ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

• Mesoblast (Australia): Largest adult stem cell company inthe world, after consolidation of investment in Angioblastin 2010; Mesoblast is developing its proprietary MPCpurified cell platform in a broad pipeline of products fromautologous proof of principle in orthopedic & cardiovascularindications to allogeneic trials in orthopedic, cardiac andhaematopoetic transplant in orthopedic and cardiacapplications.• Osiris (USA): Is developing a therapeutic platform basedon expanded adult stem cells from bone marrow thoughtto be useful to treat a variety of diseases by controllinginflammation, promoting growth of new tissue andpreventing scars. The proposed MoA is based on immuneprivilegeof cells and their immuno-modulatory and antiinflammatorycapabilities as well as anti-fibrotic and tissueregeneration capacities.• Pervasis Therapeutics (USA): This company is developinga platform of therapeutic products with the potential toimprove outcomes following vascular procedures based onthe ability of the body’s endothelium to regulate naturalhealing processes.Other clinical stage companies that work with adipose tissue asstem cell source include:• Anterogen (South Korea): In Phase II for perianal fistula(autologous)• Cytori Therapeutics (USA): In Phase I for chronic myocardialinfarction• BioHeart (USA): In pre-clinic for acute myocardial infarction• Cardio3bio: Is shifting development from bone marrow toadipose derived tissueThese companies either pursue a different approach in regardsto donor source (anterogen) or work with stromal vascularfraction instead of expanded stem cells (Cytori and BioHeart).6.14.9 Human resourcesCellerix counts on a team of experienced professionals in allareas required to meet its strategic objectives including medical& regulatory, manufacturing, R&D, business development,product development, infrastructures, intellectual propertyand finance.On March 31, 2011, Cellerix had a total of 33 permanentemployees and 7 mandate contractors. About 63% of thesepersons are engaged in research and development activities(including clinical development); about 13% are working inmanufacturing and about 24% are engaged in corporatefunctions.Cellerix is lead by a management team comprised of fourpersons:• Eduardo Bravo: CEO• Claudia D’Augusta: CFO• Jose Luis Bravo: VP Global Medical and R&D• Maria Pascual: VP Regulatory and Manufacturing6.14.10 FacilitiesCellerix’ GMP facilities in Madrid consist of two separate cleanrooms. The first of these was approved under GMP regulationsin 2004. In 2007, Cellerix built a second clean room that allowedtripling capacity. After this extension, Cellerix’ facilities nowconsist of two separate clean rooms that can work in parallelor used as backup if needed. TiGenix currently believes thatthe combined capacity of both clean rooms is sufficient andis fully authorized to take care of manufacturing for ongoingclinical trials, R&D activities and manufacturing for the initialcommercial roll-out of Cx601 in Europe. The manufacturingmodel is a standardized and coordinated process that isreproducible providing appropriate technology transfer byCellerix. Cellerix has undergone EMA quality scientific advice toensure that its manufacturing process is fully aligned with EMArequirements.6.14.11 Grants & subsidiesThe strategy of grants developed by Cellerix is focused onmaximizing public financing to support expenses relatedto R&D, clinical trials and IP strategy. In accordance with thisstrategy, Cellerix has obtained the following subsidies fromvarious public bodies:1. European Commission:• Marie Curie Actions program: European grants to promotehiring of European investigators coming from abroad. Forthe period 2007-2008, Cellerix received €32.000 under thisprogram to support its personnel expenses. No grants underthis program have been received since 2008.2. Spanish National R&D Plan:• Since inception and until December 2010, Cellerix hasreceived, through several call of proposals promoted bythe Spanish Ministry of Industry, Tourism and Trade, the149 •