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TxCell S.A.. (9/22/15). "Press Release: Financial Results for the First Half of 2015". Valbonne.

Organisations Organisation TxCell S.A. (Euronext Paris: TXCL)
  Organisation 2 MaSTherCell S.A. (Manufacturing Synergies for Therapeutic Cells)
  Group Catalent (Group)
Product Product  Ovasave®
Person Person Boissel, Stéphane (TxCell 201504– CEO before Genclis + Transgene + Innate Pharma + Lazard)
     


TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized T-cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, today reports its financial results for the first half of 2015.

The TxCell Half Year Financial Report as of June 30, 2015 is available on the company’s website: www.txcell.com.


Major operational milestones since January 1st, 2015:

> Milestone payment by Trizell as part of the collaboration agreement concerning TxCell’s lead product Ovasave®, following the inclusion of the first patient in the phase IIb clinical trial of Ovasave in refractory Crohn’s disease.

> FDA acceptance of Fast Track Designation for Ovasave for the treatment of moderate to severe Crohn’s disease, enabling TxCell to accelerate the drug development program.

> FDA acceptance of Investigational New Drug (IND) for Ovasave, granting TxCell the option of extending the current phase IIb study (CATS29) from the EU to the US.

> Grant by the United States Patent and Trademark Office (USPTO) of a key US patent that protects Ovasave until 2030 minimum.

> Amendment to the collaboration agreement with Trizell to accelerate the development of Ovasave. Also separate agreement with UK-based Cell Therapy Catapult for the process and manufacturing development of TxCell’s ASTrIA product platform.

> Presentation of positive preclinical efficacy and tolerability results for Col-Treg, TxCell’s second product candidate, in a model of autoimmune uveitis and peer-reviewed publication of these results in Investigative Ophthalmology & Visual Science (IOVS), a prominent journal in the field of ophthalmic and vision research.

> FDA acceptance of Orphan Drug Designation (ODD) in the US for Col-Treg, TxCell’s second product candidate for the treatment of chronic non-infectious uveitis. This follows the ODD already granted for the product in Europe.

> Appointment of Stéphane Boissel as Chief Executive Officer and Dr. David Horn Solomon as Independent member of the board and Chairman of the remuneration and nomination sub-committee. Also, promotion of Miguel Forte to Chief Operating Officer.

> Temporary partial hold of activities at the pilot manufacturing unit in Besançon.

> Agreement for the production of clinical batches of Ovasave for CATS29 study with MaSTherCell, a Belgian-based contract manufacturing organization (CMO).

> Successful completion of a private placement of a total amount of approximately €8 million with mostly international and healthcare investors.

> Award by the French government’s Unique Interministerial Fund (FUI) of a €1.28 million grant to the TRUST project (TRegs in Uveitis STudy), run by a consortium headed by TxCell and dedicated to process and clinical development of Col-Treg, TxCell’s second lead product, for the treatment of autoimmune uveitis. TxCell, as leader of the consortium will receive €843 thousand.


Financial results for the first half of 2015:

The following interim financial statements as of June 30, 2015, established according to IFRS standards, have been subject to a limited review by the statutory auditors and approved by the board of directors of the company on September 15, 2015. Highlights of TxCell’s results as of June 30, 2015 are:

> Increase in revenues resulting from the financing by Trizell of the early stages of the process and manufacturing development of Ovasave.

> Consistent increase in operating expenses, of which 75% are devoted to research and development, mainly due to the start of the phase IIb study of Ovasave in December 2014.

> Controlled cash management, with €7.7 million in cash as of June 30, 2015 before receipt of the private placement of approximately €8 million gross completed in July 2015 and the 2014 research tax credit of €2 million expected in the second half of 2015.

The income statement as of June 30, 2015 is as follows (in thousands of euros):

In thousands of euros 30/06/2015 30/06/2014

Revenue 534 162
Other income 1 438 1 020
Revenue and other income 1 972 1 183
Research and development expenses 5 709 3 730
General and administrative expenses 1 862 1 121
Expenses related to share-based payments 129 1 114
Net operating expenses (5 728) (4 782)
Income from cash and cash equivalents 27 21
Cost of gross financial debt 0 60
Cost of net financial debt 27 (39)
Other financial income 2 0
Other financial costs 22 1
Net income / (loss) before tax (5 721) (4 822)
Tax expense 0 0 Net income / (loss) (5 721) (4 822)
Net income / (loss) per share (€0.49) (€0.51)



Revenue for the first half of 2015 corresponds to:

> €108 thousand relating to the payment of €1 million received upon signature of the collaboration agreement with Trizell/Ferring, amortized over the estimated duration of the involvement of TxCell in future developments of the object of the collaboration agreement.

> €426 thousand relating to the financing by Trizell of the initial phases of the process and manufacturing development of Ovasave for TxCell’s future phase III clinical study and commercialization.

> Other operating revenues corresponding to public funding for research expenditures, mainly consisting of a research tax credit estimate of €1,392 thousand for the first half of 2015 (against €988 thousand as of June 30, 2014).

> An increase of research and development expenses mainly due to the launch in December 2014 of the phase IIb clinical trial of Ovasave, to the costs incurred in the process and manufacturing development program of TxCell’s ASTrIA product platform and to the exploration of a second product platform based on engineered regulatory T cells.

> Increase in general and administrative expenses of the company, in line with its new status of listed company since April 2014.

> Net result as of June 30, 2015 amounted to -€5,721 thousand against -€4,822 thousand for the period ended June 30, 2014, i.e. a variation of -€899 thousand.


Next financial event:

? Third quarter 2015 revenues on Thursday November 5, 2015 (after market close)


About TxCell: www.txcell.com

TxCell develops innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary product platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has initiated a phase IIb study of its lead product candidate, Ovasave® in refractory Crohn’s disease patients. This follows a phase I/IIa study in the same patient population reporting positive clinical efficacy and good tolerability. TxCell’s second product candidate, Col-Treg is for the treatment of autoimmune uveitis, a rare disease of the eye. Listed on the regulated market Euronext Paris, TxCell is a spin-off of Inserm (France’s National Institute for Health and Medical Research). TxCell has 66 employees based both at the headquarters located in the Sophia Antipolis technology park, Nice, France and at its manufacturing site in Besançon.


Contacts:

TxCell
Raphaël Flipo
CFO
Tél: +33 4 97 218 300
contact@txcell.com

NewCap – Investor relations
Financial Communication
Julien Perez / Pierre Laurent
Tél: +33 1 44 71 94 94
txcell@newcap.fr


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) and the Half Year Financial Report as of June 30, 2015 available at www.txcell.com. 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.

   
Record changed: 2017-04-02

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