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Press Release

Addex Therapeutics Reports First Half 2016 Operating Highlights and Financial Results

Addex Therapeutics
Posted on: 30 Sep 16

Geneva, Switzerland, 30 September 2016 - Addex Therapeutics (SIX: ADXN) announced today its first half 2016 operating highlights and financial results.

2016 First Half Operating & Financial Highlights

  • Achieved significant progress, with the support of the Michael J. Fox Foundation for Parkinson's Research, in preparation for dipraglurant Phase III clinical trial
  • Received orphan drug designation from the U.S. Food and Drug Administration (FDA) for dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease
  • Dipraglurant positive Phase II data in Parkinson's disease levodopa-induced dyskinesia published in leading peer reviewed journal of the Movement Disorder Society
  • Completed receptor occupancy study with dipraglurant in healthy volunteers to support selection of the dose for Phase III studies
  • National Institute of Drug Abuse (NIDA) generated positive results with ADX71441 in a non-human primate model of cocaine addiction
  • Generated preclinical data demonstrating potential of mGluR4 and mGluR7 programs in neurodegenerative and psychiatric diseases through collaboration with the University of Lausanne
  • Completed the half year with an operating cash burn of CHF1.4 million and cash at 30 June 2016 of CHF2.3 million

"We achieved a number of important milestones in the first half of 2016," said Tim Dyer, CEO of Addex.  "Most importantly, we made meaningful progress in preparations for the Phase III trial for our lead program, dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease, which we expect to initiate in the second half of 2017.  Looking ahead to the remainder of 2016, we expect a number of additional key milestones, including the initiation of dosing in our Phase II Proof-of-Concept study of dipraglurant for focal cervical dystonia."

CHF' thousandsH1 2016 H1 2015 Change
Income283   90 214 %
R&D expenses(1 061) (949) 12 %
G&A expenses(705) (1 948) (64) %
Total operating loss(1 483) (2 807) (47) %
Finance result, net(2) (26) (92) %
Net loss for the period(1 485) (2 833) (48) %
      
Basic and diluted net loss per share(0.11) (0.26) (58) %
      
Net cash (used) / from(376) 1 668 (123) %
      
Cash and cash equivalents2 255 3 579 (37) %
Shareholders' equity1 180 2 736 (57) %

Research & Development expenses increased to CHF1.1 million in the first half of 2016 compared to CHF0.9 million in the first half of 2015, mainly due to increased activities related to the dipraglurant development.

General and Administration expenses decrease to CHF0.7 million in the first half of 2016, from CHF1.9 million in the first half of 2015, mainly due to the 2015 write-off of a deposit held in escrow related to disputes with the French Tax authorities.

Net Loss decreased to CHF1.5 million in the first half of 2016 from CHF2.8 million in the first half of 2015.

Cash and cash equivalents amounted to CHF2.3 million at 30 June 2016, compared to CHF3.6 million at the end of 2015.

2016 Condensed Consolidated Interim Financial Statements
The 2016 condensed consolidated interim financial statements can be found on the Company's website at the investor relation page

About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a biopharmaceutical company focused on the development of novel, orally available, small molecule allosteric modulators for neurological disorders. Addex lead drug candidate, dipraglurant (mGluR5 negative allosteric modulator or NAM) has successfully completed a phase IIa POC in Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter phase III for PD-LID with support from the Michael J. Fox Foundation for Parkinson's Research (MJFF). In parallel, dipraglurant's therapeutic use in dystonia is being investigated with support from the Dystonia Medical Research Foundation (DMRF). Addex second clinical program, ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc for epilepsy. In addition, ADX71441 (GABAB receptor PAM) has received regulatory approval to start phase I and is being investigated for its therapeutic use in Charcot-Marie-Tooth Type 1A disease (CMT1A), cocaine and alcohol use disorder and nicotine dependence. Discovery programs include mGluR4PAM for neurodegenerative diseases, mGluR7NAM for psychosomatic disorders and TrkBPAM for neurodegenerative disorders which are being advanced in collaboration with the Universities of Lausanne and Geneva under the Swiss CTI grant program; and mGluR3PAM which is being advanced in collaboration with Pierre Fabre Pharmaceuticals. 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.  Addex allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention - the Addex pipeline was generated from this pioneering allosteric modulator drug discovery platform.

Press Contacts:
Tim Dyer
Chief Executive Officer
Addex Therapeutics
Telephone: +41 22 884 15 61
Email: PR@addextherapeutics.com

Disclaimer / Forward-looking statements: This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Addex Therapeutics Ltd. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.



This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Addex Therapeutics via GlobeNewswire
HUG#2045617
GlobeNewswire
globenewswire.com

Last updated on: 01/10/2016

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