On its Q3 2025 call (three months ended September 30, 2025, reported December 4, 2025), Addex described steady, low-cost progress across a partnership-driven pipeline. It continued preclinical work on its GABAB PAM chronic-cough candidate and selected a backup compound, advanced dipraglurant toward clinical studies in brain injury recovery (Sinntaxis collaboration, with Lund University), and pointed to progress at its equity investees - Neurosterix, whose M4 PAM program was on track to dose patients in 2025, and Stalicla. Financially the quarter was again minimal and pre-revenue - CHF 0.1 million income, CHF 0.2 million R&D, CHF 0.5 million G&A and a CHF 0.9 million equity-method share of Neurosterix's loss - with CHF 2.2 million of cash and a runway to mid-2026. Management reiterated that advancing its unpartnered programs into the clinic remains contingent on securing additional financing.
Thank you. Hello, everyone. I'd like to thank you all for attending our third quarter 2025 financial result conference call. I am here with Mikhail Kalinichev, our Head of Translational Science, who will be providing an update on our R&D programs. 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 disclaimers. 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 Mikhail, who will review in more detail our Dipraglurant Post-Stroke Recovery Program and GABAB PAM Preclinical Program for Cough. I will then review our Q3 2025 financial results.
Following that, we will open the call for Q&A. The third quarter of 2025 has seen several important achievements across our pipeline. We've made excellent progress in our GABAB PAM program. With this, we continue to complete preclinical characterization of our selected compound. We've also selected a backup compound for this important program. As a reminder, our partner Indivior successfully completed IND-enabling studies with their selected drug candidate for substance use disorders. Under the terms of the agreement, Addex is eligible for payments of up to $330 million on successful achievement of these 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. Also, under the terms of the agreement, we have the right to select compounds for development in a predefined list of reserve indications.
As mentioned, we have selected a compound for advancing its development for chronic cough. We have repositioned Dipraglurant, our mGluR5 negative allosteric modulator for brain injury recovery, and have made good progress in preparing the program for clinical studies. As a reminder, earlier this year, we entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of mGluR5 inhibitors in this interesting therapeutic indication. Included in this agreement is a research collaboration for which we are working with Neurosterix and Lund University to complete preclinical profiling of Dipraglurant and prepare the clinical studies. Our spin-out company, Neurosterix, is making excellent progress in advancing its portfolio of preclinical programs, including a potentially best-in-class M4 PAM schizophrenia. In June, we invested in Stalicla, a private clinical-stage neurodevelopmental disorders 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 behavioral phenotype. Proof of concept platform has been demonstrated by applying the technologies to identify and develop drugs in subpopulations of patients suffering from autism spectrum disorders. Stalicla has made excellent progress in advancing its patient stratification study in autism, as well as advancing discussions with pharma to apply its technology more broadly in neuropsychiatric disorders. We completed the third quarter with CHF 2.2 million of cash, which provides us with a cash runway through mid-2026. I'd like to highlight that the cash burn has been significantly reduced following the Neurosterix 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 Dipraglurant and are executing our plans to reposition the development of brain injury recovery. As mentioned, our partner Indivior has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND-enabling studies. We are advancing an independent GABAB PAM program for chronic cough and are ready to start IND-enabling studies subject to securing financing. Neurosterix has made excellent progress in advancing its pipeline, including completing IND-enabling studies for their M4 PAM program. The program is on track to dose patients this year, and we expect to be able to announce further progress in the coming months. Now, I will hand over to Mikhail, who will give you some more details about our exciting portfolio.
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 allosteric modulator, which we believe could improve the outcome of rehabilitation for patients suffering from traumatic brain injury or stroke. The mechanism of action of Dipraglurant targets neuroplasticity early in rehabilitation to promote rebuilding of neuronal connections and sensorimotor recovery. There is large unmet medical needs in post-stroke recovery and rehabilitation. Stroke is among the 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 promote the recovery stimulated by rehabilitation therapies. mGluR5 receptor is a suitable target to address post-stroke recovery, as it is densely expressed in the brain, involved in neuroplasticity and modulates excitatory inhibitor equilibrium. In fact, activation of mGluR5 has been observed in a range of neurological disorders, including stroke, where it plays a role in 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 new functional pathways, moving the neural network toward the pre-lesion states. Exciting new evidence recently published in the journal Brain suggests that the negative allosteric modulator of mGluR5, MTEP, administered daily in rats following stroke results in a sustained and growing improvement in sensorimotor function in comparison to vehicle treatment.
Similar improvement in sensorimotor function was observed in animals treated with our mGluR5 NAM Dipraglurant. MRI imaging of the resting state functional connectivity in post-stroke rodents shows that daily administration of MTEP 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. Dipraglurant 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 Dipraglurant-mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury patients. Let me now turn to GABAB program and the exciting opportunity that it offers to the chronic cough patients. 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 by a cough hypersensitivity syndrome. There is a large unmet medical need in novel anti-tussive drugs, as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60% of cases. In addition, the current treatments carry risks of serious side effects. Support for using GABAB.
Positive allosteric modulators 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. The three IND activities, including in vivo proof of concept studies, known GLP tox, and CMC, have been completed. Our clinical candidate has shown favorable efficacy, tolerability, and developability profiles. The compound has demonstrated a consistent minimum effective dose of one microgram and ED50 of six micrograms in models of cough in vivo. No signs of tolerance were seen after sub-chronic dosing, and more than 60-fold safety margin was demonstrated based on respiratory depression as sedation biomarker. The IND-enabling studies are planned and ready to start, subject to securing financing.
In the model of citric acid-induced coughing guinea pigs, acutely administered compound A delivered a robust anti-tussive efficacy, reducing the cough number dose-dependently and achieving 70% reductions at the maximal doses. The anti-tussive profile of compound A was similar to that of Nalbuphine, Orvepitant, Baclofen, and Codeine. Compound A increased the latency to first cough dose-dependently, thus delaying the onset of cough. The anti-tussive 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 60 micrograms. In contrast, Nalbuphine, Orvepitant, Baclofen, and Codeine resulted in robust reductions in respiratory rate at their highest doses, indicative of sedative-like effects.
When evaluation of the anti-tussive efficacy across compounds was done 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 exhibited a trend of better efficacy and potency in comparison to that of P2X3 inhibitor, while showing signs of similar tolerability. In summary, we have selected a clinical candidate for chronic cough with a robust reproducible anti-tussive efficacy of one microchick and good PKPD. The compound has the potential to have the best-in-class 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&D. Now, I'll hand it back to Tim.
Thanks, Misha. Now, for a review of the Q3 2025 financials. Starting with the income statement, income in Q3 2025 remains similar to our income Q3 2024 and amounted to CHF 0.1 million. It is mainly related to the maintenance of patent license to Indivior, which they are funding, and to the fair value of services received from Neurosterix, zero cost. R&D expenses of CHF 0.2 million in Q3 2025 are primarily related to our GABAB PAM program and remain similar to Q3 2024. G&A expenses of CHF 0.5 million in Q3 2025 remain stable compared to Q3 2024. As a reminder, we are accounting for our investment in Neurosterix using the equity method of accounting and therefore recognize our share of their net loss of CHF 0.9 million for Q3 2025, which is similar to the amount for Q3 2024. Now, to the balance sheet.
Our assets are primarily held in cash, and we completed Q3 2025 with CHF 2.2 million of cash held in Swiss francs and US dollars. Other current assets amounted to CHF 0.2 million, primarily related to prepaid R&D and G&A costs. Our non-current assets of CHF 5 million as of September 30, 2025, primarily related to our 20% equity interest in Neurosterix Group, recorded on the balance sheet under the equity method of accounting for associates, and also, to a lesser extent, our investment in Stalicla. Current liabilities CHF 1.2 million at the end of September, increased by CHF 0.4 million compared to December 31, 2024. This is primarily due to increased payables related to professional services. Non-current liabilities of CHF 0.2 million at the end of Q3 are consistent with amounts at the end of December of 2024 and primarily attributable to retirement benefit obligations.
Now, to summarize, we've made excellent progress in advancing our GABAB PAM program for cough and our Dipraglurant post-stroke recovery program. Our spin-out company, Neurosterix, continues to advance the portfolio with their M4 PAM program set to start phase one this year. We're very pleased to be able to see the progress Stalicla is making at advancing its business strategy and pipeline. We're looking forward to completing our evaluation of potential indications for our mGluR2 PAM program, which we received back from J&J, and continuing to advance our portfolio towards clinical studies. This concludes the presentation, and we will now open the call for questions.