Addex Therapeutics (NASDAQ:ADXN) held its fourth-quarter earnings conference call on Thursday. Below is the complete transcript from the call.

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The full earnings call is available at https://edge.media-server.com/mmc/p/g7c769im

Summary

Addex Therapeutics reported several achievements in 2025, including progress in the GABA B PAM Chronic Cough program, with successful preclinical results and efforts to secure funding for IND enabling studies.

The company has repositioned diproglurant for brain injury recovery and entered an agreement for exclusive licensing of intellectual property in this area, collaborating with Syntaxis and the University of Lund.

Following the termination of a partnership with J&J on ADX 71149, Addex Therapeutics regained the rights and is evaluating future development opportunities.

The company completed 2025 with 1.6 million Swiss francs in cash, providing runway through mid-2026, but highlighted the need for additional funding to advance unpartnered programs.

Revenue decreased to 0.2 million in 2025 from 0.4 million in 2024, due to the completion of a funded research phase with Indivior.

Full Transcript

Tim Dyer

Thank you. Hello everyone. I would like to thank you all for attending our 2025 full year financial results conference call. I'm here with Misha Kalinichev, our Head of Translational Science who will provide an update on our R and D programmes. 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 in More detail our mGluR5 Negative Allosteric Modulator Program for Brain Injury Recovery and the GABAB Positive Allosteric Modulator Preclinical Program for Cough. I will then review our 2025 full year financial results. Following that we will open the call for Q&A. So 2025 has seen several important achievements across our pipeline. We made excellent progress in our GABAB PAM Chronic Cough program as we continue to complete preclinical characterization of our selected compound. We recently announced robust antitrusive activity in a non human primate chronic cough model as well as solid antitrusive activity in an IPF model in guinea pigs. These data further demonstrate the potential of our selected compound in this important unmet medical need. In parallel to completing the pre clinical profiling, we are working to secure funding to advance the program into the IND enabling studies. Misha will be sharing some of the data with you later in our presentation. We've also repositioned diproglurant our MGLAR5NAM for brain injury recovery and have made good progress in preparing the program for clinical studies in post stroke recovery patients. In 2025 we entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of MGLR5 inhibitors in the brain injury recovery, including stroke and traumatic brain injury. Included in the agreement is a research collaboration under which we are working with Syntaxis and the University of Lund to complete pre clinical profiling dipraglurant and are preparing for clinical studies. Misha will also talk more about this program later in the presentation. So following the decision by our partner J and J to terminate development of ADX 71149 we have regained the rights to this phase two asset with a high value data set and significant materials. We're currently evaluating a number of therapeutic indications for future development and in parallel we are discussing with potential partners for the asset. Our partner Indivior has selected a compound for development in substance use disorders and has completed IND enabling studies. As a reminder, under the terms of the agreement, Alex is eligible for payment of up to US$330 million on successful achievement of pre specified regulatory, clinical and commercial milestones as well as tiered royalties on the level of net sales from high single digits up to low double digits. In June of 2025 we invested in Stalicla, a private clinical stage neurodevelopmental disorder focused company. Stalicla has developed a proprietary precision medicine patient stratification technology platform which allows the company to select patients based on their biological dysregulation rather than behavioural phenotype. Proof of concept of the platform has been demonstrated by applying the technologies to identify and develop drugs in subpopulations of patients suffering from autism spectrum disorder. Stalicla has made excellent progress in advancing its patient stratification study in autism and preparing its lead asset for a phase three study in cocaine use disorders. We completed the year with 1.6 million Swiss francs of cash which provides us with cash Runway through mid-2026. I'd like to highlight that the cash burn has been significantly reduced following the nearest Derrick spin out transaction. However, current cash does not fund the progression of our unpartnered programs into the clinic. Now for a quick review of our pipeline. We continue to believe in diproglurant and are executing our plans to reposition the development for brain injury recovery and in particular post stroke recovery. As mentioned, our partner in Devilla has selected a Gabab PAM drug candidate for development in substance use disorders and completed IND enabling studies. We are advancing an independent gababam program for chronic cough and expect to start IND enabling studies. This year, subject to securing financial backing for the program. As a reminder, we spun out our portfolio of neuropsychiatric assets in 2024 to create Neurosterics and raise 65 million from a syndicate of investors led by Perceptive Advisors Advisors we retained a 20% equity interest in NeuroSD has made excellent progress in advancing its pipeline in 2025, including starting phase one studies with NTX 253, its M4 positive allocate modulator program, and we are expecting phase one to be completed this quarter. Now I will hand over to Misha who will give you some more details about our exciting portfolio.

Misha Kalinichev (Head of Translational Science)

Thanks, Tim hello everyone. I will start by speaking about dipraglurant and our plans for development in brain injury recovery. Dipraglurant is an orally available, highly selective mGluR5 negative allostatic modulator which we believe could improve the outcome of rehabilitation for patients suffering from traumatic brain injury or stroke. The mechanism of action of dipreglirant targets neuroplasticity early in rehabilitation to promote building of neuronal connections and sensorimotor recovery. There is a large unmet medical need in post stroke recovery and rehabilitation. Stroke is among leading causes of chronic, often lifelong disability as it leads to motor sensory cognitive impairment and multiple comorbidities. There are over 100 million stroke survivors worldwide and the number is growing at the annual rate of 12 million. A variety of rehabilitation therapies are used with post stroke patients but the recovery is slow and often inadequate. There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation therapies. MGLU5 receptor is a suitable target to address post stroke recovery as it is densely expressed in the brain, involved in neuroplasticity and modulates excitatory inhibitory equilibrium. In fact, activation of MGL5 has been observed in a range of neurological disorders including stroke where it plays a role of so called maladaptive rewiring of the brain following stroke. Inhibition of mGluR5, on the other hand, can facilitate adaptive rewiring of the brain promoting neuroplasticity and creating of new functional pathways moving the neural network towards a pre lesion state. Exciting new evidence recently published in the journal Brain suggests that the negative allosteric modulator of MGLU5MTAP administered daily in RADs following stroke results in a sustained and growing improvement in sensorimotor function in comparison to vehicle treatment. Similar improvement in sensory motor function was observed in animals treated with our MGL5 NAM dipraglurant MRI imaging of the resting state, functional connectivity in post stroke rodents shows that daily administration of MTAP also stimulates intra and interhemispheric connectivity in the brain disrupted by stroke. It is important to note that improvement in brain connectivity after stroke is known to correlate with functional recovery and is observed across species. Depraglurant is ideally suited to be used in tandem with rehabilitation therapies in post stroke patients as it has a fast onset of action and short half life. It has shown good tolerability in healthy subjects and in Parkinsonian patients showing only mild to moderate CNS related adverse effects. We have a drug product ready and a strong patent position and believe dipraglurant can become a first in class drug to facilitate post stroke recovery. We can also speculate that the Prabhag mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury patients. As part of our agreement with Indivior, ADEX has exercised its right to select a compound to advance its own independent GABAB PAM program for the treatment of chronic cough. I will now present this exciting opportunity. There is a strong rationale for developing gabab pams for chronic cough. Chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors including respiratory infections, asthma, allergies and acid reflux, but also possibly by a cough hypersensitivity syndrome. There is a large unmet medical need in novel anti use of drugs as current standards of care are ineffective in 30% of patients or only moderately effective in up to 60% of patients. In addition, the current treatments carry risks of serious side effects. Support for using GABAB PAMs in treatment 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. The pre IND activities including in vivo proof of concept, non GLP talks 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 1mg per kg and ED50 of 6mg per kg in CO frequency in guinea pigs. No signs of tolerance were seen after sub chronic dosing and more than 60 fold safety margin was demonstrated based on respiratory depression and sedation biomarker. Recently we also confirmed the antitussive efficacy of compound 1a in the non human primates. The I D enabling studies are planned and ready to start subject to receiving funding. 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 nalbufin or or vapitant baclofen and codeine. Compound A increased the latency to first cough dose dependently thus delaying the onset of cough. The anti GC profile of compound A in delaying cough onset was similar or better than that of reference drugs in the same experiment. Compound A appeared well tolerated as there were no marked changes in respiratory rate at up to 60mg per kg. In contrast, Nalbufin or repetant baclofen and codeine resulted in robust reductions in respiratory rate at their highest doses indicative of sedative like effects. When evaluation of the antitrusive efficacy across compounds was done at the respective the highest doses free from respiratory effects, compound A was shown to be superior to nalbufin or repetent 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. 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. Also, there were no changes in the respiratory rate, body temperature and growth hormone release in animals treated subchronically with compound A. In the model of IPF related exacerbated chronic cough in guinea pigs on day zero animals received a single oropharyngeal administration of bleomycin or were left intact. Bleomycin exposed animals were then treated with compound A10XK or or vehicle orally once daily for 28 days. Intact animals received only ve go. 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 the lung tissue was collected for histopathological analysis. The total number of coughs was significantly higher in bleomycin exposed vehicle treated animals than in healthy controls. 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 reductions in in the number of coughs with 40 to 60% efficacy. The latency to first cough showed significant reductions 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 of intact control animals. A histopathological analysis of the lung tissue collected on day 28 revealed that chronic administration of compound A was associated with markedly lower Ashgrove scores and lower percentage of affected lung in comparison to bleomycin exposed vehicle treated animals. In the model of citric acid induced cough in non human primates, compound A had no effect on the number of coughs at 0.6 and 1 while producing significant and more than 60% reductions at 2mg per kg. In summary, we have selected a clinical candidate for chronic cough with a robust reproducible antitrusive efficacy of 1 nic per kg and good PKPD. The compound showed a favorable developability profile in non GLP tox studies performed in rats, dogs and non human primates. The compound has a potential to have the best disease efficacy and tolerability profile and broad application in cough patients. The compound showed a favorable developability profile in non GLP tox studies performed in rats, dogs and non human primates subject to raising financing we are ready to start the IND enabling studies. This concludes our prepared remarks on the progress of our R and D programs. Now I hand it back to Tim.

Tim Dyer

We recognized 0.2 million of income in 2025 compared to 0.4 million in 2024. The decrease is primarily due to the completion of the funded research phase of our collaboration with NDIVIOR in June of 2024. This has been partially offset by the fair value of the services received from Neurosterics R&D expenses. Sorry, R and D expenses of 0.7 million primarily related to our GABAB PAM program and decreased by 0.2 million in 2025 compared to 2024 mainly due to the completion of the research phase of our collaboration with Indivior GNA. Expenses remain stable at 2.3 million in 2024 and 2025 and primarily relate to professional service fees linked to corporate development activities. As a reminder, on April 2, 2024 we received an equity interest of 20% in Neurosterics US Holdings LLC as part of the nearest Derek Spin out transaction. Under IFRS accounting standards we are required to account for for the investment using the equity method of accounting and recognize our share of Neurosteric's results in our income statement. For the 12 month period ended December 31, 2025, our share of the net loss of NeuroStairics amounted to 4 million compared to 2.2 million for the period April 24 through December 24. The finance net result is close to nil in both 25 and 2024 and is primarily related to foreign exchange differences on our U.S. cash deposits. Now moving on to the balance sheet, our assets are primarily held in cash and we completed 2025. We've got 6 million cash held in Swiss francs US dollars. Our current assets amounted to 41,000 primarily related to decreased prepaid patent costs and retirement benefits. Our non current assets of 4.6 million as of December primarily relate to our investment in Neurosterics which has been accounted using the equity method and the investment in Stalicla of 0.8 million. Current liabilities of 1.2 million at the end of the year 2025 increased by 0.4 million compared to December of the previous year 2024 and primarily related to R and D related accruals and payables. Non Current liabilities of 0.4 million as of 12-31-25 increased by 0.2 million compared to December 2024 primarily due to an actuarial experience adjustment in the calculation of the defined benefit obligations. Now to the Cash flow statement. On December 31, 2025 the cash balance amounted to 1.6 million and decreased by 1.7 million compared to the beginning of the year. This primarily due to the cash used in operating operations and investing activities for a combined amount of 2.9 million which has been partly offset by the sale of treasury shares for a total amount of 1.3 million during the now to summarise, we've made excellent progress advancing the GABAB PAM program for Cough and our DIP Pregnant Post Stroke Recovery program. Our spin out company Neurosterics continues to advance its portfolio with their M4 positive modulator program on track to complete phase one this quarter. We are very pleased by the progress Stalicla is making at advancing on its business strategy and pipeline and we are looking forward to completing our evaluation of potential indications for our MGLR2PAM programme 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.

OPERATOR

Thank you. Dear participants, As a reminder, if you wish to ask a question, please press 11 on your telephone keypad and wait. Name to be announced. To withdraw a question, please press star one and one again. Alternatively, you can submit your questions via the webcast. Once again, if you would like to ask a question, please press star one one. And now we're going to take our first question. And it comes to the line of Rakuram Salvaradju from HC Wainwright. Your line is open. Please ask a question.

Yan Z

Hi, thank you for taking my question. This is Yan Z sitting in forum. I have two questions. The first is which subsets of patients with chronic cough is the GABAPAM most likely to be aimed at? Would you say it's ips, sarcoidosis or something else? And how large could that total market be if the compound had a broad antitussive label?

Misha Kalinichev (Head of Translational Science)

Yeah. So. Yeah. Misha, would you like to answer? Yes, of course. Well, considering the profile of this compound which has balanced central peripheral activity profile, we believe that it will be suitable for a broad range of chronic patients. Especially due to the fact that it it has central component which we believe is very important in reducing central sensitization seen in certain chronic cough patients. These patients do not respond to peripherally restricted P2X3 inhibitors, but can respond to morphine which we believe is centrally acting. So this way the profile is able to address. Problems in chronic circuit that are both peripheral and central. Our initial intention is to confirm the efficacy of the compound in chronic cough patients that come from unexplained or refractory chronic category. But once this efficacy is confirmed, we intend to broaden our patient population in subsequent studies. Thank you. And which psychiatric clinical indications might be best suited to address whether addicts portfolio of MGLUs 7am candidates

Tim Dyer

the NGR7 candidate is not in Addex. It's sitting in the spin out company Neurosterics. So we're not at liberty to talk in detail about that. But you know, in general, maybe. Misha, you can. You can say what you can say.

Misha Kalinichev (Head of Translational Science)

Absolutely. Absolutely. There are a number of academic studies looking at mGluR7 knockout mice that show quite remarkable and very broad potential for inhibitors. As mGluR7 knockouts show reduced anxiety and depression like reactivity, they show reduced expression of conditioned fear, they show reduced aggressivity and agitation and certain signs of reduced responsiveness to psychostimulants. So even with this data that have been then confirmed in several pharmacological studies, some of those that were published by us show that we can orient the mGluR7 negative modulators towards anxiety and panic, agitation, aggressivity, depression and perhaps psychosis. And Mania. Got it. Thank you so much.

OPERATOR

Thank you. Dear participants, as a reminder, if you would like to ask a question, please press star 11. Alternatively, you can submit your questions via the webcast. Dear speakers, there are no further questions for today. Thank you, ladies and gentlemen. This brings the main part of our conference to a close, and I would like to hand back to Tim Dyer for closing remarks.

Tim Dyer

Thank you. I'd just like to thank everyone for attending our 2025 conference call, and I wish you all a very nice day, and we look forward to speaking to you again soon. Thank you.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.