Oncimmune Regulatory News (ONC)

5 August 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Further evidence for the use of the EarlyCDT Lung blood test

in lung cancer screening

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, announces the presentation of two further abstracts connected to the Early detection of Cancer of the Lung Scotland ("ECLS") trial. These studies build upon the growing body of evidence which demonstrates that the EarlyCDT Lung blood test is a cost effective and safe early detection tool for people at risk of lung cancer.

The first abstract entitled "Cost-effectiveness of a blood test, plus imaging, to screen for lung cancer in high risk individuals: the Early detection of Cancer of the Lung Scotland (ECLS) trial" was presented at The European Health Economics Association ("EUHEA") virtual conference in July 2020 and is available on the EUHEA website1. The abstract shows that screening using the EarlyCDT Lung blood test to triage into CT scanning in the ECLS trial is a cost-effective method to diagnose lung cancer when compared to the established NICE guidelines on incremental cost-effectiveness ratio ("ICER") cost per quality-adjusted life-year ("QALY") for an acceptable use of NHS resources.

This evaluation was made using only those parameters observed in the ECLS trial; the abstract's conclusion that the EarlyCDT Lung blood test is cost-effective excluded the additional costs of lung cancer treatment and enhanced survival from earlier detection. Indeed, the cost-effectiveness of the EarlyCDT Lung blood test was shown to be further improved in the investigator's model when cancer prevalence was increased to 2% in the tested population, suggesting that the real world cost effectiveness of the EarlyCDT Lung blood test is likely much more attractive.

The second abstract entitled "What is the psychological impact of lung cancer screening using a novel antibody blood test?" was due to be presented at the Society for Academic Primary Care ("SAPC") conference in July 2020 but has been delayed due to COVID19 and will now be presented at the SAPC conference in June 2021. This abstract, published online2, assesses the psychological responses to screening participants using the EarlyCDT Lung blood test during the ECLS trial. These findings show that lung cancer screening using the EarlyCDT Lung blood test does not appear to have a long term negative psychological impact on patients.

Dr Adam M Hill, CEO of Oncimmune, said: "Following last week's announcement of the publication of the ECLS trial in the European Respiratory Journal, we are delighted to see these additional abstracts presented online.

"Beyond proving the ability of the EarlyCDT Lung blood test to detect cancer earlier in a screening population, it is also important to assess the negative impacts of using the test in the population, and the costs of implementing the diagnostic. These findings will no doubt assist our ongoing commercial discussions with health authorities in the UK and in other territories, and we look forward to the peer reviewed publications in due course."

1 https://www.euhea.eu/abstracts_conference_2020.html

2 https://sapc.ac.uk/sites/default/files/asm_20_abstract_book.pdf

For further information:

Oncimmune Holdings plc

Adam Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

contact@oncimmune.co.uk

Zeus Capital Limited (Nominated Adviser and Joint Broker)

Andrew Jones, Daniel Harris, Victoria Ayton

+44 (0)20 3829 5000

finnCap (Joint Broker)

Geoff Nash, Matthew Radley, Tim Redfern

+44 (0)20 7220 0500

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

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 12,208 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 Lung?

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 (IPNs).

Details of the ECLS trial

The trial was open to adults aged 50-75 considered to be at high risk of lung cancer because of smoking and family history, and healthy enough to undergo potentially curative therapy. The intervention was the EarlyCDT Lung test, followed by X-ray and computerised tomography (CT) scan in those with a positive test result. The comparator was standard clinical practice in the UK. The primary endpoint was the difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis in the intervention arm and those in the control arm.

The trial was supported by the University of Dundee, NHS Tayside and co-funded by Oncimmune, the Scottish Chief Scientist Office and the Scottish Government. It was headed by Chief Investigators Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, and Dr Stuart Schembri, until recently consultant Physician in Respiratory and General Internal Medicine at NHS Tayside. It involved collaborators at the University of Glasgow, with further work from the Universities of Aberdeen, Nottingham and Toronto, NHS Scotland, the Scottish Government, The Canberra Hospital and Oncimmune, who developed the EarlyCDT Lung blood test. Tayside Clinical Trials Unit was responsible for trial delivery, data management and analysis.

The abstract was presented by Chief Investigator for the trial, Professor Sullivan in the Presidential Symposium of the World Conference for Lung Cancer 2019, the world's largest meeting dedicated to lung cancer and other thoracic malignancies, hosting more than 7,000 delegates from more than 100 countries.

The peer review of the ECLS trial was published in The European Respiratory Journal at https://erj.ersjournals.com/content/early/2020/07/09/13993003.00670-2020

In February 2020, Oncimmune launched a series of photographs for an exhibition titled 'Extra Time. Portraits of hope and survival from early cancer detection'. Behind the science of the ECLS study were human stories. 'Extra Time' highlighted the stories of the medical professionals who worked relentlessly to identify people who met the criteria for the study, invited them to take part, undertook tests as well as monitoring their progress. But most importantly, 'Extra Time' shone a light on the stories of the people themselves who took part, as well as their families, friends and support networks. These stories illustrate the unmet patient need for diagnosing lung cancer in its early stages and is now available to view online www.extratime.gallery.

For more information, visit www.oncimmune.com