our post IPO commercialisation
plan, the board is increasingly confident that the Company is well
placed to execute that plan and deliver value in the medium and
long term.
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Broker)
Phil Walker, Giles Balleny, Dominic Wilson
+44 (0) 203 829 5000
Media enquiries:
Consilium Strategic Communications
Chris Gardner, Mary-Jane Elliott, Matthew Neal, Lindsey
Neville
oncimmune@consilium-comms.com
+44 (0) 20 3709 5708
About Oncimmune
Oncimmune is a leading early cancer detection company developing
and commercialising its proprietary EarlyCDT(R) platform
technology. Oncimmune has pioneered the development of autoantibody
tests that can detect cancer up to four years earlier than other
methods and can be applied to a very wide range of solid tumour
types. The Company's first product, EarlyCDT(R)-Lung, was launched
in 2012, as a CLIA test in the USA and since then over 150,000
commercial tests have been sold. EarlyCDT(R)-Lung is available
through physicians in the US and also privately in the UK and other
regions. EarlyCDT(R)-Lung is being used in the largest ever
randomised trial for the early detection of lung cancer using
biomarkers. The NHS Scotland ECLS study of over 12,000 high-risk
smokers is now fully recruited and in the final follow up stage.
EarlyCDT(R) tests for liver and ovarian cancer are in
development.
Oncimmune, headquartered in Nottingham, United Kingdom with
testing facilities in the US, joined AIM in May 2016 under the
ticker ONC.L. For more information visit www.oncimmune.com
This information is provided by RNS
The company news service from the London Stock Exchange
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