Addex Therapeutics' Spin-Out Neurosterix to Complete NTX-253 Clinical Study in Q2
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 23 2026
0mins
Addex Therapeutics announced that its spin-out company, Neurosterix, is on track to complete its Phase 1 clinical study evaluating NTX-253 in Q2. NTX-253 is an investigational potent, selective, orally available positive allosteric modulator of the muscarinic M4 receptor being developed for the treatment of schizophrenia. The study is designed to generate an early-stage clinical data package assessing safety, tolerability, and pharmacokinetics across both healthy adult participants and those with stable schizophrenia. The clinical study includes a multi-part, ascending-dose design intended to efficiently characterize NTX-253's clinical profile and support subsequent patient-focused development. The study includes both single ascending dose and multiple ascending dose components, incorporating key translational elements such as food-effect and cerebrospinal fluid assessments. Healthy adult participants will receive a single oral dose of NTX-253 or placebo across sequentially escalating dose cohorts. This phase includes a dedicated food-effect cohort to assess the impact of food on NTX-253 pharmacokinetics. A separate SAD cohort in healthy volunteers will evaluate NTX-253 concentrations in cerebrospinal fluid, providing early insight into central nervous system exposure and brain penetration. In the MAD phase, participants will receive once-daily oral dosing of NTX-253 or placebo for 10 consecutive days, with sequential dose escalation. This phase is designed to evaluate safety, tolerability, and steady-state pharmacokinetics following repeated dosing. The MAD phase includes two dedicated cohorts of adults with stable schizophrenia, representing early clinical evaluation in the target patient population. Participants in these cohorts will have their antipsychotic medications withdrawn for up to eight days prior to dosing with NTX-253, enabling assessment of safety and PK in patients while maintaining clinical stability. Neurosterix was spun-out of Addex in April 2024, raising $65M in a Series A financing led by funds affiliated with Perceptive Advisors. Addex retains a 20% equity interest in Neurosterix.
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About ADXN
Addex Therapeutics Ltd is a Switzerland-based clinical-stage pharmaceutical company. The Company focuses on development and commercialization of orally available small molecule drugs known as allosteric modulators for neurological disorders. The Company’s clinical programs pipeline include dipraglurant (mGlu5 NAM), which is Phase 2a placebo-controlled clinical trial for Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials for PD-LID, and ADX71149 (mGlu2 positive allosteric modulator or PAM), which is being developed in collaboration by its partner Janssen Pharmaceuticals, Inc to treat schizophrenia and anxious depression. It also is advancing several preclinical programs, including GABABPAM for pain, overactive bladder and other disorders, mGlu7 NAM for post-traumatic stress disorder, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Addex Therapeutics Reports Q1 2026 Financial Results and Corporate Update
- Financial Overview: Addex Therapeutics reported Q1 2026 income of CHF 871,000, a significant improvement from a loss of CHF 63,000 in the same period last year, although total operating loss was CHF 480,000, reflecting effective cost control with a reduction of CHF 126,000 year-over-year.
- R&D Progress: The spin-out Neurosterix made notable advancements in the clinical development of M4 positive allosteric modulator NTX-253, expected to complete Phase 1 study in July, enhancing Addex's competitive position in schizophrenia treatment and potentially paving the way for future market launches.
- Cash Flow Status: As of March 31, 2026, Addex's cash and cash equivalents decreased to CHF 900,000 from CHF 2.8 million a year earlier, a drop of CHF 1.9 million primarily due to operating and investing activities, indicating challenges in financial management.
- Shareholders' Equity Changes: The company's shareholders' equity fell from CHF 8.3 million to CHF 3.3 million, a decrease of CHF 5 million, reflecting the ongoing net losses' impact on financial health, which may affect future financing capabilities and investor confidence.
See More
Addex Therapeutics Q1 2026 Financial Report Analysis
- Financial Warning: Addex Therapeutics ended Q1 2026 with only CHF0.9 million in cash, indicating significant risk in funding unpartnered programs into clinical stages without additional financing, which could hinder future R&D progress.
- Increased Net Loss: The company reported a net loss of CHF1.7 million in Q1 2026, up from CHF1.5 million in the same period of 2025, primarily due to its share of losses from Neurosterix, highlighting escalating financial pressures.
- Positive R&D Progress: Despite financial challenges, Addex has made significant strides in its GABAB positive modulator program, demonstrating robust antitussive activity in preclinical models, potentially laying the groundwork for future clinical applications.
- Undervalued Equity: Addex retains a 20% equity stake in Neurosterix, which is currently undervalued in the market; however, this stake could provide additional financial support for Addex as Neurosterix advances into clinical stages.
See More
Addex Therapeutics Reports Q1 Earnings
- Earnings Report: Addex Therapeutics reported a Q1 GAAP EPS of -CHF0.01, indicating ongoing challenges in profitability that may affect investor confidence in the company's financial health.
- Historical Financial Data: Historical earnings data shows significant volatility in Addex's profitability, reflecting ongoing investments in R&D and marketing that could lead to increased financial pressure in the short term.
- Market Reaction: The market's response to this earnings report may influence Addex's stock price trajectory, particularly as the company has yet to achieve profitability, leading to cautious investor expectations for future growth.
- Future Outlook: Despite the current poor financial performance, Addex's efforts in developing new therapies may lay the groundwork for future revenue growth, making it essential for investors to monitor subsequent developments.
See More
Addex Therapeutics Reports Q1 Loss Amid Revenue Decline
- Financial Performance Decline: Addex Therapeutics reported a net loss of CHF 1.71 million in Q1 2026, up from CHF 1.47 million in 2025, indicating increased financial strain due to reduced revenues, which raises concerns about the company's market competitiveness.
- Significant Revenue Drop: The company's Q1 revenue plummeted to CHF 8,000 from CHF 71,000 a year ago, highlighting substantial challenges in product sales and market penetration, which could adversely affect future cash flow and operational sustainability.
- Reduced R&D Spending: Research and development expenses decreased from CHF 0.16 million to CHF 0.04 million, which, while cutting costs, may hinder the progress of new drug developments, particularly in the increasingly competitive field of neurological treatments.
- Stock Price Volatility: Addex shares fell over 6% on Wednesday to close at $6, with after-hours trading showing a slight decline to $5.99, reflecting investor concerns regarding the company's financial health and potentially impacting future fundraising efforts.
See More
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- Pipeline Update: The lead drug candidate, dipraglurant, is under evaluation for its potential in brain injury recovery, including post-stroke and traumatic brain injury, which could enhance the company's market position in the neurological disorders sector.
- Partnership Progress: Addex's collaboration with Indivior is advancing, as Indivior has selected a GABAB PAM drug candidate for development in substance use disorders and successfully completed IND enabling studies, potentially providing Addex with a new revenue stream.
- Investment and Equity Structure: Addex holds a 20% equity interest in Neurosterix US Holdings LLC, a private company advancing several allosteric modulator programs, including M4 PAM and mGlu7 NAM, demonstrating Addex's diversified investment strategy in the neuropsychiatric disorders space.
See More
Addex Therapeutics to Report Q1 2026 Financial Results and Corporate Update
- Earnings Release Schedule: Addex Therapeutics is set to announce its Q1 2026 financial results on June 25, 2026, during which it will provide a business update and product pipeline review, likely generating positive investor sentiment.
- Executive Participation: CEO Tim Dyer and Head of Translational Science Mikhail Kalinichev will host a teleconference at 16:00 CEST, expected to attract significant investor interest and enhance the company's transparency.
- Pipeline Progress: Addex's lead drug candidate, dipraglurant, is under evaluation for brain injury recovery, particularly post-stroke and traumatic brain injury, indicating the company's potential in neurological disorder treatments.
- Strategic Partnerships and Investments: Addex's collaboration with Indivior on a GABAB PAM drug candidate has successfully completed IND enabling studies, while the company is also advancing an independent GABAB PAM program for chronic cough, showcasing its diversified strategy in neuropharmaceutical development.
See More
Addex Therapeutics Reports Q1 2026 Financial Results and Corporate Update
- Financial Overview: Addex Therapeutics reported Q1 2026 income of CHF 871,000, a significant improvement from a loss of CHF 63,000 in the same period last year, although total operating loss was CHF 480,000, reflecting effective cost control with a reduction of CHF 126,000 year-over-year.
- R&D Progress: The spin-out Neurosterix made notable advancements in the clinical development of M4 positive allosteric modulator NTX-253, expected to complete Phase 1 study in July, enhancing Addex's competitive position in schizophrenia treatment and potentially paving the way for future market launches.
- Cash Flow Status: As of March 31, 2026, Addex's cash and cash equivalents decreased to CHF 900,000 from CHF 2.8 million a year earlier, a drop of CHF 1.9 million primarily due to operating and investing activities, indicating challenges in financial management.
- Shareholders' Equity Changes: The company's shareholders' equity fell from CHF 8.3 million to CHF 3.3 million, a decrease of CHF 5 million, reflecting the ongoing net losses' impact on financial health, which may affect future financing capabilities and investor confidence.
See More
Addex Therapeutics Q1 2026 Financial Report Analysis
- Financial Warning: Addex Therapeutics ended Q1 2026 with only CHF0.9 million in cash, indicating significant risk in funding unpartnered programs into clinical stages without additional financing, which could hinder future R&D progress.
- Increased Net Loss: The company reported a net loss of CHF1.7 million in Q1 2026, up from CHF1.5 million in the same period of 2025, primarily due to its share of losses from Neurosterix, highlighting escalating financial pressures.
- Positive R&D Progress: Despite financial challenges, Addex has made significant strides in its GABAB positive modulator program, demonstrating robust antitussive activity in preclinical models, potentially laying the groundwork for future clinical applications.
- Undervalued Equity: Addex retains a 20% equity stake in Neurosterix, which is currently undervalued in the market; however, this stake could provide additional financial support for Addex as Neurosterix advances into clinical stages.
See More
Addex Therapeutics Reports Q1 Earnings
- Earnings Report: Addex Therapeutics reported a Q1 GAAP EPS of -CHF0.01, indicating ongoing challenges in profitability that may affect investor confidence in the company's financial health.
- Historical Financial Data: Historical earnings data shows significant volatility in Addex's profitability, reflecting ongoing investments in R&D and marketing that could lead to increased financial pressure in the short term.
- Market Reaction: The market's response to this earnings report may influence Addex's stock price trajectory, particularly as the company has yet to achieve profitability, leading to cautious investor expectations for future growth.
- Future Outlook: Despite the current poor financial performance, Addex's efforts in developing new therapies may lay the groundwork for future revenue growth, making it essential for investors to monitor subsequent developments.
See More
Addex Therapeutics Reports Q1 Loss Amid Revenue Decline
- Financial Performance Decline: Addex Therapeutics reported a net loss of CHF 1.71 million in Q1 2026, up from CHF 1.47 million in 2025, indicating increased financial strain due to reduced revenues, which raises concerns about the company's market competitiveness.
- Significant Revenue Drop: The company's Q1 revenue plummeted to CHF 8,000 from CHF 71,000 a year ago, highlighting substantial challenges in product sales and market penetration, which could adversely affect future cash flow and operational sustainability.
- Reduced R&D Spending: Research and development expenses decreased from CHF 0.16 million to CHF 0.04 million, which, while cutting costs, may hinder the progress of new drug developments, particularly in the increasingly competitive field of neurological treatments.
- Stock Price Volatility: Addex shares fell over 6% on Wednesday to close at $6, with after-hours trading showing a slight decline to $5.99, reflecting investor concerns regarding the company's financial health and potentially impacting future fundraising efforts.
See More
Addex Therapeutics to Report Q1 2026 Financial Results on June 25
- Earnings Announcement: Addex Therapeutics will report its Q1 2026 financial results on June 25, 2026, with CEO Tim Dyer and Head of Translational Science Mikhail Kalinichev providing a business update during a teleconference and webcast, which is expected to bolster market confidence in the company's future prospects.
- Pipeline Update: The lead drug candidate, dipraglurant, is under evaluation for its potential in brain injury recovery, including post-stroke and traumatic brain injury, which could enhance the company's market position in the neurological disorders sector.
- Partnership Progress: Addex's collaboration with Indivior is advancing, as Indivior has selected a GABAB PAM drug candidate for development in substance use disorders and successfully completed IND enabling studies, potentially providing Addex with a new revenue stream.
- Investment and Equity Structure: Addex holds a 20% equity interest in Neurosterix US Holdings LLC, a private company advancing several allosteric modulator programs, including M4 PAM and mGlu7 NAM, demonstrating Addex's diversified investment strategy in the neuropsychiatric disorders space.
See More
Addex Therapeutics to Report Q1 2026 Financial Results and Corporate Update
- Earnings Release Schedule: Addex Therapeutics is set to announce its Q1 2026 financial results on June 25, 2026, during which it will provide a business update and product pipeline review, likely generating positive investor sentiment.
- Executive Participation: CEO Tim Dyer and Head of Translational Science Mikhail Kalinichev will host a teleconference at 16:00 CEST, expected to attract significant investor interest and enhance the company's transparency.
- Pipeline Progress: Addex's lead drug candidate, dipraglurant, is under evaluation for brain injury recovery, particularly post-stroke and traumatic brain injury, indicating the company's potential in neurological disorder treatments.
- Strategic Partnerships and Investments: Addex's collaboration with Indivior on a GABAB PAM drug candidate has successfully completed IND enabling studies, while the company is also advancing an independent GABAB PAM program for chronic cough, showcasing its diversified strategy in neuropharmaceutical development.
See More
