Oncimmune Holdings plc (LON:ONC), the leading global immunodiagnostics group, today announced its half year results for the six months ended 30 November 2019.
Corporate & Operational Highlights
Product Commercial Progress
· Discussions ongoing with several potential commercial partners within NHS England, including Cancer Alliances and Clinical Commissioning Groups who anticipate using EarlyCDT Lung for clinical assessment of indeterminate pulmonary nodules (IPNs) and/or as a screening test for lung cancer.
· Increased activity across our global distributor network with expected FY H2 sales from Spain, Brazil, Malaysia and Singapore.
· Approval of both EarlyCDT Lung and EarlyCDT Liver in China remains on track, with first sales expected in Q1 of calendar year 2021.
· Completion of the strategic commercialisation agreement with Biodesix, Inc. for EarlyCDT Lung in the United States with Biodesix commercial launch expected in early March (Q1) 2020; the agreement is valued at up to $28m over the initial 5 year period.
· Exclusivity agreement with R-Pharm for the use of EarlyCDT Lung in Russia (and certain other countries) with a value of at least £5m, including milestone payments of up to £2.75m, with regulatory approval for screening expected in calendar H1 2020. In addition, R-Pharm is investing up to £3.5m in screening infrastructure in Russia.
· NICE MedTech Innovation Briefing reviewing the use of EarlyCDT Lung in the clinical assessment of IPNs.
· Presentation on the Presidential Symposium at the IASLC World Conference on Lung Cancer of positive top line results of the Early Detection of Cancer of the Lung Scotland (“ECLS”) trial with 12,209 patients, which is believed to be the largest randomised controlled study using blood biomarkers for the detection of lung cancer.
Service Commercial Progress
· A growing pipeline of potential commercial projects with major pharmaceutical companies that are at various stages of negotiation for our Dortmund Research Centre in Germany. Preparatory work on several of these projects having already commenced.
Corporate and Strategic Update
· Winner of BioNewsRound Award by One Nucleus for life science companies that have announced exciting developments for patients and the sector over the past year.
· Oncimmune’s Nottingham R&D operation completed its move to MediCity Nottingham, a dedicated innovation facility.
· Appointments of Professor Tariq Sethi as Chief Scientific Officer and Matthew Luttrell as Chief Commercial Officer.
· Revenue for the period was £0.31m (H1 2018: £0.12m). Cost of sales were £0.36m (H1 2018: £0.60m).
· Total administrative expenses were £5.11m (H1 2018: £2.63m); of which c.£1.3m relates to reshaping the business (£0.7m relate to the Biodesix and Protagen Diagnostics transactions and £0.6m relates to increased staff costs); a further £0.7m relates to the IPF credit facility and increased patent costs as the Protagen patent estate was integrated.
· The implementation of an ongoing cost reduction programme post the period has delivered annual cost savings of c.£1.0m, with the sale of the US subsidiary’s laboratory to Biodesix expected to contribute further annual cost savings of c.£2.2m.
· Research & Development costs were £1.01m (H1 2018: £0.69m).
· Comprehensive loss after tax was £5.79m (H1 2018: £3.87m).
· Cash balance at the period end of £7.51m (H1 2018: £9.05m).
· Sale of the US subsidiary’s laboratory to Biodesix for $1.0m, in quarterly instalments of $250,000 with the last payment due in July 2020.
· Secured and fully drawn credit facility of €8.5m with IPF Management SA.
Dr Adam M Hill, CEO of Oncimmune Holdings said: “We grew revenues in the period and are expecting FY H2 2020 sales to continue to accelerate through increasing product sales and from our service business. We look forward to the commercial rollout of EarlyCDT Lung in several markets, including the US, in 2020 to further expand the reach of our technology to patients. With multiple late stage negotiations underway and a strong conviction in the vital importance of our technology, we have growing confidence in the business to further change patients’ lives and deliver growth.”