Core Viewpoint - Addex Therapeutics announced that its spin-out company, Neurosterix, has initiated a Phase 1 clinical study of NTX-253, a positive allosteric modulator for the treatment of schizophrenia, marking a significant milestone for both companies [1][2] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [4] - The company retains a 20% equity interest in Neurosterix, which was spun out in April 2024 and raised $65 million in Series A financing [2][4] Product Development - NTX-253 is a selective, orally available positive allosteric modulator of the muscarinic M4 receptor, designed to treat schizophrenia by potentially reducing psychosis symptoms without the side effects associated with traditional dopamine antagonists [1][3] - Preclinical studies have shown that NTX-253 has robust antipsychotic-like activity and a favorable safety profile, supporting its advancement into first-in-human clinical studies [3] Market Position - The M4 muscarinic receptor is a validated target for treating schizophrenia, offering a novel therapeutic approach compared to traditional antipsychotics that primarily target dopamine receptors [3] - Current antipsychotics can induce metabolic, cognitive, and motor side effects, which M4 PAMs aim to avoid while still providing therapeutic benefits [3]

Core Viewpoint - Addex Therapeutics announced that its spin-out company, Neurosterix, has initiated a Phase 1 clinical study of NTX-253, a positive allosteric modulator for the treatment of schizophrenia, marking a significant milestone for both companies [1][2]. Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [4]. - The company retains a 20% equity interest in Neurosterix, which was spun out in April 2024 and raised $65 million in Series A financing [2][4]. Product Development - NTX-253 is a selective, orally available positive allosteric modulator of the muscarinic M4 receptor, designed to treat schizophrenia by potentially reducing psychosis symptoms without the side effects associated with traditional dopamine antagonists [1][3]. - Preclinical studies have shown that NTX-253 has robust antipsychotic-like activity and a favorable safety profile, supporting its advancement into first-in-human clinical studies [3]. Market Position - The M4 muscarinic receptor is recognized as a validated target for treating schizophrenia, offering a novel therapeutic approach compared to existing dopamine receptor antagonists [3]. - Current antipsychotics primarily target dopamine receptors, which can lead to metabolic, cognitive, and motor side effects, highlighting the potential advantages of M4 PAMs like NTX-253 [3].

Core Viewpoint - Addex Therapeutics has amended its At The Market Offering Agreement with H.C. Wainwright & Co. to allow for the sale of American Depositary Shares (ADSs) with an aggregate offering price of up to $3.3 million [1] Group 1: Offering Details - The amended ATM Agreement enables Addex to sell ADSs at its discretion through H.C. Wainwright & Co. [1] - H.C. Wainwright & Co. will sell the ADSs using methods permitted by law, including sales on The Nasdaq Capital Market [2] - The sales commission for H.C. Wainwright & Co. is set at three percent (3.0%) of the gross sales proceeds from any ADSs sold [2] Group 2: Company Background - Addex Therapeutics is focused on developing novel small molecule allosteric modulators for neurological disorders [5] - The lead drug candidate, dipraglurant, is being evaluated for brain injury recovery, including post-stroke and traumatic brain injury recovery [5] - Addex has partnerships for developing GABAB PAM drug candidates for substance use disorders and is advancing an independent GABAB PAM program for chronic cough [5] Group 3: Corporate Structure - Addex holds a 20% equity interest in Neurosterix US Holdings LLC, which is advancing allosteric modulator programs for various mental health disorders [5] - The company has also invested in Stalicla, a private Swiss company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [5] Group 4: Stock Information - Addex shares are listed on the SIX Swiss Exchange and NASDAQ Capital Market under the ticker symbol "ADXN" [6]

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 fair value of services from Neurosterix [16] - R&D expenses were CHF 0.2 million in Q3 2025, consistent with Q3 2024, mainly for the GABA-B PAM program [16] - G&A expenses were CHF 0.5 million in Q3 2025, stable compared to Q3 2024 [16] - 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][16] Business Line Data and Key Metrics Changes - The GABA-B PAM program has made excellent progress, with IND-enabling studies ready to start, subject to financing [6][12] - The Dipraglurant program for post-stroke recovery is being repositioned, with preparations for clinical studies underway [4][6] 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% [10][11] - The market for post-stroke recovery is growing, with over 100 million stroke survivors worldwide, increasing at an annual rate of 12 million [7] Company Strategy and Development Direction - The company is focused on advancing its GABA-B PAM program for chronic cough and Dipraglurant for post-stroke recovery, with plans to collaborate with Neurosterix and Lund University [4][6][18] - The company is evaluating potential indications for its mGluR2 PAM program and continuing to advance its portfolio towards clinical studies [18] Management's Comments on Operating Environment and Future Outlook - Management highlighted the challenges in the chronic cough market, noting that up to 50% of patients on current treatments are non-responders or discontinue due to side effects [24][25] - The company is optimistic about the potential of Dipraglurant and GABA-B PAMs, believing they can address unmet needs in their respective therapeutic areas [10][11][18] 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 [9] - Neurosterix is advancing its portfolio, including an M4 PAM program set to start phase one this year [18] Q&A Session Summary Question: Commercial outlook for chronic refractory cough - Management noted that Gefapixent is not performing well and that there is a significant unmet medical need in the cough market [23][24] 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 [26][28] Question: Competitive clinical development in post-stroke recovery - Management discussed the Camaris trial with Maraviroc and its potential learnings for Dipraglurant development [22][29] Question: Indivior collaboration and future catalysts - Indivior has completed IND-enabling studies and is preparing to move the program forward, with no further details available at this stage [31]

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]

Financial Performance - Revenue from contracts with customers for the three months ended September 30, 2025, was CHF 29,724, a decrease of 44.7% compared to CHF 53,837 for the same period in 2024 [6]. - Net loss for the nine months ended September 30, 2025, was CHF 4,891,259, compared to a net profit of CHF 8,261,523 for the same period in 2024, indicating a significant shift in financial performance [6]. - Operating loss for the three months ended September 30, 2025, was CHF 696,175, an increase of 11.9% from CHF 622,199 in the same period of 2024 [6]. - The company reported a basic and diluted loss per share of CHF 0.05 for the nine months ended September 30, 2025, compared to a profit of CHF 0.08 for the same period in 2024 [6]. - The company recorded a comprehensive loss of CHF 4,893,408 for the nine months ended September 30, 2025, compared to a comprehensive income of CHF 8,060,701 for the same period in 2024 [8]. - The Group's revenue for the nine months ended September 30, 2025, was CHF 157.03 million, a decrease of 61.6% compared to CHF 408.53 million for the same period in 2024 [50]. - The Group's finance result, net for the nine-month period ended September 30, 2025, was a loss of CHF 14,136, compared to a loss of CHF 4,222 in 2024, largely due to foreign exchange losses [89]. Assets and Liabilities - Total assets decreased to CHF 7,330,802 as of September 30, 2025, down from CHF 10,678,303 as of December 31, 2024, representing a decline of approximately 31.5% [4]. - Total current liabilities increased to CHF 1,174,899 as of September 30, 2025, compared to CHF 802,093 as of December 31, 2024, reflecting a rise of approximately 46.3% [4]. - Total equity decreased to CHF 5,958,555 as of September 30, 2025, down from CHF 9,677,271 as of December 31, 2024, a decline of approximately 38.1% [4]. - The balance as of September 30, 2025, decreased to CHF 5,958,555 from CHF 11,062,228 in the previous year [11]. - As of September 30, 2025, total payables, accruals, and other current liabilities increased to CHF 1,167,314, up from CHF 794,787 as of December 31, 2024, reflecting a significant rise in trade payables and accrued expenses [59]. Cash Flow and Investments - The company reported a net cash used in operating activities of CHF 1,551,751 for the nine months ended September 30, 2025 [20]. - Cash and cash equivalents at the end of the period were CHF 2,187,202, down from CHF 3,349,180 at the beginning of the period [20]. - The Group recognized a net gain of CHF 117,747 from the Neurosterix transaction during the nine-month period [20]. - The total cash and cash equivalents as of September 30, 2025, were CHF 2.19 million, down from CHF 3.34 million as of December 31, 2024, indicating a decrease of 34.4% [52]. - The Group's investment in Stalicla SA amounted to CHF 795,029, with the fair value of the unlisted securities remaining unchanged as of September 30, 2025 [98]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were CHF 618,842, down 21.6% from CHF 788,956 in the same period of 2024 [6]. - The Group's accrued research and development costs are a significant component of expenses, recorded based on estimated services provided but not yet invoiced [41]. - The Group's patent maintenance and registration costs for the nine-month period ended September 30, 2025, were CHF 178,952, down from CHF 215,730 in 2024 [84]. Shareholder and Management Information - The Group's total share capital as of September 30, 2025, included 146,476,085 outstanding shares, excluding 37,878,411 treasury shares [62]. - Key management compensation for the nine months ended September 30, 2025, totaled CHF 352,798, showing stability compared to CHF 373,961 in the same period of 2024 [106]. - The total compensation costs related to key management transferred to Neurosterix Group amounted to CHF 1.9 million for the nine-month period ended September 30, 2024 [107]. Discontinued Operations - The Group recognized a net gain of CHF 117,747 from discontinued operations during the nine-month period ended September 30, 2025, following a gain of CHF 13,959,500 in the same period of 2024 [91]. - For the nine months ended September 30, 2025, the net profit from discontinued operations was CHF 117,747, a significant decrease from CHF 11,981,034 in the same period of 2024 [94]. - The total disposal consideration from the Neurosterix transaction amounted to CHF 117,747 for the nine months ended September 30, 2025, compared to CHF 15,594,933 in 2024 [95].

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Core Insights - Addex Therapeutics reported its financial results for Q3 and YTD 2025, highlighting a focus on developing novel small molecule allosteric modulators for neurological disorders [1][4] Financial Performance - Income for Q3 2025 was CHF 50,000, a decrease of CHF 8,000 from Q3 2024, and year-to-date income was CHF 157,000, down CHF 251,000 compared to the same period in 2024 [3] - R&D expenses increased to CHF 228,000 in Q3 2025 from CHF 204,000 in Q3 2024, while year-to-date R&D expenses decreased to CHF 619,000 from CHF 789,000 [3][5] - G&A expenses for Q3 2025 were CHF 518,000, up from CHF 476,000 in Q3 2024, with year-to-date G&A expenses decreasing to CHF 1,573,000 from CHF 1,929,000 [3][6] - The total operating loss for Q3 2025 was CHF 696,000, compared to CHF 622,000 in Q3 2024, with a year-to-date total operating loss of CHF 2,035,000, an improvement from CHF 2,310,000 [3] - Net loss from continuing operations for Q3 2025 was CHF 1,577,000, slightly higher than CHF 1,528,000 in Q3 2024, while year-to-date net loss increased to CHF 5,009,000 from CHF 3,720,000 [3][8] - Basic and diluted net loss per share for the nine-month period was CHF 0.05, compared to a profit of CHF 0.08 in the same period of 2024 [9] Cash Position - Cash and cash equivalents decreased to CHF 2.2 million as of September 30, 2025, from CHF 3.3 million a year earlier, primarily due to operating activities [10] Corporate Developments - The company is advancing its GABAB positive allosteric modulator candidate for chronic cough and dipraglurant for post-stroke recovery [2][14] - Addex holds a 20% equity interest in Neurosterix US Holdings LLC, which is developing a portfolio of allosteric modulator programs [14]

Core Viewpoint - Addex Therapeutics will report its Q3 2025 financial results on December 4, 2025, and provide a business update along with a review of its product pipeline during a teleconference and webcast [1] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [3] - The lead drug candidate, dipraglurant, is being evaluated for brain injury recovery, including post-stroke and traumatic brain injury recovery [3] - Addex's partner, Indivior, is developing a GABAB PAM drug candidate for substance use disorders, having completed IND enabling studies [3] - The company is also advancing an independent GABAB PAM program for chronic cough [3] - Addex holds a 20% equity interest in Neurosterix LLC, which is developing allosteric modulator programs for schizophrenia, psychosis, mood-related disorders, and mood disorders [3] - Additionally, Addex has invested in Stalicla, a private Swiss company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [3] Financial Information - Addex shares are listed on the SIX Swiss Exchange and NASDAQ Capital Market under the ticker symbol "ADXN" [4]