Oncimmune Regulatory News (ONC)

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® 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®-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®-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®-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®-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®-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 £5 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®-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 £5m 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 £0.6m 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®-Liver test, which is targeted to be complete in the second half of 2017, with EarlyCDT®-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® 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®-Lung, was launched in 2012, as a CLIA test in the USA and since then over 150,000 commercial tests have been sold. EarlyCDT®-Lung is available through physicians in the US and also privately in the UK and other regions. EarlyCDT®-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® 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