Latest news with #GABABPAM
Yahoo
2 days ago
- Business
- Yahoo
Addex Therapeutics Reports Q1 2025 Financial Results and Provides Corporate Update
Strong cash position of CHF2.8 million at end of Q1 2025 GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in disease models Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Indivior advanced GABAB PAM Substance use disorders program successfully through IND enabling studies Entered option agreement with Sinntaxis for an exclusive license to intellectual property covering the use of mGlu5 NAM in brain injury recovery Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, June 19, 2025 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its Q1 2025 financial results and provided a corporate update. 'We have had a great start to 2025 both in terms of product development and achieving business milestones. Progress continues well and on track with our GABAB PAM drug candidate in chronic cough. Positive data from this program in multiple preclinical models was recently presented at the prestigious American cough conference. We have also regained rights to our Phase 2 mGlu2 PAM asset, ADX71149,' said Tim Dyer, CEO of Addex. 'Solidifying our position to use mGlu5 NAMs in brain injury, we entered an option agreement with Sinntaxis to gain access to additional intellectual property. Our plan is to explore further the clinical activity of dipraglurant in this indication. Finally, our partner, Indivior, indicated that they have advanced their GABAB PAM clinical candidate through IND enabling studies, providing additional validation of our allosteric modulation approach.' Operating Highlights: GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple models of disease Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Indivior advanced their GABAB PAM program for substance use disorders successfully through IND enabling studies Entered option agreement with Sinntaxis for exclusive license to intellectual property covering use of mGlu5 NAM in brain injury recovery Key Q1 2025 Financial Data CHF' thousands Q1 2025 Q1 2024 Change Income 71 235 (164) R&D expenses (156) (245) 89 G&A expenses (521) (778) 257 Total operating loss (606) (788) 182 Finance result, net (19) 53 (72) Share of net loss of associates (848) - (848) Net loss from continuing operations (1,473) (735) (738) Net loss from discontinued operations - (2,352) 2352 Net loss for the period (1,473) (3,087) 1,614 Basic and diluted net loss per share:From continuing operations (0.01) (0.01) - From discontinued operations - (0.02) (0.02) Total basic and diluted net loss per share (0.01) (0.03) (0.02) Net decrease in cash during the period (517) (2,237) 1,720 Cash and cash equivalents 2,825 1,628 1,197 Shareholders' equity 8,296 (1,373) 9,669 Financial Summary:Income decreased by CHF 0.2 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024, primarily due to the completion of the service agreement with Indivior on June 30, 2024. R&D expenses decreased by CHF 0.1 million during three-month period ended March 31, 2025 compared to the same period ended March 31, 2024 primarily due to lower GABAB PAM outsourced R&D expenses as we successfully completed the research phase of our agreement with Indivior on June 30, 2024. G&A expenses decreased by CHF 0.3 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024 primarily due to reduced legal fees. Net loss decreased by CHF 1.6 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024, primarily due to the discontinued loss of CHF 2.4 million incurred during the three-month period ended March 31, 2024, related to activities divested on April 2, 2024, partially offset by the share of the net loss of Neurosterix Group incurred for CHF 0.9 million during the three-month period ended March 31, 2025. Basic and diluted loss per share amounted to CHF 0.01 per share for the three-month period ended March 31, 2025 compared to a basic and diluted loss per share of CHF 0.03 for the same period ended March 31, 2024. Cash and cash equivalents increased to CHF 2.8 million at March 31, 2025, compared to CHF 1.6 million at March 31, 2024. The increase of CHF 1.2 million between March 31, 2025 and March 31, 2024 is primarily due to the gross proceeds of CHF 5.0 million from the Neurosterix Transaction received in April 2024, partially offset by the cash used in operating activities. Q1 2025 Consolidated Financial Statements:The Q1 2025 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, June 19, 2025, 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: Conference call registration URL: About Addex Therapeutics 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 has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out 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 Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@ Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 msinclair@ 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, 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.
Yahoo
2 days ago
- Business
- Yahoo
Addex Therapeutics Reports Q1 2025 Financial Results and Provides Corporate Update
Strong cash position of CHF2.8 million at end of Q1 2025 GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in disease models Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Indivior advanced GABAB PAM Substance use disorders program successfully through IND enabling studies Entered option agreement with Sinntaxis for an exclusive license to intellectual property covering the use of mGlu5 NAM in brain injury recovery Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, June 19, 2025 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its Q1 2025 financial results and provided a corporate update. 'We have had a great start to 2025 both in terms of product development and achieving business milestones. Progress continues well and on track with our GABAB PAM drug candidate in chronic cough. Positive data from this program in multiple preclinical models was recently presented at the prestigious American cough conference. We have also regained rights to our Phase 2 mGlu2 PAM asset, ADX71149,' said Tim Dyer, CEO of Addex. 'Solidifying our position to use mGlu5 NAMs in brain injury, we entered an option agreement with Sinntaxis to gain access to additional intellectual property. Our plan is to explore further the clinical activity of dipraglurant in this indication. Finally, our partner, Indivior, indicated that they have advanced their GABAB PAM clinical candidate through IND enabling studies, providing additional validation of our allosteric modulation approach.' Operating Highlights: GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple models of disease Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Indivior advanced their GABAB PAM program for substance use disorders successfully through IND enabling studies Entered option agreement with Sinntaxis for exclusive license to intellectual property covering use of mGlu5 NAM in brain injury recovery Key Q1 2025 Financial Data CHF' thousands Q1 2025 Q1 2024 Change Income 71 235 (164) R&D expenses (156) (245) 89 G&A expenses (521) (778) 257 Total operating loss (606) (788) 182 Finance result, net (19) 53 (72) Share of net loss of associates (848) - (848) Net loss from continuing operations (1,473) (735) (738) Net loss from discontinued operations - (2,352) 2352 Net loss for the period (1,473) (3,087) 1,614 Basic and diluted net loss per share:From continuing operations (0.01) (0.01) - From discontinued operations - (0.02) (0.02) Total basic and diluted net loss per share (0.01) (0.03) (0.02) Net decrease in cash during the period (517) (2,237) 1,720 Cash and cash equivalents 2,825 1,628 1,197 Shareholders' equity 8,296 (1,373) 9,669 Financial Summary:Income decreased by CHF 0.2 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024, primarily due to the completion of the service agreement with Indivior on June 30, 2024. R&D expenses decreased by CHF 0.1 million during three-month period ended March 31, 2025 compared to the same period ended March 31, 2024 primarily due to lower GABAB PAM outsourced R&D expenses as we successfully completed the research phase of our agreement with Indivior on June 30, 2024. G&A expenses decreased by CHF 0.3 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024 primarily due to reduced legal fees. Net loss decreased by CHF 1.6 million during the three-month period ended March 31, 2025 compared to the same period ended March 31, 2024, primarily due to the discontinued loss of CHF 2.4 million incurred during the three-month period ended March 31, 2024, related to activities divested on April 2, 2024, partially offset by the share of the net loss of Neurosterix Group incurred for CHF 0.9 million during the three-month period ended March 31, 2025. Basic and diluted loss per share amounted to CHF 0.01 per share for the three-month period ended March 31, 2025 compared to a basic and diluted loss per share of CHF 0.03 for the same period ended March 31, 2024. Cash and cash equivalents increased to CHF 2.8 million at March 31, 2025, compared to CHF 1.6 million at March 31, 2024. The increase of CHF 1.2 million between March 31, 2025 and March 31, 2024 is primarily due to the gross proceeds of CHF 5.0 million from the Neurosterix Transaction received in April 2024, partially offset by the cash used in operating activities. Q1 2025 Consolidated Financial Statements:The Q1 2025 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, June 19, 2025, 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: Conference call registration URL: About Addex Therapeutics 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 has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out 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 Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@ Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 msinclair@ 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, 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
Addex GABAB PAM Candidate Demonstrates Robust Anti-Tussive Activity in Multiple Chronic Cough Preclinical Models
Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, June 6, 2025 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, announced today robust anti-tussive activity of its novel gamma-aminobutyric acid sub-type B receptor (GABAB) positive allosteric modulator (PAM) in multiple preclinical models of chronic cough compared to reference drugs. Some of these preclinical data with Addex GABAB PAM drug candidate will be presented on June 7, 2025 at the 10th American Cough Conference, in Dulles, Virginia by Dr Mikhail Kalinichev, Head of Translational Science at Addex. In models of chronic cough, the GABAB PAM drug candidate significantly reduced citric acid-induced cough frequency, increased cough latency and showed no signs of tolerance after sub-chronic treatment. In the same model, the antitussive efficacy of the Addex GABAB PAM drug candidate appears to be superior to that observed with nalbuphine, baclofen, codeine or a P2X3 inhibitor. In addition, the tolerability of the GABAB PAM candidate demonstrated better tolerability and a wider therapeutic margin than that observed with nalbuphine, baclofen, or codeine, while being similar to that of a P2X3 inhibitor, based on the compound's activity on respiratory rate. 'The preclinical data obtained to date demonstrate the huge therapeutic potential of our highly selective GABAB PAM. Following in vivo proof of concept seen in a range of cough models, we are now ready to advance this candidate molecule into IND enabling studies,' said Dr Kalinichev. 'Chronic cough continues to be difficult to treat, and several different approaches being evaluated in clinical trials. Based on the data we have collected to date, we believe our GABAB PAM candidate has the potential to be an effective, once-daily treatment for patients with refractory chronic cough and other conditions.' 'This data with our novel, once daily, orally available GABAB PAM drug candidate clearly demonstrates the potential of our allosteric modulator approach to deliver a better effect than baclofen for this clinically validated drug target,' said Tim Dyer, CEO of Addex. 'Congratulations to the team and we look forward to advancing this candidate rapidly through IND enabling studies and into the clinic so we can hopefully provide better treatment options for patients.' About GABAB activation and cough: The main inhibitory neurotransmitter GABA activates ionotropic (GABAA) and metabotropic (GABAB) types of receptors. GABAB receptors are widely expressed on airways and in the central and peripheral components of the cough neural circuit. Activating GABAB receptors to treat chronic cough has been clinically validated with baclofen, a selective GABAB agonist, that binds the receptor within the GABA binding, orthosteric site. Baclofen is used off-label to treat chronic cough patients, but its wider use is limited due to serious side effects, short half-life and gradual loss of efficacy during chronic treatment. Targeting an allosteric site of the receptor encompasses many advantages, including higher selectivity, better tolerability and lack of tolerance compared to an orthosteric compound. About Addex Therapeutics:Addex 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 has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out 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 Contacts: Tim DyerChief Executive OfficerTelephone: +41 22 884 15 55 PR@ Mike SinclairPartner, Halsin Partners+44 (0)7968 022075msinclair@ 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, 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 in to access your portfolio
Yahoo
05-06-2025
- Health
- Yahoo
Addex to Present Positive GABAB PAM Chronic Cough Data at the 10th American Cough Conference
Geneva, Switzerland, June 5, 2025 - Addex Therapeutics (SIX/NASDAQ: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, announced today that preclinical data from its gamma-aminobutyric acid sub-type B receptor (GABAB) positive allosteric modulator (PAM) cough program will be presented at the 10th American Cough Conference (June 6-7) in Dulles, VA. A presentation given by Mikhail Kalinichev, Head of Translational Science at Addex will describe the progress seen to date with the Addex GABAB PAM cough program, including antitussive data from in vivo models. Addex lead drug candidate is ready to start IND enabling studies. Details of the Presentation Date: Saturday, June 7, 2025Time: 11:20 am ESTTitle: Compound A, a novel positive allosteric modulator of the GABAB receptor, shows robust antitussive efficacy and signs of wide therapeutic margin in models of cough in guinea pigsLocation: Hyatt Regency Dulles, 2300 Dulles Corner Blvd., Herndon, VA, US, 20171 About GABAB activation and cough:The main inhibitory neurotransmitter GABA activates ionotropic (GABAA) and metabotropic (GABAB) types of receptors. GABAB receptors are widely expressed on airways and in the central and peripheral components of the cough neural circuit. Activating GABAB receptors to treat chronic cough has been clinically validated with baclofen, a selective GABAB agonist, that binds the receptor within the orthosteric GABA binding site. Baclofen is used off-label to treat chronic cough patients, but its wider use is limited due to serious side effects, short half-life and gradual loss of efficacy during chronic treatment. Targeting an allosteric site of the receptor is expected to provide many advantages, including higher selectivity, better tolerability and lack of tolerance compared to an orthosteric compound. About Addex TherapeuticsAddex 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 has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private spin out 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 Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@ Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 msinclair@ 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, 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
25-04-2025
- Business
- Yahoo
Addex Reports Full Year 2024 Financial Results and Provides Corporate Update
Launched Neurosterix with Perceptive Advisors, raising USD 65 million in Series A to advance preclinical portfolio Indivior selected GABAB PAM drug candidate and started IND enabling studies for development in substance use disorders Addex selected independent GABAB PAM drug candidate for development in chronic cough Repositioned our phase 2 mGlu5 NAM asset, dipraglurant in brain injury recovery Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, April 25, 2025 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its full-year 2024 financial results for the period ended December 31, 2024 and provided a corporate update. 'During 2024, we have continued to progress clinical development of key clinical assets and build on the momentum resulting from the launch of Neurosterix,' said Tim Dyer, CEO of Addex. 'Importantly, our partner Indivior selected drug candidates for further development in substance use disorders, which enable us to select and characterize our own GABAB PAM for further development in chronic cough. We have also made significant progress with dipraglurant, repositioning in brain injury recovery. Finally, we are now evaluating the future development of ADX71149, our mGlu2 PAM after regaining full control of this asset.' Operating Highlights: Launched Neurosterix with Perceptive Advisors, raising USD 65 million in Series A 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; 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; Repositioned our phase 2 mGlu5 NAM asset, dipraglurant in brain injury recovery Regained rights to our phase 2 mGlu2 PAM asset, ADX71149 Key 2024 Financial Data CHF' thousands 2024 2023* Change Income 410 1,617 (1,207) R&D expenses (854) (1,187) 333 G&A expenses (2,311) (2,673) 362 Total operating loss (2,755) (2,243) 512 Finance result, net 23 (257) 280 Share of net loss of associates (2,177) - (2,177) Net loss from continuing operations (4,909) (2,500) (2,409) Net profit / (loss) from discontinued operations 11,965 (8,056) 20,021 Net profit / (loss) for the period 7,056 (10,556) 17,612 Basic net profit / (loss) per share 0.07 (0.14) 0.21 Diluted net profit / (loss) per share 0.04 (0.14) 0.18 Net decrease in cash and cash equivalents (523) (3,092) 2,569 Cash and cash equivalents 3,342 3,865 (523) Shareholders' equity 9,677 1,145 8,532 * 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 2024 and 2023 periods, 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 2024 period, net profit from discontinued operations amounted to CHF 12.0 million, and was primarily related to the net gain of CHF 13.9 million from the sale of part of our business, partially offset by the net loss of CHF 1.9 million from discontinued operating activities. During the 2023 period, the Group incurred a net loss from discontinued operations of CHF 8.1 million. During the 2024 period, net profit amounted to CHF 7.1 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 4.9 million. During the 2023 period, the Group incurred a net loss of CHF 10.6 million of which CHF 8.1 million was related to operating discontinued activities. Diluted net gain per share amounted to CHF 0.04 for 2024, compared to a diluted net loss per share of CHF 0.14 for 2023. Cash and cash equivalents decreased to CHF 3.3 million at December 31, 2024, compared to CHF 3.9 million at December 31, 2023. The decrease of CHF 0.6 million between December 31, 2024 and December 31, 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. In 2024, income decreased by CHF 1.2 million to CHF 0.4 million in 2024 compared to CHF 1.6 million in 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. R&D expenses primarily relate to our GABAB PAM program and decreased by CHF 0.3 million to CHF 0.8 million in 2024 compared to CHF 1.2 million in 2023, primarily due to the completion of the research agreement with Indivior on June 30, 2024. G&A expenses decreased by CHF 0.4 million to CHF 2.3 million in 2024 compared to CHF 2.7 million in 2023, primarily due to reduced D&O insurance costs. The net loss from continuing operations increased by CHF 2.4 million to CHF 4.9 million in 2024 compared to CHF 2.5 million in 2023, primarily due to reduced revenue and increased costs related to the share of the net loss of the Neurosterix Group. 2024 Consolidated Financial Statements:The full-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, April 25, 2025, 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: Conference call registration URL: About Addex Therapeutics: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 Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@ Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 msinclair@ 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, 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.