29.11.2023 06:59:41
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Press Release: Addex Reports Q3 2023 Financial Results and Provides Corporate Update
-- ADX71149 Phase 2 epilepsy clinical study completes recruitment of
patients, with top line results expected in Q2 2024
-- mGlu2 NAM cognition program receives a EUR4 million Eurostars grant
-- CHF 4.8M ($5.2M) of cash and cash equivalents at September 30, 2023
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, November 29, 2023 - Addex Therapeutics https://www.globenewswire.com/Tracker?data=7HgYW0FBCCa0U4OmGhJ00Rtumd17Kqrarld-9djYUv7OQ3DUGEK3WCm2b4UbpqZtLfUYsbMTbiDSzpcZyACRv15JcEEKwNGUoZpt54EnNVWbLVsdQRTgBfI9xIjXjvlW (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today reported its Q3 2023 financial results for the period ended September 30, 2023 and provides a corporate update.
"2024 is lining up to be an exciting year for us with data from the ADX71149 Phase 2 epilepsy study expected in Q2 2024 and drug candidates from our GABAB PAM collaboration with Indivior expected to start IND enabling studies," said Tim Dyer CEO of Addex. "Our M4 PAM schizophrenia and GABAB PAM cough program continue to make solid progress as well as our dipraglurant phase 2 ready program which received a strong validation in post stroke recovery following the publication in Brain."
Q3 2023 Operating Highlights:
-- ADX71149 epilepsy Phase 2 study completes recruitment - results expected
in Q2 2024
-- GABAB PAM Indivior strategic partnership for substance use disorders
extended through to end June 2024 with CHF 2.7 million of committed
research funding - multiple drug candidates in clinical candidate
selection phase
-- GABAB PAM cough program demonstrates in vivo proof of concept
-- mGlu2NAM cognition program receives EUR4 million grant from Eurostars to
advance program to drug candidate selection
-- Data published in Brain supports development of dipraglurant post-stroke
recovery
-- M4 PAM schizophrenia program - progressing through clinical candidate
selection phase
-- Partnering discussions across the portfolio ongoing
Key Financial Data for the three-months and nine-months ended September 30, 2023:
CHF' thousands Q3 23 Q3 22 Change YTD 23 YTD 22 Change
------------------------------ ------- ------- ------- ------- -------- -------
Income 329 416 (87) 1,463 846 617
R&D expenses (1,810) (2,765) 955 (5,389) (12,277) 6,888
G&A expenses (1,171) (1,818) 647 (3,673) (5,591) 1,918
Total operating loss (2,652) (4,167) 1,515 (7,599) (17,022) 9,423
Finance result, net 35 59 (24) (100) (131) 31
Net loss for the period (2,617) (4,108) 1,491 (7,699) (17,153) 9,454
Basic and diluted net
loss per share (0.03) (0.09) 0.06 (0.11) (0.42) 0.31
Net increase / (decrease)
in cash and cash equivalents (2,415) 1,610 (4,025) (2,203) (10,062) 7,859
Cash and cash equivalents
as of September 30 4,754 10,423 (5,669) 4,754 10,423 (5,669)
Shareholders' equity
as of September 30 3,944 7,952 (4,008) 3,944 7,952 (4,008)
Financial Summary:
Income is primarily driven by amounts received under our funded research collaboration with Indivior, recognized as related costs are incurred. During the nine-months ended September 30, 2023, income increased by CHF 0.6 million to CHF 1.4 million compared to CHF 0.8 million in the nine-months ended September 30, 2022. During the third quarter of 2023, income decreased by CHF 0.1 million to CHF 0.3 million compared to CHF 0.4 million in the third quarter of 2022.
R&D expenses decreased by CHF 6.9 million to CHF 5.4 million in the nine-months ended September 30, 2023 compared to CHF 12.3 million in the nine-months ended September 30, 2022 and by CHF 1.0 million to CHF 1.8 million in the third quarter of 2023 compared to CHF 2.8 million in the third quarter of 2022, primarily due to decreased dipraglurant related external research and development activities.
G&A expenses decreased by CHF 1.9 million to CHF 3.7 million in the nine-months ended September 30, 2023 compared to CHF 5.6 million in the nine-months ended September 30, 2022 and by CHF 0.6 million to CHF 1.2 million in the third quarter of 2023 compared to CHF 1.8 million in the third quarter of 2022, primarily due to decreased share-based service costs and D&O insurance costs.
Our net loss decreased by CHF 9.5 million to CHF 7.7 million in the nine-months ended September 30, 2023 compared to CHF 17.2 million in the nine-months ended September 30, 2022 and by CHF 1.5 million to CHF 2.7 million in the third quarter of 2023 compared to CHF 4.2 million in the third quarter of 2022, primarily due to reduced R&D expenses.
Basic and diluted loss per share decreased to CHF 0.11 for the nine-months ended September 30, 2023 compared to CHF 0.42 for the nine-months ended September 30, 2022. For the third quarter of 2023, the basic and diluted loss per share decreased to CHF 0.03 compared to CHF 0.09 for the third quarter of 2022.
Cash and cash equivalents decreased to CHF 4.8 million at September 30, 2023, compared to CHF 10.4 million at September 30, 2022. The decrease of CHF 5.7 million is primarily due to the cash used in our operating activities, partially offset by the proceeds from financing activities mainly related to the equity offering executed on April 3, 2023 and to a lesser extent research funding from Indivior.
Q3 2023 Consolidated Financial Statements:
The third quarter 2023 financial report can be found on the Company's website in the investor/download section here https://www.globenewswire.com/Tracker?data=Fgazg2LHiIyZR-QK9vT5LYzNi71JE3r7OrkF7VltEkj8aZ_BGvhLM-opzq7tV-kOW77s3LmQawMBEqDOVKc5gcW0frlOfSsx-TnNwucHULQSMrjknSZNVS5CA6lV9s9t.
Conference Call Details:
A conference call will be held today, November 29, 2023, at 16:00 CET (15:00 GMT / 10:00 ET / 07:00 PT) to review the third quarter 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:
1. 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.
2. 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/BI3c9fae3a9f2f4f47a845f71e3c6922e6
Webcast URL: https://edge.media-server.com/mmc/p/dt7y766k
About Addex Therapeutics:
Addex Therapeutics https://www.globenewswire.com/Tracker?data=7HgYW0FBCCa0U4OmGhJ00Rtumd17Kqrarld-9djYUv6fmZoIRvgkMrKhJguukPk91uEddCFYPDk2_lqT4JNUb4odmSkkV_ONOb5_6mXfWNosgAvy8wSo9TL6i7QxDAqB 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) is in a Phase 2 clinical trial for the treatment of epilepsy. The company'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 PAM 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 Dyer Mike Sinclair
Chief Executive Officer Partner, Halsin Partners
Telephone: +41 22 884 15 55 +44 (0)7968 022075
PR@addextherapeutics.com msinclair@halsin.com
Addex Forward Looking Statements:
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Addex Therapeutics Ltd. | 1,37 | -17,96% | |
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