- CHF20.5M
($22.5M) of
cash and cash equivalents
at December
31, 2021
- Dipraglurant Phase 2 blepharospasm
clinical trial on track to report data in Q2
2022
- Phase 2b/3 dipraglurant study in dyskinesia associated
with Parkinson’s disease expected to
report data in H1 2023
- Janssen led ADX71149
Phase 2 study in epilepsy on
track to report data in Q3 2022
- Indivior GABAB PAM
strategic collaboration extended
with $4M additional
funding
Ad Hoc Announcement Pursuant to
Art. 53 LR
Geneva, Switzerland,
March 10, 2022
- 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, 2021 and
provided a corporate update.
“These are exciting times for Addex! We have
three ongoing clinical trials with data starting to report as early
as Q2 this year and multiple preclinical programs advancing rapidly
through clinical candidate selection phase with strong novel IP
across all programs,” said Tim Dyer, CEO of Addex. “The extension
of our collaboration with Indivior and the additional $4M of
funding as well as the $10M financing from Armistice capital
contributed to our completing the year with a strong cash position
of $22.5M.”
2021 Operating Highlights:
- Phase 2 clinical trial with
dipraglurant in blepharospasm patients on track to report data in
Q2 2022
- Phase 2b/3 dipraglurant study in
dyskinesia associated with Parkinson’s disease expected to report
data in H1 2023
- Janssen Pharmaceuticals led Phase
2a clinical study of ADX71149 in epilepsy patients on track to
report data in Q3 2022
- Extended our strategic
collaboration with Indivior to advance GABAB PAM until
mid-2022 with $4M additional funding
- Continued to advance GABAB PAM drug
candidates through clinical candidate selection phase
- Entered a research collaboration
with the Charcot–Marie–Tooth Association (CMTA) to evaluate
selected drug candidates in preclinical models of CMT1A
- Advanced Eurostars / Innosuisse
funded mGlu7 NAM program for post-traumatic stress disorder
- Continued to advance preclinical
programs to next value inflection points
Select Upcoming Milestones:
- Q2 2022 - Phase 2a data:
dipraglurant for blepharospasm
- Q3 2022 - Phase 2a data: ADX71149
for epilepsy
- H1 2023 - Phase 2b/3 data:
dipraglurant for dyskinesia associated with Parkinson’s
disease
Key 2021 Financial
Data
CHF’
thousands |
2021 |
2020 |
Change |
Income |
3,153 |
3,879 |
(726) |
R&D
expenses |
(12,840) |
(10,373) |
(2,467) |
G&A
expenses |
(5,819) |
(5,749) |
(70) |
Total operating
loss |
(15,506) |
(12,243) |
(3,263) |
Finance result,
net |
154 |
(616) |
770 |
Net loss for the
period |
(15,352) |
(12,859) |
(2,493) |
Basic and diluted
net loss per share |
(0.45) |
(0.48) |
0.03 |
Net increase /
(decrease) in cash and cash equivalents |
1,790 |
(12,842) |
14,632 |
Cash and cash
equivalents |
20,485 |
18,695 |
1,790 |
Shareholders’
equity |
16,931 |
14,610 |
2,321 |
Financial Summary:Income
decreased by CHF 0.7 million to CHF 3.2 million in 2021
compared to CHF 3.9 million in 2020, primarily due to amounts
received under the licensing and research agreement with Indivior,
recognized as related costs are incurred.
R&D costs increased by CHF 2.4 million to
CHF 12.8 million in 2021 compared to CHF 10.4 million in 2020,
mainly due to increased outsourced R&D expenses for
CHF 2.0 million of which CHF 0.6 million relates to our
dipraglurant PD-LID program and CHF 0.6 million for our
dipraglurant blepharospasm 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 remained stable around CHF 5.8
million in 2021 and 2020.
The net loss was CHF 15.4 million in 2021
compared to CHF 12.9 million in 2020 primarily due to increased
R&D expenses. Basic and diluted loss per share decreased to CHF
0.45 for the year ended December 31, 2021, compared to CHF 0.48 for
the year ended December 31, 2020.
Cash and cash equivalents increased to CHF 20.5 million at
December 31, 2021, compared to CHF 18.7 million at December 31,
2020. This increase of CHF 1.8 million is mainly due to the two
offerings executed on January 8, 2021 and December 16, 2021 for
total net proceeds of CHF 16 million partially offset by our net
loss of CHF 15.4 million. During the same period, non-cash items
mainly relating to the value of share-based services amounted to
CHF 1.4 million have been partially off-set by the net effect of
the increased net working capital of CHF 0.6
million.
2021
Consolidated Financial
Statements:The full-year 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, March 10, 2022, 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 044
580 7145
-
France 017
070 0781
-
U.S.A 1
646 741 3167
- UK /
International +44 (0) 2071 928
338
2: Provide the Operator with the
Participation Confirmation
Code:
5484873
Link to live event online:In
the 10 minutes prior to the call start time, sign in online by
following this Webex Link.
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 in a pivotal registration
clinical trial for Parkinson’s disease levodopa induced dyskinesia
(PD-LID) and has entered a Phase 2 clinical study for the treatment
of blepharospasm, a form of dystonia. Addex's third clinical
program, ADX71149 (mGlu2 positive allosteric modulator or PAM),
developed in collaboration with Janssen Pharmaceuticals, Inc., is
in a Phase 2a proof of concept clinical trial for the treatment of
epilepsy. Indivior PLC has licensed Addex’s GABAB PAM program for
the development of drug candidates with a focus in 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.
Contact:
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55 PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0) 207 318
2955msinclair@halsin.com |
James
CarbonaraHayden IR+1 646 755 7412james@haydenir.com |
Addex 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 of clinical trials. 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 10, 2022, 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 the law.
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