TxCell 2014 results: strengthening of cash position and development of ASTrIA product platform
01 April 2015 - 4:30PM
Business Wire
- IPO and receipt of milestone
payments: cash at €13.9 million end of 2014
- Start of the international phase IIb
study for Ovasave® in Crohn’s disease
- Positive results for Col-Treg,
second product candidate, in an auto-immune uveitis model
Regulatory News:
TxCell (Paris:TXCL) (FR0010127662 - TXCL), a
biotechnology company developing innovative, cost-effective,
personalized T cell immunotherapies using antigen specific
regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and
autoimmune diseases, today reports its 2014 financial results and
activities.
The fiscal 2014 accounts have been approved for issue by the
Board of Directors in its meeting held on March 30, 2015. The
accounts for fiscal year 2014 have been audited and the auditor’s
report is pending.
“TxCell in 2014 has seen a number of very important
events. The Initial Public Offering of the company gives medium
term financial visibility and allows us to accelerate the clinical
development of our targeted T-cell immunotherapies in 2015 and
beyond,” said Damian Marron, Chief Executive Officer TxCell. “The
start of the phase IIb study for Ovasave®, our lead product
candidate in refractory Crohn’s disease, was a key step in the
development of TxCell. We also obtained the GMP certificate for
TxCell’s manufacturing platform. In addition, we obtained positive
results for our second product candidate Col-Treg for the treatment
of autoimmune uveitis. Col-Treg also obtained the classification of
Innovative Medication Therapy by the European Medicines Agency as
well as the orphan drug designation from the European Commission.
This program, for which we expect to start a clinical trial phase
I/II in 2015 to establish the proof of concept, will not only allow
TxCell to expand its portfolio of cellular immunotherapy products
in clinical stage, but also to demonstrate the potential and growth
of its ASTrIA product platform.”
Product candidate pipeline progress
during the fiscal year 2014:
- Ovasave, lead product candidate
from ASTrIA product platform
- Finalization of the manufacturing
process for the phase IIb clinical study
- Start of the international phase IIb
clinical study (CATS29) in December 2014
- Col-Treg, second product
candidate from ASTrIA
- Start of Col-Treg development in
autoimmune uveitis
- Classification of Innovative Medication
Therapy by the European Medicines Agency
- Presentation of positive results
obtained in an autoimmune uveitis model
- Obtaining of European orphan drug
designation
Other highlights of the
period:
- Initial Public Offering on April 11,
2014 on Euronext market, Compartment C, with a gross fundraising of
€16.2 million, the correlative conversion of the convertible bond
loan of €3.5 million in February 2014, completed by an additional
gross fundraising of €1.5 million in May 2014;
- Issuance by the French 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, France;
- Launch and grant award of €417 thousand
for the collaborative project POSITIVE (including
€250 thousand for TxCell). This project focuses on the
development and implementation of procedures to automate the first
step of Ovasave manufacturing process;
- Obtaining of a €1.7 million zero
rate loan (Prêt à Taux Zéro Innovation (PTZI)) granted by Bpifrance
to advance Ovasave through clinical development;
- Assignment of the collaboration
agreement from Ferring to Trizell, an affiliate of the Dr Frederik
Paulsen Foundation, which allows Ovasave to benefit from the
additional focus and expertise that Trizell will supply in advanced
therapies area, i.e. cellular and gene therapies.
2015 highlights to date and next
milestones:
- Grant of a key US patent by the
American patent and trademarks office (USPTO) that protects Ovasave
until 2030 minimum.
Next milestones:
- Start of Col-Treg “proof of principle”
clinical study in steroid refractory auto-immune uveitis patients,
planned to start mid-2015;
- Ovasave and Col-Treg regulatory status
update in the United States, expected mid-2015;
- Opinion of the First Data and Safety
Monitoring Board (DSMB) meeting for Ovasave phase IIb study,
expected end of 2015;
- Top line results of Col-Treg “proof of
principle” clinical study, expected mid-2016;
- Top line results of Ovasave phase IIb
clinical study, expected at the end of 2016 to early 2017.
Results for the year under the IFRS
standard:
- Net loss for the year amounted to €8.3
million against €5.5 million in 2013, an increase of €1.2 million,
excluding expenses related to share-based payments.
- Cash and cash equivalents stood at
€13.9 million at December 31, 2014, thanks to the payment of the
first milestone of Ferring agreement, capital increases for €21.2
million gross, 2013 research tax credit for €1.8 million and PTZI
for €1.7 million gross as well as a tight control of cash flows
from operating activities.
The IFRS income statement at December 31, 2014 is as follows (in
euros):
In thousands of € 12/31/2014
12/31/2013 Revenue 1 327 17 Other
income 2 094 1 757
Revenue and other income 3 421
1 774 Research and development expenses 7 836 5 673 General
and administrative expenses 2 243 1 550 Expenses related to
share-based payments 1 615 1
Net operating expenses -8
273 -5 450 Income from cash and cash equivalents 68 1
Cost of gross financial debt 60 0
Cost of net financial debt
8 1 Other financial income 1 1 Other financial costs
5 3
Net income / (loss) before tax -8 269 -5
451 Tax expenses 0 0
Net income / (loss)
-8 269 -5 451
●●●
Next financial releases:
- First quarter 2015 revenues on May 6,
2015 (after market)
ABOUT TXCELL
TxCell develops innovative, cost-effective, 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
has a strategic partnership for the development of Ovasave with the
Swiss company Trizell Holding SA and Ferring International Center
remains the intended final commercializing party. Both companies
are affiliates of the Dr Frederik Paulsen Foundation. TxCell’s
second product candidate, Col-Treg is for the treatment of
autoimmune uveitis, a rare disease of the eye. A
placebo-controlled, dose-ranging proof of principle clinical study
is planned to start in the first half of 2015. 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 65
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.
Image Box – Press relationsNeil Hunter / Michelle
BoxallTel: +44(0) 20 8943
4685michelle.boxall@imageboxpr.co.ukneil.hunter@imageboxpr.co.ukorNewCap
– Investor relationsJulien Perez / Pierre LaurentTel: 01 44 71
94 94txcell@newcap.frorTxCellRaphaël FlipoFinancial
DirectorTel: 04 97 218 300contact@txcell.com