Oncimmune Regulatory News (ONC)

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Oncimmune Holdings plc

("Oncimmune" or the "Company")

Business Update

New distribution agreements bring total minimum sales commitments to £29.5m and strategy update to be presented at full year results on 31 October 2018

Nottingham, UK - 1 October 2018: Oncimmune Holdings plc (AIM: ONC.L), a leader in the development, manufacture and marketing of personalised immunodiagnostics for the screening, detection and care of cancer, today announces it has signed new distribution agreements for its EarlyCDT®-Lung test and provides a business update ahead of results expected on 31 October 2018.

Dr Adam Hill, CEO of Oncimmune commented: "We continue to take strides in building the international distribution network for EarlyCDT®-Lung alongside our own sales efforts and progress towards a wider distribution agreement in the US. Our R&D programmes are also advancing with new product opportunities in the pipeline, and we are also approaching the final results of the NHS trial in Scotland, expected in 2019, which we hope will demonstrate the potential of EarlyCDT®-Lung as a screening test for lung cancer in high risk patients.

"Building from this successful foundation, we will further focus on capturing the fuller value of our autoantibody platform's promise to complement new therapeutics by stratifying patients in order to improve cancer outcomes."

Business Update

EarlyCDT®-Lung 

The new agreements are for the exclusive distribution of the EarlyCDT®-Lung test in Spain and the non-exclusive distribution of the EarlyCDT®-Lung test in India. The agreement in Spain is for an initial term of three years and includes minimum sales commitments of £675,000 over the term of the contract, with first sales already distributed. The agreement in India is for an initial term of four years and includes minimum sales commitments of £1m over the term of the contract, with first sales expected in 2019.

Separately, as part of the framework agreement for an exclusive licence with Genostics Company Limited ("Genostics"), our distribution agreement with Acecgt in Hong Kong, has been terminated with all distribution rights passing to Genostics. The effect of this upon minimum sales commitments is not material, we expect this instead to accelerate sales in the region.

Oncimmune now has a total of 15 agreements a with total minimum sales commitments of £29.5m over their initial periods.

Progress is also being made towards the necessary product registrations to allow wider commercialisation. A number of our partnered territories have required additional regulatory clearances, beyond the product's CE Mark and ISO certification, which can take 12 months to obtain. The first of these are now being secured so that sales can begin to build.

In the US, the Company's pulmonary distribution discussions continue following the completion of our pilot distribution partnership with a major US pulmonology sales force which saw positive results. We expect to have a clear position by the end of the year.

Additional indications and licensing opportunities

Our EarlyCDT®-Liver test has been launched for hepatocellular cancer. EarlyCDT®-Liver will initially be available through Oncimmune's existing distribution network in the US, whilst the Company looks for further specialist distribution partners in the US and other global markets who target hepatologists.

The main commercial focus for the test will be China and the Asia Pacific region where hepatocellular cancer incidence is four times that found in the US. It is anticipated that in these regions the test will be used as a front-line screening test for high-risk patients who have Hepatitis B or C. Work has commenced with our Chinese partner to validate its use as a screening test on a Chinese population, and to gain CFDA clearance.

In addition, we intend to accelerate the development of new EarlyCDT® tests for other cancers. The tests themselves are relatively straightforward to develop as we have the process and the platform performance in the commercial setting well established.

Notice of results and update on strategy

Oncimmune will be announcing its full year results for the year ended 31 May 2018 on Wednesday 31 October 2018 alongside more details of a strategic review undertaken to identify and capitalise on the opportunities presented by Oncimmune's proprietary auto-antibody-based platform for individual profiling of cancer related antigens. This strategic review has confirmed the promise of the platform for individual profiling, early detection, improved care and new insights into the application of personalised approaches to improving cancer outcomes through new therapeutics. 

On the day of results, Dr Adam Hill, CEO of Oncimmune, will present a strategy to execute expansion plans through the roll out of additional EarlyCDT® tests and application of the platform to other applications across the cancer clinical pathway.

The presentation and live conference call for analysts will take place at 11.30am in the Guildhall Room at 85 Gresham Street, London, EC2V 7NQ. If you would like to attend, please contact Consilium Strategic Communications.

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

contact@oncimmune.co.uk

Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Ben Burnett

+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, Alix Mecklenburg-Solodkoff

+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 leader in the development, manufacture and marketing of personalised immunodiagnostics for the screening, detection and care of cancer. The Group 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 156,000 commercial tests have been sold. EarlyCDT®-Lung is available through physicians in the US and also privately in the UK, Europe & Asia. EarlyCDT®-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®-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