TiGenix Business and Financial Update for the First Half of 2014

Leuven, Belgium - 26 August, 2014 - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells, or eASC's, in inflammatory and autoimmune diseases, issued an update on business and financial progress in the first half of this year today.

 Business highlights

• eASC technology platform
  • Patient recruitment for the European Phase III study of Cx601 in complex perianal fistulas in Crohn's disease is 95% complete and is expected to finish ahead of schedule. Final results from the study should now be available earlier than previously expected in Q3 2015, and European filing for marketing authorisation is planned for H1 2016
  • TiGenix confirmed its strategy for developing Cx601 for the US market
  • The clinical development plans for Cx611 in early rheumatoid arthritis and severe sepsis were completed and implementation has begun
• ChondroCelect
  • The licensing of marketing and distribution rights and the sale of the Dutch manufacturing facility was completed
  • Marketing authorisation for ChondroCelect was renewed by the European Medicines Agency (EMA)

Financial highlights

• Sales for ChondroCelect increased by 16% compared with the same period last year
• Loss for the period from continuing operations decreased by 2% compared with the same period last year
• Liquidity position of Euro 19.2 million at 30 June 2014

 "We made significant progress in the first half of 2014," said Eduardo Bravo, CEO of TiGenix. "We have transformed the operations of TiGenix to enable the company to fully focus on realising the value in its development pipeline. Our Phase III trial of Cx601 is on track to deliver results earlier than anticipated, and our intravenously administered stem cell product, Cx611, has been endorsed by international clinical experts to move forward in two areas of high unmet medical need and significant commercial potential, early rheumatoid arthritis and severe sepsis."

Outlook

 TiGenix expects to take the following steps within the next 12 to 18 months:

• Complete patient recruitment for the Phase III study of Cx601 in complex perianal fistulas in Crohn's disease, and communicate trial results in Q3 2015
• Appoint a contract manufacturing organisation for Cx601 in the US, and to begin technology transfer by the end of 2014
• File for a Special Protocol Assessment for Cx601 with the FDA by the end of 2014
• Start a mechanism of action trial of Cx611 in severe sepsis in early 2015 and communicate the results in Q3 2015
• Start patient recruitment for a Phase IIb study of Cx611 in early rheumatoid arthritis in Q3 2015

Auditor's limited review

The review of the statutory auditors, BDO Bedrijfsrevisoren Burg. Ven. CBVA, can be found in the Condensed Consolidated Financial Statements for H1 2014 in the investor section of the TiGenix website, www.tigenix.com

Interim financial statements

The interim financial statements for H1 2014 can be found in the investor section of the TiGenix website, www.tigenix.com

Webcast

On Tuesday, 26 August, at 15:00h CEST/9.00am EDT, TiGenix will conduct a conference call webcast. The following speakers will present more details on this half year update, and will take questions:

• Eduardo Bravo, Chief Executive Officer, TiGenix
• Claudia D'Augusta, Chief Financial Officer, TiGenix

The webcast can be followed live online via the link:

http://www.media-server.com/m/p/4snzq4rq

The press release and the webcast slide presentation will be made available in the Newsroom section of the TiGenix website. A replay of the webcast will be available on the website shortly after the live webcast has finished.

For more information

Richard Simpson
Senior Consultant, Comfi sprl
T: +32 494 578 278
richard@comfi.be

 Source: TiGenix news