Addex Therapeutics reports Q3 2025 results, advancing GABAB PAM and dipraglurant programs while cash runway extends to mid-2026 amid reduced burn rate.

Good day and thank you for standing by. Welcome to The Adax 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 question during the session you need to press 11 on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press 1 and 1 again. If you wish to ask a question via the webcast, please use the Q and A box available on the webcast link anytime during the live event. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Tim Dyer. Tim Dyer. Please go ahead.

Thank you. Hello everyone. I'd like to thank you all for attending our third quarter 2025 financial conference call. I am here with Misha Kalinicheff, our Head of Translational Science who will be providing an update on our R&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 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 Misha who will review in More detail our Dipraglurant Post Stroke Recovery Program and GABAB PAM Preclinical Program for COF. I will then review our Q3 2025 financial results. Following that we will open the call for Q and 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 as 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 in 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 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. Also under the terms of the agreement, we have the right to select compounds for development in a pre defined list of reserved indications. As mentioned, we have selected a compound under 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 which we are working with Syntaxis and the University of Lund 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 pre clinical programs including a potentially best in class M4PAM for 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 behavioural phenotype. Proof of concept platform has been demonstrated by applying the technologies to identify and develop drugs in sub populations of patients suffering from autism spectrum disorders. Stalicla has made excellent progress 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 2.2 million Swiss francs 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 neurosteric 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 for brain injury recovery. As mentioned, our partner Indivior has selected the GABAB PAM drug candidate for development in substance use disorders and 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 advancing its pipeline including completing IND enabling studies for their M4PAM 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 Misha 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 sensory motor recovery. There is large unmet medical needs 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 promote the recovery stimulated by rehabilitation therapies. mGluR5 receptor is a suitable target to address post stroke recovery as it is then expressed in the brain involved in neuroplasticity and modulates excitatory inhibitory 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 of new functional pathways moving the neural network towards the pre lesion states. Exciting new evidence recently published in the journal Brain suggests that the negative allosteric modulator of mGluR5 NAM administered daily in rats following stroke results in a sustained and growing improvement in sensory motor function in comparison to vehicle treatment. Similar improvement in sensorimotor function was observed in animals treated with our Ngua5NAM depregulurat. MRI imaging of the resting state functional connectivity in post stroke organs shows that daily administration of mGluR5 NAM 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. Dipraglirant 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 depraglurod 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 excited opportunity that it offers to the chronic cough patients. There is a strong rationale for developing GABA B 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 cough hypersensitivity syndrome. There is a large unmet medical need in novel anti adjusted drugs as current standards of care are ineffective in 30% of patients and only moderately affected in up to 60% of patients. 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 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 pat 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 studies, non GLP, TOX and CMC have been completed. Our clinical candidate has shown favorable efficacy, tolerability and tilt stability profiles. The compound has demonstrated a consistent minimum effective dose of 1mg and ED50 of 6mg per kg in models of cough in vivo. 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. 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 antitrusive 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 repeat baclofen codeine. Compound A increased the latency to first cough dose dependently thus delaying the onset of cough. The antigenic profile of compound A in delaying cough onset was similar 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 migratory. In contrast, Nalbufin or repeated baclofen and codeine resulted in robust reductions in respiratory rate at their highest doses indicative of sedative like effects. When evaluation of the antitussive efficacy across compounds was done at the respective highest doses free from respiratory effects. Compound A was shown to be superior to nalbufin or repitant aquifer and codeine in both cough number and cough latency. Measures. In the model of ATP potentiated citric acid-induced 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 attitude of efficacy of one mg/kg 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 Raising Financing we are ready to start the R and D enabling studies. This concludes our prepared remarks on the progress of our R and D. Now I hand it back to Tim.

Thanks Misha. Now for a view of the Q3 2025 financials. Starting with the income statement. Incoming Q3 2025 remained similar to our income. Q3 of 2024 and amounted to 0.1 million is mainly related to the maintenance of patents licensed to indivior which they are funding and to the fair value of services received from Neurosteris Group. Zero cost. R&D expenses of 0.2 million in Q3 2025 are primarily related to our GABAB PAM program remains similar to Q3 2024. GNA expenses of 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 recognized our share of their net loss of 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 2.2 million Swiss francs of cash held in Swiss francs and US dollars. Other current assets amounted to 0.2 million primarily related to prepaid R and D and G and A cost. Our Non Current assets of 5 million as of September 30, 2025 primarily related to our 20% equity interest in Eurostatics 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 1.2 million at the end of September increased by 0.4 million compared to December 31, 2024. This is primarily due to increased payables related to professional services. Non current liabilities of 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 of late obligations. Now to summarise, we have 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 portfolio with their M4PAM programme set to start phase one this year. We're very pleased to be by the progress Stalicla is making advancing its business strategy and pipeline. We're looking forward to completing our evaluation of potential indications for mGluR2 PAM program which we received back from JJ and continuing to advance our portfolio. Towards clinical studies. This concludes the presentation and we will now open the call for questions.

Thank you. Dear participants, As a reminder, if you wish to ask a question over the phone, please press Star one one on your telephone keypad and wait for a name to be announced. To withdraw a question, please press Star one and one again. Alternatively, you can submit your questions via the webcast. Please We will compile the Q and A roster. This will take a few moments. And now we're going to take our first question. Just give us a moment. And it comes from the line of Ram Selvaraju from HC Wainwright. Your line is open. Please ask a question.

Thank you so much for taking my questions. Four quick ones Firstly, I was wondering if you could comment on the commercial outlook for a potential therapeutic intervention in chronic refractory cough, particularly in the context of the fact that gefapixent doesn't appear to now be a factor in the United States market. Secondly, I wanted to ask about ultimately what you expect the next funding catalyst for Stalikla to be and what the outlook might be for Stalicla to pursue a path to a public listing, if that's something you can comment on at this time. Thirdly, wanted to see if you could give us some context around. Competitive clinical development in the post stroke recovery space, particularly as this pertains to CCR5 receptor modulators and especially the ongoing clinical programs with Maraviroc, which was originally approved as an anti HIV medication. And if you could perhaps give us a sense of how those trials, particularly the Camaros trial, might provide important learnings for future development of a candidate in post stroke recovery like diprogurant. And lastly maybe you can give us a sense of what indivior is looking for next in your ongoing collaboration and what catalysts you expect over the course of 2026? Thank you.

Okay. Yeah. So the first question regarding the commercial outlook in cof.

You'Re absolutely right. Get for Pixent seemed not to be doing particularly well. I think, you know, I mean, there are a number. Well, first of all, it's not registered in the U.S. i mean, one of the reasons that Camlipixant was acquired by GSK when GSK acquired Bellus for 2 billion was because it seems to not have the same taste disturbance issues that Gefapixent had. And we understand that, you know, data from the phase three with KamlyPixant is coming out in the coming months. We have done some commercial assessments on chronic cough. We haven't actually disclosed our position on how we see the commercial opportunity. We still see it as a significant unmet medical need. We know from our discussions with KOLs that, you know, Baclofen is efficacious in cough patients. The only reason it's not being. It'S not being used more widely is it's a drug that has to be dosed about five times a day. You know, the efficacious dose is sedative. So, you know, patients can't drive their cars and therefore it's really a last resort. What we've also heard from KOLS that we're working with is that. Up to 50% of cough patients who take P2X3 inhibitors or get a P2X3. Are discontinuing treatment or non responding. We haven't got any breakout of, you know, the non responders versus the ones that discontinue due to the taste disturbance. So that's question one. Misha, would you like to add anything to that?

Yeah, I just wanted to mention that. A recent evaluation of. Responders to Gefapixant shows that there are up to 50% of patients that have no benefit from this mechanism, which is higher than was initially predicted, which was around 30%. It's not surprising considering that P2X3 inhibitor really captures only single mechanism, peripheral mechanism, that is responsible for chronic cough. There are multiple other referral mechanisms leading to chronic cough. And importantly, there are central mechanisms that remain to be addressed. And the advantage of the approach that we are taking is that centrally acting gabavipam will be able to address. Needs of all these patients.

So on to the question two about Stalicla. Yes, so we're very happy with the progress that Stalicla is making. I mean, they are continuing to execute on their non-pharmacological intervention study. So it's a non pharmacological intervention study that they're recruiting patients in order to stratify them into the different phenotypes that they've identified and these patients are sort of being warehoused ready for the pharmacological intervention studies. And regarding the fundraising, they are currently working on a. I mean it's a private company. I think it's well understood that they are working on a series C financing. This financing is to fund. Two clinical program, phase two clinical studies for two subpopulations within autism spectrum disorder. They're also in parallel working on out licensing an asset that they in license from Novartis. This is a Mavoglurant, an mGluR5, the most advanced mGluR5 negative allosteric modulator which is shown. Excellent data in a phase two study for cocaine use disorder. I know that they are getting some traction from various pharma parties around the outlicensing of that. So I think, you know, one of these activities or both we're hoping will occur. Now the question regarding ipo, I mean private companies are always staying close to the idea of IPOs, especially if there's a strong need for capital given the current warming up of the markets. I'm aware that Stirlictor is certainly. Looking at this as a potential. Funding mechanism. So that's number two. Number three, regarding stroke, thank you very much for raising. The topic of the camera trial with Maraviroc. Two weeks ago we were actually in Sweden discussing with our partner Syntaxis. And we had the pleasure of meeting the lead investigator, Sean. Duclo, who is leading that study. And we are certainly planning to collaborate with him and others that are involved in that study. And there's. A lot of learnings. From that study that we can certainly benefit from when planning the study of diploflurans. Misha, would you like to add anything?

Yes, happy to follow up this topic. Of course we follow this story since it was first shared by the Science magazine few years back and then a series of very elegant experiments published in the Cell journal and now a clinical trial. We follow this with interest and excitement. We believe that it shows that there is a potential for improvement in post stroke recovery via adding a pharmacological agent, exactly as we propose with mGluR5. We are not surprised as there are multiple overlapping and redundant mechanisms in the brain. And identifying yet another mechanism that follows very similar path kind of supports our hypothesis. Very much like mGluR5, CCR5 is upregulated after stroke. It's inhibition in the animal, either genetically or pharmacologically facilitates recovery. Exactly like what happens with mGluR5. Both receptors are GPCRs and both receptors are upregulated after stroke. So there are multiple parallels and we are very excited. For sure there will be many learnings for us at the end of this Camaros clinical trial, in particular to understand how one can address sensory versus motor recovery readouts. And the Camaros study is heavily leaning towards more motor and in our discussion with clinical experts we will put as much emphasis on sensory readouts as in motor ones. So for sure there is a lot to learn but we are very much. In tuned with this approach and looking forward to the outcome of this clinical trial.

Thanks. So onto the fourth question regarding indivior. I mean indivior. As I said, they successfully completed the IND enabling studies and they are currently preparing to move the program forward. Unfortunately I cannot give any more information than that at this stage, but again we are still happy with the progress they are making to move the study forward. Thank you very much.

Are there any other questions? Dear participants, as a reminder, if you wish to ask a question, please press star 11 on your telephone keypad. Alternatively, you could submit your questions via the webcast. Dear Speakers, we will just give a moment to our participants to press star 11 or just to write a question in our webcast tab. Thank you ladies and gentlemen. This brings the main part of our conference to a close and I would now like to hand the conference back to Tim Dye for closing remarks.

So I'd like to thank you all for attending and we look forward to speaking to you again soon. I wish you all a great day.

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.