TIDMONC
RNS Number : 1526Q
Oncimmune Holdings PLC
04 June 2018
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Business Update
Positive results from completed pilot distribution with major US
pulmonology sales force
Second EarlyCDT(R) test launched and continued progress across
pipeline
New distribution agreements bring total minimum sales
commitments to GBP28.8m
Nottingham, UK - 4 June 2018: Oncimmune Holdings plc (AIM:
ONC.L), a leading early cancer detection company developing and
commercialising its proprietary EarlyCDT(R) liquid biopsy platform
technology, today provides an update on the business ahead of its
full year results for the year ended 31 May 2018, expected in
October 2018.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented: "The
recent period has seen us continue our strong progress in
delivering on our strategy of generating revenues across multiple
products, regions and with different partners. Our second test,
EarlyCDT(Ò) -Liver launched in the US in May and we are also making
good progress towards obtaining regulatory clearance for the
EarlyCDT(Ò) -Lung test in China. Our Chinese partner, Genostics,
completed their GBP10m equity investment at GBP1.56 per share in
March 2018 and including the contract with them in China, we now
have a total of 14 agreements in Europe, Asia Pacific and South
America with total minimum sales commitments of GBP28.8m over their
initial periods. Furthermore, in addition to developing further
cancer specific EarlyCDT(Ò) tests, the Company is also expanding
its operations in companion diagnostics and personalised medicine.
Oncimmune is trading in line with market expectations and I believe
we are well placed to continue to execute our business strategy and
deliver value in the medium and long term."
Business Update
Since the publication of our interim results on 13(th) February
2018, the Company has continued to make good progress against its
commercialisation plans.
Progress with EarlyCDT(R)-Lung
In the US, we have commenced a marketing programme to support
our distributors and the initial data suggests that this approach
should lead to enhanced sales. However, there is considerable
further learning from the various experimental approaches being
tested before we can be reach a level of confidence that will
enable us to invest more heavily in this direct marketing approach
in the knowledge that it will generate acceptable returns.
Pilot Pulmonology Distribution Project
Our pilot distribution partnership with a major US pulmonology
sales force has been completed and the results were very positive
with the test performing as expected. The use of our
EarlyCDT(R)-Lung test led to many cancers being detected earlier
and physicians from the pilot have continued ordering the test as
part of their daily practice.
At the end of 2017, we launched a simplified blood sample
collection procedure - using a "finger stick" - which increases the
speed and simplicity with which the EarlyCDT(R)-Lung test can be
ordered and completed, with no loss of performance. As anticipated,
the finger stick collection aided adoption in the pilot, with
approximately 40% of the samples collected in this way.
Distribution terms are now being discussed which, if concluded
successfully, will give the Company access to a significant
proportion of the pulmonologists in the US. Concurrently, the
Company is also continuing to explore further pulmonology
distribution channels in the US with other parties.
In May, we published results from a health economic study in
PLOS ONE which showed that the EarlyCDT(R)-Lung test is cost
effective in the evaluation of incidentally-detected pulmonary
nodules, versus CT surveillance alone, further underpinning the
test's positioning in this setting.
China and Additional Distribution Agreements
In January, we announced we had signed a framework agreement for
an exclusive licence with Genostics Company Limited ("Genostics"),
a Hong Kong registered company part of the Gene Group Holdings
Limited group. The agreement is for the distribution, manufacturing
and future development of all products related to Oncimmune's
EarlyCDT(R) platform for the People's Republic of China. Under the
terms of the licence, Oncimmune will receive a royalty of 8% to
12.5% on the gross revenue subject to aggregate minimum royalty
payments over the first six years post market entry of GBP15.7
million and GBP5 million (index linked) per year thereafter.
Genostics has also invested a total of GBP10m in Oncimmune by way
of subscription of Ordinary Shares, the final tranche of which was
completed in March. Genostics will start to sell EarlyCDT(R)-Lung
within 36 months of the date of the agreement, subject to China FDA
approval. Good progress since January has been made in the
regulatory submission planning and we expect sales to commence on
track.
In recent weeks, we have also signed two new exclusive
agreements for distribution of the EarlyCDT(R)-Lung test in Brazil
and Colombia with Valentech International LLC, as well as in
Moldova with GBG-MLD SRL. The agreement in Brazil and Colombia is
for an initial term of five years and includes minimum sales
commitments of GBP3,000,000 over the term of the contract, with
first sales expected in Q1 2019. The agreement in Moldova is for an
initial term of three years and includes minimum sales commitments
of GBP200,000 over the term of the contract with first sales
expected in Q3 2018.
We now have a total of 14 agreements in Europe, Asia Pacific and
South America with total minimum sales commitments of GBP28.8m over
their initial periods.
Launch of EarlyCDT(R)-Liver
The EarlyCDT(R)-Liver test was validated according to schedule
and in May 2018 it was made commercially available in the US. The
test will initially be supplied as a central laboratory test in the
US in the same manner as the EarlyCDT(R)-Lung test is currently
supplied. It is a simple blood test which is complementary to
diagnosis via imaging, and can aid in stratification of high risk
patients whose diagnosis is indeterminate following ultrasound and
CT or MRI. The test can also aid in the risk assessment and early
detection of hepatocellular carcinoma ("HCC") in high-risk patients
with hepatic lesions less than 1cm. We expect the "kit" version of
the EarlyCDT(R)-Liver test to be available by our year end in 2019.
This will enable us to use our current distributor network to
generate sales worldwide.
EarlyCDT(R)-Liver will initially be available through
Oncimmune's existing distribution network in the US, and the
Company is looking for further specialist distribution partners in
the US and other global markets who target hepatologists, with a
view to a full national launch during the second half of 2018.
Liver cancer is the second most common cause of death from
cancer worldwide and is particularly prevalent in Eastern and
South-Eastern Asia with China accounting for approximately 50% of
cases globally. It is associated with hepatitis B and C infections,
consumption of alcohol, smoking, and, in the West, with fatty liver
disease related to poor diet. The prognosis for liver cancer is
very poor and there is a clear clinical need for improved
diagnostic testing. Globally 700,000 new cases are diagnosed each
year and the annual death rate is in excess of 600,000. The
EarlyCDT(R)-Liver test has the potential to offer a highly
cost-effective screening tool to complement the performance of the
current diagnostic test alpha fetoprotein (AFP), which has come
under scrutiny as the levels can be raised in many patients who
have liver disease but not HCC.
It is anticipated that territories outside the US, especially
China and the Asia Pacific region where hepatocellular cancer
incidence is four times that found in the US, the test will be used
as a front-line screening test for high-risk patients who have
Hepatitis B or C. Work has already commenced with our Chinese
partner to validate the tests use as a screening test on a Chinese
population.
Corporate update
We appointed Dr Adam Hill MB PhD, to the Company's Board as
Chief Medical Officer and Chief Strategy Officer, commencing on 9
April 2018.
Adam is a dual-qualified Clinician and Engineer, with a career
built in industry, academia and practising medicine. During his
career, Adam has held Chief Medical Officer and other senior
management roles at private and listed companies, supplemented by
advisory and government policy appointments.
Adam's appointment, along with the appointment of Annalisa
Jenkins earlier in the year, further strengthens the Oncimmune
Board as we continue to commercialise our proprietary EarlyCDT(R)
platform technology.
Additional indications and licensing opportunities
Our R&D programme continues to progress in companion
diagnostics. Studies are underway alongside drug development
programs at biotech and pharma companies. The first published set
of results from our Scancell collaboration were received positively
and we plan to continue to pursue both areas over the next year. In
addition, further studies with the fingerprinting technology, which
allows personalised immune profiling, are currently being
undertaken.
Outlook
We continue to deliver on our strategy to create value from our
core autoantibody platform and the board is confident that the
Company is well placed to execute its plan. The Company expects to
be trading in line with market expectations for revenues for the
year ended 31 May 2018 and ahead of expectations for operating
costs and cash position. With multiple distribution agreements in
place and our technologies being rapidly adopted across the
EarlyCDT(R) platform, the Board is confident in Oncimmune's future
prospects.
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Joint Broker)
Giles Balleny
+44 (0)20 3829 5000
Bryan, Garnier & Co Limited (Joint Broker)
Phil Walker, Dominic Wilson
+44 (0)20 7332 2500
Berenberg (Joint Broker)
Toby Flaux, Charlotte Sutcliffe
+44 (0)20 3207 7800
Media enquiries:
Consilium Strategic Communications
Chris Gardner, 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 155,000
commercial tests have been sold. EarlyCDT(R)-Lung is available
through physicians in the US and also privately in the UK, Europe
& Asia. EarlyCDT(R)-Lung is being used in the largest ever
randomised trial for the early detection of lung cancer using
biomarkers, the National Health Service (NHS) Scotland ECLS study
of 12,210 high-risk smokers. EarlyCDT(R)-Liver launched in May 2018
and further tests 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
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END
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