TXCELL Valbonne, France, March 10, 2016 - TxCell SA (FR0010127662 - TXCL), a biotechnology company developing innovative, personalized cell immunotherapies using regulatory T-cells for the treatment of severe chronic inflammatory and autoimmune diseases, today announces its financial results for 2015 and provides an update on its strategy and outlook.
"TxCell has implemented a shift in strategy during 2015 by transferring its production activities in order to refocus solely on the core business with high added-value, i.e. research, clinical development and strategic partnerships. TxCell now intends to fully leverage its technological breakthrough and to extend it to new autoimmune diseases with high unmet medical needs, such as lupus, multiple sclerosis and pemphigus," said Stéphane Boissel, CEO of TxCell. "TxCell is now set to deliver on a very ambitious plan with five-year objectives. These include starting first registration trials and moving up to three new product candidates into clinical development. For ENTrIA, TxCell's new platform of engineered CAR-Tregs, we expect to be able to release the first proof-of-concept data sets this year. As we progress, TxCell will aim to enter into new partnerships with pharma companies in order to accelerate its development."
"TxCell is currently assessing several options, including signing strategic partnerships with pharma companies and/or new equity financing to fund its R&D activities up to its next meaningful clinical milestones, in particular phase IIb clinical results for Ovasave® in Crohn's disease expected in late 2017 or early 2018," said Raphael Flipo, CFO of TxCell. "TxCell is convinced that its ambitious and voluntary strategy could present shareholders with a unique opportunity to participate in our growth."
Main developments since January 1, 2015:
Changes in the management team, including the appointment of Stéphane Boissel as the new CEO, and governance structure strengthened with the appointment of Dr. David Horn Solomon as a new independent director
Capital increase through a private placement of approximately €8 million, representing around 9.95% of the total capital, with the majority of investors based outside of France and specializing in healthcare
Review of TxCell's production strategy with the decision to outsource all current and future production activities in order to focus on core, high-added-value activities, i.e. research, clinical development and strategic partnerships:
Outsourcing agreement with MaSThercell for the production of the phase IIb clinical supplies for Ovasave. MaSThercell has been appointed as TxCell's exclusive production partner in Europe for all cell therapy products arising from the ASTrIA platform for a 5-year period.
Closure of TxCell's Besançon production site
Successful production of the first test batches of Ovasave by MaSTherCell, allowing plans to resume the phase IIb study in Crohn's disease in the second quarter of 2016
Launch of new laboratories for developing production processes and the TxCell Academy for Technology Transfer.
Major regulatory progress in the USA:
Fast Track Designation granted by the FDA (US Food and Drug Administration) for Ovasave
IND (Investigational New Drug) request accepted to extend to the United States CATS29, the phase IIb trial for Ovasave as a treatment for Crohn's disease
Key patent for Ovasave in the treatment of inflammatory bowel diseases delivered by the US Patent and Trademark Office
Orphan Drug Designation (ODD) granted by the FDA for Col-Treg, TxCell's product- candidate for the treatment of non-infectious uveitis.
Development of ENTrIA, a new platform for cellular immunotherapy products made up of genetically modified regulatory T cells (CAR-Tregs). Also, signature of an agreement with Yeda, the technology transfer arm of the world-famous Weizmann Institute of Sciences, granting TxCell an option to an exclusive license on CAR-Tregs patent applications.
Signature in December 2015 of an agreement terminating the Ovasave collaboration, option, development and licensing agreement with Trizell. This will allow TxCell to reacquire all rights pertaining to Ovasave which were previously granted to Trizell, in exchange for payments which could total up to €15 million1.
Notification from the Japan Patent Office of its intention to grant a key patent for Ovasave in Japan.
Financial highlights:
The financial statements for the year ended December 31, 2015 were approved by TxCell's Board of Directors on March 8, 2016. The 2015 financial statements have been audited and the auditors' report was issued on March 9, 2016. TxCell's annual financial report, included in the registration document, will be available in April 2016.
1 As per the terms of this agreement, TxCell terminates Trizell's option to obtain an exclusive license to Ovasave, in exchange for payments which could total a minimum of €6 million and a maximum of €15 million, generally split as follows:
An upfront payment of €2 million to be paid upon signature. This payment was made by TxCell in December 2015.
Two milestones payments of €2 million to be paid 2 years and 3 years post-signature, respectively, within the limit of a maximum total amount of €15 million overall
Potential royalties based on revenues generated by Ovasave, within the limit of a maximum total amount of
€15 million overall.
Financial highlights are as follows:
Cash burn of €12.3 million in 2015, including an upfront payment of €2 million to Trizell as per the terms of the termination agreement for Ovasave.
Cash and cash equivalents of €9.2 million at December 31, 2015 (€13.9 million at December 31, 2014) before receipt of the 2015 research tax credit of around €3 million.
Revenue and other income of €4.6 million (€3.4 million in 2014), mainly due to the research tax credit (€3.0 million) and the pharmaceutical partnership regarding Ovasave that was terminated on December 2, 2015 (€1.5 million).
R&D expenditure of €10.8 million (€7.8 million in 2014) representing 73% of the Company's current operating expenses. The increase was mainly due to higher outsourcing costs resulting from the increase in developments underway.
Other operating expenses of €1.2 million, consisting of restructuring costs related to the closure of the Besançon site.
Full-year net loss of €11.3 million (€8.3 million in 2014), representing a €1.9 million increase in losses excluding restructuring costs.
The IFRS income statement for the year ended December 31, 2015 is as follows:
In thousands of euros
31/12/2015
31/12/2014
Revenue
920
1,327
Other income
3,718
2,094
Revenue and other income
4,637
3,421
Research and development expenses
10,839
7,836
General and administrative expenses
3,460
2,243
Expenses related to share-based payments
483
1,615
Current operating income / (loss)
(10,145)
(8,273)
Other operating expenses
(1,189)
0
Other operating income
22
0
Operating income / (loss)
(11,312)
(8,273)
Income from cash and cash equivalents
42
68
Cost of gross financial debt
0
60
Cost of net financial debt
42
8
Other financial income
10
1
Other financial expenses
37
5
Net income / (loss) before tax
(11,297)
(8,269)
Income taxes
0
0
Net income / (loss)
(11,297)
(8,269)
Basic earnings per share (€)
-0.92
-0.78
It should be noted that, on the basis of TxCell's development plan, including the continuation of clinical trials on Ovasave® and the start of clinical trials on Col-Treg, the company's cash burn is likely to be around €15 million in 2016.
Main objectives for 2016:
TxCell's main objectives for the current year are as follows:
Resumption of phase IIb trial on Ovasave in the second quarter of 2016. The first results are expected in late 2017 or early 2018.
Completion of pre-clinical development and regulatory dossier for Col-Treg, with the aim of starting the first clinical trial in non-infectious uveitis in the near future
Generation of pre-clinical proof of concept data on the ENTrIA platform
Signature of strategic partnerships with major pharmaceuticals and biotech players to further speed up development of ASTrIA and ENTrIA platforms
Improvements to TxCell's production process for the ASTriA platform and initiation of the development of a production process for the ENTrIA platform
Selection of a CMO (Contract Manufacturing Organization) in the USA to expand TxCell's geographical production offering
Creation of a SAB (Scientific Advisory Board) to strengthen the Company's scientific expertise and strategic decision-making in relation to the development of its new ENTrIA platform.
Conference call and webcast in English:
A conference call and webcast will be held on Friday, March 11, at 3:30pm CET. To take part:
Telephone number: +33 (0)1 70 77 09 44
Link to the webcast: http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=13529 9977&PIN=73954371
Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:
+33 (0)1 72 00 15 00 / 299977#
Forthcoming financial events:
First quarter 2016 revenue and cash position: April 20, 2016 (after market)
Shareholders' general meeting: April 21, 2016
About ASTrIA
ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity) is a TxCell proprietary cellular immunotherapy product platform composed of autologous antigen specific Type 1 Regulatory T cells (Ag-Treg). Ag-Treg based products from the ASTrIA platform are produced from the peripheral blood of patients. After white blood cell isolation, CD4+ T cells are educated to recognize a specific antigen. Antigen educated Treg cells are then isolated and expanded ex-vivo. Ovasave®, the first Ag-Treg product candidate from the ASTrIA platform, has been developed for the treatment of Inflammatory Bowel Disease (IBD) and is composed of ovalbumin-specific Type 1 Treg cells. Ovasave is currently in a European Phase IIb clinical study in severe Crohn's Disease, entitled CATS29. Col-Treg is the second candidate from the ASTrIA platform and is composed of type-2 Collagen-specific Type 1 Treg cells. Col-Treg is developed for the treatment of steroid-refractory non-infectious uveitis.
TxCell SA issued this content on 10 March 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 15 March 2016 17:38:48 UTC
Original Document: http://www.txcell.com/images/CP/2016/TxCell_20160310_PR_Results_2015_EN.pdf
