Addex Therapeutics (NASDAQ:ADXN) released second-quarter financial results and hosted an earnings call on Monday. Read the complete transcript below.

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Summary

Addex Therapeutics raised $2.8 million via ATM facility, extending cash runway into Q4 2027.

The company regained rights to its GABA B PAM program from Indivior, enabling full development freedom.

Operating loss decreased to $1.1 million in H1 2026 from $1.3 million in H1 2025 due to reduced R&D expenses.

Addex holds a 20% equity interest in Neurosterix, which is advancing its NTX253 program expected to complete Phase One soon.

The company is preparing dipraglurant for Phase Two trials in post-stroke recovery, collaborating with Lund University.

Future plans include IND filing for the SUD program and starting IND-enabling studies for the cough program.

Management emphasized strategic potential in partnering and potential spin-outs, drawing from their Neurosterix experience.

Full Transcript

OPERATOR

Good day and thank you for standing by. Welcome to the Addex Therapeutics reports 2026 half-year financial results and corporate update webcast and conference call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question-and-answer session. To ask a question during the session you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised.

To withdraw your question, please press star one one again. To ask a question via the webcast, please access the Ask A Question tab. 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. Please go ahead.

Tim Dyer — Chief Executive Officer

Thank you. Hello everyone. I'd like to thank you all for attending our last year 2026 financial results conference call. I'm here with Misha Kalinshev, our Head of Translational Science, who will provide an update on our R&D programme. 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 the pipeline. I will then hand over to Misha who will review our GABA B PAM program for SUD and cough. I will then review our 2026 half-year financial results. 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$2.8 million raised through our ATM facility which provides us with the cash runway into Q4 2027.

We also regained rights to our GABA B 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 Percepto 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 NTX253, a highly selective brain-penetrant M4 PAM for schizophrenia. We expect this program to complete phase one very soon. Now for a quick review of our pipeline. We continue to believe in dipraglurant and have repositioned this proprietary mGluR5 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 mGluR5 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 Syntaxis and the University of Lund to complete preclinical profiling fit for planned clinical studies. As previously reported, we have regained the rights to ADX71149 from our partner J&J, the high-value data set and significant GMP materials. We're currently evaluating a number of therapeutic indications for future development and in parallel we're discussing with potential partners for the asset.

As already mentioned, we have recently regained all rights to the GABA B 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're expecting phase one data from the NTX253 program in Q4 this year. Backup M4 PAM NTX529 has been selected for IND-enabling studies which should start shortly. The mGluR7 NAM program has selected NTX819, a highly selective first-in-class compound which has demonstrated robust preclinical anxiolytic and antidepressant-like activities supporting its development as a potential next-generation therapy. We expect NTX819 to complete IND-enabling studies in the coming months.

Now let's speak about the GABA B 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 and a novel chemistry effort to come up with better baclofen compounds. Baclofen is a short-acting generic GABA B agonist which is registered for the treatment of spasticity. However, it has been used to demonstrate the efficacy of GABA B activation in several disease areas such as chronic 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. As a reminder, we entered into a research collaboration and 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're 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 GABA B PAM in the industry and the opportunity to pursue collaborations with industry partners.

Now I will hand over to Misha who will give you some more details about the GABA B PAM for SUD and chronic cough programs.

Misha Kalinshev, Head of Translational Science

Thank you Tim. Now let me speak about why we are so excited about the opportunity of our GABA B 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 US 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 mGluR5 negative allosteric modulators, mavoglurant, mGlu2/3 positive allosteric modulators, kappa opioid receptor antagonists, GLP-1 inhibitors and ketamine. So why GABA B PAM? 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 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 GABA B 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 GABA B PAM drug candidate has successfully completed IND-enabling studies and is ready for IND filing and phase 1 clinical trials. Also, there are several differentiated leads and backup compounds, all with robust novel IP potential. Now our GABA B PAM program for the treatment of chronic cough. There is 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 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 GABA B PAM in treatment of chronic cough comes from the clinical evidence that baclofen, a GABA B agonist, is used off-label in cough patients and from the anatomical evidence that GABA B receptors are strongly expressed in airways and in the neuronal pathway regulating cough.

Therefore, we believe that GABA B PAMs could offer superior efficacy in cough patients. The pre-IND activities including in vivo proof of concept, non-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 mcg/kg and ED50 of 6 mcg/kg in cough frequency in a guinea pig model of cough. No signs of tolerance were seen after sub-chronic dosing and more than 60-fold safety margin was demonstrated based on respiratory depression as a sedation biomarker.

Recently we confirmed that antitussive efficacy in the non-human primate and are currently evaluating the compound. IND-enabling studies are planned and ready to start subject to securing finance. Now to the data. 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, aprepitant, 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 GABA B PAM with the efficacy of reference compounds but without the CNS side effects such as sedation. In the same experiment where Compound A showed efficacy, we monitored respiratory rate, a biomarker 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 mg/kg. In contrast, nalbuphine, aprepitant, 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, aprepitant, 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. As a reminder, P2X3 inhibitors’ antitussive activities are 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, sub-chronic 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 sub-chronically 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. The bleomycin-exposed animals were then treated with Compound A at 10 mg/kg or vehicle orally once daily for 28 days.

Intact animals received vehicle. On days 7, 14, 21 and 28 animals were exposed to low concentration of citric acid to stimulate cough. 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.

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 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 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 mg/kg. In summary, we have selected a clinical candidate for chronic cough with a robust, reproducible antitussive efficacy at 1 mg/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.

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.

Tim Dyer — Chief Executive Officer

Thank you Misha. Now for a view 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. As a reminder, on April 2, 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 recognizing our share of their results in our income statement. For the six-month period ended June 30, 2026, our share of net loss of Neurosterix amounted to 2.3 million compared to 2.1 million for the six-month period ended June 30, 2025. The net loss remains stable around 3.4 million in both H1 of 2026 and H1 of 2025. Now to the balance sheet. We completed H1 2026 with 0.8 million cash held in Swiss francs and US dollars compared to 1.6 million as of 12-31-2026.

The decrease of 0.8 million is primarily due to operating costs partially offset by the sale of treasury ADS. Other current assets amounted to 0.3 million as of June 30, primarily related to prepaid retirement benefits and D&O insurance annually paid at the beginning of the year. Our non-current assets of 2.4 million as of June 30 primarily relate to our investment in Neurosterix accounted for using the equity method and to a lesser extent our investment in SpinalK.

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. Non-current liabilities primarily relate to the retirement benefit obligations calculated in accordance with IAS 19 in an amount of 0.2 million at the end of June 26th compared to 0.4 million at the end of December 25th. Now to the cash flow statement.

We started the year with 1.6 million. During the six-month period we used 1.2 million in operations primarily and we received 0.4 million from the sale of treasury ADS, resulting in balance sheet cash at the end of the period of 0.8 million. 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. So to summarise, our spin-out company Neurosterix continues to advance its portfolio with their M4 PAM program on track to complete phase one in Q4.

Delixla is working closely with NIDA to advance its program, mavoglurant, into phase three 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. We continue to prepare dipraglurant 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 mGluR2 PAM 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. To ask a question you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one 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. And our first question today comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co. Please go ahead.

Raghuram Selvaraju, Analyst at H.C. Wainwright & Co.

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 re-obtained rights to from Indivior?

Tim Dyer — Chief Executive Officer

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 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. So 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're developing for the cough indication, is sitting in one of the other patents and there are other clinical candidates sitting in separate patents.

Raghuram Selvaraju, Analyst at H.C. Wainwright & Co.

So if these were to be granted, what do you expect is likely to be the expiration time frame? 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? Were any additional patent claims or discoveries that were deemed patentable occurred during the time of the collaboration?

Tim Dyer — Chief Executive Officer

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. So it was Addex that actually filed all the patents and it's Addex that had 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. And so, and they're all, sorry, they're all NCE patents and I think there were some, I mean, there might have been a few additional claims that were added but they were pretty straightforward NCE patents.

Raghuram Selvaraju, Analyst at H.C. Wainwright & Co.

And then 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.

Tim Dyer — Chief Executive Officer

So as the research collaboration 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 mean, 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. And one of the biggest challenges with baclofen and GABA B is around therapeutic margin.

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. So you end up with 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 therapeutic margin. 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 and 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. And that's a compound that has now come back to us and it's ready to go and file an IND. 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. This is the compound we're 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. We have some that are shorter acting, we have some that have less therapeutic margin. 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.

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 arbaclofen where there was a subgroup within the patient population that did respond to arbaclofen. So 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're going to pursue discussions with potential partners.

We have the experience of the Neurosterix spin-out. So of course we are also looking at 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.

Raghuram Selvaraju, Analyst at H.C. Wainwright & Co.

Thank you.

OPERATOR

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. 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, and I would like to hand back to Tim Dyer for the closing remarks.

Tim Dyer — Chief Executive Officer

Well, thank you everyone for attending this 2026 half-year conference call, and 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.

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