TiGenix Reports Business & Financial Results for the Third Quarter 2011

Leuven (BELGIUM) - November 3, 2011 - TiGenix NV (NYSE Euronext: TIG) today gave a business update and announced the financial results for the third quarter year ending September 30, 2011.

Business highlights

• Commercial roll-out of ChondroCelect advancing according to plan
• Positive 5-year follow-up data on ChondroCelect published in leading journal
• Finnish Red Cross Blood Service to distribute ChondroCelect in Finland
• EUR 5 million soft loan obtained in October from Madrid Network for Cx601 Phase III study
• Cx611 in rheumatoid arthritis moves into randomized stage of Phase IIa trial

Financial highlights

• EUR 20.5 million cash at September 30, 2011
• Group revenues for the first 9 months of EUR 1.1 million

"We have been making steady progress in the third quarter 2011 on all fronts," said Eduardo Bravo, CEO of TiGenix. "Sales of ChondroCelect keep growing, with over 40% of third quarter sales generated in Belgium. We have demonstrated our ability to extend the territories in which ChondroCelect will be available through agreements with third parties, while our clinical adipose stem cell programs remain on track. We believe that our continued progress further underpins our position as the leading European cell therapy company."

Business update

Commercial roll-out of ChondroCelect advancing according to plan

The launch in Belgium keeps gaining momentum. Since June, 6 new Cartilage Expert Centers have been added to our network in Belgium, bringing the total to 16. This is translating into an increased number of biopsies, with more than 50% of the third quarter biopsies coming already from Belgium.

In the UK sales are on a patient per patient reimbursement basis. Eight insurance companies, who together have 85% of the privately insured under coverage, are reimbursing the ChondroCelect procedure. Importantly, ChondroCelect is now reimbursed under a new code, identifying the procedure as a characterized cartilage implant (CCI), which distinguishes it from generic and non-EMA approved autologous cartilage implantation (ACIs).

In Germany ChondroCelect is still reimbursed on a case-by-case basis. However, very recently ChondroCelect was assigned a so-called OPS code specifically created for Advanced Therapy Medicinal Products. To date ChondroCelect is the only such product. An OPS-code in Germany is a combined surgery and procedure code, and is a prerequisite for obtaining full reimbursement.

In the Netherlands we continue to sell under a risk-sharing scheme. In Spain TiGenix has recently performed its first biopsy procedure. Treatment of the patient will be reimbursed by private insurance.

Reimbursement discussions are advancing in a number of countries, including France, Spain and Germany, and the company is optimistic about obtaining a positive reimbursement decision in one of the large EU countries before the end of the year. TiGenix expects the Dutch Orthopedics Association (NOV) to issue a consensus on the treatment of cartilage lesions that should allow for resubmission of our dossier to the Dutch healthcare authorities.

In the year to date, 83 biopsies and 63 implants of ChondroCelect have been performed.

Positive 5-year follow-up data on ChondroCelect published in leading journal

On September 19, positive 5-year follow-up data of the ChondroCelect TIG/ACT/01/2000 clinical study were published online ahead of print in the American Journal of Sports Medicine, one of the highest ranked peer-reviewed orthopedic journals. The paper describes clinical outcome after 5 years of ChondroCelect compared to the current standard of care, microfracture. The 5-year follow-up data confirm that the therapeutic effect and the clinical benefit of ChondroCelect gained over baseline at 12 and 36 months is maintained up to at least five years after the cartilage repair intervention. Importantly, the data also confirm early treatment with ChondroCelect results in a superior clinical benefit over microfracture and a lower failure rate.

Finnish Red Cross Blood Service to distribute ChondroCelect

On October 10, TiGenix announced an exclusive distribution agreement with the Finnish Red Cross Blood Service (FRCBS) to facilitate the successful commercialization of ChondroCelect in Finland. The FRCBS has a vital role in Finnish health care, not only in blood product supply but also in tissue services. The FRCBS has the expertise and quality systems required to make these kinds of new cell therapy products available for Finnish clinicians and patients.

EUR 5 million soft loan obtained from Madrid Network for Cx601 Phase III

On October 3, TiGenix obtained a substantial soft loan of EUR 4.95 million from the Autonomous Region of Madrid (Comunidad Autonoma de Madrid) through the "Madrid Network" to support the development of Cx601, the company's most advanced clinical stage product for the treatment of complex perianal fistulas in patients suffering from Crohn's disease. Preparation of this Phase III program is currently ongoing and recruitment is expected to start in the first half of 2012. Based on the positive advice from the European Medicines Agency in May this year, the company believes that this single pivotal Phase III clinical trial is sufficient for filing a Marketing Authorization Application with the Agency.

Cx611 in rheumatoid arthritis moves into randomized stage of Phase IIa trial

On October 24, TiGenix received the go-ahead from the independent Safety Monitoring Board to move into the randomized stage of the Cx611 Phase IIa clinical trial in rheumatoid arthritis. This multicentre, placebo-controlled study will enroll 53 patients, divided in 3 cohorts with different dosing regimens. There are more than 20 centers open and the company expects the final results to be available in the first half of 2013.

Financial results for the third quarter of 2011

Cash position of EUR 20.5 million on September 30, 2011

At the end of September the Company had a cash position of EUR 20.5 million. On October 3, just after the reporting date, the company received a first tranche of EUR 1.9 million of the Madrid Network soft loan to support the Phase III development of TiGenix's Cx601 program. The total amount of the soft loan is EUR 4.95 million, which is to be paid in three tranches.

Net cash used in the third quarter of 2011 was EUR 4.4 million, unchanged from the same quarter last year and in line with our guidance. Please note that the Q3, 2010, figures used in the comparison are those of TiGenix on a stand-alone basis and do not yet include the business combination with Cellerix that occurred in Q2, 2011. The rationalized use of cash to fund the operating activities of the newly combined company is testimony to the successful and rapid integration of TiGenix and Cellerix. The company continues its efforts to increase efficiency and to carefully manage cash used in operations.

Group revenues for the first 9 months of EUR 1.1 million

Revenues for Q3 2011 amounted to EUR 0.6 million, consisting of EUR 0.3 million in sales revenues and EUR 0.3 million in grant revenues.

This brings the total revenues for the first nine months of the year to EUR 1.1 million, of which EUR 0.7 million are product revenues and EUR 0.4 million consists of grant revenues. Product revenues do not include EUR 0.5 million in deferred product sales to be recognized once ChondroCelect is reimbursed under the policy rule of expensive medicinal products in the Netherlands.

Total billed sales for ChondroCelect over the first nine months of 2011 amounted to EUR 1.1 million. This represents a 125% increase compared to the same period of last year. Under the new reimbursement scheme, TiGenix started to perform ChondroCelect procedures in Belgium in August, already generating EUR 0.2 million sales, which is approximately 45% of the billed sales of Q3 2011. Finally, ChondroMimetic sales in the first nine months of 2011 were EUR 0.1 million.

Outlook for the next 12 months

• ChondroCelect reimbursement updates and decisions
• Partnering of ChondroCelect in selected countries
• European production facility in Sittard-Geleen validated for commercial production
• Start of Phase III clinical study for complex perianal fistulas
• Safety data from the three patient cohorts of the Phase IIa study for Cx611
• Phase I study results for Cx621
• Preclinical data in osteoarthritis, comparing eASCs and synovial MSCs
• Further strengthened financial position through non-dilutive funding

For more information:

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

Gil Beyen
Chief Business Officer
gil.beyen@tigenix.com

Hans Herklots
Director Investor & Media Relations
T: +32 474 88 30 46
hans.herklots@tigenix.com

About TiGenix

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

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.