- 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 (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.
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
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.2: 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 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 DyerChief Executive OfficerTelephone: +41 22 884 15
55 PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)20 7318
2955msinclair@halsin.com |
James
CarbonaraHayden IR+1 (646) 755 7412james@haydenir.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,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release, are based on management's current expectations and
beliefs and are subject to a number
of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, uncertainties
related to market conditions. These and other risks and
uncertainties are described in the Company’s Annual Report on
Form 20-F filed with the SEC on March 11, 2021, as well as market
conditions and regulatory review.
Any forward-looking statements contained in this
press release represent Addex Therapeutics’ views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. Addex Therapeutics explicitly disclaims
any obligation to update any forward-looking statements, except as
required by law.
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