Oncimmune Regulatory News (ONC)

14 December 2020

Oncimmune Holdings plc

("Oncimmune" or the "Company")

EarlyCDT® Lung blood test launch into the NHS

EarlyCDT Lung invited for NICE Diagnostic Guidance

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces that it has signed a commercial contract to supply its EarlyCDT Lung blood test to NHS Norfolk & Waveney Clinical Commissioning Group ("Norfolk & Waveney"). Additionally, the Company has also signed a commercial contract to supply EarlyCDT Lung blood test into the NHS Lung Health Check Programmes in Wessex and Yorkshire as part of the iDx-LUNG evaluation programme.

Following in-depth due diligence by the NHS, the Company has also been notified that The National Institute for Health and Care Excellence (NICE) has selected the EarlyCDT Lung blood test for Diagnostics Assessment Guidance. This decision follows the publication by NICE in March 2020 of the positive Medtech Innovation Briefing 209 ("MIB") on "EarlyCDT-Lung for cancer risk classification of indeterminate pulmonary nodules". The successful completion of this assessment will further support wider market adoption of EarlyCDT Lung in the NHS.

Norfolk & Waveney Clinical Commissioning Group

Under this commercial contract, Norfolk & Waveney will be evaluating the use of the EarlyCDT Lung blood test in a clinical setting. A successful conclusion to this contract, combined with Guidance from NICE, is anticipated to support the adoption of the EarlyCDT Lung blood test into the clinical pathway for the early detection of lung cancer across NHS East of England.

The first phase of the commercial contract, which is scheduled to start in January 2021, will focus on patients with Indeterminate Pulmonary Nodules ("IPNs"). The second phase will see the EarlyCDT Lung blood test used in a screening setting with people at risk recruited in selected GP practices in Great Yarmouth, Norfolk. The contract is unconstrained, albeit the evaluation is scheduled to be completed in both settings within 12 months.

Wessex and Yorkshire iDx-LUNG programme

Oncimmune has been selected to supply the EarlyCDT Lung blood test on commercial terms into the iDx-LUNG programme which will collect blood samples from 15,000 people attending the NHS England's Lung Health Check Programme delivered through mobile CT scanning sites across Wessex and Yorkshire.

As well as targeting increased survival rates, an aim of the iDx-LUNG programme is to streamline the process of detecting incident lung cancers in the community and so reduce the NHS resource needed to find each new lung cancer case. The current optimal method of checking lung health, CT scanning, is resource-intense and expensive, with diagnosis and treatment of lung cancer currently costing the NHS an estimated £307 million every year.

In addition to these three health systems, Oncimmune is in dialogue with other regional health systems in the UK for use in lung cancer diagnostic programmes, and NICE Guidance will provide further supporting evidence of the clinical utility of the test in conjunction with existing NHS delivery programmes.

NICE Guidance

Following a positive MIB in March 2020, the NICE Topic Selection Oversight Panel further considered the merits of the EarlyCDT Lung blood test in July 2020 upon submission of additional evidence by Oncimmune and have now notified the Company that EarlyCDT Lung has been selected for Diagnostics Assessment Guidance. This Guidance evaluates new, innovative diagnostic technologies in order to help NHS staff make efficient, cost-effective and consistent decisions about adopting new products in support of innovation, transformation and improving healthcare delivery. The diagnostics assessment process for EarlyCDT Lung commenced in November 2020.

Dr Adam M Hill, CEO of Oncimmune said: "Detecting lung cancer early is key to improving chances of survival, whether patients have a nodule or not. The body of evidence supporting the use of EarlyCDT Lung in patients at risk of lung cancer continues to build and is increasingly compelling. Indeed, following the Grail, Inc. announcement, it is excellent to see the NHS increasing its focus on the early detection of cancers in order to help meet its goal of diagnosing three-quarters of all cancers at an early stage by 2028.

"In addition to commercial evaluations of the implementation and the use of the EarlyCDT Lung blood test in Wessex, Norfolk and Yorkshire, we are especially delighted to have been selected by NICE for full guidance.

"The successful publication of our co-funded Early detection of Cancer of the Lung Scotland ("ECLS") study with the NHS, which demonstrated a 36% reduction in late stage diagnoses of lung cancer which have the worst survival, has been followed by intense discussions with the NHS, leading to due diligence throughout the last six months. As a result of those discussions, we are delighted to be working with the NHS in three regions to start the work of implementing our simple blood test into clinical care to significantly improve the chances of survival for patients with lung cancer through early detection."

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

N+1 Singer (Joint Broker)

Aubrey Powell, Harry Gooden, Iqra Amin, James Fischer

+44 (0)20 7496 3000

WG Partners (Joint Broker)

David Wilson, Chris Lee

+44 (0)203 705 9321

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 to give people extra time.

Oncimmune is a leading immunodiagnostics developer, primarily focused on the growing fields of immuno-oncology, autoimmune disease and infectious diseases. Oncimmune has a diversified and growing revenue from its portfolio of diagnostic products to detect early-stage cancer and a contract discovery and development service-based platform, delivering actionable insights into therapies to its pharmaceutical and biotech partners.

Oncimmune's ImmunoINSIGHTS platform enables life-science organisations to optimise drug development and delivery, leading to more effective targeted as well as safer treatments for patients. ​Oncimmune's immunodiagnostic technology, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. Our lead diagnostic test, EarlyCDT Lung, targets a vast market estimated to grow to £3.8bn by 2024. With over 200,000 tests already performed for patients worldwide and its use being supported by peer reviewed data in over 12,000 patients, we are poised to become an integral component of future lung cancer detection programmes, globally.

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.

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).

For more information, visit www.oncimmune.com