ADXN Addex Therapeutics Ltd
$2.98
Addex Therapeutics Ltd Q2 F2026 Earnings Call Transcript
AI Conference Call Analysis
Sign in or subscribe to read.Lénaic Teyssédou
Conference Operator
Lénaic Teyssédou, Lénaic Teyssédou, Lénaic Teyssédou 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 Addicts Therapeutics. Please go ahead.
Tim Dyer
CEO, Addicts Therapeutics
Thank you. Hello, everyone. I'd like to thank you all for attending our half-year 2026 Financial Results Conference call. I'm here with Misha Kalinichev, 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 our pipeline. I will then hand over to Misha who will review our Gather B PAM programmes, SUD and COFF. 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 dollar 2.8 million raised to our ATM facility, which provides us with cash runaway into Q4, 2027. We also regained rights to our GABA B-PAM program, which we had previously licensed to Divior. This is a significant value creating event for addicts, 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 NeuroSterics, raised $65 million from a syndicate of investors led by Bersetta Advisors. We retained 20% equity interest in NeuroSterics, the value of which is unfortunately not being properly reflected in our current share price, but we hope that will change. has made excellent progress in advancing its pipeline, including its lead drug candidate, NTX253, a highly selective brain penetrant M4 pan 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 Diproglurant, and I've repositioned this proprietary mGlar5 negative acetaminophen modulator for brain injury recovery. As a reminder, in 2025, we entered into an optional agreement giving us access to an exclusive license to intellectual property covering the use of hemoglobin 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 and prepare for clinical studies. As previously reported, we have regained the rights to ADX 71149 from our partner J&J, the high value dataset and significant GMP material. 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-BPAM substance use disorder program from Indivio 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 COFF program. The next milestone for the SUD program is the filing of an IMD and for the COFF program, the start of IMD enabling studies. Also presented on this slide is the portfolio of our spin-out company, Neurosterex. We're expecting phase one data from NTX253 program in Q4 this year. Backup, M4PAM, NTX529 has been selected for IND enabling studies, which should start shortly. The MGLAR7 NAM program has selected NTX819, a highly selected first-in-class compound, which has demonstrated robust preclinical anxiolytic and antidepressant-like activity supporting is development at the Central 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 approach and a novel chemistry effort to come 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 SUD, heart pain, overactive bladder and neurodevelopmental disorders amongst others. Therefore, in addition to our active programs in constant 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 Indivio. As a reminder, we entered into a research collaboration license agreement with Indivio in 2018 and executed a funded research effort at ADDx to deliver novel candidates. In late 2024, Indivio 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 right to select our own drug candidate for development in a restricted set of disease areas. Now that Indivio has terminated the license as part of their announced merger with Superness, we're not only getting back the licensed drug candidate for SUD. We have full freedom to develop all other candidates. This gives Alex the broadest portfolio of drug candidates targeting GABA-BPAM 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-BPAM for SUD and chronic cost programs.
Misha Kalinichev
Head of Translational Science
Thank you, Jim. Now let me speak about why we are so excited about the opportunity of our GABA-V-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 acomposate. Furthermore, there are no approved drugs for cocaine or psychostimulant use disorders. Novel approaches for pharmacotherapy of SUD include mGluR5-negative ulceric modulator malognurant, mGlu2,3-positive ulceric modulators, kappa-opioid receptor antagonists, GLP-1 inhibitors, and ketamine. So why GABA-B PA? GABA-B receptor activation is a clinically validated target for SUD as baclofen, is used off-label for alcohol use disorders. Also, GABA-BPAM ADEX 71441 has shown to attenuate alcohol self-administration and relapse in rats and alcohol consumption in mice. Also, ADEX 71441 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 one 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 S3 flux, but also possibly by called hypersensitivity syndrome. There is a large unmet medical need in novel antitrusive 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. We believe that GABA-B PAMS could offer superior efficacy in COS patients. The pre-IND activities including in vivo proof of concept, known 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 1 mcg per kg and ED50 of 6 mcg 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 antidepressant efficacy in the non-human primate and are currently evaluating the compound in the rapid. 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, antitrusive efficacy, reducing the cough number dose-dependently and achieving 70% reductions at the maximal doses. The antitrusive profile of compound A was similar to that of nalbufin, orvipitant, baclofen, and codeine. Now to cough latency. Compound A increased the latency to first cough dose-dependently, thus delaying the onset of cough. The antitrusive profile of compound A in delaying cough onset was similar or better and that of reference drugs. As a reminder, our objective in this program is to design a GABA-BPAM 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 and 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 mgs per kg. In contrast, nalbufin or reputant 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 antigen efficacy across compounds at the respective highest doses, In the model of ATP-potentiated citric acid COF 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 are antidepressant activities peripherally mediated, which explains their lack of sedative activity, but also the reason more than 30% of COV patients do not respond to treatment. In the citric acid-induced COV 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 released in animals treated subchronic 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 0, animals received a single or pharyngeal administration of leomycin, or were left intact. Leomycin-exposed animals were then treated with compound A, a 10-mixter kick, or vehicle, orally once daily for 28 days. Intact animals received vehicle. On days 7, 14, 21, and 28, animals were exposed to low concentrations of citric acid to stimulate 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 realized and exposed vehicle-treated animals than in healthy control. The difference between the groups grew progressively larger over time, indicative of exacerbated cough in IPF life conditions. Chronic treatment with compound A resulted in robust and enduring reduction in the number of coughs with 40 to 60% reduction magnitude. 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. Histopathology analysis of the lung tissue collected on day 28 revealed that chronic administration of compound A was associated with markedly lower astral 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 two mgs per gig. In summary, We have selected a clinical candidate for chronic cough with a robust reproducible anti-juicer efficacy at 1 mg per kick and good PKPD. The compound showed a favorable developability profile in non-GLT-tox studies performed in rats, dogs, and non-human primates. The compound has the potential to have the best disease efficacy and tolerability profile and broad application in chronic cough patients. Subjects to Raising Financing, we are ready to start the IND Enabling Settings. This concludes our prepared remarks on the progress of our R&D Program. Now I hand it back to Tim. Thank you, Misha.
Tim Dyer
CEO, Addicts Therapeutics
Now for a review 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 vPAN program. As a reminder, on April 2nd, 2024, we received an equity interest of 20% in Eurosterex, U.S. Holdings LLC as part of the Eurosterex 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 neurastherics amounted to 2.3 million compared to 2.1 million for the six-month period ended June 30th, 2025. The net loss remained 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 December 31st, 2026. The decrease of 0.8 million is primarily due to operating costs partially offset by the sale of treasury ADSs. Other current assets amounted to 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 2.4 million as of June 30th primarily relate to our investment in Eurosterex accounted for using the equity method and to a lesser extent our investment in Spilling Club. 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, an amount of 0.2 million at the end of June 26 compared to 0.4 million at the end of December 25. Now to the cash flow statement. We started the year with 1.6 million during the six month period. We used 1.2 million operations primarily and we received 0.4 million from the sale of treasury ADSs resulting in a balance sheet at the end of balance sheet cash at the end of period of 0.8 million. I'd 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 Nearest Derrits continues to advance its portfolio with their M4 PAM programme on track to complete Phase 1 in Q4. Silicula is working closely with NIDA to advance its Phase 3 programme, Mavigloryn, into Phase 3 for cocaine use disorders. We've regained all rights to our Gatherie PAM platform, providing multiple programmes with a focus on SUD and chronic cough. We continue to prepare 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.
Lénaic Teyssédou
Conference Operator
Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 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 Raghu Ram Salvu Raju from HC Wainwright & Co. Please go ahead.
Raghu Ram Salvu Raju
Analyst, HC 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 give yours?
Tim Dyer
CEO, Addicts Therapeutics
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. 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.
Raghu Ram Salvu Raju
Analyst, HC Wainwright & Co.
So if these were to be granted, what do you expect is likely to be the expiration date timeframe?
Tim Dyer
CEO, Addicts Therapeutics
44, 2044.
Raghu Ram Salvu Raju
Analyst, HC Wainwright & Co.
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 The collaboration with Indivior involved all the chemistry and biology being done at ADEX. So it was ADEX that actually filed all the patents and it's ADEX that has been
Tim Dyer
CEO, Addicts Therapeutics
managing the patents, prosecuting them. None of the patents were actually joint patents. None of them were in the hands of Indivio. It was a pure license, and that license has been terminated. And so they're all NCE patents. And I think there was some... I mean, there might have been a few additional claims that were added, but... I mean, they were pretty straightforward NCE patents.
Raghu Ram Salvu Raju
Analyst, HC 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 Neurosterex, or if you are seeking to unlock value purely through a licensing arrangement.
Tim Dyer
CEO, Addicts Therapeutics
Yeah, so as the research collaboration evolved with Indivia, I remember we were funded by Indivia. 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 profiles. 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, it's around therapeutic margin.
Misha Kalinichev
Head of Translational Science
So one of the things that we discovered through the R&D effort
Tim Dyer
CEO, Addicts Therapeutics
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, you have 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. Non-GLP tox then they did the the IND enabling GLP tox studies and the compound successfully came out and that's compound that has now come back to us and and we 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 are going to pursue discussions with potential partners. We have the experience of the neurosteric spin-out, so of course we are also looking at Thank you. As a reminder, if you wish to ask a question, please press star 1 and 1 on your telephone keypad. That is star 1 and 1 to ask a question.
Lénaic Teyssédou
Conference Operator
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. I would like to hand back to Tim Dyer for the closing remarks.
Tim Dyer
CEO, Addicts Therapeutics
Well, thank you, everyone, for attending this 2026 half year conference call. We very much look forward to speaking to you again soon.
Lénaic Teyssédou
Conference Operator
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.