Oxford, UK – 19 November 2013: Oxford BioMedica (“Oxford BioMedica” or “the Company”) (LSE: Oxford Biomedica), the leading gene-based biopharmaceutical company, today publishes its interim management statement for the period from 1 July to 18 November 2013.
OPERATIONAL HIGHLIGHTS
LentiVector® platform manufacturing
• Winner of significant conditional funding via a competitive award from UK Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI) in September
– UK consortium won £7.7 million, of which £7.1 million awarded to the Company as lead member
– Funding to support the development of a centre of excellence in Oxford for specialist manufacture of gene-based therapies and to help create world-class excellence in supply chains
LentiVector® platform product development
Ocular portfolio
• Glaucoma-GT pre-clinical evaluation demonstrated long-term gene expression out to five months
• Winner of UK Technology Strategy Board (TSB) funding award in August; £1.8 million grant for EncorStat® confirmed by the TSB in October following successful due diligence
• Agreement from the US Food and Drug Administration (FDA) and the French regulatory agency, ANSM, to resume recruitment into the RetinoStat® Phase I, StarGen™ Phase I/IIa and UshStat® Phase I/IIa studies following a voluntary pause in recruitment
ProSavin®
• Evaluation of a more potent formulation of ProSavin® (called Oxford Biomedica-102) is ongoing
• Efficacy arm of the Oxford Biomedica-102 non-clinical programme successfully completed in Q3 2013, highlights include:
– Positron Emission Tomography (PET) data analysis demonstrates direct expression of transgenes and that expression following administration of Oxford Biomedica-102 is increased relative to ProSavin®
– Behavioural and movement analysis indicates that Oxford Biomedica-102 is at least five-fold more potent than ProSavin®
• These data are sufficient to proceed to a non-clinical toxicology and bio-distribution study which is ongoing
5T4 tumour antigen platform
• TroVax® Phase II prostate cancer data and pre-treatment biomarker analyses published in Cancer Immunology, Immunotherapy
• US$1 million milestone payment from Pfizer triggered in August; Phase I clinical trial for 5T4-targeted antibody therapy underway
FINANCIAL REVIEW
At 31 October 2013, the Company had a net cash1 balance of £3.6 million. In order to give the Company further flexibility, Oxford BioMedica has entered into a conditional £5.0 million loan facility agreement with its largest shareholder, Vulpes Life Sciences Fund – see separate announcement issued today.
1. Cash, cash equivalents and available for sale investments
OUTLOOK
During the rest of 2013 and 2014, revenues are expected to be generated from intellectual property, development and manufacturing alliances and a potential significant option fee that may arise should Sanofi choose to exercise its option over RetinoStat®. Oxford BioMedica remains focused on completing the RetinoStat® Phase I study as soon as possible, generating further recurring income and developing the next generation of highly valuable LentiVector® platform product opportunities.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “The past few months have been positive on a number of fronts and operationally the Company continues to build a very strong position. The conditional £7.1 million AMSCI award gives us the confidence to develop a UK centre of excellence and to become a partner-of-choice for companies needing gene- and cell-therapy manufacturing solutions; the LentiVector® platform product portfolio continues to generate positive data; and, following extensive characterisation studies using our internal state-of-the-art analytical methods, we received support from the US and French regulatory agencies to resume recruitment into our ocular trials. With multiple opportunities ahead, the Directors remain focused on bringing further revenue into the business and creating growth at Oxford BioMedica.”
-Ends-