Greetings. Welcome to results of the second interim analysis of CureVac's pivotal phase IIb/III HERALD stu dy. At this time, all participants will be in listening mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference over to Sarah Fakih, Head of Corporate Communications and Investor Relations. Please go ahead. Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih, and I'm the Vice President of Corporate Communications and Investor Relations at CureVac. Please let me introduce today's speakers. On the call with me are Franz-Werner Haas, the Chief Executive Officer of CureVac, Ulrike Gnad-Vogt, our Interim Chief Development Officer, and Mariola Fotin-Mleczek, CureVac's Chief Technology Officer. Pierre Kemula, Chief Financial Officer, will be available for the Q&A session after the presentation. Please note that this call is being webcast live and will be archived on the Events and Presentations section under Investor Relations on our website. Before we begin, a few forward-looking statements. The discussion and responses to your questions on this call reflect management's view as of today, Thursday, June 17th, 2021. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations, or predictions of the future. These constitute forward-looking statements for the purpose of the safe harbor provisions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVac disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Franz. Thank you, Sarah. Ladies and gentlemen, a warm welcome to this conference call from all of us here at CureVac. The COVID-19 environment has changed dramatically since the beginning of the pandemic and is now dominated by evolution of the virus and variants at the rapid spread of new emerging virus variants. Over the past six months, and in an increasingly challenging variant-rich environment, we have been conducting a pivotal phase IIb/III efficacy trial called the HERALD study with our first generation COVID-19 vaccine candidate called CVnCoV. This study is so far unmatched in geographic diversity, being conducted in 10 countries across Europe and Latin America. We believe the resulting multi-variant study presented today provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus and a different pandemic over the last six months. Within this environment, CVnCoV efficacy was calculated to be 47% on the basis of 134 adjudicated cases that met the criteria for analysis inclusion. This was calculated against any severity of disease and across all variant and virus strains. Efficacy data from this trial needs to be viewed against the background of comprehensive sequencing data acquired in parallel to the accrual of COVID-19 cases within the trial. Out of the 134 COVID-19 cases accrued and adjudicated as a basis for a first and preliminary calculation of efficacy, 124 cases were sequenced to identify the respective virus strain. The results are sobering. From the 124 sequenced adjudicated cases, only one case can be attributed to the original virus strain the world fought throughout 2020. We recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is quite challenging. Let me please go into further details of the study setup before I hand over to Ulrike for a discussion on the interim analysis. On slide five, you can see an overview of the general setup of our HERALD study. Conducted in four countries in Europe and six countries in Latin America, the HERALD study represents a multi-variant study with high geographic and ethnic diversity. Of the approximately 40,000 trial participants, about 25% were recruited in Europe, while about 75% were recruited in Latin America, a region which in May this year was considered to be an epicenter of the COVID-19 pandemic. Of these approximately 40,000 participants, roughly 5,000 participants or 30% were above the age of 60, while the majority of about 35,000 participants or 87% were between the age of 18 and 60 years. The mean age of the study participants was in the range of 43 years. Now I will hand over to Ulrike, our Interim Chief Development Officer, to walk through the case accrual process and the interim analysis outcome. Thank you, Franz. Please let me start by providing you with an overview of the COVID-19 case accrual process within the HERALD study according to the study's primary endpoint. This is defined as the occurrence of first episodes of confirmed cases of COVID-19 of any severity. Per study protocol, COVID-19 cases are eligible to be included in the vaccine efficacy calculation if they occur at least 15 days after the second vaccination, the earliest time at which the vaccine is considered to be fully protective. COVID-19 cases occurring at least 15 days after the second vaccination undergo a stringent adjudication process, which, among other things, confirms presumed COVID-19 infections via real-time PCR and makes sure to exclude those confirmed COVID-19 participants who also test positively for a COVID-19 infection before the 15-day cutoff. The present data analysis is based on 134 COVID-19 cases that met the stringent adjudication criteria and hence form the basis for the preliminary CVnCoV efficacy calculation. Of these 134 COVID-19 cases, 119 cases or approximately 19% were detected in participants below the age of 60, while 15 cases or approximately 10% were detected in participants above the age of 60. This distribution corresponds well with the general age distribution within the trial. As Franz have already highlighted, confirmed COVID-19 cases need to be seen in the context of the rapid spread of new virus variants. For some variants, vaccine-induced antibody neutralizing capacity can potentially be reduced. On slide seven, let me dive deeper into the variant background, which critically determines the context and thus the interpretation of the preliminary CVnCoV efficacy. New virus variants have been steadily spreading since the end of 2020 and have all but displaced the original virus strain. On this slide, you can see a general and non-trial-related overview of the currently estimated prevalence of the four most prominent variants, with a focus on the general geographies where we are conducting the HERALD study. Presently, we are looking at four main variants of concern. These include the Alpha strain, first detected in the U.K., the Beta strain, first detected in South Africa, the Gamma strain, first detected in Brazil, the Delta strain, first detected in India, and the new Variant of Interest, the Lambda strain, first detected in Peru. The ring diagrams on this slide illustrate the current estimated variant spread in South America and Europe. For your reference, the specific countries where we are conducting our phase IIb/III trials are marked in blue. Because of the continuing spread of variants that has shaped this image over the last several months, we see a wide range of variances in this highly international study and have conducted comprehensive sequencing analysis to understand the dynamics of the virus in our trial. Over the next two slides, I will go into the details of the unique variant distribution we have detected in the HERALD study. Within the HERALD study, 124 of the adjudicated cases were sequenced, which represents approximately 93% of the adjudicated cases that were used for the interim efficacy analysis. This means that the strain distribution illustrated on this slide provides important variant context around the preliminary CVnCoV efficacy of 47% calculated within the second interim analysis against any severity of disease according to the primary study objective. Of the 124 sequenced adjudicated cases, variants of concern, including the Alpha and the Gamma strains, represent approximately 57%. This is mainly supplemented by 21% of the Lambda or C.37 strain originating from Peru and 7% of the B.1.621 strain originating from Colombia. Both strains are less explored. However, C.37 was very recently added to the WHO watchlist of variants of interest and was assigned the name Lambda. In May, this variant was reported to be responsible for more than 80% of COVID-19 cases in Peru, and evidence has become available for high rates of transmission in multiple countries in Latin America. The strain is known to feature the D614G mutation, which is understood to have potentially higher transmissibility, as well as two critical mutations in the receptor binding motif of the spike protein. As the receptor binding motif is a primary target for neutralizing antibodies, this might potentially allow this variant to evade immunity. Together with a 13% contribution of other strains, which further subdivide into nine other strains with less prevalence, this adds up to a total of 13 variants, which provide direct context for the preliminary efficacy calculation. As shown in the geographic breakdown of the total number of sequenced cases, the broad variety of variants originates primarily in Latin America, which contributed about 80 cases, or 65%, to the 124 sequenced cases. In Europe, the 44 cases we observed, or 35% of the total, are strongly dominated by the Alpha strain in accordance with the general virus distribution there. The variant overview provided on the next slide further extends the pool of sequenced COVID-19 cases recorded in the HERALD study to include non-adjudicated cases, providing a more detailed picture of the variant dynamics within the study. This overview is based on a total of 474 COVID-19 cases which were accrued and sequenced within the HERALD study, irrespective of the former COVID-19 case adjudication process, and thereby includes the 124 adjudicated cases as well as 350 non-adjudicated cases. While the majority of these cases therefore did not contribute to the efficacy calculation, they provide a more accurate and extended picture of the circulating virus variants within the study. Overall, 29 different COVID-19 strains were identified, which cover all currently designated variants of concern, including the Alpha, Beta, Gamma, Delta, and Epsilon strain. Variants of interest including the Zeta strain, as well as the newly assigned Lambda or C.37 strain first detected in Peru. four strains belonging to the original virus and B.1.621 and B.1.1.519 with high prevalence in Colombia and Mexico respectively. In accordance with the variant mix in the group of adjudicated cases, diversity was again more pronounced in Latin America compared to Europe, where the Alpha strain dominates. I am now on slide 10 to briefly touch on the preliminary vaccine efficacy data from the second interim analysis. First, let me remind you again that preliminary vaccine efficacy of 47% was calculated for the prevention of COVID-19 cases of any severity and across all strains. Although the study was not statistically powered to provide separate subpopulation efficacies, the preliminary data show trends for age and strain-related efficacy. For age-related trends, the interim results suggest efficacy in younger participants but did not allow to conclude on efficacy in the age group above 60. For strain-related trends, interim data suggests an efficacy range within the most prevalent strains of the 13 different COVID-19 variants identified within the adjudicated cases applied for efficacy calculation. We will now continue to final analysis on the basis of approximately 80 more cases compared to the second interim analysis, which we expect in approximately two to three weeks. Based on the addition of new cases, the efficacy readout is expected to change. I'm now on slide 11 to briefly update you on the safety and reactogenicity profile of CVnCoV on the basis of the first 2,000 participants recruited within the HERALD study. The two 12 μg vaccinations of CVnCoV are shown to be well-tolerated. As previously reported for CVnCoV and in line with other mRNA-based COVID-19 vaccines, the majority of events were mild to moderate and accumulated around fatigue, headache, muscle pain or myalgia, and chills. Only few fever events were recorded. We were particularly pleased to see that there was no increase in the severity of side effects after the second vaccination compared to the first vaccination. Both reactogenicity profiles are comparable. The data is further stratified according to trial participants between the age of 18 to 60 and participants above the age of 60. As expected, side effects are generally more pronounced but still in a well-tolerated range within the groups of 18 to 60-year-old study participants compared to study participants above the age of 60. Overall, the safety profile is fully in accordance with the safety profile reported for other mRNA-based vaccines and further confirms the safe applicability of CVnCoV. Let me now hand back the call to Franz for a short summary of key messages and next steps. Thank you, Ulrike. Let me quickly summarize key messages from the present interim analysis and outline the next steps. Our technology had to prevail in one of the most challenging COVID-19 environments. While we were hoping for a stronger outcome of this second interim analysis, we see trends that indicate efficacy in younger age groups below the age of 60, as well as potentially differentiated efficacy per strain as far as the conclusions from this interim data readout with the limited statistical power allow. We will now move to the final analysis, which we expect within the next two to three weeks and which we will carry out on the basis of more than 200 cases to confirm age and strain-related trends and also look at disease severity. These cases will also be characterized by accompanying sequencing data. Data from the final analysis will allow us to look further into the efficacy to see in participants below the age of 60. Please note again, this takes into account efficacy against any severity of disease within the challenging variant environment. Final analysis will also allow us to better understand the unprecedented broad diversity and dynamics of variants in all trial countries, which had an impact on the vaccine efficacy we see so far. We mainly are fully committed to supporting ending this pandemic. Following the final analysis, we will carefully assess the most appropriate regulatory pathway for our vaccine, CVnCoV. Lastly, we had a strong second-generation candidate lined up in our COVID-19 pipeline, which we are co-developing in partnership with GSK, and which we intend to bring into the clinics within the next four months based on promising preclinical data we have. For the last part of the presentation, let me now hand over to Mariola for a quick look into the new preclinical data in our second-generation COVID-19 vaccine, which targets faster improved immune responses at even lower doses to primarily meet the challenge of the emerging new variants via multivalent vaccines, as well as combination vaccines for potential protection against multiple infectious disease in a single vaccine. Thank you, Franz. To further counter the ongoing spread of new virus variants, on slide 13, I would like to introduce two 2nd generation COVID-19 vaccines, which we are co-developing together with our partner, GSK, on the basis of a new messenger RNA backbone. This new messenger RNA backbone differs from the setup of our 1st generation vaccine candidate, CVnCoV, and was generated on the basis of our learnings over the past year. Based on non-chemically modified messenger RNA, the 2nd generation messenger RNA backbone featured targeted optimization, focusing on improved messenger RNA translation for increased and extended protein expression, as well as improved immunogenicity. It thereby targets the ability to rapidly induce improved immune responses compared to CVnCoV. These characteristics will be key for the development of multivalent vaccine, as well as combination vaccines. The 2nd generation data illustrated on slide 14 are central proof of concept data applying to the 2nd generation COVID-19 vaccine candidate, CV2CoV. The data from part of a larger preclinical data set generated in non-human primates, which is currently being generated in collaboration with the Harvard Medical School. The so far unpublished data is based on animals immunized with CV2CoV or CVnCoV, according to the vaccination schedule applied in humans, which includes two vaccinations with a 12 μg dose given on day zero and day 28. The neutralizing antibody titers shown here strongly confirm the functionality of the advanced 2nd generation approach for rapid and strong immune response. The onset of neutralizing antibodies occurs faster for CV2CoV than for CVnCoV. Already two weeks after first vaccination, CV2CoV shows good antibody titers, and while the second vaccination on day 28 efficiently boosts antibody titers for both candidates, it leads to a more pronounced booster effect of CV2CoV. The full data publication will be made available through a scientific manuscript over the next weeks. With this, we conclude our presentation and would now like to open the webcast to your questions. Thank you. At this time, we'll now be conducting a question and answer session. In the interest of time, which allows as many as possible to ask questions, please limit yourself to one question and one follow-up question. If you'd like to ask a question at this time, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. one moment, please, while we poll for questions. Once again, that's star one. Thank you. Our first question is coming from the line of Umer Raffat with Evercore. Please proceed with your question. Hi, guys. Thanks for taking my question. I wanted to go a step beyond the disappointing news from last night and perhaps try to understand your data in the context of broader vaccines for a second. I'm trying to connect the dots between the lower efficacy headline you have versus the spread of neutralizing antibody titers seen in phase I. As you recall, a third of the patients at your 12 μg dose had fairly low neutralizing antibody titers after two doses. My question is, have you compared the neutralizing antibody titers against those key variants where the patients that were protected versus the ones that were not? Is there anything we could learn from that, number one? Number two, how different was the efficacy in younger versus older adults? This question also starts to answer neutralizing titer levels which are needed for protection. Finally, if you could just clarify, the press release last night says 424 cases have happened, of which the 134 were adjudicated. On slide nine today, it implies you've had 474 cases. Could you please clarify that? Thank you. Maybe I will take the first question regarding correlation between antibody titers and protection. We don't have this data now, but this is exactly what we want to better understand. We have analyzed more than 600 subjects for induction of antibody responses. This will be the task also for next weeks, to look here whether how this antibody titers correlate with protection, et cetera, to think about establishment of correlate of protection. This work will be done during next weeks. The second question, younger versus older. Currently, also for this, we need to go for the final analysis. Because, especially for older people, we have really a few cases. Therefore, we see trends, but to state final numbers, we really need to wait for the final data because they will change. Maybe, Umer, the last statement, the 424 overall sequenced cases versus the 474 in the presentation. That is, in fact, a typo in the press release. I am very sorry for that, and it will be corrected. The correct number is 474 cases sequenced overall. Got it. Just to be clear, Sarah, of the 474, 134 were already adjudicated and another 80 will be adjudicated, meaning every case beyond the 134 plus 80 are cases that happened before day 15 post-dose two. Am I understanding that right? Yes. All the cases that were not adjudicated did not meet the adjudication criteria. Exactly. All right. Thank you very much. Our next question comes from the line of Eun Yang with Jefferies. Please proceed with your question. Thank you. I have a few questions, too. In the study at the interim, about 57% of the cases were caused by the variants of concern. Can you talk about what was the efficacy for the variants of concern versus non-variants of concern? That's question one. Second, you mentioned that at the final analysis that we are expecting at over 200 cases, the data efficacy could change. Can you elaborate on directionally what kind of changes we may see? Thirdly, can you comment on timing for phase IIb data updates? You also added a third dose. Did you add a third dose because you're not achieving the neutralizing antibody titers that you hoped for? Thank you. I can take your question about the efficacy against individual variants of concern. It is premature to conclude about this today. We need to go for the final analysis to accrue sufficient cases to draw more statistically robust conclusions, and the snapshots as of today will change. This would be premature. I think it was also the question on our 002 study in elderly in Peru, Panama. As we mentioned during our last webcast, that this study was amended also to be able to look on efficacy in this trial because we saw changes in the occurrence of COVID cases. For this focus, the study remained blinded. As you know, this is also a placebo-controlled study, and therefore, we're not able to publish or to disclose results in an unblinded way. This is now also occurring, and we will also comment and share with you results from this trial as well. It was, other question? On the third dose on phase IIa. The reason, maybe let me jump in on the third dose. We added the dose in each age group in the phase IIa, the reason for that is we also want to assess the boostability. The booster approach. We have two horizon is one month and six months after the second dose in phase IIa. This is something that we need to understand to see once you prime is how well you boost the participants. Did we answer all your question? Thank you. Our next question is coming from the line of Zhiqiang Shu with Berenberg. Please proceed with your question. Hi, good morning. Thanks for taking my questions. My first one is also on the variants, maybe particularly for Alpha strain, I think a few other mRNA vaccines have been tested specifically for that strain. Do you think in the final analysis we will be able to see, particularly on the strain, we can draw conclusion about the efficacy so that we can compare side to side with other mRNA vaccine? That's the first one. Second one, I think your secondary endpoint is the prevention of moderate to severe cases or hospitalization. Do you think in the final analysis we'll be able to see that data as part of the data package for approval? Third, can you also provide some color around your interaction with EMA regarding the path forward? Thank you. Yeah. Let me take the first question. We will continue to the final analysis, and that may allow us to get a better understanding, depending on the number of cases caused by the Alpha strain, about the strain-specific efficacy. As I said already, as of to date, some conclusion is not possible. The next question was, I think, related to the moderate to severe cases. Yeah, here I can say that this interim analysis recorded a vast majority of mild cases. We need to accrue more cases to reach significance, and this will depend on the number of additional severe cases that come in the new cases accrued for final analysis. We have to see how many we get, but the number is definitely lower, and that will make statistically some conclusions on moderate and particular severe cases more difficult. The last one, yeah, was related to interactions with EMA. We will first finish the study, but we are already in close contact with EMA as to assess the path forward. Yeah, that is the current situation. Does that answer your question? I guess for EMA interaction, maybe if you can provide some guidance on the timing and what specifically you're looking for potential approval. Yeah, first let me take this one. Certainly we have got this rolling submission, and certainly we talked about this interim analysis with EMA as well. It's quite clear that we need to provide the data and the final analysis before there is any estimation. What we can see in this changing environment, vastly changing environment with all the different variants coming in, it's quite hard to estimate what there will be. The goal is here, the totality of data to really see. There is hardly any big package as we are providing right now and to be provided. The final data, then the totality of the data to be looked at to make then an educated decision here. That's exactly the status, what we are with EMA. Great. Thank you. You're welcome. The next question is from the line of Seamus Fernandez with Guggenheim. Please proceed with your question. Oh, thanks for the question. Just wanted to get a couple of clarifications. Can you just clarify when we might see either the regional efficacy, so efficacy in Europe only? Is it possible that we could see enough events in Europe over time and against the Alpha strain specifically? I guess a part of the question is, when might we see a regional efficacy evaluation separate from the very different variants that we're seeing in South America? The separate question is when will we see data simply on Alpha? Is that possible that we could see a clear secondary endpoint, at least against just the Alpha strain? We will provide those data with the final analysis, but at present it is premature to conclude on that. Yeah, it's a pretty liquid situation when it comes to variants. I think, once we have accrued all the cases, this is where we'll report the final picture. Of course, depending on the occurrence of each one strain, you'll see a confidence interval which makes sense or less, right? We will report these when the data comes out in, we say, two to three weeks. Yeah. Okay, just a final question on your plans for advancing for moving forward. What really are the decision points from here? From my perspective, it seems like CV2CoV is promising on the basis of the preclinical data, but that still is preclinical. We've seen very different but you do have evidence of clear differentiation between the two programs. Can you just help us understand which program you're motivated to move forward with, in that context? Do we just have to wait for the final data prior to those decisions? Basically, are you going to accelerate the CV2CoV in the context of these data? Thanks. Thank you for the question. What we do is we are going full speed for final readouts. As Ulrike was saying, we are expecting the data here to come within the next three weeks, and there is no reason to slow down anything here, not with regard to the building out of our manufacturing network or to slow down the process with regards to CVnCoV. Because that's the primary product candidate close to the finish line, where exactly what all the questions came back to say, what we can say now, not very much. We're going for the final data and plan for regulatory pathway, which means approval. The data will show. There is no reason to slow this down. In parallel, what we're doing also with a lot of effort together with GSK, we are working on the CV2CoV with different properties, but also to think about multivalent vaccines. To work on those, certainly on CV2CoV, on different variants as well to start with, but also multivalent vaccines. Even to, as we have got a product collaboration with GSK, on other mRNA-based vaccines, five in the number. There are both strains. On the CVnCoV, this is going full speed, nothing to be reprioritized, not with regard to the development, the data, or the manufacturing. The same in the manufacturing, certainly there's a role for the CV2CoV as well. The other one is working completely in parallel, also full speed. There is not a strategic shift or something to decide now. This is what the final data we are also looking to get those. Yes, perhaps there will be decisions to be taken, but for now, we are going full speed exactly where we are. Okay. Thank you. You're welcome. Our next question is from the line of Geoff Meacham with Bank of America. Please proceed with your question. Thanks for the question, guys, and all the details. Just had a few. If you compare your study to prior mRNA studies, the variants are the main difference, also there are a lot more treatment options for infected patients, which helps mitigate the severity. Can you talk about how much that may have played a role in the results here? I know it's early, also, if you can talk about any metrics you've looked at with respect to T-cell, because that was previously part of the differentiation. Last question is, when you think about the CoV-2, the 2nd-gen vaccine for variants, just help us with kind of how you're generally thinking about the size and scale of how to run that type of study, just given the statistical power that you'll may need. Thank you. Okay. You asked for the comparison of messenger RNA studies, but it was regarding here the different treatment options, yeah, as subjects have now. That was one part. One was about the T-cell responses. The T-cell responses, we analyzed in our phase I trial and also in the trial 02. As I said here, just because here, especially the trial in elderly was blinded, and just we started with the analysis. What I can say, we see T-cell responses. It seems here that even for elderly, the T-cell responses are comparable to younger. This is what we will also really disclose here very soon as we will report about our two study. For the treatment, Ulrike? Yeah. Let me make sure I understand your question correctly. Your question was whether available treatments for COVID-19 disease could have influenced the severity of cases in our trials? Was that your question? That's right. Yeah. One of your secondaries was looking at disease severity and whether downstream therapies had affected that. If you look at when the mRNA, the other two mRNA vaccines, those trials were first run, right? It was obviously in the infancy of the COVID-19 pandemic. We have no strong data to conclude on that, whether that has influenced the severity. Another factor might have played a role that we have accrued more mild cases is that our case definition for the primary endpoint was slightly different from that of other trials. For instance a crude also cases that were characterized by just a single non respiratory symptom. That was not the case in all other trials that could have led to the fact that we end up with adjudicated case population of milder cases rather than more severe cases. Okay, the last question I think was around our CV2CoV candidate. Having size, scale of clinical trial, strategy for variants. This is absolutely the topic of our discussion with GSK. We are preparing here. What I can say and disclose here that for sure we took all the learnings also from CVnCoV study. Know speed and time is so important here. We will have different arms in this trial. We will go also for bivalent candidates. Also with different variants, not only with the original one. This is the goal. Still to keep the size of the trial reasonable and the goal is here to be as fast as possible, to learn as much as we can here and to get approval also for CV2CoV next year. Okay, thank you very much. Thank you. Our next question is from the line of Jonathan Miller with Evercore ISI. Please proceed with your question. Hi, guys. Thanks so much for taking my question. I guess I wanted to focus on time to the final analysis, which is now better than 200 cases. You need to say about 80 more cases at this point. Are those cases that you already have in hand and are waiting for adjudication, or are you going to need to wait for more cases to come in? Relatedly, what's the current failure rate for adjudication? It seems like your overall number was something like 30% of cases ended up being adjudicated. I'm just trying to get a sense for how much of those adjudication failures were being driven by COVID cases coming too early after second dose versus other reasons for failure, which is to say, at this point, are you still seeing high adjudication failure rates? Okay. Let me take the first point about the final analysis. We have the cases, but we need to complete the adjudication process for the remaining 80 cases. I need to check back for the exact adjudication failure rate. One thing to mention as well is that we're also sequencing the cases, and we want to wait for sequencing results of all cases that can be sequenced to use that for the final analysis as well. Reasons for adjudication failure can be the exact timing, but also the fact that subjects will turn out to have been seropositive for COVID-19 before the 15 days post those two time point. Then they would also not be included in the efficacy population. I don't know where the 30%, just to put a column that adjudication failure rate comes from, because I believe it's much lower. At this stage, of course, we have a lot of COVID cases, but these are cases which took place in the trial, I'll say from day one, right? That's why we have the trial number. The adjudication is two weeks post dose two and then goes through all these different criteria- Right, yeah. that Ulrike just talked about. The failure rate must be pretty close to completely low single digit, I would guess. Sure. Thank you very much. I guess that 30% number just coming from your total number of cases versus the adjudicated cases. I recognize that most of those are coming from cases that happened before the 15-day window was. Yeah. Okay, cool. Our next question is from the line of Eun Yang with Jefferies. Please proceed with your question. Thanks. A little follow-up. Just one question on the second-generation CV2CoV. The trial is going to go into clinic in third quarter. Will you be conducting the trial in Europe as well as Latin America, not in the U.S., similar to the first generation products? When you start trial in third quarter, when do you think we may be able to see the data? Thank you. Yeah, this is still under discussion with GSK, so it's not decided yet. It is because there's the entire strategy to go with CVnCoV, so therefore we cannot talk about this one. There will be a second session when we are doing this, and this will be together with GSK then. Sorry about that. Thank you. CV2CoV. CV2CoV? Yes. Oh, sorry. Not the CVnCoV. Sorry, I was reminded we're talking about CV2CoV here not CVnCoV. This was your question. Thanks. Next question is from the line of Denise Roland with Wells Fargo. Please proceed with your question. Oh, hi. Sorry, it's Nina with The Wall Street Journal here. I'm just trying to understand what the best-case scenario is. If these remaining 80 cases, if the data is as good as it could possibly be, what are you looking at in terms of what then? Is it that you want to be able to say that the vaccine is much more efficacious overall? Is it you want to be able to say, well, you know what, it's really efficacious against the Alpha variant, so it could be targeted to those populations? What do you have in mind as you kind of see the final analysis? Yeah, thank you for the question. This is exactly what we are looking in the final analysis, as what Mariola and Ulrike were talking about is that we see certain clear trends. Where this will end up, and if this is your question, where the label will end up with, we do not really know at the moment. We wait for these final data, and then we'll discuss with EMA regulatory authorities certainly as well. Yeah, sorry, this is the best where we are. What certainly is considered at the end of the day for a product is certainly also it's not only about primary vaccination, but it's also about the booster as a product in itself to boost with already vaccinated people. Therefore, absolutely great question, but this will be exactly the goal for the final analysis to look into this, to get into these kind of diversified look. The final data will give us a peek into the segment in which the best offering is most relevant for the vaccine. Thank you. As a reminder, you may press star one to ask a question. Thank you. At this time, I'll turn the floor back to management for closing remarks. With this, we would like to conclude this conference call. Thank you very much for your participation. Stay safe, and please don't hesitate to contact us should you have any further questions. Thank you and goodbye. Thank you. Thank you. This will conclude today's conference. Thank you for your participation. You may disconnect at this time and have a wonderful day.