08.04.2020 06:59:53
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Press Release: Addex Reports 2019 Full Year Audited Results and Provides Corporate Update
-- Robust cash position at December 31, 2019 of CHF 31.5 million providing
runway through 2021
-- Awarded Eurostars / Innosuisse grant of EUR4.85 million supporting mGlu7
NAM PTSD program
-- Additional funding of $1.6 million in 2019 from Indivior to support GABAB
PAM addiction program
-- Dipraglurant pivotal registration study in PD-LID ready to start dosing
patients subject to lifting of restrictions in US associated with the
global Covid-19 crisis
Geneva, Switzerland, April 8, 2020 --
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Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, today reported its full-year audited results
for the year ended December 31, 2019 and provided a corporate update.
"We made significant progress in 2019 in advancing our pipeline of
innovative in-house discovered allosteric modulators, including our
priority dipraglurant levodopa-induced dyskinesia program, which is
ready to start dosing patients in a pivotal registration clinical trial
as soon as the Covid-19 crisis is over," said Tim Dyer, CEO of Addex.
"We also achieved important milestones in our GABA(B) PAM collaboration
with Indivior and secured funding from Eurostars/Innosuisse to advance
our mGlu7NAM program for PTSD as well as completing the listing of
American Depositary Shares (ADSs) on the Nasdaq Stock Market."
2019 Operating Highlights:
-- Dipraglurant pivotal phase 2b/3 clinical trial expected to dose first
patient in H2 2020 and readout topline results in Q2 2022
-- Indivior funded GABAB PAM research program on track to deliver drug
candidates by end of 2020
-- Addex led consortium awarded Eurostars grant of EUR4.85 million to fund
discovery of mGlu7 NAM drug candidates for post-traumatic stress disorder
-- Completed 2019 with a strong liquidity position of CHF31.5 million of
cash and cash equivalents
-- Listed American Depositary Shares (ADS) representing our ordinary shares
on the Nasdaq Stock Market on January 29, 2020
Key 2019 Financial Data:
CHF' thousands 2019 2018 Change
-------- ------- --------
Revenue 2,763 6,044 (3,281)
Other income 71 659 (588)
R&D expenses (12,454) (4,919) (7,535)
G&A expenses (4,984) (3,209) (1,775)
Total operating loss (14,604) (1,425) (13,179)
Finance result, net (177) (220) 43
Net loss for the period (14,781) (1,645) (13,136)
Basic and diluted net loss
per share 0.56 0.07 0.49
Net cash increase/(decrease) (10,134) 39,080 (49,214)
Cash and cash equivalents 31,536 41,670 (10,134)
Shareholders' equity 25,524 39,240 (13,716)
Financial Summary:
Revenue decreased by CHF 3.2 million to CHF 2.8 million in 2019 compared
to CHF 6.0 million in 2018, primarily due to the absence of the USD 5.0
million (CHF4.8 million) upfront payment received from Indivior in
January 2018 but partially offset by the increase in collaborative
research funding from Indivior PLC.
Other income decreased by CHF 0.6 million to CHF 0.1 million in 2019
compared to CHF 0.7 million in 2018, primarily due to the absence of
MJFF research grants recognized in 2018. In 2019, research grants relate
to amounts recognized under our Eurostars/Innosuisse grant.
Research and development expenses increased by CHF7.5 million to CHF
12.4 million in 2019 compared to CHF 4.9 million in 2018, mainly due to
an increase in outsourced development costs related to our dipraglurant
PD-LID program and to a lesser extent our GABA(B) PAM program. 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 1.8 million to CHF 5.0 million in 2019,
compared to CHF 3.2 million in 2018, mainly due to the increase in
headcount and costs related to preparing the listing of ADSs
representing our shares on the Nasdaq Stock Market.
The net loss for 2019 was CHF 14.8 million compared to CHF 1.6 million
for 2018. Basic and diluted loss per share increased to CHF 0.56 for
2019, compared to CHF 0.07 for 2018.
Cash and cash equivalents amounted to CHF 31.5 million at December 31,
2019 compared to CHF 41.7 million at December 31, 2018. This decrease of
CHF 10.2 million is mainly due to the net loss of CHF 14.8 million,
adjusted for changes in net working capital of CHF 2.9 million and
non-cash items of CHF 2.1 million. Non-cash items relate mainly to the
value of share-based services. Changes in working capital relate mainly
to an increases of CHF1.1 million and CHF0.9 million in payables and
accruals, respectively that are primarily related to our dipraglurant
PD-LID program and professional service fees related to our recent
listing of ADSs on the Nasdaq stock market, as well as CHF 0.7 million
of increased contract liabilities related to our funded research
contract with Indivior.
2019 Annual Report:
The 2019 annual report can be found on the
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investor relations page of our website
Conference Call Details:
A conference call will be held today, April 8, 2020, at 16:00 CEST
(15:00 BST / 10:00 ET) 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:
https://events.arkadin.com/ev/docs/International%20Access%20Numbers_%20DETAU2.pdf
2: Provide the Operator with the Participation Pin Code: 76258295#
Link to live event online:
1: In the 10 minutes prior to the call start time, sign in online by
following this link
https://www.globenewswire.com/Tracker?data=WiDkXYqa0PrkpFWWPobBmNKphhmpz3VO7XyMbfSfvhqEdlyZopGSoioKABSt_n-BMTeP3croX35cu6f9-qJVknJZiIIVN_Y2yqXGImtyzXqflz2FPVw5JKXGmORlo5nxBVri7YQuObww62bJlw4RtPv8ZDKXlfg-R0jvcabNMKnkO5xSpIkNArbaVPe63HLPoDCDeWNPp9D6p1CRsUDPvFxlkC1XTxAoS5NGyVEKQmG_gXS1o7FQepeF7fMVpiEWwioQsN4FI2oCQRMl7yhoVSSEv7l7WVBxJpJT7E5cM8sMspFyQgQ7ek8Nj1hJhzrb4O7DuW3TbbiGZhMzHj9V8g60L8DoI7xCM0cwFak7YhagpEdoDlNKBBAKyOd33bb_YECatijKZW-vDGd_E12fZVnHQuP08YaLipyastHYcSHsKzkIk3E8bjH0b_CxprfCDDI2jbgryHKWO2mIcZ4lXb8zAb20p2_YoWQ4t9Z5x7YZcAXC-OUp34swFF95TxCpKm9Qer_vytm1z2Qvf1_xBf9IOfWvDvSZ2L21jUowJ4b6hWg6-ppHZUhBBTmParWvmeg6JgIfl9Xm_V493hYEP0hQCtd1YJPu_eO03uasyY4u_d_B0UzXjhF0n660bABMf7m4A8zv4cFTDx5HnX_9q4L7ZmJUbDdbJE37XAc5QU5JUT4_cpQ2JF83gwK-LtRg
Webex Link.
2: Password: Welcome
About Addex Therapeutics:
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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
scheduled to enter a pivotal registration clinical trial for Parkinson's
disease levodopa induced dyskinesia (PD-LID). In parallel,
dipraglurant's therapeutic use in dystonia is being investigated in
preclinical models. Addex's second clinical program, ADX71149 (mGlu2
positive allosteric modulator or PAM) is being developed in
collaboration with Janssen Pharmaceuticals, Inc for the treatment of
epilepsy. In addition, Addex's GABA(B) PAM program has been licensed to
Indivior PLC for the treatment of addiction. Preclinical programs
include GABA(B) 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.
Press Contacts:
Tim Dyer Mike Sinclair
Chief Executive Officer Partner, Halsin Partners
Telephone: +41 22 884 15 55 +44 (0)20 7318 2955
Email: mailto:PR@addextherapeutics.com PR@addextherapeutics.com mailto:msinclair@halsin.com msinclair@halsin.com
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Forward Looking Statements:
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