Addex Therapeutics Reports 2012 Financial Results

GENEVA, SWITZERLAND--(Marketwire - February 28, 2013) - 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) 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.

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Source: Addex Therapeutics via Thomson Reuters ONE

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