Addex Therapeutics First Half 2012 Financial Results

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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