Thank you, Matthew, and good afternoon, everybody in Europe. Good evening, everybody in Asia, and good morning and early 6:30 A.M., have a good start into the day from Dana Point, California. As usual in the past years, we are spread over the world. The only person right now in our Milan offices is the CFO, as he should be. He is sitting on the money that we need to spend in the upcoming period. Our Chief Medical Officer, Ravi Anand, is right now preparing for the SIRS, Schizophrenia International Research Society Conference that starts tomorrow. I am attending the Capital Link conference at Dana Point. Welcome to this call. I hope you have had a chance to download the slide deck that we are going to guide you through. I will start with slide number four.
If we look back at the last 15 months, the period that we are reporting about, I will then do the outlook for 2026 and hand over to Ravi for the new signs and on the progress, and then to Roberto for the financials and the AGM meeting that is upcoming. If we look back, this has really been a period that couldn't have been much better. We practically hit all the click points. We made all the milestones. What I want to tell you already now is that for the upcoming 12 to 15 months, we might see even better outcome. Be prepared for that. If we look back, that is all about evenamide schizophrenia for the moment, we have to start with the deal that we signed in December 2024, the validating deal with EA Pharma from the Eisai group.
We did that deal with one of the top 10 Japanese pharma groups with a CMX-experienced company. There were some reasons. We wanted to validate our unique mechanism, the only drug that modulates glutamate in schizophrenia. We wanted to validate being the first add-on therapy in schizophrenia. We wanted to validate our claim that this is the drug that is the only one that qualifies to work in the vast majority of schizophrenia patients who are poor responders or treatment-resistant to the current medication. We wanted to get an indication of the intrinsic value of that compound, which by analysts was, after that deal was signed, estimated to be more than one and a half billion euros. Finally, we wanted to get the cash to perform our phase III study because at that time, the markets were very challenging on equity.
We got all that. Since we signed the deal, that is the starting point of the 2025 success story, we collected EUR 48 million, which was exactly the money we needed to advance our evenamide into the decisive pivotal study program called ENIGMA-TRS. As you know, that is split in two studies. One is ENIGMA-TRS 1, that is a 600 patients, one-year double-blind placebo-controlled study, which was finally enrolling first patients in August after we had gotten the approval for the overall program in May. This study is right now actively enrolling on all target continents, and Ravi will give you more update on the status. Importantly, in December, we could start ENIGMA-TRS 2, the second pivotal study. Two shots at target, even if one sufficiently positive study should do to get this drug approved.
We started ENIGMA-TRS 2 in the U.S. study centers, with UCLA, and since then have added Johns Hopkins and the other studies centers are ready to initiate. We have submitted the documentation in all the other countries in which we want to enroll patients. This study is up and rolling now, and again, Ravi will give you an update. Importantly, just by the beginning of this year, 2026, we could inform markets that also our partner, Eisai, has initiated their phase III program. Right now I can say this is the most advanced clinical program schizophrenia. We are right now running three pivotal studies in total with more than 1,300 patients in the world. As you will hear later on, we expect results from the 12 weeks readout within this very year.
We did have absolutely thrilling, I'm moving to slide five, we did have absolutely thrilling one-year results from a study in treatment-resistant schizophrenia when evenamide was added to best-selling antipsychotics. We did have the first highly statistically significant efficacy results from phase III study called 008A. There was plenty of questions given the new mechanism, the new positioning. It was very important that all the clinical results of the past have by now been peer-reviewed and published in the papers. We have presented them at numerous conferences. All the space is now being educated about the benefits of this drug in those patients in which today's medications just don't do good.
It was very important last year in August that University of Pittsburgh came up with a piece of research which could explain for the first time why in the phase II and phase III studies we saw that ever-increasing efficacy, doubling treatment responder rates by one year, 50% patients no longer qualify as treatment-resistant, and for the first time ever, treatment-resistant patients being reported to be in remission for six months. We didn't know why and how our drug would do that, and I think University of Pittsburgh has provided substantial explanation how this drug does so by qualifying schizophrenia as a disease that is substantially caused at the hippocampus where today's drugs simply don't hit, and that is why they do not improve negative symptoms, nor cognition, and why they only have limited benefits symptoms.
That work of Pittsburgh, now peer-reviewed and substantial support for the positioning of our compound and the explanation of the benefits we have shown. Again, starting this year, early 2026, we got another validation that is on a new composition of matter patent on the crystalline forms of evenamide, which has the potential to extend our exclusivity to 2044. That would be 17 years post expected approval of our compound, which we expect by end of 2027. Ahead of time, the European Patent Office declared their decision to grant this patent in Europe in early January.
The same patent is right now in the process of being reviewed, and we expect it to be approved also in all the other key territories, importantly, including the U.S., where again, this would give us exclusivity until 2044, and thus 17 years post the expected approval of this drug. On the corporate ends, I'm moving to slide six. All the excitement about our results and the initiation of the U.S. study triggered three U.S. analysts to start covering Newron and the fourth one joined from Europe. We got plenty of new coverage. We saw doubling or tripling liquidity in the stock. We are right now trading between 0.7 and 1% of the stock every day, which is clearly showing us that we get better coverage around the world and more people are looking at our stock.
This is a process that must be continued and even further improved. Very importantly, we also resolved two key issues on funding. Number one is that with existing shareholders and new shareholders from Europe and Asia, we signed a funding agreement in February this year, which will give us access to up to EUR 38 million, of which EUR 15 million are already in the bank, EUR 11 million will come before this year is over with no milestones attached, and the EUR 12 million remaining will come conditional to positive results of all our pivotal studies by end of year. That money being in the bank, we now have the funds to complete our ENIGMA-TRS 1 and 2 studies to the 12-point readouts.
We will have all the money to report on the primary endpoint after 12 weeks and the secondary endpoint, and we will be able to advance our drug into NDA submission, and we will have a number of months of reserves beyond that point in time. The second component of improving our financial situation was that we reached agreement with the European Investment Bank that all future payments under our loan agreement would be delayed at least by two years and a quarter to not before June 2028. We are now in a very good financial situation. We have three pivotal studies rolling, and we have all the cash required to get to read out. On the corporate ends again, our Board of Directors, it's already one year that Chris Martin has become our new Chairman.
I have to say that it's a marvelous cooperation between management and Chris, very much appreciated. He succeeded Ulrich Köstlin, who was our Chairman for the 12 years before. In order to now complete the new set up of our Board of Directors and have completely independent directors on the board, both Patrick Langlois, after 18 years of service on the board, and Luca Benatti after 12 years of service on the board, Luca was the last founder of the company, have declared they will not stand for re-election in this year's shareholders' meeting.
I think we can say that we have found two outstanding new candidates for the board, George Garibaldi, who is a highly respected individual with years of experience, and Paolo Zocchi, a senior ex-partner in a top four audit company, who are proposed for election by our shareholders as independent non-executive directors in the upcoming shareholders meeting. What should we expect for this year, 2026 and early 2027? I am moving to slide number seven. I think it is worth to start from the end. If you look at where we want to be in the end, and you remind for yourself what are our peers. The peers, latest companies with one product, major in schizophrenia, were Karuna and Intra-Cellular. Karuna was acquired once they had submitted the NDA for their one-product company or for their one product to the FDA.
They were acquired for $14 billion by Bristol Myers. Intra-Cellular were acquired after they had launched their own compound in the United States, commercialized it for a few years up to $680 million sales. With a market cap of $9 billion, they were then acquired by J&J for $15 billion. We are now the most advanced follow-up to those companies. What are we missing? Well, to be fair, we are missing positive results from our phase III program, and we will be getting to those results in the next 12 months. What they had, what we do not have, they were listed on NASDAQ. That is something we cannot ignore because, as we have lately seen again, about two-thirds of the global biotech money is traded in the United States.
Clearly, if you want to have full access to capital markets and you want to get a fair price, you should also have your shares listed on that largest stock exchange. What we need to do is we need to work the path towards results of our clinical program. We need to prepare our NDA dossier. The initiation of the work must start way ahead of the results. Something which is important, that evenamide does not only work in schizophrenia, but like all the other compounds, like Intra-Cellular's drug that has gone big in bipolar, this drug would also work in additional indications and I am also thinking of the elderly patients with dementia and psychotic episodes. This should be a perfect drug for those patients, and that is where additional indications should be pursued and Newron should start working on those.
Clearly, on the corporate side, we should strengthen our institutional shareholder base and we are working with a number of supporting agencies to do that. This all takes us to the shareholders' meeting of April 2026 of this year, because there is things that we can do on our own with the means we have and the tools we have, and there is steps where we need the support by our shareholders, and we need to get the tools from our shareholders. You have probably seen the agenda of the shareholders' meeting. There is the usual household stuff like approval of financials, there is the important elections of the board. You will see that we have also put on the agenda of the shareholders' meeting a capital increase authorization for 15% of the capital.
I do believe this is a moderate request, it's clearly a compromise between aggressive strategy and the wish of some shareholders not to see any dilution. Clearly, the intention is that those shares would be used to advance evenamide in indications beyond schizophrenia and to support us towards submitting the NDA dossier and getting our drug approved. Clearly, also, those shares might be used for a listing of our shares on a U.S. stock exchange like NASDAQ. These are all procedures that need months and months of preparations.
What we are asking our shareholders for right now is not to approve capital increase that will be put in place tomorrow, but what we ask them for is to give us the tools and the instruments that we need to start preparations and execute transactions at the right time, which also clearly means at the right share price to the right parties. If the question is an IPO, an up-listing of Newron stocks to NASDAQ an option today? The answer is probably not because we are missing key ingredients, including share price, results, and other components. What we ask our shareholders for is support, providing us the tools and allowing us to initiate the process. Your question might well be, is it worth? What is the opportunity? That takes us to slide number nine.
What we have to offer today is truly the opportunity to transform schizophrenia treatment with evenamide. This is the first compound that offers glutamate modulation in schizophrenia, we start understanding how much more important it is to go beyond the dopaminergic pathway drugs that have dominated schizophrenia in the last 70 years. This is a huge market opportunity. We talk about 1% of the global population, but the vast majority of patients is not well-treated by today's medication. The vast majority of patients is poorly responding or treatment-resistant. What it needs is a completely new mechanism of action. That is what we offer and what we need is a first-ever add-on treatment to be approved in schizophrenia. What we need is the option for doctors not to change the current medication, but to add a drug with no additional side effects of relevance, but with additional incremental benefit.
No risk of relapses, reduced risk of hospitalization, suicidality. That is the promise of such a new mechanistic drug and add-on to the current medications. evenamide is the first, and so far, only drug that qualifies as an add-on to any antipsychotic of relevance, importantly, including clozapine and rather the TAAR1 attempts. What we offer is highly exciting one-year phase II results of evenamide as an add-on to antipsychotics, as well as highly statistically significant first phase III result in a four-week study in poor responding patients. What we have seen is excellent tolerability, the most prevalent side effects being nasopharyngitis in the phase III study. I have already spoken about the potential of evenamide beyond schizophrenia that must clearly be evaluated, we have also covered the topic of the strong IP protection.
Right now, we have a composition of matter in the U.S. of 2035 and process patent to 2042. If we get this new composition of matter 2044, that would be 17 years of a truly innovative treatment in schizophrenia protection and market exclusivity post-approval. That all said, it's my pleasure to hand over to Ravi on slide 10 for the update on science and clinical.
Thank you, Stefan, good morning and good afternoon to everybody else. I think I'm going to start with slide 10. I think this is a schematic presentation of how we currently view schizophrenia. This has been brought out by the University of Pittsburgh and some other universities. Contrary to common belief, the schizophrenia symptomatology does not begin in the basal ganglia, but in the hippocampus. The hippocampus controls the rate of abnormal firing from the dopamine receptors in the basal ganglia. When it's not working, there is hyperfiring from the dopamine receptors, and that leads to some of the symptoms of schizophrenia. What has also become very clear is that the hippocampal nuclei control negative symptoms, control cognition. You need to have a drug working there.
All current antipsychotics work at the level of the basal ganglia, where you have the dopaminergic receptors. Therefore, they will never be able to reach the hippocampal nuclei. That is one of the reasons why we don't see any benefits in negative symptoms or cognition with currently available drugs. Evenamide acts at the level of the hippocampus. It has no activity at the basal ganglia at all. The data that I'll show you will convince you, based on the work done by University of Pittsburgh, that it works on all these facets. I'm moving now to the next slide number 11. This is the experiment done. I'm very briefly describing this experiment. You should really take the effort to read the paper, which is fully published and is on the Newron website.
In this experiment, what was done by University of Pittsburgh researchers is they take rats, they give them a DNA alkylating agent called MAM. MAM changes the brain structure, changes the cytoarchitecture. The progeny, which are born, basically show many of the symptoms and signs of patients with schizophrenia. It's a neurodevelopmental hypothesis model of schizophrenia. You see hyperactive firing from the hippocampal pyramidal neurons, and that is reduced in this model. That this model creates and then basically gets reduced by evenamide. What we see is the ventral tegmental area dopamine neuron population activity is hyper, and again, that is normalized by evenamide. Some of the most important findings are that the effects of evenamide outlast its presence in the brain. There's no way to explain it because the drug has a very short half-life, and this is way beyond that.
This suggests that we are having the induction of long-term plasticity, which should be a very welcome thing for patients with schizophrenia. Again, as I said before, you will see data which suggests that basically evenamide improves cognition and improves negative symptoms in these animal models and likely will be able to do that in patients. If I move to slide 12. This is a wonderful experiment, a little difficult to understand, so you need to just concentrate on it. If you look at the first bucket, that's looking at the effects on neurons. We're looking at the active dopamine neurons per track and how they're firing. If you look at the first two bars, there's no difference because it's only normal animals, so there's no effect of evenamide. The next two bars, you see the black bar, which is high up.
That's because that's showing you increased abnormal firing in the MAM-treated animals. The same MAM-treated animals, when they get evenamide, you can see there's a significant reduction. This is within one hour, and the drug half-life is about 25 minutes. If you look at the second hour, there's no drug, meaning the drug has no active metabolite. There's no sequestration. You see that the activity is actually increasing. The difference between the black bar and the blue bar is increasing. Even when the drug is not there, it's producing a benefit. If you look at the third hour, where there's no chance even of having the drug around, the effect of evenamide is going on increasing, reducing further and further the abnormal dopaminergic firing. Nobody's able to explain this.
We can't really fully explain this, except that this is a very welcome finding because what it suggests is that patients will continue to benefit from this drug for long periods of time. Moving on to slide 13. Negative symptoms are present in all patients with schizophrenia. Even when patients improve from positive symptoms, negative symptoms don't improve. One of the main reasons why patient functioning does not improve is because of the presence of negative symptoms. In this model, what you're seeing out here, we have a rat in the middle. The rat has a choice to go to a toy chamber where there's a toy or to a social chamber where there's a real rat. Rats are very inquisitive animals. They love to interact with each other. Therefore, what will happen? Next slide, which you see now.
What in the next slide is happening is we are looking at the MAM-treated animals. There, there is no difference between the toy chamber rat, the time spent sniffing or the real one. If you look at the third and fourth bars, you can see the MAM-treated animals are not able to distinguish between the toy, whereas the evenamide-treated animals recognize which is a real rat, and they're spending significantly more time on that. This is not because of any effect on locomotion, which is shown by the other graphs, but because the animal now wishes to socialize. Asocialization is a prominent feature in patients with schizophrenia, this suggests that this drug will improve social interaction. If I now move to the next slide. This is now looking at novel object recognition. This is a test of cognition.
We take the rat, we give it an object, it familiarizes itself by sniffing. We then take it away. One hour later, we introduce the old object and the new object. The rat, which is inquisitive, will memorize that, "Oh, this is the old object. I'm not interested. I want to go to the new object." Does this really happen? In the non-treated animals who have lost a lot of the neural architecture, there is no difference between the vehicle and the evenamide treated animals, because there's no deficit. If you look at the MAM-treated animals, cognitively, these animals are impaired. The amount of time they spent on the wrong model, which is the toy, the old object, has gone down. Evenamide is able to protect against that, and there's a significant improvement.
You're seeing an improvement in negative symptoms, you're seeing an improvement in cognition. We've already seen an improvement in firing rates. This leads us to the clinical data, which is shown in the next slide. I'll walk you through that. What have we seen till now? This is slide 18 now. Evenamide has shown efficacy in virtually every study performed, whether it be a 4-week study in early patients, a 4-week study in patients who are inadequate responders, and a 1-year study in patients with treatment-resistant schizophrenia. In all these studies, it was given as an add-on treatment. The benefits are far-ranging. They are seen in positive symptoms. They are seen in negative symptoms. The drug is very well tolerated. The attrition rate is less than 5%. The most common adverse event is nasopharyngitis, which means sniffing, and the same incidence as placebo.
What we've seen in the first phase III study that we did in patients with inadequate response more or less confirmed the results that we saw in the open-label study in treatment-resistant schizophrenia. It's one of the very few first times that I have ever seen in my life all efficacy endpoints came out significant in the phase III study, which is the ADA study. This is published also. All the endpoints reached statistical significance. What we're seeing is the side effect profile is so benign that you cannot tell the difference. We are basically looking at this, these results and the animal results because we are doing a 1-year study. We expect to see efficacy continuing to improve over 1 year. Just to remind everybody, in schizophrenia, we generally have improvement in 3 weeks, 4 weeks, but rarely after that.
That's why the FDA likes responses nowadays to limit the study to 4 weeks because after that, there's no real improvement. I move on to slide 19 to show you the study ADA, which I talked about, the potentially pivotal study, which has now been published everywhere. It's a 4-week study done in 11 countries, 291 patients, where patients who are on second-generation antipsychotic received either 30 milligrams BID of evenamide or placebo. All second-generation antipsychotics were allowed in this study. The patient had to be psychotic. The design is shown on the next slide. What we did in this study is at the very beginning of the study, we took blood samples to make sure the patients were really poor responders and not non-compliant patients.
We had the blood samples analyzed to make sure the concentration of the antipsychotic was at the right level to be able to ensure that they were getting a therapeutic dose. 30% of the patients had no measurable plasma levels, which tells us that they were non-compliant rather than inadequate responders. This study took us much longer to do because of this, of the difficulty of finding patients who are compliant with medication. Ultimately, we got 291 patients, and as you can see, the study went up to four weeks, which was the endpoint of the study. The drugs that were allowed in the study, the second-generation antipsychotics, are listed at the bottom, and they constitute about 90% of all second-generation antipsychotics in the market. Slide 21 shows you the side effect profile of the drug.
If you just look at the bottom part of the table where it says preferred term, the most common adverse event is nasopharyngitis. The incident is almost the same as placebo. Again, then headache, which seems to be almost the same as in placebo. What is more important is what you do not see out here. You do not see any extrapyramidal symptoms. You don't see tremor, you don't see akathisia, you don't see hyperkinesia. You don't see weight gain. You don't see diabetes. You don't see sexual dysfunction. No abnormal changes in the ECG or in the liver function test or kidney function test. No blood pressure changes at all. No severe sedation, no severe excitation. So it's a remarkably silent drug, which is ideal as an add-on treatment. If you now go to the next slide, which is slide 22, this gives you the primary results for the study.
In line with the expectations from FDA and from ICH requirements, the primary measure should be the PANSS total score. So we designated the PANSS as the primary estimate for the study. The analysis are done in the ITT population. As you can see from the fourth row, the null hypothesis, meaning there's no difference between drug and placebo, is rejected with a p-value of 0.006. The core secondary measure, which is the CGI of severity, meaning clinical global impression of severity, is also significantly reduced with a p-value of 0.037. That's not all. If you look at the next slide, this is showing you now the slope of the curve over a four-week period of time.
Obviously, this is not long enough, but you can imagine that if this study were to go on longer, the placebo group will keep on flattening, the drug group keeps on improving. Based upon this, we have designed the next studies. The next slide is showing you the simulation in which we are imagining what would happen at week 12 and what would happen at week 26 and 24. What you can see is based upon the data from the previous studies, it seems like at week 12, we would have about a 10-14 point difference, a 12-14 point difference from baseline. That is likely to be highly significant. Similarly, if you go to 26 weeks, we expect that basically we'll have a difference between 14 and 19 points compared to baseline. That's likely to be highly significant.
I'm showing you some very interesting data. This has been published again. We looked at what happens to other antipsychotics when evenamide is added. First, much to our surprise, the clozapine patients, clozapine is the most effective antipsychotic, and even those patients, when they get evenamide, improve by about another three points compared to clozapine alone. More surprising than that is olanzapine. Olanzapine is probably one of the most effective antipsychotics, has never come out second to any antipsychotic in any trial. Those patients, when they receive evenamide, they improve by about five points more than when they get olanzapine alone. This difference is statistically significant. Overall, it looks like whenever you get patients receiving evenamide on top of second-generation antipsychotic, they improve.
This leads us to believe that this could be a drug which could help all patients who are not doing well on their current medication. What are the other results like in this study? You can look at this in slide 26, where basically, we're looking, showing you the PANSS responder analysis, clinically significant, in other words, 20% improvement, which is considered clinically significant in treatment-resistant patients or poor responders. You can see the effect is increasing over time, and at day 29, which is significant. This rate, if it continues, you can imagine at week 12, we will have a very large difference between patients who are responders on current treatment as well as those who have current treatment and evenamide. It's not only on the PANSS. We now look at the CGI of change.
This is an analysis which takes into account only those patients who show much improvement, not minimal improvement, only much improvement. Once again, by day 29, you can see almost a doubling of the number of patients who are responders on evenamide. Again, a very nice outcome. If you continue this projection forward to week 12 and 26, we will have a very significant outcome. I'm now going to just very briefly mention the pivotal ENIGMA trials which are currently ongoing. I'm now on slide 29. This is the TRS-1, the treatment-resistant schizophrenia 1 study. This is a 52-week study. The first study ever done in treatment-resistant patients, which is placebo-controlled and 52 weeks. All patients have to be treatment-resistant, have to be diagnosed as treatment-resistant.
We confirm this by taking blood samples at the beginning, three times in 42 days, to make sure that they are really taking their medication, and even then they're not responding. These data are going to an independent eligibility committee, which really decides that these patients are actually treatment-resistant. Only the patients get randomized to 15 or 30 milligrams of evenamide or a placebo add-on. The study is very tightly monitored, and we will look at the primary results at 12 weeks, and the next results at 26 weeks, and the last result at 52 weeks. These results are the basis for which we will get the registration.
The 12-week endpoint is really necessary for showing the drug in an antipsychotic and will be the basis with which we file for regulatory approval, the first regulatory approval, both in CHMP in Europe as well as in the U.S. The second TRS study is a shorter study. It is a 12-week study that is currently ongoing also. That study's only got 400 patients into the 600 patients. That study has just started. It's got approval in virtually all of the countries that we want it to. Basically, we expect this study will also complete fairly quickly. We expect the TRS-1 study to complete enrollment by the end of August, which will provide us results by the end of the year and lead, hopefully, to an NDA filing around the first or second quarter of next year.
The TRS study will come in close behind that. We will be able to include the results in that package. With that, I turn it over. We have done a lot of congresses this year, sorry. You can see that on slide 32, we have a listing of all the congresses that we are presenting at. It's been a very busy season for us. Everybody's recognizing the value of evenamide and waking up to a new mechanism of action. All these papers, we have published a lot of papers, which you can also get from there. With that, I turn it over to Roberto. Thank you for your attention.
Thank you, Ravi, and good morning and good afternoon to everybody else. I am on slide 34. As you know, Newron is listed at SIX since December 26, and since June 29, we are also traded at the Düsseldorf Stock Exchange , XETRA. By the end of the year 2025, we had around 20 million shares outstanding. Currently, they are 20.8 million because of the capital increase Stefan was mentioning to you before. Always at the end of December 2025, we have outstanding call option and derivative, or warrants, if you prefer, of up to 1.6 million, of which 50% or less were related to call options, and the remaining 50% were the warrants that we have granted to EIB. Let me welcome three new U.S. banks among our analysts, and I am talking about Wainwright, Roth Capital, and Lucid.
They are on top of the already existing ones: Berenberg, B. Riley Securities, ValueLab, Edison, and Octavian. I am now moving to slide 35. Let us just talk about a few numbers. Licensing can decrease. Of course, in 2024, we booked the down payment of the EA Pharma deal. No surprise here. The value you can see are mainly related to the new deal down payment and certain milestones that we got from the TRS-1 study production. The other income, even if it is not a big amount, I want to talk about those because I am referring at the R&D tax credit benefit that we were able to book after four years of no additional benefit. I am talking about a couple of EUR millions, so EUR 1.9 million.
What I want to tell you on top of this, R&D tax credit is that cumulated, so since 2025, we got EUR 25 million of benefit, and so far, we have used EUR 22 million. The financial results net decreased by about EUR 3 million, and the main reason is a technicality, an IFRS technicality, because according to IFRS, we are supposed to evaluate the warrant fair value and this value, because of the increase in the share, increased by EUR 2.5 million. Please note that there is no cash impact related to this effect. I want to talk about the income taxes. Last year, for the very first time, we paid income taxes. This year, the amount you see are already without being tax paid on the milestone and down payment received from the deals I was mentioning to you before.
In slide 36, I'm showing you the balance sheet on the left and the cash flow on the right. Let me start from the balance sheet. What you see in the current asset in 2024, that is EUR 51 million, is mainly the receivable related to the EA Pharma deal that became cash, and this is why you see the increase in cash in 2025. In the liabilities, the EIB loan last year was booked mainly in the non-current liabilities, and this year you see everything in the current liabilities. As Stefan was mentioning to you before, one week ago, we obtained from EIB the chance to delay the debt till June 2028. On the right, you can see mainly the bar on the working capital and the green bar.
It's green because it's generating cash, and it's exactly the effect that I was mentioning to you before. The cash we received in January and of the revenue that we booked in the December 2024, mainly partially compensated by decrease in rent and other payables. If we move to the last slide. On April 23rd, 2026, at 10:00 A.M. CET, we will have our general meeting. In the ordinary part of the agenda, the first point, as usual, is the approval of the financial statement. The second point is the approval of the new member of the board of directors. Stefan has already thanked both Patrick and Luca for being with us for so many years. Let me reiterate this concept because we really all appreciate their work.
I'm also willing to introduce to you George Garibaldi and Paolo Zocchi as Newron non-executive directors. In the extraordinary part, we will slightly amend, let me say, the bylaw in a few articles, and this is due because after 20 years and COVID, few laws have changed, we are willing to align the text of our bylaw to the new and amended share laws. The second and third point are a capital increase. In the second point, we are asking shareholders to grant 5% for option plans of capital increase. In the third point of the agenda, we are asking for a 15% of capital increase also potentially for an uplisting at NASDAQ. The point four is strictly related to point four three because the creation of ADR serves for the NASDAQ listing.
Everything has been already uploaded or will be uploaded in our website. If you want to look for additional information, please do not hesitate to visit the website. With that, I think I'm done.
I guess it is time for the Q&A session. I hand over to Matilda from CallScore to introduce us to the questions by the parties who have registered for that.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time. The first question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead.
Thanks so much for taking my questions, congratulations again on a landmark year in 2025. You really are to be congratulated on how many fronts Newron advanced on. Firstly, I wanted to ask about your feelings regarding additional indications for evenamide beyond schizophrenia. In particular, we have seen evidence that other antipsychotic drugs, while perfectly serviceable in schizophrenia, actually turn out to be even better in other indications that are ancillary to schizophrenia that may constitute even larger markets. I was wondering if you could perhaps comment on this. If there are other indications in which you believe evenamide is particularly well-suited to have a therapeutic effect, what might these be? Whether that would be bipolar disorder, patients with mixed depression and schizophrenia symptoms, or others.
Yeah. Thanks. You basically took my answer away from me. I would expect this drug to be highly effective in patients with bipolar disorder. Secondly, I think I would definitely like to go for treatment-resistant depression with psychotic features. Lastly, patients who have behavioral symptoms of dementia but cannot take second-generation antipsychotics. There, I think this drug, because it doesn't affect any neurotransmitter system, will be very well-tolerated and not have the increasing mortality that we see with all the other drugs.
That's very helpful, I think we're all familiar with the Intra-Cellular Therapies example that demonstrated just how large a market opportunity there could be for an antipsychotic with applicability beyond schizophrenia. Secondly, I wanted to ask about the information you presented regarding the ability of evenamide to augment the efficacy profiles of multiple second-generation antipsychotics. If you could perhaps drill down on that a little bit further for us and give us a sense of whether there is a particular subclass of those second-generation antipsychotics that you consider evenamide to be particularly well-suited to be combined with. If so, what might be your top one or two choices? Obviously, you furnished a lot of information, in particular on clozapine, but was wondering if you had additional granularity to provide.
Sure. I think clozapine becomes the most obvious candidate because when you talk about treatment-resistant schizophrenia, clozapine always jumps, even though it's not used that much. Second, I think what has really been surprising for me, not just in one study, but in almost two to three studies, has been the effect in combining it with olanzapine. As you know, olanzapine and clozapine share certain features, the question comes up really is it basically because of the fact that both of these drugs are affecting D2 and D1. What we see also is that it's also affecting risperidone. It's also improving patients with aripiprazole. I think this improvement facet is probably unrelated to the neurochemistry.
It's a generalized effect on brain, where it is acting in a way that's more like an antidepressant and produces some degree of conformational change in the brain receptors, which makes them amenable to treatment with the other drugs. I think we are monitoring this very carefully now in the phase III study, we're trying to collect plasma levels to exclude pharmacokinetic interaction as a reason for this.
With respect to the effect you showed of evenamide kind of having a long-term persistent impact, even when the drug is no longer necessarily biologically circulating in the system. I was wondering if you could comment on, first of all, the long-term strategic plans at Newron Pharmaceuticals to potentially explore the possibility of developing a long-acting injectable of evenamide. If that is the case, how this information indicating long-term persistent effect of evenamide might dovetail with those efforts.
No, absolutely. I think, as you probably know, some of the companies in Europe which have been left the chance to develop formulation changes, especially in France and for pediatrics, for instance, we are going to be in early discussion with them soon. I think to me, it's really a mystery almost that a drug which has only got a half-life of 25 minutes is affecting changes beyond 3 hours. In also in patients, we had a short half-life of 2.5 hours, but the effects seem to persist for more than 12-14 hours.
I think a long-term, a depot formulation would have to be very different type, would be a fantastic thing because a drug which is very well-tolerated, doesn't produce EPS, doesn't produce sexual dysfunction, could be ideal for giving long-term, not only to the confirmed schizophrenia patient, but to those patients who are early on in their career, like the first-episode patients or the at-risk patient population. That would be the way to go for those new formulations, and we would definitely explore that once we're done with the NDA.
I think it's well documented that the long-acting injectable segment of the schizophrenia market is by far the fastest-growing and at this point, probably the most lucrative. One last question from me. When do you expect U.S. office action on the composition of matter patent that was already granted in Europe that would extend protection to 2044?
Stefan?
Yes, Ram, thank you for joining. Thanks for the questions. We are right now in discussions with one of the leading U.S. IP consulting firms, and we are in discussion with the leading expert on crystalline form and solid formulations in the United States. We are discussing the strategy. As you know, there's two ways of getting a fast-track treatment of the composition of matter application in the United States. We are right now evaluating both, and I guess we will take a decision within the next few months. Depending on that decision, we might well see this patent being traded and decided upon before this year is over. That means we might get that same patent application approved in the United States as per our expectation in this year still, which would be remarkable.
Thank you so much.
Thank you, Ram.
The next question comes from the line of Joris Timmermans from Octavian. Please go ahead.
Yes, thank you. Joris Timmermans from Octavian here. Thank you so much for the call, the presentation, and the opportunity to ask questions too from my side. The first one on your cash reach guidance, throughout 2027. You mentioned that this includes EUR 50 million already received from the new financing, plus another EUR 10 million that you expect later in the year. Question is on the remaining, I think EUR 12 million from that new financing. That is not reflected in this guidance, that will provide you a further extension of the cash reach. Also in terms of the amended European Investment Bank repayment schedule, I would assume that this is already included in the guidance.
Okay. Let me start from the EIB. Yes, the EIB is absolutely included in the guidance, of course. As per the additional EUR 12 million, I am a very cautious CFO. Given that we are talking about something that is related to the data, I have kept this outside from these projections. If data will be positive, most likely we will see an additional injection of EUR 12 million, and this will, of course, increase the availability of cash in Newron, most likely till the end of 2027. This will give Newron additional, let's say, six to nine months of time to strike the most appealing deal because of the positive data. Yes.
Okay. Thank you very much for clarifying. One more question on the potential new indications and also a bit on the funding in that regard. You outlined the potential indications and where you expect most benefits of evenamide. In terms of your plans, how would that likely impact funding in the near to midterm? Is that already something in the plans or is that still to be decided upon?
I think it largely is still to be decided upon, but some initial activities are already included in the plans.
Great. Thank you so much.
Thank you. Joris.
We now have a question from the line of Aaron Adcock from Edison Group. Please go ahead.
Good afternoon. Thanks for taking my question. Just two from me here. First of all, just wanted to confirm that the ENIGMA-TRS-2 top-line readout will also be in Q4 2026. I think I've seen some approaches where it's specified and others where it's not mentioned. For this as well, will this come simultaneously with ENIGMA-TRS-1 if so, or will they be separate announcements?
Okay. Actually, let me answer this. I think ENIGMA-TRS 1 is very likely to be within this year. ENIGMA-TRS 2 is a borderline case, whether it is towards December or early January, things of this time. Both of them would be available to be included in the filing for regulatory approval. The announcements would definitely be separate.
Okay, perfect. Thanks very much for clarifying. My second question, I think you kind of covered it, I was just looking at the licensing income of EUR 8.6 million. It says that that includes upfront payment from Myung In Pharm and also some milestone payments from both partners. Just wanted to clarify, if you could provide a breakdown on how much of your licensing income was upfront versus milestone payments from the two partners.
Yeah. The EUR 8.6 are more or less 50%, let's say 40% are related to Myung In Pharm and the remaining part related to additional milestone coming from EA Pharma. I cannot be much more precise because I cannot disclose the final figures. These are more or less the percentages.
Okay, perfect. That's very helpful. Thanks for clarifying. My other questions have sort of been covered off already, no more from me. I just wanted to say congratulations again on the recent progress. Look forward to following the story.
Thank you, Aaron.
The next question comes from the line of Joseph Hedden from Rx Securities. Please go ahead.
Good afternoon. Thanks for taking my questions. Just wondered if you could say a little more on recruitment into the clinical studies.
Any information on how many patients to date or progress in terms.
-of are you on track with where you expect to be?
Yeah. That's always a challenge. As you know, the regulatory process has become very prolonged nowadays, especially the one in Europe, it takes forever, then the contracting process. At present moment, I would say that 75% of the sites that we wanted to have initiated have already initiated. We are basically just about coming up to where we should be. We have approximately 300 study patients who have been enrolled in the program in the TRS1. The TRS2, as I said, has just got approval, so it's a little bit behind. I think keeping the progress of TRS1 in mind, I think we feel very confident that we should be able to complete the enrollment on time for TRS1 and then subsequently therefore for TRS2. The TRS2 is a shorter study.
It's only a 12-week study, and it's a smaller number of patients, only 400 patients compared to the 600 plus for TRS1. We should be okay with the time enrollment timelines.
Okay, thank you. Then on the BD side, just wondering what you think the likelihood of any other regional deals ex-US before the ENIGMA results later this year. What's the likelihood, do you think?
Thank you, Joseph, for the question. This will clearly depend if any interested parties will be willing to pay fairly and dearly for the new patent life that we have just added. We understand that some parties might want to see the patent being granted first. At the same time, clearly with the European Patent Office decision to grant our patent, our expectations have increased. As we have no cash urgency or lack at this point in time, we would be confident to go full steam ahead towards the results from both clinical studies and then decide on how to deal with all those territories at the maximum value for our shareholders. That's the good news after getting all the funding done. We do not depend on income from licensing, if there are fair offers, we will absolutely consider them.
Yes, there could be other deals, conditional to fair value, including the new patent life.
Okay, great. Thank you very much.
Thank you, Joseph.
As a reminder, if you wish to register for a question, please press star 1 on your telephone. Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to Stefan Weber for any closing remarks.
Thank you, Matilda. Thank you all for joining this call. I hope we have been able to explain to you why we believe this was an extraordinary 15 months in the past, let me be clear. You, please, should stay tuned for the next 15 months because this could be much more exciting even than what we have seen in the last 15 months. This is really the opportunity to turn this company into a completely different size of company with a drug that might be approved and with a drug that we might decide ourselves to commercialize to get to the peak value for our shareholders and to secure the sustainable future of this company. Please stay tuned. We are happy to keep you updated. Looking forward to the next opportunity. Have a great day. Goodbye.
Thank you.
Goodbye.
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