Latest news with #GABAB
Yahoo
15 hours ago
- Business
- Yahoo
Addex Therapeutics Ltd (ADXN) Q1 2025 Earnings Call Highlights: Strategic Advances and ...
Cash Balance: CHF2.8 million as of March 31, 2025. Cash Runway: Expected to last through mid-2026. Continuing R&D Expenses: CHF0.1 million, primarily related to the GABAB PAM program. Continuing G&A Expenses: CHF0.5 million, primarily related to corporate loan activities. Net Loss from Discontinued Operations: Specific line item due to divested business. Current Liabilities: CHF1.1 million as of March 31, 2025. Non-Current Liabilities: CHF0.1 million as of March 31, 2025. Equity Interest: 20% equity interest in a divested business, recorded under non-current assets. Warning! GuruFocus has detected 6 Warning Signs with ADXN. Release Date: June 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Addex Therapeutics Ltd (NASDAQ:ADXN) has made significant progress in its GABAB positive allosteric modulator program with partner Indivior, completing IND-enabling studies for substance use disorders. The company regained rights to its mGluR2 positive allosteric modulator program from Johnson & Johnson, opening new therapeutic opportunities. Addex Therapeutics Ltd (NASDAQ:ADXN) has repositioned its mGluR5 negative allosteric modulator program for brain injury recovery, with promising preclinical data supporting its potential. The company has a strong cash position with CHF2.8 million, providing a runway through mid-2026, and has reduced cash burn following the Neurosterix spinout. Addex Therapeutics Ltd (NASDAQ:ADXN) has a robust pipeline with multiple programs advancing, including a promising candidate for chronic cough with favorable preclinical efficacy and tolerability. The current cash position does not fund the progression of unpartnered programs into the clinic, indicating potential future financing needs. Revenue decreased compared to the previous year due to the completion of the funded research phase with Indivior, impacting financial performance. The company faces competition in the chronic cough market, with existing compounds showing promising efficacy but challenging tolerability profiles. There is uncertainty regarding the clinical development pathway and competitive landscape for the chronic cough program, which could impact future success. Addex Therapeutics Ltd (NASDAQ:ADXN) needs to conduct further studies to optimize the use of dipraglurant in post-stroke rehabilitation, indicating a longer timeline before potential market entry. Q: Can you provide your updated thoughts on the current competitive landscape in chronic cough and the relevance of proceeding programs for your clinical development pathway? A: Mikhail Kalinichev, Head of Translational Science, explained that there are several compounds in development, such as now roofing, which has shown promising efficacy but with tolerability challenges. Addex aims to deliver similar efficacy with improved tolerability, targeting both IPF-related and refractory chronic cough. The development plan includes studies in healthy volunteers and a challenge study in chronic cough patients, followed by a Phase 2 study with advanced monitoring technologies. Q: Can you comment on the potential applicability of your agent for chronic painful cough in indications outside of IPF, like pulmonary sarcoidosis? A: Mikhail Kalinichev noted that chronic painful cough could be a suitable indication due to the sustained activation of GABAB across multiple conditions, including chronic cough. Tim Dyer, CEO, added that they are considering this indication for Phase 2 development. Q: Regarding dipraglurant in post-stroke rehabilitation, what would an appropriate control arm look like in a registration-quality study, and what is the efficacy bar in this indication? A: Mikhail Kalinichev stated that dipraglurant would be used alongside physiotherapy due to its short half-life and good tolerability. They plan to conduct clinical pharmacology studies to understand its modulation effects better, which will inform the design of a Phase 2 study. The efficacy bar is challenging as no pharmacotherapies are currently approved in this context. Q: Can you elaborate on the strategic importance of your GABAB positive allosteric modulator program with Indivior? A: Tim Dyer highlighted the program's potential to deliver a better baclofen for substance use disorders, with a longer half-life and improved side effect profile. The partnership with Indivior is crucial, as it allows Addex to advance its own independent GABAB PAM program for chronic cough, leveraging the strong rationale for GABAB PAMs in this area. Q: What are the financial implications of your recent achievements and strategic partnerships? A: Tim Dyer reported that Addex completed Q1 2025 with CHF2.8 million in cash, providing a runway through mid-2026. The cash burn has been reduced following the Neurosterix spinout, and the company is well-positioned to deliver on strategic objectives, including advancing their pipeline and exploring new partnerships. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
09-06-2025
- 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 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
09-06-2025
- 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
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
