11.03.2021 06:59:43
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Press Release: Addex Reports Full Year 2020 Financial Results and Provides Corporate Update
-- 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
(MORE TO FOLLOW) Dow Jones Newswires
March 11, 2021 01:00 ET (06:00 GMT)
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Addex Therapeutics Ltd. | 1,37 | -17,96% |
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NASDAQ Comp. | 19 524,01 | -2,20% |