Geneva, Switzerland, November 3,
2020 – Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a
clinical-stage pharmaceutical company pioneering allosteric
modulation-based drug discovery and development, today reported its
third quarter financial results and provided an update on corporate
activities.
“We continue to execute on our strategy to
advance our portfolio of in-house discovered allosteric modulator
programs and have made significant progress, with three programs
scheduled to start clinical studies in Q1 2021, and a robust
pipeline of preclinical programs advancing towards the clinic,”
said Tim Dyer CEO of Addex. “Our GABAB PAM program is on
track to deliver clinical candidates in 2021 and as announced
yesterday we have received renewed support from our partner,
Indivior. This is a tremendous position to be in and we are looking
forward to achieving these important milestones.”
Research & Development
Highlights:
- Dipraglurant PD-LID pivotal Phase 2b/3 clinical trial poised to
start in Q1 2021
- Dipraglurant dystonia program scheduled to start Phase 2
blepharospasm clinical trial in Q1 2021
- ADX71149 Phase 2 epilepsy study: Janssen (J&J) scheduled to
dose patients in Q1 2021
- GABAB PAM Indivior partnership extended with $2.8 million
of additional research funding – expect to start IND enabling
studies by end of 2021
- Advancing mGlu2NAM and mGlu7NAM programs into late lead
optimization – clinical candidate selection expected in 2021
- Awarded CHF600K Innosuisse grant in collaboration with SIB
(Swiss Institute of Bioinformatics) to identify new therapeutic
indications for ADX10061, a highly selective and potent D1 receptor
antagonist
Financial Highlights:
·Cash and cash equivalents of CHF 17.8 million
at September 30, 2020
Key Financial Data for the three-months and
nine-months ended September 30, 2020
CHF’ thousands |
Q3 20 |
Q3 19 |
Change |
YTD 20 |
YTD 19 |
Change |
Income |
102 |
511 |
(409) |
1,987 |
1,738 |
249 |
R&D
expenses |
(1,979) |
(2,915) |
936 |
(7,851) |
(8,808) |
957 |
G&A
expenses |
(1,236) |
(1,358) |
122 |
(4,496) |
(4,179) |
(317) |
Total operating
loss |
(3,113) |
(3,762) |
649 |
(10,360) |
(11,249) |
889 |
Finance result,
net |
(200) |
176 |
(376) |
(374) |
123 |
(497) |
Net loss for
the period |
(3,313) |
(3,586) |
273 |
(10,734) |
(11,126) |
392 |
Basic and
diluted net loss per share |
(0.12) |
(0.14) |
0.02 |
(0.40) |
(0.42) |
0.02 |
Net decrease in
cash and cash equivalents |
(2,857) |
(4,799) |
1,942 |
(13,723) |
(9,721) |
(4,002) |
Cash and cash
equivalents as of September 30 |
17,813 |
31,949 |
(14,136) |
17,813 |
31,949 |
(14,136) |
Shareholders’
equity as of September 30 |
15,744 |
28,775 |
(13,031) |
15,744 |
28,775 |
(13,031) |
Financial SummaryIncome
decreased by CHF 0.4 million to CHF 0.1 million in the third
quarter 2020, compared to CHF 0.5 million in the third quarter
2019, primarily due to reduced revenue recognition under our funded
research collaboration with Indivior. During the nine-month period
ended September 30, 2020, income increased by CHF 0.2 million
compared to the nine-month period ended September 30, 2019,
primarily due to increased revenue recognition under our funded
research collaboration with Indivior.
Research and development costs decreased by CHF
0.9 million to CHF 2.0 million in the third quarter 2020 compared
to the third quarter 2019, and decreased by CHF 1.0 million to CHF
7.9 million in the nine-month period ended September 30,2020
compared to the nine-month period ended September 2019, primarily
due to the postponement of the start of our dipraglurant phase 2b/3
PD-LID clinical trial.
G&A expenses decreased by CHF 0.1 million to
CHF 1.2 million in the third quarter 2020 compared to the third
quarter 2019, primarily due to reduced professional fees partially
offset by increased directors and officer’s liability insurance
premiums. During the nine-month period ended September 30, 2020
G&A expenses increased by CHF 0.3 million compared to the
nine-month period ended September 30, 2019, primarily due to
increased directors and liability insurance premiums partially
offset by lower professional fees.
The net loss decreased by CHF 0.3 million to CHF
3.3 million in the third quarter 2020 compared to the third quarter
2019 and CHF 0.4 million to CHF 10.8 million for the nine-month
period ended September 30, 2020 compared to the nine-month period
ended September 30, 2019, primarily due to reduced research and
development costs.
Basic and diluted loss per share decreased to
CHF 0.12 for the third quarter of 2020 compared to CHF 0.14 for the
third quarter of 2019. For the nine-month period ended September
30, 2020, basic and diluted loss per share decreased to CHF 0.40
compared to CHF 0.42 for the same period ended September 30,
2019.
Cash and cash equivalents amounted to
CHF17.8 million at September 30, 2020 compared to CHF 31.9 million
at September 30, 2019 and CHF 31.5 million at December 31, 2019.
The decrease was primarily due to cash used in operating
activities.
Q3 2020 Condensed Consolidated Interim
Financial Statements:The third quarter
2020 financial report can be found on the Company’s website in the
investor/download section here.
Conference Call Details:
A conference call will be held
today, Tuesday, November 3, 2020 at 16:00 CET / 15:00 GMT/
10:00 ET, to review the financial results. Tim Dyer, Chief
Executive Officer; Roger Mills, Chief Medical officer; and Robert
Lütjens, Co-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
+41445806522
-
UK
+442030092470
-
USA
+18774230830
Link for other countries
2. Provide the operator with
the Participant PIN Code: 48937768#
Joining the Live Event
Online:
- In the 10 minutes prior to the call start time, sign in online
by following this Webex Link
- Password: Welcome
About Addex Therapeutics:
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 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 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
2021. Addex’s GABAB PAM program has been licensed to Indivior
PLC 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.
Press Contacts:
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55Email: PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)20 7318
2955msinclair@halsin.com |
Forward Looking
Statements:Certain statements made in this announcement
are forward-looking statements including with respect to the
anticipated timing of the Company’s clinical candidate selection,
clinical trials and the reporting of data therefrom. These
forward-looking statements are not historical facts but rather are
based on the Company's current expectations, estimates, and
projections about its industry; its beliefs; and assumptions. Words
such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,'
'seeks,' 'estimates,' and similar expressions are intended to
identify forward-looking statements. These statements are not
guarantees of future performance and are subject to known and
unknown risks, uncertainties, and other factors, some of which are
beyond the Company's control, are difficult to predict, and could
cause actual results to differ materially from those expressed or
forecasted in the forward-looking statements, including delays
resulting from the COVID-19 pandemic and healthcare regulatory
considerations. The Company cautions securityholders and
prospective securityholders not to place undue reliance on these
forward-looking statements, which reflect the view of the Company
only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of
the date on which the statements are made. The Company will not
undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
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