CureVac N.V. (CVAC) on Q4 2021 Results - Earnings Call Transcript
Operator: Greetings. Welcome to the CureVac Fourth Quarter and Full Year 2021 Financial Results and Business Update Conference Call. . Please note, this conference is being recorded. I will now turn the conference over to your host, Sarah Fakih. Thank you. You may begin. Sarah Fakih: Thank you. Good morning, good afternoon and welcome to our conference call. My name is Sarah Fakih, and I'm the Vice President of Corporate Communications and Investor Relations at CureVac. Please let me introduce today's speakers. On the call with me are Franz-Werner Haas, the Chief Executive Officer of CureVac; Klaus Edvardsen, our Chief Development Officer; and Pierre Kemula, Chief Financial Officer of CureVac. Please note that this call is being webcast live and will be archived on the Events & Presentations section under Investor Relations on our website. Before we begin, a few forward-looking statements. The discussion and responses to your questions on this call reflect management's view as of today, Thursday, April 28, 2022. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations or predictions of the future. These constitute forward-looking statements for the purpose of the safe harbor provisions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVac disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Franz. Franz-Werner Haas: Thank you, Sarah. Ladies and gentlemen, a warm welcome to this conference call from here from us at CureVac. CureVac has made significant progress over the past several months. We are expanding our solid product development pipeline, broad technology platform and robust manufacturing capacities to strengthen our competitive position within the RNA field as a central player. Let me give you a short overview of selected key developments in these 3 areas. In prophylactic vaccines, we are successfully conducting and executing on infectious disease and dedicated COVID-19 programs in collaboration with our partner, GSK. We are extending our technology platform into multivalent as well as modified mRNA approaches to identify a highly differentiated vaccine candidate. Together with GSK, we have advanced our vaccine candidates for COVID-19 and influenza, respectively, into Phase I testing, which we believe will establish the clinical value of our improved second-generation mRNA backbone. While these first 2 studies are investigating unmodified candidates, 2 additional studies for these candidates and indications with modified candidates will be initiated later this year. A recently completed preclinical study assessing a bivalent COVID-19 candidate, combining 2 mRNAs encoding for Beta and the Delta variant has provided first evidence of the flexible variant adoption of our second-generation mRNA backbone. Encouragingly, the data also showed a potentially increased breadth of immune responses tested variants, including Omicron, demonstrating the potential of our multivalent mRNA vaccination approach. Most recently, together with GSK, we are awarded a tender for pandemic preparedness by the German government, a strong sign from our point of view, a strong sign of confidence in our ability to support, to safeguard public health. In case of an ongoing COVID-19 or other infectious disease emergency, the 5-year contract granted by the government access not only to CureVac manufacturing capacity, but also to 80 million dosages of a vaccine developed by CureVac and GSK. Leveraging our technology platform advances, we are preparing to expand our oncology pipeline as well, the next-generation driver beyond our progress in prophylactic vaccines. Our goal is to establish a meaningful pipeline of cancer vaccines with a strong focus on T cell-mediated immune responses and supported by complementary antigen discovery and vaccine optimization technologies. Our progress in oncology will be supported by the fast and flexible process of the RNA printer, our end-to-end solution for automated manufacturing of GMP-grade RNA vaccines and therapeutics. In March this year, we launched a fully owned company to accelerate development of the RNA printer with a dedicated operational infrastructure and an experienced management team. Lastly, on the financial side, we closed 2021 with a solid cash position of around €800 million. Pierre will later talk you through the financial details. On Slide 5, I would like to draw your attention to one of CureVac's most valuable, yet potentially most undervalued assets, our extensive intellectual property portfolio. Over the last 2 years, the development of safe and effective COVID-19 vaccines in record time was accomplished based on a technology that had to be developed over the decades of intense scientific research. For mRNA to become a key technology in the fight against COVID-19, discoveries in multiple disciplines had to converge, most notably, immunology, biology and molecular biology, but also mRNA design, delivery and advances in manufacturing. As the pioneers in harnessing the medical potential of mRNA, CureVac has played a critical role in developing many of the innovations that have enabled today's mRNA vaccines against COVID-19. Correspondingly, we hold one of the largest and most diverse patent portfolios in this field. Our patent portfolio comprises 120 patent families with more than 1,550 patent family members divided into large clusters that define our core competencies in mRNA technology, product development and manufacturing. Our technology cluster encompasses fundamental RNA optimization expertise as well as targeted strategies to improve mRNA immunostimulation and protein expression profiles. Looking at an extract from an independent analysis of the patent landscape related to COVID-19 vaccines on Slide 6, you can see the global patent portfolios of a number of industry players listed according to the size and technological strength. While the orange bars represent portfolio size, the blue bars represent the Patent Asset Index, a measure for technological strength of the portfolio based on the frequency with which the patent is cited in other patent applications and filings. The CureVac portfolio shows by far the strongest technology relevance in comparison to other RNA but also mRNA companies. The CureVac Patent Asset Index is, in fact, also almost twice as high as the Patent Asset Index of the next mRNA vaccine company, reflecting the strength of our innovation and our central position in the field. On Slide 7, let me highlight the CureVac pipeline to show how we are translating our strong mRNA technology expertise into a diverse portfolio of product candidates across 3 therapeutic areas to address diseases with high met unmedical need -- high unmet medical need, sorry, prophylactic vaccines, oncology and molecular therapy. Our technology platform improvements with the development of a second-generation mRNA backbone have led to significant progress in our clinical pipeline for prophylactic vaccines. We have advanced development of CV2CoV, an unmodified mRNA vaccine candidate and the first of our second-generation COVID-19 vaccine candidates. In addition, we have successfully extended our technology platform and most notably also our manufacturing capabilities to develop our first and highly differentiated multivalent unmodified mRNA influenza vaccine candidate together with GSK. Both candidates have been advanced into Phase I clinical trials, and Klaus will talk about the clinical studies of both candidates in greater detail on the next slides. Together with GSK, we have broadened our development strategy to also test chemically modified mRNA technologies. This unrestricted technology approach will enable data-driven decisions to identify the best performing product candidates. Clinical programs with chemically modified mRNA for COVID-19 and influenza are expected to start later this year. In oncology, our lead candidate, CV8102, is currently being assessed in a Phase I clinical trial in solid tumors. A CV8102 expansion cohort is advanced -- in advanced melanoma is ongoing, and we expect to provide an updated readout in the second half of this year. Our technology platform improvements will have a clear readthrough into our immuno-oncology pipeline where we plan to build a meaningful portfolio of cancer vaccine candidates, eliciting strong systemic or tumor-directed immune responses. In the third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics, together with several renowned collaboration partners for the development of antibodies and of therapeutic proteins intended to treat diseases characterized by missing or inactive proteins. Looking at the number of the studies on clinicaltrial.gov, only 10% to 15% of more than 2,000 registered clinical trials involving mRNA relate to SARS-CoV-2 vaccines, demonstrating the huge potential of mRNA technology to revolutionize medicine in the years to come. It just started. The era of RNA technology has just begun. And we expect the global mRNA pipeline to grow dramatically over the next decades. Let me now hand over the call to Klaus to try to dive you deeper into the recent progress of our prophylactic vaccine and oncology programs. Klaus Edvardsen: Thank you, Franz. I'm now on Slide 8 to walk you through the Phase I clinical trials that we are conducting in collaboration with GSK for our jointly developed COVID-19 and influenza vaccine candidates. The first 2 clinical trials with the unmodified candidates have already been initiated. The availability of unmodified messenger RNA clinical trial material based on existing manufacturing licenses initially prioritized these candidates. In the meantime, clinical trial material for the modified candidates has been produced and clinical trials are expected to start later this year. For CV2CoV, a Phase I dose escalation study was initiated in the U.S. in March of this year. CV2CoV, CVnCoV for the original SARS-CoV-2 stream, which has allowed us to directly compare its significantly improved immune responses to our first-generation candidate in several preclinical studies. In addition, a recent preclinical study in mice has shown that the second-generation messenger RNA backbone used in CV2CoV can be flexibly targeted to other variants and elicit good immune responses again in COVID variants. I will update you on these new findings later in this presentation. The Phase I trial is expected to recruit up to 210 participants in 6 dose groups ranging from 2 to 20-microgram per dose. It targets 0 positive participants to test administration of 2 doses of CV2CoV as a booster vaccination. Recruitment of participants is progressing according to plan. For the influenza candidate, CVSQIV, an equivalent Phase I dose escalation study was initiated in February this year. The candidate is a differentiated multivalent vaccine featuring multiple messenger RNA constructs. It was designed to elicit an immune response against recent antigens of the 4 different flu strains that caused the seasonal outbreaks. The trial was initiated in Panama to be separated from the flu season in Europe and North America. It is fully recruited with 240 participants in 5 dose groups ranging from 3 to 28 micrograms per dose. In accordance with conventional flu vaccines, it applies a 1-dose booster regimen. Preliminary set of reactogenicity data across all dose groups has confirmed good tolerability with no serious adverse events or other dose-limiting effects up to the highest dose of 28 micrograms. Let me give you a more detailed overview of the preliminary safety and tolerability profile of CVSQIV on the next slide. On Slide 9, you can see the percentage occurrence of the solicited systemic as well as local symptoms for all tested dose groups, stratified according to predefined age groups, including a younger population between the ages of 18 and 55, and an older age group at or above the age of 65. From left to right, the data shows adverse events in ascending order of severity, starting from grade 0 for no side effects to grade 3 for severe side effects. While we see an expected and general dose-dependent increase in adverse events, CVSQIV was well-tolerated. Among systemic symptoms, there were only very few quite great-3 fever events seen in the 6 and 20-microgram dose groups in the younger population and the 3-microgram dose group in the older population. Notably, there were no grade-3 events in the highest 28-microgram dose group. Overall, all adverse events were transient and rapidly results within 24 to 48 hours. Taken together, these first preliminary safety data further strengthen our confidence in the increased clinical value of our second-generation backbone based on the targeted optimization we implemented going from the first to the second generation messenger RNA backbone. I'm now moving to Slide 10 to discuss our most recent preclinical COVID-19 study conducted in collaboration with the Friedrich-Loeffler-Institut. The study assessed CV2CoV adoption for the beta or delta variant as well as the first bivalent candidate combining beta and delta-specific messenger RNAs in 1 vaccine candidate. In the study, mice were fully vaccinated with a 0.5-microgram dose of each candidate, including the bivalent candidate which was composed of 0.25 micrograms per messenger RNA. Impact on neutralizing titers against the beta or the delta variant is shown on the left-hand side of the slide. It illustrates very nicely how candidates show higher antibody titers against the variance they encode for, that is CV2CoV beta performed better against the beta variant than CV2CoV delta, and CV2CoV delta performed better against the delta variant than CV2CoV beta. Importantly, although the combined CV2CoV beta/delta candidate contains only half the dose per variant messenger RNA, it elicits neutralizing antibody titers against both variants that are fully comparable to the individual candidates specifically encoding the tested variant. The middle graph shows that high neutralizing antibody titers are accounted by robust T cell responses. Then vaccinated animals were directly exposed to the beta or delta virus, all vaccine candidates efficiently suppressed viral replication in the longer brain . Showing the graph on the right-hand side of the slide is the detection of residual viral load in the upper respiratory track projection is not to be challenging. In case of exposure to the animals to the delta variant, virus replication was almost fully suppressed in all but the controlled animals. In the case of exposure of the animals to the beta variant, all candidates strongly reduced the viral load. Again, the bivalent vaccine was equivalent through the matched CV2CoV beta candidate despite containing only half the dose of beta messenger RNA. In a separate set of experiment in the same study, I now move to Slide 11, showing some vaccinated list of rats was tested against the Delta or Omicron variant. Animals were vaccinated either with CV2CoV, CV2CoV delta or bivalent candidate combining -- with CV2CoV delta or the CV2CoV beta/delta candidate. Neutralizing antibody titers were 3 to 9x lower against the Omicron variant than against the Delta variant for all candidates, except for the bivalent CV2CoV beta/delta candidate. Including beta messenger RNA resulted in a twofold increase of neutralizing antibody titers against Omicron compared to Delta. Taken together, the preclinical study confirms the capacity of our second-generation messenger RNA backbone to encode and to flexible elicit strong immune responses against different COVID-19 variants. Furthermore, we were able to extend the technology applied to our multivalent influenza candidate in our COVID-19 vaccine program. Data for bivalent beta/delta candidate suggest that combining messenger RNA for variants with unrelated lineages may increase the overall breadth of the new response and thus induce heterologous protection. I'm now moving on to Slide 12 to update you on our strategy in oncology, the next growth driver we are rapidly advancing beyond our progress in prophylactic vaccines. Expanding our oncology footprint is based on mastering similar medical challenges as in infectious businesses, mainly selection of antigens and adoption of strong and targeted immune responses. However, cancer is a complex and individual disease, and antigens vary greatly between patients. To address these challenges, we plan to execute on 3 strategic pillars: apply our learning, particularly from the second-generation messenger RNA backbone to validate and optimize our technology for different classes of antigens and a focus on strong T cell-mediated immune responses. And in the second pillar, build a meaningful pipeline of new cancer vaccine candidates based on assessing novel classes of antigen, leveraging the agility of speed of the RNA Printer, our modular solution for integrated and automated manufacturing of GMP-grade messenger RNA vaccine and therapeutics. Finally, at highly complementary technology platforms to expand our expertise for efficient antigen discovery as well as new avenues for immunostimulation and vaccine design, including formulation. With this, let me hand the call back to Franz. Franz-Werner Haas: Thank you, Klaus. I'm now on Slide 13 to update you on the latest advances in the RNA Printer. As Klaus already mentioned, this system is expected to play an important role in the planned expansion of our oncology pipeline. However, the scope of the RNA Printer goes much further. In March this year, we established a fully owned CureVac subsidiary to accelerate the development of the RNA Printer under the leadership of Markus Backman, a seasoned manager in the high-tech field and a physician by training, a perfect match. The dedicated operational infrastructure will unlock the broad scope of the system as a product-enabling platform for academic and commercial partners, but also essentially for our CureVac's own proprietary technology. It is designed to facilitate broad access to mRNA for the rapid translation of science into products. Design for flexible smaller-scale quantities, the RNA printer is expected to accelerate clinical developments and open new avenues for point-of-need pandemic preparedness as well as personalized mRNA-based cancer vaccines and therapies. As the system is currently in regulatory review, the next near-term catalysts expected this year are the GMP certification, followed by a manufacturing license to produce first clinical trial material for the CureVac pipeline. I'm now on Slide 14 to give you an overview of the pandemic preparedness tender. We were recently happy to be awarded by the German government, together with GSK, to strengthen the national resilience for current COVID-19 pandemic as well as future infectious disease outbreaks. The German tender seeks to secure manufacturing capacity in Germany as well as access to high volumes of pandemic vaccines to mitigate risks associated with potentially supply challenges in public health emergency. Correspondingly, the contracts concluded with 5 different companies and consortia, differentiate between the contribution as a sole manufacturer and as a so-called originator for the additional supply of 80 million dosages of a pandemic vaccine needed in the case. Out of the 5 consortia, the CureVac/GSK consortium is 1 of only 2 originators. In this role, we plan to provide manufacturing capacity at our Germany-based industrial scale manufacturing facility GMP IV, here in Tübingen, currently in an advanced stage of construction. For the vaccine part of the contract, regulatory validation of our second-generation mRNA backbone will provide the basis for the rapid provision of pandemic vaccines developed by us and GSK. We plan to prepare both deliverables within the now ongoing 2-year setup period starting right now. Under the contract, the German government will pay CureVac and GSK an annual standby fee to maintain manufacturing capacity at constant readiness. Upon delivery of the then asked for 80 million dosages, payment per dose would be added. We appreciate the strong commitment of the German government, acknowledging our ability to protect and support public health now and in the future based on new technologies, in our case, the mRNA technology. Now let me hand over to Pierre for a review of the financial data. Pierre Kemula: Thank you, Franz, and good morning and good afternoon to everyone on the call. Looking at our cash position, we closed the fourth quarter and full year 2021 with a strong cash position of €811.5 million. In 2021, cash inflows were mainly provided by the raising of €404 million in net proceeds in the follow-on offering in Q1 of 2021, a €75 million upfront payment in Q2 2021 related to our COVID-19 collaboration extension with GSK, and an overall €93.5 million grants received from the German Federal Ministry of Education and Research. In 2021, cash used in operation was mainly allocated to the advancements of R&D activities and preparing the supply for CVnCoV, our first-generation COVID-19 vaccine candidates, which we withdrew from the regulatory approval process in October 2021. Moving to our P&L statement. Revenues increased by €35.2 million to €41.2 million for the fourth quarter of 2021, an increase by €54.1 million to €103 million for the full year of 2021 compared to the same periods in 2020. The increase was primarily driven by revenues from our GSK collaborations and the termination of the Boehringer Ingelheim collaboration agreement. So GSK collaborations provided a total of €74.3 million for the full year 2021 compared to €8.8 million in 2020. Following the termination of the Boehringer Ingelheim agreement, the remaining contract liability related to the upfront payment was fully recognized. In addition, an option fee of €5 million and a €7 million development milestone were also recognized. For the full year 2021, this led to a total €26 million being recognized as revenue stemming from the Boehringer Ingelheim collaboration compared to €1.9 million in the full year 2020. Operating loss was €5.5 million for the fourth quarter of 2021, representing a €41.1 million decrease compared to the fourth quarter of 2020. For the 12 months ended December 31, 2021, operating loss increased by €302.5 million to a total of €412.3 million. As underlined previously, this increase was mainly driven by the R&D activities and preparing for supply for CVnCoV through 2021. The operating result was affected by several key drivers. Cost of sales increased primarily due to the recognition of expenses related to the CMO setup activities and to a lesser extent, write-offs related to inventory in the period preceding the withdrawal of the EMA application for CVnCoV. R&D expenses increased primarily due to significantly higher development expenses related to the Phase IIb/III related trials for CVnCoV with 45,000 subjects. These expenses were mainly composed of costs incurred to CROs, an onerous contract provision for the remaining CVnCoV clinical trial costs and personnel costs involved in the remaining CVnCoV development efforts. In addition, the increase was also driven by the recognition of settlement costs related to the termination of several CMO contracts and write-off of CVnCoV-related prepayments and inventory. G&A expenses increased due to the consulting services for CVnCoV product launch readiness, personnel-related costs with increased headcount and higher expense recognized on share-based payment awards made in 2021. Overall, the increase in expenses was partially compensated by income related to release of government contract liabilities related to the upfront payment from the European Commission and the grant by the German Federal Ministry of Education and Research. The advance purchase agreements with the European Commission automatically terminated when we withdraw CVnCoV from the regulatory approval process in October 2021. Since we were able to demonstrate that upfront payment was spent in accordance with the contract, no repayment was required and the amount of €450 million was released and recognized as income related to the release of governmental contract liabilities in the fourth quarter of 2021. The arrangement with the federal -- German Federal Ministry of Education and Research consisted of a separate ground component and a supply component with the German Federal Ministry of Health. The amount attributed to the supply of future deliveries was presented in contract liabilities in the balance sheet. €124 million were recognized as income related to the release of governmental contract liabilities in the P&L. €67.7 million were recognized in other income, mainly driven by the grant components. Financial results for the fourth quarter increased by €11.6 million to €1 million and increased €19.8 million to minus €0.2 million over the 12 months of 2021. Net loss was based on negative interest on cash held in liquid funds to support the development and manufacturing activities of CVnCoV and CV2CoV. It was almost fully offset by foreign exchange gains. Pretax losses were €4.5 million in the fourth quarter and €412.5 million in the full year 2021. With this, I would like to hand back to Franz for today's key messages. Franz-Werner Haas: Thank you, Pierre. Let me quickly summarize the key takeaways from today's presentation. First, over the last several months, we have made significant progress in each of our core competencies, including technology, product pipeline and manufacturing, propelling us forward in our corporate development. Second, our competitive positioning in these 3 core competencies is built on one of the largest and most diverse IP portfolios in the industry, enabling our future ability to innovate and securing our competitive position as a central RNA player. Third, a total of our 4 clinical trials that we will have begun in prophylactic vaccines this year in COVID-19 and influenza, 2 of which have already been initiated, will provide a wealth of clinical data to advance and validate our second-generation mRNA backbone covering multivalent and modified mRNA approaches. Fourth, we are transferring our experience from our technology advances to our next-generation driver, oncology, where we are preparing to build up a meaningful pipeline based on strategies for strong T cell induction, novel antigens and complementary platform technologies supported by the RNA Printer. Fifth, the recent award of the pandemic preparedness tender by the German government signals the strong confidence in our ability to contribute our technology and manufacturing expertise to protect public health. And lastly, our strong cash balance positions us well to execute on our programs and priorities in 2022 and beyond. With this, we conclude our presentation, and I would like now to open the webcast to your questions. Thank you. Operator: . Our first question comes from the line of Roy Buchanan with JMP Securities. Douglas Buchanan: So I'll ask a couple and jump back in the queue. I guess the first set of questions for Pierre. I guess can you break out the expense items for 4Q COGS, R&D and SG&A? Were there any onetime items of note? And then can you kind of give us a sense of the expense outlook for the rest of this year? And then more generally, how far do you think the current cash can get you from here? What's the most likely source of cash? Is it the ATM facility for the rest of the year? And I'll follow up. Pierre Kemula: Thanks for your question. So yes, I mean of course -- the last quarter was, of course, impacted by significant impacts, and the main one being the recognition of the revenue from government grants, right, where we have recognized in the P&L -- contract liabilities, which was sitting in the balance sheet for €450 million and another extra €120-something million, right, from the German government. So this is, I would say, the main element. Other elements, of course, is as we have built the CMO network, and we are now reducing the size, of course, as the wave of initial CVnCoV is, of course, lower, we will -- we have closed some of the contracts and we have some provisions, of course, in the P&L in terms of turning down -- readapting the size of the CMO network, right? So these will be the one-off elements. Now looking forward, right, so we will have -- we had in Q4 and we will have in Q1 some exceptional elements, basically attached to the fact that we are reducing the CMO network. And you will see that the whole thing stabilize out of exceptional effects from Q2 onwards. This is what we are seeing, right? So I mean long story short, we have a solid cash position, and we think that we have no problem in terms of having close to 2 years of cash ahead of us. So that's the first point. Now in terms of sources of revenues, I think -- you're right, we have an ATM. We have $600 million ATM that we haven't used. That could be one source of -- of course, of cash as we look forward. But I mean there's no immediate need at this stage. Douglas Buchanan: Okay. Great. And then I have a follow-up on the pipeline. I guess so you talked about plans for a meaningful pipeline of cancer vaccines. How many new candidates or targets do you think might be announced this year? Or is that more of a 2023? And then any data we might expect for those new programs this year? Klaus Edvardsen: Yes. As you can rightly see, we did not disclose any of our current candidates. What I can say is it's a broad-based approach with some shared antigens that we will use for cancer vaccination and then some new antigens. What we are especially emphasizing on is to expand on our possibility to internally have a platform where we can identify new antigens with an aim of eventually moving into a personalized vaccine. I am confident that we will be in a position to share some preliminary data towards the end of the year, but you should look more into 2023. Operator: Our next question comes from the line of Eun Yang with Jefferies. Eun Yang: Question on cancer vaccine. So you mentioned the Phase I expansion study data in melanoma is expected in the second half of this year. Can you comment on what should we expect in terms of data and 8102? Is that only for melanoma at this point? And second question is on COVID vaccine. You recently dosed the first patient and then the data is expected in the second half of this year. So what kind of a data should we expect in second half of this year? Klaus Edvardsen: I can start with the last on the COVID vaccine. As you rightly said, yes, we initiated that first Phase I COVID trial. And as we have indicated, we are recruiting off the dose level as planned. So you would obviously, at a later time point, see the reactogenicity data first and foremost when we have done our dose escalation. And then eventually, you would also see the immunogenicity data. The exact timing of it, I cannot give you at this stage, but it will certainly be towards -- later in the summer period. On the cancer thing, as I alluded to, for the new platform that we are looking into, it's a base of shared antigens, meaning that they are known and to validate our backbone in a cancer vaccination strategy but also new antigens that the clinician office will be new. On the 8102, as we have alluded to here, we decided only to expand into the melanoma indication. Recruitment has been completed. And obviously, we are now just awaiting the data to see whether we can achieve and enhance the response rate in combination with 8102 and a checkpoint inhibitor. That will be towards the end of this year. Eun Yang: So can I ask you just one more question on COVID-19 vaccine? So are we going to see all the doses from 2 to 20-microgram in mid this year or second half of this year? Klaus Edvardsen: That's the plan obviously provided that we can dose up to those levels. We obviously gave you a lengthy presentation of the reactogenicity data in the seasonal flu, although you can clearly not make a direct comparison. But as you saw, we were capable of dosing it up in this case for a multivalent vaccine for 28 microgram. So expectations are that we can dose it up to the stipulated dose, and that those data at least for reactogenicity profile will be available towards the end of the summer. Franz-Werner Haas: Perhaps to give you an insight -- perhaps to give you an impression that in flu, for example, we already dosed up to 28 microgram. Of course, exactly as Klaus is saying, one should not compare flu with COVID as antigen. But -- in flu, there are different kind of strains composed with it. But here, we could see even with the nonmodified that we could go up to the target of 28 microgram. Operator: Our next question comes from the line of Umer Raffat with Evercore. Unidentified Analyst: This is Jessica on for Umer Raffat. Two questions on your flu program. Firstly, interestingly, in your Phase I disclosures, we saw grade-3 systemic events in the lowest dose. And also, this was in older adults. Can you hypothesize why the lowest dose saw Grade 3 events, but not in the highest dose. And then secondly, another competitor flu mRNA vaccine has shown less promising results against the influenza B strains. So what are your expectations on how this might affect your flu construct and trial? And are the antigen ratios between the 4 flu strains like all 1:1? And then lastly, very briefly, what is the timeline we should expect for the flu program? And when should we expect a full data readout? Klaus Edvardsen: Yes, the full data readout, I think I have alluded to on a number of occasions, especially on the reactogenicity data. It is a 1:1 for all of the constructs that is in the 1 vaccine at this stage, not disclosed exactly the number of constructs and the valency of the vaccine. But to answer about that relative contribution, yes, 1:1. I mean it's too early for me to speculate because I can obviously not predict what I will see from an immunogenicity perspective before I have the data. But if I look to what we have achieved with our second-generation backbone, and that was the whole idea about initiating the Phase I program and the first place unmodified and then at a later time point, moving to a modified chart, was to test out our second-generation backbone. And as you can see from the data that we have presented today, that mission has been successful. We are capable of seeing a higher antigen production per, if you wish, amount injected messenger, and we are certainly also seeing a reactogenicity profile that is different from what we were seeing in the -- with the first-generation platform. Operator: Our next question comes from the line of Zhiqiang Shu with Berenberg. Zhiqiang Shu: Congrats on the progress. And maybe on the COVID-19 vaccine, on Slide 11, I think you showed some preclinical results on a multivalent vaccine in the mouse model. I'm still looking at the beta/delta bivalent against Delta versus Omicron is actually more immunogenic against the Omicron than Delta. Why is that? Any hypothesis in terms of the scientific that what's happening there? And then broadly on the COVID front, I want to get your thoughts around how you want to go about the developing Omicron monovalent vaccine versus potentially bivalent or multivalent vaccine going forward? Klaus Edvardsen: I mean on the mice data that you referred to, it's pure speculation. At this time point, I think what I would extract out of it is that there is a likelihood that the prudency of having a vaccine that contains the beta strain would be more efficient against the Omicron compared to the Delta, which is obviously how the virus has evolved its spike protein. But beyond that, I do not have any further comments to why you see that difference. I think the take-home message for the story is obviously that we are -- indicating that we are speculating about how do we approach the COVID-19 moving forward. Is it an Omicron alone or is it a bivalent or is it something completely different? And you should take those data here as a reflection that we believe that we have a backbone where we can now explore these options together with our partner, the GSK. The way we want to go from a development perspective against Omicron has been finally decided and we also see the data which modified the construct against the Omicron variant. And then the ultimately regulatory aim would be to obtain an approval as an Omicron booster. Then your next question would likely be what are the timelines for that? And that I will not speculate on at this stage. It primarily depends on, obviously, the outcome of the trials that are running now or about to start, and then of the whole regulatory setting as to whether you can find -- any ideas with regulators that this is still under an emergency procedure. Those interactions are ongoing, but will obviously have to be ongoing up on to the point where you start to patent them. Franz-Werner Haas: I may add to this one. You have to see because the question was also Omicron monovalent or bivalent or -- so these are the differences what we tried to say in the presentation there as well. We have to work on the different, let's say, levels as well. The one is the technology that you can have monovalent, bivalent or even what we're doing in flu, multivalent, because we don't know what -- later this year, what the variant will be and exactly what Klaus alluded to was that most probably in a bivalent setting, it will have an effect on then whatever the variant will be, the biology will tell us at the end of the day. But therefore, on the technology level, the second-generation backbone, what we are developing, maybe without chemical modification or with chemical modification, monovalent, bivalent or multivalent. So we really have to work on all ends of the technology and then to get the best product whatever is needed. And this idea together with the manufacturing then is also the underlying basis for the German tender to say, okay, this all now started. The world most probably cannot cover with a new kind of pandemic outbreak than what we have been experienced in the last 24 months. And therefore, it is so important to look in every corner on the technology level to then have on the product level, whatever is needed in order to be ready for that. So that's exactly the story behind next to, is it Omicron or whatever kind of variant to come. Zhiqiang Shu: Great. Just a follow-up on the German government contract or tender contract there. For the 80 million doses, is that just the COVID or does it specify any virus types? It could be other flu or other things. Can you clarify that? Pierre Kemula: It's , right? It's the whole -- it is the learnings from the current situation in the pandemic situation where the government wants to have access to -- as fast as possible to vaccine. So it could be any, I would say, flu or COVID-19 or anything else for that matter. Franz-Werner Haas: And therefore, it is so important that there are the 2 who did win this tender, which originators, who are working on both ends, on the one side, the truck development for whatever it is for the next 5 years to come after the starting period and then also to have the manufacturing capacity ready. Operator: Our next question is a follow-up from Roy Buchanan with JMP Securities. Douglas Buchanan: I have quite a few, sorry. So the first one, sorry if I missed it, but the unmodified flu Phase I that's completed enrollment, can we expect to see the immunogenicity data this quarter? Are you holding that until the data from the modified RNA trial is available? And I had a broader question on the modified RNA. What benchmarks or expectations do you have for that versus the unmodified form? And do you think that the modified mRNA program can be in the clinic in 3Q? Klaus Edvardsen: We are not planning to -- eventually, we are obviously planning to release the immunogenicity data. But as I also alluded to, we go together with GSK, assess whether we can get all the way with unmodified or whether we will have to implement modified. The ultimate answer to your question about what is the benchmark going to be is obviously that we will have to receive titers that competitors have received. So that's the ultimate guidance here. Can that be achieved with the unmodified? That remains to be seen, and the decision will then be taken thereafter. Douglas Buchanan: Okay. Great. And then you said you had clinical trial material for the modified candidates already produced. I guess maybe this gets back here the entry just made. But are you planning to move forward with a single modification? Are you going to try multiple modifications? How does that look at this point? Klaus Edvardsen: I'm not sure that we have disclosed that. I will have to let Franz or someone else address that question. Douglas Buchanan: Sorry, I have a couple more, but with GSK stepping away from their self-amplifying RNA programs based on their earnings call. Can you just verify that this was totally unrelated to CureVac, you had no involvement with the self-amplifying mRNA -- RNA, sorry? Klaus Edvardsen: I can confirm that we have no involvement on GSK's position on GSK program. Franz-Werner Haas: We are working on our technology platform with GSK. And what we want to bring into the clinics here is really the same construct on the RNA level than with the chemical modification known to start the clinical trial there as well to really see the difference, what does it do, this chemical modification. Douglas Buchanan: I see. Great. Okay. And then -- sorry, one last question. But any updates on the Genmab collaboration? Franz-Werner Haas: No, nothing what we can right now talk about. We -- it's an ongoing collaboration. We are working on our work packages as defined with our partner, Genmab, but nothing to report so far. Operator: Ladies and gentlemen, we have reached the end of the question-and-answer session. I will now turn the call over to Sarah Fakih for closing remarks. Sarah Fakih: With this, we would like to conclude this conference call. Thank you all very much for your participation. Please stay safe and don't hesitate to contact us should you have any further questions. Thank you, and goodbye. Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.CVAC Ratings Summary
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CureVac Review, Focusing on 2nd-Gen COVID Vaccine
Analysts at Berenberg Bank provided their outlook on CureVac N.V. (NASDAQ:CVAC), mentioning that they believe the withdrawal of first-generation CVnCoV from the approval process effectively removes an overhang from the stock.
According to the analysts, they like the potential of the GlaxoSmithKline (GSK) partnered second-generation COVID-19 vaccine (CV2CoV) and believe it has the potential to capture what they expect will be an active booster market given the virus likely continues to mutate; the emergence of the omicron variant being a prime example of this.
