OREANDA-NEWS. Addex Therapeutics (SIX: ADXN) today provided a corporate update and reported full-year 2016 financial results.

Operating Highlights

  • Significant progress achieved in preparing dipraglurant for the start of US registration studies:

    • Phase 2 Parkinson's disease levodopa-induced dyskinesia (PD-LID) data published in leading peer review journal of the Movement Disorder Society;

    • Orphan drug designation granted by US Food and Drug Administration for dipraglurant in PD-LID;

    • Successful completion of mGlu5 receptor occupancy study in healthy subjects supporting dose selection for PD-LID registration studies;

    • Additional analysis of Phase 2 PD-LID data demonstrated robustness of anti-dyskinetic effects

  • ADX71149 anti-epileptic effect published in leading peer reviewed journal, Epilepsia

  • ADX71441 demonstrated robust efficacy in highly translational pre-clinical models of chronic osteoarthritis pain, spasticity and cocaine addiction;

  • Strengthened team with Roger Mills as Chief Medical Officer;

  • Extension of NIDA collaboration to text ADX88178 (mGluR4PAM) in preclinical models of addiction;

  • Awarded $835,000 grant from the Michael J. Fox Foundation for Parkinson's Research to advance the Company's tyrosine kinase discovery program for neuroprotection;

"We remain focused on the clinical development of our most advanced clinical-stage assets, dipraglurant and ADX71441," said Tim Dyer, Chief Executive Officer of Addex. "In addition, we continue to pursue collaborations with industry, patient advocacy groups, academic institutions, and governmental organizations, to further advance our portfolio of promising allosteric modulator drug candidates. In parallel, we are executing on our growth strategy that is centered on securing the resources necessary to advance the pipeline for the benefit of patients, while maximizing long-term shareholder value."

Financial Highlights

  • Cash and cash equivalents at February 28, 2017 of CHF3.9 million

  • 2016 income of CHF0.4 million and operating loss reduce to CHF3.1 million

Key 2016 Financial Data

 CHF' millions 2016   2015
       
Income 0.4   0.8
R&D expenses (2.4)   (1.8)
G&A expenses (1.1)   (1.7)
French tax escrow account write-off -   (1.2)
Total operating loss (3.1)   (3.9)
Finance result, net (0.0)   (0.3)
Net loss for the period (3.1)   (4.2)
       
Basic and diluted net loss per share (0.28)   (0.39)
Net cash increase / (decrease) (1.2)   0.6
Cash and cash equivalents 1.4   2.6
Shareholders' equity 0.2   1.7

Financial Summary

Income was CHF0.4 million in 2016, compared to CHF0.8 million in 2015, and was comprised of CHF0.3 million of grants from The Michel J. Fox Foundation for Parkinson's Research to cover certain clinical activities related to dipraglurant development in PD-LID, and CHF81 thousand received from Pierre Fabre Pharmaceuticals for certain research services.

Research & development expenses increased by 33%, to CHF2.4 million, in 2016, compared to CHF1.8 million in 2015, primarily due to increases in external research and development costs and consulting fees associated with preparing dipraglurant for registration clinical trials.

General & administration expenses decreased by 35% to CHF1.1 million in 2016, compared to CHF1.7 million in 2015, primarily due to reduced professional fees.

Net loss for the year decreased significantly to CHF3.1 million for 2016, compared to CHF4.2 million for 2015, primarily due to the CHF1.2 million non-recurring non-cash charge related to the write-off of the French tax dispute escrow account in 2015. Basic and diluted loss per share also decreased accordingly, to CHF0.28 for 2016, compared to CHF0.39 for 2015.

Cash and cash equivalents decreased by 46% to CHF1.4 million at December 31, 2016, compared to CHF2.6 million at December 31, 2015. This decrease of CHF1.2 million is primarily due to net cash used in operations of CHF2.7 million, offset by gross proceeds of CHF1.5 million from the sale of treasury shares.

Post year-end 2016 balance sheet event
During the period January 1 to February 28, 2017, the group sold 1,623,427 treasury shares for gross proceeds of CHF3,282,093, increasing cash and cash equivalents to CHF3.9 million at February 28, 2017.

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. 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's 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. Addex's lead drug candidate, dipraglurant (mGluR5 negative allosteric modulator or NAM) has successfully completed a Phase 2a POC in Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials 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's 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 1 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, mGluR7NAM, TrkBPAM and mGluR3NAM & PAM.