ANNUAL REPORT 2012 - TiGenix

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a patent family of one granted Spanish patent, also pending in CA, CN, JP, SG, IL, US, EP, KR, AU and IN protecting a nonosteochondral derived multipotent adult stem cell population, characterized by a set of markers. Additionally the patent claims methods for identifying and isolating such cells, its method of identification and isolation, as well as pharmaceutical compositions and therapeutic uses in healing and tissue regeneration. - “Use of adipose tissue-derived stromal stem cells in treating fistula” (PCT Publication WO2006136244) : a patent family pending in CA, CN, JP, IL, US, BR, EP, KR, AU, RU & IN; granted in AU; NZ; RU; SG & MX. Protects an adipose derived stem cell composition characterized by a panel of cell surface markers, methods of preparation of such a composition and the use thereof in treating fistulas. - “Use of adipose tissue derived mesenchymal stem cells for the treatment of graft versus host disease” (PCT Publication number WO2007065927) : a US application protecting the use of a stem cell population in the treatment of graft versus host disease. - “Uses of mesenchymal stem cells” (PCT Publication number WO/2010/015929) : a patent family of US, EP, JP, KR, CA & AU applications protecting the use of a stem cell population in the treatment of sepsis. - “Use of CXCL6 chemokine in the prevention or repair of cartilage defects” (PCT Publication number WO2005014026) : a patent family of granted patents in AU, JP, NZ, RU, SG, US and EP (validated in 21 countries) pending in CA, IL and NO protecting the use of CXCL6 in the repair of cartilage defects. - “Cell populations having immunoregulatory activity, method for isolation and uses” (PCT Publication number WO2007039150) : a patent family pending in CA, CN, JP, SG, IL, US, MX, EP, KR, AU & IN claiming a stem cell population, methods for the isolation thereof, their use in the preparation of regulatory T-cells and cell therapy of autoimmune diseases and chronic inflammation. - “Isolation of precursor cells and their use for tissue repair” (PCT Publication number WO2008/061804) : a patent family of granted patents in the US and EP (validated in 19 countries) pending in CA and the US protecting aspects of CDMP1+ cells useful in cartilage regeneration. Chondrocyte markers : Other cell therapy applications : - “Biomaterial for suturing.” (PCT Publication number WO2006035083 ): a patent family of US & EP pending applications and a Spanish granted patent protecting a suturing biomaterial coated in stem cells and its therapeutic use. - “In vivo assay and molecular markers for testing the phenotypic stability of cell populations, and selecting cell populations for autologous transplantation” (PCT Publication number WO2001/24833) : a patent family of granted patents in CA, US and EP (validated in 20 countries) pending in HK, EP and the US protecting biomarkers for chondrocyte development. 74 TiGenix I annual report 2012
- “Marker genes for use in the identification of chondrocyte phenotypic stability and in the screening of factors influencing cartilage production” (PCT Publication number WO2008/061804) : a patent family of pending patents in the US, EP, AU, CA, CN, HK, IN, IL, JP, NO, RU & SG; granted in NZ. This patent family protects a biomarker panel for chondrocyte development. eASC technology improvements : - “Compositions comprising adipose stem cells” (PCT Publication number WO/2010/070141) : a patent family of EP, US & JP applications protecting microencapsulated adipose derived stem cells and their use in therapeutic applications. Cell therapy delivery patents : - “Injection Device” (PCT Publication number WO/2009/141727) : a patent family of EP, US & JP applications protecting an injection device of use in the administration of cellular therapies. - “Methods and compositions for use in cellular therapies.” (PCT Publication number WO/2009/141727) : a patent family of BR, CA, MX, SG, US, CN, JP, IL, KR, AU, IN, NZ, RU & EP applications protecting novel methods for the intralymphatic administration of cellular therapies, cell composition, kits and therapeutic uses including in the treatment of autoimmune and inflammatory disorders. - “Cells, nucleic acid constructs, cells comprising said constructs and methods utilizing said cells in the treatment of diseases.“(PCT Publication number WO/2010/052313) : a patent family of AU, CA, KR, EP, US & JP applications protecting a genetically engineered adipose derived stem cell, nucleic acid expression constructs, methods for the preparation thereof, kits and uses of the cells in the preparation of regulatory T-cells and in the therapy of diseases. - “Stem cell culture media and methods.” (PCT Publication number WO/2012/032112) : a PCT application that protects a culture medium and cell culture methods. - “Methods and compositions for use in cellular therapies.“ (PCT Publication number WO/2012/095743) : a PCT application protecting novel compositions, dosage and dosage regimens for the intralymphatic administration of cellular therapies, cell composition, kits and therapeutic uses including the treatment of autoimmune and inflammatory disorders. - “Biopsy Device” (PCT Publication number WO/2010/092100) : a patent family of AU, CA, CN, EA, IL, IN, EP, US & JP applications protecting a device suitable for taking cartilage biopsies. - “Cell populations having immunoregulatory activity, methods for the preparation and uses thereof.” (PCT Publication number WO/2012/123401) : a PCT application protecting a population of adipose derived stem cells as characterized by cell surface markers. The application also claims methods for the preparation of said cell populations as well as kits, therapeutic applications and the use of said cell populations in the preparation of regulatory T-cells. 75
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ANNUAL REPORT 2012
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9. MAJOR SHAREHOLDERS 103 9.1. OVER
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There can be no assurance that TiGe
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educing their ultimate value to the
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eimbursement in certain instances s
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or the relevant manufacturing proce
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In recent years, it expanded its op
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making this change may be costly an
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TiGenix’s development stage produ
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qualified employees and consultants
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1. Introduction Annual report 2012
Page 23 and 24: 2. Persons Responsible for the Cont
Page 25 and 26: 4. Selected Financial Information Y
Page 27 and 28: 5.3. ORGANISATIONAL STRUCTURE TiGen
Page 29 and 30: Date Transaction Number and class o
Page 31 and 32: Date Transaction Number and class o
Page 33 and 34: (12) The shares were subscribed to
Page 35 and 36: 5.5. DESCRIPTION OF RIGHTS AND BENE
Page 37 and 38: Formalities to attend the sharehold
Page 39 and 40: amendments to the Articles of Assoc
Page 41 and 42: the existing shareholders have a pr
Page 43 and 44: Issue date Term Number of warrants
Page 45 and 46: 6. Business Overview Most of the in
Page 47 and 48: 6.2. COMPETITIVE STRENGTHS The Comp
Page 49 and 50: 6.3. IMPORTANT EVENTS IN THE DEVELO
Page 51 and 52: 6.3.5. Funding history Since its in
Page 53 and 54: non-weight bearing area of the join
Page 55 and 56: 6.4.5. Commercial launch ChondroCel
Page 57 and 58: und Behandlungsmethode”) in sever
Page 59 and 60: Therapeutics (product Hyalograft C)
Page 61 and 62: Different routes of administration
Page 63 and 64: Clinical development In January 201
Page 65 and 66: evenues from this pipeline within t
Page 67 and 68: that the average cost of treatment
Page 69 and 70: TiGenix has obtained cGMP status fo
Page 71 and 72: Biologics for treatment of Rheumato
Page 73: of the patents and patent applicati
Page 77 and 78: manufacturing process and therapeut
Page 79 and 80: Invalidation of US patent US6777231
Page 81 and 82: 7. Corporate Governance 7.1. GENERA
Page 83 and 84: 7.2.3. Independent directors As to
Page 85 and 86: 7.2.4. Composition of the Board of
Page 87 and 88: of Ravago NV, Vanbreda Risk & Benef
Page 89 and 90: Litigation statement concerning the
Page 91 and 92: As proof of the independence and an
Page 93 and 94: for their healthcare and biotechnol
Page 95 and 96: 7.5. SCIENTIFIC ADVISORY BOARD AND
Page 97 and 98: As of the date of publication of th
Page 99 and 100: (rounded down to the nearest intege
Page 101 and 102: usiness at customary market conditi
Page 103 and 104: 9. Major Shareholders 9.1. OVERVIEW
Page 105 and 106: 10. Financial Statements : General
Page 107 and 108: 11. Consolidated Financial Statemen
Page 109 and 110: 11.3. CONSOLIDATED STATEMENT OF CAS
Page 111 and 112: The consolidated financial statemen
Page 113 and 114: 11.5.2.2. Basis of consolidation Th
Page 115 and 116: are provided and costs are incurred
Page 117 and 118: of interest on the remaining balanc
Page 119 and 120: Deferred tax assets and liabilities
Page 121 and 122: - Partnering of Cx601 (i.e. finding
Page 123 and 124: The Group is mainly exposed to the
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fiscal year 2010, reference is made
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Sales and marketing expenses Years
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The number of employees in the R&D
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Analysis of profit/(loss) for the p
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(8) Disposal group held for sale Th
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(10) Property, plant and equipment
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The decrease of stock in 2012 compa
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dividends will be based upon the Co
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alance. As a consequence, the Compa
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(23) Other current liabilities The
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TiGenix SAU - Stock options Prior t
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(25) Business combination Descripti
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(26) Related party transactions Tra
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(28) Commitments and contingencies
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(30) Consolidation scope Name Subsi
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We believe that the audit evidence
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assets and liabilities, its financi
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the results of its operations and c
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12.2. STATUTORY BALANCE SHEET 2010-
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The value of receivables is reduced
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13. Annual Report of the Board of D
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2013. The facility will provide the
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year ended December 31, 2011, and T
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Operating result (EBIT) and net res
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Statement of financial position The
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- The total personnel costs of EUR
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- TiGenix may fail in successfully
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continue as a going concern and to
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Functioning of the Board of Directo
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The nomination and remuneration com
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Apart from the above remuneration f
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Shares and warrants held by indepen
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- Long-term incentive plan : warran
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Shares and warrants held by executi
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- identifying and implementing busi
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actual bonus equal to 78 % of her p
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was reduced to a half-time role com
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14. Business and Financial Update a
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Financial results for the full year
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15. Available Documents The Company
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Title Country Application number Ce
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Title Country Application number Is
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Country Trademark Classes USA CELLE
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ANNUAL REPORT 2012 - TiGenix

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