Ladies and gentlemen, welcome to the Newron update call. I am Sandra, the call operator. I would like to remind you that all participants have been placed on read-only mode and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Stefan Weber, CEO. Please go ahead, sir. Thank you, Sandra, and thank you to everyone joining us today. I am on this call with Ravi Anand, our Chief Medical Officer, who right now is in Tokyo, Japan. We appreciate the opportunity to speak with you directly about evenamide and the ENIGMA-TRS phase III program. We have received, as you read this morning, the FDA's written communication regarding the clinical hold at the U.S. study centers in the ENIGMA-TRS 2 study. Our team is reviewing the agency's feedback. Today, I want to share where that work stands and update you on the ENIGMA-TRS program. Let me start with saying that Newron has extensive experience in sodium channel pharmacology, including the development of Xadago, an approved product with sodium channel blocking activity on the market in Europe for 11 years and nine years in the United States. We are right now mostly focused on developing evenamide for people living with treatment-resistant schizophrenia and poorly responding patients with schizophrenia. The therapeutic options remain extremely limited. We believe that evenamide's novel mechanism has the potential to offer a meaningful new approach to treatment. Our commitment to the patients we serve means putting safety first. We value our continued engagement with the FDA, and we appreciate the agency's focus on patient safety. Our two phase III studies continue to make important progress, with key milestones ahead for both ENIGMA-TRS 1 and ENIGMA-TRS 2. Let me start with the FDA's written feedback and what it means for the ENIGMA-TRS program. The FDA's concern relates to a possible association between sodium channel inhibitors and arrhythmias that may lead to sudden death. In its written communication, the FDA identified a potential safety signal based on four deaths among patients treated with evenamide, compared with one death among patients receiving placebo. Please remember, when we speak about evenamide, that always evenamide as add-on to an antipsychotic, and we speak about placebo, that is always the antipsychotic alone. These deaths occurred in four different studies in the years since 2023, two of them importantly in long-term open-label extensions in which there is no or no longer placebo control. It is important to know that the adjusted combined mortality for evenamide and the background antipsychotic was 1.31 per 100 patient years, compared to 1.81 per 100 patient years for placebo, which in our studies always is background antipsychotic on its own. Of the four deaths among patients receiving evenamide, three were considered unrelated to evenamide by the investigator. One was considered possibly related, as two autopsies could not identify any compelling cause for mortality. The FDA also raised questions regarding evenamide's mechanism of action and the minimal shortening of the QTc interval observed on ECG. The FDA notes that unlike QTc prolongation, QTc shortening has no established risk threshold or intervention threshold, and that a normal screening ECG does not reliably exclude latent sodium channel disorders such as concealed Brugada syndrome, a very rare genetic condition with an estimated incidence of one to two per 100,000. Newron has not observed the pattern of cardiac abnormalities or arrhythmias, neither in the preclinical nor the clinical safety data generated with evenamide to date. The data include findings from preclinical studies, a thorough QT study and more than 5,000 ECGs from over 700 patients with schizophrenia. We believe the cardiac data generated to date provide an important foundation as we prepare our response to the FDA. Let me turn to how we are preparing that response. Our review extends across the full evenamide development program. The work includes a review of more than 10,000 ECGs generated across the evenamide program. We are also reviewing relevant data from the broader schizophrenia field, including expected mortality in this patient population. Independent cardiac and electrophysiologists are also providing input. Newron is evaluating additional cardiac screening and monitoring measures for ENIGMA-TRS 2. We intend to incorporate those findings into our response and submit it to the FDA once that work is completed. Let me turn now to the progress of our ENIGMA-TRS phase III program. ENIGMA-TRS 1 is nearing completion of enrollment with 497. I believe today we should have crossed the 500 patients randomized to treatment and another 172 patients in screening. We expect to reach that milestone of completion of randomization by mid-October. Top line 12-week data are expected in the first quarter of 2027. ENIGMA-TRS 2, the study that is impacted by the FDA hold on only the U.S. studies, continues to enroll outside the United States. 85 patients have entered screening so far, and additional clinical sites are being added as planned and announced a few days ago. We are encouraged by the progress across both studies, and we remain focused on preparing for the planned data readouts. In closing my remarks, Newron's priorities are clear. We are focused on completing our assessment of the FDA feedback, submitting our response, and preparing for the planned ENIGMA-TRS data readouts. Let's spend a second on the financial impacts and sufficient funding requirements. We are funded through most of 2027, and that means from today's perspective, beyond the expected value inflection points, which are the 12 and 26-week results from ENIGMA-TRS 1 and the 12-week results from ENIGMA-TRS 2. Which are the key milestones investors should now monitor? First of all, the completion of ENIGMA-TRS 1 enrollment, as stated, around mid-October, so in a very short time. Followed by the submission of Newron's complete response to the FDA and any FDA feedback or agreed protocol changes. The progress in non-U.S. ENIGMA-TRS 2 enrollment. The top line 12-week ENIGMA-TRS 1 data in Q1 2027. Updated ENIGMA-TRS 2 timelines when visibility are sufficient. We remain committed to the responsible development of evenamide and most importantly, to the patients and families living with treatment-resistant schizophrenia. Thank you for joining us today and for your continued interest in Newron. Sandra, we can now move to the Q&A session. Thank you, sir. We will now begin the question-and-answer session. Anyone who wishes to ask a question may press star and one on the 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 with a question may press star and one at this time. The first question comes from Boobalan Pachaiyappan from Roth. Please go ahead. Hi, Stefan. Can you hear me okay? Perfect, Boobalan. Good to hear you. Yeah, great. Thanks so much for this call, and great to talk to you as well. Maybe at a high level, I just wanted to start with sodium channel drugs because they have precedents for cardiac warnings and targeted monitoring. For instance, drugs like lacosamide. I am just curious whether in doing your review discussions, there was mentioning of these drugs. O f course, what was taken for those drugs can be taken for evenamide as well. Or are they signaling that they wanted to see the safety exposure package from the 12-week or 26-week package? I know it is a lot of questions bundled in one, but to the extent that you can answer, I will appreciate it. Hi, Boobalan, this is Ravi. Good to hear from you. Let me try to answer your questions one by one. The FDA has had concerns about sodium channel modulators for quite some time. You may probably know the report they wrote on lamotrigine. Sodium channel modulators can be both anti-arrhythmic and pro-arrhythmic. Evenamide is a pure sodium channel blocker. It has no tendency for a QTc prolongation. In animal studies, there is no evidence at all of any arrhythmia. This is despite studies done at the request of the FDA. With 15 observations per day for 12 weeks, nothing happens. 24-hour EEG, 24-hour ECG, 24-hour video recording in freely moving rats did not indicate anything at all. We have about a tenfold safety ratio for the Nav1.5 receptor, which, as you know, is expressed in the heart, so there is always a concern, but we do not have a concern because it is a tenfold higher level of exposure needed. The FDA asked us to do a TQT study, which we did, and the evidence shows that basically the prolongation of QTc was actually shorter than with placebo. The FDA then asked us to do a special assay called the Vaughan- Williams assay to look at the interaction of the type of sodium channels, and we did that, and the results indicate that evenamide is a class 1B anti-arrhythmic, not an arrhythmics. Now, the FDA's position is that these people died, and I will go through the deaths in a minute. T here must be something, a nd they focused on Brugada syndrome. I can tell you that we have 100 investigators in the trial, and not one of them has ever seen a patient with Brugada syndrome. In Brugada syndrome, what happens is that basically, there is this QTc shortening, which theoretically evenamide does do, but the extent of the shortening with evenamide is a few milliseconds. It is not massive. It is not like 30 ms, not 50 ms. T he FDA's point is, we do not know what level of shortening is needed. None of these patients had any ECG abnormalities. None of them had any complaints of an extrasystole, palpitation, faintness, dizziness. No, they did not have any of that, but they died. This is where the FDA's concern is. It is not so much that the drug did it, but because it could not find a reason, they are saying it must be the usual drug. Among these deaths, for instance, we have a patient who died a couple of months ago. She basically tried to swallow three different pieces of bread at the same time and started choking. The daughter tried to resuscitate her, pushed the bread out of her mouth. She went blue and died. Do you think choking could be due to evenamide? This woman had already had a similar episode a few months before. There is another patient who died in his sleep. No abnormalities at all. Everything was perfectly okay. The FDA's contention was that maybe it was Brugada syndrome. Then the patient's mother informed us that the patient's father had died the same way many years ago. At that time, there was no evenamide causing it. I t is not so much that there is a smoking gun that the drug has caused it. It is because the FDA cannot find any reason, and we cannot find any other reason, so that is what it is. Two independent safety monitoring boards have looked at it, including cardiologists, and they all agree that there is nothing that they can say about it. We have now asked electrophysiologists who are cardiologists to propose criteria that could rule out patients who are having Brugada syndrome or sodium channelopathy, which might also produce the same thing, and we will incorporate that input into the protocol. There is no discussion from the FDA as to what monitoring. They themselves have said they do not know exactly what criteria to produce. W hat they have done is they have turned it over to us to say, "You produce the criteria and submit it to us, and we will look at it." You mentioned some of the other things. Remember, most of the drugs that are there, they are not exactly pure. For instance, if you take quinidine, it is also a potassium channel blocker. You got drugs like procainamide, which have an arrhythmia effect also. This is not in the same category at all. We will be, of course, submitting the protocol to the FDA and discussing and trying to modify the population to exclude these theoretical patients with Brugada syndrome, which can only be done through a genetic test. As Stefan mentioned, you barely find any patients with it. W e will do the test just to make sure we satisfy the authorities that we exclude it first. I think that answers most of your questions, right? Yeah, absolutely. That's very, very helpful. Very comprehensive. Thanks for that. Let me just ask you a very hypothetical question just for our investors' understanding. Let's say the hold remains even after your 12-week and 26-week data comes out. Let's just say. How should investors think about evenamide's prospects in the U.S.? Is it possible for you to conduct TRS-2 ex-U.S. and bring TRS 1 and TRS data, assuming the data is positive, back to the U.S., and then file for an approval based off of ex-U.S. data? Just curious to hear your thoughts on that. Thank you very much. First of all, it's not a hypothetical question. It's a real question. In the case of safinamide, the pivotal studies were done ex-U.S. We had no pivotal study in the U.S. We had studies done ex-U.S., and we filed in the U.S. to get approval. Of course, that was some years ago, so now things have changed. First of all, if the 023 study, this ENIGMA-TRS 1 study, is showing significant efficacy, and the 26-week endpoint is showing significant efficacy. That is a major finding. The first time ever that an add-on treatment improved patients with treatment-resistant schizophrenia. Secondly, the improvement was such that it also was there long-term. I don't think the FDA has inherently something against the drug. I think if we were to submit that data to the FDA, I'm sure they would raise some eyebrows or they would ask some questions, but I would think definitely they would be open to it. If at the same time we had a second study, the TRS-2 study, positive, I doubt very much that anybody would say, "No, no, you cannot do this out here." Don't forget, the FDA has approved drugs without a single patient being treated in the U.S. You may remember the amyotrophic lateral sclerosis drug from Japan, where basically there's not even an IND in the U.S., and the FDA asked them to file an NDA. I definitely think we would get an approval. Thank you so much. I'll jump back in queue. The next question comes from Bob Pooler from valuationLAB. Please go ahead. Good afternoon, gentlemen. Thank you for holding this call. A few questions from my side. Unfortunately, the line is a little bit bad, so I did not hear all the answers from the previous questions. What specifically does the FDA need to see before lifting the clinical hold? Have they given any guidelines there? Yeah. I mean, the FDA has basically said, "We are not able to identify what criteria to put in. You work on the protocol, you put in some more safety criteria, you exclude patients who could be at risk." What we have done is now we have finally given in and said, "Okay, if that's what you want, we will do a test for patients with Brugada syndrome." Like I said to you, it's like maybe two patients in 100,000 or so. Yeah. We are wasting money, but we will do it. We will do a test for channelopathies, sodium channelopathies, again, to exclude them. Third, we will exclude patients with a very short QT, like 360 ms, which I have to say that I have not seen a single one till now. We will exclude patients who, during any period in the study, who show a reduction in QT, we will exclude those patients. We will do more frequent assessments for things like, do you feel palpitations? Do you feel an extrasystole? Things of this type kind of thing. That's what we are doing. We will also modify the patient population to make sure that we take patients who are definitely not improving on anything at all. We try to make a much better case for risk benefit. Those are the changes which we are working on. Again, as you can imagine, this is such an obscure field and not necessarily a field for a psychiatrist to be in to find out things about Brugada syndrome. We are going to have to go to outside experts, which we have done now, both in Europe and in the U.S. Probably in the next 10 - 12 days, we will file an amendment. Okay. Yeah. It seems you guys done a lot of work on this already, your thoughts there also with the independent experts. What are the expected timelines to respond to the FDA and potentially resolve the hold? That would be, would you say 12 days, or six? Let us say two weeks for us to file, and they will typically take one month to review. We are depending on third parties here, so let's make clear that these two weeks do depend on internal feedback from third parties. Okay. Potentially then we could see maybe some U.S. sites coming back on stream then. Yeah. Just in general, could you comment on the issue with sodium channel blockers being put on hold by the FDA? Yeah. We've had this experience. Safinamide- I go way back with you guys, too. That's right. Safinamide was put on hold for a very obscure reason. The FDA thought the drug was going to produce retinal degeneration. This was done with partner, not just with Newron, but with Merck Serono. The whole program was put on hold for more than a year or so. Yeah. Basically they realized that no, that was not the case. The hold was lifted, the studies were completed, and we went on to get approval. By the way, it's been very well-tolerated, and there's no issue at all. With the ralfinamide, the FDA raised the same concern that you got seizures. If this drug is going to produce seizures in patients, this, that, the other, reduce the dose, do this, do that. We said, "No, we think this is not a legitimate reason. We stick to this dose." Again, went on hold. We again, did the analysis to show them the sodium channel blockers can produce seizures, but it depends upon what circumstances, what dose. Under these circumstances, for patients with neuropathic low back pain, there is no risk. After having spent 1.5 years on that and doing a lot of work and EEG studies in monkeys, the FDA basically said, "Okay, go ahead." I t's not a new thing, there are other sodium channel blockers which have been stopped because of the potential risk. I think if you take a novel drug, when you ever take a novel drug, you're going to have novel issues to deal with. I think that's what it is, that we are dealing with a completely new mechanism, going into an area like treatment-resistant schizophrenia, add-on therapy, adding it on to other antipsychotics. We're adding it on to clozapine, for instance. Clozapine, as you know, is associated with high mortality. W e're in a quagmire. That's why I think it's difficult to make any prediction of any type. O f the 500- something, we have 514 patients or so who have been randomized. All are doing well. No issues with investigators. Not at all. Just how much do you believe the U.S. hold has slowed enrollment in TRS-2? Again, what was the percentage of planned TRS-2 patients coming from the U.S.? That's a good question. I have anticipated putting in 100 patients from the U.S. into the trial. Okay. And- A quarter? A quarter, basically. That was in agreement with the FDA. Of course, when this issue first hit, we slowed down enrollment everywhere just to give enough time for the U.S. to be able to come back and put in the quarter. Now looking at it, I think we're taking a more pragmatic view. We will keep the U.S. sites open. We will hope that we will be able to enroll patients, if not 100, maybe 60, maybe 80. To compensate for that, I'm opening up additional sites in some other countries. Overall timeline should not be impacted by too much. Yeah. Because I think Stefan said in Q3, you expect then the top-line results for TRS-2. Yeah, exactly. T hat's a 400-patient study. We expect now that we are done with the ENIGMA-TRS 1, all the resources will go to ENIGMA-TRS 2. Yeah. It's already, I think, close to about 100 patients screened. Yeah. Just on the U.S. patients, typically U.S. trials are a lot more expensive than non-U.S. trials. Is there maybe some upside of enrolling a non-U.S. patient into this, in that respect that, yeah, the delay costs you somewhat, but on the other hand, if you enroll and let's say like a plan B, if the hold continues, you just continue with patients outside and file those two trials. Because again, this trial's been FDA-approved. The TRS-2 trial. What's maybe your cost? Yeah. The TRS-2 trial is fully approved, is ongoing. Even the extension of the trial has been approved by some countries. You are absolutely right, the U.S. is far more expensive. At this stage, I will only say that basically, I would be ready to spend the money just to get this thing over with. [audio distortion] b y expanding the study outside the U.S. and the U.S. getting a lot more patients going down, we probably equalize the cost difference. Okay. Just because it is very actually, we are in October, so Q1 is around the corner a little bit. Do you think that positive ENIGMA-TRS 1 data, that materially can influence the FDA's risk-benefit assessment? Because then you have actually basically the first phase III trial results there, if they are positive, of course. That is true. However, if you remember the design of the TRS 1 study is such that we will have the first results for the three months, but they will not be released. Yeah. That will come only after the six months data. By the time the first three months results are available, six months data endpoint would have been reached. I don't think it's a major gain. I think it's probably better to go in with longer data, and by that time we will have the TRS-2 data. Of course, we will communicate the results at three months to the FDA in some way or manner. It won't be like in a formal submission saying, "Give us approval now." Okay. I think for that answer, yeah? Yeah. Sorry, Bob and Ravi, if I can interfere here. We will have a press release on the 12 weeks result which will confirm that on the 30 mg dose of the drug. If it comes out positive, we'll have reached the endpoint, and we'll have the data well-tolerated. There will be a communication on the 12 weeks results. Okay. If I may, just one question before going back into, of those five deaths, is there anything that is common like cardiovascular or whatever? You said that somebody died because he choked. Yeah. One patient died because she choked on bread. Yeah. Another patient who was on placebo died because he fell down from a window. Yeah. Then there was- There's nothing- There's nothing like, there's no- Nothing like a common factor of cardiovascular in the five deaths. There's no cardiac symptom. There's no cardiac finding. Yeah. That's what is the difficulty. It's difficult to prove a negative, h ow to prove that it's not cardiac when there's no cardiac finding? Yeah. The other thing, remember this, basically, I think University of Maryland did a study of looking at deaths in schizophrenia, and over 20% of the deaths in patients who are schizophrenic are sudden deaths. Yeah. Majority are cardiovascular in nature, but there's no evidence of it. Yeah. You have- In spite of everything, we will not find the evidence, no. Yeah. There's no pattern. That's very important. I think that's why the other regulators say, "Okay, continue to go." Again, if you have a phase III trial and you treat for a period, just on genes, people can die, of course, in a trial. Absolutely. Yeah. More questions? Okay. Thank you very much for the question. Okay. Thank you, Bob. The next question comes from Joseph Hedden from Rx Securities. Please go ahead. Hi, Joseph Hedden from Rx Securities. Thanks for taking my question. Just one, like, to follow up on what Ravi was saying about, kind of lamenting with the FDA and introducing some amendments into the trial. Going back to a line in the PR where we're saying standard screening ECG doesn't reliably exclude sodium channel disorders. If you could just go through the kind of amendments to the inclusion criteria again, is there something within there that can satisfy the FDA? Because this seems like a bit of a catch 22 with this statement here. Thanks. I think the first thing is to try to identify the patients who could be Brugada syndrome or channelopathy patients. For that, there's a test. Genetic test, it takes about four to six weeks to get it done. I think we are highly unlikely to find anything in that one, but we will do the test for every patient to say, "Okay, there's no patient with Brugada syndrome or sodium channelopathy in the population we have." Next, we're introducing a new criteria. One is patients with short QT syndrome, etc, would be excluded. Patients who have any family history of any cardiac arrhythmia would be excluded. Patients who have a short QT, meaning less than 360 ms, would be excluded. These are the kind of things. Then also during the study, any patient who experiences QT shortening would be excluded. Now, other than this, there's not much more that we can do, consider at the moment. W e're open to the idea that, we're thinking about things like maybe doing a subset of patients, do a Holter. W e've already done Holters before, and the Holters showed nothing at all. That was exactly what we're going in with, these criteria, and restricting the population slightly. Okay. Talking about the genetic test for this very rare syndrome, and four to six weeks to get the result. Are you then having to wait four to six weeks to work out whether you can dose the patient, or do you dose the patient first and discontinue if it? Absolutely not. First of all, we have a trial design which has a 42-day screening period. This is the first thing we would do for any patient who met screening criteria to make sure we get the result. We would never randomize a patient before getting back all the results. We also have an independent eligibility committee. All the results go to them for every patient, and then they decide whether the patient can go in or not. They would never approve randomizing a patient without getting the result. Sure. Got it. Okay, thanks very much. Thank you, Joe. The next question comes from Joris Zimmerman from Octavian. Please go ahead. Hello. Good afternoon. Thank you for organizing the call and taking the questions. Only a few minor ones from my end. Maybe on coming back to this assumption that the U.S. hold would indeed remain in place and then you file, based on the other data. Do you have a rough estimate on patient splits per region? So how many patients do you expect coming from Europe, Asia, etc, by the end of the two trials? Sure. Secondly, also on all the amendments you just explained to us, how do you think those would impact the label? Would that mean that later on, if the data is positive, approval is granted, the physicians would need to run the test, for example, for Brugada syndrome in order to prescribe evenamide to a patient? Yeah, let me take the second question first. Many a time during development, we do things which are completely bizarre, which if they were reflected in labeling, no patient would ever take. Let me give an example. For instance, safinamide. We had to do retinal scans to put in patients with Parkinson disease. Of course, once the drug is approved, that is finished. No need to do that anymore. There are other compounds, for instance, in the fenofibric, where you had to do a 24-hour special kind of ECG to look at people who would have vasovagal syndromes. Once the drug is on the market, you do not do that at all. T his would not be a criteria, because this is only a theoretical risk which the FDA identified. There is zero evidence that that is actually a real evidence base. Regarding the distribution of patients, we probably have about 30%-40% of the patients from Europe, and maybe about 30%-40% from Latin America, and maybe 20%-30% from Asia. Okay. Perfect. Thank you so much. The next question comes from Helmut Fink from Verus Capital. Please go ahead. Yeah. Thank you very much for taking my call, my questions. I have got two of them. The first one would be, I would be interested what really changed in between the beginning of July and now. You communicated that you had quite a positive, constructive meeting with FDA. What you described now, what you are intending to do, sounds like you are doing this now after you got the refusal of the lifting of the FDA hold. T he question is, what has changed now from the situation we have right now? The second one, the four cases. Maybe you can describe that a little bit more specific in which study that happened, because I think there is quite a misunderstanding. Because I think some of them are cases that are not related to TRS 1 and TRS-2 studies, but to older studies as well. Maybe you can specify that a bit. Yeah. Okay, will do. The first was the question of the FDA meeting. I have to say that it was a very positive meeting. Very friendly meeting, very good cooperation, discussion of the issues, etc. The FDA said, basically, "Look, okay, this is a good meeting. Propose to us what you have to do." That is what it is. Beauty lies in the eyes of the beholder. We thought it was a great meeting, and it was a great meeting. We reported it as such. Then basically once the FDA went through the proposal that we had made, they did not agree with it. That is when the letter came back. That is basically what we are doing. It is not that suddenly in between, we suddenly found 20 ECGs abnormalities and that is when the FDA said Nothing has changed since that time. There is no new submission. T hat is basically what it was. It is just not that anything new happened, it is just that the FDA, after having reviewed our protocols, felt, "N o, this is not going far enough. Maybe we need to do more." That is what it was. Regarding the deaths, the first death occurred in an open-label study, which was 014/015 study, in a patient who had six months of treatment, approximately. Basically was fine, no ECG abnormalities, nothing at all, and was improving, and then basically died. Nothing could be found as a cause for death. There were some changes in the heart in terms of cholesterol deposits here and there, but nothing to say that this is really a compelling cause of death. T he investigator, when pushed again and again by the authorities, he had originally said this is not related. When the autopsy reports came back and they couldn't find any other cause, he said, "M aybe it's possibly related." All the other deaths are considered not related. One was a death in a patient on placebo, so we just disregard that. There's a patient, basically, in the first month or so of treatment. No adverse events, no ECG abnormality, no vital sign changes, no blood pressure changes, nothing of the sort. Except there's a remote history of cardiac disease. Basically, the patient died in sleep. Again, no cause. Most of these countries where they study the deaths that occurred are Catholic, and they refuse to do any autopsy. That was ruled out. There's one more patient like that, a younger patient, who basically died, a 39-year-old, died again in sleep. Perfectly okay otherwise, everything was fine. The mother of the patient basically came and told us that basically the father of the patient also died just like that many years ago. Obviously at a time when there was no evenamide available. Probably it's a family genetic disorder which was there. There's no evidence of Brugada syndrome, nothing at all. Last patient who died was a patient who basically, typical schizophrenia patient, basically tried to eat three pieces of bread at the same time, got stuck in his throat, couldn't breathe, went black and blue. The daughter tried to resuscitate and push this out, could not do it, and the patient died. None of these cases sound to me like an arrhythmia. Arrhythmias just don't happen at the drop of a hat. You have extrasystoles. You're feeling that you're not breathing well. You feel dizzy. You're in chest pain, something. Nothing out here. These are the deaths. But three of them were You said the first one was at 015, and the other ones are ENIGMA 1, 2? Are ENIGMA 1. There's no death in ENIGMA 2. Okay. All right. The next question comes from Wolfgang Lickl from apoAsset. Please go ahead. Hi, Ravi. Hi, Stefan. I hope you can hear me because I'm traveling. A question on the stance of the regulatory authorities from other regions like Europe, Latin America. Have those authorities seen all the data that the FDA has seen, and have they explicitly said the study can go on, or is there simply no communication with the other authorities? The way things happen, I think on ICH rules, if there is what is called a SUSAR, which means sudden death, which is considered related, we have to immediately inform or we have to stop. Otherwise, we basically informed of all the deaths. We do not even unblind unless it is considered related. W e do not necessarily unblind the date of death occurs. It could only be once the FDA asks for it. What is the code, then we do that. We basically received questions from the MHRA first, and we gave them the answers and what the reason were for the FDA issues, and no response after that. The German health authority contacted us on behalf of CHMP because Germany was the country which reviewed the protocols, and they got a complete answer and complete documentation, and after that, none. The Indian health authority was informed of each and every thing because they are the ones who require every serious adverse event to be reported to them. T hey took credit. They took about two, three months to approve the next protocol, but then after reviewing all the data, they approved it. Lastly, I think it is the authority in Singapore basically asked for it, was submitted to them, and with no response. Health authorities never come back to tell you, "No, you are perfectly okay to go ahead." They will ask for something. If something is okay for them, then they will not respond. If something is not okay, then of course, they respond. Y ou will never get back a letter saying, "Go ahead." So that is basically where we are at the moment. Okay, thanks. 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, Sandra, and thank you all for participating. We had a very busy meeting today. We had excellent questions. I guess we could answer all your questions. I hope so at least. I would love to thank you for staying tuned to Newron. There is going to be exciting news in the months to come. Let's take this compound over the finish line in the next 6- 12 months when it comes to our two pivotal studies. As I said, stay tuned. Have a good evening. Bye. Thank you. Bye. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect the lines. Goodbye.