CureVac NV (CVAC) 2023 Q4 法說會逐字稿

Greetings, and welcome to the CureVac fourth-quarter and full year 2023 financial results and business update conference call. (Operator Instructions) Please note this conference is being recorded.

I will now turn the conference over to your host, Sarah Fakih. You may begin.

Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih, and I'm the Vice President of Corporate Communications and Investor Relations at CureVac. Please let me introduce today's speakers.

On the call with me from CureVac are Alexander Zehnder, Chief Executive Officer of CureVac; Myriam Mendila, our Chief Development Officer; and Pierre Kemula, Chief Financial Officer of CureVac. So Head of Intellectual Properties, 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, Wednesday, April 24, 2024. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations or predictions of the future. These constitute forward-looking statements for the purpose of the Safe Harbor provisions.

These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVac disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the US Securities and Exchange Commission.

I will now turn the call over to Alexander.

Thank you, Sarah. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. After recently celebrating my first year as CEO of CureVac, I'm thrilled to be speaking to you today as a leader of a company that is dramatically transforming itself.

As societies are moving beyond the COVID-19 pandemic, we are embracing a new normal, virgility and innovation are more vital than ever. At CureVac, this means we are taking decisive steps in 2024 to trim unnecessary residual pandemic infrastructure and have started redesign initiatives to increase efficiency, reduce operating costs and extend our cash runway.

These initiatives began in March this year with the voluntary leaver program that aims to reduce 150 positions and is intended to align our workforce to our business scope and priorities. At the same time, based on the rapidly changing (inaudible) environment following the end of the COVID-19 pandemic, together with our partner, GSK, we have made the decision to wind down the pandemic preparedness agreement with the German government signed in April 2022.

Based on our solid cash position of EUR402.5 million at the end of 2023, and despite a negative cash impact in '25 related to the wind-down of the pandemic preparedness agreement, our efficiency initiatives are expected to result in a net extension of our cash runway into the fourth quarter of 2025.

While we continue to streamline the company and optimize cost, it is essential for us to preserve existing and create new value by maintaining a strong focus on advancing our research and development activities. Accordingly, we have made substantial progress in our clinical trials and have grown our pipeline of development programs in infectious disease and oncology.

In infectious diseases, together with GSK, we have initiated a new Phase 1/2 study in avian flu, which is considered a potential future pandemic threat. It is the latest program progressing to clinical trials under our broad infectious disease collaboration with GSK.

Our ongoing programs in seasonal flu and COVID-19 has provided promising Phase 2 interim data, confirming that our technology platform generates strong antibody titers at well tolerated dose levels.

In oncology, the dose escalation Part A of our Phase 1 study in patients with resected glioblastoma has completed enrollment. But A successfully progressed to a safety data review confirming no dose-limiting toxicity and providing a recommended dose of 100 microgram for the Part B of the study.

This important growth driver, I'm particularly thrilled about our collaboration with MD Anderson, one of the world's leading cancer centers with whom we are joining forces for the development of novel mRNA cancer vaccines.

Further expanding such strategic collaborations will be key focus for Thaminda Ramanayake, a veteran in the biopharma industry who we are delighted to welcome as our new Chief Business Officers as of June 1 this year.

Also supporting our oncology strategy is the mRNA printer, CureVac's end to end solution for automated manufacturing of GMP-grade RNA vaccines and therapeutics. The printer achieved next important regulatory milestones by obtaining a framework license, providing even greater freedom and flexibility to manufacture different mRNA cancer vaccine candidates.

Taking a step back and looking at 2023 on slide 5. I'm profoundly inspired by the progress that has been achieved by the entire CureVac team. Last year, we made critical advancements in our clinical trials, most notably the positive Phase 1 data in COVID-19 and flu that allowed us to transition into the current Phase 2 programs with potentially differentiated vaccine candidates in collaboration with GSK.

We started the Phase 1 program in glioblastoma, kicking off our strategy for the development of next-generation cancer vaccines based on our proprietary second-generation mRNA backbone. Our successful capital raise in February 2023 was about of confidence of investors providing us with the resources to advance multiple programs and research activities.

And last but not least, we strengthened our intellectual property position by adding new IP rights to ongoing patent litigation with Pfizer, BioNTech, demonstrating that we continue to be at the forefront of mRNA innovation.

Building on our achievements in 2023, we are poised to continue in 2024 with a clear focus to make sure CureVac fit for the future. To this end, we have put strategic emphasis on an organizational redesign, which I will describe in more detail on the next slide.

In our clinical trial programs, we continue to move forward with GSK, following the promising Phase 2 interim data in COVID and flu this year as well as the newly started Phase 1/2 study in avian flu. In oncology, following the clearance of the Phase 1 Part A, we have most of the safety data. We anticipate advancing to the dose confirmation Part B mid-2024.

Expect to report a first data readout in the second half of 2024, most likely at scientific conferences such as ESMO or Citi. Our efforts to build up our manufacturing facility GMP IV are progressing, and we expect certification of the facility in the second half of 2024, contingents on regulatory approvals.

With these catalysts driving our efforts, we are confident in our ability to make meaningful strides in maturing the company and advancing our clinical trial programs in 2024.

In slide 6, let me provide you with a more detailed overview of our corporate streamline and redesign initiatives in 2024. As already mentioned, the redesign aims to significantly increase efficiencies and performance while maintaining a strong focus on innovation and R&D activities. This encompasses a range of targeted actions to trim unneeded pandemic area infrastructure, reduce operating costs, and become a leaner, more agile and focused organization.

The cornerstones of our efforts include our strategic reorganization, streamlining reporting lines, and digitizing the company. The focus is on a improved interface between our discovery, research, and clinical development areas by bringing them together under the leadership of Myriam as Chief Scientific Officer.

A unified leadership will allow for an optimal alignment on strategic goals, improved prioritization, resource allocation and seamless transition from innovation (inaudible) from discovery into the clinic. Furthermore, we will double down our company by digital and data strategy to enhance the use of data and AI throughout the company and enable accelerated business processes and pipeline innovation.

The areas where we are trimming pandemic structures, as mentioned earlier, to targeted resizing via a voluntary leaver program to reduce 150 positions is ongoing. The reduction of workforce will be accompanied by an overall stronger financial discipline.

This includes a much leaner budgeted '24 compared to '23, which is driven by lower operating costs and lower expenses and raw materials as our commitments for first-generation COVID vaccines are mostly closed. Also our CapEx spend will be significantly lower with the completion of our GMP IV manufacturing plant.

By these actions have already been initiated, we will continue to look for more opportunities to improve efficiencies throughout 2024. Pierre will go into more details in the financial update later in this call, and we will continue to inform you on the progress of these initiatives throughout the year.

In parallel with our organizational redesign, we have made significant progress in achieving our goals through strategic collaboration, such as the co-development and licensing agreement we recently entered with one of the world's most renowned cancer institutions, The University of Texas MD Anderson Cancer Center.

The collaboration focuses on the joint development of differentiated off-the-shelf mRNA-based cancer vaccines in selected hematological and solid tumor indications with high unmet medical needs. It combines CureVac's unique end-to-end mRNA capabilities for cancer antigen discovery, mRNA design and manufacturing with MD Anderson's world-class expertise in cancer (inaudible) discovery and validation, translational drug development and clinical research.

This collaboration is more than just the synergy of skills, it's a shared commitment of CureVac as the pioneer of mRNA and MD Anderson as one of the most trusted leaders in cancer care to go further and faster in making a profound impact on the lives of cancer patients.

Accordingly, both sites will contribute to the identification of novel cancer antigens based on (inaudible) of sequencing, RNA sequencing and cutting-edge bioinformatics. So preclinical validation of the highest quality cancer antigens is expected to be followed by Phase 1/2 studies with potential lead candidates conducted by MD Anderson.

We are convinced that this collaboration will be instrumental in boosting our oncology strategy. It will be an engine for the development of new cancer vaccines, helping us to deliver novel treatment options faster and more efficiently.

This context is with great pleasure that I introduce Thaminda Ramanayake as our new Chief Business Officer. Thaminda will join in our management team on June 1 at this pivotal moment in our corporate evolution.

Thaminda joins from Affini-T Therapeutics. He brings 15 plus years of international experience in business development and corporate strategy. He has a strong track record of successful clinical collaborations, M&A, assets-in-licensing and strategic financing across multiple therapeutic areas.

He has previously held positions at Sanofi, BioMarin Pharmaceuticals and Amgen. His wealth of knowledge is complemented by a strong foundation in science with focus on immunology and oncology. This broad expertise uniquely positions Thaminda to build upon our current achievements and drive CureVac's corporate strategy forward.

With this, let me hand over the call to Myriam for an update on our clinical development programs.

Thank you, Alex. Moving onto slide 9, I would like to take a moment to outline our most recent development pipeline, which forms the core of our business strategy. Based on the versatility of our unique mRNA platform, we address indications in the three therapeutic areas of prophylactic vaccines, oncology and molecular therapies.

In this updated layout, you can see that across these areas, we have focused our program resources and have discontinued legacy programs that no longer align with our development goals and expectations for adding value.

In our most advanced area, prophylactic vaccine, the Phase 2 COVID-19 and seasonal flu programs are ongoing being developed jointly with GSK. Both Phase 2 studies are fully enrolled and recent interim analysis data confirmed that our platform (inaudible) strong antibody titers at well-tolerated dose levels.

The newly initiated combined Phase 1/2 study in avian flu is being conducted in the US, and it assess a modified monovalent vaccine candidate and coding an influenza a H5 antigen in younger and older adults against a placebo controlled.

We continue to translate the progress in our prophylactic vaccines area into oncology. Our Phase 1 study in patients with resected glioblastoma is currently preparing to start Part B after having successfully completed the dose escalation Part A, as previously mentioned.

In 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 to treat diseases in different areas with unmet medical need. We remain committed to broadening and diversifying our pipeline being guided by our mission of advance innovation and health solutions for people and patients.

And now on slide 10, which offers more detail on our development programs in COVID-19 and seasonal flu. The Phase 2 part of the combined Phase 1 study for flu, assess a potentially differentiated multivalent candidate and coating antigens match to all four WHO recommended flu strains.

The candidates are selected from the Phase 1 part of the study, which tested a comprehensive series of multivalent modified seasonal flu candidates was up to eight constructs per candidate. The Phase 2 part of the study is fully enrolled with 480 younger adults, aged 18 to 64, and 480 older adults, aged 65 to 80. Both age groups were tested against age match licensed comparator vaccine.

The vaccine candidate showed an acceptable safety and tolerability profile with the majority of solicited adverse events reported at either mild or moderate. For influenza A strains, geometric mean titers generated by the vaccine candidates, numerically exceeded the geometric mean titers of the licensed comparator vaccine consistently across all tested dose levels and age groups.

For influenza B strains, geometric mean titers were generally lower than those enlisted by the licensed comparator vaccine. Based on the challenges and addressing these strains across vaccine technologies, this is in line with our expectations and the results from early studies of other mRNA-based flu development programs.

Together with GSK, we plan to assess targeted optimizations to further improve immune responses against these strains in an additional Phase 2 study. We are confident and planned optimizations will improve performance against this historically challenging influenza strains.

In the Phase 2 COVID 19 study, we assess different booster vaccinations of two vaccine candidates. CV0601 a modified monovalent construct encoding the Omicron BA.4-5 variant. And CV0701, a modified bivalent construct encoding the Omicron BA.4-5 variant as well as the original SARS-CoV-2 strain.

The study is fully enrolled with 427 participants, aged 18 or older. According to the applicable standard of care at the time, the study employed a licensed bivalent mRNA comparator vaccine. Interim data was reported in early 2024 and confirmed the favorable tolerability profile combined with competitive immune responses at low doses.

All tests at dose levels were well below those used in any of their mRNA-based COVID-19 vaccines licensed in the US and EU. As can be seen in the left of the two graphs, both vaccine candidates showed a lower of similar proportion of participants reporting solicited adverse events compared to those who received the comparator vaccine.

As illustrated in the right graph, CV0601 shown in orange was tested at a medium dose level and elicited neutralizing antibody titers against the Omicron BA.4-5 variant on day 29, which numerically exceeded the titers generated by the comparator vaccine by a factor of 1.4x.

For the low medium and high dose levels tested for bivalent CV0701, neutralizing antibody titers were open 0.7x, 1x, and 1.3 times the titers of the comparator vaccine. The study is currently ongoing with an additional expansion cohort. Taken together, the promising interim data strongly underscore the strength of our proprietary technology platform.

With this, let me shift our focus back to our oncology area. On slide 11, let me briefly remind you of the strategy for our oncology area, which we consider a cornerstone of our future growth. We have made significant strides in advancing our cancer vaccine program based on our two-pronged strategy, which encompasses both off-the-shelf and personalized cancer vaccines.

Our off-the-shelf programs targets a discovery of shared antigens with high prevalence and specific cancer types and the potential to enable more scalable and rapid cancer care. In this part, we have achieved key milestones over the past several months.

We are delivering on our glioblastoma study by targeting known glioblastoma antigens to validate our second generation (inaudible) backbone in the oncology setting. At the same time in collaboration with myNEO Therapeutics, we have identified novel shared antigen, based on minute advanced AI powered technology platform, which showed strong immunogenicity in undisclosed preclinical studies.

The combination of antigens evolving from the myNEO collaboration, with antigens discovered with our proprietary platform enables selection of the next clinical candidate in oncology. We plan to advance this candidates to the clinic in 2025.

Our collaboration with MD Anderson will also be an engine for the future development of new cancer vaccine candidates, further strengthening our off-the-shelf clinical development program.

In parallel, we are also aiming to push the boundaries of personalised cancer vaccines tailored to the unique genetic makeup of a patient's tumor. We have evolved our antigen discovery platform acquired with Frame Cancer Therapeutics and specifically directed the technology towards the identification of novel classes of personalized cancer antigen.

Fast and flexible access to cancer candidates based on novel personalized antigens will be critically enabled by the RNA Printer, which was just granted the framework license in the ongoing regulatory review. As we continue to navigate the challenges and opportunities of the oncology landscape, our achievements in both off-the-shelf and personalised cancer vaccines, position us strongly for future growth and success in this important area.

Turning our attention now to the clinical front in oncology on slide 12, let me give you a little bit more detail on our Phase 1 study in patients with surgically resected MGMT unmethylated glioblastoma. On this slide, you can see the setup of the open-label Phase 1 study was a multi-epitope cancer vaccine candidate, CVGBM.

CVGBM features a single unmodified mRNA encoding eight epitope derived from tumor associated antigens with demonstrated immunogenicity in glioblastoma. The exact nature of the epitope is not disclosed. The dose escalation Part A has successfully completed recruitment with 16 patients across four dose levels between 12 and 100 micrograms.

A review of the safety data for these dose levels by the Data Safety Monitoring Board or DSMB, confirmed no dose-limiting toxicities. Accordingly, the DSMB data recommendation for a preferred dose of 100 micrograms for the subsequent Part B of the study.

Part B expected to start in 2024, we'll enroll up to 20 patients. We are looking forward to sharing first immunogenicity data from the study in the second half of 2024 at the scientific conference.

To finalize the encouraging news flow in the context of our oncology strategy, the RNA Printer, our highly automated solution for GMP-grade manufacturing of cancer vaccines, has achieved the next important regulatory milestone.

You might remember that we reported the first manufacturing license for the printer to spot our oncology strategy in the third quarter of 2023. In an ongoing regulatory review, this license was expanded by a so-called framework license, which allows the flexible manufacturing of different mRNA constructs based on the established processes on the printer.

In 2024, our goal is to further expand this approach to also include the formulation module of the printer to complete the end-to-end capabilities of the system.

With this, let me hand back to Alexander.

Thank you, Myriam. Before we move on to the financial part of this call. On slide 14, I would like to briefly provide an update on our patent litigation against Pfizer, BioNTech in Germany and the US. Starting with the recent development in the US shown on the left hand side of the slide, please recall that a total of 10 patents are currently at issue in this geography.

In November 2023, our partner Acuitas Therapeutics moved to intervene, sever or stay our US litigation against Pfizer, BioNTech. The motion is based on a co-ownership and co-mentorship claim related to one patent family covering 4 patents out of the 10 litigated in the US.

These four patents cover the specific design of COVID-19 vaccine season. These are the lipid nanoparticle, which was used in carving out the event first introduced to the clinic by CureVac in 2019. Recently, a magistrate judge granted interventional recommendation to state litigation of all 10 patents before the District Court until the Acuitas claim is resolved.

So far, no decision has been made and we are currently preparing objections to this recommendation and anticipate a decision within the next two months.

Germany shown on the right hand side of the slide, on December 19, 2023, the German Federal Court Patent Court granted in the first instance, the 2022 request by BioNTech to nullify the German part of our technology patent on GC enrichment.

Given the broad scope of our robust patent portfolio, this initial position does not diminish the strength of our value of our intellectual property position, as this is only the first instance decision and proceedings are continuing in Germany with the remaining IP rights.

We are currently waiting to receive the written judgment of the December decision, which will enable us to file an appeal before the German Federal Court of Justice that will firmly establish the merits of our case. Patent litigation is part of the business landscape, especially in industries driven by high stakes innovations such as ours and routinely take years to play out. However, the license setbacks will not deter us from having our intellectual property rights acknowledged and fairly compensated.

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

Thank you, Alexander. Good morning and good afternoon to everyone on the call. Before we go into financial statement details, I would like to provide a little more context on our updated runway guidance and the main factors that are impacting 2024 and 2025 projections.

Alexander already mentioned the joint CureVac GSK's decision to wind down the 2022 pandemic preparedness agreement with the German government. Based on the 2024 obligation from this agreement, we expect the wind down to have a positive cash impact supporting a 2024 runway. This relate to significant savings on raw materials, stockpiling and reduction in running costs for (inaudible) facility.

On the other hand, in 2025, we will no longer receive the standby fee that the German government would have paid for maintaining (inaudible) manufacturing base, resulting in a decreased 2025 revenues. We will offset this overall negative cash impact with two things.

First, we have closed all remaining raw material commitments related to our first-generation COVID-19 vaccine. And second, our organizational redesign including voluntary leaver program, will enable reduced operating costs, allowing additional investments into selected development programs.

Further reduction in cash out in 2024 compared to 2023 will be driven by lower operating expenses in various SG&A functions. With our GMP IV facility expected to be certified in the second half of this year, subject of course to regulatory approval, the CapEx requirements in 2024 will also be significantly reduced compared to 2023.

Taken together, the results (inaudible) to extend our cash runway from mid-2025 into the fourth quarter of 2025. We will continue to look for more opportunities to increase efficiency in 2024, and we'll keep you updated.

Looking at our cash position on slide 16. As already mentioned, we closed 2023 with EUR402.5 million. Cash used in operations was mainly allocated to R&D activities, expenditures for our GMP IV production facility, and purchases of R&D materials. 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 revenues. Revenues increased by EUR10.9 million to EUR22.6 million for the fourth quarter and decreased by EUR13.6 million to EUR53.8 million for the 12 months of 2023 compared to the same periods in 2022. The decrease year-on-year was primarily driven by lower revenues from our two GSK collaboration agreements.

Revenues from both collaborations decreased year on year and amounted to a total of EUR47.1 million in 2023 compared to EUR62.3 million in 2022. The decrease was driven by the agreement of both companies to focus on the larger indications.

Revenues for the fourth quarter was higher compared to the prior year period as a significant portion of the milestone related to the initiation of Phase 2 for the seasonal flu clinical trial was recognized. Operating loss was EUR88 million for the fourth quarter of 2023, presenting a EUR33.5 million decrease compared to the same quarter of 2022. For 12 months of 2023, operating loss increased by EUR24.7 million to EUR274.2 million compared to same period in 2022.

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-19 vaccine subsided. This resulted in lower write-off of raw materials in 2023, as well as lower impact on cost related termination of CMO activities.

Second, R&D expenses increased with higher investments in later-stage infectious diseases and oncology development programs, as well as strengthening the workforce. In 2022, R&D expenses were positively impacted by a EUR38.5 million related to the reversal of an outstanding CRO provision as well as by one-off net gain for a change in contract termination provision resulting primarily in GSK taking over from the company committed capacity at the CMOs.

Third, until in 2022, other income was positively impacted by a EUR32.5 million one-off for reimbursement of prepayments and production activities setup at the CMOs. Financial results increased by EUR8.7 million to a profit of EUR1.5 million in the fourth quarter of 2023 and increased by EUR13.9 million to a profit of EUR14.2 million for the 12 months of 2023 compared to the same periods in 2022. They were mainly driven by interest income on cash investments. Pretax losses were EUR86.5 million for the fourth quarter and EUR260 million for the full year of 2023.

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

Thank you, Pierre. So building on our achievements in 2023, we have kicked off 2024 by delivering progress across several key areas and positioned ourselves for continued success throughout the year. Foremost, we have launched a comprehensive organizational redesign initiative that trims residual pandemic era infrastructure, streamlines our organization, and applies increased financial discipline.

We expect these measures to significantly improve our operational efficiency and agility and contribute to a stronger financial performance in 2024. This expectation is reflected in the extension of our cash runway for mid-2025 into the fourth quarter of 2025.

In the clinic, our infectious disease vaccine development pipeline continues to make significant progress, marked by most recently by a start of a new study in avian flu together with GSK. This is complemented by key data milestones into Phase 2 studies for COVID-19 and seasonal flu, confirming the competitiveness of our propriety mRNA technology platform.

In oncology, cornerstone of our strategy, the establishment of our cancer vaccine collaboration with MD Anderson and the advancement of our Phase 1 study in patients with glioblastoma, both reinforce our commitment to staying at the forefront of oncology innovation.

The pandemic dramatically illustrated the utility of mRNA technology, and we believe that mRNA most significant promises still lies ahead of us, and CureVac is resolute in its mission to bring that tremendous potential to life.

And with this, I would like to conclude our presentation and would now open the webcast to your questions.

Thank you. (Operator Instructions)

Evan Wang, Guggenheim.

All right. Thanks guys. Thanks for taking question that to one related to infectious disease platform. Just wondering if you could provide any timelines (inaudible) to some of the next steps that we'll see for COVID, seasonal flu, and a potential combo.

I guess, with flu, one question I did have was, you know, should we be thinking about a trivalent going forward or tried them with the WHO antigens.

And then with GBM, glad to see the progress inflection on the cohort dose. Anything you can share with respect to Part A on immunogenicity, was that evaluated? And how does the response there compared to some of the response you've seen from some competitors recently? Thanks.

Okay, thank you very much. Maybe I can start and then I will let a Myriam to comment as well. Maybe first on the ID platform, as we mentioned, we just started a new trial Phase 1/2 trial and avian flu. So that's an additional program as part of the GSK collaboration that that is moving forward and I think might address an important future need.

And then for COVID and flu, as we mentioned during the call, both Phase 2 studies are still ongoing. For flu we are far to start the additional study to improve these phase response. And for COVID, the additional product refreshes steady-state ongoing to optimize for different presentations after of the vaccine. And once we have all these data together from the relevance study, we will complete our discussions with the regulatory authorities for the setup of the pivotal Phase 3 studies.

And together with GSK, we are working on what is ever most value-driving strategy for both our collaborations and that reflect the current needs for both indications and your question to GBM and whether data is already available media. May e I'll let Myriam, comment on this.

Yes. And maybe before that, Evan had another question on flu and whether we go with the trivalent and vaccine. And yes, that's the WHO recommendation and that would be the plan for Phase 3 that we were basically and -- just for one biggest strain in the future and we will always follow the WHO recommendation. But that's sort of the plan for Phase 3.

And for GBM, we are analyzing immunogenicity data, but haven't disclosed those. And as we said in the presentation, but we are analyzing and more data coming in between if we plan to present those data at upcoming oncology conferences in the second half of 2024. So at the moment, our target is as more and potentially the Citi Conference later this year in the US.

Roy Buchanan, Citizens JMP.

Thanks for taking the question. I guess, actually she can answer this one, but the seasonal flu Phase 3 , do you think you might be in a position to start that trial as early as later this year or that on most likely, early next year. And then the frame you would have said I was wondering when you might be in the clinic with the personalized approach on this, what's dating on that, getting that into the clinic at this point? Thanks.

Myriam, so question on timing of flu Phase 3 and the timing of personalized cancer vaccines to the clinic?

Yes. So for Phase 3, right, we need to discuss with the health authorities and our goal is, of course, to bring it to the clinic as soon as possible. But right now it's difficult and we are reluctant to commit to a basically start. So maybe once we have discussed with authorities and have a clear plan, we will for sure and align with the GSK give an update on this one. For PCV, we're working on it and communicated that earlier, this is complex. And right now, we are planning to go into the clinic 2026 plus.

Okay, great and then maybe just one more on the -- I think this is what you said, but the H5N1 program, that's another target selection by GSK, so reduces their available targets by one. Thanks.

That's correct.

Okay. Thank you.

Mani Foroohar, Leerink Partners.

Yes, thank you for taking this question. I wanted to pivot over to a financial one. I'm looking at the guidance slide here, slide 15, which for helpfully breaks up the bridge there Q4 '25. Can you give us a little bit of granularity on the assumptions around the voluntary leaver program that are baked into that and some of the economics where we might be some of that severance expense versus some OpEx coming off is head count trend.

How that will flow through the financial statements and what your operational assumptions are for degree and tempo of uptake?

Hi Mani, Jeff's speaking. Thanks for your question. I'm not sure I understood the last part, but we basically you have on this slide. I think the key elements of the key driving elements, right that have an impact on the runway. We haven't disclosed, for instance, the PPA, the revenues, the second consortium approach with GSK and the government.

So it's difficult to comment on that. What I understand from my call is we have a an extension because we don't have to expense raw materials so far this year. So we have less revenues and PPA. So it's a net negative over the period.

This will be counterbalanced by I am a focused spend on R&D and stake settings that we have on the infrastructure, but also it also on the GMP going forward. Importantly, as I tried to underline as well, we had a little swings related to the end of the COVID-19 first gen, right. And so these are mostly behind us now, right?

So I think this will help us. And we talked about GMP IV where you'll see in all our documents, which kind of loaded to life. We have kind of finished investing into the building and the machines, right? So this will not be reduced going forward. So this is the color I can provide and all these pluses and minuses, you know, and specifically with the effort that we've done in terms of the lighter budget leader budget, more efficient that Alexander was talking about. We were able to extend the runway despite having a bit of headwind of the two years into the year.

Okay. And pivoting over and a quick follow up on to strategic and for a clinical development question. When you think about the usually technology in oncology, whether one wants to call it a personalized cancer vaccine, neoantigen therapy, whatever various competitors are calling and products now. How do you think about indication selection? And to what extent is that informed by you positioning in indications and data from your competitors, Moderna, BioNTech, et cetera?

(multiple speakers) I think it's a great question. And yes, we're doing all of that, right, especially for oncology, where you could go into 50 plus two months. And if you again a subset of subdivide them into molecular subtypes, it's even more.

What we did a strategic evaluation of the last quarter of last year, really looking at all of that different possibilities where to go and then applying different criteria with different weighting on how to rank those and then came up with basically a list of priorities considering commercial opportunity, considering competitive landscape available data and that basically was an underlying basis of became the underlying basis for our oncology strategy.

So we going strategically into specific indications where we see the scientific need, the scientific rationale, the medical need, a commercial opportunity. May be also an edge versus the competitors, and that's sort of like is driving how we decide until well into which indications recovering. Does that address your question?

Yes, it's a broadly. I guess a more sort of narrow question would be, where should we be looking for data sets from you guys and perhaps nano or place elsewhere that we could look at to provide a little bit of comparison on efficacy versus your competitors. So sockets are getting value for it gives us sort of evaluate your opportunity to differentiate?

Yes, that answered right, but we haven't published clinical data, right? And if that's your question. So that's why, right now, those data are not available. From basically from our cancer vaccine in the clinic. Maybe I misunderstand your question, but ?

I'm thinking about what the timing to do or how we should think about the timing when we could see a data set that we could sort of an indication where we can compare it with an existing competitor?

It's difficult to answer question because our current trial is ongoing in glioblastoma. And to my knowledge, there is no other mRNA vaccine ongoing in this space, right? So if you're specifically asking to compare our platform with other platforms. And our next Phase 1 trial is in planning, right? So it will take some time. And so data will become available and where you could probably compare in across indications.

But the one thing we all have to be cautious when you're comparing across trials because we're doing that ourselves as well when you're looking at the other data, but we realize how difficult it is to compare data in one tumor indication based on different vaccine platforms based on different assays, patient selection criteria and so on.

And while we all want to have a do those comparisons, we also have to be cautious cross-trial comparisons cause platform comparisons. We'll have the limitation. So while I understand the nature, what like to do that, that's also a I want to say, limited value. So I think when we publish the GBM data, we have to take some SARS, is this a validation of the platform. Will it show a ready-made immunogenicity? And we can compare across other vaccine technologies. But you know that the those comparisons again have all the caveats and pitfalls.

Yes, maybe just to add to that. I do believe here the MD Anderson collaboration will be able to help us a lot because at the end to have a differentiated product, it's all about having the right antigens, good backbone, good delivery, good translational capabilities. And I think this collaboration that we announced a few weeks back with MD Anderson will really help us there and to create an engine for us to produce, hopefully differentiated products that make a difference from patients.

So I think this is something that is going to increase our capabilities a lot. No, it'll take some time. As Myriam alluded until we see the declining, but at least we have a great engine with this cooperation that should help us a lot to be faster and be more efficient as well and bring differentiated products to the market.

Umer Raffat, Evercore ISI.

Hi, guys. Thanks for taking my question. I have a three here, if I may. First, I know you talked about your wind down of the pandemic agreement with the German government. How does that change your anticipated timelines to market with your COVID vaccine, I would have thought Germany would have a larger, more rapid path to market. And secondly, for your largest and most advanced trial of everything you're running, which is the COVID vaccine.

I noticed the slides keep mentioning 601 and 701 formulations, but not the 801, which is a monovalent strain that you do have also as part of this trial. Could you give us more color on the anticipated timing on the readout of that and the specific stream that data 1 covers?

And then finally, on acute as related delay on your on your on your litigation wasn't as only hoping to be a core owner on your formulation patents, meaning your CG and your (inaudible) would have been unaffected anyways. And I'm just trying to think about why all those plans were also looked up as part of the broader stakeholder. Thank you very much.

Thanks, for that, Umer. So three questions, 100 PPA time lines, COVID vaccine strain and then markets. I will I will let you comment on acute those and the recent updates here. So overall the PPA should not impact the time lines at all because, you know, following the pandemic emergency procedures that were replace to accelerate some of the approvals, they are they are largely gone. So there's no impact at all related to PPA or discontinued PPA and in terms of time lines in Germany, Myriam, do you want to comment on? You must questions on strengths?

Yes. So 601 is a monovalent strain for the BA.4-5 variant and the 701 is a B variant and 801 was the wild type and a task will be one change. So that's why, as you know, I'm not sure I understand your question. That's why basically there wouldn't be additional data coming. Maybe I misunderstood the question, but our focus is definitely on the updated strain and our focus is and again, continuing to develop and monovalent strain and monovalent strain vaccine that is matching the most recent and COVID or corona strain.

I guess maybe just clarify, shouldn't just either 801 or 901 have been the XBB.1.5 instead of BA.4-5 variant at this point of development.

Now at the time when we started this Phase 1 and Phase 2 program, actually XBB.1.5 was just basically on the right and yet, right, if we were to have when we're planning for the next clinical trial, whether it's a Phase 3 are something different than we would, of course, any code for whatever is the next strain now XBB.1.5 , but it could be again until then until we start the Phase 3, the strain product change

So we were always and cold again in the next wave, the most recent and updated strain that was recommended by the WHO of the CureVac. But again, at the time we designed the study, right that the current strength and circulating strains was the BA.4-5 variant.

Okay.

Marcus, do you want to comment on Acuitas and I would like you with us.

Yes, sure. So and your question was right there. And can you just only ask for the severing of the four formulation patents. The court didn't want to sell Acuitas. Let me may also be clear. There is no decision yet to say we will stay there is a decision Acuitas can intervene in the case, but the severance phase and recommendation by the magistrate judge it has to be endorsed by the trial judge and that will take some time.

We have brands to objects, which have to be in, and then there will be a response from the other side. And so it is the trial is still ongoing and the work for the trial is ongoing at the moment. So you're right, actually, Acuitas didn't ask calls, nobody asks for the stay of the whole proceedings as well as a decision of the magistrate judge to recommend that to the trial judge. And as Alexander said in his presentation, we expect that to be resolved in the next two months or so in the interim, all the work is carrying on.

Thank you very much.

Ellie Merle, UBS.

This Sarah, thanks so much for taking our questions. I have first on and COVID flu, how are you and GSK thinking about prioritizing the combo vaccine versus individual vaccines? And then are you still planning to initiate clinical development in the second half? And how should we be thinking about sort of economics here? And then on your oncology program for the data second half, what are you looking for in particular to serve kind of those proof of concept for your platform in oncology?

And so two questions on COVID and how we think about Pierre, I guess the second one in terms of anchor and what we are looking for in terms of the data. Maybe I can start with the first one and then maybe Myriam you can comment on the onco one side. So with regards to COVID, even though the pandemic has ended, obviously, but it will likely most likely stay with us and will require seasonal booster vaccination, especially for the patients at risk.

And due to the continued need for these vaccines, we do believe that the COVID market is still expected to be a multi billion-dollar market. However, there's definitely added convenience and potential for better immunization. And it's clear for us. And I guess from GSK as well that there is real value for the combination vaccine that will be attractive population requiring both vaccines and M&A technology obviously is perfect to address opportunities to its potency and flexibility.

And GSK as we pieces they made, the comment that combo vaccine and flu are a focus for them and with expectation of three billion-plus peak sales for this vaccine. So overall, we believe flu definitely still has a lot of potential, but the combination is definitely something that we're looking at very closely. And once we have the individual pieces from the Phase 2 data, I think we will be able to provide more guidance in detail that is moving forward. The second question in oncology, I guess it was forecast proof of concept data. We will look into.

Yes. Thank you, and thanks, Sarah, for the question. So in the Part A of the GBM trial will because it's a Phase 1 dose escalation trial, primary endpoint, of course, first of all, to look at safety and tolerability. And then we do have secondary endpoints and exploratory endpoints regarding immunogenicity. And that part A, we are looking at basically T cell activation by 80 spots ex vivo as well as after in vitro stimulation.

In the Part B, we do a more expanded immunogenicity testing program where we, of course, continue to look at elite sport, but also do more quantitative test and measurements and more in-depth analysis of T-cell repertoire in those patients. And so that's what you can expect. And we have defined our internal sort of like hurdles we'd like to take, but I hope you can understand that at the moment.

I don't feel comfortable to share those. But clearly, we want to be ambitious and what we would like to see to declare that the especially immunogenicity data from that trial confirm basically that the platform works in oncology. But we at we have defined that if that's your question.

Okay, great. Thanks, guys.

[Tiara Monteleone], Van Lanschot Kempen.

Hello. Thank you very much for taking my question. I'm Tiara Monteleone on behalf of Van Lanschot, Kempen. And so I have to say my phone disconnected. So I really hope I didn't miss what our outlook. So I wanted to ask you if you could elaborate a bit more on the recently announced MD Anderson collaboration. So I was wondering how do you go about choosing programs and indication and how you're going to use the same strategy that medium just discussed five years ago?

So maybe I can take that. (multiple speakers) Okay, so far with MD Anderson, of course, we discussed a selection of indications and follows the same approach where MD Anderson has our priorities. We have our priorities. And then we sort of like, look, what is the where is that overlapping? And so we have agreed already on the indication, but we will focus on our collaboration. And I don't recall about the second part of the question.

Oh, that was it. Okay, thank you.

Thank you.

Charlie Yang, Bank of America.

Thanks for taking the questions. I have a few, please. The first one is can you just talk about the regulatory pathway for glioblastoma trial. I guess my impression maybe perhaps was that this is going to be more of a proof of concept, but your focus will be on the other indications were the other account platforms. But no, is this a path forward though?

What would that timeline look like? And I guess my second question is just thinking about all the different accounts, early-stage programs that you have in the past because of actually thinking about the cash balance and the wrong way on how you think about I count prioritization among those programs as which one is kind of more important versus the others and why not just focus on one set of countries a few?

And lastly, with hiring of color, new Chief Business Officer, what kind of comes strategic deals that you have and the company is thinking of how in coming perhaps months or quarters? And how should we think about it from the therapeutic standpoint. Thank you.

(multiple speakers)

Yes, maybe I can take the first to Alex and then you can address the third one. So for GBM, as you rightly stated, right, for us, this is a proof of principle study we already announced that are the cause of disclosed earlier calls. This is for us a trial where we are using basically our platform in oncology for the very first time. And our intention is to show it safe and well tolerated and it's inducing an immune response against the encoded antigens.

We didn't have and don't have plans to then have to take this as a pox to proof of concept and then start a Phase 2 or Phase 3 program and you never know. If we would see which is unexpected some strong compelling efficacy signal, which will take time and the GBM trial because we're here treating patients that have undergone surgery.

So they don't have remaining two more and hence, assessing efficacy will always be based on an endpoint driven parameters such as disease-free survival or progression-free survival. But in case with longer follow-up, if we would see something compelling cellular visits that decision. Right now, we're not considering to takes us all the way through clinical development and into Phase three. But again, just want to use the GBM data as a proof of principle, the platform works in oncology.

Then the regarding the privatization of different oncology programs and the sort of like cash runway we're having is, of course, something that will happen once we have the data. Right now and we have the GBM program. We are preparing for another Phase 1 program with a clinical candidate. And the collaboration with MD Anderson is just starting right? And we need to see if we can find shared antigens that will enable us to nominate a candidate.

And then again, based on what I described before, different parameters, and we will see what we can take to the clinics and otherwise prioritize based on scientific evidence and the signals we see in terms of what we'll take into the clinic.

Thank you, Myriam. And I think the last question was regarding with the incoming of the new CBO to Thaminda and the strategic direction for business development or additional partnerships, right. A few focus area for us. One being oncology for sure. Even though we have announced a collaboration with MD Anderson, this will not preclude us from additional partnerships for these assets if they make it to through Phase 2.

So oncology is definitely a big focus for us in looking for additional partnerships. We also still have opportunities on the infectious disease side for programs that are not partnered with GSK beyond this in molecular therapies. We have a few programs ongoing that we haven't fully disclosed, but that could be interested for partnering in selected indications.

So it's definitely something that we are looking at a very, very, very broadly and we are engaged and with Thaminda coming on board, we can engage even further on this. Thank you.

Thank you we have reached the end of the question-and-answer session. I'll now turn the call back over to Sarah Fakih for closing remarks.

Thank you. With this, we would like to conclude this conference call. Thank you very much for your participation and stay safe and please don't hesitate to contact us, should you have any further questions? Thank you and goodbye.