Addex Reports 2018 Full Year Audited Results and Provides Corporate Update

  • Robust cash position of CHF41.7 million providing runway through 2021
  • Dipraglurant on track to start pivotal registration study in PD-LID by end of year
  • Strengthened team of clinical and preclinical experts
  • Developing broad allosteric modulator pipeline addressing multiple CNS indications

Geneva, Switzerland, April 30, 2019 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, today reported its full-year audited results for the year ended December 31, 2018 and provided a corporate update.

 

“Our solid financial position and strong operating performance has positioned Addex well for the future. We rebuilt the core structure of the company, including key hires, to fully prepare us to deliver on key product development milestones,” said Tim Dyer, CEO of Addex. “Before the end of 2019, we will begin a pivotal registration study with dipraglurant in Parkinson’s disease levodopa-induced dyskinesia (PD-LID), a significant milestone for Addex. We have also made significant progress in advancing our preclinical portfolio which we expect to feed our clinical pipeline in the coming years.”

 

2018 Operating Highlights

  • Completed CHF40 million financing from leading US healthcare investors.
  • Dipraglurant: solid progress made to start US registration study by end of year for PD-LID -manufacturing of drug product on track, CRO selected and US based development team hired.
  • Signed partnership with Indivior: discovery activities on track to deliver novel gamma-aminobutyric acid subtype B receptor (GABAB) positive allosteric modulator (PAM) compounds for future development.
  • ADX10061 received £1.2 million funding for manufacture and investigator led clinical studies as part of the Tools for Human Drug and Brain Research (THuNDR2) Initiative from the Wellcome Trust.
  • Tyrosine kinase type B (TrKB) PAM program develivered drug candidates for in vivo profiling with support from The Michael J. Fox Foundation for Parkinson’s Research.
  • Janssen partnership: ADX71149 highlighted in review of epilepsy drugs to watch.
  • Strengthened team to 17 from 5 including Dr Rocher as Head of Discovery Chemistry.

Key 2018 Financial Data

CHF’ thousands

2018

2017

change

Revenue from contract with customer

6,043

-

6,043

Other income

658

499

159

R&D expenses

(4,918)

(2,628)

(2,290)

G&A expenses

(3,208)

(1,106)

(2,102)

Total operating loss

(1,424)

(3,235)

(1,811)

Finance result, net

(220)

(45)

(175)

Net loss for the period

(1,644)

(3,280)

(1,636)

Basic and diluted net loss per share

0.07

0.25

(0.18)

Net cash increase/(decrease)

39,080

1,214

37,866

Cash and cash equivalents

41,670

2,591

39,079

Shareholders’ equity

39,240

1,343

37,897

 

 

 

 

Financial Summary

Revenue in 2018 was CHF6.0 million and relates to upfront fees and research funding recognized under our license and research agreement with Indivior PLC. Other income in 2018 was CHF0.7 million compared to CHF0.5 million in 2017, and comprises primarily grants from The Michael J. Fox Foundation for Parkinson’s Research related to dipraglurant development in PD-LID and TrKB PAM discovery activities.

 

R&D expenses increased by CHF2.3 million to CHF4.9 million in 2018 compared to CHF2.6 million in 2017, mainly due to manufacturing and consulting activities related to the preparation of dipraglurant PD-LID registration studies as well as research activities related to our GABAB PAM and TrKB PAM programs. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third party R&D.

 

G&A expenses increased by CHF2.1 million to CHF3.2 million in 2018, compared to CHF1.1 million in 2017, mainly due to the recognition of the fair value of equity incentive units granted during the year of CHF1.4 million compared to CHF0.3 million in 2017. Other G&A expenses consist primarily of staff costs, professional fees for legal, tax and strategic purposes and overheads related to general management, human resources, finance, information technology, business development and communication functions.


The net loss for 2018 was CHF1.6 million compared to CHF3.2 million for 2017. Basic and diluted loss per share decreased to CHF0.07 for 2018, compared to CHF0.25 for 2017.

                    
Cash and cash equivalents amounted to CHF41.7 at December 31, 2018 compared to CHF2.6 million in 2017. This increase is primarily due to the gross proceeds from the CHF40 million capital increase completed on 28 March 2018.


2018 Annual Report

The 2018 annual report can be found on the investor relations page of our website

 

Conference Call Details

A conference call will be held today, April 30, 2019 at 4:00 p.m. CEST / 10:00 a.m. EDT to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer, Jean-Philippe Rocher, Head of Discovery Chemistry and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

 

Joining the Conference Call:

1: In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.   

Dial-In Numbers:

  • Switzerland                +41 44 580 65 22
  • UK                               +44 20 30 09 24 70
  • U.S.A                           +1 87 74 23 08 30
  • Other Countries

2: Provide the Operator with the Participation Pin Code: 63704995#          

 

Link to live event online:

1: In the 10 minutes prior to the call start time, sign in online by following this link Webex Link.

2: Password: Welcome

 

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 has been 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. In parallel, dipraglurant's therapeutic use in dystonia is being investigated. 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, Addex’s GABAB PAM program has been licensed to Indivior PLC for the treatment of addiction. Discovery programs include mGluR4PAM, mGluR7NAM, mGluR3PAM and TrkBPAM.

 

Press Contacts:

Tim Dyer

Chief Executive Officer

Telephone: +41 22 884 15 61

Email: PR@addextherapeutics.com

Mike Sinclair

Partner, Halsin Partners

+44 (0)20 7318 2955

msinclair@halsin.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.

2019.04.30