Oncimmune Holdings plc (LON:ONC), the leading global immunodiagnostics group, today announced its interim results for the six months ended 30 November 2020.
Commercial highlights
Services – ImmunoINSIGHTS
· Marked increase in commercial activity as large pharmaceutical and leading biotech companies recognise the advantages of utilising Oncimmune’s two proprietary biomarker discovery platform technology tools, SeroTagTM and NavigAIDTM.
· Seven contracts signed in the period, including with Roche Pharmaceuticals and Genentech, Inc., with work on these recently completed or very advanced.
· Evidence of sustainable growth with a commercial pipeline of over 100 opportunities (up 50% since October 2020) of which 19 are potential contracts with a value of £10.8 million from follow-on contracts with existing customers or proposals for new customers. We expect to announce the signing of a number of these before the end of this financial year.
· Further investment made in equipment and additional staff to increase capacity and remove potential operational bottlenecks and to capitalise on all available growth opportunities.
Services – Infectious diseases (COVID-19)
· Funding awarded from the UK Government to support a joint collaboration between Oncimmune and Medicines Discovery Catapult to deliver a research panel for profiling patients with COVID-19.
· This IMmunity Profiling of pAtients with COVID-19 for Therapy and Triage (IMPACTT) programme is progressing to plan, with a development panel to be made available to commercial customers in February 2021 and completion of the validated infectious disease panel expected within the first half of 2021.
· Subsequent partnership with Cedars-Sinai Medical Center, California, US, signed to analyse COVID-19 samples as biomarkers for this disease. In advanced discussions with several global biopharmaceutical companies for the use of the Infectious Diseases panel.
Product – EarlyCDT® Lung
· First commercial contracts signed to supply EarlyCDT® Lung blood test to the NHS with patient samples already analysed and increasing engagement with NHS England’s Cancer Alliances and Clinical Commissioning Groups, bolstering confidence in the delivery of further supply contracts in the near-term.
· Currently in final negotiations for additional NHS trust contract to screen over 2,000 patients, expected to commence in the first calendar half of 2021. Also commenced negotiations for a substantial NHS trust contract for the diagnosis of indeterminate pulmonary nodules (IPNs).
· NICE selected EarlyCDT Lung for its Diagnostics Assessment Programme for IPNs and the guidance process is underway. NICE draft final guidance on the utility value and cost effectiveness of the EarlyCDT Lung test could be available from Autumn 2021 (assuming successful assessment) and would provide further support for adoption of the test across the NHS and other UK healthcare providers.
· Sales volumes and forecasts in United States with Biodesix, Inc. for EarlyCDT Lung have materially improved through FY Q2 and Q3. Confirmed purchase orders, as well as Biodesix’s planned national sales team expansion from 32 to 76 by 2022, pointing to an expected increase in commercial activity in 2021 and beyond.
· Despite the COVID-19 constraints on customer interactions by our distributors, marketing activity across our global distributor network continues to progress as countries recognise the importance and value of identifying lung cancer early. As national hospital systems open up, we expect product sales to at least return to pre-pandemic forecasts.
· Commercialisation supported by further technical validation with the publication of positive results from the Early detection of Cancer of the Lung Scotland (ECLS) trial in the European Respiratory Journal.
Product – NHS lung cancer screening trials
· In late stages of planning and the securing of funding for a large, real-world, cancer control evaluation to follow up on the promising results of ECLS, expected to study a population of approximately 65,000 people.
· Research partners are now in receipt of the three-year follow-up data to ECLS and are analysing the results to determine where there is a statistically significant survival benefit at this interim time point.
Financial highlights
· Revenue for the period was £1.83m (H1 2019: £0.31m).
· Gross profit for the period was £1.41m (H1 2019: gross loss £0.05m).
· Total administrative expenses were £2.88m (H1 2019: (Restated) £4.88m), reflecting the absence of significant one-off costs and a continued focus on tight cost control.
· Research & Development costs were £0.62m (H1 2019: £1.01m).
· Loss after tax was £2.60m (H1 2019: (Restated) £5.27m).
· Investment in the ImmunoINSIGHTS business with additional equipment purchases and headcount to further increase capacity and remove possible operational bottlenecks.
· Gross cash balance at the period end of £3.28m (FY 2020: £4.24m) and gross debt at the period end of £9.59m (FY 2020: £7.29m). A further €3.0m available to be drawn under the IPF Management SA credit facility subject to the attainment of certain milestones which the Company expects to meet.
Dr Adam M Hill, CEO of Oncimmune said: “We are pleased with the continued growth that the Company has achieved over the last six months as we deliver on our strategic plan. We have experienced a sixfold increase in revenue against the same period last year as we continue to establish partnerships with leading pharmaceutical and biotech companies in the key areas of oncology and autoimmune diseases and, most recently, infectious diseases.
“The ImmunoINSIGHTS business is underpinned by world leading technologies and expertise which, despite the impact of COVID-19, has delivered significant commercial opportunities. Our progress is a testament to the hard work of our team under the challenging circumstances the pandemic has presented. The key now is to optimise this value creation with growth becoming more evident as we approach the end of FY21 and enter FY22.”
Chairman & Chief Executive’s Review
We are pleased to report the Group’s unaudited half year results for the six months ended 30 November 2020 and provide an update on the commercial and operational progress since last year end.
Oncimmune remains a leading developer of applied immunodiagnostics for the early detection of disease and drug discovery and development, with over 18 years as a leader in autoantibody-enabled immunodiagnostics. Oncimmune’s proprietary platform technology includes a substantial immunogenic protein library, over 200 patents granted and pending in 47 countries and over 150 peer-reviewed materials.
Services – ImmunoINSIGHTS commercial update
Having acquired our Dortmund operation in March 2019 to drive service contracts with pharmaceutical and biotechnology companies, it has since been integrated well and been transformed into our ImmunoINSIGHTS service business. We are seeing increasing scientific and commercial validation that our two proprietary biomarker discovery platform tools – SeroTagTM and NavigAIDTM – are state-of-the-art and able to provide valuable, actionable insight into our customers’ therapeutic and other assets.
We are pleased to report that ImmunoINSIGHTS commercial activity within the first half and subsequently has been strong, with seven contracts signed, including contracts with Roche Pharmaceuticals (Roche), Genentech, another leading global biopharmaceutical company with extensive experience in developing novel immune checkpoint inhibitors, and other well financed biotechs.
The opportunities we are pursuing are mainly within the field of oncology and autoimmune diseases; specifically, where our customers are seeking our expertise to help them improve both the selection of patients for current therapies as well as the identification of new pathways for the discovery of new therapies.
We believe we are now in a position to evidence sustainable growth in our ImmunoINSIGHTS business, which has a current pipeline of over 100 separate opportunities (up 50% since October 2020). Currently we have 19 potential contracts with a value of £10.8 million from follow-on contracts with existing customers or proposals for new customers. We expect to be able to announce the signing of a number of these contracts, in particular those follow-on contracts from existing customers, before the end of this financial year.
Reflecting on the commercial activity since the start of this reporting period, in late May 2020 we signed a substantial follow-on contract with Roche to profile autoantibodies in patient samples collected during cancer immunotherapy trials. Then, in July 2020, we signed an extension to this contract, which substantially increased the number of autoantibody samples to be profiled. We are pleased to report that we have delivered our initial report and data, meaning we remain on track to deliver our final report to Roche by the end of February 2021.
In early September 2020, we signed an autoantibody profiling contract with a leading global biopharmaceutical company, aimed at identifying tumour antibody markers which could be predictive of response and immune-related adverse events. Once again, we are pleased to report that the work under this contract has been completed and our initial report has been delivered. We are now in the process of reviewing the results with the customer, ahead of negotiating a significantly larger contract to profile patients on a range of their immune-oncology clinical trials.
In late September 2020, we signed a collaboration agreement with Genentech, to characterise the autoantibody profiles of patients in clinical trials for rheumatological diseases, including Systemic Lupus Erythematosus (SLE). SLE is a chronic, incurable autoimmune disease associated with multiple symptoms that can flare up over time, but which can be challenging to diagnose. Better characterisation should enable the development of more effective treatments in an area of high unmet clinical need. As with previous contracts, this one has the potential to significantly expand, with additional samples being profiled in the future. Work on this contract is ongoing and is progressing to the current schedule; we expect to deliver our initial report by the end of February 2021.
Then, in mid-November 2020, we signed a contract with Augmenta Bioworks to profile plasma samples in both cancer and infectious disease patients and characterise therapeutic candidates from its discovery platforms. Once again, this contract has been completed to schedule and we are in the process of agreeing a follow-on contract which is expected to commence before the end of this financial year.
As the number of signed contracts increases and the pipeline of potential contracts grows, we took the decision to further invest in the Dortmund operation. Additional equipment has been purchased to further increase capacity and remove possible operational bottlenecks. We have also employed additional staff within the laboratory operations, and we are expecting to add an additional specialist protein scientist and two additional bioinformaticians to increase our data analytics and report writing capacity. As contracted activity increases, we will again review equipment and other capacities and invest further in our infrastructure, as and when appropriate, to ensure we are well placed to capitalise on all available growth opportunities.
Product – EarlyCDT® Lung commercial update
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, the Company’s EarlyCDT Lung test can also provide an effective assessment of cancer risk in indeterminate pulmonary nodules (IPNs).
A significant milestone was reached during the period when we secured our first commercial contracts for the supply of the EarlyCDT Lung blood test to the NHS. The NHS is recognised as a leading public health system and, as such, the acceptance by the NHS of the benefits of the EarlyCDT Lung blood test is an important signal to other national healthcare systems. The contract with the Norfolk & Waveney Clinical Commissioning Group, which will result in blood tests being used on over 2,000 patients mainly in the Great Yarmouth area, commenced in January 2020 and the first patients have already been tested. This contract is expected to be completed within 12 months.
In addition, we signed a contract for the supply of the EarlyCDT Lung blood test on commercial terms into the iDx-LUNG programme being undertaken in Wessex and Yorkshire. Under this programme, 15,000 people attending the NHS England’s Lung Health Check Programme will be tested with EarlyCDT Lung. As well as targeting increased survival rates, the iDx-LUNG programme aims to identify the optimum process for detecting lung cancers in the community, which is currently resource-intense and expensive, costing the NHS an estimated £307 million every year in diagnosis and treatment of lung cancers.
We are also currently in the final stages of agreeing an additional NHS contract for the screening of over 2,000 lung cancer patients with a scheduled start date in the first half of calendar year 2021. We continue to have a number of active discussions ongoing with other Clinical Commissioning Groups and Cancer Alliances across England. In time, we are hopeful the growing implementation of the EarlyCDT Lung blood test will eventually lead to the widespread adoption of the test within the clinical pathway for the early detection of lung cancer across the NHS.
The National Institute for Health and Care Excellence (NICE) has selected EarlyCDT Lung for a Diagnostic Assessment Programme for IPNs, with the diagnostics assessment process having started in November 2020. This assessment is considering the utility value and costs effectiveness of EarlyCDT Lung in a handful of clinical settings and will hopefully result in NICE guidance released across the NHS. On the basis of the current timetable, we expect NICE to provide its draft final guidance in Autumn 2021. We regard this NICE assessment and guidance as further, important validation for EarlyCDT Lung, which could have a positive effect on the future adoption of the test across the NHS and UK.
Outside of the UK, Biodesix, Inc. (“Biodesix”) is the Company’s strategic partner for the commercialisation of EarlyCDT Lung in IPNs in the US. Having signed an agreement with Biodesix in June 2019, its launch of the EarlyCDT Lung test in March 2020, as Nodify CDTTM under its Nodify LungTM brand, was initially hampered by COVID-19. However, we are now receiving substantial orders against which we are shipping product as well as receiving forecasts which point to an increase in commercial activity during the remainder of calendar year 2021.
We also note that Biodesix’s IPO during the period identified Nodify Lung as a keystone to its commercial strategy which should ensure sufficient resources are deployed to achieve its revenue forecasts from this product. Specifically, Biodesix plans an increase in its direct sales team from 32 to 76 by 2022, allowing their team to reach a higher number of clinicians and drive higher sales. In July 2020, the United States Preventative Services Task Force (USPSTF) published a draft recommendation statement[1] on screening for lung cancer which recommends annual screening using low-dose computed tomography scans for people aged 50 to 80 years old. Due to this recommendation, Biodesix’s current strategy to position Nodify CDT as a triage to annual screening is expected to drive increased lung nodule assessment in the 50 to 55 year old age group in particular, leading to increased commercial demand for the Nodify CDT test.
More broadly across our global distributor network, while COVID-19 has had an effect on the rate of growth of product orders, we are nonetheless encouraged by the progress made over the first half year. Our distributors remain committed to the advantages of EarlyCDT Lung for healthcare systems and during the period we made sales to Singapore, Denmark, Italy, Spain, Portugal, and Brazil, with further orders being shipped post period end.
In South America, our distributor, Valentech Pharma, has formed a collaboration with Brazil-based Diagnosticos da America SA (DASA), the largest medical diagnostic company in Latin America, to offer the EarlyCDT Lung blood test across its extensive clinical network. The collaboration will allow DASA to run the EarlyCDT test in its laboratories, private hospitals and clinics expanding the reach of our test within South America.
Services – Infectious Diseases (COVID-19) update
Oncimmune’s ability to discover and develop a comprehensive diagnostic tool capable of characterising the immune system’s response to COVID-19 was recently recognised with the awarding of UK Government funding. The IMmunity Profiling of pAtients with COVID-19 for Therapy and Triage (IMPACTT) programme is a collaboration with Medicines Discovery Catapult to develop and validate an Infectious Disease NavigAID panel of biomarkers that can be used in COVID-19 research. The research tool is being designed to predict both likely patient responses to the virus and the effectiveness of vaccines and treatment against it.
As part of this programme, Oncimmune is curating an extensive COVID-19 sample severity-based biorepository and data registry from 3,000 COVID-19 patients, representing a cross section of responses. This biorepository will be utilised to support the Company’s future commercial projects with a growing portfolio of biopharmaceutical customers. Work on this project is proceeding to plan and we aim to have the Infectious Disease NavigAID panel delivering data during February 2021.
The potential of this panel to anticipate the immune response to novel disease therapeutics in patients with differing disease severity, as well as predicting potential side effects to drugs, will be critical for optimising individual therapy and developing safe and effective vaccines in the fight against COVID-19. We are in detailed discussions with several global biopharmaceutical companies over the use of the panel, not only in their COVID-19 vaccine research efforts and research into targeted treatments for the symptoms caused by the virus, but also in connection with its use in other infectious diseases areas.
In October 2020, we announced the first commercial contract with Cedars-Sinai, California, US to provide antibody profiling in COVID-19 samples as composite biomarkers for this disease. Work is progressing to plan and we expect to have completed the contract in March 2021.
NHS Lung Cancer Screening Trials
The Early detection of Cancer of the Lung Scotland (ECLS) trial which was co-sponsored by Oncimmune and NHS Scotland to assess the utility of EarlyCDT Lung in earlier detection of lung cancer, successfully met its primary endpoint of reducing late-stage lung cancers and demonstrated an encouraging reduction in all-cause as well as lung cancer mortality. Oncimmune and its ECLS partners are in the late stages of planning and obtaining funding for a large, real-world, cancer control evaluation to follow-up on the promising results of ECLS. The interventional evaluation will look at a population of c.60,000 to 70,000 people and consider the value added to a screening programme by using EarlyCDT Lung to triage participants into computed tomography (CT) imaging.
Publications
During the period we continued to publish academic and clinical research to further demonstrate the strengths of our platforms. In July 2020, the academic and clinical reach of the ECLS study was expanded further with the publication of the ECLS study in the peer-reviewed European Respiratory Journal[2], providing validation of the potential to use the platform technology as a screening modality, which can detect cancer on average four years or more before standard clinical diagnosis.
In addition, during the same month, a research publication entitled ‘Profiling IgG antibodies targeting unmodified and corresponding citrullinated autoantigens in a multicentre national cohort of early arthritis in Germany’ was published in Arthritis Research & Therapy[3], demonstrating the potential to improve early Rheumatoid arthritis (RA) detection using autoantibodies, which, when combined with appropriate therapy or treatment, could substantially improve outcomes for patients. The aim of the research, led by Oncimmune’s Dr Petra Buddle and Dr Hans-Dieter Zucht, from our Dortmund ImmunoINSIGHTS business, was to assess the diagnostic potential of Immunoglobulin G (IgG) antibodies to citrullinated and corresponding native autoantigens in early arthritis. The research concluded that the autoantibody cTRA2B-IgG has the potential to improve diagnosis of early-stage RA.
In September 2020, PLOS ONE published a study led by Leeds University Academic Unit of Health Economics, supported by NIHR Leeds In Vitro Diagnostics Co-operative, and funded by The National Institute for Health Research’s SBRI Healthcare programme, which evaluated the cost-effectiveness of the EarlyCDT Lung blood test in combination with CT imaging, compared to CT surveillance alone in the diagnosis of lung cancer amongst patients with IPNs. The results of the study demonstrated that at an example cost of £70 per test, the EarlyCDT Lung blood test has a positive impact on the outcomes of those patients observed and, when used alongside CT surveillance, is a cost-effective approach to the management of patients with IPNs. The study calculated the ICER (incremental cost-effectiveness ratio) to be £2,417, substantially below the accepted £20,000 per QALY (quality adjusted life year) threshold set by NICE.
Board changes
In line with the Company’s decision to restructure its Board in order to be as agile and lean focused as possible and to support the Executives as they continue to deliver on Oncimmune’s corporate strategy, on 4 June 2020 Geoffrey Hamilton-Fairley, Non-executive Vice Chairman; Julian Hirst, Independent Non-executive Director; and Carsten Schroeder, Independent Non-executive Director, stepped down from the Board.
On 19 January 2021, Dr Cheung To also stepped down as a Non-executive Director to focus on the continued development of Genostics and Gene Group in China of which he is a director. Genostics remains Oncimmune’s exclusive partner in China and Dr Cheung To continues to work closely with Oncimmune to gain market entry in China.
We would like to thank Geoffrey, Julian, Carsten and Cheung for their continued advice and support whilst they have been on the Board of Oncimmune and wish them all the best in their future endeavours.
Outlook
The six months to 30 November 2020 has seen the Company deliver significant and profitable revenues in line with our strategy. Our ImmunoINSIGHTS business has been particularly busy with the awarding of several new contracts as well as the continued successful delivery of data analysis and reports under these contracts. For these clients we are focused on securing follow-on contracts and are actively discussing the delivery of our immune-profiling service offering across their wider clinical portfolios. We hope to be able to announce further new and follow-on contracts over the second half and anticipate scheduling these contracts to begin before the end of this financial year. This new momentum and our business development efforts have resulted in a strong pipeline of potential further contracts, and we are therefore confident in the Group’s commercial future.
Within our product business, we have seen real commercial progress, especially within the NHS with the awarding of two commercial contracts and the prospects of further NHS contracts in the near term as we drive adoption of the EarlyCDT Lung Test across the UK. In the US, we are shipping product against increased orders from our partner alongside their investment in further expanding their direct sales force, which also points to a more buoyant market for the remainder of 2021.
In summary, we are successfully delivering against our strategic objectives and have created a business which has a broad commercial offering and significant revenue growth potential. It is against this backdrop of momentum that the Board is confident of delivering increasing value to all stakeholders.
| Adam Hill Chief Executive Officer | Meinhard Schmidt Chairman |
| 15 February 2021 |
