TiGenix : Business Update & Financial Highlights for the First Half of 2013

Leuven (BELGIUM) - August 20, 2013 - TiGenix NV (NYSE Euronext: TIG), the European leader in cell therapy, gives an update of its business activities and provides key financial data for the half year ending June 30, 2013.

Business highlights 

• ChondroCelect:
  • ChondroCelect sales EUR 2.3 million, up 55% from H1 2012
  • ChondroCelect obtains national reimbursement in Spain
• Product development pipeline
• ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula enrollment on track
• Cx611 Phase IIa in rheumatoid arthritis (RA) shows good safety data and first evidence of therapeutic activity in RA patients
• Madrid production facility renews GMP license
• Corporate:

Financial highlights

• ChondroCelect sales of EUR 2.3 million
• Loss for the period reduced by 11%
• EUR 3.7 million cash on hand at June 30 (and, after private placement completed on July 26, EUR 8.9 million on July 31)

"Despite challenging conditions we continue to make significant progress in reaching our corporate objectives," says Eduardo Bravo, CEO of TiGenix. "We are in advanced discussions to license our lead program Cx601, and we remain confident that we can conclude our partnering discussions before year-end. This will bring some non-dilutive funds plus external validation of our innovative platform of adipose derived stem cells. In addition, we are making progress with a number of players in the cell therapy space to allow us to monetize our state-of-the-art cell therapy facility in the Netherlands. This transaction should further decrease our fixed cost base and reduce operational complexity."

Business update

Commercial roll-out of ChondroCelect continues apace

ChondroCelect sales for the first half of 2013 amounted to EUR 2.3 million, up 55% compared to the same period of last year on a like for like basis.

Current revenues are still mainly fueled by sales in Belgium and the Netherlands. Based on increased traction with private payers in the UK, the Company expects that the UK market will start making a more substantial contribution to ChondroCelect sales in the second half of the year. Similarly, based on its pre-marketing activities in Spain, the Company expects the Spanish market to start contributing to ChondroCelect's continued growth in the last four months of the year. Taken together, the Company anticipates that the growth will be maintained for the second half of this year and will further increase in 2014, turning ChondroCelect a cash flow positive asset in the course of 2014.

ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula in Crohn's Disease - enrollment on track

The enrollment of the ADMIRE-CD trial remains on track. Recruitment of this Phase III study is expected to be finalized in early 2014, and should allow the Company to file for marketing authorization with the European Medicines Agency in the first half of 2015. The product has orphan drug designation and could be launched in Europe in 2016.

ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled pivotal Phase III trial that is to enroll approximately 278 patients at 46 centers across 7 European countries and Israel.

TiGenix is in advanced discussions with a number of companies in connection with the rights to Cx601 for different geographic regions and remains confident that it can close an agreement before year-end.

Cx611 Phase IIa reports good safety and first indication of efficacy in refractory rheumatoid arthritis

On April 22, the Company announced that its 6-month multicenter, randomized, single-blind, placebo-controlled Phase IIa study of Cx611 in refractory rheumatoid arthritis (RA) met all of its endpoints of safety and therapeutic activity on standard outcome measures of inflammation for at least three months after dosing. Preliminary results suggest Cx611 has the potential to positively impact disease in refractory patients, showing a clear improvement over placebo over three months and a sustained benefit over six months. Four patients were in DAS28 (one of the key outcome measures of RA studies) remission after six months, which is a remarkable result in this difficult to treat patient population.

 The Company is working closely together with an advisory board of key opinion leaders on the appropriate design of follow-up studies for Cx611/Cx621 in RA and other autoimmune disorders and expects to finalize the development plan before year-end.

 Exploratory partnering discussions are underway with a number of companies.

 Manufacturing facilities in Spain and the Netherlands

In January, Spanish health authorities renewed TiGenix's manufacturing authorization for stem cell products at its GMP facility in Madrid, Spain, where the Company manufactures high-quality, clinical grade allogeneic stem cell products to fuel its key clinical programs. This approval supports the leading position of TiGenix in the allogeneic cell therapy production and demonstrates the robustness of the current manufacturing process.

TiGenix is in advanced discussions with several companies that are active in cell therapy to monetize the state-of-the-art European GMP cell therapy facility the Company operates in Sittard-Geleen, the Netherlands, to manufacture commercial grade ChondroCelect. Such a transaction should bring non-dilutive funds to the Company, reduce operational complexity and improve the margins of ChondroCelect at least in the first years.

Financial results for the first half of 2013 can be found on the website

For more information:

Eduardo Bravo
Chief Executive Officer
eduardo.bravo@tigenix.com

Claudia D'Augusta
Chief Financial Officer
claudia.daugusta@tigenix.com

Hans Herklots
Director Investor & Media Relations
hans.herklots@tigenix.com
+32 16 39 60 97

About TiGenix

TiGenix NV (NYSE Euronext: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect^®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.