Addex Reports 2023 Half Year and Second Quarter Financial Results
and Provides Corporate Update
- ADX71149 Phase 2
epilepsy
clinical
study Cohort 2
continues recruiting
following the Independent Interim Review
Committee (IRC) recommendation
- Indivior GABAB PAM
collaboration extended to
June 2024 with CHF 2.7 million of committed
research funding
- CHF
7.2M
($8.0M) of cash and cash
equivalents at June
30, 2023
Ad Hoc Announcement Pursuant to Art. 53
LR
Geneva, Switzerland,
August 10, 2023
- Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN),
a clinical-stage pharmaceutical company pioneering allosteric
modulation-based drug discovery and development, today reported its
half-year and second quarter financial results for the periods
ended June 30, 2023 and provided a corporate update.
“During the first half, we were encouraged by
the progress being made in the ADX71149 Phase 2 epilepsy study
being conducted by our partner, Janssen. Recruitment is continuing
into patient Cohort 2 following the IRC recommendation to continue
the study after review of Cohort 1 Part 1 unblinded data. We look
forward to reporting progress later this year,” said Tim Dyer CEO
of Addex. “Our GABAB PAM collaboration with Indivior continues to
advance and recently extended the research period to June 2024,
providing a further CHF 2.7 million in funding. We also continue to
make solid progress across our preclinical portfolio and advance
business discussions.”
Half-Year
2023 Operating
Highlights:
- ADX71149 epilepsy Phase 2 study –
Cohort 1 complete and Cohort 2 continues recruiting following IRC
recommendation to continuing after review of Cohort 1 Part 1
unblinded data
- Dipraglurant is Phase 2 ready –
preclinical profiling in post-stroke recovery ongoing
- GABAB PAM Indivior strategic
partnership for substance use disorders extended through to end
June 2024 with CHF2.7 million of committed research funding -
multiple drug candidates in clinical candidate selection phase
- GABAB PAM for chronic cough -
multiple drug candidates in clinical candidate selection
- mGlu7 NAM for stress related
disorders, including PTSD – ready for IND enabling studies
- M4 PAM schizophrenia program -
progressing through clinical candidate selection phase
- CHF 5.7 million in equity financing
year to date
- Partnering discussions across the
portfolio ongoing
Key Financial Data for the Second Quarter and the First
Half of 2023:
CHF’ thousands |
Q2 23 |
Q2 22 |
Change |
H1 23 |
H1 22 |
Change |
Income |
632 |
186 |
446 |
1,134 |
430 |
704 |
R&D
expenses |
(1,875) |
(5,747) |
3,872 |
(3,579) |
(9,512) |
5,933 |
G&A
expenses |
(1,304) |
(1,531) |
227 |
(2,501) |
(3,773) |
1,272 |
Total operating
loss |
(2,547) |
(7,092) |
4,545 |
(4,946) |
(12,855) |
7,909 |
Finance result,
net |
(128) |
(129) |
1 |
(136) |
(190) |
54 |
Net loss for the
period |
(2,675) |
(7,221) |
4,546 |
(5,082) |
(13,045) |
7,963 |
Basic and diluted
net loss per share |
(0.04) |
(0.19) |
0.15 |
(0.08) |
(0.34) |
0.26 |
Net increase /
(decrease) in cash and cash equivalents |
1,574 |
(6,075) |
7,649 |
212 |
(11,672) |
11,884 |
Cash and cash
equivalents as of June 30 |
7,169 |
8,813 |
(1,644) |
7,169 |
8,813 |
(1,644) |
Shareholders’
equity as of June 30 |
6,126 |
6,862 |
(736) |
6,126 |
6,862 |
(736) |
Financial Summary:Income is
primarily driven by amounts received under our funded research
collaboration with Indivior, recognized as related costs are
incurred. During the first half of 2023, income increased by CHF
0.7 million to CHF 1.1 million compared to CHF 0.4 million in the
first half of 2022. During the second quarter of 2023, income
increased by CHF 0.4 million to CHF 0.6 million compared to CHF 0.2
million in the second quarter of 2022.
R&D expenses decreased by CHF 5.9 million to
CHF 3.6 million in the first half of 2023 compared to CHF 9.5
million in the first half of 2022 and by CHF 3.9 million to CHF 1.8
million in the second quarter of 2023 compared to CHF 5.7 million
in the second quarter of 2022. The decrease in R&D expenses is
primarily due to decreased dipraglurant related external research
and development activities.
G&A expenses decreased by CHF 1.3 million to
CHF 2.5 million in the first half of 2023 compared to CHF 3.8
million in the first half of 2022, primarily due to reduced
share-based service costs and decreased D&O insurance costs.
During the second quarter of 2023, G&A expenses decreased by
CHF 0.2 million to CHF 1.3 million compared to CHF 1.5 million in
the second quarter of 2022, primarily due to decreased D&O
insurance costs.
Our net loss decreased by CHF 8.0 million to CHF
5.0 million in the first half of 2023 compared to CHF 13.0 million
in the first half of 2022 and by CHF 4.5 million to CHF 2.7 million
in the second quarter of 2023 compared to CHF 7.2 million in the
second quarter of 2022. The reduced net loss is primarily driven by
reduced R&D expenses and to a lesser extent increased
income.
Basic and diluted loss per share decreased to
CHF 0.08 for the first half of 2023 compared to CHF 0.34 for the
first half of 2022. For the second quarter of 2023, the basic and
diluted loss per sharedecreased to CHF 0.04 compared to CHF 0.19
for the second quarter of 2022.
Cash and cash equivalents decreased to CHF 7.2
million at June 30, 2023, compared to CHF 8.8 million at June 30,
2022. The decrease of CHF 1.6 million is primarily due to the cash
used in our operating activities, partially offset by the proceeds
from financing activities mainly related to equity offerings
executed on April 3, 2023 and to a lesser extent research funding
from Indivior.
Half-Year
2023 Consolidated
Financial Statements:The half-year 2023
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, August 10, 2023, at 16:00
CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial
results. Tim Dyer, Chief Executive Officer, Robert Lütjens, Head of
Discovery - Biology and Mikhail Kalinichev, Head of Translational
Science will deliver a brief presentation followed by a Q&A
session.
Joining the Conference
Call:
- Participants are required to
register in advance of the conference using the link provided
below. Upon registering, each participant will be provided with
Participant Dial-in numbers, and a unique Personal PIN.
- In the 10 minutes prior to the
call’s start time, participants will need to use the conference
access information provided in the e-mail received at the point of
registering. Participants may also use the call me feature instead
of dialing the nearest dial in number.
Online Registration:
https://register.vevent.com/register/BI3df82968423c4258930719a84f76d6bf
Webcast URL: https://edge.media-server.com/mmc/p/gp4h8rth
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, ADX71149 (mGlu2 positive
allosteric modulator or PAM), developed in collaboration with
Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for
the treatment of epilepsy. Addex's second clinical program,
dipraglurant (mGlu5 negative allosteric modulator or NAM), is under
evaluation for future development in post-stroke recovery. Indivior
PLC has licensed Addex’s GABAB PAM program for the development of
drug candidates, with a focus on substance use disorder. Addex is
also advancing a broad preclinical pipeline, which includes
development of a range of GABAB PAMs for chronic cough, mGlu7 NAM
for stress related disorders, M4 PAM for schizophrenia and
other forms of psychosis and mGlu2 NAM for mild neurocognitive
disorders and depression. 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.
Contacts:
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)7968
022075msinclair@halsin.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 statements about the
intended use of proceeds of the offering. 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 greater detail in the section entitled “Risk Factors”
in Addex Therapeutics’ Annual Report on Form 20-F for the year
ended December 31, 2022, as filed with the SEC on March 30, 2023,
the final prospectus supplement and accompanying prospectus and
other filings that Addex Therapeutics may make with the SEC in the
future. 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.
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