Dr Adam Hill, CEO of Oncimmune commented: “With the fundraise in early 2018 with Genostics Company Ltd, providing access to the China market, the foundations are laid for our forward strategy.
“The year ahead presents significant opportunity with the final read-out of the ECLS study, which we anticipate will open up volume opportunities for EarlyCDT®-Lung, as well as topping off the clinical evidence base for the product in triaging asymptomatic patients to an appropriate diagnostic pathway. This, in turn, provides further confidence in our platform capability.
“Unlocking latent value in Oncimmune’s immunogenic protein library over the next three years, designed to layer on revenue to our existing clinical testing business, will open up applications to generate scale and reach wider end markets across the cancer care continuum.”
Oncimmune Holdings plc (LON: ONC), a leader in the development, manufacture and commercialisation of personalised immunodiagnostics for the screening, detection and care of cancer, today announced its full year results for the year ended 31 May 2018.
Corporate & Operational Highlights (including post-period end)
· Exclusive licence agreement signed with Genostics Company Limited (“Genostics”) for the distribution, manufacturing and future development of all products related to the EarlyCDT® platform in China
· New distribution agreements signed for EarlyCDT®-Lung test making a total of 15 agreements with total minimum sales commitments of £29.5m over their initial periods
· Continued progress on long term plan of supporting its distributors deliver high quality sales for EarlyCDT®-Lung in the US
· EarlyCDT®-Liver test for hepatocellular cancer launched in May 2018 in the US
· NHS ECLS trial continued to monitor its cohort of over 12,000 patients for occurrence of lung cancer. Final results expected in early 2019
· Data published in the Journal of Cancer Therapy and in PloS One in support of the role of EarlyCDT®-Lung in the management of indeterminate pulmonary nodules
· Dr Adam Hill, MB PhD, was appointed as new Chief Executive Officer having joined as Chief Medical Officer and Chief Strategy Officer in April 2018
· Geoffrey Hamilton-Fairley appointed to a new role as Vice Chairman of the Board
· Appointment of Dr. Cheung To and Dr. Annalisa Jenkins to the Board as Non-Executive Directors
Financial Highlights
· £10m equity investment from Genostics Company Ltd completed in March 2018
· £5m raised from new and existing investors in October 2017
· Revenue for the year was £240k (2017: £215k)
· Operating expenses before share based charges and exceptional items were £5.56m (2017: £4.88m)
· Loss before tax of £6.34m (2017: £5.32m)
· Net loss for the year was £6.34m (2017: £5.02m)
· R&D costs for the year were £1.08m of which £281k has been capitalised (2017: £1,025k of which £415k has been capitalised)
· Strong cash balance at the period end of £12.95m (2017: £5.1m)
Strategic Update
Following the appointment of Dr Adam Hill in March as Chief Medical Officer and Chief Strategy Officer in March 2018, the management and Board have undertaken a review to identify and capitalise on the wide range of opportunities presented by Oncimmune’s proprietary autoantibody-based platform that are additional to continuing to build scale and momentum in the core business.
This review has confirmed the utility of Oncimmune’s immunogenic protein library, the ability to rapidly develop in-vitro diagnostic panels to detect cancer early, and the potential of this technology to have an impact across the cancer care pathway, which presents multiple paths to increasing shareholder value.
In addition to maintaining focus on the core business of developing and commercialising clinical tests for the early detection of single cancer types, the Board believes latent value can be unlocked from Oncimmune’s platform through strategic partnerships across a breadth of applications, and with a range of partner companies. These opportunities are designed to be capital light in nature, leveraging the investment in Oncimmune’s platform to date, whilst maximising optionality, and include:
· Integrating Oncimmune’s tests into third-party established ecosystems (established installed base of testing equipment, for example, to gain access to a new and proprietary distribution channel);
· Combining EarlyCDT® products with another provider’s diagnostic tools to improve clinical decision making, and enhance market share (with another in-vitro diagnostic, or diagnostic imaging modality, for example);
· Stratifying risk for underwriters of life and critical illness risk by incorporating EarlyCDT®-Lung, and other products, to reduce claims cost; and
· Partnering with pharmaceutical companies to develop complementary diagnostics against immuno-oncology biomarkers such as PDL1 to improve therapy selection, or enhance therapy targeting.
In the coming three years, Oncimmune intends to continue delivering its core strategy, which focusses on early detection, including exploiting the potential in screening following the upcoming results from the NHS ECLS study. In addition to this, the Company will seek to enhance projected revenues from clinical tests, leveraging the investment made in the platform, by accelerating value creation through partnering across a range of applications to generate scale and reach wider end markets.
Pulmonology Distribution and Trading Update
As set out in our interim results announcement issued on 13 February 2018, our pilot distribution project with a major US pulmonology sales force was successfully completed in February 2018, and the Company has been in negotiation regarding the terms of a full distribution contract since this time. These discussions have not reached a satisfactory conclusion and, as of 30 October, the Board has agreed that discussions will cease as a firm timetable for agreement and implementation cannot be committed to by both parties. Whilst this is disappointing given the positive data points the pilot has produced, this arrangement now unlocks Oncimmune to focus more time on developing discussions with other US pulmonary salesforces with the goal of reaching an agreement that fully realises the value of EarlyCDT®-Lung in this indication.
The inability to reach agreement with the original distribution partner and the subsequent decision to engage with additional potential partners will affect the timing of revenue related to such partnerships. As a result, the Company’s revenue expectations for the current financial year are materially reduced by these events. In the meantime, Oncimmune will continue to sell to the physician practices already active from the pilot and to build the case for using EarlyCDT®-Lung to aid in assessing risk of indeterminant pulmonary nodules. In these practices, the number of tests sold has doubled despite no active sales activity since February, with newly contracted, and significantly enhanced, reimbursement rates per test being honoured
