Geoffrey Hamilton-Fairley, CEO of Oncimmune said of the Interims: “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 GBP10m equity investment and GBP15.7m in minimum royalties. We have now secured agreements for 12 countries with minimum sales commitments of GBP25.6m. 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.”
Oncimmune Holdings plc (LON:ONC), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT(R) 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(R)-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(R) platform
o Royalty payments of 8% to 12.5% with minimum royalties over the first six years post market entry of GBP15.7 million, and GBP5 million (index linked) per year thereafter
o GBP10m equity investment in Oncimmune with first investment tranche of GBP7m completed on 29 January 2018
-- New agreements signed in multiple territories
o EarlyCDT(R)-Lung kit has minimum payment guarantees of GBP7.9m over the next five years in Asia Pacific (not including China).
o EarlyCDT(R)-Lung kit has minimum sales commitment of approximately GBP2.0m over the next five years in Europe
— First commercial batches of the EarlyCDT(R)-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(R)-Lung test
— Preliminary distribution partnership progressing well with a major US pulmonary sales force for the use of EarlyCDT(R)-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(R)-Lung test
R&D and Trials
— Development of the kit version of our EarlyCDT(R) tests is helping expand our geographical reach and we expect to make significant progress on this going forward
-- Validated EarlyCDT(R)-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(R) platform with patients on average showing an early detection lead-time of four years
— Appointment of Dr. Annalisa Jenkins to the Company’s Board as an Independent Non-Executive Director
-- Revenues of GBP0.1m (2016: GBP0.1m) generated from early sales of the EarlyCDT(R)-Lung test
— Loss before one-off and non-cash items of GBP3.04m (2016: GBP2.3m) reflecting recruitment of staff, product development and commercialisation activities
-- GBP5.0m raised from new and existing investors -- Cash balance at the period end was GBP6.3m (H1 2016: GBP7.6m)
— Post period end receipt of first tranche equity subscription of GBP7.0m from Genostics making the cash balance GBP11.8m at the time of these results