Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih, and I'm the Vice President Investor Relations at CureVac. Please let me introduce today's speakers. On the call with me are Franz Haas, the Chief Executive Officer of CureVac, Pierre Kemula, our Chief Financial Officer, and Antony Blanc, our Chief Business and Chief Commercial Officer. 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 discussions and responses to your questions on this call reflect management's view as of today, Friday, February 5th, 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 statement. 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. In this presentation, we will provide you with an overview of our recently announced COVID-19 partnerships and the synergies being created by joining our respective expertise to provide broader and faster protection against the current and future viral infections and threats. We all believe these collaborations will create short-term and long-term value for our company. Since development of our first mRNA-based COVID-19 vaccines began one year ago, the world has made tremendous advances to better understand the nature of the virus. mRNA technology has emerged as a key technology to rapidly provide potent, flexible, and easy-to-manufacture vaccines, and that, without a doubt, will have a long-lasting impact on the way we will globally address and prepare for future preparedness and for the vaccine development in general. CureVac will deliver on COVID-19, supported by three key partnerships and the value they create by enabling the joint development of a broad pipeline of both first and second-generation COVID-19 vaccines. Please let me start to highlight the contribution of these partnerships by clarifying the differences between our first and second-generation COVID-19 vaccines and how we define them. Our first-generation vaccines are being developed to tackle the current pandemic, starting with a focus on the initially dominant strain of COVID-19. When we say first generation, we are referring to the vaccines which apply to the same mRNA backbone, meaning the same mRNA setup as our lead vaccine candidate, CVnCoV, which is currently in late stage phase IIb/III clinical testing. Our second-generation vaccines refer to vaccines applying a new mRNA backbone or setup, which differs from the setup of our leading first-generation candidate COVID, CVnCoV, and which is generated on the basis of our learnings from CVnCoV over the last year. The aim of our second-generation vaccine program is to further improve on important mRNA characteristics such as protein expression level, low dose immune activation, and stability. A second-generation lead candidate is currently being developed at CureVac and has shown strong preclinical potential. As shown here, both our first and our second-generation vaccines are not only geared toward addressing the current pandemic, but also are intended to address both current and future emerging variants. This will, however, cover multiple approaches, including vaccines that address specific mutations and multivalent vaccines, which combine several antigens. We are using CVnCoV backbone to develop new variants of our lead vaccine candidate, which will protect against emerging virus variants such as the current South African strain. Manufacturing of a CVnCoV version can be realized within several weeks only, and availability will be facilitated on the basis of existing CVnCoV clinical data. Both generations of our COVID-19 vaccines are designed to address central concepts to better the challenging landscape of the COVID-19 pandemic, as well as prepare for future pandemics. With the support of our recently announced partners and partnerships, we feel prepared to cover the full spectrum of the vaccine approaches. To better understand how these partnerships create substantive value for CureVac and the importance of each of our recently announced partnerships, I would like to provide you with these four central messages. First, with Bayer, we have a powerful pharma partner at our side whose operational expertise and infrastructure will enable us to advance and deliver our first-generation vaccines. This includes our lead vaccine candidate, CVnCoV, as well as new versions of CVnCoV being generated to address mutations in the SARS-CoV-2 spike protein. CVnCoV, as well as all derived first-generation vaccines, are wholly owned by CureVac, and CureVac will be the market authorization holder for these vaccines in the EU. Second, with GSK, we have the support of the world-leading vaccine expert with whom we will jointly advance vaccine candidates that leverage our second generation of mRNA setup. This includes second generation mRNA vaccines, including for the original spike protein, spike protein mutations, and the development of multivalent or so-called combination vaccines. The latter being particularly interesting in view of our initial collaboration with GSK, which we entered into in July last year, 2020, in the field of non-COVID infectious diseases. Cost and profit for all second-generation COVID-19 vaccines under the GSK partnership are equally shared between both companies. We fully anticipate the collaboration with GSK will be a strong and sustainable value driver for CureVac going forward and beyond COVID-19 pandemic. Third, the U.S. government and its Vaccine Taskforce, set up by the Department for Business, Energy and Industrial Strategy, has been at the forefront of variants surveillance and scientific variant expertise during the pandemic from the beginning. Our collaboration, which we announced earlier today, will grant us access to the best quality scientific input to define critical questions, such as, what is the most relevant strain to address in a new vaccine? What combination of strains has the highest current or future relevance and is a target offer the broadest protection? The scientific insight we will receive through this collaboration will provide a fast track to select the most relevant mutations for both our first and second generation vaccines. In return, CureVac will tech transfer our manufacturing processes to enable fast manufacturing for the U.K., in the U.K. Over the following slides, please let me remind you of the details associated with each of these value driving partnerships. I'm now on slide 4 to show you a summary of our strategic collaboration on how it works and services, with Bayer, which began in the early January of this year. For the development of our lead generation vaccine candidate, CVnCoV, we choose Bayer as our ideal partner based on the operational expertise, infrastructure, and key territory operations of this highly experienced and global pharma company. This will allow us to accelerate market readiness of CVnCoV, as well as potential new versions of CVnCoV addressing spike protein mutations. Within the scope of this agreement, Bayer will add execution power and critical competencies to our setup with additional headcounts in the range of several hundreds. This covers areas such as clinical operations, regulatory affairs, pharmacovigilance, and supply chain performance, which represent important pieces of the puzzle to bring our first generation vaccine to a broad population of people worldwide. On slide 5, you can see an overview of the GSK partnership we announced on Wednesday, February 3rd. This partnership builds on our existing strategic mRNA technology collaboration for non-COVID infectious diseases, which we entered into with GSK in July 2020. Spurred on the emergence of new viral variants that have the potential to affect the efficacy of the first generation COVID-19 vaccines, GSK and CureVac seek to jointly accelerate efforts to stay one step ahead of the pandemic. Through novel second generation vaccine approaches, we aim to offer broader protection against a variety of different SARS-CoV-2 variants, and to enable a quick response to new variants as they emerge in the future. The partnership exclusively targets second generation vaccines and those with the potential of a multivalent or even combination approach to address multiple emerging variants in one vaccine. To achieve this challenging goal, we are looking for a partner with a strong vaccine experience and are proud to be collaborating with the world's largest vaccine company. Our partnership of second generation COVID-19 vaccines with GSK will begin immediately with the target of introducing a vaccine in 2022, subject to regulatory approval. Slide 6 provides you with an overview of our collaboration with the U.K. government. This collaboration combines the following. On the one hand, CureVac's resources and technological expertise in mRNA vaccine development and, on the other hand, the world-class scientific insight and expertise in genomics and virus sequencing of the U.K. government's Vaccine Taskforce and the U.K.'s network of experts in SARS-CoV-2 vaccine research and development. It's just great. The objective of our collaboration with the U.K. government and the Taskforce, which we only announced today, is to access the most impactful scientific insights to assess emerging variants and jointly generate new variants of vaccine candidates against those selected. This is expected to contribute to mitigate the effects of the current pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variants of vaccines. As part of the agreement, CureVac and the U.K. Vaccine Taskforce will continually track epidemiology and assess multiple virus variants for potential development of both first and second generation COVID-19 vaccines. New variants and versions of our lead vaccine candidate, CVnCoV, which will protect against the emerging virus variants such as the current South Africa strain, could become available in fall 2021. As clinical development of our vaccine candidates advances, the U.K. government will also support expediting clinical trials with the goal of securing emergency or conditional marketing authorization for jointly selected vaccines, as well as manufacturing and distribution of resulting vaccines in the U.K. and its territories. Let me hand over now to Pierre to go through the commercial framework and effects of these deals. Thank you, Franz, hello to everyone on the call. On slide 7, please let me walk you through the details of the commercial frameworks and how the described partnership work. Within the terms of the Bayer deal, we are closer to a service agreement where we pay an undisclosed fee to access Bayer's international infrastructure, expertise, and manpower. As Franz explained earlier, this collaboration is a key success factor for our broad clinical commercial CVnCoV rollout and delivery. CureVac will hold the market authorization in the EU, the U.K., and Switzerland, while Bayer has an option to be market authorization holder in other geographies. The recently announced extension of the GSK partnership focusing on the second-generation COVID-19 vaccine is built differently. Here, CureVac will receive an upfront of EUR 75 million and potential milestone of another EUR 75 million. The companies will equally split the cost and margin derived from the COVID vaccines built on the second-generation backbone. Our partner, GSK, will be market authorization holder in most geographies. Today, we also announced a third and R&D-focused collaboration with the U.K. government and its widely recognized Vaccine Taskforce. Here, each party will bear its own R&D costs. CureVac will tech transfer its manufacturing processes, and in exchange, will have access to the broad and valuable scientific expertise and concrete clinical output to jointly generate vaccine addressing the most relevant variants. Lastly, the U.K. government will purchase 50 million doses of our vaccine. Turning now to slide 8, just to remind you of our broad and decentralized manufacturing approach, and to update you on the current capacity guidance for 2021 and 2022. We are currently building a Pan-European network of highly experienced partners for each of the key manufacturing steps of our mRNA, including manufacturing of the mRNA itself, formulation, and fill and finish. Just as mRNA is a platform technology for flexible encoding of any protein, manufacturing is also a platform process. Since the encoded information within mRNA is the only that there is, i.e., no changes to the backbone, manufacturing applies the same process and equipment for every mRNA vaccine and therapeutic, and this significantly increases the manufacturing flexibility. The manufacturing platform is therefore a key component in the advancement of the broad COVID-19 vaccines. In terms of capacity, our manufacturing network will allow us to provide up to 300 million doses of CVnCoV in 2021. For 2022, we have updated our expected manufacturing capacity from formerly 600 million doses to up to 1 billion doses based on the increased partnership support or partner support and further network optimization. The manufacturing platform approach also applies to our RNA Printer, a mobile and fully automated manufacturing unit, which covers the entire GMP-grade mRNA vaccine production process. We believe that with the decentralized and flexible manufacturing, the RNA Printer has the potential to further support pandemic preparedness and containment directly at outbreak sites. With this, let me hand over to Franz for the summary of today's messages. Thank you, Pierre. Let me quickly summarize today's key messages before we move into the question and answer session. Three recently announced partnerships support our continued development of a broad pipeline of both first and second generation COVID-19 vaccines. The Bayer partnership centers on our first-generation vaccines, and particularly the development, manufacturing, and distribution of our lead candidate, CVnCoV, which is currently in late-stage clinical trials. The GSK partnership announced this week focuses on second-generation vaccines and opens the door for the development of multivalent vaccines, which have the potential to address multiple COVID-19 variants in a single vaccine. Lastly, the partnership with the U.K. government will be critical for the expertise on genomic for virus sequencing as we advance our strategy to address both current and emerging COVID-19 variants. All three partnerships position us well for the current and future pandemic preparedness. Our manufacturing capabilities, bolstered by these recent partnerships, will continue to grow in 2021 and 2022. This includes our in-house capabilities and our Pan-European network, as well as the RNA Printer as a model for future pandemic preparedness. With this, I would like to conclude our presentation and would now open the webcast to your questions. Thank you very much. Thank you. At this time, we'll be conducting a question and answer session. If you'd 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 sta,r two if you'd 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 keys. In order to allow for as many questions as possible, we ask that you please keep to one question and one follow-up each. Our first question comes from the line of Seamus Fernandez with Guggenheim Securities. Please proceed with your question. Hi. Thanks for taking the question. This is Evan Wang on for Seamus. First question on the next gen vaccine effort. Just wondering, what is the opportunity for greater efficacy, specifically for SARS-CoV-2, given the kind of efficacy observed with the original strain? Was this specifically in response to data on mutants, or has this been in the works for a while? I have a follow-up. Yeah. Perhaps Mariola is taking over, our Chief Technology Officer. If you ask about changes in the next generation, as mentioned, there are changes in the backbone of messenger RNA. Specifically in the non-coding areas, i t means the protein encoded is still the same. There is always a possibility also to use this backbone for the future variants, what we also presented. Maybe to complement the answer. We have been working on the second generation since the start. Got it. Just wanted to confirm, will a multivalent approach also be tested with the first gen or just the second gen? What is the kind of regulatory pathway for either new variants or multivalent under the first gen and then under the second gen? Will the second gen kind of require larger trials just given the new backbone, or will there be an expedited process? Yes. We will test and apply different approaches. Cocktail combination, we will do this for first generation and next generation. All of this is important also to support and enable clinical trials. We are also in the discussion with regulatory, what is the path to bring not only the new variants on the already tested backbone. This is straightforward, and we have a lot of already good hints here, but also to be able to introduce changes in the backbone, which really are done and optimized to even lower dose, improve stability and immunogenicity. Okay. Thank you. You're welcome. Thank you. Our next question comes from line of Eun Yang with Jefferies. Please proceed with your question. Thanks very much. The collaborations with the GSK and the U.K. government, it seems like for variant strains of COVID-19 vaccine development, to me, there seems some overlap. Can you kind of clarify if there is overlap and how you share the information between the two parties? The second question is on multivalent vaccine. The first generation vaccine, you have much lower dose than other messenger RNA vaccines on the market. That said, you also saw higher Grade 3 events in phase I compared to placebo. How do you think of potential challenges with the multivalent approach? Thank you. Thank you very much for the question. The first question I will refer to Antony Blanc, our Chief Commercial Officer and Chief Business Officer, and with regard to the multivalent vaccines and how this works, will be answered by Mariola. Antony? Yep, absolutely. There's no overlap between the U.K. collaboration and the GSK one, in the sense that the variants that we develop in the R&D with the U.K. collaboration can be equally used on a first generation platform and on the second generation platform. In fact, it will be faster to get them into the first generation platform because of the state of development of that first generation. It'll be a nearer jump also from a regulatory point of view. The same variants or other ones, of course, later, will also be able to be loaded onto the second generation backbone. Okay. Let me explain this multivalent vaccine approach. We saw nice immune responses with very low doses, even if you are now with 12 μg for our CVnCoV candidate. We also saw good responses, even with lower doses. Therefore, it will be tested, what is the final dose that we will need for the multivalent vaccines. We think here is the advantage, to have this low dose efficacy. For sure, the reactogenicity you need to keep in mind. What we see and what it seems to be the case, that the reactogenicity we observed in the very first phase I study maybe is not really representative. From all the experiences we have now, and many trials running now in parallel on the huge amount of people, the reactogenicity profile seems to be better. Therefore, we are very optimistic that with our multivalent vaccine, and with our low dose multivalent vaccine approach will be possible. Thank you. Perhaps to add to this one, it's really that the collaboration with the U.K. government, with the Taskforce, is really providing the content, what is the new variant to go with, which we can implement on the first generation as well as on the second generation. To really get the optimized vaccine, which is therefore also important that there is a tech transfer for manufacturing that this can be done rapidly. Can I ask you one more question? It's not related to the partnerships, but you are enrolling people, individuals in phase III currently. I don't know if you can answer this, but are you seeing the variant COVID-19 cases in your study? Though we don't have this information now, for sure. You can be sure that we do everything to include sequencing of virus material to be able to say what kind of virus infection are we facing in our trial. This is absolutely key and important information, and the goal is to have this data together with our efficacy data. To have a really differentiated look. Thank you. Thank you for answering my questions. You're welcome. Thank you. Our next question comes from line of Geoff Meacham with Bank of America. Please proceed with your question. Hey, guys. It's Geoff Meacham. Thanks for taking our questions, I just have a couple. I wanted to follow up on that last question. Maybe just get a sense of how you're thinking about the efficacy of the current CVnCoV vaccine candidate in some of the strains that we have emerging so far. Understanding you don't have efficacy data yet, just wanted to get your thoughts there. Also, just wanted to see how that phase III study is progressing so far, if you're still on track for Q2 results. Yes, for sure. In the case of efficacy, as we know that this is provided in the first line by antibodies, they have potential to neutralize the virus. Knowing that maybe some of these variants, South Africa variant, are more difficult to protect and you need higher amounts of antibodies, because they are reduced, what has been demonstrated also for other mRNA vaccine encoding exactly the same protein, what we do. We will expect this will be maybe similar also for us. Therefore, we cannot exclude that with the current variant of vaccine, the neutralization of South Africa variant specifically will be more difficult. This is exactly why we have all these efforts to work on mutation, on providing better vaccine, which are optimized specifically for this circulating strain. At the end, we will need to look at the data we will have, hopefully soon. Regarding your question, how the trial is progressing, it's everything on track. If you know we have this phase II trial in Peru and Panama is completely recruited and data analysis started, and our phase II/III trial is also progressing well. Thank you. Thank you. Our next question comes from line of Zhiqiang Shu with Berenberg. Please proceed with your question. Hi, t hanks for taking my questions. Congrats on the progress. Two questions from me. First one, for the U.K. government collaboration. If I understand correctly that you will use your first gen backbone to tackle different variants. I was wondering, is this your goal to put this vaccine in the clinic this year and potentially authorize? For this, how should we think about the regulatory framework and timeline for this approval? I guess, is there a phase III trial required? Secondly, on the potential a one-dose booster vaccine. Some of the other vaccine players have tried to explore a potential third vaccine boosters for the vaccine. I remember in your phase I data, you showed very interesting result in one dose actually have some effect for some seropositive patients. Can you provide some idea on that front? Thank you. Antony, I would propose if you would take the first question with regard to the U.K. Yes, indeed. The priority in the U.K. will indeed be using our CVnCoV current constructs to put in the variants. Here, we're looking at, as soon as the clinical lots are made, we can move quickly through phase I and then immunobridging. We're discussing with the MHRA the process to then convert the base, to do variation from the base registration, which will be done in Europe but also in the U.K. In essence, the thinking which is emerging from the different authorities in the U.K. but also in Europe and in the U.S., is that it will be more akin to a flu variation the way it's done every year on the back of a relatively small immunobridging study. Regarding the booster idea, so it makes a lot of sense. As I explained, what we see that the current vaccines, the neutralizing capacity is lower towards the South Africa strain. It means you need more antibodies or higher levels to secure protection. This can be indeed achieved here with the third vaccination. You are right, referring to our published data from our trial, because it's indeed, we saw that with even very low amounts of messenger RNA in the seropositive subjects, even with very low titers, we can boost these titers immediately and, in some cases, even by factor 20 within several days. Their titers remain stable. It means there is a good approach and maybe the fastest approach, as a way to bring antibodies to this level that you are in good area also for this South African strain. Great. Thank you very much. Welcome. Thank you. Ladies and gentlemen, as a reminder, if you would like to join a question queue, please press star, one on your telephone keypad. Our next question comes from the line of Wassili Papas with Union Investment. Please proceed with your question. Yes. Hi, this is Wassili Papas from Union Investment. Thank you for taking my question. I want to follow up on the possible efficacy of CVnCoV against the South African strain, given that Novavax and Johnson & Johnson's Janssen reported some efficacy in the South African part of their trials. On the call, the head of R&D of Janssen was speculating that he had this hypothesis that given that their vaccine induces a T-cell response as well, that the T-cells were handling the virus at that point, knowing that the antibodies are not [by neutralizing it as well. Do you have any thoughts about the potential T-cell activity of CVnCoV against the South African strain, or is it too early because you haven't fully analyzed the T-cell data from your phase I trial yet? I have a follow-up. Okay. The analysis of T-cell responses from our phase I trial is running, but this analysis is directed against the Wuhan, the original strain. We will not have the information whether we generate other T-cell responses, they are cross-reactive and can also recognize the South Africa strain. This needs to be tested as well. It's not straightforward because the material, the PBMCs are already used, and if you don't have enough material to do this re-analysis. Therefore, we need to do this in our current running trials. There is a good possibility that T-cell responses can contribute to protection because we know they can be cross-reactive, and this is exactly the explanation for people, they didn't develop any antibodies even against Wuhan strain, but still were well protected. The hypothesis was it was due to the fact that in the past, they were exposed to other coronaviruses and cross-reactive T-cells provided this protection. This can be also the case. Therefore, it's always good if your vaccine also induces T-cell responses, what we know for our CVnCoV already. Can you comment how robust your T-cell or how strong the T-cell response of CVnCoV is relative to Moderna's or BioNTech's or some of the other vaccine data that you've seen out there? As you know, for antibodies, it's different comparison. For T-cell responses, it's even more difficult because all the protocols for analysis of T-cell responses are so complex. There's a lot of different factors as stimulation time, peptides, et cetera, and even the analysis on FACS. Therefore, it's really difficult to compare. Therefore, what we do is compare the responses to what we see in convalescent subjects. Because we know that people develop T-cell responses. This is our control, and it seems we are in good rate here and comparable to convalescent. Okay, very helpful. One question on your molecular printers. How can we imagine this, that if you decode a new strain, you can send the new encoded vaccine data via the cloud to the mobile p rinters, and they will print the vaccine against the new strain? Yes, perhaps for me to answer this one. It works. In the end version, it works exactly like that. At the moment, we have the pDNA, which is now in this module, you have got the three steps. You have got the pDNA, then the drug substance, the RNA, and then the formulation, three different compartments, which we are bringing together in one compartment. That's exactly because this is also why we call it the printer, because all what you have is defined by letters. It's like book printing then. Yes, to really send then this optimized RNA, which we then have to pre-clinically evaluate via the RNA optimizer, what we have then, the best working RNA in terms of reactogenicity, balanced immune response expression, and also stability and longevity. You've got a box where you've got all the starting material, which are the enzymes and polymerases and nucleotides. Exactly this printer is in the first step, producing exactly this pDNA according to the sequence you're giving into. Out of this, via separate, it's a different process than we are having in the upscaled manufacturing process, then produce the RNA, which is then purified and then formulated in the last chamber of the printer to have the formulated mRNA. This is now at the moment in the process of certification by the Regierungspräsidium, by the regulatory authority. This process, this newly established process, then can be multiplied by several printers to be manufactured and then distributed worldwide. That's the system, how it works. Thank you. Ladies and gentlemen, that concludes our time allowed for questions. I'll turn the floor back to Ms. Fakih for any final comments. Thank you. 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. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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