Oxford, UK – 3 November 2014: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: Oxford Biomedica), a leading gene and cell therapy company, today publishes its interim management statement for the period from 1 July to 31 October 2014.
OPERATIONAL HIGHLIGHTS
LentiVector® platform
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New contracts signed with Novartis worth up to $90 million over the next three years and additional potential undisclosed royalties on future sales of CTL019 and other CAR T cell products
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Novartis paying $14 million upfront including a $4.3 million equity subscription for a non-exclusive worldwide development and commercialisation licence in oncology under the Group’s LentiVector® platform
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Novartis granted an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products on arising IP from the process development collaboration.
RetinoStat®
The Company is pleased to announce that the RetinoStat® Phase I study has met its primary end points of safety and tolerability at 6 months post-surgery. The study protocol requires patients to be followed up to 48 weeks after dosing. After the last patient’s 48 week follow-up visit in March 2015 the Company will be able to finalise the clinical study report and assess the final data and strategy thereafter.
Combined LentiVector® and 5T4 platforms
The Company announces that it has initiated a pre-clinical research programme to establish proof-of-concept for a Chimeric Antigen Receptor (CAR) T-cell therapy for cancer that combines the specificity of the 5T4 antigen with the delivery efficiency of our proprietary Lentivector® platform. The goal is to exploit the power of CAR T-cells to target 5T4 expressed on tumour cells from a range of different cancers.
Acquisition of Windrush Court
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Acquired the freehold of the Windrush Court office and laboratory facilities for £3.2 million
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Consolidates entire activities on one site, improving operational effectiveness and provides additional capacity for anticipated expansion of operations
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Expected to recover the purchase cost within four years on rental and service charge costs.
Management changes
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With immediate effect, Oxford BioMedica’s new senior executive decision making body will be the Senior Executive Team, comprising the four executive directors, John Dawson, Tim Watts, Paul Blake and Peter Nolan, together with Kyriacos Mitrophanous and James Miskin
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Appointment of Paul Blake as Chief Development Officer from 1 September 2014 as previously announced – Paulhas responsibility for the clinical development of the Company’s pipeline of gene and cell therapies. Paul was previously a Non-Executive Director and remains a Director of the Company
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Peter Nolan’s role has now broadened to become Chief Business Officer, covering Business Development, IP, Quality Control & Assurance, Health & Safety and Facility Management. Peter joined Oxford Biomedica in 1997 and has been a Board member since 2002
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Kyriacos Mitrophanous becomes Chief Scientific Officer, covering identification/evaluation of new scientific opportunities, cell & vector engineering, analytical development, and pre-clinical product development. Kyriacos joined the Company in 1997
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James Miskin becomes Chief Technical Officer, covering manufacturing operations and manufacturing process development, including the capacity expansion projects. James joined the Company in 2000.
FINANCIAL REVIEW
In June 2014 the Company raised net proceeds of £20.1 million and had a cash balance of £18.3 million at 30 June 2014. Taking into consideration the equity investment and upfront payments from Novartis and the likely revenues from the manufacturing and process development activities under the new contracts with Novartis, the Company has sufficient funds for the foreseeable future.
OUTLOOK
The Company has several key priorities for the next few months. First, Oxford BioMedica will ensure that the process development and manufacturing activities with Novartis make excellent progress. Secondly, the Company will put into action the capacity expansion plans required to ensure we can deliver in line with demand over the initial 3 year Novartis contract. In parallel Oxford BioMedica will continue to drive forward the product development programmes. In particular the Company will finalise the follow-up and analysis of the RetinoStat® Phase I study to determine the optimal future path in the first half of 2015, and will continue the preparatory work required prior to the start of clinical studies for EncorStat® and Oxford Biomedica-102. The Company will also continue to look for new product development ideas, such as the CAR-T 5T4 programme announced above. Finally, Oxford BioMedica will continue to seek out further revenue-generating contracts from licensing its technology or providing process development and manufacturing services to other third parties.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “The signing of our recent major agreement with Novartis is transformational for Oxford BioMedica. The contracts endorse our unique expertise and capabilities in the gene and cell therapy field and the strength of our LentiVector® IP position. They also fundamentally change our financial prospects as the revenues in the next 3 years could allow us to become operationally cash positive and there is the potential for additional longer term revenues from royalties. This financial transformation will allow us to take forward our enviable pipeline of gene and cell therapy candidates and I look forward to reaching the upcoming value inflection points across our portfolio as well as realising the benefits of our sought after manufacturing capabilities.”
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