Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, December 11, 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 announced that it has amended its At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright & Co.”) initially entered into on January 30, 2024. The at-the-market offering program en ...

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]

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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]

Core Points - Addex Therapeutics has issued 34,300,000 new registered shares at a nominal value of CHF 0.01, fully subscribed by its wholly-owned subsidiary, Addex Pharma S.A, to enhance future financing flexibility [1] - The total issued share capital has increased to CHF 2,186,544.96, with a total of 218,654,496 shares issued, while the number of outstanding shares remains unchanged [1] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [2] - The lead drug candidate, dipraglurant, is being evaluated for brain injury recovery, including post-stroke and traumatic brain injury recovery [2] - Addex has partnered with Indivior for a GABAB PAM drug candidate aimed at substance use disorders, which has completed IND enabling studies [2] - The company is also advancing an independent GABAB PAM program for chronic cough and holds a 20% equity interest in Neurosterix LLC, which is developing allosteric modulator programs for various neurological conditions [2] - Additionally, Addex has invested in Stalicla, a private Swiss company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [2] Stock Information - Addex shares are listed on the SIX Swiss Exchange and NASDAQ under the ticker symbol "ADXN" [3]

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]

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]