Q3 2023 CureVac NV Earnings Call
Participants
Alexander Zehnder; CEO, MD & Member of Management Board; CureVac N.V.
Marcus Dalton
Myriam Mendila; Chief Development Officer, MD & Member of the Management Board; CureVac N.V.
Pierre Kemula; MD, CFO & Member of Management Board; CureVac N.V.
Sarah Fakih; VP Corporate Communications & IR; CureVac N.V.
Boran Wang; Associate; Guggenheim Securities, LLC, Research Division
Chen Yuan Yang; Research Analyst; BofA Securities, Research Division
Eliana Rachel Merle; Analyst; UBS Investment Bank, Research Division
Eun Kyung Yang; MD & Senior Equity Research Analyst; Jefferies LLC, Research Division
Presentation
Operator
Greetings, and welcome to the CureVac Financial Results for Third Quarter and First 9 Months of 2023 business update. (Operator Instructions) 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, Sarah, 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 from CureVac are Alexander Zehnder, Chief Executive Officer of CureVac; Myriam Mendila, our Chief Development Officer; and Pierre Kemula, Chief Financial Officer of CureVac. Our Head of Intellectual Property, Marcus Dalton will be present for the Q&A session. Please note that this call is being webcast live and will be archived on 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 view as of today, Tuesday, November 14, 2023. 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 intentional 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.
Alexander Zehnder
Thank you, Sarah. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. As another year of strong performance [trails] to a close, we continue to successfully maintain our forward momentum in the clinical development programs in infectious diseases as well as in oncology, and we are delivering on our strategic priorities. Our lead programs in COVID-19 and seasonal flu jointly developed with GSK are now in Phase II and we are on track for delivering interim top line data in 2024. The Phase II COVID-19 study recently completed enrollment, and we expect interim data early next year.
In the Phase II part of the combined Phase I/II study for seasonal flu, the first participant was dosed, and we expect interim Phase II data in the first half of 2024. In oncology, our Phase I study in patients with resected glioblastoma is advancing and has recently progressed to the opening of the third dose level in the initial dose escalation part of the study, and we continue to expect data in the second half of 2024. Supported this Phase I study with promising data for a preclinical study that we presented at the beginning of this month at the 11th mRNA Health Conference, which CureVac hosted in Berlin and which is a global flagship mRNA R&D event.
Also supporting our oncology strategy is the mRNA Printer, CureVac's end-to-end solution for integrated and automated manufacturing of GMP-grade vaccines and therapeutics. The Printer achieved an initial regulatory milestone by obtaining its first manufacturing license for an mRNA cancer vaccine candidate. The regulatory review process is ongoing to provide greater freedom and flexibility to manufacture different mRNA cancer vaccine candidates. Considering our cash runway, our efforts in advancing our clinical development programs continue to be supported by prudent fiscal discipline. Our cash position of $464.1 million at the end of the third quarter provides a solid basis to continue to execute on our programs and priorities till mid-2025.
As the pioneering company in mRNA technology, having maintained a traditional scientific leadership for more than two decades, CureVac continues to defend a broad and diversified intellectual property portfolio. Our litigation against Pfizer and BioNTech in Germany and the U.S. has progressed with favorable developments in the German court and the provision of a trial date in the U.S. on October 1, 2024. Please let me remind you that in an industry where innovation is a key driver of value that disputes are commonplace. In our currently pending cases, our interest is solely in having our intellectual property rights acknowledged and fairly compensated so that all parties can continue advancing new transformative mRNA-based medicines.
On slide 5, we showed a CureVac product development pipeline, which forms the core of our business strategy. The pipeline leverages our unique platform in three therapeutic areas of prophylactic vaccines, oncology and molecular therapy. In our most advanced area, prophylactic vaccines, we have two programs in Phase II, which are driven by our clinically validated technology platform and proprietary second-generation mRNA backbone. Phase II COVID-19 and seasonal flu vaccine candidates are developed in collaboration with GSK. Two Phase I studies we started last year have successfully evolved into two current Phase II studies, which are testing updated candidates.
We continue to translate the insight from our clinical infectious disease study into our oncology area as well. Our proof-of-concept Phase I trial in patients with resected glioblastoma is well on track, as previously mentioned. Combined with our highly differentiated capabilities in tumor antigen discovery, the study will be an important basis to further optimize our mRNA backbone to provide differentiated clinical cancer vaccines. The third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics, together with several collaboration partners which are intended to enable the expression of therapeutic proteins (inaudible) rare metabolic diseases. And we are continuously investing in our development pipeline to advance innovation and healthcare solutions for people and patients.
With this, let me hand over to Myriam for an update on our clinical development programs.
Myriam Mendila
Thank you, Alexander. I'm now on slide 6 to give you an overview of our two most advanced clinical vaccine development programs in COVID-19 and seasonal flu jointly being developed with GSK. As Alexander already mentioned, we recently reported solid progress in those programs with the completion of enrollment in the ongoing COVID-19 Phase II study and dosing of the first participant in the Phase II part of the combined Phase I/II study in seasonal flu. In the Phase II COVID-19 study shown on the left-hand side of the slide, we assess the safety and immunogenicity of different single booster doses of two vaccine candidates based on our proprietary second-generation mRNA backbone.
The first candidate, CV0601 is a modified monovalent construct encoding the Omicron BA.4-5 variant. The second candidate, CV0701 is a modified bivalent contract encoding the Omnicom BA.4-5 variant as well as the original SARS-CoV-2 strain. According to the applicable and available standard of care when the first participant of the Phase II COVID-19 study was dosed in early August 2023 the study absorbs a licensed bivalent mRNA vaccine as a comparator. We expect interim Phase III data early next year, which will inform the design of a pivotal Phase III study planned to start in 2024. Following the September update of the COVID-19 standard of care in the U.S., the planned Phase III study is expected to feature an updated vaccine candidate and updated comparator has been according to the latest requirements.
The Phase I/II study for seasonal flu is shown on the right-hand side of the slide. In this study, we are assessing the safety, reactogenicity and immunogenicity of flu vaccine candidate compared to a licensed comparator vaccine. The Phase I dose escalation part has already completed initial data analysis. (inaudible) comprehensive series of multivalent modified seasonal flu candidate with up to 8 mRNA construct per candidate at different dose levels in 270 younger adults. Interim Phase I safety data showed no safety concerns across all (inaudible). The observed antibody responses to process the selection of a preferred vaccine candidate, which has now been advanced to the Phase II part of the study.
The potentially differentiated multivalent candidates and (inaudible) antigens that address all four (inaudible). It will be tested in both healthy younger and older adults at different dose levels and will be compared to two different licensed seasonal flu comparator vaccines with intended use for the respective age group. Interim data from this Phase II part are expected in the first half of 2024. Let us take a closer look at the study design of the two ongoing Phase II studies in COVID-19 and seasonal flu on slide 7. While we don't disclose the expected dose levels for both studies, the COVID-19 Phase II study features a medium dose, framed by a higher and a lower dose for the bivalent candidate CV0701 and a medium dose level for the monovalent candidate CV0601.
All dose levels, including the licensed bivalent mRNA comparator vaccine are fully recruited with a total of 427 participants aged 18 years and older. For seasonal flu, the selected multivalent candidate is being tested in two separate age groups, 480 younger adults aged 18 to 64 and 480 older adults aged 65 to 85. Each age group features three different dose levels of the candidate as well as the age appropriate license comparator vaccine. With this, let me now shift gears and turn to our development progress in the oncology area. On slide 8, I would like to provide a more detailed overview of the ongoing Phase I study we are currently conducting in patients with surgically resected MGMT-unmethylated glioblastoma.
On the left-hand side of the slide, you can see the schematic setup of the applied cancer vaccine candidate CVGBM with a focus on its coding region. The candidate is based on our advanced second-generation mRNA backbone and features a single unmodified mRNA stream. And in code 8 epitope derived from tumor-associated antigen which demonstrate immunogenicity in glioblastoma. The exact nature of the epitope is not being disclosed. However, you can see that CVGBM and code 5 [NHANHC+1] epitope and [3 NHC+2] epitope. NHC complexes of both classes are expressed on [immune] and other cells antigens, including tumor antigens to initiate CD8 and CD4 T cell responses against those antigens.
CVGBM utilizes this concept to activate CD8 and CD4 T cells for optimal antitumor response. We clinically assess the vaccine design and the open-label Phase I study, which is described in more detail on the right-hand side of the slide. The study evaluates the safety and vulnerability of CVGBM in two parts. The currently ongoing dose escalation Part A is expected to enroll up to 24 patients and a subsequent dose expansion Part B will include approximately 20 patients. In the dose escalation part, four core dose levels between 12 and 100 micrograms are being tested.
The first three dose levels have successfully been opened and recruitment is progressing well without dose limiting toxicities of (inaudible) to-date. The trial is being conducted in Germany, Belgium and the Netherlands. Our first data readout is expected in the second half of 2024. In this context, on slide 9, I would like to highlight the results of a preclinical study that was we presented two weeks ago at the 11th International mRNA Health Conference hosted by CureVac at Berlin. We conducted this extensive study in mice to assess the potential of the multi-epitope mRNA design we applied for our clinical candidate CVGBM. The study assessed a multi-epitope mRNA design and encoding 10 separate cancer antigen epitope derived from the B16.F10 melanoma cell line, a well-known melanoma cancer model in mice.
Similar to glioblastoma, the B16.F10 melanoma grows very aggressively due to an immune suppressive tumor microenvironment. The result in tumors are purely hemogenic so-called co-tumors, which are cytokine deficient and exhibit only very little T cell infiltration. Accordingly, the tumor model is known to be resistant to checkpoint inhibitors and cannot be addressed with the PD-1 blocking antibody monotherapy. We are, therefore, all the more pleased that the immunogentic data obtained on day 21, illustrated on the left side of the slide demonstrates prominent induction of CD8 T cell responses against 5 and CD3 T cell responses against two of the encoded epitope.
In B16.F10 tumor bearing mice, the successful induction of solid T cell responses against the superantigen led to a significantly expanded medium survival by approximately 50% for treated mice compared to mice vaccinated with the formulated controlled mRNA. In the pre-clinical data such as the monotherapy regimen with our multi-epitope mRNA construct was aiming to efficiently recruit T cells to the challenging tumor microenvironment thereby exhibiting tumor growth and extending (inaudible).
With this, let me hand back the call to Alexander.
Alexander Zehnder
Thank you, Myriam. To finalize our oncology update, the RNA Printer, our highly automated solution for GMP-grade manufacturing of cancer vaccines has achieved its first regulatory milestone. The Printer obtained its first manufacturing license for a defined mRNA construct to support our oncology strategy. The first license was granted for the manufacturing of the therapeutic mRNA by the DNA and mRNA modules of the Printer. Subject to ongoing regulatory review, we aim to license to be extended to a framework license, which will allow the flexible manufacturing of different mRNA construct based on the established processes.
In 2024, our goal is to further expand this approach and also include the formulation module of the printer to complete the end-to-end capabilities of the system. Let me now address on the next few slides, a topic that has gained attention in 2023, mainly our broad and diversified intellectual property portfolio. Over the next few slides, I would like to address the background of the ongoing legal action in Germany and the U.S. by laying out the intellectual property rights in both jurisdictions, the innovations they referred to, the responsible courts as well as timelines and upcoming milestones. So let's start by looking at Germany, where the process is generally more complex compared to the U.S.
On the left side of slide 11, you can see that there are a total of 8 intellectual property rights and issue in Germany, which can be divided into 3 patents and 5 utility models. Utility models don't have an equivalent in the U.S. but are available in different countries, including Germany. They represent a class of intellectual property rights, which unlike a patent is not subject to an examination and therefore, does not have an initial perception of validity. Correspondingly, the utility model is registered rather than granted. However, utility models are much faster to obtain than patents. They offer the same protection as patents, but their term is limited to 10 years.
Point to damages if validities confirmed in associated proceedings will be awarded in the same way as for a patent. Patent protection normally evolves alongside a multi-year product development. In the case of COVID-19, we chose to file utility models as speed was critical to protect our innovations in the unprecedented dynamic mRNA field generated by the pandemic. On the right-hand side of the slide, the 8 IP rights are sorted by patent family. The first two patent families cover foundational inventions to improve mRNA stability for medical use. This includes enrichment of the G/C content of the mRNA molecule and the implementation of a split Poly-A tail.
The third patent family covers inventions that were specific to the development of prophylactic vaccines against SARS-CoV-2. Under German law, the courts that determine IP infringement are separate from the authorities that decide on IP validity. This means infringement and validity cases often proceed in parallel with damages assessed only when infringement and validity have been established. On slide 12, you can see a schematic of this bifurcated German process. The upper stream represents the infringement proceedings that will lead to a subsequent damages trial. For our IP dispute, infringement as well as potential damages related to all 8 IP rights is initially decided by the regional court in Dusseldorf.
The lower stream represents validity proceedings. Validity of our IP rights is heard by different authorities depending on the nature of the IP rights. This includes the European patent office or split poly-A tail patents, the German Federal Patent Court for the G/C Enrichment Patent and the German Patent and Trademark Office for all five utility models. I would like to draw your attention to the fact that this 2-stream setup applies to each of the 8 IP rights issued in Germany. Each right is handled as a separate case for which infringement, validity and potential damages will be decided separately. So this provides us with multiple opportunities in our German proceedings to have some aspect of our intellectual property rights acknowledged and fairly compensated.
On slide 13, you can see a timeline overview of the infringement as well as validity proceedings in terms of the past as well as upcoming milestones in 2023 and 2024. The part above the timeline references infringement milestones, the part below validity milestones. Looking at the validity proceedings on the bottom part of the slide, you can see that on April 6, 2023, the German Federal Patent Court issued a positive preliminary opinion on the G/C Enrichment Patent supporting its validity. At the same time, the court set an oral hearing for December 19, '23, where we expect the ruling on the validity of the patent. Looking at infringement, proceedings at the top part of the slide are public hearing on the first 5 IP rights took place on August 15, '23 before the original court in Dusseldorf.
At this hearing, the court announced that on December 28, '23, a ruling on infringement of the G/C Enrichment Patent will be given. This means that the G/C Enrichment Patent will be the first IP right for which both validity and infringement are decided and that December 23 will be the first major milestones in our German litigation. For the remaining 4 rights under consideration from the August 15 hearing, infringement proceedings continued until September 28, when the court in Dusseldorf postponed an infringement ruling on those remaining 4 rights until their validity challenges have been resolved by the respective authorities.
Now let me explain why we consider this postponement a favorable outcome for CureVac. German infringement courts typically delay their proceedings to wait for a decision on validity only in cases where they consider that the challenged intellectual property right to be infringed. Therefore, it can be inferred that the regional court in Dusseldorf considers all 4 intellectual property rights infringed. The court noted that the questions of validity is still needed to be determined. Accordingly, it decided to postpone the infringement proceedings until the validity of these 4 IP rights has been assessed. This postponement does not reflect the preliminary assessment by the Dusseldorf Court of Validity.
Validity can only be determined by authorities that are technically qualified and specialized in validity cases. Moving on to the litigation in the U.S., again, on the left-hand side of slide 14, you can see that there is a total of 10 U.S. patents currently at issue. These patents cluster into families, which mostly relate to the same innovations already discussed for the German litigation, namely the stabilization of mRNA via G/C Enrichment, the implementation of a split poly-A tail as well as the design of SARS-CoV-2 specific vaccines. An additional patent family added in the U.S. relates to the innovation of filtration based MRNA purification methods, which forms a critical part of the overall mRNA manufacturing process.
Looking at the litigation timelines and milestones in the U.S. on slide 15; the picture is more straightforward and a lot less complex compared to Germany. For a start, all proceedings, including validity infringement and potential damages are public and heard by the same court. Also, all three proceedings will be decided in one trial, and this trial will cover all 10 patents. Therefore, there is no differentiation between proceedings featured in this timeline overview. As a brief reminder, the U.S. litigation was initiated with a declarative judgment action filed by Pfizer and BioNTech in July 2022 and the federal district court of Massachusetts, seeking confirmation that COVID-19 does not infringe (inaudible) patents.
In May '23, we successfully transferred the case to the U.S. District Court for the Eastern District of Virginia, followed by our counterclaim alleging infringement of six additional patents which were further extended by another patent in July '23 to result in the 10 overall patents being mitigated now. The District Court for the Eastern District of Virginia is well known to have one of the fastest trial [docs] in the U.S. Accordingly, a trial that has already been set for October 1, 2024. We remain confident in the strength of our IP portfolio and continue to make progress towards the recognition of our pioneering contributions to the development of COVID-19 mRNA vaccines.
With this, I would like to conclude the business update and hand over to Pierre for a review of the financial data.
Pierre Kemula
Thank you, Alexander. Good morning and good afternoon to everyone on the call. Looking at our cash position on slide 16; as already mentioned, we closed the third quarter and the first 9 months of 2023 with EUR 464.1 million. Cash used in operation was mainly allocated to R&D activities, expenditures for our GMP IV production facility and purchases of R&D material. I will underline in this presentation the significant one-off effects that took place in 2022 as a consequence of closing our first-generation vaccine assets in COVID-19. First, let us look at the revenues. Revenues increased by EUR 5.3 million to EUR 16.5 million in the third quarter and decreased by EUR 24.5 million to EUR 31.2 million in the first 9 months of 2023 compared to the same period in 2022.
The decrease over the first 9 months year-on-year was primarily driven by lower revenues from our two GSK collaboration agreements. Revenue from both collaboration decreased year-on-year and amounted to a total of EUR 28.7 million, the first 9 month of 2023 compared to EUR 52.7 million in the same period in 2022. The decrease was driven by two elements. First, the agreement of both companies to focus on larger indications; and second, a higher 2022 comparator base due to the recognition of the milestone related to the start of the flu Phase I clinical trial in Panama. Operating loss was EUR 54 million for the third quarter of 2023, representing a EUR 1.6 million increase compared to the same quarter of 2022.
The first 9 months of 2023, operating loss increased by EUR 58.3 million to EUR 186.2 million compared to the same period in 2022. Beyond the lower revenues, the operating result was affected by several key drivers. First, cost of sales decreased year-on-year, mainly as the impact of our first-generation COVID vaccine subsided. This resulted in lower write-off of raw materials in the first 9 months of 2023 as well as lower impact on costs related to the termination of CMO activities. Second, R&D expenses increased with higher investment in later-stage infectious disease and oncology development programs as well as strengthening the workforce.
The first 9 months of 2022, R&D expenses were positively impacted in the amount of EUR 36.8 million related to the reversal of an outstanding CRO provision as well as by a one-off net gain for a change in the contract termination provision, resulting primarily in GSK taking over from the company committed capacity at the CMO. Third, and still in first 9 months of 2022, other income was positively impacted by a one-off amounting to EUR 32.5 million for reimbursement of prepayments and production activity setup at the CMO. Financial results increased by EUR 0.6 million to a profit of EUR 5.4 million in the third quarter of 2023, an increase by EUR 5.2 million to a profit of EUR 12.7 million for the first 9 months of 2023 compared to the same period in 2022. They were mainly driven by interest income and cash investments. Pretax losses were EUR 48.7 million for the third quarter and EUR 173.5 million for the first 9 months of 2023.
With this, I would like to hand back the call to Alexander for the summary of today's key messages.
Alexander Zehnder
Thank you, Pierre. So let me summarize the key takeaways for today. We continue to deliver across our strategic priorities for 2023 by successfully advancing our clinical lead programs, both in infectious diseases as well as oncology. Our Phase II studies in COVID-19 and seasonal flu, which are being conducted in collaboration with GSK as well as our Phase I trial in glioblastoma are progressing well and according to plan.
And we expect to maintain our strong momentum in '24 with key clinical data readouts from all three studies as well as expected advancement to Phase III developments in infectious diseases. Together with the progress we have made in safeguarding our investment in innovation and our strong cash position of EUR 464.1 million we will support the execution of our priorities to mid-2025. This clinical progress underscores our strong commitment to introduce new healthcare solutions to the market.
And with this, I would like to conclude our presentation and we would now open the webcast for your questions.
Question and Answer Session
Operator
Thank you. (Operator Instructions) Our first question comes from the line of Evan Wang with Guggenheim.
Boran Wang
I have one and then another follow-up. Just firstly, with IP, a number of dates coming up related to the intellectual property. Maybe just seeing on the upcoming German ruling in December, where you had the preliminary opinion. Can you highlight the patent that December (inaudible) covers and how we should be thinking about how damages would be assessed, particularly given some of the patent life there? And then I have one follow-up.
Alexander Zehnder
I'm going to bring in Marcus Dalton, who's our Head of IP to the call. Marcus, I think there was a question on expectation for the December 28 proceedings and how potential damages would be accessed. Marcus, do you want to take that?
Marcus Dalton
Yeah, surely. The -- thanks for the question. The first thing that happens is the December 19 validity trial. If that is successful for us, we will get the infringement proceedings. Then as a practical matter, the assessment of damages is opened in Dusseldorf, where the calculation of the amount of sales, the doses and all the rest of it has to be assessed and then a reasonable royalty will be applied to that. So that will take place throughout '24.
Boran Wang
Great. And then one follow-up in terms of the vaccines and specially flu we've seen some reformulations by both Pfizer and Moderna, address some of the influenza B strains and improved tolerability. So just thinking as you guys are looking at your Phase II formulations now I guess, how confident are you that one of those Phase II formulations will be a go-forward formulation for a Phase III?
Alexander Zehnder
So question Myriam on flu, go ahead, Myriam.
Myriam Mendila
Yeah. I guess if I heard the question right, your question is how confident are we? And I think we say we are confident. We have tested different concepts in our Phase I study. We have tested different doses in the Phase I study. And from the data that we have seen, we have, I think, a reasonable level of confidence that the data from the Phase II will look strong, including immunogenicity and reactogenicity against A and B strains and that we can move forward to Phase III. I cannot give you a likelihood of success. But everybody is making, I think, great progress with mRNA vaccines in the flu space. And I am very confident that we have a very competitive and differentiated candidate.
Operator
Our next question comes from the line of Eli Merle with UBS.
Eliana Rachel Merle
Just another on IP. So just from the German Patent Court ruling on December 19, I guess, what are the implications of this, if at all, for the other court decisions in Germany for the other patents and utility models? And then just as you think about your IP landscape broadly, in terms of the different patents and patent estate, as we think about potential damages, are there certain patent families that you think would be more valuable versus others, if you were to prevail in winning the validity and infringement of those versus others just as we think to a potential learnings of economics if you were to prevail next year?
Alexander Zehnder
Yes. Thank you, Eli. So two kind of questions. One is implications of potential German ruling. And two, I think, more broader thinking, how we think about the strength of the different patent rights or patent families. Marcus, do you want to take that?
Marcus Dalton
Yeah. Thanks for the question. In reality, the impact of the German G/C, this is all about the G/C Enrichment Patent will not impact on either other jurisdictions or other patents, they will all be held on their merits. In relation to which ones are stronger than others. The only thing I think I can point you to is the dates of when things are granted. Normally, you can only collect royalty from the date of grant or in the case of the utility model, the date of registration. And so you'll see that the patents, you'll see from the slides that was presented earlier the patents issued [over a longer or] shorter period of time. And although there are some patents that were issued prior to the first sales of vaccine, there is -- some of the others would come a bit later, we would expect less to collect less from those.
Alexander Zehnder
Yeah. Thank you, Marcus. And maybe Eli just add to that, I think what we feel really good about is the breadth of our portfolio, right, with 8 rights in Germany and 10 in the U.S. And I think as I tried to outlined as part of my presentation, each one of these rights is assessed on an individual basis. So this gives us a lot of shots on goal to really make sure that our intellectual property rights, it's fairly valued and by bringing the basis for a fair compensation as well.
Operator
Our next question comes from the line of Eun Yang with Jefferies.
Eun Kyung Yang
I have one question on the IP and second question for Pierre on financials. So the European Patent 668 in one of your slides, Alexander, you mentioned, I think you showed at least the ruling on validity in the spring 2024. And I was under the assumption that preliminary opinion on the validity of 668 patent is expected sometime October and November this year. So could you give us an update on that on the preliminary opinion? And then second question for Pierre. So first patient dosing in the seasonal flu Phase II trial totaled EUR 15 million from GSK, is that booked in third quarter or is it going to be booked in the fourth quarter?
Alexander Zehnder
On IP, you're referring to the split poly-A tail patent. I think you are right. We are expecting normally a preliminary opinion around this time. Now we cannot exactly say when that's going to happen because this is going to be fully up to the relative authority that assesses this. So it hasn't happened yet, but might happen soon. But we have not received yet, but it's pending. And then Pierre on the milestone trigger from the GSK collaboration.
Pierre Kemula
Sure. So thanks for the question, Eun. I think you were referring to sort of EUR 15 million milestone related to the entry in Phase II, right? So it is not booked into the Q3, right? And we don't have the cash, but we hope to have that in Q4, of course.
Eun Kyung Yang
Okay. So that EUR 13 million is going to be booked at the revenue in fourth quarter?
Pierre Kemula
Yes. So we hope to have both in the booking -- I mean, the booking for sure and the cash as well in the fourth quarter.
Operator
Our next question comes from the line of Mani Foroohar with Leerink Partners.
This is [Lili] for Mani. I had maybe, I guess, a two-part question. So the first one would be regarding the COVID market. We've seen several of the current COVID players reviewing their potential revenue for the year down based on the current market dynamics. I was wondering how do you think about the kind of tail end of the COVID vaccine market? And in addition to that, how could you -- or I guess could you give us maybe a little more detail in terms of potential flu, COVID counter vaccine approach? How far are we to a potential development and the combination? And how do you think about the construct that you'll be taking potentially in this approach?
Alexander Zehnder
Yes. Thank you. So two questions, one on COVID and then on combination of COVID and flu. Maybe I can start, and Myriam, I mean if you want to add as well. I mean, how we see COVID more broadly, obviously, it's going to fluctuate a lot. It might vary a lot over time. So it's kind of hard to predict exactly how big the market will be moving forward. However, we do believe, based on our platform, we've seen very good induction of immunicity with relatively low reactogenicity. So we believe we can have a competitive product here for COVID. Also as part of the Phase II trial that you've seen in the presentation, we are comparing our construct with a licensed competitor. So this will be interesting to see how our platform performs against an established player.
So that will be interesting for us. And then moving forward, nevertheless, even though it might be small, if they've got to be an important indication for us. Also, from a development point of view, it's almost three option for us because we met the EUR 100 million cap in terms of R&D expenses. So that's important. And of course, it's going to be a springboard for us to do the combination of COVID and flu, where we see the actual potential. But that's part of our development strategy as well, of course, with GSK. And I think once early next year, early to mid next year, we will see both Phase II running out, and that will enable us to really choose the best combination possible for a combination product then.
Myriam Mendila
Yeah. And maybe I can add to this as well because you're right, the COVID market is going down, but the COVID infection per se and the related respiratory disease remains or continues to be a health risk especially for the elderly population. Most countries in the meantime have moved on to recommend an annual vaccination to update it strains, especially for the elderly population. And this reflects a similar situation like we have been having for flu for the last 20 years or more.
But basically, the flu vaccinations are recommended every year with the updated flu strain for especially elderly patients at risk and for patients who have comorbidities that expose them at risk. And so we do see the continued need for certain populations to be regularly on an annual basis vaccinated with either a vaccine against COVID or against flu. And that's why, especially for that population, the combination makes sense, right, because you basically can increase vaccine adherence by combining basically a vaccine against two diseases in one.
You can make it for patients convenient -- and basically, it's better to have the side effects associated with the vaccine, a better level than one go with one shot rather than having a twice if it happens by two separate vaccines. That's one part why we do believe it's important to continue with the combination program. The other thing is that the health systems are really heavily burdened in many, many countries, especially during the vaccination season against flu and COVID. And so by offering basically one combined vaccine is the relief also for the practices, applying those vaccines and pharmacies in the U.S. and there we also see a significant advantage.
Operator
(Operator Instructions) Our next question comes from the line of Charlie Yang with Bank of America.
Chen Yuan Yang
Great. I have one on the patent infringement case. Can you just talk about the potential kind of appeal timeline I'm assuming the counterparty will appeal if they rule in favor of CureVac. So how will that timeline kind of potentially delay the damage for negotiation? And then I have a follow-up.
Alexander Zehnder
Thank you, Charlie. So a question on appeal and time line and impact on how that would impact the damages process. I'll let Marcus comment further but once in the case, we get validity confirmed that infringement confirmed as well at the end of December that would start to damage proceeding irrespective of a potential appeal. But I will let Marcus comment further on this.
Marcus Dalton
Yeah. So Alexander is exactly right. So for Germany, you will -- we would start the damages assessment in parallel with any appeal and the likely timing is about a year for both proceedings. And so the collection would happen at the end of next year, beginning of '25, that's sort of thing for the first case. In the U.S., if that was where your question was also directed an appeal will also likely take place, and it would be another year from the ruling. So we expect the ruling October, end of October, it will be a three-week trial in the U.S. and then the federal circuit would rule roughly a year after. And then damages would be collected at that point.
Chen Yuan Yang
Great. My second question is regarding the cancer vaccine. Can you just talk about how -- once we see the data in the first half of next year, like how quickly can CureVac move into the pivotal study? And then maybe just another one just in terms of kind of the broader cancer program. When should we expect to see the next (inaudible) trial design for the other indications?
Alexander Zehnder
Myriam, you want to take that?
Myriam Mendila
Yes, of course, with pleasure. Thanks for the great question, Charlie. So regarding the GBM vaccine, this is a trial that we basically are conducting to show the proof of principle or that our vaccine platform works in the oncology setting. So far, we have shared and seen very, very strong and promising preclinical data, but we have not tested so far our vaccine in the clinical setting. So the glioblastoma trial is actually designed to show this, that the platform works that our cancer vaccine candidate induces strong immunogenicity and uses CD8 and CD4 responses against the encoded antigens.
And that's why we selected the glioblastoma setting because we are encoding for antigens that have been shown to be immunogenic and glioblastoma patients. At the moment, we do not have intentions to take this vaccine candidate further into the next clinical setting because we have moved on to a much more advanced antigen discovery platform. And that's what we have been working on for the last year, where we, again, took a different approach to antigen discovery because in cancer vaccines, it's really all about finding the right cancer antigens and coding those inducing immunogenicity. So for these antigens, we have used in the glioblastoma trial, we know that they are immunogenic, but we do not know that they are the right ones to induce a strong clinical response.
And so we really want to bring the output of our antigen discovery platform into the next vaccine candidates that we have been working on. It will be in additional cancer indications. And the plan is, again, you never know where science works out but the plan is that we have a clinical candidate nomination towards the end of this year, beginning of next year and are already planning to start the -- basically to start for the next Phase I trial exploring again the next vaccine candidate, which will encode for antigens that came out as a result of our new antigen discovery platform, which is much, much broader and much, much deeper in finding the right antigen compared to what was used and done in the past.
Yeah, proof of principle, it's glioblastoma but the sort of like pivotal programs and Phase I programs will be starting with a different candidate in the coming, let's say, potentially 18 months. Maybe one thing to add is where we are going, again, based on our antigen discovery platform, we are going in two directions in the cancer vaccine space. One is basically designing off-the-shelf vaccines where we are encoding for antigens that are shared across different cancer types and patient populations. And the other direction is the personalized cancer vaccine that basically every vaccine has to be manufactured for a given patient based on the genomic profile of the tumor of that given patient. And the first trial that we are right now planning is for shared cancer vaccines. And in parallel, we are already preparing also for our personalized cancer vaccine, but those trials will start later. I hope that answers your question.
Chen Yuan Yang
If I can just ask one clarifying question over there. So the two programs we're seeing right now, is the intention of moving those programs into kind of pivotal trial or are they more of a proof-of-concept programs?
Alexander Zehnder
So maybe I can step in. So you're referring to the oncology program, right? The GBM current ongoing trial, right? It's more of a like a proof-of-concept trial. So I would say, unless we see (inaudible) efficacy because this is kind of a construct with known antigens that are relevant for GBM. But we believe in our [Frame Pro] platform, as Myriam mentioned, we will be able to have a much more comprehensive approach to antigens and picking the right antigens, right? So we've got to focus on that second generation, let's say, based on our proprietary research coming from the Frame Cancer Therapeutics acquisition. And that's what we're working on and moving these programs to the clinic off-the-shelf. And as Myriam mentioned, we are working on the personalized cancer vaccines as well.
Chen Yuan Yang
I see. So the CV8102, that's also a proof-of-concept program, but the main focus for you guys will be on the new antigen one that those are kind of in the -- still in the preclinical development phase. Is that -- is that how I should think about it?
Myriam Mendila
Yes. This is Myriam. Sorry, I was kicked out of the call, I'm back. Yes, you're absolutely right. Our focus will be basically using the new antigens that we -- that came out of our own discovery work and because we do believe that we have a very sophisticated approach to select signals antigens. So first to discover them, but also to select them to predict the immunogenicity and hence, that's basically the way we want to go forward.
Operator
There are no further questions at this time. And I would like to turn the floor back over to Sarah Fakih for closing comments.
Sarah Fakih
Thank you. With this, we would like to conclude this conference call. Thank you very much for your participation. Stay safe, and please don't hesitate to contact us should you have any further questions. Thank you, and goodbye.
Operator
Thank you. This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation.
