Addex Therapeutics H1 2025 Earnings Call Transcript

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October 1, 2025

Key Takeaways

  • Positive Sentiment: GABA B PAM program advance: Partner Indivior completed IND enabling studies for its substance use disorders candidate, unlocking up to $330 million in milestones and tiered royalties, while ADX’s independent chronic cough GABA B PAM has robust preclinical anti-tussive data and is ready for IND enabling studies pending financing.
  • Neutral Sentiment: mGluR2 PAM rights regained: ADX regained full rights to its mGluR2 positive allosteric modulator program (ADX-71149) from Johnson & Johnson and is exploring multiple therapeutic indications.
  • Positive Sentiment: Dipraglurant repositioning: The company repositioned dipraglurant, its mGluR5 negative modulator, for brain injury recovery and secured an option to exclusively license mGluR5 inhibitor IP for this indication.
  • Positive Sentiment: Stellicla investment: ADX invested in Stellicla’s precision medicine platform for neurodevelopmental disorders, which has demonstrated proof of concept in patient stratification and autism-focused drug development.
  • Negative Sentiment: Cash runway constraints: With CHF 2.3 million of cash, ADX has a runway into mid-2026 but requires additional financing to advance its unpartnered programs into clinical development.
AI Generated. May Contain Errors.
Earnings Conference Call
Addex Therapeutics H1 2025
00:00 / 00:00

There are 4 speakers on the call.

Operator

Thank you. Hello, everyone. I'd like to thank you all for attending our half year twenty twenty five financial results conference call. I'm here with Mikhail Kalinichev, who will provide an update on our R and D programs. I draw your attention to the press release and the financial statements issued yesterday, which are available on the website.

Operator

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 in more detail our GABA B ham preclinical program for cough. I will then review our financial results.

Operator

Following that, we will open the call for questions. The 2025 has been has seen several important achievements across our pipeline. We've made excellent progress in our GABA B PAM program with our partner Indivior successfully completing IND enabling studies with their selected drug candidate for substance use disorders. As a reminder, under the terms of the agreement, ADX is eligible for payments of up to 330,000,000 US dollars on successful achievement of prespecified regulatory clinical and commercial milestones as well as tiered royalties on the level of net sales from high single digit 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.

Operator

We have selected a compound to advance our own independent GABA BPAM program for the treatment of chronic cough. We have substantially completed preclinical profiling of our drug candidate and recently published robust anti TUSIV data in multiple preclinical models of COB. Misha will speak about this exciting data later in our presentation. We also regained rights to our m bluR2 positive allosteric modulator program, including the phase two asset ADX-seventy 1149 from our partner Johnson and Johnson. We are currently evaluating a number of therapeutic indications for the future development of program.

Operator

We have repositioned diproglurant, our mGluR five negative modulator, for brain injury recovery and recently entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of mGluR five inhibitors in this interesting therapeutic indication. In June, we invested in Stellicla, a private clinical stage neurodevelopmental disorder focused company. Stellicla has developed proprietary precision medicine patient stratification technology platform, which allows the company to select patients based on their underlying biological dysregulation rather than their behavioral phenotype. Proof of concept to the platform has been demonstrated by applying the technologies to identify and develop drugs in subpopulations of patients suffering from autism spectrum disorders. We believe that Stellicla's technology platform can be broadly applied to other disease areas where patients are defined based on behavioral phenotype or where there is significant heterogeneity within the patient population.

Operator

Moving on to the financials. We completed the half year with 2,300,000.0 Swiss francs of cash, which provides us with a cash runway through mid twenty twenty six. I'd like to highlight that the cash burn has been significantly reduced following the NeuroStarix 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 dipaglutide and are executing our plans to reposition development of the drug for brain injury recovery.

Operator

As mentioned, our partner, Indivior, has selected a GABA B PAM drug candidate for development in use disorders and successfully completed IND enabling studies. We are advancing our independent GABA B PAM program for chronic cough and are ready to start IND enabling studies subject to securing financing. Neuroserx has made excellent progress in advancing its pipeline, including completing IND enabling studies for their m four PAM program. 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.

Speaker 1

Thank you, Tim. Let me start with GABA b posturing modulator program, which is partnered with Indivior. The aim of this collaboration is to deliver abasubiquefim for substance use disorders. As a reminder, GABA B receptor activation has been clinically validated in a number of disease areas using baclofen, a GABA B autosteric agonist. Baclofen is FDA approved for treatment of spasticity and is widely used off label to treat numerous diseases, including substance use disorders.

Speaker 1

However, baclofen has a short half life and comes with significant side effects, hampering its wider use. Thus, there's a strong need for a better baclofen. We believe this can be achieved with positive allosteric modulators and their differentiated pharmacology, having the efficacy that is similar or better than that of baclofen, but longer half life and improved side effect profile. Our partner, Indivior, has selected agave b PAM, drug candidate for development in substance use disorders, and completed IND enabling studies in h one twenty twenty five. As part of our agreement with Indivior, ADX has exercised its right to select a compound to advance its own independent GABA B PAM program for the treatment of chronic cough.

Speaker 1

I will now present this exciting opportunity. There is a strong rationale for developing double BPAM 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.

Operator

There is

Speaker 1

a large unmet medical need in novel anti juicing drugs as current standards of care are ineffective in thirty percent of patients and only moderately effective in up to sixty percent of patients. In addition, the current treatments carry risks of serious side effects. On the next slide, we show that gabapam are likely to have a superior tolerability profile in comparison to the current standard of care and show no taste related side effects as seen with a newly approved p two x three inhibitor gefapixox. Support for using dapavirtauvs in treatment of chronic cough comes from the clinical evidence that arquatine, the gamma B agonist, is used off label in cough patients. And from the anatomical evidence that gamma b receptors are strongly expressed in airways and in the neuronal pathway regulating cough.

Speaker 1

Therefore, we believe that gamma vPAMS 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 developability profile. The compound has demonstrated consistent minimum effective dose of one mg per kg and e d fifty of six mg per kg in models of cough in vivo. No signs of tolerance were seen after subchromic doses closing, and more than 60 fold safety margin was demonstrated based on respiratory depression as sedation biomarker.

Speaker 1

The IND enabling studies are planned to start this year. In the model of citric acid induced cough in guinea pigs, acutely administered compound a delivered a robust, anti juices efficacy, reducing the cough number dose dependently and achieving 70% reductions at the maximal doses. The anti juicer profile of compound a was similar to that of nalbuphine or repitant baclofen and codeine. Compound a also increased the latency to first cough dose dependently, thus delaying the onset of cough. Its profile in delaying cough onset was similar or better than that of reference drugs.

Speaker 1

In the same experiment, compound A appeared well tolerated as there were no marked changes in respiratory rate at up to six mg per kg. In contract in contrast, nalbufin or Repetam, baclofen, and codeine resulted in robust reductions of respiratory rate at their high doses indicative of sedative like effect. When evaluating when evaluation of the attitudes of efficacy across compounds was done at the respective high doses free from respiratory effects, compound a was shown to be superior to nabufin or rifitant baclofen encoding in both of number and cof latency measures. Reductions in body temperature, rodent specific biomarker of GABA B receptor occupancy in the brain suggest that at six mg per kg of ADX compound, there are less than 50% GABA B receptors occupied in contrast to near 100% set occupancy at three mg per kg of buckwheat. Increases in gross hormone releasing plasma and translational biomarker of GABA B receptor occupancy in the brain confirmed less than 50% receptor occupancy at up to sixty mgs per kg of compound Following subchronic administration for seven days, compound A showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment.

Speaker 1

No marked changes in respiratory rate, body temperature, and gross hormone were seen in subchronic versus acute treatment conditions with compound A. In the model of ATP potentiated citric acid cough in guinea pigs, in a head to head comparison experiment, acutely administered compound A exhibited a trend of better efficacy and potency in comparison to that of p two x three inhibitor while showing signs of similar tolerability. In summary, we have selected a clinical candidate for chronic cough with a robust reproducible anti juices efficacy of one mg per kg and good PKPD. The compound has a potential to have the best in class, best in disease efficacy, and tolerability profile, and broad application in cove patients. The compound showed a favorable developability profile in non GLP tox studies performed in rats, dogs, and nonhuman primates.

Speaker 1

Subject to raising financing, we are ready to start the IND enabling study. This concludes our prepared remarks on the progress of our R and D program. Now I hand it back to Tim.

Operator

Thanks, Risha. Now for a review of our Q2 twenty twenty five financials. Starting with the income statement. Income decreased by $100,000 in Q2 twenty twenty five compared to 2024 and amounted to 100,000.0. The decrease is primarily due to the completion of the funded research phase of our collaboration with Indivior.

Operator

R and D expenses of $200,000 primarily related to our gaba b pound program and decreased by $100,000 in q two twenty twenty five compared to q two twenty twenty four and, again, mainly due to the completion of the research phase of our collaboration with Indivior. G and A expenses of $500,000 decreased by $100,000 in Q2 twenty twenty five compared to Q2 twenty twenty four, primarily due to decreased legal fees. The share of net loss from the 20% participation in Eurosteryx Group accounted for using the equity method since 04/02/2024 increased 5,700,000.0 and amounted to $1,200,000 for Q2 twenty twenty five compared to Q2 twenty twenty four. Under IFRS, we are required to recognize our share of their results, which is a net loss. Now to the balance sheet.

Operator

Our assets are primarily held in cash, and we completed H1 twenty twenty five with CHF2.3 million of cash held in Swiss francs and US dollars. Other current assets amounted to 400,000.0, primarily related to prepaid R and D and G and A costs. Our noncurrent assets of CHF 5,800,000.0 as of June 30, primarily related to the 20% equity interest in Neuroserx Group recorded on the balance sheet under the equity method of accounting for associates and our investment in Stoliglav. Current liabilities of 1,100,000.0 at the June increased by 300,000.0 compared to December 2024, primarily due to increased payables. Noncurrent liabilities of 100,000.0 at the June decreased by 100,000.0 compared to the December, primarily due to the reduction in retirement benefit obligations following changes in financial assumptions.

Operator

Now to summarize, we have made excellent progress in our GABA v PAM program with our partner Indivior successfully completing IND enabling studies with their selected compound for development in substance use disorders. Neurosterics has made excellent progress with their lead m four PAM drug candidate successfully completing IND enabling studies. We have strengthened the IP in our mGluR5 nan program, and Dipicon is ready to restart clinical development of brain injury recovery. Our GAVA V PAM COF program has demonstrated excellent preclinical efficacy and tolerability with IND enabling studies ready to start. We are validating partnerships with industry, supportive investors, and a reasonably strong balance sheet, which puts us on a solid position to deliver on our strategic objectives.

Operator

This concludes the presentation, and we will now open the call for questions.

Speaker 2

Thank Thank you. We are now going to proceed with our first question. And the questions come from the line of Raghuram Selvaraju from H. C. Wainwright and Co.

Speaker 3

Thank you so much for taking my questions, and congratulations on all the recent progress. I just wanted to ask if you could comment on recent developments in the neuropsychiatry space, both from a precedent M and A as well as a licensing standpoint that might conceivably have implications for both Neurosterics and Stellicla? And also if you could comment on Stellicla's future funding requirements as well as the possibility of public listing for that entity? Thank you.

Operator

Okay. Thank you very much, Ram, for that, that question. I mean, it's it's very encouraging to see that there is, you know, continued renewed, you know, excitement within the the neuropsychiatry CNS space. I mean, as you know very well, this all started at the 2023 and continued through 2024, and now we see renewed interest with a number of recent transactions. We are strong believers in CNS, and and, again, we've, you know, we've spun out Neurosterics with 65,000,000 in financing in the series a in April really to as a financing mechanism to get our portfolio of neuropsych assets moving, and they are moving very, very nicely.

Operator

I really cannot speculate about, the future of neurosterics as we are a passive investor now only holding 20%. With respect to Stellicla, Stellicla is currently pursuing a number of strategies around financing. As as are most biotechs private biotechs that are looking for money, They are discussing, you know, actively with, you know, potential pharma partners, both at the at the preclinical sorry, at the the pipeline level, but also at the platform level. As you know, one of the things that Stiriclose pioneered and potentially is, you know, world leader in this ability to to stratify patients, you know, based on their underlying biological dysregulation as opposed to just select them based on phenotypes. And they very much focus the platform on autism spectrum disorders, and they've developed a portfolio in house.

Operator

We're very excited about what they're doing. Now the financing need, they're pursuing, you know, a number of discussions with investors to do a series c financing. And and, you know, we we will continue to be very supportive of what they are doing. So I hope that answers your question.

Speaker 3

Yep. No. Very helpful. Two other very quick ones, if I may. Notwithstanding the inability to speculate on the future of neurosterrics, I was just wondering if you could give us some insights into whether or not the development of long acting injectable formulations could conceivably be a part of Neurosterics' long term strategy in targeting the neuropsych space.

Speaker 3

And, also, if you could comment on the ideal or optimal target patient population for your chronic cough program, specifically as this pertains to those patients who have chronic cough of specific etiology? You know, to what extent you've already determined what the ideal target patient population would be for future clinical development? Thank you.

Operator

Okay. So there's, yeah, there's two questions there. I'll leave Misha to answer the, the question on on chronic cough. I mean, with regard to, the muscarinic m four space, I mean, we all we're all fully aware that, Caruna has launched Covenzi. You know, this new class of of antipsychotic is getting a lot of traction.

Operator

I mean, there's a number of competitors out there both in the fixed dose combination area, but we are very focused well, we, Neurotherics, are very focused on the on an absolutely selective m four PAM. And as you know, AbbVie have now moved moving their m four PAM emiratadine back into clinical development. So this is very exciting news despite, you know, the the them hitting a little bit of a bump in the road last year or earlier this year, I should say. We've also seen Pneumora as well moving two compounds into phase one. I think, you know, we and others are strongly believing in the m four PAM space.

Operator

You know, we are moving forward a compound which is a once daily small molecule. Now we all know that in schizophrenia compliance is an issue. So, you know, while at the moment, the development within urosterics is very focused on, you know, on moving through phase one and then into a phase two study. And I'm sure m four PAMs will be developed into longer acting formulations, not because they need to be, but just from a compliance point of view. That's the comment that I can make on the the m four PAM program within your studies, and I'll hand over to Misha to comment on the on the GABA B.

Speaker 1

Yeah. From the range of GABA B PAMs that we had, we intentionally selected a centrally acting compound in order to broaden and maximize the range of chronicle patients that we can aim at. This has been discussed a number of times with KOLs, and the progress of nalbuphine nicely captures the potential of centrally acting attitudes and drugs and their superiority over peripherally restricted attitudes of drugs such as gefapixant and other p two x three inhibitors. We saw very robust effect of Norbufin IPF cough patients, and also the recent data, they replicated this effect in refractory chronic cough patients. So that suggests that indeed the central approach, the central activity is essential for achieving maximal coverage of variety of patients within chronic cough domain.

Speaker 3

Thank you very much for that clarification. Very helpful.

Speaker 2

Thank you. You. There are no further questions showing. Thank you, ladies and gentlemen. This brings the main part of our conference to a close.

Speaker 2

And I would like to hand back to Mr. Tim Dyer for the closing remarks.

Operator

Well, thank you everyone for attending, our half year twenty twenty five conference call, and we look forward to speaking to you again soon. And wish you all a very pleasant rest of your day.

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