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Topline data from ADX71149 Phase 2 epilepsy study expected to be presented by mid-May 2024
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Launches Perceptive Advisors and Neurosterix and raises $63 million in Series A to accelerate development of preclinical portfolio
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Receives upfront payment of CHF 5 million and 20% stake in Neurosterix, securing cash runway from 2026 onwards
Temporary announcement based on art. 53LR
Geneva, Switzerland, April 18, 2024 – Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced its 2023 full-year financial results for the period ended December 31, 2023. and provided company updates.
“The progress made in 2023 and the efforts of our entire team recently led to the launch of Neurosterix, a game-changing transaction for Addex. The Neurosterix transaction validates decades of work and moves Addex forward into 2024. Importantly, topline data from ADX71149's Phase 2 epilepsy study is expected soon, putting us in a strong position to pursue an IND with GABAB's drug candidate. PAM will partner with Indivior by the end of 2024,” said Tim Dyer, CEO of Addex. “In our other programs, we continue to prepare the dual aromatic agent for a Phase 2 study in post-stroke recovery and characterize the GABAB PAM drug candidate for cough programs.”
Highlights of operation:
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ADX71149 Epilepsy Phase 2 Study Completed – Results Expected by Mid-May 2024
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Dipraglurant is ready to resume Phase 2 development of PD-LID
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Supporting Development in Post-Stroke Recovery Data Validating Diparagrant in an In Vivo Model After Stroke Published in Brain
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GABAB PAM Inter-individual collaboration on substance use disorders extended until end of June 2024 with additional research funding of CHF 2.7 million
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GABAB PAM drug candidate demonstrated robust in vivo proof of concept in preclinical models of substance use disorder and cough
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Adex-led consortium secures €4 million Eurostars grant for mGlu2NAM Mild Neurocognitive Impairment Discovery Program
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US$63 million secured to advance allosteric modulator drug discovery platform and unaffiliated preclinical portfolio through Neurosterix launch with Perceptive Advisors
Key financial data for 2023
thousand Swiss francs |
2023 |
2022 |
change |
income |
1,647 |
1,445 |
202 |
Research and development expenses |
(6,962) |
(14,665) |
7,703 |
General and administrative expenses |
(4,966) |
(7,300) |
2,334 |
total operating loss |
(10,281) |
(20,520) |
10,239 |
Financial results, net |
(275) |
(284) |
9 |
Net loss |
(10,556) |
(20,804) |
10,248 |
Basic and diluted net loss per share |
(0.14) |
(0.46) |
0.32 |
Net decrease in cash and cash equivalents |
(3,092) |
(13,528) |
10,436 |
cash and cash equivalents |
3,865 |
6,957 |
(3,092) |
Shareholders' equity |
1,145 |
4,913 |
(3,768) |
Financial overview:
Revenue primarily relates to amounts received under funded research collaborations with Indivir and is recognized as an accrual of related expenses. Revenues in 2023 increased by CHF 200,000 to CHF 1.6 million compared to CHF 1.4 million in 2022. Research and development expenses decreased by CHF 7.7 million to CHF 7.0 million in 2023 compared to CHF 14.7 million in 2022. This is primarily due to a decrease in external research related to diaromatics. and development activities. General and administrative expenses decreased by CHF 2.3 million in 2023 to CHF 5.0 million compared to CHF 7.3 million in 2022, mainly due to lower stock-based service costs and D&O insurance costs. Our net loss decreased by CHF 10.2 million in 2023 to CHF 10.6 million compared to CHF 20.8 million in 2022, primarily due to lower research and development expenses. Basic loss and loss per diluted share decreased to CHF 0.14 in 2023 compared to CHF 0.46 in 2022. Cash and cash equivalents decreased to CHF 3.9 million in 2023 compared to CHF 7 million in 2022. The decrease of CHF 3.1 million was primarily due to cash used in our operating activities, proceeds from financing activities related to the USD 5.0 million stock offering, which took place on April 3, 2023, and To a lesser extent, this has been partially offset by research funding from Indivior.
Consolidated financial statements for 2023:
The full year 2023 financial report is available on the Investors/Downloads section of our website.
Conference call details:
A conference call will be held today, April 18, 2024 at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Chief Executive Officer Tim Dyer and Director of Translational Sciences Misha Kalinichev will give a brief presentation, followed by a Q&A session.
Join the conference call:
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Participants must pre-register for the conference using the link below. Upon registration, each participant will be provided with a participant dial-in number and a unique personal PIN.
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Participants must use the meeting access information provided in the email they received during registration no later than 10 minutes before the call start time. Participants can also use the Call Me feature instead of dialing their local dial-in number.
Webcast registration URL: https://edge.media-server.com/mmc/p/x5teqtxq
Conference call registration URL: https://register.vevent.com/register/BI89ea15fb1edc42c5bba59bbd3f7ab1d3
About Adex Therapeutics:
Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological diseases. ADX71149 (mGlu2 positive allosteric modulator or his PAM), Adex's lead drug candidate, was co-developed with Janssen Pharmaceuticals and is in Phase 2 clinical trials for the treatment of epilepsy. His second clinical program at the company, Zipragrant (mGlu5 negative allosteric modulator or NAM), is being evaluated for future development in Parkinson's disease-associated dyskinesia and recovery after stroke/traumatic brain injury. His Addex partnership with Indivior on GABAB PAM is advancing multiple drug candidates through clinical candidate selection for substance use disorders. Under the agreement with Indivior, Addex is advancing his independent GABAB PAM program for chronic cough through clinical candidate selection. Addex also owns a 20% stake in Neurosterix LLC, a privately held company that is advancing a portfolio of allosteric modulator programs including M4 PAM for schizophrenia, mGlu7NAM for stress-related disorders, and mGlu2NAM for mild neurocognitive disorders . Adex's shares are listed on the Swiss SIX Exchange, and the American Depositary Shares representing its shares are listed on the Nasdaq Capital Market, trading on each exchange under the ticker symbol “ADXN.” For more information, please visit www.addextherapeutics.com.
contact address:
Appendix 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 regarding the use of proceeds from the offering. “may”, “would”, “could”, “would”, “should”, “expect”, “plan”, “anticipate”, “intend”, ” The words “believe,” “estimate,” “anticipate,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements. However, not all forward-looking statements contain these identifiable words. The forward-looking statements in this press release are based on management's current expectations and beliefs and may cause actual events or results to differ materially from those expressed or implied by the forward-looking statements. It is subject to a number of risks, uncertainties and important factors. Statements contained in this press release are subject to uncertainties, including, without limitation, those related to market conditions; These and other risks and uncertainties are discussed in Adex Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC on April 18, 2024. are further explained in the section entitled “Risk Factors''. the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future; The forward-looking statements contained in this press release represent Adex Therapeutics' views only as of the date of this press release and should be relied upon as representing its views as of any subsequent date. Not. Addex Therapeutics expressly disclaims any obligation to update any forward-looking statements.