Unlock Your Global Business Potential: UK Regenerative Medicine and Stem Cells

1. Unlock Your Global Business Potential: UK Regenerative Medicine and Stem Cells

2. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL 1960 Sir Peter Brian Medawar is awarded the Nobel Prize in Physiology or Medicine, with Sir Frank Macfarlane Burnet, for his work on graft rejection and the discovery of acquired immune tolerance was fundamental to the practice of tissue and organ transplants. • By placing your business in the UK, your company can benefit from a rich heritage in regenerative medicine and stem cells 1972 Sir Martin Evans, university of Cambridge (Nobel Prize for Medicine 2007), isolated mouse embryonic stem cells and showed that cells could be taken directly from a mouse embryo, cultured in a dish outside the mouse’s body, genetically manipulated, and then mixed with normal mouse cells to form an embryo. 1978First IVF babyborn after Cambridge university scientists: Sir Robert Edwards (Nobel Prize for Medicine 2010) and surgeon Patrick Steptoe fertilise human eggs outside the body. 1990 Human Fertilisation and Embryology Act passed by both Houses of Parliament. Human Fertilisation and Embryology Authority (HFEA) designated statutory body to enforce provisions of legislation and established in 1991. 1996Dolly the sheep is cloned by cell nuclear replacement (CNR) techniques at the Roslin Institute in Edinburgh, led by Professor Sir Ian Wilmut. 2002 UK Stem Cell Bank established as a repository for stem cells derived from adult, foetal and embryonic tissues and to be open to academics and industrialists from the UK and abroad. 2002 Sydney Brenner, a researcher at the Medical Research Council Unit in Cambridge is awarded the Novel Prize in Physiology or Medicine for his work on the genetic regulation of organ development and programmed cell death. 2003 Researchers at King’s College London, led by Professor Peter Braude, generate the UK’s first embryonic stem cell line. 2005The UK Government sets up the UK Stem Cell Initiative, with the aim of working with the public and private sectors to draw up a ten-year vision for UK stem cell research. • The UK has led the field through ground breaking innovation as well as supportive policy and initiatives, making it easy for you to tap into world class expertise and resources • International companies are already benefiting from working in the UK

3. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL 2007Teams of researchers at Cambridge and Oxford universities independently discover a new type of stem cell in mice and rats that is very similar to human embryonic stem cells. • By placing your business in the UK, your company can benefit from a rich heritage in regenerative medicine and stem cells 2008A child suffering from gut failure was the first in the world to receive a life-saving haematopoietic stem cell transplant. Two hospitals in the UK now offer the adult stem cell therapy: Great Ormond Street and Great North Children’s. 2010ApaTech, a spin-out from Queen Mary University of London, and a world-leader in bone graft technologies is sold for $330M to Baxter. 2011UK approved Europe’s first clinical trial using human embryonic stem cells (hESCs). US based company Advanced Cell Technology (ACT) received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin a trial to treat 12 patients with Stargardt's macular dystrophy. 2011ReNeuron’sPISCES study (Pilot Investigation of Stem Cells in Stroke) is conducted in the UK and is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. 2012the UK Regenerative Medicine Platform is established, with funding from Research Councils UK, to address the technical and scientific challenges associated with translating promising scientific discoveries in this area towards clinical impact. 2012The Cell Therapy Catapult is established to grow the cell therapy industry and support the development, delivery and commercialisation of cell therapies and advanced therapeutics in the UK. 2013The House of Lords Science and Technology Select Committee, under the Chairmanship of Lord Krebs, launched an inquiry into regenerative medicine focusing on UK’s expertise in the field, the applications of this research to treatments, the regulatory and financial barriers to translation and commercialisation of the findings of this research, and international comparisons. 2012Sir John Gurdon, of the Gurdon Institute in Cambridge, together with Shinya Yamanaka, is awarded the Nobel Prize for the discovery that mature cells can be converted to stem cells. • Recognising the challenges facing the application of regenerative medicine, the UK continues to invest in, and develop this sector, supporting world-first clinical trials and financially supporting innovative new companies with non-dilutive funding

4. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK recognises the need to support industry deliver patient benefit and achieve commercial viability

5. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK holds a leading position in the science and commercial translation of regenerative medicine. Resulting in world class resources that your company can tap into: • Cutting edge, well funded, research in cell therapy and stem cells, tissue engineering, biomaterials, medical technologies and nanotechnology • Connectivitythrough specialised networks: connecting you to the research, clinical and industry base and creating opportunities for collaboration • Talent and expertise: highly skilled researchers and clinicians and regenerative medicine experts • World-classcell and tissue banking facilities available for industry • Fundingfor UK based companies through government initiatives • Leveraged funding through collaboration with academia 1 • Collaborate and work in the UK to access world class resources that are delivering results Pfizer Regenerative Medicine opened a facility in Cambridge, UK, in 2010 to lead its move into the stem cell industry. In 2011, the operation embarked on a landmark collaboration with University College London (UCL) to develop a treatment for certain forms of blindness using stem cell therapy. Pfizer noted that “locating the new laboratory in the area will give us access to one of Europe's strongest biotech hubs”.

6. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • You can tap into an established and accessible commercial supply chainthat is evolving and adapting to support regenerative medicine activities: • Ease of access to numerous specialist suppliers, and logistics providers, helping you deliver in a timely, cost effective manner • Access to storage solutions and established cold chain logistics experts • A well connected, efficient transport network connecting you nationally and internationally • Established expertise, accessible to industry, through the NHS Blood and Transplant (NHSBT) and Scottish National Blood and Transfusion Services (SNBTS) in cell and tissue collection and logistics 2 • Comprehensive supply chain and logistics allow you to deliver on time • and cost effectively Roslin Cells and the Cell Therapy Catapult partner to establish a source of clinical grade induced pluripotent stem cells (iPS) banked according to Good Manufacturing Practice (GMP) in the UK. The establishment of the cell bank with an initial £2m investment provides the UK with an important source of iPS cells acceptable to the regulatory authorities. These iPS cell lines will be available for clinical research in both academia and industry, with the initial six expected to be available by the end of 2014.

7. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Companies can work with established manufacturing facilities experienced in delivering for clinical trials • A large number of manufacturing and bioprocessing facilities • Established Good Manufacturing Practice (GMP) facilities with experience in working with industry • Advanced Therapy Medicinal Product (ATMP) manufacturing • The UK is also leading the innovative manufacturing revolution with investment into centres of excellence actively collaborating with andsupporting industry activities to develop processes and techniques for cost-effective scale up and manufacturing • Support for product developers in manufacturing innovation • Expertise in Scaffold design, fabrication and analysis 3 • Access existing manufacturing capabilities with proven ability to deliver ReNeuron is the first commercial customer for Roslin Cells’ new GMP Cellular Therapy Manufacturing Facility in Edinburgh. Under the contract, Roslin Cells will manufacture clinical-grade cell banks of ReNeuron’s CTX cell product, the basis of its ReN001 stem cell therapy for stroke and its ReN009 cell therapy for critical limb ischaemia. The work will be undertaken in Roslin Cells’ Edinburgh facility which secured its licence from UK authorities earlier this year.

8. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK is committed to delivering efficient clinical translation. Companies can access a strong health research infrastructure to deliver high quality clinical trials quickly and cost effectively • Access an infrastructure that can help you deliver • The UK is Investing £500 million annually in health research infrastructure • Support through the National Institute for Health Research (NIHR) Clinical Research Network (CRN) enabling over 25 clinical studies in regenerative medicine to take place within the NHS at the current time • Access to a single healthcare system that treats 60 million patients, generating vast volumes of structured real world data. • Access to specialist clinical expertise – Clinician led translation from bench to patient • Streamlined approvals for clinical research (Health Research Authority) • Simplified access for industry through the NIHR Office for Clinical Research Infrastructure (NOCRI), NHS Research Scotland (NRS) Permissions Coordinating Centre and Health Research Wales 4 • Access a strong clinical research infrastructure allowing you to deliver clinical trials efficiently An ongoing phase II trial to compare Autologous Chondrocytes Implantation (ACI) versus existing techniques for knee cartilage repair is being carried out over 27 UK sites (and 2 sites in Norway) with 400 patients recruited. The trial is sponsored by Keele University and is hosted by Jones & Agnes Hunt Orthopaedic Hospital NHS Trust.

9. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The Cell Therapy Catapult has been established to accelerate delivery of therapies to the patient and will work with industry by: • Taking products into clinical trial, de-risking them for further investment • Providing clinical expertise and access to NHS clinical partners • Providing technical expertise and infrastructure to ensure products can be made to GMPand delivered cost effectively • Providingregulatory expertise to ensure that products can get to the clinic safely in the shortest time • Providing opportunities for collaboration, nationally and globally • Providing access to business expertise networks and finance opportunitiesso that commercially viable products are progressed and investable propositions aregenerated • The UK hosts numerous experienced commercial and business advisors and consultancies • The UK regenerative medicine Industry has a united voice through the BioIndustry Association’s (BIA) Cell Therapy and RegenMed Advisory Committee 5 • The UK provides commercial support for all your activities The Cell Therapy Catapult and ReNeuron are collaborating on new cell therapy manufacturing technologies and assays, focusing on the development and optimisation of the processes required to scale up manufacture of the CTX cell line. The Catapult will contribute £1.3 million into the collaboration - in the form of expert knowledge, plus state-of-the-art laboratories, equipment and services, while ReNeuron will also provide facilities staff and relevant expertise.

10. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Accessing the UK market, and the National Health Service (NHS), is of strategic importance, increasing the probability of successful entry into the European market as evidenced by the number of European Headquarters in the UK: • A clear, well established regulatory framework making the UK a recognised route into the European market • Regulatory advice and support through the Medicines and Healthcare products Regulatory Agency (MHRA) and other organisations • London is the HQ for the EMA and the MHRA, making the UK a convenient base for interactions with regulators • Guidance and recommendations by the National Institute for Health and Care Excellence (NICE) are respected Europe-wide. (The Scottish Medicines Consortium (SMC), in Scotland) • The NHS allows you to deliver robust clinical trial data to support market access • NHS England has developed innovative commissioning approaches including Commissioning through Evaluation. • As the largest public health service in the world, the NHS is an ideal resource for recruiting for and conducting clinical trials; and commercialisation of innovative therapies. 6 • The UK is your gateway to Europe and the global markets In April 2013, the MHRA approved Athersys’ application to expand its ongoing Phase 2 study evaluating the administration of MultiStem® therapy to patients who have suffered an ischemic stroke. Ethics Committee review was been successfully completed in August, 2013, and enrolment at multiple United Kingdom sites will commence following the completion of final preparations at participating clinical centres.

11. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK business environment has changed; new fiscal incentives have been created to support life sciences and innovation • The UK government has introduced fiscal measures to stimulate innovation and growth for companies • There has never been a better time to develop and grow a commercial footprint in the UK in this sector 23%Corporation tax will drop further to 20% TSB Funding of industry activities from the Technology Strategy Board R&D tax credits for SMEs worth approximately 25p on every £1 (7p for large companies) Low corporation tax rate currently standing at 23 per cent decreasing further to 20 per cent by April 2015. £180m Biomedical Catalyst = £180m programme of public funding for growth Patent Box £300m Patent box: 10% corporation tax on qualifying profits To stimulate R&D partnerships between universities businesses & charities

12. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL You can work with leading clinicians and clinical centres to deliver your clinical trials easily, efficientlyand to a high quality. • Clinical success: the UK is one of the leading European countries developing Advanced Therapy Medicinal Products Figure 1: Clinical trials, in the UK, by therapeutic area • 34cell therapy clinical trials and 37cell therapy pre-clinical studies (Cell Therapy Catapult) • Expertise in numerous therapeutic indications • The UK is in the top three leading European countries developing Advanced Therapy Medicinal Products (ATMPs) in Europe Trials by stage: Data from Cell Therapy Catapult report

13. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL You can work with leading clinicians and clinical centres to deliver your clinical trials easily, efficiently and to a high quality. • Multi-disciplinary clinical successes in regenerative medicine from voice box reconstruction to tendon repair Stroke Huntington Disease Voice-box Reconstruction Multiple Sclerosis Rheumatoid Arthritis Ophthalmology Tendon repair Cardiovascular Cartilage repair Diabetes Immunotherapy Digestive Tract Oncology Liver cirrhosis

14. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Your competition is already benefiting from the UK Offer in Regenerative Medicine • Ease of doing business: a supportive business environment coupled with Government commitment to support the sector • Business incentives such as year on year reductions in corporation tax, R&D tax credits and the Patent Box, culminating in an improved business environment in the UK. • Increased funding into the sector from Government as well as UK charities • Rich and Diverse Ecosystem to tap into • World class researchers, centres of excellence and research infrastructure • A strong and growing supply chain • Established manufacturing facilities • Innovative manufacturing approaches • A single healthcare system that treats 60 million patients, generating vast volumes of structured real world data. • Unrivalled access to cell and tissue samples to enable discovery and development. • A Cell Therapy Catapult to support your activities from business models, manufacturing to clinical and regulatory expertise • Market Access: the UK, European and global markets • Clear, well established regulatory framework, harmonised for Europe • New commissioning models available for specialised products and services allowing direct access to the whole of the NHS • Strategy being developed for NHS readiness and action plan to facilitate adoption of regenerative medicine products • A track record of successful collaboration with industry • The NHS and research base working closely with industry • Available support and funding for UK based companies

15. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Our practical help and advice is free and confidential • UKTI’s professional trade and industry advisers operate in the UK alongside a network of experts based in all British diplomatic offices overseas. • UKTI can: • Provide tailored information on the UK offer and capabilities that match your business needs • Support your business journey to invest in and grow in the UK • UKTI’s Life Science Investment Organisation (LSIO) • The LSIO is here to help your business navigate the opportunity to partner with and invest in the UK and to connect you to the wider UK life science community • Find out how UK Trade & Investment (UKTI) can help your business For further details on the LSIO and the UK life sciences offer for industry, visit: www.ukti.gov.uk/lifesciences

17. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • AHSC – Academic Health Science Centre • AHSN – Academic Health Science Network • ARUK – Arthritis Research UK • ATMP – Advanced Therapy Medicinal Product • BBSRC - Biotechnology and Biological Sciences Research Council • BRC – Biomedical Research Centre • BRU – Biomedical Research Unit • CPRD – Clinical Practice Research Datalink • CtE – Commissioning through Evaluation • EMA - European Medicines Agency • EPSRC – Engineering and Physical Sciences Research Council • KTN – Knowledge Transfer Network • LRMN – London Regenerative Medicine Network • LSIO– Life Science Investment Organisation • MRC – Medical Research Council • MHRA – Medicines and Healthcare products Regulatory Agency • NHSBT – NHS Blood and Transplant • NHS– National Health Service • NICE – National Institute for Health and Care Excellence • NIHR – National Institute for Health Research • NISCHR - National Institute for Social Care and Health Research • NOCRI– NIHR Office for Clinical Research Infrastructure • OSCI – Oxford Stem Cell Institute • SNBTS – Scottish National Blood and Transfusion Services • TSB– Technology Strategy Board • UKTI– UK Trade and Investment • UKRMP – UK Regenerative Medicine Platform • WT – the Wellcome Trust • Acronyms

18. Appendix: Success Stories

19. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL ReNeuron • ReNeuron is a leading, clinical-stage stem cell business. The company’s primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need. • ReNeuron’s clinical trials in disabled stroke patients: The PISCES study (Pilot Investigation of Stem Cells in Stroke) is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. The trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. • Phase II of the stroke trial is starting with support of a £1.5 million grant from the Technology Strategy Board (TSB) • Also received regulatory and ethical approvals to commence a Phase I clinical trial in the UK with its ReN009 stem cell therapy programme critical limb ischaemia (CLI). The trial will be undertaken through NHS Tayside at Ninewells Hospital and Medical School, Dundee, Scotland. • Cell manufacturing for the trial will be carried out by Roslin Cells • Completed significant £33 million fundraising, with £7.8 million from the Welsh Government, to continue development and build a new manufacturing facility. • How the UK environment helped ReNeuron be a leader in the field

20. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Cell Medica • Founded in 2006 by Gregg Sando. Funded by the Wellcome Trust and Imperial Innovations • Three Technology Strategy Board (TSB) grants to develop and progress novel cell therapy to treat infections in children following bone marrow transplant. Partner: Great Ormond Street Hospital (GOSH) • Two other TSB grants to support manufacturing and reimbursement models • Currently running early phase trial at GOSH – with support from TSB. • Company has grown to 41 employees with offices and laboratories in London, Berlin and Houston. Three development projects – global clinical trials. • Founded in 2006 by Gregg Sando. Funded by the Wellcome Trust and Imperial Innovations • Three Technology Strategy Board (TSB) grants to develop and progress novel cell therapy to treat infections in children following bone marrow transplant. Partner: Great Ormond Street Hospital(GOSH) • Two other TSB grants to support manufacturing and reimbursement models • Currently running early phase trial at GOSH – with support from TSB. • Company has grown to 41 employees with offices and laboratories in London, Berlin and Houston. Three development projects – global clinical trials. • How the UK environment helped Cell Medica succeed “Fortunately for us the Government had identified areas of important innovation in industry - and cell therapy was one of them…Through the Technology Strategy Board's involvement, we had the benefit of collaboration with Great Ormond Street Hospital and University College London, and the opportunity to exchange ideas with other organisations working in the same field’. Karen Hodgkin, Senior Vice President of Clinical Development “Fortunately for us the Government had identified areas of important innovation in industry - and cell therapy was one of them…Through the Technology Strategy Board's involvement, we had the benefit of collaboration with Great Ormond Street Hospital and University College London, and the opportunity to exchange ideas with other organisations working in the same field’. Karen Hodgkin, Senior Vice President of Clinical Development

21. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Intercytex • Intercytex is a regenerative medicine product and services company focused on developing its lead product to treat a variety of skin related problems. These treatments are being brought to patients through Intercytex’s innovative Progressive Translation system which is available to third party clients through their Cell2Therapy CMO service • Intercytex operates a fully licensed GMP manufacturing facility and has experience in producing a variety of autologous and allogeneic 2D and 3D cell therapy products. Its current product Vavelta/ICX-RHY, an injectable allogeneic fibroblast suspension, is a good example of Intercytex applying the Progressive Translation approach: • Intercytex: using a Progressive Translation approach to take product to market • Progressive development:A close partnership between client, contract developer and hospital allowing iterative development of new treatments Progressive licensing: Focus on unmet medical need and orphan products in order to allow access to the current legislative frameworks already in place of conditional approvals. Progressive reimbursement:Obtain early reimbursement from a variety of sources that will both help development finances as well as providing marketing information • Orphan designation obtained in EU and US • Phase II clinical trialcompleted • Specials license obtained for Intercytex manufacturing facility • Biocatalyst grant to Improve shelf life and logistics to enable pharmacy supply • Working with Cell Therapy Catapult to produce less painful injection system • Created a partnership with University Hospital of South Manchester to develop Progressive Translation system and recently announced the expansion of their GMP facility onto the Manchester Airport City Enterprise Zone • Working with suppliers on scale-up options • Developed costing models for current system and scale up options • Obtained full hospital reimbursement to treat first patients under Specials • Working with charities to examine reimbursement possibilities “Fortunately for us the Government had identified areas of important innovation in industry - and cell therapy was one of them…Through the Technology Strategy Board's involvement, we had the benefit of collaboration with Great Ormond Street Hospital and University College London, and the opportunity to exchange ideas with other organisations working in the same field’. Karen Hodgkin, Senior Vice President of Clinical Development “The UK provides a unique mix of highly networked world-class scientists, a globally respected and helpful regulatory system, a National Health service and a succession of supportive Governments”, Dr Paul Kemp, Chief Executive and Chief Scientific Officer

22. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Neusentis: working in partnership with academic researchers in Cambridge and across the UK Neusentis • Neusentis is a Cambridge-based Pfizer research unit that delivers 'new science therapeutics', with a particular focus on pain and sensory disorders. It works in partnership with academic researchers in Cambridge and across the UK. • Within regenerative medicine, Neusentis is developing cell based therapies for ulcerative colitis, age related macular degeneration and a drug to regenerate neural circuit function in stroke patients. • A key partnership case study is the work being done on Cell Replacement Therapy for Age Related Macular Degeneration in the ‘London Project’. ‘The London Project’ was formed by Professor Pete Coffey (Institute of Ophthalmology, UCL) and Lyndon da Cruz (Moorfields Eye Hospital) to produce a cell replacement therapy for AMD. In 2008 The London Project teamed up with Pfizer to help move the project into the clinic so as to determine whether this cell replacement therapy was safe and whether it lead to an increase in vision in patients with AMD. The work has pulled in expertise from across the whole Pfizer organisation and the team have received approval from the authorities to proceed with the trial.

23. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL GE Healthcare Life Sciences chooses Wales for its new state of the art laboratories for cell therapy and cell bioprocessing GE Healthcare • In 2012, GE Healthcare Life Sciences, a business unit of GE Healthcare, opened its new £3 million cell science laboratories in Cardiff , Wales. The state-of-the-art investment at the company’s Maynard Centre creates is a world-class facility for research and technology innovation in cell science, to help advance the rapidly emerging fields of cell therapy and cell bioprocessing, and to support the development of new, more effective and safer medicines. • The laboratories will focus on the development of novel technologies for the rapidly emerging field of cell therapy and on advancing new cellular based tools to help pharmaceutical companies develop better and safer medicines at lower cost. The facility is equipped with the latest technologies for cell bioprocessing and cell imaging, as well as an industry-leading clean-room manufacturing facility. In addition, GE’s customers and scientific collaborators will benefit from an advanced technical training centre. “Cellular research has an extraordinary potential to address some of the world’s biggest healthcare challenges. Our investment in these new laboratories is a great milestone and demonstrates our commitment to innovation and excellence in cellular science. Here in Cardiff we have established an outstanding team of scientists, many of whom are leaders in their field, and these new facilities will allow us to greatly expand our work.”

24. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Advanced Cell TechnologyMoorfields Eye Hospital • Advanced Cell Technology, a US-based company received permission, in 2011, by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to start Europe's first clinical trial involving human embryonic stem (hES) cells. • The ongoing trial aims to treat 12 patients with Stargardt's macular dystrophy. The disease strikes people between the ages of 10 and 20, causing progressive vision loss. There is currently no treatment. • Eye surgeon James Bainbridge of Moorfields Eye Hospital and University College London leads the UK trial. • UK Approves Europe's First Embryonic Stem Cell Clinical Trial

25. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Athersys • Athersys (Cleveland, OH, US) is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. • In April 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Athersys’ application to expand its ongoing Phase 2 study evaluating the administration of MultiStem® therapy to patients who have suffered an ischemic stroke. Ethics Committee review was been successfully completed in August, 2013, and enrolment at multiple United Kingdom sites will commence following the completion of final preparations at participating clinical centres. • The study is expected to enrol approximately 136 patients in total and is currently being conducted at multiple centres throughout the United States. • Athersys is working with the Newcastle Cell Therapies Facility for production of cells for the trials • MHRA Authorizes Athersys to Expand Ongoing Phase 2 Clinical Trial of MultiStem Cell Therapy in Ischemic Stroke "The MHRA authorization will enable us to bring several leading United Kingdom stroke centres into the study, which will help us to speed the completion of the stroke clinical trial. The authorization is also noteworthy as it marks the initiation of MultiStem clinical development activity in the United Kingdom.” Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys

26. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL EPSRC Centre for Innovative Manufacturing in Regenerative Medicine collaborating with industry The EPSRC Centre for innovative manufacturing in regenerative medicine • The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine provides an integrated platform of fundamental and translational research as a ‘go-to’ resource for the regenerative medicine product developer. • It is one of the few centres in the world providing academic and industrial translational research in regulated regenerative medicine manufacturing, in order to grow the industry, deliver benefit to patients, and develop the UK research community. • It is a partnership of Loughborough, Keele and Nottingham Universities and industry, with currently around 20 industry and clinical partners. Centre institutions participate in three of the UK Regenerative Medicine Platform hubs. • The Centre places an emphasis on cost-effective, robust manufacturing system and process design with a focus on both regulatory compliance and informing the regulators, in particular with respect to the implementation and principles of good manufacturing practice. • An example of the collaborative work carried out at the centre is the collaboration with Ruskinn Technology Ltd -one of the world’s leading suppliers and manufacturers of anaerobic and modified atmosphere workstations. Ruskinn was recently acquired by The Baker Company, USA - around the development of HypoxyCOOLTM. Ruskinn “The EPSRC project has provided the essential proof of principle for HypoxyCOOLTM, and through such support has better ensured positive outcomes both in terms of the application of autologous cell production and adding value to the Ruskinn business.” Huw David Thomas, UK Commercial/Sales Manager, Ruskinn Technology Ltd

27. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL A University of Swansea spin-out joins efforts with Biotec Services International to form TrakCel TrakCel • TrakCel is an orchestration platform to safeguard patients being treated with regenerative therapies. The platform ensures that the right patient receives the right therapy at the right time and location. Efficiently tracking, tracing and documenting the movement and handling of multiple regenerative therapies with minimal resources required, using state of art technologies including biometrics, Radio Frequency Identification (RFID) and Global Positioning.  • TrakCel’s was formed as a joint venture between AwenID (a university of Swansea spin-out) and Biotec Services International (storage and distribution of unlicensed, temperature-sensitive medicinal products for use in clinical trials). • The company’s technology platform is going to be assessed by GSK in Q1 2014. As part of a Department of Business Innovation and Skills, Advanced Manufacturing Supply Chain Initiative (AMSCI) the company has received financial assistance to develop its technology for gene therapy applications.

28. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Tissue Regenix • Tissue Regenix is a medical technology company which uses a proprietary technology platform, dCELL ®, which removes cells and DNA to make replacement body parts from biological (animal) materials. • The three priority markets for the application of the technology are: Vascular; Cardiac; and Orthopaedics • A Technology Strategy Board (TSB) quality systems project led to Tissue Regenix’sdCELL® vascular patch achieving European certification in August 2010. • The dCELL® technology, which reduces the immunological response so negating the need for immunosuppressants, is already benefitting patients worlwide. • Vital translation projects such as this can be difficult for an SME to fund privately. Further support, for Tissue Regenix’s knee meniscus material, allowed the company to successfully raise £6m through an AIM listing. • Tissue Regenix is founded on IP developed solely at the University of Leeds and they continue to work with those researchers to develop future products within the portfolio. The collaboration has also helped Tissue Regenix develop quality control methodologies for their products. • How the UK environment supported Tissue Regenix