Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih, 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, and Ulrike Gnad-Vogt, our Interim Chief Development Officer. Mariola Fotin-Mleczek, CureVac's Chief Technology Officer, and 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 Presentation 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 views as of today, Thursday, July 1st, 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 US 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 us here at CureVac. Over the last past six months, we have been conducting a pivotal phase II-B/III efficacy trial called HERALD study, our first-generation COVID-19 vaccine candidate, CVnCoV. Conducted in 10 countries and across two continents, in Europe and Latin America, the HERALD study is so far unmatched by similar trials in terms of geographic diversity and, even more important, in terms of increasingly challenging, variant-rich environments the vaccine faced. In this highly dynamic variant enrichment and across this broad geography, CVnCoV met the statistical success criteria on the basis of 228 adjudicated cases, including an additional 68 cases compared to predefined 160 cases for final analysis as per trial protocol. Efficacy was calculated to be 53% in the age group of 18-60 on the basis of 228 adjudicated cases that met the criteria for analysis inclusion. This was calculated against any severity of the disease and across a total of 15 different virus variants, which in some featured 86% variants of concern and variants of interest and two additional variants beyond the 13 variants in the second interim analysis. In the same age group and across the same broad range of 15 different variants, protection against moderate to severe disease was calculated at 77%. Full protection was provided against hospitalization or death, with six cases occurring in the placebo arm and none in the vaccine arm. Efficacy across all age groups amounted to 48%. This was across any severity of disease and in the face of 15 different variants that were detected within the adjudicated cases. The age group of above 60 included 21 cases, or approximately 9% of the adjudicated cases. In this predefined group, as per protocol, the data available from these 21 cases did not enable a statistically significant determination of efficacy. We believe CVnCoV is, to date, the only vaccine which has been able to show robust protection against moderate to severe disease, as well as hospitalization or death, while being challenged with a confirmed spectrum of 15 different virus variants in a placebo-controlled pivotal study. We believe this data establishes CVnCoV as an effective vaccine that has the potential to make an important contribution to the continued fight against COVID-19. Now, let me hand over to Ulrike, our Interim Chief Development Officer, to walk you through the details of the study setup, the case accrual process, and the efficacy analysis within the final analysis. Thank you, Franz. Please let me start by briefly reminding you on slide five of the highly international scope and the age distribution within the HERALD study. Conducted in four countries in Europe and six countries in Latin America, HERALD constitutes a multivalent 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, the region which today accounts for approximately 32% of COVID-19 related deaths worldwide. These approximately 40,000 study participants were distributed in two predefined age groups. Roughly 5,000 participants or 13% were above the age of 60, while the majority of about 35,000 participants or 87% were between the age of 18 and 60. The mean age of study participants was about 43 years. I am now on slide six to give you 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. PCR-confirmed COVID-19 cases that occur at least 15 days after the second vaccination additionally undergo a stringent adjudication process, including the exclusion of those confirmed COVID-19 participants who test positively for a prior COVID-19 infection. Since the second interim analysis communicated on June 16th on the basis of 134 adjudicated cases, 94 additional cases have been accrued and adjudicated, resulting in a total of 228 cases used for the final efficacy analysis. Of these 228 COVID-19 cases, 207 cases were detected in participants in the age group of 18 to 60, representing an increase of 88 cases compared to the second interim analysis. 21 cases were detected in participants above the age of 60, representing an increase of six cases compared to the second interim analysis. As occurrence of COVID-19 cases needs to be seen in the context of the rapid spread of new virus variants, 204 of the 228 adjudicated cases were sequenced to identify the variant causing each infection. A total of 24 cases could not be sequenced due to insufficient sample material. The next slide is a frequently used slide in our presentation that illustrates the currently estimated variant spread in the two study geographies, Latin America and Europe. New virus variants have emerged and spread steadily since the end of 2020 and have all but displaced the original virus strain. As Franz has already highlighted, the dynamic variant background must be considered for the interpretation of the CVnCoV efficacy results. Variants of concern initially included mainly three lineages, namely the Alpha strain first detected in the U.K., the Beta strain first detected in South Africa, and the Gamma strain first detected in Brazil. This group was recently extended to include the Delta strain first detected in India. Over the past three to four months, the Delta strain has rapidly spread around the globe and is today estimated to show an approximate 13% prevalence in Latin America and an approximate 26% prevalence in Europe. Also, new variants of interest have been added to the watchlist based on genomic properties or other evidence that imply a potential impact on transmissibility, severity, and/or immunity. This includes the Lambda strain first detected in Peru and the B.1.621 strain first detected in Colombia. Because of the continuing spread and emergence of new virus variants, we have conducted comprehensive sequencing analysis to better 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, 204 cases, or approximately 89% of the 228 adjudicated cases that were used for the final efficacy analysis, were sequenced. As said before, 24 cases could not be sequenced due to insufficient sample material. The strain distribution resulting from these sequencing analysis is illustrated on slide eight and provides important context around the CVnCoV efficacy results calculated at final analysis against any severity of disease according to the primary study objective. Of the 204 sequenced adjudicated cases, variants of concern, including the Alpha, Gamma, and Delta strains, represent approximately 51%. Variants of interest contributed approximately 35%, including the Lambda or C.37 strain originating from Peru and the B.1.621 strain originating from Colombia. The Lambda variant was previously 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 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. Overall, the final efficacy calculation reflects performance against a total of 15 different variants, majority of them known to have mutations concerning increased transmissibility or immune resistance. As shown in the geographic breakdown of the total number of sequenced cases, the diversity of variants originates primarily in Latin America, which provided the majority of newly adjudicated cases and contributed overall 155 cases to the 204 sequenced cases. In Europe, the 49 cases we observed are strongly dominated by the Alpha strain in accordance with the general virus distribution there. The variant overview provided on slide nine further extends the pool of sequenced COVID-19 cases recorded in the HERALD study to look at a combined pool of adjudicated and non-adjudicated cases in order to provide a more detailed picture of the variant dynamics within the study. This overview is based on a total of 588 COVID-19 cases, which were accrued and sequenced within the HERALD study, irrespective of the formal COVID-19 case adjudication process. This group includes the 204 adjudicated cases as well as 384 non-adjudicated cases which occurred prior to the 15-day post second vaccination cutoff, and therefore did not qualify for adjudication. While the latter group of cases therefore did not contribute to the efficacy calculation, they helped to provide a more accurate and extended picture of the circulating virus variants within the study. Overall, 29 different COVID-19 variants were identified, which cover all currently designated variants of concern, including the Alpha, Beta, Delta, Epsilon, and Gamma strains. Variants of interest including the Lambda, Iota, Zeta and B.1.621 strain, the B.1.1.519 strain with high prevalence in Mexico, and three lineages related to the original virus. 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'm now on slide 10 to discuss CVnCoV efficacy data from the final analysis. In the context of 15 different virus variants and in the predefined age group of 18 to 60, CVnCoV exhibited a favorable efficacy of overall 53% against any severity of disease. This includes the occurrence of more than 80% of mild cases, which are characterized by the occurrence of at least one and not necessarily a respiratory symptom in combination with a positive PCR test. In the same age group, a 77% protection was achieved against moderate to severe disease, and full protection was shown against hospitalization or death. Preventing hospitalization or death with a robust and widely variant-tested vaccine is an important prerequisite to support the global fight against COVID-19 and the associated burden on healthcare systems. In the predefined age group above 60, the available data does not enable a statistically significant determination of efficacy. On slide 11, let me now go a bit more into detail of the efficacy trends we observed in view of selected variants with higher prevalence in the pool of adjudicated and sequenced cases. As the HERALD study was not powered to provide a statistically robust efficacy read out for strains, case numbers for the separate variants are too low to calculate statistically robust efficacies or conduct further correlations with specific disease severities. We therefore present the efficacy data in this table together with the corresponding case numbers detected in the placebo and vaccine arm, as well as the upper and lower limit of the confidence interval to allow for a better assessment of the statistical robustness of efficacy numbers. We were able to assess efficacy trends in the age group of 18-60 for the two prevalent variants of concern, the Alpha and Gamma variants, as well as two prevalent variants of interest, the Lambda and the Colombia strain. Results shown in this table indicate robust and balanced protection against the separate variants spanning a range from 42% observed against the B.1.621 strain originating in Colombia, to 67% observed against the Gamma variant. Please remember that these efficacy results are calculated against any severity of disease. I'm now on slide 12 to remind you again of 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, and 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- 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 group of 18- 60-year-old study participants compared to study participants above the age of 60. Overall, this 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 next steps and key messages. Thank you, Ulrike. Let me quickly summarize the key messages from the present final analysis and outline the next steps. The readout of the final analysis of the HERALD study confirmed strong public health value of CVnCoV vaccination in the predefined age group of 18 to 60, providing 77% protection against moderate to severe disease and full protection against hospitalization and death. These would be satisfactory numbers when tested against a handful of the currently circulating virus variants. Against the combined, simultaneous, and unprecedented influence of 15 different variants, including mainly variants of concern and variants of interest, this is truly a major achievement. We remain fully committed to supporting the effort to end the COVID-19 pandemic, which continues to cause many thousands of deaths each day. We intend to file for regulatory approval, leveraging CVnCoV demonstrated strength against the continuous variant dynamics and in populations where it can provide a great benefit and serve the highest unmet need. We are in a continued and constructive dialogue with the European Medicines Agency, EMA, and data submission process are ongoing. In the meantime, we will further execute on the manufacturing ramp-up and build-up of our broad European manufacturing network, as well as the development of our strong second-generation COVID-19 vaccine candidate, which we are co-developing in partnership with GSK and which we intend to bring into the clinic within the next month. With this, we conclude our presentation and would now like to open the webcast to your questions. Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key Our first question comes from Umer Raffat with Evercore. Please proceed with your question. Hi, guys. Thanks so much for taking my question. I have three, if I may. Perhaps first, I would say we all agree that the study did not achieve the efficacy targets we all had in mind. I guess what I'm trying to reconcile is the comments you're making around strong public health value proposition from the current data. What I'm really getting at is if you could walk us through, A, the visibility you have on the regulatory approval, and B, the dollar contracts that you think you basically pretty much have locked in based on the current data that you have. That's first. Secondly, Mariola, we never saw neutralizing antibody titers for patients above 60 years of age in your phase I data. Now we know in phase III, there was an imbalance on COVID infections in that age group. There were more infections on 60+ on vaccine versus not. I guess what can we learn from that as it relates to correlate of protection, and what can we learn broadly from the younger person's data on the correlate of protection? Which leads me to my ultimate question, which is, the non-human primate data for your next gen vaccine shows the neutralizing titers are 10 times higher. The mouse data yesterday didn't quite show that, and I'm just trying to reconcile the two and when can we have the non-human primate data for review? Thank you very much. Thank you, Umer. First of all, perhaps to start with your first question with regard to the regulatory approval process, which I will lead over to Ulrike to comment. On the contracts, what you mentioned, as you know, we have got this contract with the EU on 225 million dosages, which has been signed last year. Of course, we are in discussion also with the EU, and sharing with them the data, which is going to happen now soon, the data we have been presenting to you. We clearly see that we are on the road to find a pathway to get approval for what we think there is a public health benefit of the data we are having with all these 15 different variants, which have not been known when we developed the vaccine, and we see this efficacy. We are in conversation with them, and we don't have any sign that these contracts are not going to be served, and certainly, we are producing, as we said, to deliver the dosages. On the other hand, certainly, we are in discussion also with other governments, especially in the countries where we have been running the clinical trials, which there certainly the regulatory authorities also see the data. As we also think that we can make a difference here for public health interest with our vaccine, we are talking to those as well. Long story short, the one is we don't have any sign that the agreements we have been signing are going to be terminated, but we will show certainly, especially the EU, the data, and we are in discussion with other governments there as well. On the regulatory path, Ulrike? Yeah. We are in dialogue. With EMA and remain in the rolling review process. We'll work together with EMA based on totality of data on the most appropriate path for approval of our vaccine. That is work in progress, and we are in close interaction. If I may say, with regard to the timeline, certainly we cannot say something as we talk now, because also we are, as Ulrike was saying, in conversation with the EMA, and we will certainly finalize our clinical trial report, and then we are going to discuss with EMA, and then certainly they will take their time, but only they can make an estimate if they've seen the totality of data here. Exactly. Okay. Maybe on correlate of protection, where we stand here and what can be learned from the data? There is a lot of efforts here to establish this correlate of protection. It's not only our study, but also an organization work and try to compile all the data available, yeah, to establish that correlate of protection. What is already known, it's difficult to do this on the single-subject basis. It's rather per population. For sure, we hope with all our data, we can contribute to this as well. Therefore, we also will measure antibody titers in HERALD study in the huge population, and this is ongoing, and yeah, will be also part of our submission, also the serological data. In our phase I, as you mentioned correctly, we didn't include subjects above 60 years old, the age, it was done in our phase II study conducted in Panama. We measured here antibody responses, also in elderly, this study was blinded for the longer time period, just recently, this study was unblinded for the analysis, which is still ongoing. Therefore, we will publish and present the data soon. What I can say that we see antibody titers in elderly, but they are lower as compared to, which is also normal, as we know, that elderly immune system is not as efficient as by younger. This is also true in our study. We see also nice T-cell responses in elderly. There is immunogenicity observed. Whether this will explain these cases we see in elderly, we need to see. I need to mention that we had really less cases. Therefore, majority of them, of the 21, is mild. Therefore, it's difficult to comment on moderate severe in this population. Getting to your question, second-generation in comparison to first, we showed in the NHP data 2-fold increase. That was microgram dose. In recently published mice data, maybe the difference is not so huge. I think it's due to the dose for the comparison, because it was only 1 dose of 8 µg, if I'm right. This can explain that the differences are not so huge as for NHP. NHP data will be published soon. This is collaboration with laboratory of Dan Barouch. There's a lot of data produced here, therefore the manuscript will be very comprehensive, is in preparation, publication will come soon. Thank you guys so much. Thank you. Thank you Thank you. Our next question comes from Seamus Fernandez with Guggenheim Securities. Please proceed with your question. Hi, guys. This is Evan Wang on for Seamus Fernandez. I have a few questions. First, just want more detail on the regulatory path forward, specifically for the 18-60 age population. I know the trial protocol kind of separated overall pop with the secondary endpoint for the elderly population. Can you provide any color on ongoing discussions there based on this age subset? If you can provide more detail within that 18-60 age population, whether you saw a difference in efficacy across there and whether we may see further stratification based on age. Second, just want more detail on the manufacturing. How many doses have been produced at risk, and what is the anticipated cost and scale-up if authorization is granted? Third, with the next-gen efforts, I believe this CV2CoV will be using the UTR modifications but not the modified bases. I know GSK has described the modified bases there, so any ways to accelerate development or run those next-gen vaccines in parallel? Thanks. Yeah. On your first question. We are in dialogue with EMA also about the different age groups. As we said already, the 18- 60 years old age group was pre-specified for protocol, and we will, of course, also discuss certain option to approve for an age subgroup. I cannot comment on certain substrata. At this point in time, because also case numbers are low and one has to be cautious at this stage to conclude on these data. Of course, we will share all that data with the EMA and discuss the most appropriate path forward. Perhaps on the manufacturing, I take over. We have been building up now since a while, a pan-European manufacturing network, which is taking over our, here in Tübingen, running what we call GMP3 commercial facility, and we are duplicating this quite tremendous often times with Rentschler, Wacker, Celonic, Novartis, and to have this capacity. We never stopped with this one, even not with the interim data we have been seeing. It's going full speed that we are producing, which is still the goal, that we are producing up to 300 million dosages towards the end of this year. We have to see how many of those dosages can be released then because it's a regulatory part as well, because this is part of the dossier as well, what we are handing in, certainly with the EMA at the moment. This is still the goal, and it's also providing certainly the manufacturing capacity which we need for next year. The same capacity then is needed, certainly up to a certain point of time, also to produce, you mentioned it, the CV2CoV. It's the second generation, what we are developing together with GSK, not only on a monovalent but also multivalent. Perhaps you have seen last week, also GSK at a press conference also mentioning here that it's a combination also blended together with flu based on mRNA. This is why we need the capacity. Mariola, perhaps you want to take the last one on chemical modification CV2CoV. Yeah. Next generation candidates we presented here is based on our technology and focus on natural nucleotides. It's optimized backbone and antibody responses, T-cell responses we observed in NHP are absolutely occurring. Therefore, we want really to bring this construct into human in different forms as also bivalent vaccines. Optimization never stops. For sure, we are open and test different kind of optimization and not excluding also testing of chemical modification. We did this also in the past. So far the data support our decision to go with the second generation as it is now into the clinic. Got it. Thank you for both. Thank you. Thank you. Our next question comes from Eun Yang with Jefferies. Please proceed with your question. Thank you. The primary efficacy endpoint of the study is in all age groups, which is about 48% vaccine efficacy, missing the 52% or higher efficacy bar in final analysis. You continue to mention 18- 60 age group was predefined, but I cannot seem to find that pre-specification in your protocol. Is that predefined by EMA before you started the study, or is this a post hoc analysis? Yeah. Let me comment on that. It is not post hoc. It was pre-specified in our SAP, and we have also a key secondary efficacy endpoint in the older age group. There it is mentioned. Okay. Another question is, on the older population, you have more the infection cases than placebo. Because of that, do you think that EMA, when they review your application, they would want to see phase II study data where you had about 270 participants above age 60? If so, when do you think that data may be available? This data will be available very soon and also be part of the rolling submission and will be considered also for the evaluation. As EMA has said, they will evaluate totality of data, which means not only data from HERALD but also from this trial, which you correctly say included higher percentage of subjects, about 60 exactly. Okay, thanks. The EMA guidelines for COVID-19 vaccine kind of specify that the lower bound of 95% confidence interval should be above 20%, preferably 30% or above. Can you talk about your confidence interval in efficacy data points? We have a lower bound of 30%. We have achieved that criteria for our primary efficacy endpoint. As you correctly stated, EMA, and that was also a statement from Marco Cavaleri some time ago, will also look really at the totality of data. They do not give a certain percentage of efficacy, like 50%, that needs to be met for an approval. We think most what is really relevant that we have achieved statistical significance with a lower boundary of above 30%. Okay, the last question. I'll jump on the queue. You have agreement with the European Commission to purchase 225 million doses and potential for additional doses. My understanding is that once it's approved, the European Commission is obligated to buy 225 million doses. Is there a chance that based on the data, they may cancel the order? Well we are having very soon a discussion and certainly discussing with the European Commission, but also with the member states, because the contract works like that, the member states are the recipients of certainly the dosages that we are presenting here the data. You're right, because this APA, Advance Purchase Agreement, is public. It's public knowledge that, certainly if there is approval, the dosages have to be ordered, at least we feel now. We will have these discussions. Certainly, we will present, and that's good because they are our customers, to take these dosages to show the data where we think we have not only a second-class vaccine here, but a vaccine in this subgroup, really vaccine which is also needed from a public health system, independently, whether these dosages are staying in Europe or wherever. Therefore, we are providing this information, and we don't have any sign that this is not going to happen after approval. Thank you. You're welcome. Thank you. Our next question comes from Zhiqiang Shu with Berenberg. Please proceed with your question. Hi. Thanks for taking my questions. I have a few. First one is I'm trying to understand the Delta variant, specifically. In your chart, you show Delta variant is quite prevalent in the regions that you tested your phase III. In the actual cases, it's very few, only 1%. Can you provide any color, any hypothesis you may have regarding this disconnect? That's the first question. The second question is around, I think you looked at slide 11, you looked at efficacy on different variants. Have you looked at moderate to severe cases, the efficacy across the board, and also the hospitalization and death, six cases? What are the variants in these six cases? That's the second question. The third question I want to also ask about age stratification. When you submit the application to EMA, do you specify that you're looking for 18-60, or you are going after the overall population? Thanks very much. Yeah. Maybe on your first question on the Delta variant. As you correctly state, in our cases, actually, we have just 1% Delta, right? I think we need the timing when this data has been collected. The Delta variant is now spreading more and more. Apparently at the time when the cases occurred, this seems that it was not that prevalent yet. I think that seems, to me, the most likely explanation for that apparent discrepancy. On your question regarding the age group, so as I said, we are in dialogue with EMA, and they will, of course, look at the totality of data. As of today, we cannot yet comment on the specific age group for the approval or if they will go for an age-specific approval. As said, we are in dialogue and need to see all data across all the trials. And your- Okay. How about yeah. Yeah. I think that was about the variants that caused the hospitalized to severe cases, the strains. I need to check back on that. I do not have this information available. Fundamentally, when you look at the efficacy across different variants, I think it was actually said in the presentation, is that we don't have necessarily the power to draw any conclusions here because the trial was not powered to look at so many different variants initially. I think it's something that we need to be careful with. Yeah. That is right. We will not have statistically a power to conclude on strain-specific efficacy in the trial. That is very important. Yeah, thanks, Pierre, for making that point. Especially in regard to moderate to severe. Yeah, exactly. It gets more and more. The numbers get lower and lower with very wide confidence intervals. Even more so, it is so important to see that this overall protection among these 15 different variants is, from our point of view at least, quite significant with 77% in this age group. Okay, great. Thanks very much. Thank you. Thank you. Our next question comes from Jonathan Miller with Evercore ISI. Please proceed with your question. Thanks so much for the answer. I would love to hear a couple of things, I guess. When should we expect an update on the full 588 cases that have been accumulated, not just the ones that were adjudicated for the primary endpoint, but all of those cases, including in seropositives at baseline and the ones that accrued before the 15-day window ended? Secondly, are you considering what the pricing dynamics are for your European contract? Would you price materially lower than competitor vaccines given the data that you've seen thus far? Perhaps let me start with the last question. At the moment, with the Advance Purchase Agreement, we have agreed to a fixed price. This agreement is in force. As we see here, a benefit also for public health, certainly, we are talking with other governments there as well on what we have. We will present these data there as well because we think we can make a significant difference, even also outside Europe with this vaccine in this age group, what we have been talking about. Therefore, and most probably, yeah, it can well be that there will be a price difference because also that there is a price discussion saying that, in different economies, certainly as well, most probably, what is an affordable price? I think there we can be competitive as well. Absolutely. Maybe a question regarding update on all cases non-adjudicated here we had in our study. I am not sure whether you will provide here more update on this because you can imagine, we decided to sequence all cases coming also to learn what are we facing in our trial. Especially for Latin America, such data were very limited available in some countries. For us, what's important to know, and the study run during the third pandemic wave in these countries. There are a lot of these cases, they data collected about the situation was collected immediately after start of the study. After first dose, before they got second dose. This is the information we have. Currently, no further analysis is planned, especially for these cases. For sure, if you are positive, yeah, then also you don't get second vaccination, yeah, in this case. Yeah, you are out of this regular analysis. Therefore, I'm not sure what beyond, yeah, we will provide, yeah, for this group. Okay. For your next-gen vaccine, do you expect that regulators will require a full phase III study with efficacy endpoints and events and things like that? Is there a possibility there'll be a quicker path to approval by the time that Gen 2 vaccine is in the clinic? Yeah. This is always the decision of the regulatory authorities, not ours. We are in the discussion with them, but we can imagine very well that a huge efficacy trials will be not possible, feasible at this time point. Therefore, there's a lot of efforts to establish this correlate of protection. This is the one possibility. The another is to take the approved vaccine as a comparator and also demonstrate that we are comparable, et cetera. There is a lot of opportunities. I don't think such efficacy trials with placebo control, whatever, will be feasible. Agree. Yeah. Correlate of protection will be an important question. If this can be identified based on antibodies, that will, of course, facilitate the development of next-generation vaccines a lot. Okay. Thank you very much. Thank you. Thank you. Our next question is a follow-up from Eun Yang with Jefferies. Please proceed with your question. Thank you. In the age group of 18- 60, vaccine efficacy is 53%. In the final analysis in your protocol, efficacy bar is 52% or higher. Question to you is that, how confident are you of 53 efficacy in this age group, and do you think that would still stand when could it be potentially different when EMA analyze the data on their own? As said, EMA will look at the data, of course, also with their statistician and make their own assessment. They will also take, eventually, data from the CVnCoV-002 study into account in addition. Actually, to answer your question, I think EMA will make their own assessment. The methodology is established, yeah? Yeah. We describe our methodology. We will not expect the other statistician will come to the different results. Okay. This data are final. They are prepared independent on CureVac. It's official analysis. Exactly, yeah. Therefore, we are absolutely convinced that everybody who will calculate again will come to the same thing. According to our methodology, yeah, as it is defined in our plan. This methodology is also independent. It's not discovered by CureVac. Yeah. These are also including the very mild cases. There's nothing to add here. Yeah. Everything is exactly described in our statistical analysis plan. Yeah. That's helpful. In the older age group, obviously, you didn't have enough number of patients and cases to really do statistical analysis. I get that. At least can you comment on whether protection against hospitalization and death, would it be 100% there as well? Here we have really a very low number of cases, and the majority of cases in this group is mild. Yeah. Therefore, it's really difficult to comment. There is a trend for sure, especially if you look on more severe cases, yeah, that they are in the placebo and not. Again, it's not in vaccine, but again, there are very small numbers. Therefore, we really don't want to conclude something. The data are not conclusive and do not allow to conclude on efficacy in this age group yet. We don't want to comment on too low numbers. As said, we also see no clear trend in this age group, and that is important to mention. It's clear now the benefit we see here, what we see in the younger. Yeah, definitely. That is quite a clear statement there as well. Yeah. Okay. It's kind of a minor point, but on slide six, the sequenced and adjudicated cases are 204. On slide nine, overall vaccine efficacy of 53% seems to be based on 207 cases. It's a three cases difference. Can you clarify what the difference was? Sorry, can you repeat? You said on slide six it's- 204. 204. On slide 9? 207. When you look at 53% vaccine efficacy in the younger age group, seems like there's 71 cases on vaccinated group and 136 placebo. Altogether, it's about 207. There seems to be notably different. No, 207, this is the younger population. The total number is 228. Yeah. Cases. Cases. Yeah. Of this cases, 204 are sequenced. Sequenced. For the residual 24, we didn't have enough material. On the later slides, we are talking about younger population. Here the total number is 207. Of adjudicated cases. Of adjudicated cases. Yeah. You have 21 cases coming from elderly and 21 plus 207, then you have 228, the total number of cases. It's not our sample sequenced. 204 were the sequenced in the total population. I see. That's helpful. The last question is, even if this vaccine uncertain. You are quite behind compared to others already on the market. Question to you is that as you work on the second generation as well as others, so why not just focus on second generation targeting variants? It seems to me that getting to market quickly is quite important in order to secure contracts with the various governments. I'm kind of wondering, what's your strategy behind just continue to pursue this first gen vaccine product? It's a very good question, thank you. There are different timelines. We will start with second generation this year with the clinical trial. We have been producing already this material, and it will take time in order to get there according to the clinical development plan. What we are doing right now, according to the previous question we received, is that we are producing already at risk in our own manufacturing facility but also in the network, manufacturing network, what we've been building up. Certainly, we hope to get this approval of the first generation. This will be certainly before the approval of the second generation. Exactly as we see and we clearly believe that our first-generation vaccine in this subpopulation where we have been concentrating on, where we see the 77% in moderate and severe cases, that the vaccine can make a difference. Therefore, we are producing. Certainly according to the timeline and the planning, there will be a certain point when we are switching the manufacturing into the second generation. Stop there as well as soon as it is approved, that we can get out with this one as well. According to the capacity, what we did build up, there is a reason also from public health point of view, to deliver the contract which we have signed and perhaps even beyond, before the second generation is then ready to market. That's exactly what we do, and therefore it's good that we have got this capacity to do this accurate planning. Thank you. You're welcome. Thank you. Our final question comes from Wassili Papas with Union Investment. Please proceed with your question. Yes. Hi. Thanks for taking my question. Just for clarification on severe protection from severe disease and hospitalization. If one looks at the definition of severe disease in the protocol, it strikes me that any of the symptoms of severe disease would have led to hospitalization. I'm trying to connect, to find the discrepancy here or maybe there isn't one, why you have 100% protection from hospitalization but not 100% apparently, or it seems like not 100% protection from severe disease. Thanks. Yeah, what is important to understand it is really the case that severe disease did not in every case lead to hospitalization. What we have seen in particular is that this should not necessarily happen in the Latin American countries because participants sometimes choose not to go to hospital. That is important to know. Therefore, it's not to be expected that this was an exact overlap for hospitalization and severity. Does that explain it? Does that answer your question? Yes. Thank you very much. Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Sarah Fakih 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.