Oncimmune Holdings plc (LON:ONC), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT® liquid biopsy platform technology, today announced its interim results for the half year ended 30 November 2017.
Corporate & Operational highlights (including post-period end)
EarlyCDT®-Lung Commercial Progress
· Framework agreement with Genostics Company Limited (“Genostics”) for China signed
o Exclusive licence for the distribution, manufacturing and future development of all products related to the EarlyCDT® platform
o Royalty payments of 8% to 12.5% with minimum royalties over the first six years post market entry of £15.7 million, and £5 million (index linked) per year thereafter
o £10m equity investment in Oncimmune with first investment tranche of £7m completed on 29 January 2018
· New agreements signed in multiple territories
o EarlyCDT®-Lung kit has minimum payment guarantees of £7.9m over the next five years in Asia Pacific (not including China).
o EarlyCDT®-Lung kit has minimum sales commitment of approximately £2.0m over the next five years in Europe
· First commercial batches of the EarlyCDT®-Lung kit shipped to distributors for introductory testing prior to full market release
· Distributor base in the US being trained for the sale of our EarlyCDT®-Lung test
· Preliminary distribution partnership progressing well with a major US pulmonary sales force for the use of EarlyCDT®-Lung in assessing indeterminate lung nodules:
o Initial phase is expected to complete by the end of the month
o Following completion, the parties will assess the results and, if successful, it is expected that this should lead to a distribution agreement for the U.S. pulmonologists
· “Finger stick” test launched, increasing speed and simplicity of EarlyCDT®-Lung test
R&D and Trials
· Development of the kit version of our EarlyCDT® tests is helping expand our geographical reach and we expect to make significant progress on this going forward
· Validated EarlyCDT®-Liver test and on track to begin commercial sales in H1 2018
· NHS lung cancer screening trial is fully recruited: 12,210 patients with final study results in 2019
Personalised Medicine & Companion Diagnostics
· Presented data on the use of Oncimmune’s technology to predict disease recurrence in patients undergoing immunotherapy for malignant melanoma in collaboration with Scancell Holding plc
· Autoantibody “fingerprint” technology development progressing well; first publications presented at the IASLC in November 2017
o Reaffirmed the early detection capabilities of the EarlyCDT® platform with patients on average showing an early detection lead-time of four years
Board Changes
· Appointment of Dr. Annalisa Jenkins to the Company’s Board as an Independent Non-Executive Director
Financial Highlights
· Revenues of £0.1m (2016: £0.1m) generated from early sales of the EarlyCDT®-Lung test
· Loss before one-off and non-cash items of £3.04m (2016: £2.3m) reflecting recruitment of staff, product development and commercialisation activities
· £5.0m raised from new and existing investors
· Cash balance at the period end was £6.3m (H1 2016: £7.6m)
· Post period end receipt of first tranche equity subscription of £7.0m from Genostics making the cash balance £11.8m at the time of these results
Geoffrey Hamilton-Fairley, CEO of Oncimmune Holdings Plc said: “Oncimmune continues to make excellent progress in delivering on the potential of our platform to detect up to four years earlier than other methods based on a simple, robust, blood test – a liquid biopsy.
We have recently entered an exclusive distribution and product development agreement in China which includes a £10m equity investment and £15.7m in minimum royalties. We have now secured agreements for 12 countries with minimum sales commitments of £25.6m. We have also entered a preliminary distribution partnership with a major US pulmonology salesforce which is progressing well and, if successful, should lead to a significant distribution agreement focused on the risk detection of indeterminate pulmonary nodules – a large and growing market.
With our R&D programme delivering new tests and commercial opportunities in personalised medicine and companion diagnostics, we are excellently placed to deliver value in the medium and long term.”
