ADDEX THERAPEUTICS L

ADXN
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1.535CHF -0.97%

Press Release: Addex Reports Full Year 2020 Financial Results and Provides Corporate Update

03/11/2021 | 01:00am
 
   -- 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) 
 
 
   Geneva, Switzerland, March 11, 2021 -- 
https://www.globenewswire.com/Tracker?data=qkAvEdFGCX6jWz0zNvrExlHrqQX_GtuRpdo9GAKwWQ4tLpR8hsJa0fxfuQF5KBZgaDDhVR39Ds5PKoMp0V9SrPlFyKhA080v_jbot3zcr9E= 
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 
 
 
   Key 2020 Financial Data 
 
 
 
 
CHF' thousands                2020      2019     Change 
                            --------  --------  -------- 
Income                         3,879     2,834     1,045 
R&D expenses                (10,373)  (12,454)     2,081 
G&A expenses                 (5,749)   (4,984)     (765) 
Total operating loss        (12,243)  (14,604)     2,361 
Finance result, net            (616)     (176)     (440) 
Net loss for the 
 period                     (12,859)  (14,780)     1,921 
Basic and diluted 
 net loss per share           (0.48)    (0.56)      0.08 
Net decrease in cash 
 and cash equivalents       (12,842)  (10,133)   (2,709) 
Cash and cash equivalents     18,695    31,537  (12,842) 
Shareholders' equity          14,610    25,524  (10,914) 
 
   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: 
 
   The full-year 2020 financial report can be found on the Company's 
website in the investor/download section 
https://www.globenewswire.com/Tracker?data=dmjhZ6hgi0jzP4YaVlUiqqA2bd9dTFzRnHPzafRXA0mLkP7PeTBwxWXvXOm8fYOazzF63FRQhXvTuGW-c5oirRmM40NkFmlyv8sSWIO3it_4H_u2fvFwkl0EyDYHFz1t 
here. 
 
   Conference Call Details: 
 
   A conference call will be held today, March 11, 2021, at 16:00 CET 
(15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim 
Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer 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 
 
   -- USA: +1 87 74 23 08 30 
 
   --  https://arkadinuk.sharefile.com/share/view/s0e04fcb522ce4024872b3086835672ec 
      Other Countries 
 
 
   2: Provide the Operator with the Participation Pin Code: 92320595# 
 
   Link to live event online: 
 
   1: In the 10 minutes prior to the call start time, sign in online by 
following this 
https://www.globenewswire.com/Tracker?data=BbNGe43WqcmK-rZ6X4d20zy4kBiJ1zeVu0X91OtUA2gnCJD5iMK2c5G9cQuHo70W8obvsZvsw-Zzz39zqVEnxb3KNoiU_Cdjz3inBC2T_tRjv1ar2UYVc7_5oq8Re8cgZNYhg-2yxv0E-GF7TdEGxmBegfXTRIlEtNBUgYmfCy_FkFCrYJLJLeUcwJPbseCf 
Webex link. 
 
   2: Password: Welcome 
 
   About Addex Therapeutics: 
 
   https://www.globenewswire.com/Tracker?data=qkAvEdFGCX6jWz0zNvrExnJ3RFUeUDBF6VRVIw_QS2bBN1Aslhbxr0cTPaF6DhahN3GiGo7Q_D5t0c-GwxdyUlQko5bHyxb5-ZBhkmU8m5Y= 
Addex Therapeutics is a clinical-stage pharmaceutical company focused on 
the development and commercialization of an emerging class of novel 
orally available small molecule drugs known as allosteric modulators for 
neurological disorders. Allosteric modulators offer several potential 
advantages over conventional non-allosteric molecules and may offer an 
improved therapeutic approach to 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. Addex's lead drug 
candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is 
poised to start a pivotal registration clinical trial for Parkinson's 
disease levodopa induced dyskinesia (PD-LID) in H1 2021. Addex is also 
investigating dipraglurant's therapeutic use in blepharospasm (a type of 
dystonia), for which a clinical trial is expected to be initiated in H1 
2021. Addex's third clinical program, ADX71149 (mGlu2 positive 
allosteric modulator or PAM), developed in collaboration with Janssen 
Pharmaceuticals, Inc, is scheduled to enter a phase 2a proof of concept 
clinical study for the treatment of epilepsy in Q2 2021. Addex's GABAB 
PAM program has been licensed to Indivior PLC who are focused on 
development for the treatment of addiction. Preclinical programs include 
GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild 
neurocognitive disorders, mGlu4 PAM for Parkinson's disease and mGlu3 
PAM for neurodegenerative disorders. Addex is listed on the SIX Swiss 
Exchange and the NASDAQ Capital Market and trades under the ticker 
symbol "ADXN". 
 
   Press Contacts: 
 
 
 
 
Tim Dyer                          Mike Sinclair                 James Carbonara 
 Chief Executive Officer           Partner, Halsin Partners      Hayden IR 

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March 11, 2021 01:00 ET (06:00 GMT)

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