GENEVA--(Marketwire - August 22, 2012) -
Addex Therapeutics / Addex Therapeutics First Half 2012 Financial Results.
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Addex Therapeutics (SIX: ADXN), a leading
company pioneering allosteric modulation-based drug discovery and
development,
announced today financial results for the first half of 2012, and
reviewed the
status of its pipeline and business operations.
Financial Highlights
* Cash and cash equivalents of CHF20.2 million at 30 June 2012
* Operating expenses reduced by 17% to CHF14.9 million
* Cash utilization of CHF15.8 million for H1 2012
Operational Highlights
* Dipraglurant Phase 2 Parkinson's disease positive top-line trial
results
reported in March 2012
* Right-sizing to 55 FTEs successfully implemented in May 2012
* Addex partner, Janssen Pharmaceuticals Inc., initiated Phase 2 clinical
trial of ADX71149 for the treatment of major depressive disorder with
anxiety symptoms in June 2012
* Graham Dixon appointed as Chief Scientific Officer and Head of Research
in
July 2012
"We are pleased with the achievements we have made in the first half of
2012.
With positive dipraglurant phase 2 data and the progress being made
by our
partner Janssen with ADX71149, it is shaping up to be a pivotal year in
Addex'
turnaround," said Bharatt Chowrira, President and CEO of Addex. "We are
focused
on implementing our strategic plan, including securing a partner
for
dipraglurant, which we expect to have on board by the end of 2012. We are
also
looking forward to sharing the top-line results of the ADX71149 phase 2
study in
schizophrenia towards the end of the year."
Commenting on the financials, Tim Dyer, CFO, said: "We have improved
operational
effectiveness through restructuring the organization and externalizing
non-core
activities, and expect these measures to further reduce our operating
cash
utilization in the second half of 2012, so that we can meet our 2012 full
year
cash utilization guidance of CHF25-27 million."
Key Financial Data
CHF' thousands H1 2012 H1 2011 Change
---------------------------------------------------------------------------
Income 121 3 173 (96%)
R&D expenses (11 562) (14 558) (21%)
G&A expenses (3 307) (3 299) -
---------------------------------------
Total operating loss (14 748) (14 684) -
Finance result, net (10) (143) -
---------------------------------------
Net loss for the period (14 758) (14 827) -
---------------------------------------
Basic and diluted net loss per share (1.91) (2.07) (8%)
Net cash used (cash burn) (15 829) (13 567) 17%
---------------------------------------------------------------------------
CHF' thousands Jun. 30, 2012 Dec. 31, 2011 Change
---------------------------------------------------------------------------
Cash and cash equivalents 20 237 36 065 (44%)
Shareholders' equity 19 475 33 836 (42%)
---------------------------------------------------------------------------
First Half 2012 Financial Summary
Income was CHF0.1 million in the first half of 2012 compared to CHF3.2
million
in the first half of 2011, and corresponded to grants recognized
from The
Michael J. Fox Foundation for Parkinson's Research. First half of 2011
revenue
included a CHF2.6 million milestone received from Janssen Pharmaceuticals
Inc.
under the mGluR2 PAM license agreement.
Research & development expenses decreased by 21% to CHF11.6 million in the
first
half of 2012 compared to CHF14.6 million in the first half of 2011,
mainly due
to our reduced headcount.
General and administration expenses remained stable at CHF3.3
million,
reflecting the effects of the reduced headcount offset by one-off
restructuring
costs.
Net loss remained stable at CHF14.8 million, mainly due to reduced
operating
expenses being offset by lower revenues from collaborations.
Cash and cash equivalents amounted to CHF20.2 million at 30 June 2012,
compared
to CHF36.1 million at the end of 2011. Cash utilization for the first
half of
2012 of CHF15.8 million is due to the cash used in operations.
Outlook: Based on current expectations, full year cash burn guidance is
CHF25-27 million.
Pipeline Status Review
Dipraglurant is a novel oral small molecule, which inhibits the
metabotropic
glutamate receptor 5 (mGluR5), and has potential to be used in combination
with
levodopa or dopamine agonists for treatment of Parkinson's disease
(PD). Our
initial focus is on testing dipraglurant for the treatment of PD
levodopa-induced dyskinesia (PD-LID). Together with a partner, we
hope to study
dipraglurant's potential for treatment of the non-motor symptoms of PD
(e.g.
anxiety, depression and impulse control disorders), motor symptoms of
PD and
also non-parkinsonian dystonias.
While dipraglurant has broad potential for treating Parkinson's and
other
diseases, the most direct path to market is treatment of PD-LID. No
drug is
approved for PD-LID, and dyskinesia has been identified by the
regulatory
authorities, patient advocacy groups, such as The Michael J. Fox
Foundation for
Parkinson's Research, and key opinion leaders, as a very important unmet
medical
need. The potential market opportunity for dipraglurant in Parkinson's
disease
is well in excess of $1 billion. Further label expansion outside of
Parkinson's
disease could more than double the peak sales potential for dipraglurant.
As a
result, we believe that dipraglurant is a compelling partnering
opportunity.
In the double-blind, placebo-controlled, EU and U.S. trial in PD-LID
patients,
the data showed that dipraglurant met the primary objective of the
study by
exhibiting a good safety and tolerability profile. Dipraglurant 50 and
100 mg
doses reduced dyskinesia severity and appeared to have effect on
dystonia as
well as chorea (AIMS score). Dipraglurant (50 and 100 mg) increased "on"
time
without dyskinesia in all four treatment weeks and appeared to reduce "off"
time
in the final week of treatment (patient diaries) and clinicians
rated
dipraglurant as giving greater improvement in dyskinesia than placebo
(CGIC).
The anti-parkinsonian effectiveness of levodopa was maintained with
co-administration of dipraglurant (UPDRS scores). The study was partially
funded by
a $900,000 grant from The Michael J Fox Foundation for Parkinson's
Research.
Addex is currently seeking a partner to rapidly advance this program
further.
ADX71149 is undergoing a 105-patient Phase 2a trial for the
treatment of
schizophrenia and a Phase 2a trial in major depressive disorder patients
with
anxiety symptoms. This orally available mGluR2-selective positive
allosteric
modulator (PAM) small molecule was discovered and developed in
collaboration
with our partner, Janssen Pharmaceuticals Inc., which is responsible
for all
clinical development and commercialization of ADX71149. Under the
licensing
agreement, Addex is eligible for development and regulatory milestones of
up to
a total of EUR112 million plus low double-digit royalties. Top-line data
in the
Phase 2a schizophrenia trial are expected in Q4 2012.
Addex is continuing to advance its robust pre-clinical pipeline,
including
GABABR PAM for treating overactive bladder and other important
indications; and
mGluR4 PAM for treating Parkinson's disease, MS, anxiety and a number of
other
diseases with huge unmet medical need.
Also, Addex continues to invest in expanding its proprietary
industry-leading allosteric modulator technology platform for addressing
a number of
high-value GPCR and non-GPCR targets.
A webcast and conference call will be held today at 16:00 CET (15:00
GMT/10:00
EST). To participate, please listen to the webcast or call one of the
following
telephone numbers. RSVP is not necessary.
Dial-in numbers: +41 91 610 56 00 (Europe)
+44 203 059 58 62 (UK)
+1 866 291 4166 (USA)
The live webcast, slides, webcast replay and transcript, as well as the
2012
half year financial statements will be available at
www.addextherapeutics.com.
Addex Therapeutics (www.addextherapeutics.com) discovers and
develops an
emerging class of small molecule drugs, called allosteric modulators, 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 address receptors and other
proteins
that are recognized as attractive targets for modulation of important
diseases
with unmet medical needs. The Company's two lead products are being
investigated
in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5
negative
allosteric modulator or NAM) is being developed by Addex to treat
Parkinson's
disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2
positive
allosteric modulator or PAM) is being developed by our partner
Janssen
Pharmaceuticals Inc. to treat schizophrenia and anxiety seen in
patients
suffering from major depressive disorder. Addex also is advancing
several
preclinical programs including: GABABR PAM for overactive bladder and
other
disorders; mGluR4 PAM for Parkinson's, MS, anxiety and other
diseases. In
addition, Addex is applying its proprietary discovery platform to
identify
highly selective and potent allosteric modulators of a number of both
GPCR and
non-GPCR targets that are implicated in diseases of significant unmet
medical
need.
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 mGluR2, mGluR4, mGluR5, GABABR 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 mGluR2, mGluR4, mGluR5, GABABR 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 mGluR2,
mGluR4,
mGluR5, GABABR 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 mGluR2, mGluR4, mGluR5, GABABR 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
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