Addex Therapeutics Q2 2026 Earnings Report

Addex Therapeutics EPS Results

• Actual EPS: -$1.48
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Addex Therapeutics Revenue Results

• Actual Revenue: $0.01 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Addex Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 9/25/2026
• Time: Before Market Opens
• Conference Call Date: Monday, September 28, 2026
• Conference Call Time: 10:00AM ET

Addex Therapeutics (NASDAQ:ADXN) Ltd. (NASDAQ: ADXN) is a clinical-stage biopharmaceutical company headquartered in Geneva, Switzerland. The company develops small-molecule medicines that act through allosteric modulation, a drug-discovery approach designed to influence G protein-coupled receptors (GPCRs) at sites distinct from where naturally occurring signaling molecules bind.

Addex’s research has focused primarily on treatments for disorders of the central nervous system. Its development programs have included ADX71149, an investigational positive allosteric modulator of the metabotropic glutamate receptor 2 (mGluR2), and other compounds targeting neurological and psychiatric conditions. The company has also investigated allosteric modulators of mGluR5 and the GABA-B receptor for potential applications including epilepsy, pain, addiction and other brain disorders.

Founded in 2002, Addex has advanced its programs through internal research and collaborations with pharmaceutical and biotechnology companies. Its activities are centered in Switzerland, while its clinical development and commercial opportunities are international in scope. As a clinical-stage company, Addex’s product candidates remain subject to clinical testing and regulatory review and are not necessarily approved for commercial use.

Addex Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Cash runway extended into Q4 2027 after Addex raised $2.8 million through its ATM facility, strengthening near-term funding despite ending H1 with CHF 0.8 million in cash.
• Positive Sentiment: Addex regained full rights to its GABAB PAM platform from Indivior, including an SUD candidate that has completed IND-enabling studies and is ready for IND filing, while retaining flexibility to partner or potentially spin out the portfolio.
• Positive Sentiment: The GABAB PAM chronic-cough candidate showed dose-dependent efficacy, more than 60% cough reduction in non-human primates, no observed tolerance in subchronic studies, and a reported 60-fold safety margin; IND-enabling work is ready to begin subject to financing.
• Positive Sentiment: Neurosterix, in which Addex retains a 20% stake, expects Phase I data for its lead M4 PAM NTX-253 in Q4 2026, while backup and mGlu7 programs continue advancing toward IND-enabling studies.
• Negative Sentiment: Addex remains dependent on additional financing to advance key programs, particularly chronic cough, and reported only CHF 0.8 million in cash at June 30; its share of Neurosterix’s net loss also increased to CHF 2.3 million in H1.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to the Addex Therapeutics Report 2026 Half-Year Financial Results and Provides 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 and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and 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, CEO at Addex Therapeutics]

Thank you. Hello, everyone. I would like to thank you all for attending our half-year 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 Mikhail, who will review our GABAB PAM programs, 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.

[Tim Dyer, CEO at Addex Therapeutics]

Firstly, we have strengthened the balance sheet with $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 CHF 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.

[Tim Dyer, CEO at Addex Therapeutics]

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 Sinntaxis and Lund University to complete preclinical profiling for dipraglurant and prepare for clinical studies. As previously reported, we have regained the rights to ADX-71149 from our partner, Janssen Pharmaceuticals, the high-value dataset, 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.

[Tim Dyer, CEO at Addex Therapeutics]

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.

[Tim Dyer, CEO at Addex Therapeutics]

We expect NTX-819 to complete IND-enabling studies in the coming months. 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.

[Tim Dyer, CEO at Addex Therapeutics]

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'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 GABAB PAM in the industry and the opportunity to pursue collaborations with industry partners.

[Tim Dyer, CEO at Addex Therapeutics]

Now, I will hand over to Mikhail, who will give you some more details about the GABAB PAM for SUD and chronic cough programs.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Thank you, Tim. 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, mavoglurant, mGlu2/3 positive allosteric modulators, kappa-opioid receptor antagonists, GLP-1 inhibitors, and ketamine. Why GABAB-PAM?

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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 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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

The pre-IND activities, including in vivo proof of concept, 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 rabbit. IND enabling studies are planned and ready to start subject to securing financing. Now to the data.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

As a reminder, P2X3 inhibitors' antitussive activity is 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. Also, 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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

On days seven, 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%-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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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 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.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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, CEO at Addex Therapeutics]

Thank you, Mikhail. Now for a view of our 2026 half year 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 April 2nd, 2024, we received an equity interest of 20% in Neurosterix U.S. 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 June 30th, 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 June 30th, 2025.

[Tim Dyer, CEO at Addex Therapeutics]

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 U.S. dollars compared to CHF 1.6 million as of December 31st, 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 June 30th, 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 June 30th primarily relate to our investment in Neurosterix accounted for using the equity method, and to a lesser extent, our investment in Stalicla.

[Tim Dyer, CEO at Addex Therapeutics]

Current liabilities increased by CHF 0.2 million to CHF 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 calculation 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.

[Tim Dyer, CEO at Addex Therapeutics]

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 dipraglurant 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.

[Operator]

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and 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. 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 reobtained rights to Indivior.

[Tim Dyer, CEO at Addex Therapeutics]

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'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.]

If these were to be granted, what do you expect is likely to be the expiration date timeframe?

[Tim Dyer, CEO at Addex Therapeutics]

2044. 2044.

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

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?

[Tim Dyer, CEO at Addex Therapeutics]

Yeah. I think it's important to understand that the collaboration with Indivior involved all the chemistry and biology being done at Addex. 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. None of them were in the hands of Indivior. It was a pure license, and that license has been terminated. They're all NCE patents. I think 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.]

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, CEO at Addex Therapeutics]

Yeah. 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. 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's 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. 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.

[Tim Dyer, CEO at Addex Therapeutics]

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. 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. The compound successfully came out, and that's the compound that has now come back to us. It's 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'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.

[Tim Dyer, CEO at Addex Therapeutics]

We have some that are shorter acting. We have some that have less therapeutic margin. 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. 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. So neurodevelopmental disorders is also another very interesting area that we could pursue with a central compound. At the moment, the answer to your question is that we are going to pursue discussions with potential partners.

[Tim Dyer, CEO at Addex Therapeutics]

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-

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

Thank you.

[Tim Dyer, CEO at Addex Therapeutics]

we're pursuing a number of avenues to basically 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 and one on your telephone keypad. That is star one and 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. Now I would like to hand back to Tim Dyer for the closing remarks.

[Tim Dyer, CEO at Addex Therapeutics]

Well, thank you, everyone, for attending this 2026 half year 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.

Participants

Executives

• Tim Dyer, CEO
• Mikhail Kalinichev, Head of Translational Science

Analysts

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