Logo of jester cap with thought bubble.

Image source: The Motley Fool.

CureVac (NASDAQ:CVAC)
Q4 2020 Earnings Call
Apr 15, 2021, 10:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Sarah Fakih

Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih. I'm the vice president of investor relations at CureVac.

Please let me introduce today's speakers. On the call with me are Franz Haas, the chief executive officer of CureVac; Pierre Kemula, our chief financial officer; and Ulrike Gnad-Vogt, our interim chief development officer. Mariola Fotin-Mleczek, the CureVac chief technology officer will be available for the Q&A session after the presentation. 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 discussion and responses to your questions on this call reflect management's view as of today, Thursday, April 15th, 2021. 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 provision.

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

I will now turn the call over to Franz.

Franz Haas -- Chief Executive Officer

Thank you, Sarah. Ladies and gentlemen, a warm welcome to this conference call from all of us here at CureVac. 2020 was a year of fundamental corporate transformation, which has propelled us forward in our growth from a research-oriented biotech company into an integrated commercial biopharma company. We believe the progress we made in developing the company but also in advancing our COVID-19 vaccine program based on our differentiated mRNA technology has created a solid foundation for continued growth in 2021.

Let me begin by giving you an overview of selected key highlights in 2020 and of the success we were able to achieve since the beginning of this year. In the clinical development, our lead COVID-19 vaccine candidate, CVnCoV, we have successfully completed enrollment for our two central clinical trials, our Phase 2a trial with over 670 participants and our pivotal Phase 2b clinical trial with over 40,000 subjects recruited. For our Phase 2a trial, the occurrence of a high number of COVID-19 cases prompted us to submit a protocol amendment to introduce a secondary endpoint for vaccine efficacy. We believe additional data in the total population by particularly in a group aged above 60 will be highly complementary to the data of the Phase 2b/3 interim analysis which is expected in the second quarter of this year.

We are further expanding the COVID-19 vaccine program and are expecting to initiate three clinical trials soon. The trial will evaluate -- one trial will evaluate immune responses in different age groups, the flu coadministration trial is the second, and a third trial looking at selected comorbidities. Ulrike will tell you more about these trials later in this presentation. In oncology, we announced the expansion of the ongoing Phase 1 trial of our lead asset CV8102 in advanced melanoma.

Following the promising results announced in the third quarter of 2020, the expansion of the Phase 1 trial aims to confirm the safety and preliminary efficacy of CV8102 at a selected dose of 600 micrograms. Our strategic partnerships with Bayer, GSK, and the U.K. government, the latter being under advanced negotiations, are progressing well and continuing to accelerate the development of our first and second-generation COVID-19 vaccines, both of which will be advanced to also address new virus variants. To rapidly -- to readily supply CVnCoV, our integrated European manufacturing network is rapidly expanding with experienced CDMO partners and the additional support of our strategic partners, Bayer and GSK.

We reaffirm our anticipated manufacturing capacity for 2021 of up to 300 million dosages produced and have raised our manufacturing guidance for 2022 to 1 billion doses of CVnCoV. On the financial side, we closed 2020 with a favorable cash position of EUR 1.32 billion. Since then, we were able to raise an additional USD 517 million issuing new shares in a successful follow-on to our IPO in August last year. Pierre will later walk you through the financial details.

I'm now on Slide 5 of the presentation to briefly highlight the fundamental corporate transformation that has taken the company to a new level in 2020 and is continuing in 2021. Since initiation of our COVID-19 vaccine program at the beginning of 2020, our business has evolved as a clinical development of the lead vaccine candidates, CVnCoV accelerated. We are going to -- we are growing the talent base in every area of the company and are rapidly building our commercial infrastructure and expertise under the leadership of Antony Blanc, who joined us as chief business and commercial officer in December 2020. In 2020, we secured a commercial commitment from the European Commission for 225 million doses of CVnCoV with the option of an additional 180 million dosages to be delivered.

We are executing on our financial strategy. And in 2020, we're able to secure significant funds through a private financing round directly followed by our NASDAQ listing, as well as, a grant from the German government. In addition, we received a EUR 450 million upfront payment from the European Commission as part of the order for the 225 million vaccine dosages. Since then, we were able to add another USD 517 million through a successful IPO follow-on financing.

We believe that this progress has put us into an optimal position to further grow the business and accelerate our corporate transformation and development from a biotech into a commercial biopharma company. On Slide 6, you can see how the corporate transformation is based on a solid foundation of our 20 years of scientific expertise and differentiated mRNA technology, both of which continue to be the core drivers of our success as a biopharma company. The rapid buildup of our commercial organization is expected to enter the next stage with the planned launch of CVnCoV as our first commercial product and the anticipated generation of revenues, both of which are contingent on regulatory approval. To expedite our commercial development, we have already started to prepare commercial territories inside and outside the European Union while also planning to leverage the international reach of our strategic partners, Bayer and GSK.

Moving into 2021, we continue to transform as a business and move toward executing on our core mandate to deliver a safe and effective COVID-19 vaccine. To achieve this goal, we leverage the solid foundation we have laid in 2022. First, succeed in the clinic. In the second quarter of this year, we expect to deliver clinical results from our pivotal Phase 2b/3 trial interim analysis that we expect will enable us to finalize the rolling submission to EMA to allow for a potential conditional approval shortly thereafter.

Second, to create manufacturing capacity. Internally, we are driving toward the optimization of our GMP 3 manufacturing suite here in Tubingen and the progressive buildup of our large-scale GMP 4 manufacturing site also here in Tubingen. Externally, we are continuing to build our broad and integrated European manufacturing network with experienced partners and with additional support from our strategic partners, Bayer and GSK. We are already producing CVnCoV dosages at risk, as we speak, to readily supply CVnCoV at the time of a potential market authorization.

Third, to deliver the vaccine. We are adding operational muscle and execution power with the partner Bayer to accelerate the development, market readiness, and market access of CVnCoV. With GSK, we add vaccine-specific expertise to create value also beyond the pandemic on the basis of advanced second-generation COVID-19 vaccines. Let me now hand over to Ulrike, our interim chief development officer, to guide you through our clinical program and program updates.

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Thank you, Franz. On Slide 8, please let me remind you of our broad and diverse pipeline which builds on our differentiated mRNA technology platform. In 2020, mRNA has emerged as a key technology in the site against the COVID-19 pandemic. However, we believe that the technology is only in its infancy and has great potential in a broad range of medical indications in which prophylactic vaccines represent the current sweet spot.

To explore the full potential of mRNA, we focus our preclinical and clinical pipeline on the three therapeutic areas in which we think we can make a difference, prophylactic vaccines for infectious diseases, immunotherapy in oncology, and protein therapies for a variety of diseases. The prophylactic vaccine pipeline is led by our COVID-19 vaccine lead candidate CVnCoV which we are advancing together with our partner, Bayer. A large part of our prophylactic vaccine portfolio is being developed in collaboration with GSK. The initial GSK partnership we entered into in July 2020 focuses on mRNA-based vaccines and monoclonal antibodies for infectious diseases and it was recently expanded to also include COVID-19.

For COVID-19, CureVac and GSK are already jointly developing second-generation vaccines based on new mRNA backbones. Second-generation vaccines will also address virus variance and new vaccine formats such as multivalent vaccines to provide advanced solutions beyond the CoV endemic. In oncology, our lead candidate is CV8102, an immunomodulator activating TLR7/8 and RIG-I for which we presented updated Phase 1 data at the Society for Immunotherapy of Cancer Conference in November 2020. In February '21, we initiated the expansion of our Phase 1 trial at a selected dose of 600 micrograms in patients with advanced melanoma.

In protein therapy, in addition to collaborating with CRISPR Therapeutics and Genmab, we have also collaboration with Yale and Harvard University that are focused on lung diseases and ocular diseases. Through these programs, we are also developing our proprietary polymer-based formulation technology. I'm now on second line to show you a detailed overview of our COVID-19 vaccine program, including the studies that are currently under way, as well as, the studies we are planning to initiate shortly. The better first differentiated COVID-19 protection needs, we expect to initiate three new clinical trials, a Phase 3 trial for high-risk population with selected comorbidities, a Phase 3 trial for the coadministration of CVnCoV, and the licensed quadrivalent influenza vaccine, and a Phase 2 trial for deep characterization of immune response in the age group of 18 to 45 in comparison to the age group of above 65.

Our other age-related data is expected to be generated via a protocol amendment of the ongoing Phase 2a trial in Peru and Panama to enroll adolescents at the age of 12 to 17. For the later data, an amendment was filed on March 27th to enroll an initial cohort of approximately 14 adolescent participants in Peru and is expected to start recruitment toward the end of April. Contingent on a successful safety review, it is planned to further enlarge enrollment in this age group and additionally extend it to other Latin American countries, as well as, Europe. Let me go into a little more detail about the individual trials.

The Phase 3 trial, including participants with selected comorbidities, is expected to begin very shortly. As comorbidities represent a high risk factor for severe cause of a COVID-19 infection, we aim to evaluate the safety, reactogenicity, and immunogenicity of CVnCoV vaccination in these vulnerable populations. Selected comorbidities to be featured in this trial include obesity, chronic cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease or COPD, HIV, type 2 diabetes mellitus, and post-renal transplantation. The trial is planned as a multicenter trial to be conducted in Belgium and is expected to enroll approximately 1,200 participants.

Half of the ongoing large-scale COVID-19 vaccination programs for administration with seasonal flu vaccinations may be established to simplify the process to provide the most effective protection for the populations. Together with our partner, Bayer, we will therefore initiate a coadministration study of CVnCoV to assess compatibility with the licensed quadrivalent influenza vaccine, focusing on participants above the age of 60. The Phase 3 multicenter study will evaluate the safety, reactogenicity, and immunogenicity of CVnCoV following this coadministration and aims to enroll approximately 1,000 participants. Last but not least, we intend to collect further age-related data in another Phase 2 trial.

This trial will focus on characterizing immunogenicity in a cohort of older adults above the age of 65, compared to a cohort of younger adults aged between 18 to 45. While we already collect data in this age groups in our ongoing late-stage clinical trials, this trial is intended to provide a much deeper analysis based on growth and partially explore the range of immunogenicity markers. The nonrandomized, open-label clinical trial is expected to start in the second quarter of '21. It will be conducted in France and aims to include approximately 180 participants.

Let me now turn to a topic that currently and significantly influences the context and the cause of almost every COVID-19 clinical trial. New virus variants have been steadily spreading since the end of 2020 while displacing the original COVID-19 virus strain. On Slide 10, you can see an overview of the estimated prevalence of the three most prominent variants of concern with a focus on the general geographies where we conduct our pivotal Phase 2b/3 trial. Variance of SARS-CoV-2 are classified as variant of concern based on evidence of an increase in transmutability, a more severe cause of the disease and for some variance, a reduction of neutralizing capability of antibodies generated, either as per previous infection or vaccination.

We thus believe that the potential to evade an existing immunity leads to an impairment of vaccine efficacy, although the true impact needs to be better understood. Presently, we are looking at three main variants commonly referred to after the country where they were first detected, namely U.K. strain which is considered to be approximately 50% more transmissible, but to remain susceptible to neutralizing antibodies induced by licensed vaccines. The South African strain which is also considered to be approximately 50% more transmissible and such has been shown to be less susceptible to neutralizing antibodies on previous vaccination or infection in numeral study.

As for Brazil strain which also seems to be less susceptible to vaccine in neutralizing antibodies. The pie chart on the slide illustrates the presently estimated and rapidly increasing variants spread in South America and Europe. For your reference, specific countries where we conduct our Phase 2b/3 trial are marked in blue. Since our Phase 2b/3 clinical trial for safety and efficacy started in the middle of December 2020, we believe it is likely that there will be a contribution of variants of concern in our data which is presently difficult to estimate.

On the next slide, I will go into detail of how we plan to address this additional complexity. On Slide 11, I would like to walk you through the recent protocol additions that we announced for our trials. For our safety and efficacy Phase 2b/3 trial, first efficacy data is expected from an upcoming interim analysis. As I described earlier, the South African and Brazilian strains have shown in numerous studies the potential to be less susceptible to antibody neutralization by vaccination with a vaccine targeting the original strain and hence efficacy against these strains might be lower.

We will take the contribution of these strains to our COVID-19 cases into account when interpreting the results of our trials. On March 27, we filed an amendment to our Phase 2b/3 trial following discussions with the European Medicines Agency to include an additional secondary endpoint in the study protocol. The secondary endpoint will allow us to provide an efficacy need of fully based on cases from the original strain, as well as, the U.K. strain in addition to the overall primary efficacy readout.

For a dose confirmation Phase 2a trial, we also filed an amendment to include the secondary endpoint for vaccine efficacy on March 31st, '21. Based on the high prevalence of COVID-19 in Peru and Panama throughout the course of the trial, we were able to record a relevant number of COVID-19 infections. We intend to harness these case numbers to provide efficacy data which we believe will be highly complementary in the Phase 2b/3 efficacy data. Vaccine efficacy data will be reported in the overall study population.

However, we consider data in the subgroup of approximately 270 participants above the age to be particularly relevant. To conclude the context of variant of concern in this presentation, I would like to briefly highlight a preclinical study on the protective effect of CVnCoV against the South Africa strain that we have recently published on the bioRxiv pre-print server. The study examines the protection provided by CVnCoV vaccinations in mice exposed to, either the original SARS-CoV-2 strain or the novel variant of concern, B.1.351 commonly refer to as the South Africa variant. While we're able to confirm the previously described reduction of neutralizing antibodies in CVnCoV vaccinated mice exposed to default Africa strain, not with the original strain.

Vaccination fully protected mice from both signs of the disease, as well as, death and these are proven. We consider this an important study as it is the first challenge infection study in a preclinical mouse model to provide evidence for protection against the variant of concern. It complements earlier preclinical study results for CVnCoV with variant specific data to provide further evidence on the overall protecting efficiency of CVnCoV. With this, let's now hand back the call to Franz.

Franz Haas -- Chief Executive Officer

Thank you, Ulrike. I'm now on Slide 13 to update you on the progress we are making on our broad and integrated European manufacturing network to accelerate the availability of large-scale volumes of CVnCoV at the time of market authorization contingent certainly on the regulatory approval. Please let me remind you that at its core, the network is based on the optimized production process we established in 2020 for CVnCoV in our in-house GMP 3 manufacturing facility here in Tubingen which serves as a blueprint for the tech transfer to our manufacturing partner sites. The network is expanding with highly experienced CDMO partners and the additional support of our strategic partners, Bayer and GSK.

We are steadily expanding the European network in 2021. Our manufacturing capacity will increase accordingly. We reaffirm our 2021 capacity guidance for 300 million dosages of CVnCoV produced and we are able to raise our guidance for manufacturing capacity for 2022 from 600 million doses to 1 billion doses of CVnCoV. While progressing along the regulatory pathway for CVnCoV, we are already producing commercial vaccine dosages at risk, as we speak, to be able to start distribution of CVnCoV once market authorization is granted.

While we are expanding our large-scale manufacturing capacity, we are also advancing our system for downscaled manufacturing. On Slide 14, let me update you on the latest development status of our mobile and fully automated production system for GMP-grade mRNA vaccines and therapeutics which are developing -- in which we are developing in collaboration with Tesla, the RNA Printer. We have advanced the RNA Printer to the next system generation proceeding from the first generation in which we introduced the highly innovative core for mRNA synthesis. The RNA Printer 2.0 completes the manufacturing workflow around this core to cover the entire mRNA truck substance production workflow.

The combination of decentralized manufacturing and of approximately 1 to 3 grams of vaccine per week to be produced and cloud-based connectivity for rapid exchange of data and protocol positions, positions the RNA Printer as an ideal system for future pandemic preparedness and containment directly at the outbreak site. Manufacturing needs within the pandemic would depend less on large consolidated manufacturing facilities and would be supported by rapid point of need access to GMP-grade mRNA vaccines at site. We are currently establishing a full second-generation system under clean room conditions at CureVac here in Tubingen to further verify the GMP manufacturing process and expect to ship the first systems to customer sites early 2022. I'm now on Slide 15 to review the two synergistic COVID-19 partnerships we entered into over the past months with Bayer and GSK, within which CureVac occupies a central position.

In addition, we are under final discussions with the U.K. government and its vaccine task force for an R&D collaboration agreement. These two partnerships and the expected partnership with Vaccine Taskforce, not only enable us to support the fight against the pandemic and virus variants, but also expand our pipeline beyond the pandemic with second-generation COVID-19 vaccines and beyond. With Bayer, we have a pharma partner whose operational expertise and execution power accelerates the development and delivery of our first-generation vaccine CVnCoV, as well as, CVnCoV addressing variants of concern.

Opposite this, our co-development partnership with GSK lays a strong foundation to create value also beyond the pandemic. Together with this world-leading vaccine expert, we will jointly advance second-generation mRNA vaccines. For COVID-19, new vaccines will address new virus variants and feature new formats such as multivalent or so-called combination vaccines. The latter is particularly of interest in light of our initial collaboration with GSK in 2020 in the field of non-COVID infectious diseases.

As I mentioned briefly before, we are currently in a final negotiation stage of an R&D collaboration agreement with the U.K. government and its Vaccine Taskforce. Once finalized, the R&D collaboration with the task force is expected to grant us access to the best quality scientific input for COVID-19 variants, epidemiology, and genetics. We expect this will allow a fast track selection of the most relevant mutations for both our first- and second-generation vaccine.

In return, CureVac would tech transfer its manufacturing process for the manufacturing of 50 million vaccine dosages in the U.K., which the U.K. government is expected to order. With this, I would like to hand over to you, Pierre, for the financial update.

Pierre Kemula -- Chief Financial Officer

Thank you, Franz, and good morning and good afternoon to everyone on the call. We're continuing to execute our financial strategy and we're able to considerably change the financial profile of the company in 2020, as illustrated on Slide 16. The development of our cash position throughout 2020 was mainly driven by the following elements. We raised EUR 874 million in equity, mainly driven by the private placement round that took place in July 2020, raising approximately EUR 560 million, and our NASDAQ IPO in August 2020 with net proceeds of approximately EUR 193 million and the concurrent private placement of Mr.

Hopp for EUR 100 million. We raised another EUR 579 million from collaboration and upfront payments, of which EUR 120 million upfront payment came from the GSK partnership signed in July '20 and a EUR 450 million upfront payment was made by the European Commission within our advanced purchase agreement. The cash position was further strengthened by a grant by the federal -- by the German Federal Ministry of Education and Research for a total of up to EUR 252 million. The grant supports the development and manufacturing of CVnCoV under a time period of two years and just over EUR 100 million were claimed in 2020.

All of this is partially offset by third-party related costs. We closed the full-year 2020 with a favorable cash position of EUR 1.32 billion as of December 31st, 2020. On Slide 17, I would like to briefly highlight our first follow-on financing after our NASDAQ listing which was closed in early February of 2021. In the follow-on, we issued 5 million common shares to raise approximately USD 450 million.

The underwriters fully exercised their options to purchase the additional 750,000 common shares, which resulted in a total gross proceed of approximately USD 517.5 million. This clearly further strengthens our favorable cash position as we were moving into 2021. Looking at our condensed profit and loss statement on Slide 18. Our revenues for the fourth quarter of 2020 decreased by EUR 0.8 million to EUR 6 million, compared to the same period in 2019.

This decrease was mainly due to lower sales following the termination of the Eli Lilly agreement in June 2020. The decrease was partially compensated by the recognition of EUR 4.1 million from the deferred EUR 120 million upfront payment from the GSK partnership. For the first 12 months of 2020, revenues increased EUR 31.5 million to EUR 48.9 million, compared to the same period in 2019. The decrease -- this increase, sorry, was mainly driven by the one-off event of the termination of the Eli Lilly partnership.

As a result, we recognized a full deferred revenue amount of EUR 33.1 million in our top line. Operating loss was EUR 46.6 million for the fourth quarter of 2020, representing a 32.8% increase, compared to the fourth quarter of 2019. Increased operating loss was mainly driven by the higher R&D costs for the CVnCoV development program. This was in turn partly offset by other operating income driven by higher cost reimbursements received from both CEPI and the German government.

For the 12 months of 2020, we posted an operating loss of EUR 109.8 million, increasing by 10.4%, compared to the same period in 2019. This was mainly driven by higher R&D costs in relation to the high CVnCoV expenses, and of course, partially offset by the recognition of EUR 33.1 million in contract liabilities upon the termination of the Eli Lilly collaboration. Additionally, during both these periods in '20 as compared to 2019, the increased operating loss was partially offset by a decrease in cost of sales due to a lower set of activities and lower commercial manufacturing for our collaboration partners. In 2020, we posted a final -- financial loss of EUR 20 million mainly driven by interest for convertible loans which were fully repaid in August 2020, as well as, a negative interest rate on cash, and a net negative FX impact mainly in the fourth quarter of this year.

In the 12 months of 2020, we recorded a loss before tax of EUR 129.8 million, compared to a loss before tax of EUR 100.1 million for the same period in 2019. With this, I would like to hand back to Franz for today's key takeaway messages.

Franz Haas -- Chief Executive Officer

Thank you, Pierre. Let me quickly summarize before we move into the question-and-answer session. 2020 was a year of fundamental corporate transformation which has taken us to the next level in our development from a research-orientated biotech to commercial biopharma company, based on our unique platform technology and broad clinical COVID-19 vaccine program. Our lead vaccine candidate, CVnCoV is in the final stage of its clinical development.

We are expecting important data readouts from our late-stage clinical trials in the coming weeks and we believe that they will allow us to seek regulatory approval in the second quarter of this year. We have positioned CureVac to create sustainable value during and beyond the pandemic with strong and experienced partners based on our COVID-19 pipeline of first- and second-generation COVID-19 vaccines, including the variants. Our European manufacturing network is successfully ramping up with experienced partners. The capacity we are creating with these partners enabled us to raise our 2020 manufacturing guidance from 600 million to 1 billion dosages of CVnCoV.

We closed 2020 with a very favorable cash position of EUR 1.32 billion, and since then, we're able to raise another USD 517 million in a highly successful follow-on to our 2020 IPO. This will continue to fuel our ongoing transformation and the clinical expansion around and beyond CVnCoV, including oncology. With this, we conclude our presentation and would like to open the webcast to your questions. Thank you.

Questions & Answers:


Operator

[Operator instructions] Our first questions come from the line of Geoff Meacham with Bank of America. Please proceed with your questions.

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

Hi, guys. It's Aspen on for Geoff. Thanks for taking our questions. So first off, I just want to get a sense of how you are framing the two studies you have reading out sometime over the next couple of weeks being the Phase 2a/3 study and the Phase 2b/3 study.

You know, which one should we expect to read out first? And if it is the Phase 2a study, now that the vaccine efficacy data is included, should we think of that as telegraphing for the data for the Phase 2b/3? Or are there some nuances you'd want to point out there? And I have a follow-up question as well.

Franz Haas -- Chief Executive Officer

OK. Thank you very much, Geoff. Ulrike, do you want to take this, please?

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Yeah. So of course, it is difficult to say precisely the exact date of the readout, but our expectation is that the readout will come around in the second quarter for both trials. Does that answer your question?

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

Yeah. And then on top of that is, I guess, do you think that the -- are there any nuances between the two studies that you think are worth pointing out? Like let's say, we get the data from one before the other, should we view it as a one-to-one read-through and efficacy data? Or is there something you'd want to point out as some differences there?

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Yeah. Not sure, so did I answer your question? Or I'm not sure I understood your second question. Could you maybe repeat?

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

Yeah, sure. So I guess I'm just trying to understand what the differences are between the Phase 2a/3 study and the Phase 2b/3 study and if we should think about the efficacy results from both studies to be -- should we compare those as a both apples-to-apples comparison? Or are there differences between the two studies, do you think that are worth noting?

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Yeah. Yeah. So, of course, the Phase 2b/3 study is much larger study which was primarily designed to bring the efficacy readout. So I would say the data from the 2a study will be complementary to the Phase 2b/3 study and will provide complementary data, in particular, for the age group above 60, yeah.

But the main readout will come from the Phase 2b/3 study.

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

OK.

Franz Haas -- Chief Executive Officer

Perhaps to add to this, Geoff -- perhaps to add to this, Geoff, we started the Phase 2a study in order to have sooner than later also elderly people beyond 60 years included in the clinical trial. So the trial was, first of all, set up as a safety trial to cover more subject than we started in the Phase 1 and a confirmatory trial on the dosage. Therefore, we started with 6 and 12 microgram. And then with 12 microgram, we recruited quite a lot of elderly there as well, so people beyond 60 years and then we saw what we collected there, including the number of subject that we amended there.

The endpoint in order to have this data also as confirmatory for our efficacy trial which is a Phase 2b/3.

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

Got it. Got it. That's very helpful and one more last follow-up, if you don't mind. So it's very clear that you guys are taking a pretty comprehensive approach to tackling COVID-19.

I think Slide 9 was outlined all your different studies you have going on. But how about outside of COVID-19 for the other vaccine infectious disease programs, are those less of a priority now? Or maybe you can just help us understand what the status of those are and how those are progressing?

Franz Haas -- Chief Executive Officer

Yeah, absolutely. Thanks for the question. So we have signed mid-last year 2020 with GSK a broad collaboration which is a kind of platform collaboration where we have the entire infectious disease included. So unfortunately, we cannot talk about the activities on the different pathogens we are working here, but these are considerable huge indications which certainly are falling outside the pandemic.

Which what we saw on the basis of our Phase 1 COVID trial and 2a so far is -- was very convincing also for GSK to say, well, this is really nice what we see based on the other activities we had to say, well, can we not base here on the second generation, something more on a multivalent kind of development, including certainly combo products with other pathogens. Again, we cannot talk about this, but these are quite very interesting indications outside the pandemic.

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

OK. Thank you.

Operator

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

Serra Goudarzi -- Jefferies -- Analyst

Hi, this is Serra on for Eun. Just a couple for me. I really appreciate the detailed update. It's a little puzzling that we haven't seen the efficacy data after the COVID vaccine, but there is still a continued amendment and new trials being added.

How should we interpret this? And why not report the Phase 2a data you have in hand while enrolling the new adolescent group? And then I have a follow-up as well.

Franz Haas -- Chief Executive Officer

Ulrike, you want to take this?

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Yeah. So as you may have noted in our recent press release, yeah, we have hired in the management to add an efficacy endpoint to the Phase 2a trial and that is the reason why we did not yet initiate the readout, yeah. So we have this increasing prevalence of COVID-19 cases in Peru and Panama. And in order to utilize to case data, we have decided to add this efficacy endpoint and to defer to readout until the point in time when we will have the amendment approved and analyze the trial.

That was the reason behind it. Does that answer your question?

Serra Goudarzi -- Jefferies -- Analyst

Yes. Thank you and then just one for the Phase 2b/3, are there any changes to the statistical plan? And what should we expect for the efficacy from the U.K. variant versus the Wuhan strain?

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Yeah. So I think I cannot go into the level of details of the plan today. But as we have mentioned, so we -- it does not change the primary endpoint of the trial with regard that we were adding strain-specific efficacy there. But we added the efficacy against U.K.

and Wuhan strain, as a secondary endpoint that will allow us to also look at the efficacy in these particular strains, but as a secondary endpoint.

Serra Goudarzi -- Jefferies -- Analyst

OK. Thank you.

Operator

Thank you. Our next questions come from the line of Shu Zhiqiang, Shu with Berenberg. Please proceed with your question.

Zhiqiang Shu -- Berenberg Capital Markets -- Analyst

Hi, thank you for taking the questions. Congrats on the progress. The first question probably is for Pierre on the financials. Maybe can you provide a bit of color on the upfront payment from EU, EUR 450 million? How much doses does it cover? And also on that that the second one for Pierre is for the one -- I calculated about EUR 1.8 billion currently in the bank.

How would you plan to use that cash for further development of the company?

Pierre Kemula -- Chief Financial Officer

Yeah. Thanks for the question. I'm happy to jump in. So the way that we discussed with the European Commission was that when you, of course, put a lot of resources upfront on clinical trials but also production, it was very important some of the risks would be shared, right, upfront.

So basically, the EUR 450 million is a share of the price of the vaccine and the way it works is, that as we filed, there will be another milestone. And then as we deliver the doses, these will be recognized into revenue, so that's the way this deal works. On your other question, so you are mentioning EUR 1.8 billion in cash. So I don't believe we actually stated that number.

There's a bit of dollars, there's a bit of euros, and there's also a little bit of spend in the first quarter. So it's probably a bit lower. But you know, of course, the immediate use of this cash is to push all these clinical efforts that we have and you heard about new trials coming in as well. And beyond that, I think if you put COVID aside for a little while, it's really -- you know, we, as a company, have been super capital efficient, but we really need to grow the company, the structures to be able to really tap at the full potential of Messenger RNA.

So we will need to have bigger clinical teams, we'll need to have bigger regulatory teams, we will have to beef up our, I would say, disease area teams, etc., etc. So I mean, this is, I think, you know, what Franz was trying to explain is we're leaning to a turning point and we need to continue to grow the company. So this is really one of the key use cases for the cash.

Zhiqiang Shu -- Berenberg Capital Markets -- Analyst

Got it. And the second question, maybe for Franz or Pierre. In terms of 2022, you upped the guidance for production. I guess, have you been in the negotiation with governments for contracts versus 2022?

Franz Haas -- Chief Executive Officer

Yes, definitely, we are and you know, as the overall landscape of the availability of vaccines independently from which platform. It doesn't look good globally, really, saying, there is much more vaccines needed than available. And certainly, we are talking, well, primarily with the governments, but also international organizations, as you can imagine, with COVAX. And, yes, there is a huge demand and, certainly, a high expectation on also our data to come in and our vaccine adding to the demand and available vaccine.

So, you're absolutely right. There are very hot discussions. And the frustrating part certainly is, as with all the others is, that the vaccines are needed now in order to fight the pandemic. And then in parallel and this is also why we are so broad working on the variants as well to say, OK, how can we get a protection also against the variant? So, therefore, even more so, it's so important that we are building up these franchise, not only with regard to the manufacturing capacity because the more variants are there, the more capacity you need in order to produce also this and so we are still adding partners to the network.

And on the other side, also on the development part, it is so important to have this further clinical trials, but also the second gen in order to have perhaps even multivalent vaccines which are covering more than just one strain.

Zhiqiang Shu -- Berenberg Capital Markets -- Analyst

Got it. This is very helpful. And final question, maybe for Mariola on the Phase 3 reporting -- data reporting. I remember you guided earlier that potentially split the cases based on the -- whether original variant or the new variants.

Would you clarify that? Would that still be the case when you finally report the efficacy endpoint?

Mariola Fotin-Mleczek -- Chief Technology Officer

Yes. What we do in our trials, we collect all the COVID cases and we will sequence all of them. This is the goal to have a very clear information what kind of strains are we facing in all our trials. This will be in our Phase 2b/3 trial HERALD study for our study in Peru and Panama only for the last cases because originally, the study was not planned to do this.

But also here, we tried at least for the last cases to implement sequencing as well.

Zhiqiang Shu -- Berenberg Capital Markets -- Analyst

Great. Thanks very much. Thanks for the great work.

Franz Haas -- Chief Executive Officer

Thank you.

Mariola Fotin-Mleczek -- Chief Technology Officer

Thank you.

Operator

Thank you. Our next question has come from the line of Seamus Fernandez with Guggenheim Securities. Please proceed with your question.

Seamus Fernandez -- Guggenheim Securities -- Analyst

Oh, great. Thanks very much for the questions and all the updates. Maybe just to start off, I just wanted to clarify, is the reason that you're looking to incorporate the Phase 2a events analysis and efficacy analysis. Is that based on a rapid accrual of events and you do not actually have the data in hand, so you don't actually know what the difference is? You're not -- you remain unblinded to that information? Or have you been unblinded and if you've been unblinded, how -- what is it that is preventing the release of that information? I just think there's a little bit of confusion in that regard.

If you could just maybe clarify that first?

Franz Haas -- Chief Executive Officer

Absolutely. Thank you very much for the question. If this is not clear, absolutely, so we are still blinded and the ratio between -- in this recruitment was 90% of vaccine group and 10% placebo. And as we can see that the attack rate in Peru and Panama is quite high and we see the cases coming in, so this is very predictive for us.

And therefore, we wanted to stay blinded in order to make much more out of this clinical trial.

Seamus Fernandez -- Guggenheim Securities -- Analyst

Perfect. No, that makes perfect sense. I just wanted to clarify that. And then the second question, as we think about and I'm sure you're monitoring the evolution of the strains in the markets where you're conducting your clinical study.

In terms of where we've seen other interim analyses at, let's say, 50 events. For your interim analysis, will that also be at 50 events? Will it be at a higher number because of the variability in the strains and the need to evaluate different strains? Just wanted to get a better sense of the compare and contrast that I'm confident we're all likely to do when the data initially hit.

Franz Haas -- Chief Executive Officer

Mariola?

Mariola Fotin-Mleczek -- Chief Technology Officer

Yeah, I can comment on this. As Ulrike mentioned, we didn't change our primary endpoint for the HERALD study. It's still protection against any strains. And therefore, also our first analysis will be done for the cases of something about 50, but for sure, we will also follow further with the higher numbers, and we will collect, as I explained, sequencing data to be able then to discriminate.

But currently, the interim data -- the cases needed for the interim data is not increasing.

Seamus Fernandez -- Guggenheim Securities -- Analyst

OK. Great. And then just in terms of the, I guess, evolution of strains in the countries where you are evaluating CoV-2. Just wanted to get -- or CVnCoV.

Just wanted to get a sense of, you know, what -- do you have a good sense of the strengths that are in the trial? Do you expect it to be predominantly 117 in Wuhan? You know, I imagine that you have a decent sense of the evolution there. Any guess at kind of how the percentages in the markets where you are affecting your studies are evolving?

Mariola Fotin-Mleczek -- Chief Technology Officer

Yeah. I think we presented this also on the slide. We monitored this very closely and what we see, there are short differences, yeah. As in Europe, the U.K.

variant is dominating here, it's not the case for Latin America. So we have different circulating strains in different areas. And therefore, it's very important, if you look on the data, yeah, how does -- what are the cases, how many cases in different areas? I am sure, we will learn a lot from our HERALD study also regarding this point.

Franz Haas -- Chief Executive Officer

Yeah. I think as you know, there will be about, in total, say, to make it simple, a third of European subjects and two-third of South American subjects in the HERALD study. It is key that in Europe, I think the epidemiology is pretty good. I think we know more or less ways out there.

I think the situation is more contrasted in South America, where you don't always have super up-to-date data, and I think the trial will prove, will bring us a lot of information when the cases will be sequenced.

Seamus Fernandez -- Guggenheim Securities -- Analyst

Great. And just I know it seems somewhat obvious, but is it possible that the first interim or that -- can you just tell us whether or not the number of events has actually occurred that we've passed 50 events? Or you actually expect that threshold to be achieved in the near future?

Mariola Fotin-Mleczek -- Chief Technology Officer

We didn't reach this. Yeah, this is what I can tell you. The cases are coming, but we are not there, yeah.

Seamus Fernandez -- Guggenheim Securities -- Analyst

OK. Understood. And then just in terms of some of the updates that we've received and presentations from competitors in the last week. Just love to get your thoughts on a couple of opportunities on a go-forward basis.

First is really -- it seems like there are second-gen evolutions of the vaccine programs in RSV, in particular, at some competitors that are showing meaningful changes in immunogenicity, particularly, in RSV. Just love to know how CureVac is thinking about that potential opportunity. And then separately and I know it may fall under the GSK program. And then separately, also just sort of the flu opportunity from your perspective and how you envision the market for flu, perhaps, evolving and the pace at which it could evolve with the entry of mRNA vaccines.

You know, how promising do you think that is? Thanks.

Mariola Fotin-Mleczek -- Chief Technology Officer

OK. Thank you for the questions. Yeah, we are not surprised that all the competitors go from a second-generation vaccine in different areas. This is, I think, was a success of COVID vaccine.

It's obvious and everybody is accelerating all the other programs, yeah, showing really that there's huge potential and you can imagine that the same is also the case for us, yeah. Nobody stopped the other optimization of Messenger RNA just by initiating COVID trial. And although we had different programs in our pipeline, we entered the collaboration with GSK for different indication outside of COVID and all of this also benefit from the experiences in COVID. You know, all this optimization on Messenger RNA will be also implemented in other programs as well.

And for sure, the safety data we are collecting now from huge amount of people, this will be also relevant for all other programs. Therefore, yes, all this is what you can expect and from other companies that you will try to use this potential and go for further vaccine as soon as possible.

Franz Haas -- Chief Executive Officer

And perhaps to add to this one because it fits exactly into this. What we are talking with the government at the moment is also what to do in order to be prepared for the next variants to come and we don't know how they look like, but also preparedness on other viruses' pandemics to come. We see that the world is really somehow paused for a while and now, all the manufacturing capex invested into the capacity is going to stay also for other vaccines because these facilities just produce RNA and this is exactly the need -- the interesting part also of this technology that in the same facility you can produce it, and there is a decentralizing of manufacturing going on. There is no centers of global excellence anymore.

It's more a kind of regional excellence and manufacturing capacities. Again, and here RNA really can make a difference. So the bottlenecks, what we are seeing with regard to having available vaccines which is due to the fact that no capacity is available, this capacity is built up, so the capex is well invested.

Seamus Fernandez -- Guggenheim Securities -- Analyst

OK. Thanks very much.

Operator

Thank you. There are no further questions at this time. I would like to hand the call back over to management for any closing remarks.

Sarah Fakih

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

Franz Haas -- Chief Executive Officer

Thank you.

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Thank you.

Pierre Kemula -- Chief Financial Officer

Thank you.

Duration: 60 minutes

Call participants:

Sarah Fakih

Franz Haas -- Chief Executive Officer

Ulrike Gnad-Vogt -- Interim Chief Development Officer

Pierre Kemula -- Chief Financial Officer

Aspen Mori -- Bank of America Merrill Lynch -- Analyst

Serra Goudarzi -- Jefferies -- Analyst

Zhiqiang Shu -- Berenberg Capital Markets -- Analyst

Mariola Fotin-Mleczek -- Chief Technology Officer

Seamus Fernandez -- Guggenheim Securities -- Analyst

More CVAC analysis

All earnings call transcripts

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.