CureVac Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

Key Takeaways

  • Our lead COVID-19 and seasonal flu vaccine programs with GSK are in Phase 2, with enrollment complete for the COVID-19 study and first dosing in the flu study, and interim topline data expected in early to mid-2024.
  • The Phase 1 study in resected glioblastoma has advanced to the third dose level without dose-limiting toxicities, and we expect initial data readout in the second half of 2024.
  • Our proprietary mRNA printer secured its first manufacturing license for an mRNA cancer vaccine candidate and is on track for a broader framework license and full end-to-end GMP capabilities during 2024.
  • With a cash position of US$464.1 million at the end of Q3, we maintain a solid runway to fund operations and advance our clinical programs into mid-2025 under prudent fiscal discipline.
  • Revenues declined by €24.5 million in the first nine months of 2023, and operating loss widened to €186.2 million year-to-date, driven by lower GSK collaboration revenues and increased R&D investments.
AI Generated. May Contain Errors.
Earnings Conference Call
CureVac Q3 2023
00:00 / 00:00

There are 10 speakers on the call.

Operator

Greetings, and welcome to the CureVac Financial Results for Third Quarter and First 9 Months of 2023 Business Update. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. 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.

Operator

Thank you, Sarah. You may begin.

Speaker 1

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 Curec. Please let me introduce today's speakers. On the call with me from Curec are Alexander Sender, Chief Executive Officer of Curec Miriam Mendila, our Chief Development Officer and Ker Kuehler, Chief Financial Officer of Curec.

Speaker 1

Our Head of Intellectual Property, Markus Dorten, will be present for the Q and 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.

Speaker 1

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. QHEC disclaims any intention or obligation to revise any forward looking statements. For more information, please refer to our filings with the U. S.

Speaker 1

Securities and Exchange Commission. I will now turn the call over to Alexander.

Speaker 2

Thank you, Sara. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. As another year of strong performance draws 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-nineteen and seasonal flu Jointly developed with GSK are now in Phase 2 and we are on track for delivering interim top line data in 2024. The Phase 2 COVID-nineteen study recently completed enrollment and we expect interim data early next year.

Speaker 2

In the Phase II part of the combined Phase III study for seasonal flu, the first participant was dosed And we expect interim Phase 2 data in the first half of twenty twenty four. In oncology, our Phase 1 study in patients with resected is advancing and has recently progressed to the opening of the 3rd dose level in the initial dose escalation part of the study. And we continue to expect data in the second half of twenty twenty four. 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 and D event. Also supporting our oncology strategy is mRNA printer, CureVac's end to end solution for integrated and automated manufacturing of GMP grade vaccines and therapeutics.

Speaker 2

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 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 US464.1 million dollars At the end of the Q3 provides a solid basis to continue to execute on our programs and priorities till mid-twenty 25. As the pioneering company in mRNA technology, having maintained a tradition of scientific leadership for more than 2 decades, PureVac continues to defend a broad and diversified intellectual property portfolio.

Speaker 2

Our litigation against Pfizer BioNTech in Germany and the U. S. Has progressed with favorable developments in the German court and the provision of trial date in Our currently pending cases are interested 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 show the CureVac product development pipeline, which forms the core of our business strategy. The pipeline leverages our unique platform in 3 therapeutic areas of prophylactic vaccines, oncology and molecular therapy.

Speaker 2

In our most advanced area prophylactic vaccines, we have now 2 programs in Phase 2, which are driven by our clinically validated technology platform and proprietary 2nd generation mRNA backbone. Form and proprietary 2nd generation mRNA backbone. Our Phase 2 COVID-nineteen and seasonal flu vaccine candidates are developed collaboration with GSK. 2 Phase 1 studies we started last year So we evolved into the 2 current Phase 2 studies, which are testing updated candidates. We continue to translate the insight from our clinical infectious disease study into our oncology area as well.

Speaker 2

Our proof of concept Phase 1 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 or mRNA backbone to provide differentiated clinical cancer vaccines. The 3rd therapeutic area, We are developing optimized mRNA therapeutics together with several collaboration partner, which are intended to enable the expression of therapeutic proteins to treat rare and metabolic diseases. And we are continuously investing in our development pipeline advance innovation and healthcare solutions for people and patients. With this, let me hand over to Miriam for an update on our clinical development programs.

Speaker 3

Thank you, Alexander. I am now on Slide 6 To give you an overview of our 2 most advanced clinical vaccine development programs in COVID-nineteen and seasonal flu jointly being developed this case. As Alexander already mentioned, we recently reported solid progress in both programs with the completion of enrollment in the ongoing COVID-nineteen Phase

Speaker 2

2 study and dosing of the

Speaker 3

1st participants in the In the Phase 2 COVID-nineteen study shown on the left hand side of the slide, we assess the safety and immunogenicity of different single booster doses of The first candidate, CV-six zero one is a modified monovalent construct encoding the Omicron BA. 4five variant. The second candidate, CVO-seven zero one, is a modified bivalent construct, encoding the Omicron CA45 variant as well as the original SARS CoV-two strain. According to the applicable and available standard of care, when the first bivalent mRNA vaccine as a comparison. We expect interim Phase 3 data early next year, which will inform the design of a pivotal Phase 3 study planned to start at 2024.

Speaker 3

Following the September update of the COVID-nineteen standard of care in the U. S, the planned Phase 3 study is This is feature an updated vaccine candidate and updated comparator vaccines according to the latest requirements. The Phase III study for seasonal flu is shown on the right hand side of the slide. In this study, we are assessing the safety, reactogenicity The Phase I dose escalation part has already completed initial data analysis. It tested a comprehensive series of multivalent modified mRNA seasonal 2 candidates with up to 8 mRNA constructs per candidate at different dose levels in 270 healthy younger adults.

Speaker 3

Intuance Phase 1 safety data showed no safety concerns across all testesocia. We observed antibody responses to process the selection of a preferred vaccine candidate, which has now been advanced to the Phase 2 part of the study. The potentially differentiated multivalent candidate and codes antigens that address all 4 WHO recommended flu strains. It will be tested in both Younger and older adults at different dose levels and will be compared to 2 different licensed seasonal flu comparator vaccine with intended use for the respective age group. Interim data from this safety part are expected in the first half of twenty

Speaker 4

twenty four.

Speaker 3

Let us take a closer look at the study design of the 2 ongoing Phase 2 studies in COVID-nineteen and seasonal flu on Slide 7. While we don't disclose the exact dose levels for both studies, the COVID-nineteen Phase 2 study features a medium dose ranked by a higher and a lower dose for the bivalent candidate CV-seven zero one and a medium dose level for the monovalent 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 2 separate age groups, 480 younger adults aged 18 to 64, and 480 older adults aged 65 to 85. Each age group features 3 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 areas.

Speaker 3

On Slide 8, I would like to provide a more detailed overview of the ongoing Phase 1 study we are currently conducting in patients with surgically with selected MGMT unmethylated glioblastoma. On the left hand side of the slide, you can see the schematic setup of the cancer vaccine candidate, CD GBM, with a focus on its coding region. The candidate is based It encodes A epitopes derived from tumor associated antigen with demonstrated immunogenicity in glioblastoma. The exact nature of the epitopes is not being disclosed. However, you can see that CV GBM encodes 5 NHC plus 1 epitope and 3 MHC plus 2 epitope.

Speaker 3

NHC complexes of both classes are expressed on immune and other cells and present antigens, including tumor antigen to initiate CD8 and CD4 T cell responses against those antigen. CDGBM utilizes its concept to activate CD8 and CD4 T cells for an optimal antitumor response. We clinically assess this vaccine design in the open label Phase 1 study, which is described in more detail on the right hand side of the slide. The study evaluates the safety and tolerability of CV GBM in 2 parts. The currently ongoing dose escalation Part A is to enroll up to 24 patients and the sub sequence dose expansion Part B will include approximately 20 patients.

Speaker 3

In the dose escalation part, 4 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 observed to date. The trial is being conducted in Germany, Belgium and the Netherlands. A first data readout is expected in the second half of twenty twenty four. In this context, on Slide 9, I would like to highlight the results of a preclinical study that was represented 2 weeks ago at the 11th International mRNA Health Conference post the FactURIC in Berlin.

Speaker 3

We conducted this extensive study in mice to assess the potential of the multi epitope mRNA design we apply for our clinical candidate CDGBM. The study assessed a multi epitope mRNA design encoding 10 Separate cancer antigen epitopes derived from the B16X10 melanoma cell line, A well known melanoma cancer model in mice. Similar to glioblastoma, the B16F10 melanoma grows very aggressively Neutronut to an immune suppressive tumor microenvironment. The resulting tumors are purely hemogenic, so called co tumors, which is 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-one blocking antibody monotherapy.

Speaker 3

We are therefore all the more pleased that the immunogenicity data obtained on day 21, illustrated on the left side of the slide demonstrates prominent induction of TBA T cell responses against 5, NCD4 T cell responses against 2 of the encoded epitopes. In B16S10 tumor bearing mice, The successful induction of solid T cell responses against the SUBA antigen led to a significantly extended median survival by approximately 60% for treated mice compared to mice vaccinated with a formulated controlled mRNA. The preclinical data such as Levi is using tumor growth and extending animal survival. With this, let me hand back the call to Alex Wadhman.

Speaker 2

Thank you, Miriam. 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 1st 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.

Speaker 2

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 intellectual property rights in both Jurisdictions, the innovations they refer to, the responsible courts as well as timelines and upcoming milestones.

Speaker 2

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 total of 8 intellectual property rights at 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.

Speaker 2

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 presumption 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. Claim to damages if validity is confirmed in associated proceedings will be awarded in the same way as for a patent.

Speaker 2

Patent protection normally evolves alongside a multiyear product development. In the case of COVID-nineteen, we chose to file utility models as It 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 include enrichment of the GC content of the mRNA molecule and the implementation of a split Polyatel.

Speaker 2

The 3rd patent family covers inventions that were specific to the development of prophylactic vaccines against SARS CoV-two. 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 subsequent damages trial.

Speaker 2

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. Lower stream represents validity proceedings. Volatility of our IP rights is served by different authorities depending on the nature of the IP rights. This includes the European Patent Office for split polyethyl patents, the German Federal Patent Court for the GC enrichment patent and the German Patent and Trademark Office for all 5 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 at issue in Germany.

Speaker 2

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 drilling 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 2024. The part above the timeline, for instance, infringement milestones, the part below, brevity 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 GSM Enrichment patent supporting its validity.

Speaker 2

At the same time, the court set an oral hearing for December 19, 2023, where we expect the ruling on the validity of the patent. Looking at infringement, proceedings at the top part of the slides, a public hearing on the first 5 IP rights took place on August 15, 2023 before the original court in the store. At this hearing, the court announced that On December 28, 23, a ruling on infringement of the GC enrichment patent will be given. This means that the GC enrichment patent will be the 1st IP right for which both validity and infringement are decided And that December 23 will be the 1st major milestones in our German litigation. For the remaining four rights Under consideration from the August 15 hearing, infringement proceedings continued until September 28, when the court in the Suttorf an infringement ruling on those remaining four rights until their validity challenges have been resolved by the respective authorities.

Speaker 2

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 of 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 still needed to be determined. Accordingly, it decided to postpone the infringement proceedings until the validity of these 4 IP rights has been assessed.

Speaker 2

This postponement does not reflect the preliminary assessment by the district of quota 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's a total of 10 U. S.

Speaker 2

Patents currently at issue. These patents cluster into families, which mostly relate to the same innovations already discussed the German litigation, namely the stabilization of mRNA via GC enrichment, the implementation of a split polyatelle as well as the design of SARS CoV-two specific vaccines. And 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.

Speaker 2

Looking at the litigation timelines and milestones in the U. S. On Slide 15, the picture is more straightforward and a lot less complex 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.

Speaker 2

As a brief reminder, The U. S. Litigation was initiated with the declarative judgment action filed by Pfizer BioNTech in July 2022 The Federal District Court of Massachusetts seeking confirmation that Comenati does not infringe through Tourback patents. In May 23, we successfully transferred the case to the U. S.

Speaker 2

District Court for the Eastern District of Virginia followed by our counterclaim alleging infringement of 6 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 We 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 the development of COVID-nineteen mRNA vaccines.

Speaker 2

With this, I would like to conclude the business update and hand over to Pierre for a review of the financial data.

Speaker 4

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 Q3 and the 1st 9 months of 2023 with €464,100,000 Cash used in operation was mainly allocated to R and D activities, expenditures for our GMP-four production facility and purchases of R and D material. I will underline in this presentation significant one off effects that took place in 2022 as a consequence of closing our 1st generation vaccine efforts in COVID-nineteen. First, let us look at the revenues.

Speaker 4

Revenues increased by €5,300,000 to €16,500,000 in the 3rd quarter and decreased by €24,500,000 to €31,200,000 in the 1st 9 months of 2023 compared to the same periods in 2022. The decrease over the 1st 9 months year on year was primarily driven by lower revenues from our 2 GSK collaboration agreements. Revenue from both collaboration decreased year on year and amounted to a total of €28,700,000 in the 1st 9 months of 2023 compared to €52,700,000 in the same period in 2022. The decrease was driven by 2 elements. First, the agreement of both companies to focus on larger indications and second, a higher 2022 comparative base to the recognition of the milestone related to the start of the Flu Phase 1 clinical trial in Panama.

Speaker 4

Operating loss was 50 €4,000,000 for the Q3 of 2023, representing a €1,600,000 increase compared to the same quarter of 2022. The 1st 9 months of 2023 operating loss increased by €58,300,000 to €186,200,000 compared to the same period in 20 Beyond the lower revenues, the operating result was affected by several key drivers. 1st, Cost of sales decreased year on year, mainly as the impact of our 1st generation COVID vaccines subsided. This resulted in lower rise of raw materials The 1st 9 months of 2023 as well as lower impact on costs related to the termination of CMO activities. 2nd, R and D expenses increased with higher investments in later stage infectious disease and oncology development programs as well as strengthening the workforce.

Speaker 4

The 1st 9 months of 2022 R and D expenses were positively impacted in the amount of €36,800,000 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 CNO. 3rd, and still in 1st 9 months of 2022, Other income was positively impacted by a one off amounting to €32,500,000 for reimbursement of prepayments and production activity set up at the CMO. Financial results increased by €600,000 to a profit of €5,400,000 in the Q3 of 2023 It increased by €5,200,000 to a profit of €12,700,000 for the 1st 9 months of 2023 compared to the same period in 2022. They were mainly driven by interest income and cash investments. Pre tax losses were €48,700,000 for the 3rd quarter and €173,500,000 for the 1st 9 months of 2023.

Speaker 4

With this, I would like to hand back the call to Alexander for the summary of today's key messages.

Speaker 2

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 2 studies in COVID-nineteen and seasonal flu, which are being conducted in collaboration with GSK as well as our Phase 1 trial in glioblastoma are progressing well and according to plan. And we expect To maintain our strong momentum in 2024 with key clinical data readouts from all three studies as well as expected advancement to Phase 3 developments in infectious diseases.

Speaker 2

Together with the progress we have made in safeguarding our investment in innovation and our strong cash position €4,100,000 We will support the execution of our priorities to mid-twenty 25. 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 would now open the webcast for your questions.

Operator

Thank you. We will now be conducting a question and answer session. A confirmation tone will indicate that your line is in the question In the interest of time, we ask that you please limit your questions to 1 and to one follow-up question. One moment please while we pull for questions. Thank you.

Operator

Our first question comes from the line of Evan Wang with Guggenheim. Please proceed with your question.

Speaker 5

Great. Hey guys, thanks for taking the question. I have one and then another follow-up. Just firstly with the IP, number of dates coming up related to the intellectual property. Maybe just focusing on the upcoming German ruling in December where you have the preliminary opinion.

Speaker 5

Can you highlight the patent that December readout 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. Thanks.

Speaker 2

Thank you, Evan. I'm going to bring in Marcus Dalton, who is our Head of IP to the call. Markus, I think there was a question on expectation for the December 28 proceedings and how Potential damages would be excess. Marcus, do you want to take that?

Speaker 6

Yes. Yes, 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.

Speaker 6

Then as a practical matter, the assessment of damages is opened in The sold off, 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 would take place throughout 2024.

Speaker 5

Great. And then one follow-up in terms of the vaccines and specifically 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 2 formulations. Now, I guess, how confident are you that one of those Phase 2 formulations will be to go forward formulation for a Phase 3?

Speaker 5

Thanks.

Speaker 2

So question maybe for Miriam or on flu and Go ahead, Miriam.

Speaker 3

Yes. 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 1 study. We have tested different doses in the Phase 1 study.

Speaker 3

And from the data that we have seen, we have, I think, a reasonable level of confidence that the data from the It too will look strong, including in unogenicity and reactogenicity Against A and B frames and that we can move forward to Phase 3. 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

Thank you. Our next question comes from the line of Ellie Merle with UBS. Please proceed with your question.

Speaker 7

Hey guys, thanks for taking the question. Just another on IP. So just from this German patent 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 estates, 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, such as we think to potential learnings of economics if you were to prevail next year? Thanks.

Speaker 2

Thank you, Eli. So two kind of questions. 1 is implications of potential German ruling And 2, 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?

Speaker 6

Yes. Thanks for the question. In reality, the impact of the German GC, this is all about the GC 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 When things were granted, normally, you can only collect royalty from the date of grants or in case of the utility model, The date of registration.

Speaker 6

And so you'll see that the patents you'll see from the slides that we presented earlier, the patents were issued over Long 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 will come a bit later and we would expect less to collect less from those.

Speaker 2

Thank you, Markus. And maybe Ali just to add to that, I think what we feel really good about is the breadth Our portfolio, right, with 8 rights in Germany and 10 in the U. S. And I think as I tried to outline 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 is fairly valued and You know, bringing the basis for a fair compensation as well.

Speaker 7

Great. Thanks for the color.

Operator

Thank you. Our next question comes from the line of Eun Yang with Jefferies. Please proceed with your question.

Speaker 8

Thank you. 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 November this year. So could you give us an update on that on the preliminary opinion?

Speaker 8

And then second question for Pierre. So first patient dosing in the seasonal follow-up Phase II trial We've got a €15,000,000 from GSK. Is that booked in 3rd quarter or is it going to be booked in the Q4? Thank you.

Speaker 2

On IP, you're referring to the split polyatel Patent, I think you're 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 it yet, but it's pending.

Speaker 2

And then Pierre on the milestone trigger from the GSK collaboration. Sure. So thanks for

Speaker 4

the question, Ewan. I think you were referring to sort of $15,000,000 milestone related to the entry in Phase 2, 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.

Speaker 8

Thank you. So that $15,000,000 is going to be booked over revenue in 4th quarter?

Speaker 4

Yes. So we hope to have both the booking I mean the booking for sure and the cash as well in Q4.

Speaker 8

Okay, great. Thank you.

Operator

Thank you. Our next question comes from the line of Mani Foroohar with Leerink Partners. Please proceed with your question.

Speaker 3

Hi, good morning or afternoon. This is Lily Musonga for Manny. I had maybe I guess a 2 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.

Speaker 3

I was wondering how do you think about the Okay. And that's the COVID vaccine market. And in addition to that, how also do you or I guess could you Give us maybe a little more detail in terms of a potential COVID combo vaccine approach. How far are we to potential development as a combination? And how do you think about the construct that you'll be taking potentially in this direction?

Speaker 2

Yes, thank you. So two questions, one on COVID and then one on combination of COVID and flu. Maybe I can start and Miriam if you want to add as well. I mean how we see COVID more broadly, obviously it's going to fluctuate a lot and 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 We've seen very good induction of immunicity with relatively low reactogenicity.

Speaker 2

So we believe we can have a competitive product Here for COVID, also as part of the Phase 2 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. That will be interesting for us. And then moving forward, nevertheless, even though it might be small, It's still going to be an important indication for us. Also from a development point of view, it's almost free option For us, because we met the CAD100 million cap in terms of R and D expenses.

Speaker 2

So that's important. And of course, it's going to be a springboard for us to Due to the combination of COVID and flu where we see the actual potential, right? And 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 2s Running out and that will enable us to really to choose the best combination possible for a combination product then.

Speaker 3

Yes. 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 its 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 vaccination is recommended every year with the updated flu strain for especially elderly patients at risk and for patients We have comorbidities that expose them at risk.

Speaker 3

And so we do see the continued need for certain populations to be regularly on 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 2 diseases in 1. You can make it for patients' convenience. And basically, it's better to have the Side effects associated with the vaccine, a better driver than one go with one shot rather than having it twice, if it happens, By 2 separate vaccines.

Speaker 3

That's one part, right, 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 and especially during the vaccination season Again, so in COVID, and so by offering basically one combined vaccine, it's a relief also for the practices Applying those vaccines and pharmacies in the U. S. And there we also see a significant advantage.

Speaker 2

Thank you, Miriam.

Operator

Thank you. Our next question comes from the line of Charlie Yun with Bank of America. Please proceed with your question.

Speaker 9

Great. Thanks for taking the question. I have one on the patent infringement case. Can you just talk about the potential account appeal Time line, I'm assuming the counterparty will appeal if they rule in favor of CureVac. So How will that time line count potentially delay the damage count negotiation?

Speaker 9

And then I have a follow-up.

Speaker 2

Thank you, Charlie. So question on appeal and timeline 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 and infringement Confirmed as well at the end of December, that would start the damages proceeding irrespective of a potential appeal, but I would let Marcus comment further on this.

Speaker 6

Yes. 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 Both proceedings and so that the collection would happen at the end of next year beginning of 25, that 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.

Speaker 6

So we expect the ruling October end of October. It will be a 3 week trial in the U. S. And then the federal So that would rule roughly a year after and then damages would be collected at that point.

Speaker 9

Great. Thanks for that. My second question is regarding the cancer vaccine. Can you just talk about Once we see the data, the first half next year, like how quickly can CureVac can 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 count trial design for the other count indications?

Speaker 9

Thanks.

Speaker 2

Thank you, Charlie.

Speaker 3

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 Seeing a very, very strong and promising preclinical data, but we have not tested so far our vaccine in the clinical setting.

Speaker 3

So the glioblast tumor trial is actually Designed to show this, that the platform works that our cancer vaccine candidate end users strong immunogenicity and uses CD8 and CD4 cell responses against the encoded antigen. 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 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 strong immunogenicity. So for these antigens we have used in the glioblastoma trial, we know that they are immunogenic, but we do not know if that they are the right ones to induce a strong clinical response.

Speaker 3

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 what science works out, but the plan is that we'll 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 1 trial exploring against the next vaccine candidate, which will encode for antigens that came out as a result of our new antigen Which is much, much broader and much, much deeper in finding the right antigen compared to what was used and done in the past. Got it. So short yes, got it.

Speaker 3

Yes, group of principle, It's glioblastoma, but the sort of like pivotal programs and Phase 1 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 2 directions in the cancer vaccine space. 1 is basically designing off the Shell vaccines where we are encoding for antigens that are shared across different cancer types and patient population. And the other direction is the personalized cancer vaccines that basically every vaccine has to be manufactured for a given patient based on the genomic profile of the tumor of the skipping patients. And the first trial that we are right now planning is for shared cancer vaccines.

Speaker 3

And in parallel, we are already preparing also for our first blood cancer vaccine, but those trials will start later. I hope that answers your question.

Speaker 9

If I can just ask kind of one clarifying question over there. So The 2 programs we're seeing right now, is there intention of moving those programs into

Speaker 2

So maybe I can step in. You're referring to the oncology program, right, the GBM current ongoing trial, right? It's more like a proof of concept trial. So I would say unless we see overall immunohistocracy, because this is kind of a construct with known Antigens that are relevant for GBM. But we believe in our FramePro platform, as Miriam mentioned, we will be able to have a much more comprehensive Approach to antigens and picking the right antigens, right?

Speaker 2

So we're going to focus on that second generation, let's say, Based on our proprietary research coming from the Brain Cancer Therapeutics acquisition and that's what we're working on and moving these programs to the clinic off the shelf. As Miriam mentioned, we are working on the personalized cancer vaccines as well.

Speaker 9

I see. So the CV A102, 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 currently in the still in the preclinical development phase. Is that how I should think about it? Yes.

Speaker 3

This is Miriam. 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 selecting those antigens, so first to But also to select them to predict the immunogenicity and hence that's basically the way we want to go forward.

Speaker 9

Great. Thanks so much.

Operator

Thank you. There are no further questions at this time. And I would like to turn the floor back over to Sarah Fakih for closing comments.

Speaker 1

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

Operator

Thank you. This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation.

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