- CHF15.5M
($16.6M) of cash and cash
equivalents at September
30,
2021
- Cash used
in Q3 2021 of
CHF2.6M
- Dipraglurant
Phase 2 blepharospasm clinical trial
Initiated
- Phase 2b/3 dipraglurant
study in dyskinesia associated with Parkinson’s disease on
track
- Janssen led
ADX71149 Phase 2 study in
epilepsy on track
- Indivior
GABAB PAM strategic
collaboration extended
with $4M additional
funding
Ad Hoc Announcement Pursuant to
Art. 53 LR
Geneva, Switzerland, November 4,
2021 - Addex Therapeutics (SIX: ADXN and
Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering
allosteric modulation-based drug discovery and development, today
reported its Q3 2021 financial results for the periods ended
September 30, 2021 and provided a corporate update.
“We continue to make excellent progress
throughout our pipeline as we advance all programs to their next
valuable creating milestones. With the initiation of the
placebo-controlled Phase 2 clinical trial of dipraglurant in
blepharospasm patients, Addex now has three active clinical
programs, all of which are due to readout in 2022,” said Tim Dyer,
CEO of Addex. “The extension of our collaboration with Indivior and
the additional $4M of funding contributed to our completing the
quarter with a strong cash position of $16.6M.”
Q3 2021 Operating
Highlights:
- Initiated a placebo-controlled
Phase 2 clinical trial with dipraglurant in blepharospasm
patients
- Continued to advance pivotal Phase
2b/3 dipraglurant study in dyskinesia associated with Parkinson’s
disease
- Janssen Pharmaceuticals continued
to advance a Phase 2a clinical study of ADX71149 in epilepsy
patients
- 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:
- Q1 22 - Phase 2a data: dipraglurant
for blepharospasm
- Q2 22 - Start IND enabling studies
for GABAB PAM for Addiction and CMT1a
- 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 and nine-months ended
September 30, 2021:
CHF’ thousands |
Q3 21 |
Q3 20 |
Change |
YTD 21 |
YTD 20 |
Change |
Income |
758 |
102 |
656 |
2,752 |
1,987 |
765 |
R&D
expenses |
(2,862) |
(1,979) |
(883) |
(9,342) |
(7,851) |
(1,491) |
G&A
expenses |
(1,472) |
(1,236) |
(236) |
(4,641) |
(4,496) |
(145) |
Total
operating loss |
(3,576) |
(3,113) |
(463) |
(11,231) |
(10,360) |
(871) |
Finance
result, net |
(22) |
(200) |
178 |
303 |
(374) |
677 |
Net loss for
the period |
(3,598) |
(3,313) |
(285) |
(10,928) |
(10,734) |
(194) |
Basic and
diluted net loss per share |
(0.11) |
(0.12) |
0.01 |
(0.32) |
(0.40) |
0.08 |
Net decrease
in cash and cash equivalents |
(2,622) |
(2,857) |
235 |
(3,209) |
(13,723) |
10,514 |
Cash and cash
equivalents as of September 30 |
15,486 |
17,813 |
(2,327) |
15,486 |
17,813 |
(2,327) |
Shareholders’
equity as of September 30 |
13,341 |
15,744 |
(2,403) |
13,341 |
15,744 |
(2,403) |
Financial Summary:
Income is primarily driven by amounts received
under our funded research collaboration with Indivior. During the
nine-month period ended September 30, 2021, income increased by CHF
0.8 million to CHF 2.8 million compared to the nine-month period
ended September 30, 2020. During the third quarter of 2021, income
increased by CHF 0.7 million compared to CHF 0.8 million in the
third quarter of 2020.
R&D expenses increased by CHF 1.5 million to
CHF 9.3 million in the nine-month period ended September 30, 2021
compared to CHF 7.9 million in the nine-month period ended
September 30, 2020, due to increased outsourced R&D costs for
CHF 1.2 million primarily relating to our dipraglurant
blepharospasm program, GABAB PAM program and other discovery
programs. During the same period staff costs increased by CHF 0.3
million, primarily due to increased R&D headcount. During the
third quarter of 2021, R&D expenses increased by CHF 0.9
million compared to the third quarter of 2020 primarily due to
increased outsourced R&D costs for CHF 0.6 million primarily
relating to our dipraglurant PD-LID and dipraglurant blepharospasm
programs. During the same period, staff costs increased by CHF 0.2
million primarily due to increased R&D headcount. 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 slightly increased by CHF 0.1
million to CHF 4.6 million in the nine-month period ended September
30, 2021 compared to CHF 4.5 million in the nine-month period ended
September 30, 2020, primarily due to increased legal fees relating
to setting-up our US shelf registration and “at-the-market” (ATM)
ADS equity sale program with Cantor Fitzgerald. During the third
quarter of 2021, G&A expenses increased by CHF 0.2 million
compared to the third quarter of 2020, mainly due to increased
legal fees.
The net loss is primarily driven by the
evolution of income, research and development costs and financial
result. During the nine-month period ended September 30, 2021, the
net loss increased by CHF 0.2 million to CHF 10.9 million compared
to the nine-month period ended September 30, 2020. During the third
quarter of 2021, the net loss increased by CHF 0.3 million to CHF
3.6 million compared to the third quarter of 2020.
Basic and diluted loss per share decreased to
CHF 0.32 for the nine-month period ended September 30, 2021,
compared to CHF 0.40 for the nine-month period ended September 30,
2020. For the third quarter of 2021, the basic and diluted loss per
share decreased to CHF 0.11 compared to CHF 0.12 for the third
quarter of 2020.
Cash and cash equivalents amounted to CHF
15.5 million as of September 30, 2021, compared to CHF 17.8 million
as of September 30, 2020. The decrease was primarily due to cash
used in operating activities partially offset by the proceeds from
the capital increase executed on January 8, 2021 and research
funding from Indivior relating to our research collaboration.
2021
Q3 Condensed Consolidated Interim
Financial Statements:The Q3 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, November 4, 2021, at 16:00
CET (15:00 GMT / 11:00 EDT / 08:00 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:
89492779#
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 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)20 7318
2955msinclair@halsin.com |
James
CarbonaraHayden IR(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 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.
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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