SOURCE: TiGenix

TiGenix

May 14, 2013 01:36 ET

TiGenix Business Update & Financial Highlights for Q1 of 2013

LEUVEN, BELGIUM--(Marketwired - May 14, 2013) - TiGenix NV (EURONEXT BRUSSELS: TIG)

  • ChondroCelect Sales up 55% over Q1 2012
  • Cx611 Phase IIa delivers positive results in refractory RA
  • Cx601 Phase III enrollment on schedule

TiGenix NV (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, gives an update of its business activities and provides the financial highlights for the first quarter ending March 31, 2013.

Business highlights

  • ChondroCelect:
    • TiGenix obtained reimbursement in Spain for ChondroCelect
    • ChondroCelect sales benefit from continued uptake in Belgium and in the Netherlands
  • Progress development pipeline
    • Positive Cx611 Phase IIa study results in refractory rheumatoid arthritis
    • Cx601 ADMIRE-CD Phase III trial enrollment on plan
  • Corporate:
    • TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid
    • Partnering discussion for Cx601 on-going
    • Transfer of corporate development responsibilities to CEO complete

Financial highlights

  • ChondroCelect sales for the first three months of 2013 amounted to EUR 1.04 million, up 55% compared to the same period of last year
  • EUR 6.8 million cash on hand

"With the sustained ramp-up of ChondroCelect sales, driven by increased uptake and additional reimbursement approvals in new markets, we are moving in the right direction to make ChondroCelect a cash flow positive asset in 2014," said Eduardo Bravo, CEO of TiGenix. "Sales growth is expected to increase in H2 2013 as a result of the anticipated development of the private insurance market in the UK and the launch of ChondroCelect in Spain. On the partnering front, we are still fully engaged in discussions to co-develop Cx601 with a number of parties. And after the positive results of our Phase IIa trial with Cx611 in refractory RA, we have added another high-value clinical asset to our development portfolio and to our business development efforts."

Business update

ChondroCelect sales up 55% compared with Q1 2012

ChondroCelect sales for the first quarter of 2013 amounted to EUR 1.04 million, up 55% compared with the same period last year, and 19% compared with the previous quarter, reflecting the continued uptake in Belgium and the Netherlands.

ChondroCelect obtains national reimbursement in Spain

Following a positive decision by the Spanish health authorities, ChondroCelect has gained full market access in one of the largest European pharma markets. Discussions are on track to obtain or expand reimbursement in France, Germany, and the UK.

Cx611 Phase IIa reports positive results in refractory rheumatoid arthritis

On April 22, the Company announced positive results of its 6-month Phase IIa study of Cx611 in refractory rheumatoid arthritis (RA).

The multicenter, randomized, single-blind, placebo-controlled Phase IIa trial enrolled 53 patients with active refractory rheumatoid arthritis (mean time since diagnosis 15 years), who failed to respond to at least two biologics (actual patients enrolled had a mean previous treatment with 3 or more disease-modifying antirheumatic drugs and with 3 or more biologics). The study results reaffirmed the safety profile of Cx611 in this patient population, and suggested a positive impact on outcomes in refractory RA patients, who showed a clear improvement at three months and a sustained benefit over six months. Five patients out of 46 were in remission (DAS28 CRP < 2,6) after three months, which is notable in this patient population.

As a first in class product with a novel and different mechanism of action, the safety and activity of Cx611 in a patient population that has failed all available treatment options make it an attractive candidate for further development in RA.

Patient enrollment on plan in ADMIRE-CD Phase III trial (Cx601) in complex perianal fistulas

Patient enrollment in the ADMIRE-CD trial, the Company's pivotal Phase III clinical trial with Cx601, is progressing on plan. Cx601 is an adipose derived allogeneic stem cell suspension for the treatment of complex perianal fistulas in Crohn's disease patients. ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that will enroll approximately 278 patients at 55 centers across 7 European countries and Israel. Final results of the trial are expected in H2 2014, and, if positive, will allow the Company to file for marketing authorization with the European Medicines Agency.

Manufacturing authorization renewed for stem cell production facility

In January, Spanish health authorities renewed TiGenix's manufacturing authorization for stem cell products at its manufacturing facility in Madrid, Spain. At its GMP facility in Madrid, the Company manufactures high-quality, clinical grade allogeneic stem cell products to fuel its key clinical programs.

Partnering discussion for lead program Cx601 on-going and starting for Cx611

TiGenix keeps advancing its discussions with a number of parties regarding the commercial rights to Cx601 to maximize the value of its lead program. Closing of a partnering deal is expected to take place before the end of the year. After the positive results of the phase IIa study with Cx611 in RA, several pharma companies have expressed an interest to explore licensing opportunities for this compound.

Transfer of corporate development responsibilities to CEO complete

Gil Beyen, co-founder of TiGenix, has assumed the role of CEO at Erytech, Lyon, France. Over the past year Mr Beyen has gradually transferred all his corporate development responsibilities to Eduardo Bravo. The transition complete and effective May 13, Mr Beyen stepped down as Managing Director and as a member of the Executive Committee, but remains as a valuable member of TiGenix's board of Directors.

Cash position of EUR 6.8 million on March 31, 2013

On March 31, the Company had a cash position of EUR 6.8 million. Net cash used during the first three months of 2013 was EUR 1.4 million per month, in line with management's expectations. During the month of April the company received EUR 1 million, the last tranche of the Madrid Network soft loan granted to support the Cx601 Phase III trial.

Outlook next 12 months

  • Reimbursement decisions in major European countries for ChondroCelect
  • Finalize recruitment of Cx601 phase III trial in complex perianal fistula in Crohn's patients
  • Partnering agreement for Cx601
  • Start of next clinical trial with Cx611

About TiGenix
TiGenix NV (EURONEXT BRUSSELS: 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.

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.

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