Valbonne, France, July 26, 2017, 6.00pm CEST
TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe inflammatory and autoimmune diseases as well as transplant rejection, today reports its financial information for the 2nd quarter of 2017 and provides business update.
Cash position and revenues as of June 30, 2017
As of June 30, 2017, the cash and cash equivalents amounted to €8.7 million(1), including €0.6 million for the partial pre-funding of TxCell’s 2017 research tax credit.
In February 2017, TxCell successfully completed a capital increase through the issue of 5,549,300 new shares with warrants attached. The offer was fully subscribed and raised €11.1 million in gross proceeds. These proceeds will cover TxCell’s cash requirements for 2017, which include the costs of the CAR-Treg research and manufacturing process development programs as well as TxCell’s ongoing expenses and overheads.
The additional proceeds from the potential exercise of all the warrants which were attached to new shares issued in February 2017 would enable TxCell to further finance its activities through to the IND approval to initiate a first-in-man study with a CAR-Treg candidate. This is expected by the end of 2018. As a reminder, these warrants have a maturity of one year and are traded on a separate Euronext trading line (FR0013231792). At any time up to February 26, 2018 (included), 4 warrants will entitle holders to buy 3 TxCell’s new shares at a subscription price of €2.60 per new share.
As expected, TxCell did not generate any revenue during the second quarter 2017.
Key recent operational highlights
Strategic agreement with Lentigen Technology, Inc. to manufacture the lentiviral vector for the CAR-Treg transplantation program
In June 2017, TxCell appointed Lentigen Technology, Inc. (LTI) as its contract manufacturing organization (CMO) for the GMP production of its HLA-A2 CAR lentiviral vector. This vector will be used to manufacture TxCell’s CAR-Tregs targeting transplant rejection. This program is expected to enter clinical studies by the end of 2018, with a first-in-man study to be conducted in the setting of solid organ transplantation (lung and/or kidney).
R&D collaboration with Inserm to develop new CAR-Tregs in transplantation and multiple sclerosis
In May 2017, TxCell signed an agreement covering R&D activities taking place with the Center for Research in Transplantation and Immunology (CRTI), in Nantes, France. TxCell and the CRTI are collaborating on the development of CAR-Treg cells using a proprietary Treg cell population expressing the CD8 marker. In December 2016, TxCell had obtained an exclusive worldwide license on this CD8+ Treg population identified by the CRTI. This R&D collaboration focuses on the treatment of transplant rejection and autoimmune diseases, specifically multiple sclerosis.
In May 2017, TxCell published an article on cellular therapy based on regulatory T cells for the treatment of uveitis, a rare ophthalmic disorder, in the Journal of Ocular Pharmacology and Therapeutics (JOPT), international global peer-reviewed journal(2). The publication reviews various results obtained in this area, notably by TxCell.
Next financial milestones
- September 21, 2017: Half-year 2017 financial results (post-market)
- October 19, 2017: Q3 2017 financial information (post-market)
- Unaudited and not subject to approval by the board of directors.
- Foussat A, Gregoire S, Clerget-Chossat N, Terrada C, Asnagli H, Lemoine FM, Klatzmann D, LeHoang P, Forte M, Bodaghi B. Regulatory T Cell Therapy for Uveitis: A New Promising Challenge. J Ocul Pharmacol Ther 2017, 33(4): 278-284.