Addex Therapeutics (NasdaqCM:ADXN) Q3 2025 Earnings Call December 04, 2025 10:00 AM ET Company ParticipantsMikhail Kalinichev - Head of Translational ScienceRam Selvaraju - Managing DirectorTim Dyer - CEOOperatorThank you for standing by. Welcome to the Addex Therapeutics third quarter 2025 financial results and corporate update conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question-and-answer session. To ask a questi ...

Financial Data and Key Metrics Changes - Income in Q3 2025 remained similar to Q3 2024, amounting to CHF 0.1 million, primarily related to patent license maintenance and services from Neurosterix [17] - R&D expenses were CHF 0.2 million in Q3 2025, consistent with Q3 2024, mainly for the GABA-B PAM program [17] - G&A expenses were CHF 0.5 million in Q3 2025, stable compared to Q3 2024 [17] - Cash at the end of Q3 2025 was CHF 2.2 million, providing a runway through mid-2026, with a significant reduction in cash burn following the Neurosterix spin-out [5][18] Business Line Data and Key Metrics Changes - Progress was made in the GABA-B PAM program, with IND-enabling studies ready to start, subject to financing [6][12] - The Dipraglurant program for post-stroke recovery is advancing, with preparations for clinical studies ongoing [4][10] Market Data and Key Metrics Changes - There is a significant unmet medical need in chronic cough treatment, with current standards of care ineffective in 30% of patients [11][25] - The market for post-stroke recovery is growing, with over 100 million stroke survivors worldwide, increasing at an annual rate of 12 million [8][9] Company Strategy and Development Direction - The company is focusing on advancing its GABA-B PAM program for chronic cough and repositioning Dipraglurant for brain injury recovery [19] - Collaboration with Neurosterix and Lund University is ongoing to complete preclinical profiling of Dipraglurant [4][19] - The company is evaluating potential indications for its mGluR2 PAM program, received back from J&J, to advance towards clinical studies [19] Management's Comments on Operating Environment and Future Outlook - Management highlighted the urgent need for pharmacological agents to promote recovery in post-stroke patients, emphasizing the potential of Dipraglurant [9][10] - The company is optimistic about the progress of its spin-out company, Neurosterix, and its M4 PAM program, which is set to start phase one this year [19] Other Important Information - The company has a strong patent position for Dipraglurant and believes it can become a first-in-class drug for post-stroke recovery [10] - Stalicla, a private clinical-stage company, is advancing its patient stratification study in autism and is working on a Series C financing [5][28] Q&A Session Summary Question: Commercial outlook for chronic refractory cough - Management noted that Gefapixent is not performing well in the U.S. market, and there is a significant unmet medical need in chronic cough treatment [24][25] Question: Funding catalyst for Stalicla and potential IPO - Stalicla is working on Series C financing to fund clinical programs and is considering an IPO as a potential funding mechanism [27][28] Question: Competitive clinical development in post-stroke recovery - Management acknowledged the ongoing Camaris trial with Maraviroc and expressed interest in learning from its outcomes for Dipraglurant development [22][30] Question: Indivior's next steps in collaboration - Management stated that Indivior has completed IND-enabling studies and is preparing to move the program forward, but further details could not be disclosed [32]

Financial Data and Key Metrics Changes - Income in Q3 2025 remained similar to Q3 2024, amounting to $100,000, primarily related to patent maintenance funded by Indivior and fair value of services from NeuroStarix Group [21] - R&D expenses were $200,000 in Q3 2025, remaining stable compared to Q3 2024, mainly related to the GABA B PAM program [21] - G&A expenses were $500,000 in Q3 2025, consistent with Q3 2024 [22] - The company completed Q3 2025 with CHF 2.2 million in cash, providing a cash runway through mid-2026 [8][22] Business Line Data and Key Metrics Changes - The GABA B PAM program for chronic cough is advancing, with IND enabling studies planned, subject to securing financing [10][19] - The dipraglutide program for post-stroke recovery is being repositioned, with good progress in preparing for clinical studies [6][10] Market Data and Key Metrics Changes - There is a significant unmet medical need in chronic cough treatment, with current standards of care ineffective in 30% of patients and only moderately effective in up to 60% [15][16] - The post-stroke recovery market shows a large unmet need, with over 100 million stroke survivors worldwide and a growing annual rate of 12 million [12] Company Strategy and Development Direction - The company is focusing on advancing its pipeline, particularly the GABA B PAM program and dipraglutide for brain injury recovery [24] - A research collaboration with Syntaxis and the University of Lund is in place to complete preclinical profiling and prepare for clinical studies [7] Management's Comments on Operating Environment and Future Outlook - Management highlighted the progress in the GABA B PAM program and the dipraglutide program, expressing optimism about their potential [24] - The company is aware of the competitive landscape in post-stroke recovery and is planning to collaborate with ongoing clinical programs to gain insights [39][40] Other Important Information - The cash burn has been significantly reduced following the NeuroStarix spin-out transaction, although current cash does not fund the progression of unpartnered programs into the clinic [8] Q&A Session Summary Question: Commercial outlook for chronic refractory cough - Management noted that gefapixant is not performing well, and there is a significant unmet medical need in chronic cough treatment [31][32] Question: Funding catalyst for Stellixla and potential IPO - Stellixla is working on Series C financing to fund Phase II studies and is considering an IPO as a potential funding mechanism [38] Question: Competitive clinical development in post-stroke recovery - Management acknowledged the importance of the CAMARUS trial and plans to collaborate with involved parties to learn from the study [39][40] Question: Indivior's next steps in collaboration - Indivior has completed IND enabling studies and is preparing to move the program forward, but specific details could not be disclosed [43]

Core Viewpoint - The U.S. tariff policy and the attractiveness of the pharmaceutical market are driving European drugmakers to increase investments in the U.S., including new manufacturing facilities and stock listings [1][4][10]. Group 1: U.S. Market Dynamics - Since early 2025, European drugmakers have intensified their presence in the U.S., with AstraZeneca announcing a direct listing on the NYSE and committing $50 billion in U.S. investments by 2030 [3][4]. - The U.S. accounted for over 54.8% of global prescription medicine sales in 2024, significantly outpacing Europe, which held 22.7% [7]. - Non-U.S. drugmakers are highly exposed to tariff risks, with the EU exporting nearly €120 billion ($127 billion) worth of medicines to the U.S. in 2024, making it the largest pharmaceutical trading partner [8]. Group 2: Tariff Policy Impact - President Trump announced a 100% tariff on imports of branded and patented medicines unless manufacturers establish U.S. plants, prompting pharmaceutical companies to adapt their strategies [5][10]. - The U.S. tariff policy, combined with pressures for lower drug prices, is accelerating strategic shifts among pharmaceutical companies [10][12]. - Companies planning to build factories in the U.S. can avoid extra tariffs, influencing their decisions on manufacturing locations [10]. Group 3: Financial Considerations - The London Stock Exchange has been experiencing lower liquidity compared to the U.S. market, making U.S. listings more attractive for companies [19]. - Analysts estimate that a 15% tariff could reduce earnings by about 9% for U.S. companies and 6% for European ones, but the impact may be mitigated by outsourcing and securing multiple suppliers [23]. Group 4: Regional Differences - The UK spends only 9% of its healthcare budget on medicines, compared to 15-17% in France, Germany, and Italy, which may explain the trend of companies moving away from the UK [13]. - The European Union is revising drug rules to extend the period of protection for new medicines, which could influence market dynamics [15].

Financial Data and Key Metrics Changes - The company completed H1 2025 with cash of CHF 2.3 million, providing a runway through mid-2026 [6] - Income decreased by $100,000 in Q2 2025 compared to Q2 2024, amounting to $100,000, primarily due to the completion of the funded research phase with Indivior [18] - R&D expenses of $200,000 in Q2 2025 decreased by $100,000 compared to Q2 2024, mainly due to the completion of the research phase with Indivior [19] - G&A expenses of $500,000 decreased by $100,000 in Q2 2025 compared to Q2 2024, primarily due to decreased legal fees [19] - Current liabilities increased by $300,000 compared to December 2024, primarily due to increased payables [20] Business Line Data and Key Metrics Changes - The GABA B PAM program has made significant progress, with IND enabling studies completed by the partner Indivior for substance use disorders [21] - The company has advanced its independent GABA B PAM program for chronic cough and is ready to start IND enabling studies, subject to securing financing [21] - The repositioning of diproglurant for brain injury recovery has been initiated, with an exclusive license agreement for mGluR5 inhibitors [5] Market Data and Key Metrics Changes - The chronic cough market presents a large unmet medical need, with current treatments ineffective in 30% of patients and only moderately effective in up to 60% [12] - The company believes that GABA B PAMs could offer superior efficacy in chronic cough patients compared to current standards of care [12] Company Strategy and Development Direction - The company is focused on advancing its GABA B PAM program and has regained rights to its mGluR2 positive allosteric modulator program [4] - The strategic objective includes validating partnerships with industry and supportive investors while maintaining a strong balance sheet [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the renewed interest in the neuropsychiatry space, highlighting recent transactions and the potential for Neurosterics and Stellicla [25] - The company is actively pursuing financing strategies for Stellicla, which is focused on patient stratification technology [26] Other Important Information - The company has invested in Stellicla, which has developed a precision medicine platform for neurodevelopmental disorders [5] - The IND enabling studies for the GABA B PAM program are planned to start this year, with promising preclinical data [16] Q&A Session Summary Question: Recent developments in the neuropsychiatry space and implications for Neurosterics and Stellicla - Management noted renewed excitement in the neuropsychiatry space and highlighted the successful financing of Neurosterics [25][26] Question: Insights into long-acting injectable formulations for Neurosterics - Management indicated that while they cannot speculate, there is potential for longer-acting formulations in the m4 PAM space due to compliance issues [30][31] Question: Ideal target patient population for the chronic cough program - Management stated that the GABA B PAMs were selected to maximize the range of chronic cough patients, focusing on centrally acting compounds [33]

Core Viewpoint - Indivior plans to relocate its corporate domicile from the UK to the United States, establishing a new parent company based in Delaware [1] Company Summary - The decision to move to the US comes just months after the pharmaceutical firm made significant changes to its corporate structure [1] - This relocation is part of a broader strategy to enhance operational efficiency and align with market opportunities in the US [1] Industry Context - The pharmaceutical industry is witnessing a trend of companies relocating their headquarters to jurisdictions with more favorable regulatory environments and tax structures [1] - This move may reflect a growing preference among pharmaceutical firms to be closer to key markets and investors in the US [1]

Core Viewpoint - Addex Therapeutics reported significant progress in drug development and business milestones during the first half of 2025, particularly with its GABAB PAM drug candidate for chronic cough and the mGlu2 PAM asset ADX71149 [2][5][16] Financial Performance - Income for H1 2025 decreased to CHF 107,000 from CHF 350,000 in H1 2024, a decline of CHF 243,000 [4] - R&D expenses reduced to CHF 391,000 in H1 2025 from CHF 584,000 in H1 2024, reflecting a decrease of CHF 193,000 [4][8] - G&A expenses decreased to CHF 1,056,000 in H1 2025 from CHF 1,453,000 in H1 2024, a reduction of CHF 397,000 [4][9] - Total operating loss improved to CHF 1,340,000 in H1 2025 from CHF 1,687,000 in H1 2024, an improvement of CHF 347,000 [4] - Net loss from continuing operations increased to CHF 3,432,000 in H1 2025 from CHF 2,192,000 in H1 2024, an increase of CHF 1,240,000 [4][10] - Basic and diluted loss per share was CHF 0.03 for H1 2025 compared to a profit of CHF 0.10 for H1 2024 [11] Cash Position - Cash and cash equivalents decreased to CHF 2.3 million as of June 30, 2025, down from CHF 3.8 million as of June 30, 2024, a decrease of CHF 1.5 million [7][11] Corporate Developments - The GABAB PAM chronic cough candidate showed robust anti-tussive activity in multiple disease models [5][6] - The company regained rights to the Phase 2 mGlu2 PAM asset, ADX71149, and is evaluating next steps internally [2][5] - An option agreement was entered with Sinntaxis for exclusive licensing of intellectual property related to mGlu5 NAM in brain injury recovery [2][5] - Indivior successfully advanced its GABAB PAM program for substance use disorders through IND enabling studies [5][6] - The company invested in Stalicla, reinforcing its commitment to innovative treatments for CNS disorders [2][5][16]

Core Viewpoint - Addex Therapeutics reported significant progress in drug development and business milestones during the first half of 2025, particularly with its GABAB PAM drug candidate for chronic cough and the mGlu2 PAM asset ADX71149 [2][5][16] Financial Performance - Income for H1 2025 decreased to CHF 107,000 from CHF 350,000 in H1 2024, a decline of CHF 243,000 [4] - R&D expenses reduced to CHF 391,000 in H1 2025 from CHF 584,000 in H1 2024, an improvement of CHF 193,000 [4][8] - G&A expenses decreased to CHF 1,056,000 in H1 2025 from CHF 1,453,000 in H1 2024, a reduction of CHF 397,000 [4][9] - Total operating loss improved to CHF 1,340,000 in H1 2025 from CHF 1,687,000 in H1 2024, a decrease of CHF 347,000 [4] - Net loss from continuing operations increased to CHF 3,432,000 in H1 2025 from CHF 2,192,000 in H1 2024, an increase of CHF 1,240,000 [4][10] - Basic and diluted loss per share was CHF 0.03 for H1 2025 compared to a profit of CHF 0.10 for H1 2024 [7][11] - Cash position decreased to CHF 2.3 million at the end of H1 2025 from CHF 3.8 million at the end of H1 2024 [5][11] Operational Highlights - The GABAB PAM chronic cough candidate showed robust anti-tussive activity in multiple disease models [5][6] - Rights to the Phase 2 mGlu2 PAM asset, ADX71149, were regained, with internal evaluations for next steps ongoing [2][5] - Indivior successfully advanced its GABAB PAM program for substance use disorders through IND enabling studies [5][6] - An option agreement was entered with Sinntaxis for exclusive licensing of intellectual property related to mGlu5 NAM in brain injury recovery [5][6] - Investment in Stalicla SA was made, reinforcing the commitment to innovative treatments for CNS disorders [5][6][16]

Core Insights - Addex Therapeutics has made a strategic investment of CHF 2 million in Stalicla, a company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [1][2] - The investment aims to support Stalicla's portfolio of autism-focused drug candidates and its series C financing, while also enhancing Addex's commitment to advancing innovative treatments for CNS disorders [2][3] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company developing novel small molecule allosteric modulators for neurological disorders, with a lead drug candidate, dipraglurant, under evaluation for brain injury recovery [4] - Stalicla has raised over $50 million in equity and more than $30 million in non-dilutive funding, focusing on transforming treatments for neurodevelopmental disorders [3][4] Investment Details - The investment will enable Stalicla to advance its lead autism candidate STP1 and a second asset into Phase 2 trials, targeting specific subpopulations within autism spectrum disorder (ASD) [2][3] - Stalicla is also progressing its STP7 program (mavoglurant) for cocaine use disorders, which is the most advanced treatment candidate in development for this indication [2][3] Leadership Changes - As part of the investment, Addex CEO Tim Dyer has been appointed to Stalicla's Board of Directors and nominated as Chairman, indicating a deeper collaboration between the two companies [1][2]

Core Viewpoint - Addex Therapeutics reported a strong start to 2025 with significant progress in product development and business milestones, particularly in their GABAB PAM drug candidate for chronic cough and regained rights to their Phase 2 mGlu2 PAM asset, ADX71149 [2][5]. Financial Summary - Income for Q1 2025 was CHF 71,000, a decrease of CHF 164,000 from CHF 235,000 in Q1 2024 [4]. - R&D expenses decreased to CHF 156,000 from CHF 245,000, a reduction of CHF 89,000 [4][8]. - G&A expenses decreased to CHF 521,000 from CHF 778,000, a reduction of CHF 257,000 [4][8]. - Total operating loss improved to CHF 606,000 from CHF 788,000, an improvement of CHF 182,000 [4]. - Net loss from continuing operations was CHF 1,473,000, compared to CHF 735,000 in Q1 2024, an increase of CHF 738,000 [4]. - Net loss for the period decreased to CHF 1,473,000 from CHF 3,087,000, a reduction of CHF 1,614,000 [4][9]. - Basic and diluted net loss per share was CHF 0.01, down from CHF 0.03 in the same period last year [4][10]. - Cash and cash equivalents increased to CHF 2.8 million from CHF 1.6 million, an increase of CHF 1.2 million [4][11]. - Shareholders' equity improved significantly to CHF 8.3 million from a negative CHF 1.4 million [4]. Operational Highlights - The GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple disease models [5][6]. - The company regained rights to its Phase 2 mGlu2 PAM asset, ADX71149 [5][6]. - Indivior successfully advanced their GABAB PAM program for substance use disorders through IND enabling studies [5][6]. - An option agreement was entered with Sinntaxis for exclusive licensing of intellectual property related to mGlu5 NAM in brain injury recovery [5][6].