Half Year 2025 Addex Therapeutics Ltd Earnings Call and Busines Update
We will provide an update on our R&D programs.
Draw your attention to the press release and the financial statements issued yesterday, which are available on the 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 Michelle who will review in more detail on our Gaba Pam preclinical program for call.
I will then review.
Financial results.
Following that we will open the call.
Questions.
The first half of 2025 has been has seen several important achievements across our pipeline. We've made excellent progress in our Gaba Pam program with our partner <unk> successfully completing IND, enabling studies with that selective drug candidate substance use disorders.
As a reminder, under the terms of the agreement <unk> is eligible for payments up to $330 million of successful achievement of Prespecified regulatory clinical and commercial milestones as well as tiered royalties on the level of net sales from high single digit 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.
We have selected a compound to advance our own independent Gaba Pam program for the treatment of chronic cough.
Operator: Good day and thank you for standing by. Welcome to the Addex Therapeutics Half Year 2025 Financial Results Corporate Day Conference Call and Webcast. 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, please 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 note that today's conference is being recorded. I will now hand the conference over to your speaker, Tim Dyer, CEO. Please go ahead, sir.
Speaker #2: Good day, and thank you for standing by. Welcome to the Addex Therapeutics half-year 2025 financial results corporate update conference call and webcast. At this time, all participants are in a listen-only mode.
We have substantially completed preclinical profiling of a selective drug candidate and recently published robust antitumor data in multiple preclinical models.
Michel will speak about this exciting data later in our presentation.
Speaker #2: After the speakers' presentation, there will be a question and answer session. To ask a question during the session, please press star one and one on your telephone.
We also regained rights to our emblem to positive allosteric modulator program, including the phase two asset <unk> 1149 from our partner Johnson <unk> Johnson.
Speaker #2: You will then hear an automated message advising that 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.
We are currently evaluating a number of therapeutic indications for the future development of this program.
Speaker #2: Please note that today's conference is being recorded. I would now like to turn the conference over to your speaker, Timothy Dyer, CEO. Please go ahead, sir.
We have repositioned that prochloron RMB <unk> five negative modulator.
Brain injury recovery and recently entered into an option agreement, giving us access to an exclusive license to intellectual property covering the use of <unk> in this interesting therapeutic indication.
Tim Dyer: Thank you. Hello everyone. I'd like to thank you all for attending our Half Year 2025 Financial Results Conference Call. I'm here with Mikhail Kalinichev, who will provide an update on our R&D programs. I draw your attention to the press release and the financial statements issued yesterday, which are available on the 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 in more detail our GABAB PAM preclinical program for cough. I will then review our financial results. Following that, we will open the call for questions. The first half of 2025 has seen several important achievements across our pipeline.
Speaker #3: Thank you. Hello, everyone. I would like to thank you all for attending our half-year 2025 financial results conference call. I am here with Mikhail Kalinichev, who will provide an update on our R&D programs.
In June we invested in select club, a private clinical stage neurodevelopmental disorder focused company.
Speaker #3: I draw your attention to the press release and the financial statements issued yesterday, which are available on the website. I also draw your attention to our disclaimer.
Select has developed proprietary precision medicine patient transportation technology platform, which allows the company to select patients based on that underlying biological dis regulation, rather than the behavioral phenotypes.
Speaker #3: 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.
Proof of concept for the platform has been demonstrated by applying.
The technologies.
Speaker #3: Before reviewing our pipeline, I will then hand over to Misha, who will review in more detail our GABAB-PAM preclinical program for cough. I will then review our financial results. Following that, we will open the call for questions.
To identify and develop drugs in sub populations of patients suffering from autism spectrum disorders.
We believe that electric technology platform can be broadly applied to other disease areas, where patients are defined based on behavioral phenotype, where there is significant heterogeneity within the patient population.
Speaker #3: The first half of 2025 has seen several important achievements. Across our pipeline, we have made excellent progress in our GABAB-PAM program, with our partner INDIVIO successfully completing I&D enabling studies with their selective drug candidate for substance use disorders.
Moving onto the financials, we completed at the half year with $2 3 million Swiss francs of cash, which provides us with a cash runway through mid 2026, I'd like to highlight that the cash burn has been significantly reduced following the neurostar spin out transaction.
Tim Dyer: We've made excellent progress in our GABAB PAM program with our partner Indivior successfully completing R&D enabling studies with their selected drug candidate for substance use disorders. As a reminder, under the terms of the agreement, Addex Therapeutics is eligible for payments of up to $330 million on successful achievement of pre-specified regulatory, clinical, and commercial milestones, as well as tiered royalties on the level of net sales from high single 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. We have selected a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. We have substantially completed preclinical profiling of our selected drug candidate and recently published robust antitussive data in multiple preclinical models of cough.
Speaker #3: As a reminder, under the terms of the agreement, Addex is eligible for payments of up to $330 million on successful achievement of pre-specified regulatory, clinical, and commercial milestones, as well as tiered royalties on the level of net sales from high single-digit up to low double digits.
However, current cash does not fund progression of our unimportant programs finish.
Yeah.
Now for a quick review of our pipeline, we continue to believe in the plant switching our plans to reposition development.
Three of the drug for brain injury recovery.
Speaker #3: Also, under the terms of the agreement, we have the right to select compounds for development in a pre-defined list of reserved indications. We have selected a compound to advance our own independent GABAB-PAM program for the treatment of chronic cough.
As mentioned our partner <unk> drug candidate for development and substance use disorders and successfully completed our IND, enabling studies.
We are advancing our independent Gaba Pam program for chronic cough and already just R&D, enabling studies subject scaring financing.
Speaker #3: We have substantially completed the preclinical profiling of our selected drug candidate and recently published robust anti-tussive data in multiple preclinical models for cough. Misha will speak about this exciting data later in our presentation.
<unk> has made excellent progress in advancing its pipeline, including completing IND, enabling studies for them.
Tim Dyer: Misha will speak about this exciting data later in our presentation. We also regained rights to our mGlu2 NAM program, including the Phase II asset ADX71149 from our partner Johnson & Johnson. We are currently evaluating a number of therapeutic indications for the future development of this program. We have repositioned dipraglurant, our mGlu5 NAM 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 mGlu5 inhibitors in this interesting therapeutic indication. In June, we invested in Stalicla, a private clinical stage neurodevelopmental disorder-focused company. Stalicla has developed a 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.
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 Michelle who will give you some more details about our exciting portfolio.
Thank you Tim.
Let me start with a couple of deep allosteric modulator program, which is partnered with <unk> the.
The aim of this collaboration is to deliver at <unk> Buc Wilson for substance use disorders.
As a reminder, <unk> receptor activation has been clinically validated in a number of disease areas using backward <unk> Ultra series all goodness.
<unk> is FDA approved for treatment of spasticity and is widely used off label to treat numerous diseases, including substance use disorders.
However, <unk> has a short half life and comes with significant side effects Humphery, it's wider use.
There is a strong need for a better backlog.
Tim Dyer: 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 Stalicla'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. Moving on to the financials, we completed the half year with CHF 2.3 million of cash, which provides us with a cash runway through mid-2026. I'd like to highlight that the cash burn has been significantly reduced following the new Neurosterix spin-out transaction. However, current cash does not fund the progression of our unpartnered programs into the finish. Now, for a quick review of our pipeline, we continue to believe in dipraglurant and are executing our plans to reposition the development of the drug for brain injury recovery.
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 <unk> has selected a Gaba Pam drug candidates for development in substance use disorders and completed our IND, enabling studies in H one 2025.
Yeah.
As part of our agreement with <unk> <unk> has exercised its right to select a compound to advance its own independent Gaba Pam program for the treatment of chronic cough I will now present this exciting opportunity.
There is a strong rationale for developing <unk> for chronic cough.
Protocols is a persistent calls that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infections asthma allergies and acids reflux, but also by cost hypersensitivity syndrome.
Tim Dyer: As mentioned, our partner Indivior has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed R&D enabling studies. We are advancing our independent GABAB PAM program for chronic cough and are ready to start R&D enabling studies subject to securing financing. Neurosterix has made excellent progress in advancing its pipeline, including completing R&D enabling studies for their M4 PAM program. The program is on track to dose patients this year, and we expect to be able to announce further progress in the coming months. Now, I will hand over to Misha, who will give you some more details about our exciting portfolio.
There is a large unmet medical needs in <unk>.
Antitrust suit drugs as current standards of care are ineffective in 30% of patients and only moderately effective at up to 60% of patients.
In addition, the current treatments carry risks of serious side effects.
On the next slide we show that <unk> are likely to have a superior tolerability profile in comparison to the current standards of care and show no case related side effects.
Mikhail Kalinichev: Thank you, Tim. Let me start with GABAB positive allosteric modulator program, which is partnered with Indivior. The aim of this collaboration is to deliver a better baclofen for substance use disorders. As a reminder, GABAB receptor activation has been clinically validated in a number of disease areas using baclofen, a GABAB allosteric agonist. Baclofen is FDA approved for treatment of spasticity and is widely used off-label to treat numerous diseases, including substance use disorders. However, baclofen has a short half-life and comes with significant side effects hampering its wider use. Thus, there is 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.
Now, I will hand over to Misha, who will give you some more details about our exciting portfolio.
As seen with our newly approved pizza extra inhibitor give up itself.
Support for using up of his house in treatment of chronic cough.
Thank you, Tim. Let me start with GABA B positive, our story-modulated program, which is partnered with Indivior. The aim of this collaboration is to deliver a better baclofen for substance use disorders.
On the clinical evidence that Aqua.
About the agonist is used off label in cough patients and from the anatomical evidence that <unk> receptors are strongly expressed in Airways and then the eurodollar pathway regulated cost.
As a reminder, Gaba B receptor activation has been clinically validated in a number of disease areas.
Using B, A Gaba.
Therefore, we believe that <unk> could offer superior efficacy in <unk> patients.
Is FDA approved for treatment of spasticity and is widely used off-label. To treat numerous diseases including substance use disorders.
With pre R&D activities, including in vivo proof of concept studies non GOP talks and CMC has been completed our clinical candidate has shown favorable efficacy tolerability and develop ability profile.
However, bacon has a short half-life and comes with significant side effects, hampering its wider use. Thus, there is a strong need for a better Buckler.
The compounds has demonstrated a consistent minimum effective dose kick.
<unk> and <unk> of 60 in models of cost can be.
Mikhail Kalinichev: Our partner Indivior has selected a GABAB PAM drug candidate for development in substance use disorders and completed R&D enabling studies in H1 2025. As part of our agreement with Indivior, Addex has exercised its right to select a compound to advance its own independent GABAB PAM program for the treatment of chronic cough. I will now present this exciting opportunity. There is a strong rationale for developing GABAB PAM for chronic cough. Chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infections, asthma, allergies, and acid reflux, but also by cough hypersensitivity syndrome. There is a large unmet medical need in novel antitussive drugs, as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60% of patients.
Better than that tobacco fan, but with a longer half-life and an improved side effect profile.
No signs of tolerance were seen after sub clothing doses.
And more than 64 safety margin was demonstrated based on respiratory depression and sedation biomarker.
Our partner, Indivior, has selected the GABA-B PAM drug candidate for development in substance use disorders and completed IND-enabling studies in H1 2025.
The IND, enabling studies are planned to start this year.
In the volatile of citric acid reduce costs in key pigs, acutely administered compound <unk> delivered a robust anti juices efficacy, reducing the cost number dose dependency and achieving 70% reduction at the maximum dose.
As part of our agreement, Addex has exercised its right to select a compound to advance its own independent government program for the treatment of chronic cough.
I will now present this exciting opportunity.
There is a strong rationale for developing double V Pam for chronic cough.
The antitrust suit profile of compound they was similar to that of <unk> already done <unk> and Cody.
Okay.
Compounding <unk> also increased the latency to first close dose dependent fleet thus.
The onset of <unk>.
Its profile in delaying onset with similar measure that of retro trucks.
In the same experiment compounds appeared well tolerated as there were no market changes and respiratory rate at up to 6% kick in contract. In contrast, now bluefin or rapidan baclofen and codeine resulted in robust reductions of respiratory rate had their highest dose.
Mikhail Kalinichev: In addition, the current treatments carry risks of serious side effects. On the next slide, we show that GABAB PAMs 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 P2X3 inhibitor, Gefapixant. Support for using GABAB PAMs 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. The pre-R&D 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.
Chronic cough is a persistent cough that lasts for more than 8 weeks and can be caused by a variety of factors, including respiratory infections, asthma, allergies, and acid reflux. It can also be caused by cough hypersensitivity syndrome. There is a large unmet medical need in this area.
In addition, the current treatments carry risks of serious side effects.
Indicative of sedatives.
When evaluating.
Evaluation of the antitrust efficacy across compounds was down at the respective highest doses free from respiratory effects compound <unk> was shown to be superior to now moving over to Chuck Baclofen and coding in both number and coastal agency measures.
On the next slide, we show that GABA V pams 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 PTO X3 inhibitor, GABA itself.
Reductions in body temperature corrosion specific biomarker or Gaba b receptor occupancy of the brain suggests that at six Sigma for kimco.
Support for using GABA's, hands in treatment of chronic cough, comes from clinical evidence that GABA B agonists are used off-label in core patients and from the anatomical evidence that GABA B receptors are strongly expressed in the airways and in the neuronal pathways regulating cough.
IDEXX compound they are less than 50% Gaba b receptors occupied in contrast to near 100% occupancy at <unk> can keep all farquhar.
Therefore, we believe that Gaba B paths could offer Superior efficacy in Co patients.
Increases in growth hormone plasma at translational biomarker of Gaba B receptor occupancy in the brain confirmed less than 50% percent receptor.
Mikhail Kalinichev: The compound has demonstrated a consistent minimum effective dose of 1 micro kg and ED50 of 6 micro kg in models of cough in vivo. No signs of tolerance were seen after sub-chronic dosing, and more than 60-fold safety margin was demonstrated based on respiratory depression as sedation biomarker. The R&D 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 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 nabiximols 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 to that of reference drugs.
The pre-id activities, including in Vivo proof of custom studies known glp tox and CMC have been completed. Our clinical candidate has shown favorable efficacy tolerability and developability profile.
Ultimately, it's up to six.
Okay.
The compound has demonstrated a, a consistent minimum effective dose of 1, M kick and ed50 of 6. Mm kick. It models of cough in Vivo
Following sub chronic administration.
Four seven days compounded showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment.
No signs of Tolerance were seen after sub chronic doses closing and more than 60 ft. Safety margin was demonstrated based on respiratory depression, as sedation biomarker,
No marks changes in respiratory rate quoted temperature and growth hormone, we have seen in sub chronic versus that.
The IND-enabling studies are planned to start this year.
This compound.
And the model of ETP potentiate, its citric acid called Edp.
Head to head comparison experiments should forget administered compound.
In the model of citric acid, induced cough in guinea pigs. Acutely administered, compound a delivered, a robust anti-us. Efficacy reducing the Cog number. Those dependently and achieving 70% reductions at the maximum doses.
Exhibited a trend of better efficacy and potency in comparison to that of <unk> inhibitor, while showing signs of similar tolerability.
The attitudes of profile of compounds. A was similar to that of nalbin, or repetitive buckles and coding
In summary, we have selected our clinical candidate for chronic cough with a robust reproducible attitude efficacy or one week per kipp and good PK PD. The compound has the potential to have the best in class.
Compound. They also increase the latency to first scope those dependently, thus delaying the onset of the call.
Mikhail Kalinichev: In the same experiment, compound A appeared well tolerated, as there were no marked changes in respiratory rate at up to 60 micro kg. In contrast, nabiximols or repitant, baclofen, and codeine resulted in robust reductions of respiratory rate at their highest doses, indicative of sedative-like effects. When evaluation of the antitussive efficacy across compounds was done at the respective highest doses free from respiratory effects, compound A was shown to be superior to nabiximols or repitant, baclofen, and codeine in both cough number and cough latency measures. Reductions in body temperature, rodent-specific biomarker, or GABAB receptor occupancy in the brain suggest that at 60 micro kg of Addex compound, there are less than 50% GABAB receptors occupied, in contrast to near 100% receptor occupancy at 3 micro kg of baclofen.
Its profile in delaying of onset with similar or better than that of reference drugs.
Best in disease efficacy and Tolerability profile and broad application in cough patient.
The compound showed at favorable develop ability profile in non GOP Tox studies performed in rats dogs and non human primate.
In the same experiment, compound A appeared well tolerated, as there were no marked changes in respiratory rate at up to 16 per kick in contract. In contrast, now, buffing or Rapidan bleed, and codeine resulted in robust reductions of respiratory rate at their highest doses, indicative of sedative-like effects.
Subject to raising financing we are ready to start the IND, enabling study.
when evaluating
This concludes our prepared remarks.
Our RSV program.
uh, when evaluation of the anticus compound was done at the respective highest doses, free Prosperity effects,
Now I'll hand, it back to Tim.
Thanks, Felicia now for a review of our Q2.
25 financial.
Compound a was shown to be superior to now buffing or repetitive backload and coding in both of number and Co latency measures.
Starting with the income statement.
Income decreased $5 1 million in Q2, 2025, compared to 2024 and amounted to <unk> 1 million. The decrease was primarily due to the completion of the funded research phase of our collaboration with <unk>.
Reductions in body temperature, rodent-specific biomarker, or GABA B receptor occupancy in the brain suggest that at 60 m.
Okay.
R&D expenses of <unk> 2 million, primarily related to our <unk> program and decreased by $3 1 million in Q2 2025 compared to Q2 2024.
Mikhail Kalinichev: Increases in growth hormone release in plasma, a translational biomarker of GABAB receptor occupancy in the brain, confirmed less than 50% receptor occupancy at up to 60 micro kg of compound A. Following sub-chronic administration for seven days, compound A showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment. No marked changes in respiratory rate, body temperature, and growth hormone were seen in sub-chronic 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 P2X3 inhibitor, while showing signs of similar tolerability. In summary, we have selected a clinical candidate for chronic cough with a robust reproducible antitussive efficacy of one microkick and good PKPD.
Near 100% occupancy at 3 mi per kick of backward.
And again, mainly due to the completion of the research phase of our collaboration with individuals.
Yeah.
G&A expenses.
Increases in Gross hormones, religion, plasma a translational, biomarker of Gaba. B receptor occupancy in the brain, confirmed less than 50% recent occupancy at up to 16 week of compound.
<unk> 5 million decrease.
<unk> $0 1 million in Q2, 2025, compared to Q2 2024, primarily due to decreased legal fees.
Following sub chronic Administration.
The share of net loss from the 20% participation in <unk> group accounted.
For 7 days, compound treatment showed signs of improved efficacy, which is important. We see no signs of tolerance in comparison to an acute treatment.
For using the equity method since April and second the 'twenty 'twenty four increased by $7 million.
Wanted to one 2 million for Q2 2025 compared to Q2 2024.
No marked changes in respiratory rate, body temperature, and growth hormone waste were seen in sub-chronic versus acute treatment conditions with Compound A.
Under our price we are required to recognize our share of their results.
Which is a net loss.
Now to the balance sheet.
Our assets are primarily held in cash and we completed a $1 2025 to $2 3 million Swiss francs of cash held in Swiss francs in U S dollars.
In the model of ATP, potentiated citric acid cough in Gibbs in a head-to-head comparison. The experiment actually administered compound A, which exhibited a trend of better efficacy and potency in comparison to that of the P2X3 inhibitor, while showing signs of similar tolerability.
Other current assets amounted to <unk> 4 million, primarily related to prepaid R&D and G&A costs.
Our non current assets.
Mikhail Kalinichev: The compound has the potential to have the best in class, best in disease efficacy, and tolerability profile and broad application in cough patients. The compound showed a favorable developability profile in non-GLP tox studies performed in rats, dogs, and non-human primates. Subject to raising financing, we are ready to start the R&D enabling study. This concludes our prepared remarks on the summary of our R&D progress. Now I hand it back to Tim.
1.8 million as of June 30th.
Primarily related to the 20% equity interest in <unk> group recorded on the balance sheet under the equity method of accounting for associates.
In summary, we have selected a clinical candidate for chronic cough with robust, reproducible antigens, efficacy of 1 m per kick, and good PK/PD. The compound has the potential to be best in class.
And our investments in select clubs.
Best disease, efficacy, and tolerability profile and broad application in Cork patient.
Current liabilities of $1 1 million.
At the end of June increased $5 3 million compared to December.
The compound showed a favorable developability profile in non-GLT talk studies performed in rats, dogs, and non-human primates.
<unk> thousand 24, primarily due to increased payables.
Subject to raising financing, we are ready to start the IND-enabling studies.
Non current liabilities of $1 1 million at the end of June decreased by $1 1 million compared to the end of December primarily due to reduction in retirement benefit obligations following changes in financial assumptions.
This concludes our prepared remarks.
Rd progress.
Now, I hand it back to Tim.
Tim Dyer: Thanks, Misha. Now for a review of our Q2 2025 financials. Starting with the income statement, income decreased by CHF 0.1 million in Q2 2025 compared to 2024 and amounted to CHF 0.1 million. The decrease is primarily due to the completion of the funded research phase of our collaboration with Indivior. R&D expenses of CHF 0.2 million primarily related to our GABAB PAM program and decreased by CHF 0.1 million in Q2 2025 compared to Q2 2024, mainly due to the completion of the research phase of our collaboration with Indivior. G&A expenses of CHF 0.5 million decreased by CHF 0.1 million in Q2 2025 compared to Q2 2024, primarily due to decreased legal fees.
Thanks Misha. Now for a review of our Q2 2025 financials.
Now to summarize we have made excellent progress in our <unk> program with our partners <unk> successfully compete on DNA been studies with that compound.
Starting with the income statement.
Compounds for development and substance use disorders.
<unk> made excellent progress with our lead <unk> drug candidates successfully completing IND, enabling studies.
Income decreased by $0.1 million in Q2 2025 compared to 2024, amounting to $0.1 million. The decrease is primarily due to the completion of the funded research phase of our collaboration with individual.
We have strengthened the IP <unk> five non program in decline is ready to restart clinical development brain injury recovery.
I'll cover the cost program has demonstrated excellent preclinical efficacy and tolerability with DNA studies ready to start.
Validating partnerships with industry supported invest business on a reasonably strong balance sheet.
R&D expenses of 0.2 million, primarily related to our Gaba, V, Pam program, and decreased by 0.1 million Q2 2025 compared to Q2 2024. And again, mainly due to the completion of the research phase of our collaboration with individuals,
GNA expenses.
Puts us on a solid position to deliver on our strategic objectives. This concludes the presentation and we will now open the call for questions.
Of 0.5 million decreased.
Tim Dyer: The share of net loss from the 20% participation in Neurosterix Group accounted for using the equity method since April 2, 2024, increased by CHF 0.7 million and amounted to CHF 1.2 million for Q2 2025 compared to Q2 2024. Under IFRS, we are required to recognize our share of their results, which is a net loss. Now to the balance sheet. Our assets are primarily held in cash, and we completed H1 2025 with CHF 2.3 million of cash held in Swiss francs and U.S. dollars. Other current assets amounted to CHF 0.4 million, primarily related to prepaid R&D and G&A costs. Our non-current assets are CHF 5.8 million as of June 30, primarily related to the 20% equity interest in Neurosterix Group recorded on the balance sheet under the equity method of accounting for associates and our investment in Stalicla.
Okay.
By $0.1 million in Q2 2025 compared to Q2 2024, primarily due to decreased legal fees.
Thank you.
To ask a question. Please press star one and one on your telephone and wait for your name to be announced until we've got your question. Please press star one and one again once again, please press star one and one on your telephone and wait for your name to be announced until we've got your question. Please press star one and one again to ask a question about the webcast for today's access Pls.
The share of net loss from the 20% participation in Euro, sterics group accounted.
for using the equity method since April, the 2nd of 2024 increased by 7 million,
And amounted to 1.2 million for Q2 2025.
Compared to Q2 2024.
Question Todd Thank you.
Now going to proceed with our first question.
Under IFS, we are required to recognize our share of their results.
Which is a net loss.
now, to the balance sheet,
And the question is come from the line of <unk> Sundararajan from H C. Wainwright <unk> co. Please ask your question.
Our assets are primarily held in cash, and we completed H1 2025 with CHF 2.3 million in cash held in Swiss Francs and US dollars.
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 neuropsychiatric space both from a precedent M&A as well as the licensing standpoint that might conceivably have implications for both Neurostar X and select class.
The current assets amounted to $0.4 million, primarily related to prepaid R&D and G&A costs.
And also if you could comment on select close future funding requirements as well as the possibility.
Are non-current assets of 5.8 million as of June 30th, primarily related to the 20% Equity interest in neuroservices.
Tim Dyer: Current liabilities of CHF 1.1 million at the end of June increased by CHF 0.3 million compared to December 2024, primarily due to increased payables. Non-current liabilities of CHF 0.1 million at the end of June decreased by CHF 0.1 million compared to the end of December, primarily due to the reduction in retirement benefit obligations following changes in financial assumptions. To summarize, we have made excellent progress in our GABAB PAM program with our partner Indivior successfully completing R&D enabling studies with their selected compound for development in substance use disorders. Neurosterix has made excellent progress with their lead M4 PAM drug candidate successfully completing R&D enabling studies. We have strengthened the IP in our mGlu5 NAM program, and dipraglurant is ready to restart clinical development for brain injury recovery. Our GABAB PAM cough program has demonstrated excellent preclinical efficacy and tolerability with R&D enabling studies ready to start.
And our investment in Split Club.
Current liabilities are 1.1 million.
<unk> public listing for that entity. Thank you.
At the end of June increased, 5.3 million compared to December.
Okay. Thank you very much round to that.
<unk>.
2024, primarily due to increased payables.
<unk>.
I mean, it's it's very encouraging to see that there is continued renewed.
The excitement within the neuropsychiatry CNS space.
As you know very well this all started at the back end of 2023 and continue through 2024 and now we see renewed interest with the number of recent transactions.
Non-current liabilities of $0.1 million at the end of June decreased by $0.1 million compared to the end of December, primarily due to the reduction in retirement benefits of the GS following changes in financial assumptions.
<unk>.
But we are strong believers in CNS.
And again we've.
The first spun out numerous derricks and with 65 million in financing in our series a in April last year really to as a financing mechanism to get our portfolio of Neurostar cassette smoothing.
Studies with their selected compound for development, substitutes disorders, and neuroses made excellent progress with their lead M4 PAM drug candidate successfully completing IND enabling studies.
We have strengthened the IP and RML-5, NAN program, and Dupin is ready to restart clinical development for brain injury recovery.
And they are moving very very nicely.
Really cannot speculate about.
Tim Dyer: We have validating partnerships with industry, supportive investors, and a reasonably strong balance sheet, which puts us in a solid position to deliver on our strategic objectives. This concludes the presentation, and we will now open the call for questions.
The future of <unk> as we are.
Our Gather V, PAM Cough program has demonstrated excellent preclinical efficacy and tolerability, with IND studies ready to start.
A passive investor now only holding 20%.
With respect to <unk>.
The late class.
And select.
<unk> is currently pursuing a number of strategies around financing.
Operator: Thank you. As a reminder to ask a question, please 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. Once again, please 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. To ask a question via the webcast, please access the Ask a Question tab. Thank you. We are now going to proceed with our first question. The questions come from the line of Raghuram Silvaraju from HC Wainwright & Co. Please ask your question.
You know, validating partnerships with industry support from investors and a reasonably strong balance sheet puts us in a solid position to deliver on our strategic objectives. This concludes the presentation, and we will now open the call for questions.
As a as a most.
Reminder to ask a question, please press.
Biotechs private biotechs that are looking for money.
They are discussing actively with.
Potential pharma partners.
At the <unk>.
Preclinical.
Sorry.
The pipeline level, but also at the platform level as you know one of the things that stood at close upon it in.
And wait for your name to be announced 2 weeks ago. Your question, please, press star 1 and 1. Again once again, please 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 to ask a question about the webcast, please access the ask a question tab. Thank you.
We are not going to proceed with our first question.
And potentially as world leader in disability too.
To stratify patients.
Based on their underlying biological dysregulation as opposed to just.
[Analyst]: 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&A as well as a licensing standpoint that might conceivably have implications for both Neurosterix and Stalicla, and also if you could comment on Stalicla's future funding requirements as well as the possibility of public listing for that entity. Thank you.
So that's been based on phenotypes.
And the questions come from the line of raguram selvaraju from HC, Wayne Wright and Co please ask your question.
Much focus the platform on autism spectrum disorders.
In the developed portfolio in house, we're very excited about what they are doing now.
Now the financing need that pursuing.
A number of discussions with investors.
To do a series C financing.
And.
We will continue to be very supportive of what they are doing.
So I hope that answers your question.
Yeah, no very helpful. Two other very quick ones if I may.
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 neuros psychiatry space, both from a precedent M&A as well as a licensing standpoint that might conceivably have implications for both Neurotic and Stella. Also, if you could comment on Celica's future funding requirements, as well as the possibility of a public listing for that entity. Thank you.
Mikhail Kalinichev: Okay. Thank you very much, Ram, for that question. It's very encouraging to see that there is continued renewed excitement within the neuropsychiatry CNS space. As you know very well, this all started at the back end of 2023 and continued through 2024, and now we see renewed interest with a number of recent transactions. We are strong believers in CNS, and we've spun out Neurosterix with $65 million in financing in the Series A in April last year, really as a financing mechanism to get our portfolio of neuropsych assets moving, and they are moving very, very nicely. I really cannot speculate about the future of Neurosterix as we are a passive investor now, only holding 20%. With respect to Stalicla, Stalicla is currently pursuing a number of strategies around financing.
Notwithstanding the inability to speculate on the future of Neurostar because 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 Neurostar acts as the long term strategy in targeting the neuroscience.
Okay, thank you.
That's uh, that question. Um,
Space and also if you could comment on the ideal or optimal target patient population for your chronic cough program specifically as this pertains to.
I mean, it's, uh, it's very encouraging to see that there is, you know, continued renewed, um, you know, excitement within the, uh, the Neuroscience Psychiatry CNS space. I mean, as you know very well, this all started at the back end of 2023 and continued through 2024. And now we see renewed interest with a number of recent transactions.
But we are strong Believers in CNS. Um,
Those patients who have chronic cough of specific etiology to what extent you've already determined what the ideal target patient population would be for future clinical development. Thank you.
Yeah.
Okay save us.
Two questions that I'll leave may shift to the.
The question on chronic tolls.
I mean with regard to the muscarinic M for space I mean, we all.
And and again we've you know, we first spun out neuros sterics um with 65 million, in financing in a series, a in April, last year really to as a financing mechanism to get our portfolio of neuros. Psych assets moving, uh and they are moving very, very nicely. And I really cannot speculate about uh, you know, the future of newer sterics as we are a uh,
We are all fully aware that Corona has launched.
You know, a passive investor. Now only holding 20%
K C.
This new class of.
Of of antipsychotic is getting a lot of traction I mean, there's a number of <unk>.
Mikhail Kalinichev: As are most private biotechs that are looking for money, they are discussing actively with potential pharma partners, both at the preclinical, sorry, at the pipeline level, but also at the platform level. As you know, one of the things that Stalicla has pioneered and potentially is a world leader in is this ability to stratify patients based on their underlying biological dysregulation as opposed to just selecting based on phenotypes. They very much focus the platform on autism spectrum disorders. They've developed a portfolio in-house. We're very excited about what they're doing. The financing need, they're pursuing a number of discussions with investors to do a Series C financing, and we will continue to be very supportive of what they are doing. I hope that answers your question.
<unk> is out there both in the fixed dose combination area, but we are very focused.
Neuroscience is very focused on the.
On that absolutely select to them for Pam.
As you know and Abbvie have now moved moving there and for Pam and ratcheting back into clinical development.
With respect to, um, the liqui. Um, the liqui um, is currently pursuing a number of strategies around financing, um, as as our most, um, biotechs private biotechs that are looking for money. Um, they are discussing, you know, actively with, uh, you know, potential farmer Partners both at the, at the pre-clinical. Sorry at the, um, the pipeline level, but also at the platform level,
So this is very exciting news despite the.
as, you know, 1 of the things that stood, it closed pioneered and
Hitting a little bit of a bump in the road.
Potentially, Addex Therapeutics Ltd is, you know, a world leader in this ability to...
to stratify patients.
Last year.
Four earlier this year I should say.
We've also seen in <unk>.
More as well moving two compounds into phase one I think.
Um you know based on their underlying biological dysregulation as opposed to just uh you know selecting based on phenotypes and they're very much focused, the platform on autism spectrum, disorders.
We and others are strongly believing in the M. Four.
Um, they've developed a portfolio in-house. We're very excited about what we're doing.
Pam space.
We are moving forward a compound which is a once daily.
Now, the financing need. They're pursuing, you know, a number of discussions with investors.
Um, to do a series C financing.
Small molecule.
Now.
We all know that in schizophrenia compliance is an issue.
And, um, we will continue to be very supportive of what they are doing.
So while at the moment the developments within <unk> is very focused on.
[Analyst]: No, very helpful. Two other very quick ones, if I may. Notwithstanding the inability to speculate on the future of Neurosterix, 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 Neurosterix's long-term strategy in targeting the neuropsych space. 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, to what extent you've already determined what the ideal target patient population would be for future clinical development. Thank you.
So I hope that answers your question.
Moving through phase, one and then into a phase III study.
And.
I am sure and for Pam.
It 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 <unk> program, but in your stacks and I'll hand over to Asia.
<unk>.
That would be.
The range for <unk>.
There'll be times that we had we intentionally selected essentially acting compound in order to broaden and maximize the range of clinical patients as we can.
A mix.
This has been discussed.
Mikhail Kalinichev: Okay. So there's two questions there. I'll leave Misha to answer the question on chronic cough. With regard to the muscarinic M4 space, we are all fully aware that Coruna has launched Cobenzi. This new class of antipsychotic is getting a lot of traction. There are a number of competitors out there, both in the fixed dose combination area, but we are very focused, Neurosterix is very focused on an absolutely selective M4 PAM. As you know, AbbVie have now moved, are moving their M4 PAM, Imratadine, back into clinical development. This is very exciting news, despite them hitting a little bit of a bump in the road last year, or earlier this year, I should say. We've also seen NUMORA as well moving two compounds into phase one. I think we and others are strongly believing in the M4 PAM space.
DX's long-term strategy in targeting the neurocytes. And also, if you could comment on the ideal or optimal Target, patient population for your chronic cough program, uh, specifically is this pertains to, uh, those patients who, uh, 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.
A number of times with Kols and the progress of bluefin.
Nicely captures the potential of centrally acting drugs and their superiority over peripheral the restricted.
Drugs, such as scale up except another pizza extreme temperatures, we saw very robust effects.
Okay. So there's um, yeah, there's 2 questions there. I'll leave Misha to answer the, um, the question, on on chronic Health. Um, I mean with regard to uh, the muscular inic M4 space. I mean, we all we are all fully aware that karuna has launched.
Notebooks in IPF.
Patients and also the recent data they replicated this effect in refractory chronic cough patients. So that suggest that indeed, the central approach central activity is essential for achieving maximal.
Coverage of <unk>.
<unk> page.
Patients within chronic cough.
Domain.
Thank you very much for that clarification very helpful.
Um, COI, um, you know, this new class of, um, of of antiscion. I mean, there's a number of of competitors out there both in the fixed dose combination area, but we are very focused. Oh well, we near a very focused on the um, on an absolutely selective M4. Pam, um, as you know, um, Abby have now moved, uh, moving their M4 Pam enacted in back into clinical development. And so this is very exciting news despite, you know, the
Thank you as a reminder to ask a question. Please press star one and one on your telephone and wait for your name to be announced until we've done. Your question. Please press star one and one again.
The, uh, the hitching of a little bit of a bump in the road, um, last year,
Or earlier this year, I should say. Um,
I'll ask a question via the webcast. Please access the ask a question tab.
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We've also seen new Mora moving to Compounds Interface 1. So I think, you know, we and others are strongly believing in the M4.
Mikhail Kalinichev: We are moving forward a compound which is a once-daily small molecule. We all know that in schizophrenia, compliance is an issue. While at the moment the development within Neurosterix is very focused on moving through phase one and then into a phase two study, I'm sure M4 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 M4 PAM program within Neurosterix, and I'll hand over to Misha for comments on the GABAB.
Okay.
Pam space. Uh,
you know, we are moving forward, a compound which is a 1 day uh small molecule. Um now
There are no further questions showing thank you ladies and gentlemen display brings the main part of our conference can be closed and I would like to hand back to Mr. Tim <unk>.
Losing remarks.
Well. Thank you everyone for attending our half year 2025 conference call and we look forward to speaking to you again soon and wish you all.
We all know that in schizophrenia compliance is an issue so you know while at the moment the development within your sterics is very focused on you know on moving through Phase 1 and then into a phase 2 study. Um
I'm sure M4. Pam.
Uh, we will be developed into, um, longer-acting formulations.
Very pleasant rest of your day.
Yeah.
[Company Representative]: Yeah. From the range of GABAB PAMs that we had, we intentionally selected a centrally acting compound in order to broaden and maximize the range of chronic cough patients that we can aim at. This has been discussed a number of times with KOLs, and the progress of nabiximols nicely captures the potential of centrally acting antitussive drugs and their superiority over peripherally restricted antitussive drugs such as gefapixant and other P2X3 inhibitors. We saw very robust effect of nabiximols in IPF cough patients, and also in the recent data, they replicated this effect in refractory chronic cough patients. That suggests that indeed the central approach, the central activity is essential for achieving maximal coverage of a variety of patients within the chronic cough domain.
Not because they need to be but just from a compliance point of view, um, that's uh, the comments that I can make on the, uh, the M4 Pam program within us Dax. And I'll hand over to Misha for comments on the, on the Gabby. Yeah. From the range of cover, the pams that we had, we intentionally selected essentially acting compound in order to broaden and maximize the range of Chronicle patient that we can, uh,
Payment.
Um, this
Has been discussed a number of times with kols and the progress of nalbin uh, nicely captures the potential of centrally acting, attitudes, and drugs, and their superiority over peripheral restricted, attitudes, drugs, such as giveaway, something, other P2 extreme inhibitors.
We saw very robust effect uh of notebooking ipf uh cough patients. And uh also in the recent data, uh they replicated this effect in uh, refractory chronic quotations. So that suggests that, indeed the central approach the central activity is essential for achieving a maximal. Um,
Uh, coverage of a variety of uh, patients within the chronic cough uh, domain.
[Analyst]: Thank you very much for that clarification. Very helpful.
Thank you very much for that. The clarification was very helpful.
Operator: Thank you. As a reminder to ask a question, please 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. To ask a question via the webcast, please access the Ask a Question tab. Please stand by while we compile the Q&A roster. This will take a few moments. Thank you. There are no further questions showing. Thank you, ladies and gentlemen. This brings the main part of our conference to a close, and I would like to hand back to Mr. Tim Dyer for the closing remarks.
Thank you as a reminder to ask a question. Please press *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 to ask a question via the webcast. Please access the "Ask a Question" tab.
Please stand by what we compare the Q&A roster. This will take a few moments. Thank you.
There are no further questions showing. Thank you, ladies and gentlemen; this brings the main part of our conference to a close, and I would like to hand back to Mr. Tim Dia for the closing remarks.
Tim Dyer: Thank you, everyone, for attending our Half Year 2025 Conference Call. We look forward to speaking to you again soon and wish you all a very pleasant rest of your day.
A half year 2025 conference call. Um we look forward to speaking to you again soon and wish you all a very pleasant rest of your day.
Operator: This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you.
This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you.