Trading Update for 12 months to 31 May 2020

RNS Number : 8941O

Oncimmune Holdings PLC

04 June 2020

 

4 June 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Trading Update for 12 months to 31 May 2020

Substantial progress made midway through delivery of 3 year forward strategy

Revenue in line with market expectations for FY 2020 with further strong growth expected in FY 2021

Tight control on costs including restructuring of Board

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today provides a trading update for the 12 months ended 31 May 2020 ("FY 2020").

Commercial trading update

FY 2020 has been a pivotal year for Oncimmune with the Company delivering its first full year of trading against its 3 year forward strategy, initiated 18 months ago. Recent commercial progress, as demonstrated by the three contracts signed with biopharmaceutical companies in Q4 2020, demonstrate management's ability and commitment to deliver the strategy and unlock the latent value of Oncimmune's immunogenic protein platform technology, broadening its reach into patient stratification for therapy.

Product - EarlyCDT

Within the product business, the announcement of the results of the Early detection of Cancer of the Lung Scotland ("ECLS") study and its subsequent presentation at the 2019 World Conference on Lung Cancer in Barcelona, set the scene for the commencement of the major multi-centre lung cancer study in the People's Republic of China. Results from this study are expected in Q1 2021.

Within the UK, the publications of a study by Leeds University Academic Unit of Health Economics and the NICE Medtech Innovation Briefing ("MIB") on EarlyCDT Lung and its use in Indeterminate Pulmonary Nodules , added significant weight to our commercial negotiations to introduce the EarlyCDT Lung test into the UK. Whilst impacted by the health system response to COVID-19, we expect to present progress with adoption of the EarlyCDT Lung test within Q1 2021.

Outside the UK, our strategic commercialisation agreement with Biodesix, Inc, for EarlyCDT Lung in the US has provided access to the largest healthcare market in the world and substantially reduced Oncimmune's ongoing cost base. The launch by Biodesix in early March 2020 of EarlyCDT Lung, marketed in the US as Nodify CDT™, coincided with the outbreak of COVID-19. Whilst we have seen an unexpected impact on product sales, we are hopeful that, as the US is now emerging from lock-down, the impact will be limited to Q4 2020/Q1 2021. This US agreement was followed by a significant commercial partnership with R-Pharm in Russia to use EarlyCDT Lung for the detection of lung cancer, the registration process for which is progressing.

In Q4 2020, the EarlyCDT Lung test was selected by one of the world's largest pharmaceutical companies under commercial terms to detect incident lung cancer cases in an asymptomatic cohort of at risk smokers. Importantly, this signed contract is expected to develop into a long-term partnership following successful completion of this initial engagement in Q1 2021.

Services - ImmunoINSIGHTS

Since the acquisition of Protagen Diagnostics AG (now known as Oncimmune Germany GmbH) in March 2019, and the launch of ImmunoINSIGHTS, Oncimmune's service based platform, the pipeline of signed and potential commercial projects with major pharmaceutical and biotechnology companies has substantially increased.

Having signed an initial contract with Roche in February 2020, the awarding of a second and substantial contract with Roche in May 2020 evidences the commercial and scientific value of Oncimmune's services business, including its proprietary discovery and profiling tools, SeroTag™ and NavigAID™.

This value has been further highlighted in the signed contract with a leading US biopharmaceutical company to identify antigen targets from selected human immunoglobulin antibodies. Of significant commercial potential is the right granted to Oncimmune to either develop commercial companion diagnostic devices for each candidate that is validated or benefit from milestone payments in the event the Company waives the development rights, and these are taken up by a third party.

Trading over the next 18 months

Whilst FY 2020 has been an important year in laying the foundation for commercial success, the next 18 months are expected to accelerate this success by creating substantial revenues within the EarlyCDT product business. Furthermore, the pipeline of contracts within the ImmunoINSIGHTS services business is building which means that, when combined with the prospects for the product business, we can look with confidence into FY 2021 and beyond.  

Financial update

The Board is confident in reporting revenue in line with market expectations for FY 2020. Cash at year end is expected to be approximately £4.2 million and net debt of approximately £3.1 million, reflecting the ongoing cost reduction programme highlighted in the Half Year Report on 12 February 2020.

The contracts signed within the ImmunoINSIGHTS business, and agreements signed with strategic biopharmaceutical partners to develop commercial companion diagnostic devices, provide the Board with confidence that the Group is well positioned to have a strong start to FY 2021.

Board Changes

As we focus on delivering the second 18 months of the 3 year forward strategy, we believe now is the right time to restructure the Board in order to be as agile, lean and focused as possible. As such, the Directors have agreed that the size and composition of the current Board will be updated. With immediate effect, the Board will comprise Meinhard Schmidt, Non-Executive Chairman; Dr Adam M Hill, Chief Executive Officer; Dr Annalisa Jenkins, Senior Independent Non-Executive Director; Andrew Unitt, Independent Non-Executive Director; Tim Bunting, Non-Executive Director; and Dr Cheung To, Non-Executive Director.

Accordingly, Geoffrey Hamilton-Fairley, Non-Executive Vice Chairman; Julian Hirst, Independent Non-Executive Director; and Carsten Schroeder, Independent Non-Executive Director, have stepped down from the Board with immediate effect.

Online presentation and conference call for analysts and investors and virtual laboratory tours

Dr Adam M Hill, Chief Executive Officer, together with Matthew Hall, Chief Financial Officer, and Professor Tariq Sethi, Chief Scientific Officer, will host an online presentation and conference call for analysts and investors at 10:30am BST today.

The Company will also be conducting live a virtual tour of both laboratory facilities led by senior scientists in Nottingham, UK and Dortmund, Germany. This will provide the attendees with a rare insight into the science behind Oncimmune's EarlyCDT tests and its core immune profiling technology service, ImmunoINSIGHTS.

For video conference details please contact Alex Davis at FTI Consulting at [e-mail] or 020 3727 1000.

Dr Adam M Hill, CEO of Oncimmune said: "Following the launch of our 3 year forward strategy, announced in late 2018, we have undertaken a ground up assessment, identifying and capitalising upon the wide range of opportunities presented by Oncimmune's proprietary autoantibody-based platform built up over the past fifteen years; exploiting both its depth through novel indications, and its breadth across the entire patient care pathway. At every opportunity, we look to strengthen relationships with existing partners, and forge new relationships with those aligned to our strategy.

"We firmly believe that the momentum we are now building from the foundations laid over the last 12 months validates our strategy and underpins the future commercial potential of our business. We would not be where we are today had it not been for the expertise and strategic counsel that we have received. On behalf of the executive leadership, I would like to thank the Board for its counsel, insight and good governance. I look forward to updating the market on progress made as we enter into the second 18 months of our 3 year forward strategy. "

Meinhard F Schmidt, Non-Executive Chairman of Oncimmune, commented: "On behalf of the Board, I would like to thank Geoffrey, Julian and Carsten for their considerable contributions and support to Oncimmune and their dedication and efforts in highlighting the importance of the fight against cancer. My special thanks must go to Geoffrey, who since co-founding the Company, has served as Chairman and then CEO, thereby securing the solid foundations that we are now building so successfully upon. We wish them all every success."

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

[e-mail]

Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Daniel Harris, Victoria Ayton

[phone]

finnCap (Joint Broker)

Geoff Nash, Matthew Radley, Tim Redfern

[phone]

Bryan, Garnier & Co Limited (Joint Broker)

Phil Walker, Dominic Wilson

[phone]

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

[e-mail]

[phone]

About Oncimmune

Our intimate understanding of the human immune system enables us to harness its sophisticated response to disease to detect cancer earlier and to support the development of better therapies.

The key to improving cancer survival is early detection and better selection for therapy. As a company, we are driven by our passion to improve cancer survival and give people extra time. Oncimmune's immunodiagnostic test, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis.

The unique combination of our core technology and understanding of the immune system, powers our ImmunoINSIGHTS service; a proprietary platform that enables life science organisations to optimise drug development and delivery, leading to more effective, targeted as well as safer treatments for patients.

Oncimmune was founded in 2002 and launched its platform diagnostic technology in 2009, followed by the launch of its first commercial tests, EarlyCDT Lung and EarlyCDT Liver. To date, over 200,000 tests have been performed for patients worldwide. EarlyCDT Lung was also used in what is believed to be the largest randomised controlled trial for the early detection of lung cancer using biomarkers, the successful National Health Service (NHS) Early detection of Cancer of the Lung ("ECLS") trial of 12,209 high-risk smokers in Scotland. This trial demonstrated that EarlyCDT Lung reduced the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis, compared to standard clinical practice.

Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research centre in Dortmund, Germany and a partner representative office in Shanghai, China. Oncimmune joined the Alternative Investment Market (AIM) of the London Stock Exchange in May 2016 under the ticker ONC.L.

What is EarlyCDT?

EarlyCDT is a simple blood test that detects the elevated presence of autoantibodies generated by the body's immune system as a natural defence against cancer cells. EarlyCDT Lung is the world's most thoroughly validated blood test for the detection of lung cancer and requires only a small volume of blood which can be taken using a test in the home or community setting as well as a doctor's surgery.

Shown to detect lung cancer on average four years earlier compared to current standard clinical diagnosis, EarlyCDT Lung can also provide an effective assessment of cancer risk in Indeterminate Pulmonary Nodules.

What is ImmunoINSIGHTS?

The ImmunoINSIGHTS service business leverages Oncimmune's technology platform and methodologies across multiple diseases, to offer life-science organisations actionable insights for therapies across the development and product lifecycle. Our core immune-profiling technology is underpinned by our library of over eight thousand immunogenic proteins, one of the largest of its kind. This helps identify trial participants and patients into clinically relevant subgroups, enabling development of targeted and more effective treatments.

For more information, visit  www.oncimmune.com

 

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