Last checked at 1 Nov 2019 07:10
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Oncimmune and Biodesix, Inc. Commence Commercialisation of EarlyCDT® Lung in the Strategic US Market
1 November 2019 - Oncimmune Holdings plc (AIM: ONC.L), a leading global immunodiagnostics Group, announces the completion of the strategic commercialisation agreement with Biodesix, Inc. ("Biodesix") for EarlyCDT Lung in the United States, which was announced on 28 June 2019.
We believe this agreement will unlock the potential of EarlyCDT Lung in the US, a key strategic market for Oncimmune. Biodesix is a leading lung cancer diagnostic solutions company which has now commenced the commercialisation of EarlyCDT Lung. Biodesix will make increasing volume-based revenue-sharing payments to Oncimmune from its sales of the EarlyCDT Lung test.
To satisfy the expected growth in sales volumes, Oncimmune will provide Biodesix with diagnostic plates and associated reagents under a profitable supply agreement which was also signed today. Biodesix's current sales force of around 30 is set to increase to over 80 over the next two years, enabling wider reach across the US.
Under the terms of the commercialisation agreement, Biodesix today completed the acquisition of Oncimmune's CLIA laboratory facilities in Kansas, US and will pay $1.0 million to Oncimmune in quarterly instalments of $250,000, with the first being made within 30 days from today. The sale of Oncimmune's US laboratory operations will materially improve the Company's cash position through a reduction of ongoing US operating costs, which were approximately $3.2 million over the past 12 months.
Biodesix is focused on exploiting the full potential of EarlyCDT Lung by extending the utility of the test to screening in the US. To facilitate this significant opportunity, Oncimmune has granted Biodesix an option to commercialise EarlyCDT Lung as a screening diagnostic for lung cancer in the US in exchange for a further significant cash payment. The option is exercisable by the end of 2020. Following the announcement by the Company on the 4 June 2019 that the Early detection of Cancer of the Lung Scotland ("ECLS") trial had met its primary end-point, it is the Board's belief that lung cancer screening, over and above the current lung nodule application, increases substantially the total addressable market for EarlyCDT Lung in the US, and indeed, in all other major markets.
This strategic commercialisation agreement with Biodesix represents value to Oncimmune of up to $28 million in the five-year period to 1 November 2024, of which approximately $7.2 million derives from minimum volume-based revenues. The balance of approximately $20.8 million is represented by both cash lump sum payments, including the $1.0 million sale of Oncimmune's US subsidiary's operations, as well as the significant payment that will be due if the screening option is exercised, together with the material cost savings resulting from a reduction in US operating costs. The Agreement can be renewed by Biodesix for a further five years to 1 November 2029, and by mutual agreement thereafter.
Oncimmune will also continue to collaborate with Biodesix on research and development activities in order to fully leverage the commercial potential of EarlyCDT Lung in the US.
Dr Adam M Hill, CEO of Oncimmune commented: "We are delighted to be working with Biodesix, a company with a successful track record of commercialising clinical diagnostic lung tests in the US and dedicated to improving patient management and outcomes. Biodesix is focused on extending the utility of EarlyCDT Lung to screening in the US, and this partnership, which fully realises the value of EarlyCDT Lung, will accelerate market access and save lives through earlier detection of lung cancer.
"This partnership and other agreements announced this year, demonstrate our ability to deliver on the core objective to drive organic growth through commercial collaborations. In addition, we have secured further funding through a credit facility arrangement, which puts us in a strengthened cash position to deliver on our three-year forward strategy."
David Brunel, CEO of Biodesix commented: "More than 1.6 million patients a year in the US are found to have an incidental pulmonary nodule, and most of these patients do not have cancer. Avoiding unnecessary invasive procedures and expediently moving those with cancer into treatment are equally high priorities, and with our current Nodify XL2 and now with EarlyCDT Lung, Biodesix brings the most comprehensive, simple, blood-based testing solutions to address this urgent problem."
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For further information:
Oncimmune Holdings plc
Matthew Hall, Chief Financial Officer
contact@oncimmune.com
Cléa Rosenfeld, Head of Investor Relations
ir@oncimmune.com
Zeus Capital Limited (Nominated Adviser and Joint Broker)
Andrew Jones, Mike Seabrook
+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, Brett Pollard, Andrew Ward
oncimmune@fticonsulting.com
+44 (0)20 3727 1000
Kena Hudson for Biodesix
Kena@HudBio.com
+1 (510) 908-0966
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.
About Biodesix
Biodesix is a lung cancer diagnostic solutions company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence. Biodesix is the first company to offer three best-in class tests for patients with lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies. The Biodesix Lung Reflex® strategy integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours. The Nodify XL2™ nodule test, which will be commercially available in the second half of 2019, evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action. Biodesix also partners with the world's leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.