• Thursday, March 11, 2021 @ 7:00 am

  • Strong cash and cash equivalents position at Dec 31, 2020 of $20.2M (CHF18.7M)
  • Balance sheet further strengthened by $11.5M fundraising on January 11, 2021
  • Three clinical studies in neurology programs expected to start during H1 2021
  • Clinical stage neurology programs aimed at large underserved market opportunities (Epilepsy, Parkinson’s disease LID and Blepharospasm)

Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today reported financial results for the full-year ended December 31, 2020 and provided a corporate update.

“We ended 2020 in a strong financial position, which was supplemented by our successful $11.5 million fundraising at the beginning of 2021,” said Tim Dyer, CEO of Addex. “Throughout 2020, we advanced preparations for the start of clinical studies targeting large underserved market opportunities. Clinical studies starting in the first half of 2021 include two internal programs, dipraglurant in Parkinson’s disease LID and blepharospasm. Additionally, our partner, Janssen is expected to start clinical studies with ADX71149 for epilepsy in the second quarter. Our collaboration with Indivior continues to move forward at a rapid pace and expect to deliver compounds for IND enabling studies by the end of this year.”

Select Upcoming Milestones

  • Q2 21 - Phase 2a study starting: ADX71149 for epilepsy. Partnered with Janssen
  • H1 21 - Phase 2b/3 study starting: dipraglurant for Parkinson’s disease LID (Uncontrolled, involuntary muscle movement)
  • H1 21 - Phase 2a study starting: dipraglurant for blepharospasm (Uncontrolled squeezing or twitching of the eyelids)
  • Q4 21 - Phase 2a data: dipraglurant for blepharospasm
  • H1 22 - Phase 2a data: ADX71149 for epilepsy
  • Q4 22 - Phase 2b/3 data: dipraglurant for Parkinson’s disease LID (PD-LID)

2020 Operating Highlights

  • Ended 2020 with a strong cash position of $20.2 million (CHF 18.7 million), coupled with an additional $11.5 million fundraising on January 11, 2021, provides runway till mid 2022
  • Ensured dipraglurant is ready to start pivotal registration study in levodopa induced dyskinesia associated with Parkinson’s disease (PD-LID) following delay due to the global Covid-19 crisis; study initiation expected H1 2021
  • Prepared dipraglurant exploratory placebo-controlled clinical trial in blepharospasm patients, which is scheduled to start in H1 2021
  • Partner, Janssen prepared the start of a Phase 2a proof of concept clinical study of ADX71149 for epilepsy, which is scheduled to start in Q2 2021
  • GABAB PAM research program entered clinical candidate selection phase
  • Extended research agreement with Indivior until June 30, 2021, with a commitment for an additional funding of $2.8 million
  • Awarded CHF600K Innosuisse grant in collaboration with SIB (Swiss Institute of Bioinformatics) to identify new therapeutic indications for ADX10061 (D1 antagonist) program
  • Appointed Darryle D. Schoepp, PhD, one of the world’s leading and most successful neuroscience drug developers as Chairman newly formed scientific advisory board
  • Advanced Eurostars / Innosuisse funded mGlu7 negative allosteric modulator research program for post-traumatic stress disorder
  • Continue to advance remaining preclinical programs to their next value inflection points
  • Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020

Financial Summary
Income increased by CHF 1.0 million to CHF 3.9 million in 2020 compared to CHF 2.8 million in 2019, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D expenses decreased by CHF 2.1 million to CHF 10.4 million in 2020 compared to CHF 12.4 million in 2019, primarily due to delays in starting certain clinical development activities due to the global coronavirus pandemic. 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 CHF 0.7 million to CHF 5.7 million in 2020 compared to CHF 5.0 million in 2019 mainly due to the increase of CHF 1.3 million relating to increased directors and officer’s liability insurance premiums partially offset by a decrease of CHF 0.5 million in audit and legal fees.

The net loss for 2020 was CHF 12.9 million compared to CHF 14.8 million for 2019 primarily due to the decrease in R&D costs. Basic and diluted loss per share decreased to CHF 0.48 for 2020, compared to CHF 0.56 for 2019.

Cash and cash equivalents amounted to CHF 18.7 million at December 31, 2020 compared to CHF 31.5 million at December 31, 2019. This decrease of CHF 12.8 million is mainly due to the net loss.

2020 Condensed Consolidated Interim Financial Statements
See the full-year 2020 financial report.