Hello, everyone. Welcome to the H.C. Wainwright 28th Annual Global Investment Conference. My name is Lander, VP of Equity Research at the firm. We are pleased to have you with us today, and it is now my pleasure to introduce our next presenter. Please join me in welcoming Stefan Weber, CEO of Newron Pharmaceuticals, a biopharmaceutical company developing novel therapies targeting the central and the peripheral nervous system. Stefan, over to you. Thank you, Lander, and the team of H.C. Wainwright. Thank you for joining this presentation for the update on Newron. This is a company with 26 years track record of developing assets in the CNS space, in the central nervous system. What I present to you today is the most advanced clinical asset in schizophrenia, and one of the very few independent assets left in schizophrenia. I will refer to the excitement caused by Karuna and Intra-Cellular, our previous peers, who have been acquired for $14 billion, respectively $15 billion. The company is headquartered in Milan, Italy, listed on the Swiss Stock Exchange since 2006. Was one of the top three global IPOs at the time, but you should absolutely expect that those shares will be available on the Nasdaq upon positive data in the next few months. Well, 26 years of existence, you would expect to see some progress and some success. Yes, indeed, we do have a drug on the market, an add-on drug to levodopa in Parkinson's disease, which is on the market in Europe for 11 years, in the United States for nine years. Has paid, accumulated more than $120 million of royalties, and will do so for the next few years. But take this just as a test run. We know how to take drugs to the markets in the CNS space. The real game changer is evenamide, and that is our drug in schizophrenia. It is transformative treatment for all those poorly responding and treatment-resistant patients in schizophrenia. Schizophrenia, as you know, is 1% of the global population. We are targeting more than half of that population who are poorly responding or treatment-resistant with no treatment option, which is safe and efficacious today. We do already have exciting phase II and phase III results, and we have a global phase III program going with two pivotal studies on our own, more than 1,000 patients. Our partner, Eisai Group, is running its own phase III program in Japan with another close to 400 patients. Management has done it before. Novartis, Roche, Organon, J&J, especially our chief medical, has taken more than a handful of CNS drugs to the market, and a fully independent board. Let's look at the evenamide opportunity, which has, I believe, all the click boxes that an investor would want to see. This is a large indication, 25 million patients, 1% of the population wherever you go, and the vast majority of those patients are not doing well on today's treatments. Poor responders or treatment-resistant. What we need is a completely new mechanism of action. Non-dopaminergic, non-serotonergic. Here comes the first and only glutamate modulator in schizophrenia. Not only but it targets the hippocampus, which as per new research by University of Pittsburgh, is the origin of schizophrenia. You will see soon why the other drugs won't work in positive, negative symptoms and cognition, because they don't hit the hippocampus. This will be the first add-on therapy in a space which is very rare in CNS to have no add-on therapy. There is no add-on because the FDA rightfully says there is no good in adding one dopaminergic drug to another well-dosed patient with a dopaminergic drug, because it just increases side effects. So we need an innovative mechanism of action, and we don't have any but dopamine or serotonin, directly or indirectly. Phase II results, the first ever one-year phase II study in schizophrenia in treatment-resistant patients, and highly statistically significant phase III data from a four-week study. You will see both of that. This drug is extremely safe. The worst side effect we had in our phase III trial was nasopharyngitis in 3% of the patients. Compare that to a pound weight gain, sexual dysfunction, hormonal changes, Parkinson-like symptoms in all today's drugs. Very importantly, this is the one drug which is perfect for the doctor, the patient, the family. You keep him on his current best standard of care. You just add an additional drug. You stabilize him, give him additional benefits, long-term benefits, and you don't have incremental side effects. The perfect drug. No relapses. We didn't have a single relapse in a one-year study in our patients. No hospitalization, no increased suicidality. This drug, like all the other schizophrenia drug, qualifies for development in bipolar depression. Importantly, we will develop this drug also in demented patients with psychosis, in which you shouldn't use today's dopaminergic drugs. We have a strong IP. The composition of matter goes to 2035. We have process patents till 2042, and we have just been granted by the European Patent Office a new composition of matter to 2044. That would be 17 years post-approval. Expected approval, I should say. That patent is also on its way in the United States, and I believe it has just a few days ago been approved in Hong Kong. This is all validated by a wonderful deal we have signed with the Eisai Group, which is one of the top 10 Japanese pharma companies, one of the key players in CNS. They have paid or are paying up to EUR 117 million down payment and milestones. Half the money is already in the bank, and they will pay up to double-digit royalties. The net present value, risk-adjusted as per Jefferies who advised us, is more than EUR 100 million for that, and they only got 7% of the world market. So already two years ago, the theoretical value of the compound was more than EUR 1.5 billion. The two studies that are rolling, very importantly, last week, we have announced that the first study has crossed 996 patients for screening. That will, by mid-October, make us cross the 600 patients randomized to treatment that we are targeting. This is the first ever one-year double-blind placebo-controlled study as an add-on in treatment-resistant patients, as an add-on to any antipsychotic on the market, including clozapine, because it is the first drug that has ever shown to improve clozapine treatment in resistant patients. Importantly, the first decisive results will be after 12 weeks, and that readout will be in Q1 2027, so less than six months from now. These are the relevant results for the U.S. FDA and the European Medicines Agency to approve this drug. We will still go on double-blind placebo control to week 26, because then, if positive, the Europeans will waive the relapse prevention study request, and we will go on double-blind placebo control to 52 weeks just to show the true potential of this drug, never seen before with any treatment in schizophrenia. ENIGMA-TRS 2, a 12-week study, 400 patients, starting in the U.S. centers. We then added Latin America and Asia. This study, unfortunately, is on hold in the United States only due to one unexpected sudden death in Argentina. We are on track with the FDA and expect the hold to be lifted by end of this month. We have delivered all the arguments to FDA. There was a Type A meeting, which was held in a very constructive atmosphere, so that should work out. That second study will then report in second quarter of 2027. One of those two studies sufficiently positive is enough to get the drug approved. Two is a safe run because you have two statistically significant studies. What does this drug do? It does nothing else, but I call it a magic switch. My Chief Medical says, "Bullshit. It's pure science." This drug does reduce excessive neuronal activity in brain cells, in nerve cells. In those that are firing excessively, we will reduce the activity, in those nerve cells that are firing normally, we will not do anything. The effect of that is that we have a dose-dependent reduction of excessive release of glutamate in the brain, most importantly in the hippocampus. You see that we do not touch the basal levels of glutamate, which is extremely important. That is why we do not see the side effects. That is why I call it a magic switch. If there is a need, the drug works dose-dependently. If there is no need, drug is silent, no side effects, no effect on basal levels of glutamate. Pittsburgh University has done some research in a mouse model, and they have said, "Look, we might have looked at schizophrenia wrongly." All today's drugs are hitting four levels down of the origin. The origin of schizophrenia, they say, is the hippocampus. If you hit the hippocampus with the right drug, and if you reduce the excessive neuronal activity at the hippocampus, you will improve positive symptoms, negative symptoms, and cognition, and that is exactly what Pittsburgh University has seen with our drug and not with the other drugs. We have normalized neuronal activity, we have improved cognition, we have improved negative symptoms. The most important finding of all is that after the drug is long gone, the drug efficacy is still increasing and staying for a long time, which explains the phase II results that you are going to see in a moment. Let us look at the phase II study, the first ever one-year study in treatment-resistant schizophrenia. What we took is patients in an open label environment who were on the best medication the doctor could give them in this study, excluding clozapine. They were treatment-resistant by all the definitions. They had failed on at least other two antipsychotics of different classes. They still, even though they were given the best medication possible, did have a PANSS total of 70- 90. The PANSS positive was more than 20. CGI-S was four to six on the 7 scale. What we saw, first surprise in that study, was that adding evenamide to standard of care after six weeks, we still had 95% patients in the study, while you would have expected 25%-30% dropout. We did not see anything like that. We then asked patients, "Do you want to stay for the full year?" Of the 95%, 90% said yes. After one year, we still had 75% of patients in the study. There is two messages. This drug is safe, because if there were material side effects like with today's drugs, you would have seen a run out of the study, like 40%, 50% and more. This drug does something because nobody would stay in a one-year study if there is no benefit. Now, we looked at the efficacy, and we are measuring it by the PANSS total, which is the regulatory endpoint. After six weeks, you see a 12% improvement of the PANSS total compared to baseline, which is a moderate improvement, and plenty people said, "Well, that is what we do see with placebo." 10%, 15% has been the placebo response in the United States schizophrenia studies over the last years. So might be there is nothing. But then people started scratching their head when after six months we saw an additional improvement by 16%, and then after one year we saw an improvement up to 20% on the mean change of the PANSS total. They said, "Okay, might be we have some super performers, but the large majority does not respond." So we looked at the responder rates, and we defined the responder rate on the PANSS total as being a minimally 20% improvement. You see after six weeks, it is only 15% patients who improve by at least 20%, but this rate doubles by six months, and it almost triples by one year. Never seen before with any other therapy when usually you see antipsychotics go up to the peak effect after six weeks. Then plateau and then fall off. That is why FDA says, do six weeks, no more than eight weeks in schizophrenia. This is the first one-year study in treatment-resistant patients. They should see no benefit because they are on the best standard of care doctor can give them. So we looked at this and all the other endpoints, CGI-S, level of functioning, all worked and came out with the same pattern improvement up to one year. So after one year, we said, "Okay, let us look at the inclusion criteria. Why did we include those patients? Because they were treatment-resistant by those standards. If we then look after one year, how many of the patients do still fulfill any of the criteria? Less than half. This is the one drug that has made 50% of patients no longer show symptoms for treatment resistance. Then we looked at the chances of remission, and remission has not been reported in treatment-resistant schizophrenia before. The requirements are at least eight weeks or 24 weeks being free of relevant schizophrenic symptoms, and 25% of patients did, by both standards, qualify as being free of symptoms, being in remission in that phase II study. Now, there was a lot of criticism because most patients were from India. It was the COVID times, everybody else closed down. It was open label. Everybody agreed to the message, all the KOLs that we presented it to. This is absolutely significant, call it revolutionary in CGI-S, if it can be confirmed in a double-blind, placebo-controlled environment in an international study. We did that study in 11 countries, 291 patients. Again, patients who are qualifying almost as treatment-resistant. This was patients who are poorly responding. We had 70% overlap. This time, we included clozapine as a base medication as well. What we did for the first time, we did include a screening period of 21 days in which we took blood samples because we wanted to make sure we only get patients who are truly qualifying as treatment-resistant. You know there's a major issue with patients who are non-compliant in schizophrenia. By blood samples, we took them out. That is 1/3 of patients who had no blood levels or different drugs or combination of drugs, they were non-compliant, so they didn't make it into the study. The rest of the patients made it either to placebo, which I should say is active control, so the standard of care, or evenamide twice a day, 30 mg. Let's talk about the side effects. I mentioned it already. The worst we had was three patients, or 2.3%, with nasopharyngitis. Compare that to the usual flower of side effects. This is nothing. This is a wonderful drug for those patients. Then let's look at the effect. PANSS total improved with a P value of 0.006. That is about 10x better than it has to be. The same applies to the CGI-S, Clinical Global Impression of Severity, of 0.037. This was just after four weeks of treatment. Patients were on the best treatment the doctor could give them. They were not expected to improve. They improved by statistically significant means. This is the curve. It shows you that this drug takes its time. There's nothing for eight days. When they start separating, the placebo turns off and the drug goes on. We did the simulation, what would be the result after 12 weeks, and we saw very healthy, close to 10 points improvement, which will absolutely take us to approval of this drug. Now, very importantly, that is the magic slide for this study. We looked at the different background medications. Let's start with clozapine, because clozapine has a reputation of being a magic drug when it works and it does not kill the patient because it has massive load of side effects. That is why it is absolutely underused in the Western world and in the Eastern world. Clozapine, of all the drugs, is the one that you want patients to take, but most patients will not take it. This is the one drug that has improved clozapine patients who did no longer respond to their medication. You see that as a monotherapy, they are improving by 4.4 points. We are improving them if we add evenamide by 7.3 points. Much more relevant commercially is olanzapine, the second best-selling antipsychotic in the world. There is not a single study in which ever a drug has beaten olanzapine. We are beating them. We are hitting them in the ground. 7.9 points improvement on olanzapine. Adding evenamide, that is a 13.4 point improvement. That is, for this small subgroup of 32 patients, statistically significant in the overall population. We are going to the responder analysis again. Patients on the best medication they can be given, already after four weeks, we are more than twice, we are close to twice the responder rate of standard of care on the PANSS total. On the CGI-S responder analysis, we now look at only those patients who have much or very much improved. We do not look at moderate improvement. Again, we are almost twice the responder rate compared to standard of care. That all made us start the pivotal program, which has been approved by all the regulatory agencies around the world. The first one, a 52-week study, again, add-on to any antipsychotic on the market, including clozapine, adding evenamide at a low dose, 15 mg, and a high dose, 30 mg BID. The screening period is 42 days. We will take three times blood samples and another four times blood samples during the one-year treatment, so seven times blood samples in total. I can tell you that by getting 996 patients into screening, we will make it to probably 600 and 630 by mid-October when the study will be fully enrolled. The endpoints are the PANSS total and the CGI-S as per regulatory requirements around the world. We will measure the efficacy after 12 weeks. We will disclose the results if the drug has proven to show statistically significant effects and if it is safe and well-tolerated. We will continue double-blind, placebo-controlled with no penalty as per agreement with the agencies to 26 weeks and to 52 weeks in order to show that this drug has a maintenance effect and the long-term efficacy that we have seen in the phase II study. If we should get positive results from this study starting from first quarter next year, then this drug and this study would be a landmark in treatment-resistant schizophrenia. There is no drug but clozapine that is approved for TRS. There is not a single drug approved as an add-on therapy in schizophrenia overall. This drug is the one drug that has shown to work in all those patients, regardless of the background medication. The one drug that works by a glutamatergic mechanism and the one drug that hits the hippocampus. This is the second study. Because one study is sufficiently positive, we will cut the pie. The second study is only 12 weeks, and the second study is only 400 patients. Sorry. That means it is standard of care and a low dose. If any of those two studies is sufficiently positive, that would be enough to get the drug approved. If both studies are positive, without doubt, this drug will be approved. Otherwise, the study is the same as the previous study. Again, we have 42-day screening, seven times blood samples overall. That is the investment summary. First-in-class glutamate modulator, I should say. It is also not only the first in class, it is the only. There is no competition in clinical development right now. Strong IP, possibly up to 2044. Large market opportunity, more than half the patients not served by today's drugs. We do already have phase II and phase III evidence the drug works, and the program to get the drug approved is rolling. The money is in-house, and we know how to take drugs to the market. Thank you for your attention. Thank you, Stefan. Very nice overview. We have time for a question.