Oncimmune Regulatory News (ONC)

4 March 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

US Commercial Launch

Biodesix launches Early CDT Lung® in US

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces that Biodesix, Inc. ("Biodesix"), its exclusive commercial partner in the US for the Company's EarlyCDT® Lung test, has commercially launched its test in the US.

Marketed in the US under Biodesix's Notify LungTM brand, the Nodify CDTTM test will assist physicians to identify patients with lung nodules at high risk of lung cancer. This test partners with Biodesix's existing Notify XL2TM test which is designed to help identify lung nodules with a very low risk of cancer. Both tests will be offered together as the Nodify LungTM Nodule Risk Assessment strategy, giving physicians the ability to order both tests from a single blood draw.

Biodesix has a direct US national sales force who sell direct into pulmonologists and corporately into national hospital systems.

Dr Adam M Hill, CEO of Oncimmune said: "Biodesix is a leader in lung cancer diagnostics and therefore is an excellent partner to unlock the potential of Early CDT Lung in the US, one of the largest addressable markets in the world. Since completing the strategic commercialisation agreement with Biodesix on 1 November 2019, they have exceeded our expectations and are fully motivated to deliver the full commercial potential of the product, now branded Nodify CDT™ in the US."

Scott Hutton, Biodesix's CEO said: "Between the Nodify CDTTM and Nodify XL2TM tests, we believe we have an opportunity to redefine risk assessment for patients with suspicious lung nodules. With a single blood draw, we can help physicians identify people who are either more or less likely to have lung cancer. Given the short turnaround time of these tests, we can help physicians move patients quickly from lung nodule discovery to a definitive care plan.

"1.6 million Americans are diagnosed with incidental lung nodules each year; the problem physicians face is that it's often difficult to determine whether a nodule is cancer or not without the patient undergoing an invasive procedure to get a tissue sample for further testing. These procedures are costly and carry a risk of complications even though many times the nodule is harmless. The alternative is to enter a watchful waiting period where a patient comes in every 3-6 months for follow up scans to see if the nodule grows or changes in a way that indicates it may be cancer. This waiting can cause a stress for the patient and their families. Physicians need better tools to assess the risk of cancer and inform which path to take.

"Launching the Nodify Lung strategy represents an important step for Biodesix and is driven by our vision of equipping physicians with reliable, actionable data so they can recommend with confidence the right pathway for every patient."

Commenting on the availability of the two tests, Bonnie Addario, Co-Founder and Board Chair for the GO2 Foundation for Lung Cancer said: "We are grateful for Biodesix's leadership in developing tests that help patients to know, without subjecting them to unnecessary procedures and losing precious time, what their risk level is for lung cancer. This reduces much of the uncertainty that plagues patients from the time a nodule is discovered until a care plan is determined."

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

Bryan, Garnier & Co Limited (Joint Broker)

Phil Walker, Dominic Wilson

+44 (0)20 7332 2500

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

About Oncimmune

Beating cancer, one test at a time 

The battle against cancer hinges on early detection and then the delivery of effective treatment. Oncimmune is working to revolutionise both the detection of cancer and its treatment by harnessing the sophisticated disease detecting capabilities of the immune system to find cancer in its early stages. Our range of diagnostic tests assist clinicians to identify the presence of cancer four years or more before standard clinical diagnosis, whilst our technology platform and sample biobanks are helping healthcare companies to develop new cancer treatments.

Oncimmune was founded in 2002 and launched its platform technology in 2009, followed by its first commercial tests, EarlyCDT Lung and EarlyCDT Liver. To date, over 158,000 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) ECLS trial of 12,209 high-risk smokers in Scotland which demonstrated 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 in London, UK 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?

A blood test using a panel of seven immunogenic proteins for the testing of tumour-related antibodies specific to lung cancer.

For more information, visit www.oncimmune.com