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TxCell S.A.. (11/5/15). "Press Release: Financial Information for the 3rd Quarter of 2015". Valbonne.

TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cell immunotherapies using regulatory T-cells (Treg) for the treatment of severe chronic inflammatory and autoimmune diseases, today reports its revenues1 for the 3rd quarter of 2015 and its cash position as of September 30, 2015.


Revenues:

In the first nine months of the year 2015, the company generated revenues of €882 thousand, including €348 thousand for the 3rd quarter of 2015, compared with €245 thousand for the same period in 2014.

The revenue as of September 30, 2015 corresponds to:

> €719 thousand for income related to the financing by Trizell of the initial phases of the process and manufacturing development of Ovasave for the company’s future phase III clinical study and commercialization ;

> €163 thousand relating to the payment of €1,000 thousand received upon signature in 2013 of the collaboration agreement with Trizell/Ferring concerning Ovasave®, and amortized over the estimated duration of the involvement of the company in future developments of the object of the collaboration agreement.


Cash and cash equivalents:

Cash and cash equivalents amounted to €12.1 million as of September 30, 2015, compared with €7.7 million as of June 30, 2015 and €13.9 million as of December 31, 2014. This amount includes proceeds from the July 2015 private placement for approximately €8 million gross, but does not include 2014 Research Tax Credit accrued for €2 million.


“Over the past few months, we have operated a major strategic shift at TxCell so to specialize specifically in our key areas with the flexibility that the personalized cell therapy market demands. We also are now more able to reinforce our technological leadership in cellular immunotherapy to fight auto-immunity and inflammation, a field that is rapidly gaining momentum in the pharmaceutical industry,” said Stéphane Boissel, CEO of TxCell. “With a healthy balance sheet and costs under control, we are in a position to complete this transformation and move to a new exciting era for the development of TxCell”.


1 Unaudited and not subject to approval by the board of directors


Major operational milestones since July 1st, 2015:

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

> 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.

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

> 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, for the treatment of autoimmune uveitis. TxCell, as leader of the consortium will receive €843 thousand.

> Peer-reviewed publication of positive preclinical efficacy and tolerability results for Col-Treg in a model of autoimmune uveitis 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 for the treatment of chronic non-infectious uveitis. This follows the ODD already granted for the product in Europe.

> Revision of TxCell’s manufacturing strategy consisting in outsourcing all existing and future clinical and commercial manufacturing operations and focusing on R&D and strategic partnerships - its core, high added value businesses.

> Exclusive option agreement with Yeda Research and Development Co. Ltd, the technology transfer arm of the Weizmann Institute of Science in Rehovot, Israel, covering redirected, genetically engineered T regulatory cells (CAR-Treg) and their use in suppression of autoimmune and inflammatory diseases.


Next financial milestone:
> 2015 revenue, Tuesday February 2, 2016 (after market close)


Next events:

> Société Générale Healthcare & Biotechnology Conference, Paris, France - November 5, 2015
> 3rd Annual EU Advanced Therapies Investor Day organized by the Alliance for Regenerative Medicine, London, UK – November 12, 2015
> 3rd European Healthcare Conference organized by Bryan Garnier, Paris, France - November 12 – 13, 2015
> Salon Actionaria, Paris, France - November 20 – 21, 2015
> The 19th Oddo forum, organized by Oddo, Lyon, France - January 7 – 8, 2016
> JP Morgan 34th Annual Healthcare Conference, San Francisco, US - January 11 – 15, 2016
> NobleCon12, the 12th Annual Emerging Growth Investor Conference, organized by Noble Financial Capital Markets, Florida, US - January 19 – 20, 2016
> Invest Securities BioMed Event®, Paris, France – January 27, 2016


About TxCell: www.txcell.com

TxCell is a publicly listed biopharmaceutical 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®, 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, should enter clinical trials in 2016. Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 62 employees.


Contacts:

TxCell
Raphaël Flipo
CFO
Tél: +33 4 97 21 83 00
contact@txcell.com

NewCap
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: 2018-05-13

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