Valbonne, France, April 20, 2016 – TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe chronic inflammatory and autoimmune diseases, today reports its cash position and its revenues for the first quarter of 2016.
Cash position and revenues as of March 31, 2016
As of March 31st, 2016, the cash and cash equivalents amounted to EUR 5 million [1], excluding proceeds from the 2015 Research Tax Credit estimated around EUR 3 million. TxCell also has access to the standby equity facility (SEF(R)) implemented on December 22, 2015 to which it has not withdrawn to date.
As expected, TxCell did not generate revenues during the first quarter 2016.
Key operational highlights since January 1, 2016
• Successful key milestone achieved in technology transfer to European CMO MaSTherCell for the production of lead drug candidate Ovasave(R)
• Amendment of Ovasave Phase IIb study (CATS29) protocol submitted to European regulatory authorities, with the aim of restarting trial by end Q2 2016
• Appointment of PCT as US CMO
• Launch of new manufacturing process development laboratories and technology transfer academy
• Appointment of new Scientific Advisory Board (SAB) led by CAR pioneer Pr. Zelig Eshhar as Chairman
• Grant by the Japan Patent Office of ‘Intent to grant’ status on key patent for Ovasave
As announced, TxCell is thus executing its shift in strategy by transferring its current and future production activities in order to refocus solely on its core business with high added-value, research, clinical development and strategic partnerships. TxCell now intends to leverage its breakthrough technology to new autoimmune and inflammatory diseases and is fully committed to resume its phase IIb clinical trial in refractory Crohn’s disease patients, and further develop ENTrIA, TxCell’s CAR-Treg platform.
Next financial milestones:
• Ordinary and Extraordinary shareholders’ meeting on April 21, 2016
• Second quarter 2016 revenue and cash position on July 27, 2016 (after market close)
[1] Unaudited and not subject to approval by the board of directors
About TxCell – www.txcell.com
TxCell is a publicly listed biotechnology company that develops platforms for innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory and autoimmune diseases with high unmet medical need. TxCell is the only clinical stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs). Tregs are a recently discovered T cell population for which anti-inflammatory properties have been demonstrated. Ovasave(R), TxCell’s lead product candidate, is currently in a phase IIb clinical trial in refractory Crohn’s disease patients. Col-Treg, its second product candidate, for the treatment of autoimmune uveitis, is expected to enter in clinical studies in the near future. Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 49 employees.
