Greetings and welcome to the CureVac Financial Results and Business Update for the third quarter and first nine months of 2024 conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Sarah Fakih, Vice President of Corporate Communications and Investor Relations. Thank you. You may begin. 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 from CureVac are Alexander Zehnder, Chief Executive Officer of CureVac; Myriam Mendila, our Chief Scientific Officer; and our Chief Financial Officer, Axel Malkomes. He made his debut in the press release last week announcing his joining the CureVac leadership team. Rita Vogt, Senior Vice President of Finance, will be available for the Q&A session. Please note that this call is being webcast live and will be archived in the Events and Presentations 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 views as of today, Tuesday, November 12, 2024. 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 Alexander. Thank you, Sarah. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. The first nine months, and particularly the third quarter of 2024, marked a turning point for CureVac. We made significant progress on our 2024 priorities, taking decisive steps, right-sizing the company, streamlining our processes, and improving our business operations. We have successfully delivered on key milestones, including a new licensing agreement with GSK announced in July. This agreement, valued at up to EUR 1.45 billion, includes an upfront payment of EUR 400 million, which was fully booked in the third quarter. Additional potential milestones and royalty payments from this agreement are expected to provide significant capital going forward while strongly validating our mRNA technology. Alongside this, we launched a corporate redesign, including a roughly 30% reduction of our workforce, which will be completed by the end of this year. These efforts help us to reduce costs while maintaining a strong focus on research and development. Looking ahead, we set clear development priorities with a sharp focus on high-value indications in oncology and infectious diseases. In oncology, our phase I study in glioblastoma has yielded promising preliminary data showing the potential of our mRNA technology in this highly aggressive cancer, and today, we are disclosing a new cancer vaccine program targeting squamous non-small cell lung cancer, expanding our off-the-shelf cancer vaccine pipeline. In infectious diseases, we launched a new program to treat urinary tract infections, or UTIs, one of the world's most common infections. This program addresses a critical unmet medical need driven by recurring infections and the increase in prevalence of antibiotic resistance against uropathogenic E. coli, the bacteria that primarily causes these infections. Our UTI program exemplifies our focus on leveraging our technology for areas of high unmet need with significant commercial potential. On slide five, you can see these achievements in the context of our transformation journey. After I started in April 2023, we conducted a thorough business analysis, identifying key areas to improve our financial discipline, reducing unneeded pandemic-era infrastructure, and focusing the organization on innovation and R&D. In 2024, we are executing on these insights. We have launched a corporate redesign, which is on track for roughly 30% workforce reduction by the end of this year without compromising our R&D and manufacturing capabilities. Operational expenses are expected to decrease by over 30% starting in 2025. The €400 million upfront payment from our new licensing agreement with GSK was fully booked in the third quarter, providing us with a strong cash position of €551 million at the end of September and resulting in a net profit for the first nine months. As we approach the end of 2024, we are now leaner, more strategically aligned, and financially stronger. And from this position of strength, we will double down on research and development activities with a focus on high-value opportunities in oncology and infectious diseases. On slide six, we outlined the pipeline expansion in both oncology and infectious diseases. In oncology, shown on the left, our pipeline expansion spans both off-the-shelf and personalized cancer vaccines. For the off-the-shelf cancer vaccines, we are disclosing a new shared antigen cancer vaccine program in squamous non-small cell lung cancer, which will include novel cancer antigens derived from our proprietary antigen discovery. We are preparing for IND and CTA submissions in the first half of 2025 and expect to start phase I trial shortly thereafter. Discovery activities for additional shared antigen programs continue with a second clinical candidate expected in 2026. Pre-clinical development of a fully personalized cancer vaccine candidate is also progressing, with the first candidate expected to enter the clinic in the second half of 2026. In infectious diseases, we are also following a dual strategy, having licensed our most advanced program in respiratory diseases to GSK by focusing our proprietary programs primarily on non-respiratory diseases with high unmet medical needs. Here, we have launched a new program for urinary tract infections, which are the world's most common infections, and Myriam, we'll present the promising pre-clinical data for this program later in the presentation. Before I go into the business update, I'm delighted to have our new Chief Financial Officer, Axel Malkomes, who joined CureVac just yesterday on the call with us on behalf of the whole CureVac team. Welcome. Axel brings over 30 years of experience across both the corporate and banking sides of our industry. His deep expertise will be crucial for the next chapter of CureVac as we advance our strategic initiatives and strengthen our financial foundation. Axel, would you like to say a few words? Thank you, Alex, and good morning or good afternoon to everyone on the webcast and conference call. I'm truly excited to join CureVac during this pivotal moment in the company's evolution. I believe CureVac is poised to make continued remarkable progress in the development of innovative mRNA-based medicines. By applying my expertise in financial management and corporate growth, I'm convinced I can help drive CureVac's mission forward and contribute to its future success. Thank you, Axel. As we continue moving forward with our business and pipeline priorities, it's important to highlight what makes CureVac unique. On slide eight, you can see these key strategic and technological differentiators that set CureVac apart in the mRNA field. In terms of strategic differentiators, we have a dual strategy in oncology, working on both off-the-shelf and personalized cancer vaccines to cover a wide range of cancer types. We use a similar dual approach in infectious diseases, where we are focusing on proprietary programs for non-respiratory diseases like viral, bacterial, or fungal infections, while we have outlicensed our respiratory disease programs to GSK. Our scalable manufacturing capabilities, including the RNA printer, give us the flexibility to produce pre-clinical and clinical trial materials efficiently, and our strong intellectual property portfolio further supports our innovation by protecting our technology. In terms of technology differentiators, our positioned mRNA backbone is built on 20 years of experience, helping us design highly efficient mRNA constructs that improve protein expression and low-dose efficiency. In oncology, we have a unique ability to discover new classes of antigens, which paves the way for innovative cancer treatments. Our work on advanced lipid nanoparticle delivery systems, tailored for specific indications, aims to enhance the effectiveness and stability of our vaccines. Together, these differentiators give us a strong competitive position and drive our mission to develop transformative medicines for patients. Slide nine shows how our differentiators feed directly into the key focus area of oncology and infectious diseases. Our precise mRNA backbone and proprietary delivery systems are at the heart of our technology platform, which is continuously evolving. We aim to deliver best-in-class products. By focusing our development efforts on high-potential areas in oncology and infectious diseases, we are positioning ourselves to deliver impactful health solutions. And with that, I will hand over to Myriam to explain how we turned these technologies into a strong and focused clinical pipeline. Thank you, Alex, and good morning, good afternoon to everyone. Moving on to slide 10, let me outline our most recent pipeline, which reflects our focused strategic approach to high-value development programs relevant to patients. Both our existing programs and the new programs disclosed today demonstrate our commitment to selecting indications where mRNA technology can make a substantial difference, addressing unmet clinical needs and attractive market opportunities. In oncology, our existing pipeline for off-the-shelf cancer vaccines is led by our phase I study in patients with resected glioblastoma, which has recently provided promising data for the completed dose escalation part A of the study. The study started enrollment for the dose confirmation part B in August 2024, testing the recommended dose of 100 micrograms, and enrollment is progressing well. We also announced a new program with an off-the-shelf cancer vaccine to treat patients with squamous non-small cell lung cancer. The vaccine candidate to be tested and codes for new antigens discovered with our proprietary antigen discovery platform. In the infectious disease area, our most advanced programs cover respiratory indications fully licensed with GSK. Programs for seasonal influenza, avian influenza, and COVID-19 are based on CureVac's proprietary second-generation mRNA backbone and are currently in phase II development. GSK recently announced positive phase II headline data for seasonal influenza, confirming strong antibody titers against influenza A strains and, most importantly, also against the notoriously challenging influenza B strains, compared to the age-matched standard of care in younger and older adults. The study met all three defined success criteria, and GSK reported that the program is progressing to phase III next year. Based on the validation of our platform in infectious diseases, we launched a new proprietary program to develop a prophylactic vaccine against Uropathogenic E. coli the primary cause of urinary tract infections, which ranks among the most common infections worldwide. I will go into more detail later in the presentation. In the third therapeutic area, molecular therapies, while a collaboration with the Schepens Eye Research Institute in ocular diseases was recently terminated, we continue to develop optimized mRNA therapeutics in different areas. We are committed to focus our pipeline on selecting indications where mRNA technology can outperform conventional approaches, guided by our mission to advance innovation in preventive and therapeutic health solutions. On slide 11, we delve deeper into our oncology strategy, where we see tremendous opportunity for mRNA cancer vaccines to bring precision immunotherapy to large patient populations. We have made significant progress in advancing our two-pronged strategy for both off-the-shelf and personalized cancer vaccine development. As a brief reminder, the off-the-shelf assets in our oncology pipeline target tumor antigens that are shared across different patient populations and/or tumor types to induce de novo or amplify pre-existing immune responses in different cancer settings, including advanced stages of cancer. CVGBM, our lead oncology clinical candidate, is currently being evaluated in a phase I study in patients with resected glioblastoma encoding known antigens relevant to this highly aggressive brain cancer. All our next-generation shared antigen cancer vaccines, including the one in squamous non-small cell lung cancer, feature novel antigens discovered through our proprietary antigen discovery platform and will expand our pipeline with new clinical candidates in 2025 and 2026. By identifying novel shared antigen targets, also within our global collaboration with MD Anderson, we aim to make our vaccines even more effective in reducing the risk of tumor recurrence and enhancing outcomes for patients in different cancer settings. For the other part of our oncology strategy, applying personalized cancer vaccines, whole genome sequencing of individual patients' tumor samples combined with advanced bioinformatics is utilized to identify new antigens and/or novel tumor-associated antigens unique to a patient's individual genomic tumor profile. This precision medicine approach increases the likelihood of targeting antigens susceptible to immunotherapy and aims to provide a curative approach, especially in early-stage cancers with lower tumor burden. Our personalized cancer strategy is complemented by the RNA Printer, our solution for fast and highly automated manufacturing. We made significant progress with our oncology pipeline and recently presented data from our clinical lead program with the off-the-shelf vaccine candidate CVGBM, which was tested in a phase I study in patients with resected glioblastoma. You might recall that CVGBM features a uniquely designed single unmodified mRNA construct encoding eight segments derived from four tumor-associated antigens with demonstrated immunogenicity in glioblastoma. It was administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. Patients received seven intramuscular vaccinations within 10 weeks and optional maintenance vaccinations in case of non-progression or potential benefit. Preliminary safety and immunogenicity data from the dose escalation part A of the study were recently presented at the ESMO and SITC Congress. In this highly challenging and aggressive cancer type, the data confirmed a favorable safety and tolerability profile with no dose-limiting toxicities observed in this part of the trial. Successful induction of antigen-specific T-cell responses was demonstrated in the vast majority of evaluable patients, with 77% of patients showing either a CD8 and/or CD4 T-cell response to at least one of the encoded antigens on the vaccine. Most importantly, within the group of evaluable patients, 84% of immune responses were induced de novo, meaning T-cell responses were successfully induced in patients who had no pre-existing T-cell activity against encoded antigens prior to vaccination with CVGBM. Additionally, 67% of responding patients had T-cell responses against multiple encoded cancer antigens, supporting our antigen selection and successful mRNA design. At the highest tested dose of 100 micrograms, ongoing monitoring of T-cell durability showed that responses were sustained over a period of 99 days. The 100-microgram dose was also selected for the dose confirmation part B of the study, which began enrollment in August this year. A first data readout of part C is expected in the second half of 2025. We continue to advance our oncology pipeline, and on slide 13, we have summarized our upcoming oncology catalyst, which provides strong development paths over the next 24 months. CVGBM is our most advanced phase I off-the-shelf program in glioblastoma, as already mentioned, and enrollment of the dose confirmation part B of the study is progressing well. We expect enrollment to be completed the latest in the first half of 2025, allowing for a part B data readout in the second half of 2025. Data from an additional up to 20 patients dosed at 100 micrograms will provide the basis for potential continuing to a phase II study, which could start in the second half of 2026. The newly announced off-the-shelf program in squamous non-small cell lung cancer is expected to enter phase I clinical development in the second half of 2025. With our proprietary antigen discovery work continuing, we intend to disclose additional off-the-shelf programs with new clinical candidates in different indications in 2026. Lastly, the first clinical phase I study with a personalized cancer vaccine candidate is expected to start in the second half of 2026. These strong catalysts highlight our strategic focus on opportunities in oncology, leveraging our mRNA technology designed to ensure continuous progress and innovation in our oncology pipeline. Let me now shift gears and turn to our infectious disease area. In infectious diseases, we are directing our current proprietary research and development efforts towards new non-respiratory indications while benefiting from the ongoing clinical development of respiratory indications with current programs licensed to GSK. Targeting non-respiratory infections caused by bacteria, viruses, and fungi, we aim to deliver safe and cost-effective vaccines for high unmet medical needs areas with compelling market potential where our mRNA technology offers an advantage over conventional vaccine technologies. In this area, we are excited to introduce a new fully owned infectious disease program targeting uropathogenic Escherichia coli bacteria, in short, UPEC. UPEC is the primary cause of urinary tract infections, which rank amongst the most common infections worldwide. The statistics presented on slide 15 highlighted the significant incidence and disease burden associated with UPEC in the U.S. The high prevalence of UTIs with more than 50% of patients requiring antibiotic therapy, leading to increased antibiotic resistance and high rates of recurrence, presents a substantial challenge in current medical practice. This results in direct medical costs reaching billions of dollars annually in the U.S. alone. Currently, there are very limited treatment options to prevent recurring UTIs. Our mRNA technology has the potential to deliver a best-in-class solution, including inducing functional antibodies as well as T-cell responses against UPEC. To tackle this infection, we developed mRNA vaccine candidate CVUTI targeting FimH, a bacterial protein considered crucial for adhesion of the bacteria to blood or tissue and biofilm formation. FimH is highly conserved in UPEC strains and therefore represents an excellent vaccine target for the vast majority of patients. For our vaccine candidates tested in preclinical studies, we have applied rational antigen designs to optimize immunogenicity. In addition, we have applied a unique technology to design candidates that lead to the in vivo self-assembly of a FimH nanoparticle. This innovative design is expected to lead to even higher immunogenicity. Let me show you the very promising preclinical data we created with two of our candidates. On slide 16, you can see the first preclinical data, which are currently being presented at the first mRNA Health Conference taking place this week in Boston. We tested our vaccine candidates in two preclinical models, with direct and biopsy might, in comparison to non-licensed recombinant protein vaccines. Titers of binding and functional antibodies, meaning antibodies inhibiting chemotaxis and/or bacterial adhesion, were measured in both models in serum and urine samples. Additionally, CD8 and CD4 T-cell responses were determined in mice. Both mRNA vaccine candidates induced high levels of binding antibody titers in blood and urine in both models that also correlated with high functional antibody titers in serum. Importantly, functional serum antibodies were higher with both mRNA vaccine candidates compared to the protein-based comparator vaccines. Our FimH nanoparticle candidate demonstrated the highest overall levels of FimH specific binding and functional antibody responses in serum and urine of the animals, outperforming all other tested candidates. Additionally, both mRNA vaccine candidates induced higher T-cell responses than the comparator protein-based vaccines, with the nanoparticle candidate again strongly outperforming all other candidates. Overall, our infectious disease programs show promising progress with both non-respiratory and respiratory areas advancing based on solid development catalysts outlined on slide 17. For our newly launched UPEC program, we expect to select a clinical candidate in the first half of 2025, enabling us to file for IND submission in the second half of 2025. This is anticipated to allow phase I clinical development to start in the first half of 2026. Additional discovery work in other non-respiratory diseases is also progressing, and we anticipate strengthening our pipelines in this area with additional programs in 2025, for which clinical candidates could be selected in the second half of 2026. For the respiratory program licensed to GSK, please note that the disclosure of the timeline remains at the discretion of GSK. As recently confirmed by GSK, the seasonal influenza program is expected to progress to phase III in 2025. Further available timelines for the licensed program include an anticipated data readout for the avian influenza study in the first half of 2025. GSK is also about to initiate a new combined phase I study for an influenza COVID-19 combination vaccine. Corresponding information can be found on ClinicalTrials.gov. Data is expected in the first half of 2025. With this, I would like to conclude the portfolio update and hand over to Axel for a review of the financial data. Thank you, Myriam. Looking at the significant progress we've made in streamlining our operations and focusing on strategic priorities, I'd like to provide context to key financial metrics on slide 18, demonstrating our financial health and enabling us to reinvest in key areas of growth and innovation. Today, we report a strong cash position of €551 million at the end of the third quarter of 2025 and reaffirm our cash runway into 2028. Our quarterly results are driven by the new licensing agreement with GSK, which positively impacted our cash position as well as revenues. The EUR 400 million upfront from the agreement was received as a non-refundable payment for granting licenses to GSK and the right to use CureVac intellectual property, but no further R&D work obligation on our side. As such, it was fully recognized as revenue in the third quarter of 2024. Given that under the terms of the new licensing agreement, all obligations from prior collaborations relating to R&D services had expired, remaining contract liabilities amounting to EUR 18.4 million were also recognized as revenue in the third quarter of 2024. Setting the course for increased future financial stability, our strategic redesign is key to enhancing our operational efficiency to further reduce costs. The efficient execution of the 30% workforce reduction on track to be complete by the end of this year, 2024, incurred costs approximately 40% below the allocated budget. From 2024 onwards, we anticipate a substantial increase in operating expenses by over 30%, including a notable EUR 25 million reduction in personnel costs. Our licensing agreement with GSK and renewed focus on innovation and R&D activities have also eliminated the need for commercial buildup and large-scale manufacturing activities. Streamlining of our in-house manufacturing capacities to provide a new manufacturing footprint better suited to our needs was accompanied by a partial impairment of a large-scale GMP IV production facility. Lastly, we have successfully terminated all remaining raw material commitments and closed all contract manufacturing organization, or CMO, related arbitrations for our first-generation COVID-19 vaccine in the third quarter, ensuring no further related payments. Moving on to our condensed financial statement on slide 19, you can see that our cash position of EUR 550.9 million increased from EUR 402.5 million at the end of 2023 based on the EUR 400 million upfront payment from GSK in August 2024. The increase is partially offset by our ongoing R&D activities as well as last payments related to our first-generation COVID-19 vaccine. As already discussed, revenues strongly increased by EUR 477.4 million to EUR 493.9 million for the third quarter and by EUR 489.5 million to EUR 520.7 million for the nine months of 2024 compared to the same period in 2023. As the year-on-year increase was primarily driven by the license agreement with GSK, this must be seen as a positive one-time event. Operating profit was EUR 368.4 million for the third quarter of 2024 compared to an operating loss of EUR 54 million for the same quarter in 2023. For the first nine months of 2024, operating profit was EUR 221.4 million compared to an operating loss of EUR 186.2 million for the same period in 2023. The operating result was affected by several key drivers. First, cost of sales increased year-on-year mainly due to high arbitration costs for CMO activities related to the first-generation COVID-19 vaccine, as well as due to higher personnel expenses related to the redesign of the organization. Second, R&D expenses increased with higher investments in oncology development programs, as well as increased expenses related to the litigation to enforce intellectual property rights. Third, general administrative expenses decreased compared to the prior year period, mainly driven by lower personnel expenses. Lastly, other operating expenses increased due to the discussed partial impairment of CureVac's GMP IV production facility. Financial results increased by EUR 3.1 million to EUR 2.2 million in the third quarter of 2024 and decreased by EUR 4.7 million to EUR 80 million for the first nine months of 2024 compared to the same periods in 2023. The decrease was mainly driven by lower interest income on cash investments. Pre-tax profit was EUR 370.6 million for the third quarter and EUR 229.4 million for the first nine months of 2024 compared to a pre-tax loss in the same periods of 2023. With this, I'd like to hand back the call to Alexander for today's key messages. Thank you, Axel. Now, let's summarize the key highlights for Q3 2024. We closed the third quarter of 2024 with a cash balance of EUR 550.9 million, providing us with a solid financial runway into 2028. This strengthens our ability to continue driving innovation and growth. In addition, we are making significant progress on our strategic transformation, including a 30% workforce reduction by the end of 2024. This will contribute to substantial cost savings starting in 2025 and enhancing our operational efficiencies. In oncology, we are advancing our off-the-shelf and personalized cancer vaccines. Our glioblastoma trial has shown promising early results, and we are planning new trials in 2025 and 2026, and in infectious diseases, we are moving forward with the UPEC vaccine for UTIs. Additionally, our partner GSK is advancing a seasonal influenza vaccine into phase III next year and is about to initiate a combined phase 1/2 study for COVID influenza combination vaccine, both leveraging our platform, and as we enter 2025, we are well-positioned, well-financed, focused on high-value opportunities, and supported by strategic partnerships and a robust IP portfolio. These elements position us well for ongoing growth and success in tackling major health challenges, and with that, I would like to conclude our presentation and open the floor for your questions. Great, 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 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star keys. One moment, please, while we pull the questions. First question here is from Charlie Yang from Bank of America. Please go ahead. Great. Thanks for taking the question. I have two, please. I think one, can you discuss perhaps your thoughts about business opportunity, licensing opportunity outside of the mRNA, your core expertise, whether that is an area of potential interest just given your cash position? And second of all, can you discuss about the litigation update and what should we expect on that front? Thank you. Okay, thank you. So on your first question on business opportunities, at the moment, we stay very focused on the two areas that we described during the presentation, which is oncology on one hand and infectious diseases on the other hand. And within these two areas, we already do have collaboration with GSK on one hand and with MD Anderson on the other hand. But of course, we are always open to look at new opportunities within these two areas that will help us to strengthen our portfolio and especially accelerate our path to the clinic. With regards to litigation, so these are ongoing. I think the next high point for you to keep in mind is the U.S. court case, which has been scheduled for March 25, so March next year. So work is ongoing for us to prepare as best as we can for these events. So other than that, we don't have much to update you on just now. Thank you. Our next question is from Mani Foroohar from Leerink Partners. Please go ahead. Hi there. Thanks for taking our question. This is CJ on for Mani. Following your encouraging flu data, I was wondering if you could share any commentary on plans for developing a combo vaccine for flu COVID. Thank you. Question on flu combo, flu COVID combo, Myriam? Yeah. I mean, this question should ideally be addressed by GSK, but of course, we all believe that given the epidemiology and the occurrence of infections, a combination for patients of the flu vaccine and COVID vaccine would be the most convenient approach, right, and most promising. That's why all of the development efforts in the past, when we were still in collaboration, were focused on this. The phase I study starts now, as we also shared, and we expect the data readout next year for decision-making to progress to phase II. I'm not sure I addressed your question, but I think the program is progressing, especially because of the very positive phase II data and influenza, and we are optimistic that this is going to be a continued successful program. Great. Thank you so much. Next question is from Chiara Montironi of Van Lanschot Kempen. Please go ahead. Hello team, congrats with the update. This is Chiara from Van Lanschot Kempen, and I'm on behalf of Suzanne. So I was wondering any color or reasoning you can provide on selecting lung cancer as the new indication? And then following up the previous question, can you say something regarding patent litigation on the EUA front, on the Europe front? Thanks. Okay. Myriam, maybe one question for you. I think it was a question, if I understood correctly, on indication selection or prioritization. Exactly. That's what I also understand. I'm sorry because the acoustics weren't great. Yeah. So we have to, of course, when we select the candidates, we have to follow the science, right? And basically, in our approach, this covers antigens, shared antigens that are shared across different cancer indications. We also wanted to include novel classes of antigens. In our research, again, we found appropriate coverage of novel antigens in squamous non-small cell lung cancers. Following the signals that the indication we selected for our what we think very innovative next-generation shared antigen cancer vaccine to address the high unmet need in this population. The indication is basically based on the signals of the data and the readout of our antigen discovery work. Does that answer your question? Again, because it wasn't super easy to understand the acoustics. Yes, perfectly. I hope my sound is now better, but it was perfectly on point. Regarding patent litigation on the European front? Yeah. So in Europe, it's a bit more complex, whereas in the U.S., all the different cases are bundled under one case, and we have one court case on validity infringement and damages. In Europe, it's really on a case-by-case basis. So this is something that will continue throughout the next years. We do expect further rulings from the European Patent Office on our patents in the second quarter of next year, as well as from the regional court in Düsseldorf, more in the second or third quarter. Right. So in Europe, it's going to be an ongoing process throughout 2025 and mainly leading into 2026 on a patent-per-patent basis. Right. But I think the key visibility, the key event, at least for the first half, will be the U.S. case in March. Okay. Thank you so much. Our next question is from Roy Buchanan from Citizens. Please go ahead. Hey, thanks for taking the question. Just a couple of FimH questions. I think there was a prior protein-based program that didn't move forward. Can you just maybe comment on if your engineering approaches address maybe why that program didn't move forward? And then any thoughts on how your—I think there's a GlycoConjugate program in phase III. Any thoughts on how your approach could be better than that? Thanks. Again, I'm sorry. The audio is a little bit difficult. I heard the first question, why FimH, right? If I understand correctly. And why FimH is easy to address? It's a highly conserved antigen in UPEC bacteria. And by selecting and targeting this antigen, we basically are able to cover about 95% of the population affected by UPEC. That's the first one. The second one is this basically antigen target. It has been kind of validated in preclinical trials, and even if you want to go there in a phase 1/2 study by another sort of company who is testing a peptide-based vaccine. So FimH is validated, I think, as a target to address UPEC bacteria, and this is a promising antigen. If your second part of the question is about the antigen design, again, we applied something very innovative, right? And the way how we selected to target FimH in it, I don't want to get too much into the detail, but in a pre-binding conformation so that we really can get the bacteria before it has attached to the endothelial cells in the bladder. And then we have, for the first time, applied a design where, again, the encoded protein forms a nanoparticle with ferritin in the core, and then basically a lot of FimH proteins expressed on the surface to really induce a stronger immune response. And that design, again, in our preclinical studies, translated to a really beautiful immunogenicity, showing very high titers of binding and, what is even more important, functional antibodies. And when we compared it to a protein-based design targeting FimH, it showed basically superior immunogenicity, both for humoral antibody responses and T cell responses. I know you had a part in the question about another program, but I didn't hear that very clearly. I think there was more a question around differentiation, right? With our more advanced program, why do we believe an approach with an mRNA or RNA vaccine could be differentiated or different? I think, especially in this setting, again, mRNA per se is differentiated in that we can show clearly induction of humoral and cellular immune responses, as shared in our preclinical data, because we believe UPEC, you have to address through, again, targeted antibodies as well as cellular responses because the bacteria rest on the cells in the bladder. So that's the first part why it is differentiated. And then the other part is, of course, because of the way how we designed our vaccine and the target that we have selected. Okay, great. And the design was all in-house, or did you license any technology? Thanks. That's it. If I understand correctly, this is a proprietary technology that is all owned by CureVac. Got it. Thank you. Next question is from John Miller from Evercore. Please go ahead. Oh, hi. This is Zhen Shan for John. Thanks for taking our question. I guess on the GBM program, apparently, very good response from T cells, but how should we think about the translation towards tumor response based off the data? And also for the overall off-the-shelf program, what are the indications that of most interest? Thank you. Yeah, thanks a lot. So maybe for GBM, this is a super important question, right, that nobody can answer at this point. How does the immunologic response translate into clinical benefits? And there, again, we need to wait for more data coming from our expansion cohort. We have presented it as very early preliminary clinical readouts from our phase I dose escalation cohort. In those data, we shared that we had one partial response in a patient who entered the trial with only a partial tumor resection. And again, under monotherapy with our vaccine, that patient developed a partial response. Unfortunately, the immunogenicity readouts did fail in this patient because they couldn't collect enough cell samples, but at least one partial response was observed in our phase I dose escalation part. Then the other parameters you could look at, again, all under the caveat of early data at 16 patients, but we also looked at the PFS at six months in this bad prognosis population, where we saw in our trial a PFS at six months of about 34%. Then you compare this to data shared at ASCO this year from basically a trial conducted by similar investigators that participated in our trial, the NOA-20 trial. They shared that patients with unmethylated GBM treated just with radiotherapy plus minus temozolomide had a PFS at six months of only 18%. So again, I have to caveat that this is early data at a handful of patients, but we do see some promising even clinical signals. Now, what we are doing in the dose expansion part, again, we collect more information on more patients. We collect more and also deeper immunogenicity data, and we will collect, of course, the clinical data so that at the end, we can hopefully correlate the two and then make a robust decision whether we go into phase II or not. I guess the second question was around indication selection for the rest of the off-the-shelf vaccines. I think we already communicated candidate in squamous non-small cell lung cancer, right? And I think work on the indication selection for the next CHEREC program, potentially from the MD Anderson collaboration is still ongoing. Right. Maybe just to build on this, we have conducted end of last year, beginning of this year, an extensive oncology strategy exercise where we looked at all different kinds of indications which could be targeted by a cancer vaccine. We considered criteria such as likelihood of scientific success, unmet medical need, competitive environment, commercial opportunities, and have prioritized a few cancer indications where we will go deeper into the discovery for cancer antigens. Its selection of next indications is really following a strategic approach that has been also translated into our collaboration with MD Anderson, where we focused together on, again, promising scientifically, but also commercially promising areas in oncology. Thank you very much. As a final reminder, if you'd like to ask a question, it is star one. If there are no further questions, I'd like to turn the floor back to management for any closing comments. With this, we would like to conclude our 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. This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.
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