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spk07: 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 story zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Sarah Fahke, Vice President of Corporate Communications and Investor Relations Thank you. You may begin.
spk05: Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Funke, and I'm the Vice President of Call Communications and Investor Relations at CureVac. Please let me introduce today's speakers. On the call with me from CureVac are Arizona State's Chief Administrative Officer of CureVac, Miriam Yadina, our Chief Scientific Officer, and our National Financial Officer, Axel Markowitz. You may have seen the press release last week announcing his joining the Q&A initiative. Lydia Orff, 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 on the investor relations on all websites. Before we begin the Q&A, the discussions and responses to your questions on this call reflect many of the 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 retention. These constitute forward-looking statements for the purpose of the state hardware provision. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. QLAC has stated any intention or obligation to provide any form of state news. For more information, please refer to our financial and U.S. Securities and Exchange Commission. I will now turn the call over to Ari Lande.
spk06: Thank you, Sara. 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 QLAC. We made significant progress on our 2024 priorities, taking decisive steps, rightizing 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 1.45 billion euros, includes an upfront payment of 400 billion euros, which is 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 evaluating 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 helped 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, Glioblastoma, is the 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-sponsored lung cancer, expanding our off-the-shelf cancer vaccine pipeline. In infectious diseases, we launched a new program called 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. The UTI program exemplifies our focus on leveraging our technology commercial potential. On slide five, you can see this achievement 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 euro upcharge payment for 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 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 one trial shortly thereafter. Discovery activities for additional shared antigen programs continue with the second clinical candidate expected in 2026. Preclinical 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 medical needs. Here, we have launched a new program for urinary tract infections, which are the world's most common infections. And we will present the preclinical data for this program later in the presentation. Before I go into the business update, I'm delighted to have a new checking financial officer, Axel Markomes, 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 to the 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 forced to make continued remarkable progress in the development of innovative and learning-based medicines. By applying my expertise in financial management and corporate growth, I'm convinced that can help drive CureVac's mission forward and contribute to its future success. Thank you, Axon. 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 had a dual strategy in oncology, working on both off-the-shelf and personalized cancer vaccines to cover a wide range of cancer types. Used 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 out-licensed our respiratory disease programs to GSK. Our scalable manufacturing capabilities, including the RNA printer, gives us flexibility to produce preclinical 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 precision mRNA backbone is built on 20 years of experience, helping us design highly efficient mRNA constructs that improve protein expression and lower dose efficiency. In oncology, we have a unique ability to discover new classes of antigens, which paves the way for innovative cancer treatments. And our work on advanced liver nanoparticle building system, tailored for specific indications, aims to enhance the effectiveness and stability of our experience. Together, these differentiators give us a strong competitive position and drive our mission to develop transformative medicines for patients. Plan 9 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 VPA 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 it over to Miriam to explain how we turn these technologies into a strong focused clinical pipeline.
spk05: Thank you, Alex. 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 effective market opportunities. In oncology, our existing pipeline for off-the-shelf cancer vaccines is led by our phase one study in patients with resected cleoblastoma, 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 Kramer's non-small cell lung cancer. The vaccine can be actually 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 Curex proprietary second-generation mRNA backbone and are currently in Phase II development. GSK recently announced positive Phase II headline data for seasonal influenza concerning strong antibody targets against influenza A, 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 three next year. Based on the validation of our platform in infectious diseases, we launched a new proprietary program to develop a prophylactic vaccine against neuropathogenic E. coli. the primary cause of urinary tract infection, 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 in collaboration with the Chapman's Eye Reset Institute in ocular diseases most recently terminated, we continue to develop, optimize mRNA therapeutics in different areas. We are committed to focus our pipeline on selecting indications where mRNA technology can also form conventional approaches, guided by our mission to advance innovation in preventive and therapeutic health solutions. On that level, we delved 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-point 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 the novel or and precisely existing immune responses in different cancer settings, including advanced stages of cancer. CBGBM, our lead oncology clinical candidate, is currently being evaluated in a phase one study in patients with resected bilioblastoma and coding known antigens relevant to this highly aggressive brain cancer. All our next generation share antigen cancer vaccines, including the one in squamous non-monster 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 neoantigens 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 growth. Our first-time 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 Oxfordshire vaccine candidate CDGVM, which was tested in a phase one study in patients with redacted . You might recall that CDGVM features a uniquely designed, single, unmodified mRNA construct. encoding eight segments derived from four tumor-associated antigens with immunogenicity . It was administered as a monotherapy after surgical resection and completion of radiotherapy with chemotherapy. Patients received seven intramuscular vaccinations within 10 weeks and optional maintenance vaccinations in case of nonprogression for potential . Preliminary safety and immunogenicity data from the dose escalation of the study were recently presented at the Congress. In this highly challenging and aggressive cancer type, the data confirmed the safety and tolerability profile with no dose limited toxicity 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 CD14 cell response to lead to 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 are successfully induced in patients who had no pre-existent lethal activity against encoded antigens prior to vaccination with CBGVN. 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 of this year. A first data readout is expected in the second half of 2025. We continue to advance our oncology pipeline, and on that circuit, we have summarized our upcoming oncology catalysis, which provides strong development paths over the next 24 months. That includes our most advanced phase one of the SHERV program, and we expect a new blastoma, as already mentioned, and enrollment of the dose confirmation that we offer that is progressing well. We expect enrollment to be completed the latest in the first half of 2025, allowing for a Data agreed out in the second half of 2025. Data from an additional up to 20 patients dose at 100 micrograms will provide the basis for potential continuing to a phase two study, which could start in the second half of 26. The newly announced of the SHELD program in squamous non-small cell lung cancer is expected to enter phase one clinical development in the second half of 2025. With our proprietary antigen work continuing, we intend to disclose additional official programs with new clinical candidates in different indications in 2026. Lastly, the first phase one study with a personalized cancer vaccine candidate is expected to start in the second half of 2026. These strong highlights our strategic focus on opportunities in oncology, leveraging our mRNA technology designed to ensure continuous progress and innovation in our oncology . 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-hospital infections caused by bacteria, viruses, and fungi, we aim to deliver safe and cost-effective vaccines for high medical need 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 neuropathogenic E. coli bacteria, in short, ZUPAC. UPEC is the primary cause of urinary tract infections, which rank amongst the most common infections worldwide. The statistics presented on slide 15 highlight the significant incidence and disease burden associated with UPEC in the U.S. The high prevalence of UTIs with more than 60% of patients requiring antibiotic therapy, leading to increased antibiotic resistance and high rates of recurrence, presented substantial silence 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 recurrent UTIs. Our mRNA technology has the potential to deliver a best-in-class solution, including functionally using unsanctioned antibodies as well as clear pre-cell responses against mucus. To tackle this infection, we developed mRNA vaccine cannibals that encode SYNH, a bacteria protein considered crucial for adhesion of the bacteria to bladder tissue and biofilm formation. SYNH is highly conserved in UPEX strains and therefore represents an excellent vaccine target for the vast majority of patients. For our vaccine cannibals 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 thin-H 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 60, 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 in comparison to non-licensed recombinant protein vaccines. Types of binding and functional antibodies, meaning antibodies inhibiting hemagglutination and or . were measured in both models in serum and urine samples. Additionally, CD8 and CD4 key cell responses were determined in mice. Both mRNA vaccine candidates induced high levels of binding antibody types in blood and urine in both models. This also correlated with highly functional antibody types 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 function 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 comparison of protein-based vaccines, with the nanoparticle candidate again strongly outperforming all other candidates. Overall, our infected disease programs show promising progress with both non-respiratory and respiratory areas advancing based on solid development catalysts outside on site 70. For our newly launched impact program, we expect to select a clinical candidate in the first half of 2025, enabling us to file for IMD submission in the second half of 2025. This anticipated to allow, say, one 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 2023. 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 three in 2025. Further available timelines for the license program include an anticipated data readout for the alien influenza study in the first half of 2025. GSA is also about to initiate a new combined phase one study for an influenza COVID-19 combination vaccine. Corresponding information can be found on clinicaltries.gov. Data is expected in the first half of 2025. With this, I would like to conclude the portfolio update and then hold for two. Axel for a review of the financial data.
spk06: Thank you, Miriam. 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 home and enabling us to reinvest in key areas of growth and innovation. Today, we report a strong cash position of €551.9 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 J.K., which positively impacted our cash position as well as revenues. The €400 million upfront from the agreement was perceived as a non-refundable payment for granting licenses to JSA and the right to use QM in the next intellectual property, but no further R&D or obligation on our side. As such, it would fully, it was fully recognized as revenue in the third order 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 18.4 million euros were also recognized as revenue in the third quarter of 2024. Tending the course for increased future financial stability, our strategic redesigns lead to enhancing our operational efficiency to further reduce costs. The efficient execution of the 30% workforce reduction contract to be completed by the end of this year of 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 25 million euro reduction in personnel costs. Our licensing agreement with JFK and renewed focus on innovation and R&D activities have also eliminated the need for commercial buildup and large-scale manufacturing activities. Streetlining our in-house manufacturing capacity to provide a new manufacturing footprint that is suited to our needs was accompanied by a partial impairment of a large-scale GDP4 production facility. Lastly, we have successfully terminated all remaining raw material commitments and closed all contract manufacturing organization, or CMO, related arbitration for our first-generation COVID-19 vaccine, the third order, ensuring those voter-related payments. Moving on to our condensed financial statement on slide 19, you can see that our cash position of 550.9 million euros increased from 402.5 million euros at the end of 23, based on the 400 billion euro upfront payment from JCA 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 477.4 million euros to 493.9 million euros for the third quarter and by 489.5 million euros to 520.7 million euros for the nine months of 2024 compared to the same period of 2023. And the year-on-year increase was primarily driven by the license agreement with JFK that must be seen as a positive one-time event. Operating profit was 368.4 million euros for the same order in 2024, compared to an operating loss of 54 million euros for the same order in 2023. So the first nine months of 2024 operating profit was 221.4 million euros compared to an operating loss of 186.2 million euros for the same period in 2023. The operating result was affected by several key drivers. First, constant sales increased year on year mainly due to high arbitration costs for CMO activities related to the first generation COVID-19 vaccine as well due to high personnel expenses related to the redesign of the organization. Second, R&D expenses increased with high 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 QOXGP4 production facility. Financial results decreased by 3.1 million euros to 2.2 million euros in the third quarter of 2024, decreased by 0.7 million euros to 80 million euros for the first nine months of 2024 compared to the same periods in 2023. The decrease is mainly driven by the less explicit income on cash investments. Pre-tax profit was €317.6 million for the third quarter and €229.4 million for the first nine months of 2024, compared to a pre-tax loss in the same periods of 2023. And with this, I'd like to hand back the call to consensus on today's event issues. Thank you, Axel. Now, let's summarize the key highlights from Q3 2024. It goes to third quarter of 2024 with a cash balance of 550.9 million, providing us with a solid financial runway into 2028. This track is our ability to continue driving innovation and growth. In addition, we are making significant progress on our strategic transformation, including a 30% more reduction by the end of 2024. This will contribute to substantial cost savings starting in 2025, and enhancing our operational efficiencies. In oncology, they're advancing shelf and personalized cancer vaccines. Our trial has shown promising early results, and we are planning new trials in 2025 and 2026. In infectious diseases, we are moving forward with the UMAG vaccine for UTIs. Additionally, our partner GSK is advancing a seasonal influenza vaccine into phase three next year. And it's about to initiate a combined phase 1 to 34 COVID influenza combination vaccine for leveraging our platform. And at the end of 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 as 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.
spk07: 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 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while I pull up a question. First question here is from Charlie Yang from Bank of America. Please go ahead.
spk01: Great. Thanks for taking the question. I have two, please. I think one, can you discuss, perhaps, kind of your thoughts about, you know, business opportunity, you know, licensing opportunity outside of the ML&A, kind of your core expertise, you know, whether that is an area of, kind of, potential interest, just given your cash position? And second of all, can you discuss about the kind of litigation kind of update and kind of what should we expect on that front? Thank you.
spk06: 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 the MD Anderson on the other hand. But of course, we are always open to look at new opportunities within these two areas, you know, 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 time point, you know, for you to keep in mind is the U.S. court case, which has been scheduled for March March 25th, so March next year. So, you know, 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.
spk08: Thank you. Our next question is from Manny Florejar from Liebring Partners.
spk07: Please go ahead.
spk02: Hi there. Thanks for taking our questions. This is CJ on for . Following your encouraging flu data, I was wondering if you could share any commentary and plans for developing a combo vaccine for flu COVID. Thank you.
spk06: question on flu combo, flu COVID combo, may I?
spk05: Yeah. I mean, these questions, you know, should ideally be addressed by GSK, but of course, We all believe that, you know, 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 one study starts now, as we also shared. We expect the data readout next year for decision-making to progress to phase two. I'm not sure I addressed your question, but I think the program is progressing, especially because of the very positive phase two data and influenza. And we are optimistic that this is going to be a continuous and successful program.
spk02: Great. Thank you so much.
spk07: The next question is from Chiara Mentoree from CureVac. Please go ahead.
spk04: Hello, Tim. Congrats with the update. This is Chiara from Valencia Camp, 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.
spk06: Okay, I may have had a wrong question for you. I think it was a question, if I still understood correctly, of indication selection, so why squamous?
spk05: Exactly, that's what I also understand. I'm sorry, because the acoustics were on break. Yeah, so we have to, of course, when we select a candidate, we have to follow the signs, right? Basically, we, in our approach, discovered antigens, shared antigens that are shared across different cancer indications. And we also wanted to include novel classes of antigens. And so in our research, again, we found appropriate coverage of novel antigens in squamous non-small cell lung cancer. So following the signs, that's the indication we selected for our study. what we think very innovative antigen to address the high unmet need in this population. So, the indication is basically based on the science of the data and the readout of our antigen recovery work. So, then I'll answer questions, again, because it wasn't
spk06: easy to understand yes yes perfectly i i hope my sound is now better but um it was perfectly on point and regarding litigation on the european front yeah so in europe uh it's a bit more complex whereas in the us all the different uh cases are bundled in one case and you know 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, you know, from the regional court in Dusseldorf, more in the second or third quarter. But, so, Europe is going to be an ongoing process throughout 2025 and maybe leading into 2026. on a patent-profession basis, right? So, but I think the key visibility, the key event from, at least for the first time, will be the U.S. case in March.
spk04: Okay. Thank you so much.
spk07: Our next question is from Ray Buchanan from Citizens. Please go ahead.
spk03: Hey, thanks for taking the questions. Just a couple questions. I think there was a prior protein-based program that didn't move forward. 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 three. Any thoughts on how your approach could be better than that? Thanks.
spk05: So I, again, I'm sorry. The audio is a little bit difficult. So I heard the first question, why SIMH, right, if I understand correctly. and age is easy to address. It's a highly conserved antigen in nucleic bacteria. And basically are able to cover about 95% of the population affected by Lupec. That's the first one. The second one is there basically antigen . It's been kind of validated in preclinical trials, and even if you want to go there in a phase one, two study by another certified company who is testing a peptide-based vaccine. So, FIMH is validated, I think, as a target to address this type of 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, in the way how we selected to target FIMH in it. I don't want to get too much into the details, but in a pre-binding transformation, so that we really can get the bacteria before it has attached to the endothelial cells and 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 thin H proteins expressed on the surface to really induce a stronger immune response. And that design, again, in our preclinical study, translated to a really beautiful immunogenicity, showing very high sizes of binding and was even more important functional antibodies. And when we compared it to a protein-based design targeting thin H, it showed basically superior immunogenicity both for humoral antibody responses and T-fill responses. I know you had a part of the question about another program, but I didn't hear that very clearly.
spk06: I think it was more a question around differentiation, but with a more advanced program, why do we believe an approach with an mRNA or a vaccine could be differentiated or different?
spk05: Well, I think in, especially in this setting, again, mRNA per se is differentiated in that we can show clearly induction of humoral and cellular new responses as shared in our preclinical data. Because we believe you have to address to again targeting antibodies as well as cellular responses because the bacteria in the bladder. So that's first part why it is different. And then the other part is of course because of the way how we designed our vaccine and the target that we have selected.
spk03: Okay, great. And the design was all in-house or did you in-license any technology? Thanks, that's it.
spk05: This is a proprietary technology that is all .
spk08: Thank you.
spk07: Next question is from John Miller from Evercore. Please go ahead.
spk00: Oh, hi. This is 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 are of most interest? Thank you.
spk05: 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 we, again, we need to wait for more data coming from our expansion cohort. We have presented it as a very early preliminary clinical readout from our phase one dose escalation cohort. In those data, we shared that we had one partial response in the patient when it was a trial with only a partial tumor reduction. And again, under more than 30 vaccines, that patient developed a partial response. Unfortunately, the immunogenicity readout did fail in this patient because they couldn't connect enough cell samples. But it means one partial response was observed in our case, one dose escalation part. And then the other parameter you could look at, again, all under the caveat that early data is 16 patients, But we also looked at the PFS at six months in this population where we saw in our trial a PFS at six months of about 34%. And then you compare this to data shared at ASCO this year from basically a trial conducted by, you know, similar investigators that participated in our trial, in our 20 trials. They shared that patients with un-humestimated GBMs treated just with a radiotherapy plus minus hemazolamide, had a PFS at six months of only 18%. So, again, I have to copy this early data of a handful of patients, but we do see some, you know, promising even clinical signals. Now, what we are doing in the drug extension 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 two or not.
spk06: I guess the second question was around, you know, indication selection for the rest of the aftershock vaccines. I think we are in a community, again, we don't spoil this, non-spots are not cancer, right? And I think work on the indication selection for the next program, potentially ask the MDN some questions that are going.
spk05: Right. And 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, and we considered criteria such as you know, of scientific success, medical needs, competitive environment, commercial opportunities, and have prioritized a few cancer indications that where we will go deeper into the discovery for cancer and cancer antigen. So it's, you know, it's a selection of next indications and really following a strategic approach This has been also translated into our collaboration with Sandy Andersen, where we focused together on, again, promising scientifically, but also commercially promising areas in oncology.
spk00: Thank you very much.
spk07: And 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 it back to management for any closing comments.
spk05: 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.
spk07: This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.
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