TIDMONC
RNS Number : 5967C
Oncimmune Holdings PLC
23 January 2018
23 January 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 and Notice of Interim Results
New distribution agreement for Turkey brings total minimum sales
commitment in Europe and the Asia-Pacific region to GBP25.6
million
Nottingham, UK - 23 January 2018: Oncimmune Holdings plc (AIM:
ONC.L), 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 the announcement of interim results
expected on 13 February 2017.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented: "The
recent period has seen us continue our strong progress in
delivering on our strategy to generate revenues across multiple
products, regions and with different partners. We have entered into
a distribution and product development agreement in China which
includes a contracted GBP10m equity investment and GBP15.7 million
in minimum royalties. Today we also announce a new distribution
agreement for Turkey which brings our total number of agreements in
Europe and the Asia Pacific region to 12 with total minimum sales
commitments of GBP25.6m. We continue to be very confident of
delivering value in the medium and long term."
Business Update
Since the publication of our full year results in October 2017,
the Company has continued to make good progress against its
commercialisation plans.
EarlyCDT(R)-Lung
In the US, we have commenced a marketing programme to support
our distributors. However, as stated in our results we continue to
be cautious in terms of near term revenue growth from this channel
as positioning the test is key to long-term success. We anticipate
that sales will start to build post the end of this financial year
as distributors prime their local-market place.
In November, 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. The introduction of this
alternative to full blood draw has been timely as a new
interpretation of the regulations has resulted in an increasing
number of distributors requiring Oncimmune to enter individual
direct contracts with each institution where blood is taken. These
contracts are taking in the region of two to three months to
execute. Over time we expect "finger stick" collection to make the
test more accessible but currently a significant proportion of the
market still relies on blood draw. This requirement for individual
contracts has had an impact on the speed with which we are able to
build sales and show traction from our sales and marketing
strategy.
Pilot Pulmonology Distribution Project
Our preliminary distribution partnership with a major US
pulmonology sales force is progressing well. While the changes to
regulations around blood draw described above have impacted
timelines, we expect the project to complete in the next two months
and if successful should lead to a distribution agreement covering
a significant proportion of the pulmonologists in the US. Results
so far have been encouraging. The Company is also continuing to
explore further pulmonology distribution channels in the US with
other parties and, since the announcement of the pilot study, has
seen further interest from potential partners active in the
pulmonology space.
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 will start to sell EarlyCDT(R)-Lung within 36 months of
the date of the agreement, subject to China FDA approval, although
both parties expect this to be sooner.
We are today announcing a new distribution agreement for Turkey.
The exclusive distribution agreement with Biruni Laboratuvari in
Istanbul is for three years in the first instance, with minimum
sales commitments of GBP630,000. Turkey is a major market for
Oncimmune, with nearly 19 million smokers. The country also
performs approximately 14 million CT scans a year and therefore a
large number of lung nodules are detected annually. This creates a
significant unmet medical need in risk assessment of intermediate
pulmonary nodules that our EarlyCDT(R)-Lung test can address.
Having also signed an agreement for Iran in November, we now
have a total of six agreements in place for the Asia-Pacific region
(not including the China deal) with minimum committed revenues of
GBP8.0m over the next 5 years. In Europe, the total is GBP2.1m over
the same period.
Additional indications and licensing opportunities
Our R&D programme continues to progress. We have completed
validation of the commercial panel for the EarlyCDT(R)-Liver test,
and remain on track to begin commercial sales in H1 2018.
We also continue to progress our work in companion diagnostics
with studies in progress alongside drug development programs and in
fingerprinting. The first published set of results from our
Scancell collaboration have been received positively and we plan to
continue to pursue both areas over the next year.
In conclusion, we continue to deliver on our plan to create
value from our core autoantibody platform and the board is
increasingly confident that the Company is well placed to execute
that plan and deliver value in the medium and long term.
The Company will report interim results for the half year ended
30 November 2017 on 13 February 2018.
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, Hugh Kingsmill Moore
+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 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 National Health Service (NHS) Scotland ECLS study
of 12,210 high-risk smokers. 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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