ADDEX THERAPEUTICS L

ADXN
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1.6CHF +0.63%

Press Release: Addex Reports Q1 2021 Financial Results and Provides Corporate Update

05/05/2021 | 01:00am
 
   -- Strong cash and cash equivalents position at March 31, 2021 of CHF25.2M 
      ($26.7M) 
 
   -- Completed $11.5M fundraising in January 2021 
 
   -- Three clinical studies in neurology programs remain on track to start 
      during Q2 2021 
 
   -- Neurology programs aimed at large underserved market opportunities in 
      dyskinesia associated with Parkinson's disease, blepharospasm and 
      epilepsy 
 
 
   Geneva, Switzerland, May 5, 2021 -- Addex Therapeutics 
https://www.globenewswire.com/Tracker?data=vPnWrw36Je3FIMJ-VXeGxVk1PAV375UYG3VqCsasWyKwSMWYg5JOdOs0Db_imoC7AGgwBvFieiOc7oMwrYr6HDi5ffWVUqm5KEgVXCW_tY0= 
(SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company 
pioneering allosteric modulation-based drug discovery and development, 
today reported financial results for the quarter ended March 31, 2021 
and provided a corporate update. 
 
   "We are on track with clinical studies planned to begin this quarter, 
including two internal dipraglurant programs in dyskinesia associated 
with Parkinson's disease and blepharospasm, as well as a Phase 2a 
clinical study with ADX71149 for epilepsy conducted by our partner 
Janssen," said Tim Dyer, CEO of Addex. "Our successful $11.5 million 
fundraising at the beginning of 2021 has further strengthened our 
balance sheet and provides a solid basis for executing our strategy and 
advancing our pipeline." 
 
   Q1 2021 Operating Highlights: 
 
 
   -- Ended Q1 2021 with a strong cash position of CHF25.2 million ($26.7 
      million), supported by an $11.5 million fundraising on January 11, 2021, 
      which provides a runway into Q3 2022 
 
   -- Remain on track for dipraglurant pivotal registration study in dyskinesia 
      associated with Parkinson's disease; study initiation expected Q2 2021 
 
   -- Prepared dipraglurant placebo-controlled clinical trial in blepharospasm 
      patients, scheduled to start in Q2 2021 
 
   -- Strategic partner, Janssen Pharmaceuticals, ready to start a Phase 2 
      clinical study of ADX71149 for epilepsy, initiation scheduled for Q2 2021 
 
   -- Continued to advance GABAB positive allosteric modulator research program 
      through clinical candidate selection phase 
 
   -- Advanced Eurostars / Innosuisse funded mGlu7 negative allosteric 
      modulator research program for post-traumatic stress disorder 
 
   -- Continuing to advance remaining preclinical programs to their next value 
      inflection points 
 
 
   Select Upcoming Milestones: 
 
 
   -- Q2 21 - Phase 2b/3 study starting: dipraglurant for dyskinesia associated 
      with Parkinson's disease 
 
   -- Q2 21 - Phase 2a study starting: dipraglurant for blepharospasm 
 
   -- Q2 21 - Phase 2a study starting: ADX71149 for epilepsy; partnered with 
      Janssen 
 
   -- Q4 21 - Phase 2a data: dipraglurant for blepharospasm 
 
   -- Q3 22 - Phase 2a data: ADX71149 for epilepsy 
 
   -- Q4 22 - Phase 2b/3 data: dipraglurant for dyskinesia associated with 
      Parkinson's disease 
 
 
   Key Financial Data for the Three Months Ended March 31, 2021 
 
 
 
 
CHF' thousands                  Q1 2021  Q1 2020  Change 
Income                              922      952     (30) 
R&D expenses                    (2,748)  (3,553)      805 
G&A expenses                    (1,322)  (1,672)      350 
Total operating loss            (3,148)  (4,273)    1,125 
Finance result, net                 508     (33)      541 
Net loss for the period         (2,640)  (4,306)    1,666 
Basic and diluted net 
 loss per share                  (0.08)   (0.16)     0.08 
Net increase / (decrease) 
 in cash and cash equivalents     6,020  (4,379)   10,399 
Cash and cash equivalents 
 as of March 31                  25,220   27,126  (1,906) 
Shareholders' equity 
 as of March 31                  20,699   21,781  (1,082) 
 
 
   Financial Summary: 
 
   Income remained stable in the first quarter 2021 compared to the first 
quarter 2020 and related primarily to amounts received under our funded 
research collaboration with Indivior. 
 
   R&D expenses decreased by CHF 0.8 million to CHF 2.7 million in the 
first quarter 2021 compared to CHF 3.6 million in the first quarter 
2020, primarily due to the postponement of the start of our dipraglurant 
phase 2b/3 PD dyskinesia clinical trial. Research and development 
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 decreased by CHF 0.4 million to CHF 1.3 million in the 
first quarter 2021 compared to CHF 1.7 million in the first quarter 
2020, primarily due to professional fees that were abnormally high in 
the first quarter 2020 due to the company's listing on the Nasdaq Stock 
Market on January 29, 2020. 
 
   The net loss decreased by CHF 1.7 million to CHF 2.6 million in the 
first quarter 2021 compared to CHF 4.3 million in the first quarter 2020 
primarily due to reduced research and development costs. Basic and 
diluted loss per share decreased to CHF 0.08 for the first quarter 2021, 
compared to CHF 0.16 for the first quarter 2020. 
 
   Cash and cash equivalents amounted to CHF 25.2 million as of March 31, 
2021 compared to CHF 27.1 million as of March 31, 2020. The decrease of 
CHF 1.9 million was primarily due to cash used in operating activities 
partially offset by the proceeds from the capital increase executed on 
January 8, 2021. 
 
   Q1 2021 Condensed Consolidated Interim Financial Statements: 
 
   The first quarter 2021 financial report can be found on the Company's 
website in the investor/download section here 
https://www.globenewswire.com/Tracker?data=Ip3dLqirFtmJh7eDn4hayM5h7fEmdKw8wxEehzMj2NSwLYy26D_sS8VDUzviqRvZedzNN997uaVDT-SL81ztk29it5ZOw-5ArlyZXG2pg_bnwwyMD51YaJpos6mQpc-T 
. 
 
   Conference Call Details: 
 
   A conference call will be held today, May 5, 2021, at 16:00 CEST (15:00 
BST / 10:00 EDT / 07:00 PDT) 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 
 
   -- U.S.A                        +1 87 74 23 08 30 
 
   -- Other Countries: 
      https://events-ftp.arkadin.com/ev/docs/International%20Access%20Numbers_%20DETAU2.pdf 
 
 
 
   2: Provide the Operator with the Participation Pin Code: 64754025# 
 
 
   Link to live event online: 
 
   1: In the 10 minutes prior to the call start time, sign in online by 
following this Webex link 
https://www.globenewswire.com/Tracker?data=DXk_Llbu7qZU_T2sqVsZq5Pd_WrROKmefn08xg4XnJ7dIoPjugrT_NbutZA0cDhq3wI8C0MayiRns1C9NCq950D1Fb8-l1RkIK_wpC5La1NIBm2KCQkDDDIEZnv8rHAMZAyTQC30NgdEksaN-3vcurAfbTE_Qlpuzwq_isAc9jl1rwdJ6pzSFibqKHLtn02f 
. 
 
   2: Password: Welcome 
 
   About Addex Therapeutics: 
 
   https://www.globenewswire.com/Tracker?data=vPnWrw36Je3FIMJ-VXeGxSVKbbVTwDv3HfOzckbBHzO-MY196SubxGRjLdqH8LY2CfAe-4SebtbscdtEJ2EgqITr9-vgH0cFqkHBztVxdwE= 
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 
product 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 Q2 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 Q2 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 trial for the treatment of epilepsy 
in Q2 2021. Addex's GABAB PAM program has been licensed to Indivior PLC, 
which is 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 shares are 
listed on the SIX Swiss Exchange and American Depositary Shares 
representing its shares are listed on the NASDAQ Capital Market, and 
trade under the ticker symbol "ADXN" on each exchange. 
 
   Press Contacts: 
 
 
 
 
Tim Dyer                   Mike Sinclair              James Carbonara 
 Chief Executive Officer    Partner, Halsin Partners   Hayden IR 
 Telephone: +41 22 884 15   +44 (0)20 7318 2955        +1 (646) 755 7412 
 55                         msinclair@halsin.com       james@haydenir.com 
 PR@addextherapeutics.com 
 
   Forward Looking Statements: 
 
   This press release contains forward-looking statements within the 
meaning of the Private Securities Litigation Reform Act of 1995, as 
amended, including in respect of the anticipated initiation and progress 
of clinical trials and preclinical studies, and its future financing 
activities. The words "may," "will," "could," "would," "should," "expect, 

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May 05, 2021 01:00 ET (05:00 GMT)

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