Half Year 2026 Addex Therapeutics Ltd Earnings Call
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Speaker #1: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Tim Dyer, CEO of Addex Therapeutics.
Speaker #1: Please go ahead.
Speaker #2: Thank you. Hello, everyone. I'd like to thank you all for attending our Half-Year 2026 Financial Results conference call. I'm here with Misha Kalin, Chair and Head of Translational Science, who will provide an update on our R&D program.
Tim Dyer: Thank you. Hello, everyone. I would like to thank you all for attending our H1 2026 financial result conference call. I am here with Mikhail Kalinichev, our Head of Translational Science, who will provide an update on our R&D program. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimer. We will be making certain forward-looking statements that are based on the knowledge we have today. I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing our pipeline. I will then hand over to Misha, who will review our GABAB PAM programs for SUD and cough. I will then review our H1 2026 financial results. Following that, we will open the call for questions. Since our last update, we have seen several important achievements.
Speaker #2: I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimer.
Speaker #2: We will be making certain forward-looking statements that are based on the knowledge we have today. I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing our pipeline.
Speaker #2: I will then hand over to Misha, who will review our GatherBee PAM program for SUD and COF. I will then review our 2026 half-year financial results.
Speaker #2: Following that, we will open the call for questions. Since our last update, we have seen several important achievements. Firstly, we have strengthened the balance sheet with US dollar 2.8 million raised through our ATM facility, which provides us with cash runway into Q4 2027.
Tim Dyer: Firstly, we have strengthened the balance sheet with USD 2.8 million raised through our ATM facility, which provides us with cash runway into Q4 2027. We also regained rights to our GABAB PAM program, which we had previously licensed to Indivior. This is a significant value-creating event for Addex, which we will speak more about later in this presentation. As a reminder, we spun out our portfolio of preclinical neuropsych assets in 2024 to create Neurosterix, raised 65 million from a syndicate of investors led by Perceptive Advisors. We retained 20% equity interest in Neurosterix, the value of which is unfortunately not being properly reflected in our current share price, but we hope that will change. Neurosterix has made excellent progress in advancing its pipeline, including its lead drug candidate, NTX-253, a highly selective brain-penetrant M4 PAM for schizophrenia. We expect this program to complete phase I very soon.
Speaker #2: We also regained rights to our GatherBee PAM program, which we had previously licensed to Indivior. This is a significant value-creating event for Addex.
Speaker #2: Which we will speak more about later in this presentation. As a reminder, we spun out our portfolio of preclinical neuropsych assets in 2024 to create Neurosterics, which raised $65 million from a syndicate of investors led by Percepto Advisors.
Speaker #2: We retained 20% equity interest in neurosterics. The value of which is unfortunately not being properly reflected in our current share price, but we hope that will change.
Speaker #2: Neurosterics, as made excellent progress in advancing its pipeline, including its lead drug candidate NTX-253, a highly selective brain-penetrant M4 PAM for schizophrenia, we expect this program to complete phase one very soon.
Speaker #2: Now for a quick review of our pipeline. We continue to believe in diproglorant, and I've repositioned this proprietary mGlu5 negative allosteric modulator for brain injury recovery as a reminder.
Tim Dyer: Now for a quick review of our pipeline. We continue to believe in dipraglurant and have repositioned this proprietary mGlu5 negative allosteric modulator for brain injury recovery. As a reminder, in 2025 we entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of mGlu5 inhibitors in brain injury recovery, including stroke and traumatic brain injury. Included in the agreement is a research collaboration, under which we are working with Syntxis and the University of Lund to complete preclinical profiling of dipraglurant and prepare for clinical studies. As previously reported, we have regained the rights to ADX71149 from our partner, J&J, with a high-value data set and significant GMP material. We are currently evaluating a number of therapeutic indications for future development, and in parallel, we are discussing with potential partners for the asset.
Speaker #2: In 2025, we entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of Mglas5 inhibitors in brain injury recovery, including stroke and traumatic brain injury.
Speaker #2: Included in the agreement is a research collaboration, under which we are working with Syntaxis and the University of Lund to complete preclinical profiling of diproglorant and prepare the clinical studies.
Speaker #2: As previously reported, we have regained the rights to ADX-71149 from our partner, J&J, with a high-value dataset and significant GMP materials. We are currently evaluating a number of therapeutic indications for future development, and in parallel, we're discussing with potential partners for the asset.
Speaker #2: As already mentioned, we have recently regained all rights to the GatherBee PAM substance use disorder program from Indivior, and are now free to develop all drug candidates in any indication.
Tim Dyer: As already mentioned, we have recently regained all rights to the GABAB PAM substance use disorder program from Indivior and are now free to develop all drug candidates in any indication. We plan to continue the development of both the substance use disorder and the cough programs. The next milestone for the SUD program is the filing of an IND, and for the cough program, the start of IND-enabling studies. Also presented on this slide is the portfolio of our spin-out company, Neurosterix. We are expecting phase I data from NTX-253 program in Q4 this year. A backup M4 PAM, NTX-529, has been selected for IND-enabling studies, which should start shortly. The mGlu7 NAM program has selected NTX-819, a highly selective first-in-class compound, which has demonstrated robust preclinical anxiolytic and antidepressant-like activity, supporting its development as a potential next-generation therapy. We expect NTX-819 to complete IND-enabling studies in the coming months.
Speaker #2: We plan to continue the development of both the substance use disorder and the COF programs. The next milestone for the SUD program is the filing of an IMD and the for the COF program, the start of IMD enabling studies.
Speaker #2: Also presented on this slide is the portfolio of our spin-out company, Neurosterics. We're expecting Phase 1 data from the NTX-253 program in Q4 this year.
Speaker #2: A backup M4 PAM, NTX-529, has been selected for IMD enabling studies, which should start shortly. The Mglas7 NAM program has selected NTX-819, a highly selective first-in-class compound, which has demonstrated robust preclinical anxiolytic and antidepressant-like activity supporting its development as a potential next-generation therapy.
Speaker #2: We expect NTX-819 to complete IMD enabling studies in the coming months. Now let's speak about the GatherBee PAM platform. A bit of history for you.
Tim Dyer: Now let's speak about the GABAB PAM platform. A bit of history for you. We started this program 20 years ago with the idea that we could use positive allosteric modulation pharmacology approach and a novel chemistry effort to come with better baclofen compounds. Baclofen is a short-acting generic GABAB agonist, which is registered for the treatment of spasticity. However, it has been used to demonstrate the efficacy of GABAB activation in several disease areas such as SUD, cough, pain, overactive bladder, and neurodevelopmental disorders, amongst others. Therefore, in addition to our active programs in cough and substance use disorders, we plan to explore the development in some of these additional indications with potential partners. Now on to the termination of our agreement with Indivior.
Speaker #2: We started this program 20 years ago with the idea that we could use a positive allosteric modulation pharmacology approach and a novel chemistry effort to come up with better baclofen compounds.
Speaker #2: Baclofen is a short-acting generic GatherBee agonist, which is registered for the treatment of spasticity. However, it has been used to demonstrate the efficacy of GatherBee activation in several disease areas, such as SUD, COF, pain, overactive bladder, and neurodevelopmental disorders, amongst others.
Speaker #2: Therefore, in addition to our activity programs in COF and substance use disorders, we plan to explore development in some of these additional indications with potential partners.
Speaker #2: Now, on to the termination of our agreement with Indivior. As a reminder, we entered into a research collaboration license agreement with Indivior in 2018 and executed a funded research effort at Addex to deliver novel candidates.
Tim Dyer: As a reminder, we entered into a research collaboration license agreement with Indivior in 2018 and executed a funded research effort at Addex to deliver novel candidates. In late 2024, Indivior selected a drug candidate from the research and entered IND-enabling studies in 2025. As part of the collaboration, we received approximately $20 million in funding and the rights to select our own drug candidate for development in a restricted set of disease areas. Now that Indivior has terminated the license as part of their announced merger with Supernus, we are not only getting back the licensed drug candidate for SUD. We have full freedom to develop all other candidates. This gives Addex the broadest portfolio of drug candidates targeting GABAB PAM in the industry and the opportunity to pursue collaborations with industry partners.
Speaker #2: In late 2024, Indivior selected a drug candidate from the research and entered IMD-enabling studies in 2025. As part of the collaboration, we received approximately $20 million in funding and the rights to select our own drug candidate for development in a restricted set of disease areas.
Speaker #2: Now that Indivior has terminated the license as part of their announced merger with Supernus, we're not only getting back the licensed drug candidate for SUD, we have full freedom to develop all other candidates.
Speaker #2: This gives Addex the broadest portfolio of drug candidates targeting GatherBee PAM in the industry and the opportunities to pursue collaborations with industry partners. Now I will hand over to Misha who will give you some more details about the GatherBee PAM for SUD and chronic COF programs.
Tim Dyer: Now, I will hand over to Misha, who will give you some more details about the GABAB PAM for SUD and chronic cough programs.
Speaker #3: Thank you, Tim. Now, let me speak about why we are so excited about the opportunity of our GatherBee PAM substance use disorder program, starting with unmet medical need.
Mikhail Kalinichev: Thank you, Jim. Now, let me speak about why we are so excited about the opportunity of our GABAB PAM substance use disorder program. Starting with unmet medical need, SUD, which includes opioid, alcohol, cocaine, and other use disorders, is described as uncontrolled use of a substance despite its harmful consequences and is characterized by development of tolerance and withdrawal. There is high unmet medical need for treatment of SUD, as nearly 17% of the U.S. population is affected by this disorder, and nearly 90% of patients remain untreated. There is a limited selection of approved drugs for SUD, which includes methadone, buprenorphine, naltrexone, and acamprosate. Furthermore, there are no approved drugs for cocaine or psychostimulant use disorders. Novel approaches for pharmacotherapy of SUD include mGlu5 negative allosteric modulator, dipraglurant, mGlu2/3 positive allosteric modulators, kappa-opioid receptor antagonists, GLP-1 inhibitors, and ketamine. Why GABAB PAM?
Speaker #3: SUD, which includes opioid, alcohol, cocaine, and other use disorders, is described as uncontrolled use of a substance despite its harmful consequences. It is characterized by the development of tolerance and withdrawal.
Speaker #3: There is a high unmet medical need for treatment of SUD, as nearly 17% of the U.S. population is affected by this disorder, and nearly 90% of patients remain untreated.
Speaker #3: There is a limited selection of approved drugs for SUD, which includes methadone, buprenorphine, naltrexone, and acomposate. Furthermore, there are no approved drugs for cocaine or psychostimulant use disorders.
Speaker #3: Novel approaches for pharmacotherapy of SUD include Mglas5 negative allosteric modulator maboglorant, Mglu-23 positive allosteric modulators, kappa opioid receptor antagonists, GLP-1 inhibitors, and ketamine. So why GatherBee PAM?
Speaker #3: GABA-B receptor activation is a clinically validated target for SUD, as baclofen is used off-label for alcohol use disorders. Also, GABA-B PAM Addex attenuates alcohol self-administration and relapse in rats, and alcohol consumption in mice.
Mikhail Kalinichev: GABAB receptor activation is a clinically validated target for SUD, as baclofen is used off-label for alcohol use disorders. Also, GABAB PAM ADX71441 has shown to attenuate alcohol self-administration and relapse in rats and alcohol consumption in mice. Also, ADX71441 reduced cocaine self-administration in non-human primates. The mechanisms mediating anti-SUD effects of GABAB activation include reductions in firing of mesolimbic dopamine neurons, dopamine release in the nucleus accumbens, incentive reward value of the drug, and stress anxiety that leads to craving and ultimate relapse. The GABAB PAM drug candidate has successfully completed IND-enabling studies and is ready for IND filing and phase I clinical trials. Also, there are several differentiated leads and backup compounds, all with robust novel IP potential. Now, our GABAB PAM program for the treatment of chronic cough. There is strong rationale for developing GABAB PAMs for chronic cough.
Speaker #3: Also, Addex 71441 reduced cocaine self-administration in non-human primates. The mechanisms mediating anti-SUD effects of GatherBee activation include reductions in firing of mesolimbic dopamine neurons, dopamine release in the nucleus accumbens, incentive reward value of the drug, and stress and anxiety that lead to craving and ultimate relapse.
Speaker #3: The GatherBee PAM drug candidate has successfully completed IMD enabling studies and is ready for IMD filing and phase one clinical trials. Also, there are several differentiated leads and backup compounds, all with robust novel IP potential.
Speaker #3: Now, our GatherBee PAM program for the treatment of chronic COF. There is strong rationale for developing GatherBee PAMs for chronic COF. Chronic COF is a persistent COF that lasts for more and is caused by a variety of factors, including respiratory infections, asthma, allergies, and S3 flux, but also possibly by COF hypersensitivity syndrome.
Mikhail Kalinichev: Chronic cough is a persistent cough that lasts for more than 8 weeks and can be caused by a variety of factors, including respiratory infections, asthma, allergies, and acid reflux, but also possibly by cough hypersensitivity syndrome. There is a large unmet medical need in novel antitussive drugs, as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60% of patients. In addition, the current treatments carry risks of serious side effects. Support for using GABAB PAM in treatment of chronic cough comes from the clinical evidence that baclofen, a GABAB agonist, is used off-label in cough patients, and from the anatomical evidence that GABAB receptors are strongly expressed in airways and in the neuronal pathway regulating cough. Therefore, we believe that GABAB PAMs could offer superior efficacy in cough patients.
Speaker #3: There is a large unmet medical need for novel antitussive drugs, as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60% of patients.
Speaker #3: In addition, the current treatments carry risks of serious side effects. Support for using GatherBee PAM in the treatment of chronic COF comes from clinical evidence that baclofen and GatherBee agonists are used off-label in COF patients, and from anatomical evidence that GatherBee receptors are strongly expressed in airways and in the neuronal pathway regulating COF.
Speaker #3: Therefore, we believe that GatherBee PAMs could offer superior efficacy in COF patients. The pre-IMD activities, including in vivo proof of concept, known GLP tox, and CMC, have been completed, and our clinical candidate has shown favorable efficacy, tolerability, and developability profiles.
Mikhail Kalinichev: The pre-IND activities, including in vivo proof of concept, no GLP tox, and CMC have been completed, and our clinical candidate has shown favorable efficacy, tolerability, and developability profiles. Our clinical candidate has demonstrated a consistent minimum effective dose of 1 mg per kg and ED50 of 6 mg per kg in cough frequency in a guinea pig model of cough. No signs of tolerance were seen after subchronic dosing, and more than 60-fold safety margin was demonstrated based on respiratory depression as sedation biomarker. Recently, we confirmed that antitussive efficacy in the non-human primate, and are currently evaluating the compound in the rat. IND-enabling studies are planned and ready to start subject to securing finance. Now to the data.
Speaker #3: Our clinical candidate has demonstrated a consistent minimum effective dose of one mcpc and ED50 of six mcpc, in COF frequency, in a Guinea pig model of COF.
Speaker #3: No signs of tolerance were seen after subchronic dosing and more than 60-fold safety margin was demonstrated based on respiratory depression as sedation biomarker. Recently, we confirmed that antitussive efficacy in the non-human primate and our current and our currently evaluating the compound in the rabbit.
Speaker #3: IMD enabling studies are planned and ready to start, subject to securing financing. Now to the data: In the model of citric acid-induced COF in guinea pigs, acutely administered compound A delivered a robust antitussive efficacy, reducing the COF number dose-dependently and achieving 70% reductions at the maximal doses.
Mikhail Kalinichev: In the model of citric acid-induced cough in guinea pigs, acutely administered compound A delivered a robust antitussive efficacy, reducing the cough number dose dependently and achieving 70% reductions at the maximal doses. The antitussive profile of compound A was similar to that of nalbuphine, orvepitant, baclofen, and codeine. Now to cough latency. Compound A increased the latency to first cough dose dependently, thus delaying the onset of cough. The antitussive profile of compound A in delaying cough onset was similar or better than that of reference drugs. As a reminder, our objective in this program is to design a GABAB PAM with the efficacy of reference compounds, but without the CNS side effects such as sedation. In the same experiment where the compound A showed efficacy, we monitored respiratory rate, a biomarker of sedation.
Speaker #3: The antitussive profile of compound A was similar to that of Nalbufen, Orvepitant, Baclofen, and Cody. Now, to COF latency. Compound A increased the latency to first COF dose-dependently, thus delaying the onset of COF.
Speaker #3: The antitussive profile of compound A in delaying COF onset was similar to, or better than, that of reference drugs. As a reminder, our objective in this program is to design a GatherBee PAM with the efficacy of reference compounds but without the CNS side effects, such as sedation.
Speaker #3: In the same experiment where compound A showed efficacy, we monitored respiratory rate and biomarkers of sedation. As you can see from the slide, compound A was well tolerated, as there were no marked changes in respiratory rate at up to 60 mcpc.
Mikhail Kalinichev: As you can see from the slide, compound A was well-tolerated, as there were no marked changes in respiratory rate at up to 60 mg per kg. In contrast, nalbuphine, orvepitant, baclofen, and codeine resulted in robust reduction in respiratory rate at doses required to achieve maximal efficacy, indicative of sedative-like effects. When we evaluated the antitussive efficacy across compounds at the respective highest doses free from respiratory effects, compound A was shown to be superior to nalbuphine, orvepitant, baclofen, and codeine in both cough number and cough latency measures. In the model of ATP-potentiated citric acid cough in guinea pigs, in a head-to-head comparison experiment, acutely administered compound A and the P2X3 inhibitor had similar efficacy and tolerability profiles.
Speaker #3: In contrast, Nalbufen, Orvepitant, Baclofen, and Codeine resulted in a robust reduction in respiratory rate at doses required to achieve maximal efficacy, indicative of sedative-like effects.
Speaker #3: When we evaluated the antitussive efficacy across compounds, at their respective highest doses, free from respiratory effects, Compound A was shown to be superior to nalbufen, orvepitant, baclofen, and codeine.
Speaker #3: In both COF number and COF latency measures. In the model of ATP potentiated citric acid COF in Guinea pigs, in a head-to-head comparison experiment, acutely administered compound A and the P2X3 inhibitor had similar efficacy and tolerability profiles.
Speaker #3: As a reminder, P2X3 inhibitors are antitussive activities peripherally mediated, which explains their lack of sedative activity, but also the reason more than 30% of COF patients do not respond to treatment.
Mikhail Kalinichev: As a reminder, P2X3 inhibitors are antitussive activities peripherally mediated, which explains their lack of sedative activity, but also the reason more than 30% of cough patients do not respond to treatment. In the citric acid-induced cough model, subchronic administration of compound A for seven days showed no signs of tolerance, neither in cough frequency nor in latency to first cough. There were no changes in the respiratory rate, body temperature, and growth hormone release in animals treated subchronically with compound A. Compound A was also assessed in the IPF-related exacerbated chronic cough model in guinea pigs. Here is the study design. On day zero, animals received a single oropharyngeal administration of bleomycin or were left intact. Bleomycin-exposed animals were then treated with compound A at 10 mg per kg or vehicle orally once daily for 28 days. Intact animals received vehicle.
Speaker #3: In the citric acid-induced COF model, subchronic administration of compound A for seven days showed no signs of tolerance, neither in COF frequency nor in latency to first COF.
Speaker #3: Also, there were no changes in the respiratory rate, body temperature, and gross hormone release in animals treated subchronically with compound A. Compound A was also assessed in the IPF-related, exacerbated chronic COF model in guinea pigs.
Speaker #3: Here is the study design. On day zero, animals received a single oropharyngeal administration of leomycin, or were left intact. Leomycin exposed animals were then treated with compound A at 10 mcpc or vehicle, orally once daily for 28 days.
Speaker #3: Intact animals received vehicle. On days 7, 14, 21, and 28, animals were exposed to low concentration of citric acid to stimulate COF. On day 28, at the end of the experiment, lung tissue was collected for histopathological analysis.
Mikhail Kalinichev: On days 7, 14, 21, and 28, animals were exposed to low concentration of citric acid to stimulate cough. On day 28, at the end of the experiment, lung tissue was collected for histopathological analysis. The total number of coughs was significantly higher in bleomycin-exposed vehicle-treated animals than in healthy control. The difference between the groups grew progressively larger over time, indicative of exacerbated cough in IPF-like condition. Chronic treatment with compound A resulted in robust and enduring reduction in the number of coughs, with 40% to 60% reduction magnitudes. The latency to first cough showed significant reduction in bleomycin exposed vehicle treated animals versus intact controls starting day 14. Chronic treatment with compound A reversed the effect of bleomycin throughout the testing period, returning the latencies to the levels of intact control animals.
Speaker #3: The total number of COFs was significantly higher in leomycin-exposed vehicle-treated animals than in healthy controls. The difference between the groups grew progressively larger over time, indicative of exacerbated COF in IPF-like condition.
Speaker #3: Chronic treatment with compound A resulted in robust and enduring reductions in the number of COFs, with a 40–60% reduction magnitude. The latency to first COF showed significant reductions in bleomycin-exposed, vehicle-treated animals versus intact controls, starting on day 14.
Speaker #3: Chronic treatment with compound A reversed the effect of leomycin throughout the testing period, returning the latencies to the levels of intact control animals. A histopathology analysis of the lung tissue collected on day 28 revealed that chronic administration of compound A was associated with markedly lower Ashcroft scores and a lower percentage of affected lung in comparison to leomycin-exposed, vehicle-treated animals.
Mikhail Kalinichev: A histopathology analysis of the lung tissue collected on day 28 revealed that chronic administration of compound A was associated with markedly lower Ashcroft scores and lower percentage of affected lung in comparison to bleomycin exposed vehicle treated animals. This suggests that compound A, administered over 28 days, reduced lung fibrosis. Now to the non-human primate data. Similar to what we saw in the guinea pig, in the model of citric acid induced cough in non-human primates, compound A demonstrated a more than 60% reduction in number of coughs at 2 mgs per kg. In summary, we have selected a clinical candidate for chronic cough with a robust, reproducible antitussive efficacy at 1 mg per kg and good PK/PD. The compound showed a favorable developability profile in non-GLP tox studies performed in rats, dogs and non-human primates.
Speaker #3: This suggests that compound A administered over 28 days reduced lung fibrosis. Now, moving to the non-human primate data—similar to what we saw in the guinea pig—in the model of citric acid-induced COF in non-human primates, compound A demonstrated more than a 60% reduction in number of COFs at 2 mcpc.
Speaker #3: In summary, we have selected a clinical candidate for chronic COF with robust, reproducible antitussive efficacy at 1 mcpc and good PK/PD. The compound showed a favorable developability profile in non-GLP-2 studies performed in rats, dogs, and nonhuman primates.
Speaker #3: The compound has the potential to have the best-in-disease efficacy and tolerability profile, as well as broad application in chronic COF patients. Subject to raising financing, we are ready to start the IND-enabling study.
Mikhail Kalinichev: The compound has the potential to have the best in disease efficacy and tolerability profile and broad application in chronic cough patients. Subject to raising financing, we are ready to start the IND-enabling studies. This concludes our prepared remarks on the progress of our R&D program. Now I hand it back to Tim.
Speaker #3: This concludes our prepared remarks on the progress of our R&D program. Now I hand it back to Tim.
Speaker #1: Thank you, Misha. Now for a review of our 2026 half-year results. Starting with the income statement, the operating loss amounted to $1.1 million in H1, compared to $1.3 million in H1 of 2025. The decrease of $0.2 million between both periods is primarily due to reduced outsourced R&D on our GABA-B PAM program.
Tim Dyer: Thank you, Misha. Now for a view of our 2026 H1 results. Starting with the income statement, the operating loss amounted to CHF 1.1 million in H1 compared to CHF 1.3 million in H1 of 2025. The decrease of CHF 0.2 million between both periods is primarily due to reduced outsourced R&D on our GABAB PAM program. As a reminder, on 2 April 2024, we received an equity interest of 20% in Neurosterix US Holdings LLC as part of the Neurosterix spin-out transaction. Under IFRS, we are required to account for the investment using the equity method of accounting and recognize our share of their results in our income statement. For the six-month period ended 30 June 2026, our share of net loss of Neurosterix amounted to CHF 2.3 million compared to CHF 2.1 million for the six-month period ended 30 June 2025.
Speaker #1: As a reminder, on April 2, 2024, we received an equity interest of 20% in Eurasterics, US Holdings, LLC, as part of the Eurasterics spin-out transaction.
Speaker #1: Under IFRS, we are required to account for the investment using the equity method of accounting and recognize our share of their results in our income statement.
Speaker #1: For the six-month period ended June 30, 2026, our share of net loss of Eurasterics amounted to $2.3 million, compared to $2.1 million for the six-month period ended June 30, 2025.
Speaker #1: The net loss remained stable at around $3.4 million in both H1 2026 and H1 2025. Now, moving to the balance sheet: we completed H1 2026 with $0.8 million in cash held in Swiss francs and U.S. dollars, compared to $1.6 million as of December 31, 2026.
Tim Dyer: The net loss remained stable around CHF 3.4 million in both H1 of 2026 and H1 of 2025. Now to the balance sheet. We completed H1 2026 with CHF 0.8 million cash held in Swiss francs and US dollars compared to CHF 1.6 million as of 31 December 2026. The decrease of CHF 0.8 million is primarily due to operating costs, partially offset by the sale of treasury ADSs. Other current assets amounted to CHF 0.3 million as of 30 June, primarily related to prepaid retirement benefits and D&O insurance annually paid at the beginning of the year. Our non-current assets of CHF 2.4 million as of 30 June primarily relate to our investment in Neurosterix, accounted for using the equity method, and to a lesser extent, our investment in Stalicla.
Speaker #1: The decrease of $0.8 million is primarily due to operating costs, partially offset by the sale of treasury ADSs. Other current assets amounted to $0.3 million as of June 30, primarily related to prepaid retirement benefits and DNO insurance, annually paid at the beginning of the year.
Speaker #1: Our non-current assets of $2.4 million as of June 30, primarily relate to our investment in Eurasterics accounted for using the equity method and to a lesser extent our investment in spelling club.
Speaker #1: Current liabilities increased by 0.2 million to $1.4 million. At the end of June 2026, compared to December 31, 2025, and primarily relate to accruals and payables from outsourced R&D and professional service activities.
Tim Dyer: Current liabilities increased by CHF 0.2 million to CHF 1.4 million at the end of June 2026, compared to 31 December 2025, and primarily relate to accruals and payables from outsourced R&D and professional service activities. Non-current liabilities primarily relate to the retirement benefit obligations calculated in accordance with IAS 19, and amount to CHF 0.2 million at the end of June 2026, compared to CHF 0.4 million at the end of December 2025. Now to the cash flow statement. We started the year with CHF 1.6 million. During the six-month period, we used CHF 1.2 million operations primarily, and we received CHF 0.4 million from the sale of treasury ADSs, resulting in a balance sheet at the end of balancing cash at the end of the period of CHF 0.8 million.
Speaker #1: Non-current liabilities primarily relate to the retirement benefit obligations calculated in accordance with IAS 19 and amount to €0.2 million at the end of June 2026, compared to €0.4 million at the end of December 2025.
Speaker #1: Now to the cash flow statement. We started the year with $1.6 million during the six-month period. We used $1.2 million operations, primarily and we received 0.4 million from the sale of treasury ADSs, resulting in a balance sheet at the end of balance sheet cash at the end of period of 0.8 million.
Speaker #1: I'd like to highlight that we successfully raised $2.8 million in Q3 through our ATM facility and now have a cash runway through into Q4 of 2027.
Tim Dyer: I would like to highlight that we successfully raised $2.8 million in Q3 through our ATM facility and now have a cash runway through into Q4 of 2027. To summarize, our spin-out company, Neurosterix, continues to advance its portfolio with their M4 PAM program on track to complete phase I in Q4. Stalicla is working closely with NIDA to advance its phase III program, mavoglurant, into phase III for cocaine use disorders. We have regained all rights to our GABAB PAM platform, providing multiple programs with a focus on SUD and chronic cough. We continue to prepare the grant for phase II in post-stroke recovery in collaboration with Lund University. We are looking forward to completing the evaluation of potential indications for our mGlu2 PAM program and securing the financial resources to advance our portfolio into clinical studies. This concludes the presentation, and we will now open the call for questions.
Speaker #1: So, to summarize, our spin-out company in Eurasterics continues to advance its portfolio, with their M4 PAM program on track to complete Phase One in Q4.
Speaker #1: Stellicular is working closely with NIDA to advance its Phase 3 program, Maviglon, for cocaine use disorders. We've regained all rights to our GABA-B PAM platform, providing multiple programs with a focus on SUD and chronic cough.
Speaker #1: We continue to repair dipoglon for phase two in post-stroke recovery, in collaboration with the Lund University. We are looking forward to completing the evaluation of potential indications for our Emglu R2 PAM program and securing the financial resources to advance our portfolio into clinical studies.
Speaker #1: This concludes the presentation, and we will now open the call for questions.
Speaker #2: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone, and wait for your name to be announced.
Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. If you wish to ask a question via the webcast, please type it into the box and click submit. We will now go to our first question. One moment please. Our first question today comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co. Please go ahead.
Speaker #2: To withdraw your question, please press star 1, and then 1 again. If you wish to ask a question via the webcast, please type it into the box and click submit.
Speaker #2: You will now go to our first question. One moment, please. And our first question today. Comes from the line of Raghu Ram Savuraju from HC Wainwright & Co.
Speaker #2: Please go ahead.
Speaker #1: Thanks so much for taking our questions. Can you please comment on the patent expiration with respect to the composition of matter patent claims? As these refer to the compound portfolio that you have reobtained rights to DVR.
Raghuram Selvaraju: Thanks so much for taking our questions. Can you please comment on the patent expiration with respect to the composition of matter patent claims, as these refer to the compound portfolio that you have reobtained rights to Indivior?
Speaker #3: Hello, Ram, and thanks very much for the question. We filed five patents in the GABA-B PAM program in 2024, and they are progressing toward being granted.
Tim Dyer: Hello, Ram, and thanks very much for the question. We filed five patents in the GABAB PAM program in 2024, and they are progressing towards being granted. Two of them had been licensed to Indivior, and two of them have come back, and the other three were never covered by the license. We have five very young patents. The compound of Indivior sits within one of them. The other compound, which has a differentiated profile, which we are developing for the cough indication, is sitting in one of the other patents, and there are other clinical candidates sitting in separate patents.
Speaker #3: Two of them had been licensed to Indivior, and two of them have come back, and the other three were never covered by the license.
Speaker #3: So, we have five very young patents. The compound of Indivior sits within one of them. The other compound, which has a differentiated profile and which we're developing for the cough indication, is sitting in one of the other patents. There are other clinical candidates sitting in separate patents.
Speaker #1: So if these were to be granted, what do you expect as likely to be the expiration date time frame?
Raghuram Selvaraju: If these were to be granted, what do you expect is likely to be the expiration date timeframe?
Speaker #3: 44, 2044.
Tim Dyer: 2044.
Speaker #1: And can you give us any insight as to how the overall patent portfolio pertaining to these compounds that you received back from Indivior has developed during the period of the Indivior collaboration?
Raghuram Selvaraju: Can you give us any insight as to how the overall patent portfolio pertaining to these compounds that you received back from Indivior has developed during the period of the Indivior collaboration? Were any additional patent claims or discoveries that were deemed patentable occur during the time of the collaboration?
Speaker #1: Were any additional patent claims or discoveries that were deemed patentable occur during the time of the collaboration?
Speaker #3: Yeah. So, the collaboration—I think it's important to understand that the collaboration with Indivior involved all the chemistry and biology being done at Addex.
Tim Dyer: Yeah. I think it is important to understand that the collaboration with Indivior involved all the chemistry and biology being done at Addex. So it was Addex that actually filed all the patents, and it is Addex that has been managing the patents, prosecuting them. None of the patents were actually joint patents. None of them were in the hands of Indivior. It was a pure license, and that license has been terminated. They are all NCE patents. I think there might have been a few additional claims that were added, but they were pretty straightforward NCE patents.
Speaker #3: So it was Addex that actually filed all the patents, and it's Addex that has been managing the patents, prosecuting them. None of the patents were actually joint patents.
Speaker #3: None of them were in the hands of Indivior. It was a pure license, and that license has been terminated. And so and they're all sorry, they're all NCE patents.
Speaker #3: And I think there were some—I mean, there might have been a few additional claims that were added, but I mean, they were pretty straightforward NCE patents.
Speaker #1: And then, lastly, I was wondering if you could comment—strategically speaking—if you would consider the possibility of spinning out the portfolio that originally was the subject of the Indivior collaboration into a separate company, somewhat in the same vein as Neurosterics, or if you are seeking to unlock value purely through a licensing arrangement.
Raghuram Selvaraju: Lastly, I was wondering if you could comment on, strategically speaking, if you would consider the possibility of spinning out the portfolio that originally was the subject of the Indivior collaboration into a separate company, somewhat in the same vein as Neurosterix, or if you are seeking to unlock value purely through a licensing arrangement.
Speaker #3: Yeah. So with the research collaboration that evolved with Indivior, I remember we were funded by Indivior. We did a huge amount of medicinal chemistry. We identified several scaffolds. I mean, we put forward, I think if I remember correctly, more than five clinical candidates.
Tim Dyer: Yeah. As the research collaboration evolved with Indivior, remember we were funded by Indivior. We did a huge amount of medicinal chemistry. We identified several scaffolds. We put forward, I think if I remember correctly, more than five clinical candidates. They got profiled. We had candidates ranging from fully peripheral compounds to highly potent brain penetrant compounds. One of the biggest challenges with baclofen and GABAB, it is around therapeutic margin. One of the things that we discovered through the R&D effort is that if you have a very potent compound that floods the brain, you have a baclofen-like profile. So you have wonderful efficacy, but you have no therapeutic margin when it comes to sedation and somnolence. We worked intensively to find compounds that went to the brain and had central effects but had therapeutic margin.
Speaker #3: They got profiled. We had candidates ranging from fully peripheral compounds to highly potent brain-penetrant compounds. And one of the biggest challenges with Baclofen and GABA-B, it's around therapeutic margin.
Speaker #3: So one of the things that we discovered through the R&D effort is that if you have a very, very potent compound that floods the brain, you have a Baclofen-like profile.
Speaker #3: So you end up with, no—you have wonderful efficacy, but you have no therapeutic margin when it comes to sedation and somnolence. And so we worked intensively to find compounds that went to the brain and had central effects, but had a therapeutic margin.
Speaker #3: And in the end, we ended up with two compounds. One of them was slightly more central and went a little bit more to the forebrain, and this was the compound that was selected by Indivior.
Tim Dyer: In the end, we ended up with two compounds. One of them was slightly more central, and went a little bit more to the forebrain, and this was the compound that was selected by Indivior. This was extensively profiled by Indivior in alcohol use disorders. They did a lot of non-GLP tox. Then they did the IND-enabling GLP tox studies, and the compound successfully came out. That is a compound that has now come back to us, and it is ready to go and file an IND. We selected a compound that went to the brain, stayed in the brain, but didn't flood the forebrain. Therefore, we noticed an even better 60-fold therapeutic margin. This is the compound we are taking forward in cough. We have a number of other candidates which are at the clinical candidate stage, and they are ready to be advanced in other areas.
Speaker #3: And this was extensively profiled by Indivior in alcohol use disorders. They did a lot of, I mean, non-GLP talks; then they did the IMD-enabling GLP talk studies.
Speaker #3: And the compound successfully came out, and that's a compound that has now come back to us. And it's ready to go and file an IMD.
Speaker #3: We selected a compound that was less went to the brain, stayed in the brain, but didn't flood the forebrain. And therefore, we noticed an even better 60-fold therapeutic margin and this is the compound we're taking forward in cough.
Speaker #3: We have a number of other candidates which are at the clinical candidate stage, and they are ready to be advanced in other areas. We have some that are shorter-acting; we have some that have less therapeutic margin.
Tim Dyer: We have some that are shorter acting. We have some that have less therapeutic margin. You could speculate, for example, that a shorter acting 4 or 5-hour half-life compound that had a bit of sedation could be used in narcolepsy. You could also consider a fully peripherally restricted compound being used in a number of dermatological indications or overactive bladder. Then, of course, you've got the study that was done by Roche in Fragile X with r-baclofen, where there was a subgroup within the patient population that did respond to r-baclofen. Neurodevelopmental disorders is also another very interesting area that we could pursue with a central compound. So at the moment, the answer to your question is that we are going to pursue discussions with potential partners. We have the experience of the Neurosterix spin-out.
Speaker #3: And I mean, you could speculate, for example, that a shorter-acting, sort of four- or five-hour half-life compound that had a bit of sedation could be used in narcolepsy.
Speaker #3: You could also you could also consider a fully peripherally restricted compound being used in a number of dermatological indications. Or overactive bladder. And then, of course, you've got the study that was done by Roche in fragile X with R-Baclofen.
Speaker #3: There was a subgroup within the patient population that did respond to R-Baclofen. So, neurodevelopmental disorders is also another very interesting area.
Speaker #3: But we could pursue with a central compound. So, at the moment, the answer to your question is that we are not. We are going to pursue discussions with potential partners.
Speaker #3: We have the experience of the Neurosterics spin-out. So, of course, we are also having discussions with investors about a potential spin-out. But ultimately, we're pursuing a number of avenues to secure the capital to drive the programs forward.
Tim Dyer: Of course, we are also looking at having discussions with investors about a potential spin-out. Ultimately, we're pursuing a number of avenues to basically secure the capital to drive the program forward.
Speaker #1: Thank you.
Raghuram Selvaraju: Thank you.
Speaker #2: Thank you. As a reminder, if you wish to ask a question, please press star one one on your telephone keypad. That is star one one to ask a question.
Operator: Thank you. As a reminder, if you wish to ask a question, please press star 1 and 1 on your telephone keypad. That is star 1 and 1 to ask a question. If you wish to ask a question via the webcast, please type it into the box and click submit. Thank you, ladies and gentlemen. This brings the main part of the conference to a close. Now I would like to hand back to Tim Dyer for the closing remarks.
Speaker #2: If you wish to ask a question via the webcast, please type it into the box and click Submit. Thank you, ladies and gentlemen. This brings the main part of the conference to a close.
Speaker #2: And I would like to hand back to Tim Dyer for the closing remarks.
Speaker #3: Well, thank you, everyone, for attending this 2026 Half-Year Conference Call. We very much look forward to speaking to you again soon.
Tim Dyer: Well, thank you everyone for attending this 2026 H2 conference call. We very much look forward to speaking to you again soon.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
