Business and Financial Update for the First Quarter of 2009
Leuven (BELGIUM) - May 19, 2009 - TiGenix (NYSE EURONEXT: TIG) gives a business update and reports cash position as of March 31, 2009.
ChondroCelect registration procedure
During the first quarter of this year, the company's activities were primarily focused on resolving the outstanding questions on the ChondroCelect product and process validation
processes that were raised by the regulatory authorities in the 4th quarter of 2008. We have now completed all required validation assays and were able to submit the report to EMEA
according to schedule.
Cash position of EUR 22 million on March 31, 2009
Net cash used in the first quarter was EUR 3.20 million. On March 31 2009, TiGenix had cash and cash equivalents of EUR 21.97 million on the balance sheet.
Outlook
- CHMP opinion for ChondroCelect
- Following an EMEA approval, launch of ChondroCelect in selected European countries
- Expansion of the cell manufacturing capacity in Europe
Filing of the registration application for ChondroCelect in the US
- Start clinical development of the next generation 3D product
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext: TIG) is a late-stage biomedical company that focuses on innovative local treatments for damaged and osteoarthritic joints. The Company is
exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage,
which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical
need. Current therapies do not provide satisfying, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage.
Forward-looking information
This document contains 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 the Company's 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 the Company's 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
For more information, please contact
Gil Beyen
Chief Executive Officer
+32 16 39 60 60
+32 16 39 60 98
gil.beyen@tigenix.com
Kris Motmans
representative of MC-Services
Corporate Communications
kris.motmans@tigenix.com
ChondroCelect registration procedure
During the first quarter of this year, the company's activities were primarily focused on resolving the outstanding questions on the ChondroCelect product and process validation
processes that were raised by the regulatory authorities in the 4th quarter of 2008. We have now completed all required validation assays and were able to submit the report to EMEA
according to schedule.
Cash position of EUR 22 million on March 31, 2009
Net cash used in the first quarter was EUR 3.20 million. On March 31 2009, TiGenix had cash and cash equivalents of EUR 21.97 million on the balance sheet.
Outlook
- CHMP opinion for ChondroCelect
- Following an EMEA approval, launch of ChondroCelect in selected European countries
- Expansion of the cell manufacturing capacity in Europe
Filing of the registration application for ChondroCelect in the US
- Start clinical development of the next generation 3D product
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext: TIG) is a late-stage biomedical company that focuses on innovative local treatments for damaged and osteoarthritic joints. The Company is
exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage,
which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical
need. Current therapies do not provide satisfying, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage.
Forward-looking information
This document contains 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 the Company's 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 the Company's 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
For more information, please contact
Gil Beyen
Chief Executive Officer
+32 16 39 60 60
+32 16 39 60 98
gil.beyen@tigenix.com
Kris Motmans
representative of MC-Services
Corporate Communications
kris.motmans@tigenix.com
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