Business Update

3 November 2015


Oxford, UK – 4 November 2015: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE: OXB), a leading gene and cell therapy group, is pleased to announce the following business update.

The Group continues to make good progress in line with its strategy across the business model, leveraging its extensive patent estate and know-how (intellectual property or “IP”) and its expertise and capabilities in the field of lentiviral vectors.

Recent developments across the three key components of the Group’s business model are summarised below. The Group has recently introduced a numbering system for product development candidates (Central nervous system products will be numbered OXB-1XX, ophthalmology products OXB-2XX, and oncology candidates OXB-3XX).

Strong progress with wholly-owned product pipeline 

  • Preparations continue according to plan to start clinical studies for OXB-102 (higher potency formulation of OXB-101 (ProSavin®)) and OXB-202 (EncorStat®) in 2016.

  • OXB-201 (RetinoStat®) – a meeting with investigators and key opinion leaders at the American Academy of Ophthalmology congress will take place in November 2015; the Group expects to announce its intentions for OXB-201 in Q1, 2016.

  • OXB-301 (TroVax®) – recruitment to the SKOPOS (mesothelioma) study has now been completed and the data are being analysed. Data publication in a peer-reviewed journal is planned for 2016.

  • OXB-302, the 5T4 targeting CAR-T (Chimeric Antigen Receptor modified T cell), is currently in research/pre-clinical development and preliminary results have demonstrated proof of concept in an industry standard model. Pre-clinical development is expected to complete during 2016.

Process development and manufacturing via OXB Solutions 

  • Batch manufacturing for Novartis continues to fully occupy Harrow House facility.

  • Harrow House facility GMP2 expansion and upgraded enabling services are likely to complete in the first few months of 2016.

  • New Yarnton manufacturing facility has been handed over by contractors to the Group – validation for GMP production is now underway, and production is expected from early 2016 creating extra capacity for Novartis, other potential customers and in-house wholly-owned pipeline requirements.

  • Novartis confirmed on 27 October 2015 that the marketing application of CTL019 for Acute lymphoblastic Leukaemia is still on track for 2016.

  • Windrush Court facility laboratory construction well underway, completion expected in the first few months of 2016.

Industry leading IP 

  • As announced on 28 October 2015, GlaxoSmithKline PLC (GSK) exercised an option to obtain a non-exclusive licence for two rare orphan disease indications under Oxford BioMedica’s LentiVector® platform technology patents. This follows an agreement signed between GSK and the Group in December 2013.

Financial position 

  • Cash at end October 2015 of £14.9m (unaudited).

  • $10m loan tranche remains available for draw down from Oberland’s $50m facility.

  • Revenue and other income in the first four months of the second half of the year has been well ahead of first four months of the first half of year.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented:

“I am pleased with the progress we are making in line with our strategy. The expansion of our two manufacturing sites and the laboratories at Windrush Court is progressing well and we are looking forward soon to the approval of the new Yarnton site for GMP manufacture. We are also working hard on preparing OXB-102 and OXB-202 for their next clinical studies, which we are planning to initiate in 2016, and identifying the development path for OXB-201.

The Group continues to be recognised for its IP and expertise and continues to have strong commercial relationships with Sanofi, Novartis and GSK. I was pleased that GSK have recently re-emphasised the value of our LentiVector® platform by exercising their options to take a licence for two rare orphan disease indications. Our revenue and other income is now beginning to grow in line with our expectations with July to October being well ahead of the first four months of the year.”

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