- Indivior selected GABA B
PAM drug candidate for development in substance use disorders (SUD)
and starts IND enabling studies
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, November 22,
2024 - Addex Therapeutics (SIX/NASDAQ:
ADXN), a clinical-stage biopharmaceutical company focused on
developing a portfolio of novel small molecule allosteric
modulators for neurological disorders, today reported its third
quarter financial results for the periods ended September 30, 2024,
and provided a corporate update.
“During the third quarter of 2024, Indivior
selected a GABAB PAM drug candidate from our collaboration for
development in substance use disorders, allowing us to select our
proprietary GABAB PAM drug candidate as a potential treatment for
chronic cough. While we intend to further advance this new program
in-house, we will also look for partners to fund the later clinical
development stages of the program,” said Tim Dyer CEO of Addex.
Q3 2024 Operating
Highlights:
- Successfully completed funded
research phase of the Indivior collaboration with both Indivior and
Addex each selecting GABAB PAM drug candidate for further
development in SUD and chronic cough, respectively
- Completed Q3 2024 with cash and
cash equivalents of CHF3.3 million
Key Financial Data for the three-months and nine-months
ended September 30, 2024:
CHF’ thousands |
Q3 24 |
Q3 23* |
Change |
YTD 24 |
YTD 23* |
Change |
Income |
59 |
329 |
(270) |
408 |
1,464 |
(1,056) |
R&D
expenses |
(205) |
(490) |
285 |
(789) |
(1,038) |
249 |
G&A
expenses |
(476) |
(588) |
112 |
(1,929) |
(1,939) |
10 |
Total
operating loss |
(622) |
(749) |
127 |
(2,310) |
(1,513) |
(797) |
Finance result,
net |
(31) |
38 |
(69) |
(4) |
(89) |
85 |
Share of net
loss of associates |
(875) |
- |
(875) |
(1,405) |
- |
(1,406) |
Net loss
from continuing operations |
(1,528) |
(711) |
(817) |
(3,719) |
(1,602) |
(2,117) |
Net
profit / (loss) from discontinued operations |
(2) |
(1,906) |
1,904 |
11,981 |
(6,097) |
18,078 |
Net
profit / (loss) for the period |
(1,530) |
(2,617) |
1,087 |
8,262 |
(7,699) |
15,961 |
Basic net profit
/ (loss) per share |
(0.02) |
(0.03) |
0.01 |
0.08 |
(0.11) |
0.19 |
Diluted net
profit / (loss) per share |
(0.02) |
(0.03) |
0.01 |
0.05 |
(0.11) |
0.16 |
Net increase /
(decrease) in cash and cash equivalents |
(439) |
(2,415) |
1,976 |
(516) |
(2,203) |
1,687 |
Cash and cash
equivalents as of September 30 |
3,349 |
4,754 |
(1,405) |
3,349 |
4,754 |
(1,405) |
Shareholders’
equity as of September 30 |
11,062 |
3,944 |
7,118 |
11,062 |
3,944 |
7,118 |
* The comparative information has been
re-presented due to discontinued operations that have been
reclassed to the financial line called “Net profit or loss from
discontinued operations” following Neurosterix transaction.
Financial Summary:Under IFRS,
the sale of our allosteric modulator drug discovery platform and
unpartnered preclinical portfolio to Neurosterix on April 2, 2024,
required the identification of continuing operations related to
retained programs by the Group and discontinued operations,
including the net gain from the sale of a part of our business and
discontinued operating activities related to income and expenses of
divested activities by the Group during the nine-month and
three-month periods ended September 30, 2024 and 2023,
respectively. The net gain from the sale of a part of our business,
the income and expenses from discontinued operating activities have
been reclassed to the financial line called “Net profit or loss
from discontinued operations.”
During the nine-month period ended September 30,
2024, net profit from discontinued operations amounted to CHF 12.0
million, and was primarily related to the net gain of CHF 14.0
million from the sale of part of our business, partially offset by
the net loss of CHF 2.0 million from discontinued operating
activities. During the same period ended September 30, 2023, the
Group incurred a net loss from discontinued operations of CHF 6.1
million.
During the nine-month period ended September 30,
2024, net profit amounted to CHF 8.3 million, primarily related to
the net profit from discontinued operations of CHF 12.0 million
partially offset by the net loss from continuing operations of CHF
3.7 million. During the same period ended September 30, 2023, the
Group incurred a net loss of CHF 7.7 million of which CHF 6.1
million was related to operating discontinued activities.
During the third quarter of 2024, the Group
incurred a net loss of CHF 1.5 million compared to a net loss of
CHF 2.6 million in the third quarter of 2023. The decrease of CHF
1.1 million is primarily due to the sale of part of our business
whose related operating activities of CHF 1.9 million incurred in
the third quarter of 2023 were partially offset by the share of the
net loss of Neurosterix’s Group amounting to CHF 0.9 million in the
third quarter of 2024.
Diluted net gain per share amounted to CHF 0.05
for the nine-month period ended September 30, 2024, compared to a
diluted net loss per share of CHF 0.11 for the same period ended
September 30, 2023.
Cash and cash equivalents decreased to CHF 3.3
million at September 30, 2024, compared to CHF 4.7 million at
September 30, 2023. The decrease of CHF 1.4 million between
September 30, 2024 and September 30, 2023 is primarily due to the
cash used in operating activities, partially offset by gross
proceeds of CHF 5.0 million from the Neurosterix Transaction
received in April 2024.
All financial variances described below
relate to continuing operations: Income is primarily
driven by amounts received under our funded research collaboration
with Indivior, recognized as related costs are incurred. During the
nine-month period ended September 30, 2024, income decreased by CHF
1.1 million to CHF 0.4 million compared to CHF 1.5 million for the
same period ended September 30, 2023, primarily due to the
completion of the research agreement on June 30, 2024. On August
27, 2024, Indivior selected a compound for future development in
substance use disorder and undertakes all future development of its
selected compound. During the third quarter of 2024, income
decreased by CHF 0.2 million to CHF 0.1 million compared to CHF 0.3
million in the third quarter of 2023.
R&D expenses primarily relate to our GABAB
PAM program and decreased by CHF 0.2 million to CHF 0.8
million during the nine-month period ended September 30,2024
compared to CHF 1.0 million during the same period ended September
30, 2023, primarily due to the completion of the research agreement
with Indivior on June 30, 2024. R&D expenses decreased by CHF
0.3 million to CHF 0.2 million during the third quarter of 2024
compared to CHF 0.5 million in the third quarter of 2023.
G&A expenses remain stable at around CHF 1.9
million for both nine-month period ended September 30, 2024 and
2023. G&A expenses decreased by CHF 0.1 million to CHF 0.5
million during the third quarter of 2024 compared to CHF 0.6
million in the third quarter of 2023, primarily due to reduced
D&O insurance costs.
The net loss from continuing operations
increased by CHF 2.1 million to CHF 3.7 million for the nine-month
period ended September 30, 2024 compared to CHF 1.6 million during
the same period ended September 30, 2023, primarily due to reduced
revenue and increased costs related to the share of the net loss of
the Neurosterix Group. The net loss from continuing operations
increased by CHF 0.8 million to CHF 1.5 million in the third
quarter of 2024 compared to CHF 0.7 million in the third quarter of
2023 primarily due to the share of the net loss of the Neurosterix
Group.
Q3 2024 Consolidated Financial
Statements:
The Q3 2024 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 22, 2024, at
16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the
financial results. Tim Dyer, Chief Executive Officer 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.
Webcat registration URL:
https://edge.media-server.com/mmc/p/gttu5dw9
Conference call registration
URL: https://register.vevent.com/register/BIb069acb5b9074ca781bc6e22b5426dc2
About Addex: Addex
Therapeutics is a clinical-stage biopharmaceutical company
focused on developing a portfolio of novel small molecule
allosteric modulators for neurological disorders. Addex’s lead drug
candidate, dipraglurant (mGlu5 negative allosteric modulator or
NAM), is under evaluation for future development in brain injury
recovery, including post-stroke and traumatic brain injury
recovery. Addex’s partner, Indivior, has selected a GABAB PAM drug
candidate for development in substance use disorders. Addex is
advancing an independent GABAB PAM program for chronic cough. Addex
also holds a 20% equity interest in a private company, Neurosterix
LLC, which is advancing a portfolio of allosteric modulator
programs, including M4 PAM for schizophrenia, mGlu7 NAM for mood
disorders and mGlu2 NAM for mild neurocognitive 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.
For more information, visit www.addextherapeutics.com
Contacts:
Tim DyerChief
Executive OfficerTelephone: +41 22 884 15
55PR@addextherapeutics.com |
Mike
SinclairPartner, Halsin Partners+44 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, 2023, as filed with the SEC on April 18, 2024,
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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