- Launched Neurosterix with
Perceptive Advisors to accelerate the development of M4PAM for
schizophrenia
- Indivior selected GABA B
PAM drug candidate for development in substance use
disorders
- Addex selected independent
GABAB PAM drug candidate for development in chronic
cough
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, September 30,
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 half-year
and second quarter financial results for the periods ended June 30,
2024, and provided a corporate update.
“During the first half, we achieved major
milestones with the launch of Neurosterix with a series A financing
of $63m led by Perceptive Advisors and the selection of drug
candidates in our GABAB PAM collaboration with Indivior. Indivior
has selected a drug candidate for further development in substance
use disorder and will now take full responsibility for future
development. Importantly, this decision has enabled Addex to select
and develop our own GABAB PAM drug candidate, which will be
evaluated for the treatment of chronic cough,” said Tim Dyer CEO of
Addex.
Half-Year 2024 Operating
Highlights:
- Launched Neurosterix with committed
funding of USD 63 million in Series A led by Perceptive Advisors to
accelerate the development of a preclinical portfolio including M4
PAM for schizophrenia;
- Received CHF 5.0 million and 20% of
equity interest in Neurosterix, securing cash runway beyond
2026;
- Successfully completed our research
agreement with Indivior and both Indivior and Addex selected drug
candidates for further independent development; and
- Our partner, Janssen
Pharmaceuticals Inc., completed ADX71149 epilepsy Phase 2 study -
top-line results did not show statistical significance.
Key Half Year and Q2 2024 Financial Data:
CHF’ thousands |
Q2 24 |
Q2 23* |
Change |
H1 24 |
H1 23* |
Change |
Income |
115 |
632 |
(517) |
350 |
1,134 |
(784) |
R&D
expenses |
(339) |
(291) |
(48) |
(584) |
(547) |
(37) |
G&A
expenses |
(675) |
(737) |
62 |
(1,453) |
(1,351) |
(102) |
Total
operating loss |
(899) |
(396) |
(503) |
(1,687) |
(764) |
(923) |
Finance result,
net |
(27) |
(125) |
98 |
26 |
(127) |
153 |
Share of net loss
of associates |
(531) |
- |
(531) |
(531) |
- |
(531) |
Net loss
from continuing operations |
(1,457) |
(521) |
(936) |
(2,192) |
(891) |
(1,301) |
Net profit
/ (loss) from discontinued operations |
14,336 |
(2,154) |
16,490 |
11,983 |
(4,191) |
16,174 |
Net profit
/ (loss) for the period |
12,879 |
(2,675) |
15,554 |
9,791 |
(5,082) |
14,873 |
Basic net profit /
(loss) per share |
0.13 |
(0.04) |
0.17 |
0.10 |
(0.08) |
0.18 |
Diluted net profit
/ (loss) per share |
0.08 |
(0.04) |
0.12 |
0.06 |
(0.08) |
0.14 |
Net increase /
(decrease) in cash and cash equivalents |
2,160 |
1,574 |
586 |
(77) |
212 |
(289) |
Cash and cash
equivalents as of June 30 |
3,788 |
7,169 |
(3,381) |
3,788 |
7,169 |
(3,381) |
Shareholders’
equity as of June 30 |
12,651 |
6,126 |
6,525 |
12,651 |
6,125 |
6,525 |
* 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 Addex 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 six-month and three-month periods ended June 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.”
The net profit from discontinued operations
amounted to CHF 11.98 million for the six-month period ended June
30, 2024, and primarily related to the net gain from the sale of a
part of our business of CHF 13.96 million, partially offset by the
net loss from operating discontinued activities of CHF 1.98
million. During the same period ended June 30, 2023, the Group
incurred a net loss from discontinued operations of CHF 4.19
million.
The net profit amounted to CHF 9.79 million for
the six-month period ended June 30, 2024 and primarily related to
the net profit from discontinued operations of CHF 11.98 million
partially offset by the net loss from continuing operations of CHF
2.19 million. During the same period ended June 30, 2023, the Group
incurred a net loss of CHF 5.08 million of which CHF 4.19 million
was related to operating discontinued activities.
Diluted net profit per share amounted to CHF
0.06 for the six-month period ended June 30, 2024, compared to a
diluted net loss per share of CHF 0.08 for the same period ended
June 30, 2023.
Cash and cash equivalents decreased to CHF 3.8
million at June 30, 2024, compared to CHF 7.2 million at June 30,
2023. The decrease of CHF 3.4 million between June 30, 2024 and
June 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 first half of 2024,
income decreased by CHF 0.8 million to CHF 0.3 million compared to
CHF 1.1 million in the first half of 2023. During the second
quarter of 2024, income decreased by CHF 0.5 million to CHF 0.1
million compared to CHF 0.6 million in the first quarter of
2023.
R&D expenses primarily relate to our GABAB
PAM program and remain stable at around CHF 0.5 million for both
first half of 2024 and 2023 and at CHF 0.3 million for both second
quarter of 2024 and 2023.
G&A expenses increased by CHF 0.1 million to
CHF 1.5 million in the first half of 2024 compared to CHF 1.4
million in the first half 2023, primarily due to increased legal
fees. G&A expenses remain stable at around CHF 0.7 million for
both second quarter 2024 and 2023.
The net loss from continuing operations
increased by CHF 1.3 million to CHF 2.2 million in the first half
2024 compared to CHF 0.9 million in the first half 2023, and by CHF
0.9 million to CHF 1.4 million in the second quarter of 2024
compared to CHF 0.5 million in the second quarter of 2023 primarily
due to reduced income and the share of net loss incurred by
Neurosterix from April 2, 2024 to June 30, 2024 in accordance with
IFRS.
Half-Year 2024 Consolidated Financial
Statements:The half-year 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, September 30, 2024, at
16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) 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.
Webcast registration
URL: https://edge.media-server.com/mmc/p/dus6oz27
Conference call registration URL:
https://register.vevent.com/register/BI2705eb99ef6048ed87a2b734c0ffcfee
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 and expects to
start IND enabling studies in H1 2025. Addex is advancing an
independent GABAB PAM program for chronic cough and expects to
start IND enabling studies in 2025. 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 (0)20 7318
2955msinclair@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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