Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces its interim results for the six months ended 30 November 2020.
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.
· 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.“