Oxford, UK - 2 March 2011: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a leading gene therapy company, today announces its preliminary results for the year ended 31 December 2010.
Operational highlights:
ProSavin(R) : Parkinson’s disease
-- Safety and tolerability endpoints sustained for >2 years, now extended to nine patients
-- Two-year Phase I/II data indicate long-term efficacy at lowest (1x) dose level
-- Improvements in “ON” time and quality of life, with stable or reduced L-DOPA, in all cohorts to date
-- Enhanced administration procedure is safe and reduced surgery delivery time at the 2x dose
-- Data Monitoring Committee supports progression to higher (5x) dose level cohort with initial data expected mid-2011
Ocular gene therapies: partnered with sanofi-aventis
-- RetinoStat(R) IND approval received from the FDA
-- StarGen(TM) CTA and IND dossiers submitted to AFSSAPS and FDA
-- First data from RetinoStat(R) Phase I study expected H1 2012
TroVax(R) : cancer
-- Phase II study in hormone refractory prostate cancer initiated with initial data expected from mid-2012
-- Positive TRIST analyses published in Clinical Cancer Research
-- Multiple collaborative studies expected to start in 2011
Financial highlights(1) :
-- Revenue of GBP11.2 million (2009: GBP19.1 million including exceptional revenue GBP10.1 million)
-- Research & development costs incl. exceptional items of GBP19.9 million (2009: GBP18.3 million)
-- Exceptional loss (impairment) of GBP3.9 million (2009: exceptional profit of GBP6.0 million)
-- Net loss before exceptional items of GBP6.3 million (2009: GBP9.5 million)
-- Net loss after exceptional items of GBP10.3 million (2009: GBP3.5 million)
-- Net cash burn(2) of GBP13.0 million (2009: net cash generated(2) GBP3.0 million)
-- Net cash(3) of GBP12.3 million (2009: GBP25.3 million)
1. Audited financial results
2. Net cash used in /generated from operating activities plus sales and purchases of non-current assets and interest received
3. Cash, cash equivalents and available for sale investments
Post-period end highlights:
-- Fundraising of GBP20 million before expenses, completed on 10 January 2011
-- Acquisition of manufacturing facility for GBP1.9 million, completed in February 2011
John Dawson, Chief Executive Officer at Oxford BioMedica, said: “2010 has been a successful year for Oxford BioMedica and our progress to date underlines the Company’s strong fundamentals. We continue to build the value of our lead programmes and expect key data and milestones over the next 12-18 months for ProSavin(R) , TroVax(R) and the ocular products partnered with sanofi-aventis. Thanks to existing and new shareholders we were also able to secure GBP20 million of funding which will enable us to maximise the opportunities ahead, including the enhancement of our specialist manufacturing processes. With exciting future prospects, we remain committed to driving momentum and delivering value for shareholders.”
Analyst meeting: An analyst briefing will be held at 9:30am GMT on Wednesday 2 March 2011 at the offices of M:Communications, CityPoint, 1 Ropemaker Street, London, EC2Y 9AW.
Webcast: Simultaneously to the analyst briefing at 9:30am GMT, there will be a live audio webcast of the presentation. To connect to the webcast facility, please visit the Company’s website: www.oxfordbiomedica.co.uk approximately 10 minutes (9:20am GMT) before the start of the briefing. A replay will be made available shortly after the presentation.
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
John Dawson, Chief Executive Officer
Andrew Wood, Chief Financial Officer
Lara Mott, Head of Corporate Communications
Singer Capital Markets Limited: Tel: +44 (0)20 3205 7500
Shaun Dobson/Claes Spang
Media/Financial Enquiries: Tel: +44 (0)20 7920 2342
Emma Thompson/Amber Bielecka/Katja
Toon
M:Communications
1. Oxford BioMedica
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company’s technology platform includes a highly efficient LentiVector(R) gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer. Further information is available at www.oxfordbiomedica.co.uk.
CHAIRMAN’S STATEMENT
“2010 was an important year for Oxford BioMedica. In particular, we made considerable progress across our lead development programmes and this, in turn, has augmented active discussions with potential partners. The Company is actively pursuing partnering deals on a number of fronts in order to deliver real shareholder value. In addition, Oxford BioMedica completed a GBP20 million fundraising in January 2011 and, while this was highly dilutive for some shareholders who did not participate in the issue, the Directors believe that strengthening the balance sheet, securing funds for a dedicated LentiVector(R) platform manufacturing facility and being able to keep ProSavin(R) on track will be fundamental to maximising the opportunities to complete revenue-generating deals over the next 18 months.”
Oxford BioMedica is one of the leading companies in gene therapy and immunotherapy with a platform of exclusive and pioneering technologies to design and develop unique gene-based medicines. Our pipeline addresses diseases for which there is currently no treatment or that are inadequately treated today, including cancer, neurodegenerative and ocular diseases, and our product candidates have the potential to transform treatment landscapes. Through our in-house development programmes and our collaborations with leading industry partners, our goal is to improve the lives of patients with debilitating and life-threatening diseases.
World-class industry collaborations
In January 2011 the first of four ocular gene therapies partnered with sanofi-aventis, RetinoStat(R) , started Phase I clinical development in the first US study using our LentiVector(R) platform technology. This represents a major event for the Company and demonstrates our ability to bring novel products into first-in-man studies within an impressive timeframe following the initiation of this landmark collaboration in 2009. In addition, Pfizer has strengthened its commitment to develop product strategies to target Oxford BioMedica’s proprietary 5T4 tumour antigen for the treatment of cancer. These partnerships are an endorsement of our innovative LentiVector(R) technology and 5T4 tumour antigen platforms.
Increasing value
Our lead development programmes, ProSavin(R) and TroVax(R) , also made strong progress during the period. The final cohort using the higher 5x dose of ProSavin(R) is underway and is expected to generate key results in H2 2011. Following approval by the US regulatory agencies, TroVax(R) is also in Phase II development after positive analyses of previous Phase III data (published in Clinical Cancer Research in November 2010) demonstrated that patients who are likely to respond well to TroVax(R) can be identified by a simple blood test. Data generated from these clinical programmes add further value to these important assets and take the Company closer to securing licensing deals.
Board changes
Two new independent Non-Executive Directors, Dr Paul Blake and Dr Andrew Heath, were appointed to the Board at the start of 2010. Both Paul and Andrew are industry veterans with extensive experience in building successful biopharmaceutical companies internationally. At the same time, Mark Berninger retired from the Board having served as a Non-Executive Director for more than ten years. In June 2010 Nick Woolf stepped down as Chief Business Officer and Executive Director following seven years as a member of the senior management team. I would like to record my sincere thanks to Mark and Nick for their dedicated services to the Company.
Strategy commitment
Our mission is to build a top-tier profitable biopharmaceutical company founded on the successful development and commercialisation of novel gene-based medicines. In addition, we continue to evaluate partnership opportunities and value-enhancing corporate activity to accelerate profitability.
In conclusion
Firstly, I would like to thank our staff for their commitment and hard work over the past year; we could not have accomplished as much during 2010 without their dedication. Secondly, I would also like to thank our partners and shareholders for their support. With significant opportunity ahead, I believe that Oxford BioMedica is poised to deliver strong growth and success.
Dr Alan Kingsman
Chairman
CHIEF EXECUTIVE’S STATEMENT
“During 2010 we delivered positive momentum across our lead development programmes as a result of favourable data, successful regulatory approvals and continuous hard work within the Company. We also secured further financial support, thanks to existing and new shareholders, in January 2011. Looking forward, we have established a strong platform from which to maximise opportunity and achieve further success.”
