ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

• Clinical stage pipeline. TiGenix’ lead clinical developmentstage product, Cx601, successfully completed Phase II clinicaltrials in 2010 and received positive scientific advice fromEMA in March 2011. Cx611 has recently commenced Phase I/IIclinical trials and is targeting Rheumatoid Arthritis (RA), withthe potential to become a product offering a substantialrevenue stream to the Group in the mid-term.• Two allogeneic adult stem cell platforms formingthe basis of an R&D engine. The acquisition of Cellerixprovides TiGenix 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 TiGenix’ 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 TiGenix 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. TiGenixhas 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.• Solid intellectual property and commercialprotection. TiGenix 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. TiGenix’ 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,TiGenix 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.As a result of the Contribution, the Company acquired all sharesin Cellerix. Further details on the competitive strengths ofCellerix are provided in section 6.14.2.• In-house industrial cell manufacturing capability.Since its inception, the Company has focused onmanufacturing excellence. The in-house competence, theapproved GMP licence and GMP accredited facilities in Spainare key assets to further develop its leadership position inthe field of Regenerative Medicine and cell therapy.106 • TiGenix • Rights Offering