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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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• Two allogeneic adult stem cell platforms formingthe basis of an R&D engine. The acquisition of Cellerixprovides <strong>TiGenix</strong> with a second adult stem cell platform,which the Company can utilize to target a broader rangeof therapeutic indications. Cellerix’ allogeneic expandedadipose derived stem cells (“eASCs”) platform has beenextensively characterized in line with EMA requirements andbenefits from exhaustive preclinical and CMC packages thathave been discussed with EMA in various occasions. Theimmunomodulatory properties of these cells offer potentialnovel treatments for autoimmune and inflammatorydiseases and promising preclinical results have beenachieved. This complements <strong>TiGenix</strong>’ existing proprietarystem cell platform which exploits the Company’s in-depthknow-how of the biology of the joint, its tissues and stablecartilage.• Key opinion leader support. The evidence-basedapproach <strong>TiGenix</strong> has followed throughout thedevelopment of its lead products has been appreciatedby leading orthopaedic surgeons. The composition ofthe Company’s scientific and clinical advisory board is areflection hereof.• A clear focus on major unmet medical needs. <strong>TiGenix</strong>has a clear and singular focus on Regenerative Medicineand cell therapy approaches to treat major unmet medicalneeds within joint disorders and autoimmune andinflammatory diseases, which include some of the largestand fastest growing disease areas in Western societies aswell as debilitating conditions with well defined patientpopulations.• In-house industrial cell manufacturingcapability. Since its inception, the Company has focusedon manufacturing excellence. The in-house competence,the approved GMP licence and GMP accredited facilitiesin Spain are key assets to further develop its leadershipposition in the field of Regenerative Medicine and celltherapy.• Solid intellectual property and commercialprotection. <strong>TiGenix</strong> has built a strong intellectual propertyportfolio consisting of patents and trade secrets surroundingthe Company’s genetic markers, cell culture methods, stemcell technologies and platforms, biomaterials and medicaldevices. The Company’s core patents have been granted inEurope and the US while several others are pending. TheCompany’s lead clinical stage program, Cx601, has beengranted orphan drug designation by the EMA, which confersup to 10 years’ marketing exclusivity from the date of theproduct’s launch as well as other significant benefits.• Experienced management team. <strong>TiGenix</strong>’ managementteam contains a strong mix of highly experiencedprofessionals with a track record in the biomedical andpharmaceutical fields. The team has shown its ability todeliver by bringing the Company’s lead products to themarket as well as gaining GMP certification for commercialmanufacture of cell-based therapies, and in doing so hasbuilt up a unique expertise in the field of RegenerativeMedicine and cell therapy.• Strong balance sheet. As a result of the Contributionand assuming that the Offering will be fully subscribed to,<strong>TiGenix</strong> will have approximately €33 million in cash andequivalents and short term investments on completion ofthe Offering, which will support commercialisation of theCompany’s regulatory approved products and developmentof clinical and preclinical stage products.Reasons for the OfferingThe principal purposes of the Offering are to support theCompany’s growth, to increase the Company’s capitalisationand financial flexibility.If the Offering is fully subscribed, the net proceeds from theissue of the offered shares are estimated to be €13.9 million,which will be allocated to the Company. For further informationon the costs and expenses of the Offering, see section 3.10 ofthe prospectus.The Company intends to use the net proceeds of the Offeringfor research and development, clinical trials, sales andmarketing, working capital, capital expenditure, acquisitionsif and when they present themselves, and other generalcorporate purposes.More specifically, the Company intends to use the net proceedsof the offering as follows (in order of priority):• To ensure market access, pricing & reimbursement ofChondroCelect and ChondroMimetic in Europe;• To complete the commercial launch and European marketroll out of ChondroCelect and ChondroMimetic andmaximize product sales;6 • <strong>TiGenix</strong> • Rights Offering

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