04.08.2014 17:45:00

TxCell Reports Revenues for the First Half 2014

Regulatory News:

TxCell (Paris:TXCL) (FR0010127662 - TXCL), a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, today reports its revenues as of June 30, 20141.

Revenues:

In the first six months of the year 2014, the company generated revenues of €162 thousand1, including €82 thousand for the second quarter of 2014, compared with no reported revenues during the same period in 2013. This amount corresponds to income relating to the amortization of the payment of €1 million from Ferring International Center for the exclusive option agreement signed on December 12, 2013 for Ovasave® in inflammatory bowel diseases (IBD), notably Crohn’s disease.

Cash and cash equivalents:

Cash and cash equivalents stood at €17.4 million1 at June 30, 2014, compared with €2.2 million at March 31, 2014 and €0.7 million at December 31, 2013. This amount includes the total of €17.7 million of financing raised by TxCell from its Initial Public Offering on the Euronext regulated market in Paris.

Highlights of the period:

  • Initial Public Offering on April 11, 2014 on Euronext market, Compartment C, with a fundraising of €16.5 million completed by an additional fundraising of € 1.5 million in May.
  • Obtaining of Advanced Therapy Medicinal Product classification by the European Medicines Agency for Col-Treg, TxCell’s second product candidate for the treatment of autoimmune uveitis, a rare disease and a leading cause of blindness in the industrialized world.
  • Issuance by the Agence Nationale de Sécurité du Médicament (ANSM) of the certificate of compliance with Good Manufacturing Practices (GMP) for TxCell’s cell therapy production unit in Besançon.

"These results for the first half of 2014 are in line with TxCell’s expectations and strategy. Due to our recent Initial Public Offering, we are able to push forward the clinical development of our new-generation cellular therapies. In particular, we received GMP certificate of compliance for our manufacturing process, which should allow us as planned to launch in the second half of 2014 our phase IIb clinical study with Ovasave in six European countries for the treatment of refractory Crohn's disease patients.” said Damian Marron, Chief Executive Officer, TxCell.

Next events:

  • Half Year Financial Report 2014 on Wednesday September 24, 2014 (after market close)

ABOUT TXCELL

TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigenspecific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave® in refractory Crohn’s disease patients and has reported good tolerability and positive clinical efficacy. The company plans to initiate a phase IIb study in the same patient population. Listed on Euronext-Paris, TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 40 employees based at its headquarters and at its manufacturing site in Besançon.
For more information, please visit www.txcell.com.

Important Disclaimers:
Forward Looking Statements. This press release contains forward-looking statements with notably respect to the strategy and outlook of TxCell. Although TxCell believes that such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance of the company. Actual results may differ materially from the forward-looking statements as a result of a number of risks and uncertainties, many of which are outside our control, including but not limited to the risks described in the documents TxCell filed with the Autorité des Marchés Financiers (French securities regulator). Investors and security holders may obtain a free copy of documents filed by TxCell with the Autorité des Marchés Financiers at www.amf-france.org, or directly from TxCell. Forward-looking statements contained herein are made as of the date of this press release.

1 Figures were subjected to a limited review by the statutory auditors.

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