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Addex Therapeutics Reports 2012 Financial Results


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© Marketwire 2013
2013-02-28 07:46:23 -

GENEVA, SWITZERLAND -- (Marketwire) -- 02/28/13 -- Addex Therapeutics /
Addex Therapeutics Reports 2012 Financial Results
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.



2012 Financial Highlights



* CHF20.8 million of cash used, in line with the guidance of CHF20-21
million



* Cash and cash equivalents of CHF15.3 million at 31 December 2012



* Cash utilization guidance of CHF15-16 million for 2013



2012 Operating Highlights



* Dipraglurant Phase 2 Parkinson's disease positive top-line trial
results reported in March 2012



* Phase 2 clinical study of ADX71149 for the treatment of anxiety seen in
major depressive disorder patients commenced by our partner, Janssen
Pharmaceuticals, Inc. in June 2012



* ADX71149 reported top-line data from a successful Phase 2a clinical
study in schizophrenia patients in November 2012



* Completion of preclinical development activities in support of CTA
filing for Phase 1 testing of ADX71441 (GABA-BR PAM)



* Demonstration of preclinical proof-of-concept in multiple sclerosis
(MS) pre-clinical models with mGlu4 PAM compound



* Screening and identification of validated PAM hits targeting A2AR GPCR
target



* Completion of a USD10M PIPE financing



* US listing on track for first half 2013



Addex Therapeutics (SIX: ADXN), a
leading company pioneering allosteric modulation-based drug discovery
and
development announced today 2012 financial results and that it has
completed the
organizational changes announced on 7 February 2013.





Key 2012 Financial Data

 CHF' thousands        2012     2011   Change     2H12     2H11     Change
--------------------------------------------------------------------------


Income                    121    3 743  (97%)          -      570   (100%)
                    ------------------------------------------------------
R&D expenses         (20 650) (27 986)  (26%)    (9 088) (13 428)    (32%)

G&A expenses          (6 481)  (6 731)     (4%)  (3 173)  (3 432)     (8%)
                    ------------------------------------------------------
Total operating loss (27 010) (30 974)  (13%)   (12 261) (16 290)    (25%)
                    ------------------------------------------------------
Finance result, net       (8)    (167)  (95%)          1     (24)        -
                    ------------------------------------------------------
Net loss for the
period               (27 018) (31 141)  (13%)   (12 260) (16 314)    (25%)
                    ------------------------------------------------------


Basic and diluted
net loss per share     (3.41)   (4.19)  (19%)     (1.50)   (2.12)    (29%)



Net cash used (cash
burn)                (20 808) (27 732)  (25%)    (4 980) (14 165)    (65%)



Cash and cash
equivalents            15 257   36 065  (58%)     15 257   36 065    (58%)

Shareholders' equity   16 291   33 836  (52%)     16 291   33 836    (52%)




2012 Financial Summary



Income was CHF0.1 million in 2012 compared to CHF3.7 million in
2011, and
corresponds to the final installments recognized under the grant received
from
The Michael J. Fox Foundation for Parkinson's Research for our
dipraglurant
Phase 2a clinical trial.



Research & Development expenses decreased by 26% to CHF20.7 million in
2012
compared to CHF28.0 million in 2011, primarily due to our reduced
headcount and
pipeline prioritization.



General and Administration expenses decreased by 4% to CHF6.5 million in
2012
compared to CHF6.7 million in 2011 mainly due to our reduced headcount.



Net Loss decreased by 13% to CHF27.0 million for 2012 compared to
CHF31.1
million for 2011, mainly due to the decrease in our operating expenses.



Cash and cash equivalents amounted to CHF15.3 million at 31 December
2012,
compared to CHF36.1 million at the end of 2011. 2012 cash burn of
CHF20.8
million is mainly due to the cash used in operations of CHF29.5 million,
off-set
by the proceeds from the capital increase, net of costs, of CHF8.9 million.



Outlook: Based on current expectations, which include the costs of
the
restructuring and the progression of our prioritized clinical and
preclinical
projects, full year 2013 cash burn guidance without cash inflows is
CHF15-16
million.



Organizational Changes



The Company has completed the organizational changes necessary to execute
on its
strategy of advancing innovative development-stage programs targeting
diseases
with high unmet medical need, especially certain rare diseases.
The new
organization's headcount is now 18 full-time employees. Following
the
consultation period, required under Swiss law, 37 employees were made
redundant.
As a part of this restructuring, Dr. Charlotte Keywood, Dr. Robert
Lutjens, Dr.
Jean-Philippe Rocher and Mr. Christopher Maggos have stepped down from
their
positions on the Executive Committee of the Company. There should be no
impact
or delay on the Company's proposed timelines or ability to deliver on its
near-term value drivers due to these organizational changes. The new
organization's
expertise and capabilities supported by consultants and key opinion
leaders is
well positioned to continue our development focused efforts.



Strategy



Over the past several years, we have established ourselves as a leading
allosteric modulation-based drug discovery company and now find ourselves
in a
strong position to transition from a platform and discovery-based company
to a
development stage company. We have a strong clinical and pre-clinical
pipeline
and believe that focusing our resources on the advancement of that pipeline
to
market is critical to continuing to build shareholder value. We will focus
our
resources on developing our clinical stage pipeline for rare diseases. In
pursuing this strategy, we will advance current clinical and pre-IND
programs in
certain diseases where orphan drug designation can be reasonably achieved
in the
major commercial markets - U.S., Europe and Japan. In executing this
strategy
and to maximize potential clinical success in at least two programs over
the
next 12 months, the company reduced its overall cost structure,
particularly
related to our early-stage discovery efforts. We have maintained the
capability
to rapidly re-build our discovery effort to support potential
collaborations or
our own internal discovery needs in the future by maintaining key
intellectual
property as well as critical know-how. Pending the potential future
success of
our clinical programs, and industry and market drivers, we would be in a
position to restart our drug discovery engine. We continue to seek means of
increasing our cash position through non-dilutive partnerships and will
endeavour to monetize both the drug discovery platform capability as well
as our
discovery programs via licensing and strategic transactions. Finally, to
improve the Company's liquidity and long term outlook, Addex will secure a
listing on a US stock exchange.



We believe we have successfully redefined Addex and positioned ourselves
as a
development-focused company. We will utilize our cash runway through
2013 to
achieve key value drivers in the following three programs:
dipraglurant,
ADX71441 targeting GABAB-Receptor and our mGlu4 PAM program. In
addition,
continued clinical progress with ADX71149 by our partner
Janssen
Pharmaceuticals, Inc., could potentially drive additional value for
Addex and
our shareholders.



Addex Therapeutics ( www.addextherapeutics.com : www.addextherapeutics.com ) is a development stage
company
focused on advancing innovative oral small molecules against rare
diseases
utilizing its pioneering allosteric modulation-based drug discovery
platform.
The Company's two lead products are being investigated in Phase 2
clinical
testing: dipraglurant (ADX48621, an mGlu5 negative allosteric modulator or
NAM)
is being developed by Addex to treat Parkinson's disease
levodopa-induced dyskinesia (PD-LID) and rare forms of dystonia; and
ADX71149 (mGlu2 positive
allosteric modulator or PAM) is being developed in collaboration with
Janssen
Pharmaceuticals, Inc. to treat both schizophrenia and anxiety as
seen in
patients suffering from major depressive disorder. Addex is also
advancing
several preclinical programs including: GABA-BR positive allosteric
modulator
(PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patients
with
multiple sclerosis (MS), pain, overactive bladder and other disorders; and
mGlu4
PAM for MS, Parkinson's disease, anxiety and other diseases.
Allosteric
modulators are an emerging class of small molecule drugs which
have the
potential to be more specific and confer significant therapeutic advantages
over
conventional "orthosteric" small molecule or biological drugs. The Company
uses
its proprietary discovery platform to target receptors and other proteins
that
are recognized as essential for the therapeutic modulation of important
diseases
with unmet medical needs.



Disclaimer: The foregoing release may contain forward-looking statements
that
can be identified by terminology such as "not approvable",
"continue",
"believes", "believe", "will", "remained open to exploring", "would",
"could",
or similar expressions, or by express or implied discussions regarding
Addex
Therapeutics, formerly known as, Addex Pharmaceuticals, its
business, the
potential approval of its products by regulatory authorities, or
regarding
potential future revenues from such products. Such forward-looking
statements
reflect the current views of Addex Therapeutics regarding future events,
future
economic performance or prospects, and, by their very nature, involve
inherent
risks and uncertainties, both general and specific, whether known or
unknown,
and/or any other factor that may materially differ from the plans,
objectives,
expectations, estimates and intentions expressed or implied in such
forward-looking statements. Such may in particular cause actual results
with allosteric
modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutic targets
to be
materially different from any future results, performance or
achievements
expressed or implied by such statements. There can be no guarantee
that
allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other
therapeutics
targets will be approved for sale in any market or by any regulatory
authority.
Nor can there be any guarantee that allosteric modulators of mGlu2,
mGlu4,
mGlu5, GABA-BR or other therapeutic targets will achieve any particular
levels
of revenue (if any) in the future. In particular, management's
expectations
regarding allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or
other
therapeutic targets could be affected by, among other things, unexpected
actions
by our partners, unexpected regulatory actions or delays or
government
regulation generally; unexpected clinical trial results, including
unexpected
new clinical data and unexpected additional analysis of existing clinical
data;
competition in general; government, industry and general public
pricing
pressures; the company's ability to obtain or maintain patent or
other
proprietary intellectual property protection. Should one or more of these
risks
or uncertainties materialize, or should underlying assumptions prove
incorrect,
actual results may vary materially from those anticipated, believed,
estimated
or expected. Addex Therapeutics is providing the information in this
press
release as of this date and does not undertake any obligation to
update any
forward-looking statements contained in this press release as a result
of new
information, future events or otherwise, except as may be required by
applicable
laws.



This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:



(i) the releases contained herein are protected by copyright and
other applicable laws; and



(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.



Source: Addex Therapeutics via Thomson Reuters ONE



[HUG#1681892]




Tim Dyer
Chief Financial Officer
Addex Therapeutics
+41 22 884 15 61
Email Contact : www2.marketwire.com/mw/emailprcntct?id=B3F54AB3EA337F4F



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