CureVac (CVAC) Q3 2021 Earnings Call Transcript

CureVac (CVAC -9.16%)
Q3 2021 Earnings Call
Nov 19, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Greetings, and welcome to the CureVac AG third quarter and first nine months 2021 financial results and business update. [Operator instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Sarah Fakih, head of the corporate communications and investor relations for CureVac AG.

Please go ahead.

Sarah Fakih -- Head of Corporate Communications and Investor Relations

Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Fakih. 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 Franz-Werner Haas, the chief executive officer of CureVac; Klaus Edvardsen, our chief development officer; and Pierre Kemula, chief financial officer of CureVac. Mariola Fotin-Mleczek, our chief technology officer, will be available 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, Friday, November 19, 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-Werner Haas -- Chief Executive Officer

Thank you, Sarah. Ladies and gentlemen, a warm welcome to this conference call from here, from us at CureVac. Let me begin with a brief assessment of where we stand today. The global fight against SARS-CoV-2 continues.

And while licensed vaccines have helped to manage initial large-scale vaccination programs, the world still needs additional and improved vaccines to allow for broader vaccination coverage, more differentiated protection, and simplified delivery logistics to control the virus in long term. Recognizing this challenging situation, our decisions made during the third quarter of 2021 have positioned CureVac well to develop vaccines that are expected to meet these goals. Let me give you a short overview of selected key developments in the third quarter. In October this year, we made the strategic decision to withdraw our first-generation COVID-19 vaccine CVnCoV from regulatory review based on a combination of factors that included potential overlap with the time lines for a second-generation candidate and the changing needs toward differentiated vaccines.

We made this decision because we remain committed to the long-term fight against COVID-19, and, together with our partner, GSK, have decided to be fast with a second-generation vaccine rather than late with an age-restricted first-generation product. The first candidate from our jointly developed COVID-19 second-generation program, CV2CoV, is an unmodified mRNA construct that has shown great potential in several preclinical models. Comprehensive preclinical data in nonhuman primates show that CV2CoV outperforms our first-generation candidate in every tested parameter. These data were recently complemented by a direct comparison of Cv2CoV with commercially available Pfizer BioNTech vaccine, showing that Cv2CoV is able to induce highly comparable neutralizing antibody titers in nonhuman primates.

The full comparison data was published in Nature yesterday, providing substantiated support of the unmodified mRNA approach for the entire field of mRNA technology, and Klaus will update you on our technology approach in this manner in -- of our second-generation vaccine program later. In oncology, we recently presented updated Phase 1 data of our lead candidate CV8102 at SITC. Deep analysis of immune cell activation in blood samples and tumor biopsies supported a mechanism by which CV8102 induces immune responses throughout the entire body, to fight tumors that are directly injected with CV8102 as well as distant noninjected tumors. In our third therapeutic area, protein therapy, as we recently renamed it molecular therapy, we recently published preclinical data in the Journal of Hepatology.

The data provided the first experimental proof that an mRNA therapeutic can serve as potential treatment option for liver fibrosis, showing the potential of the technology in this challenging era. Beyond the mRNA technology platform, we are also advancing our manufacturing technologies, adjusting our capacity needs to the anticipated volume of second-generation vaccines in COVID-19 and other infectious diseases. On the financial side, we closed the third quarter of 2021 with a favorable cash position of EUR 1.06 billion. Subject to market conditions, we may conduct in future at market offerings to sell shares of up to $600 million.

Applying this facility will potentially provide additional means to accelerate the development of our company as well as our technology across all therapeutic areas. Before we now go to the detail of these program updates, I would like to take a step back and provide a look at CureVac's pipeline, and the areas of diverse indications where we apply RNA technology to address diseases with a high unmet medical need. We have said it many times before, but please let me repeat. The era of RNA technology has only just begun.

While mRNA was validated as a key technology in the fight against it COVID-19, its potential exceeds to a much broader range of medical indications in prophylactic vaccines and beyond. Correspondingly, the CureVac pipeline builds on three main therapeutic areas: prophylactic vaccines, oncology, and molecular therapy. Following the withdrawal of our first-generation vaccine candidate CVnCoV, our prophylactic vaccine pipeline is led by the broad second-generation infectious disease program, including COVID-19 developed in collaboration with GSK. The program applies an unrestricted technology approach, investigating both unmodified as well as modified mRNA constructs.

As already mentioned, the first representative of the second-generation COVID-19 program is CV2CoV, an unmodified mRNA, which has the -- which has preclinically shown significantly improved immune responses compared to our first-generation candidate, matching neutralizing antibody titers of the Pfizer BioNTech vaccine, comminate in a direct comparison. In the broader infectious disease program, the first non-COVID representative is an influenza vaccine. First constructs are currently being assessed in preclinical models and a clinical study is expected to start in the first half of 2022. There is a clear translation of COVID-19 learnings for immuno-oncology, where the same principles are applied to induce a strong systemic and tumor-directed immune response.

In oncology, we are exploring a range of different approaches. Our lead candidate, CV8102, is currently being assessed in a Phase 1 clinical trial in solid tumors. We are also evaluating approaches to novel cancer vaccines targeting shared neoantigens and tumor-associated antigens. In the third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics, together with a number of renowned collaboration partners for the development of antibodies or therapeutic proteins intended to treat diseases characterized by missing or inactive proteins.

Let me now hand over the call to Klaus to walk you through the details of our program updates.

Klaus Edvardsen -- Chief Development Officer

Thank you, Franz, and hello, everyone. Let me move to Slide 6 and start by describing our prophylactic vaccine area. Let me briefly remind you of the scope of our broad infectious disease collaboration with GSK, in which we are jointly developing a suite of potentially improved second-generation vaccine candidates for COVID-19 as well as a broad range of other infectious diseases. Our second-generation vaccines are based on an advanced messenger RNA setup featuring targeted optimization to the untranslated regions of the messenger RNA to enable improved translation and extended protein expression for stronger and earlier into responses.

Due to the need for more differentiated vaccines in the ongoing fight against COVID-19, these characteristics will be key to develop advanced vaccine candidates, but also future multivalent formats for simultaneous protection against different COVID-19 variants or for a combination of different infectious diseases such as COVID and flu. As Franz highlighted before, this includes an extension of our technology platform to modified messenger RNA constructs to allow for data-driven selection of the best possible candidates. With CV2CoV, we have preclinically advanced the first representative of a large second-generation COVID-19 program, which I will speak about in more detail on the coming slides. We aim to kick off the second-generation COVID-19 clinical development program within the next few months and intend to also explore modified construct within the trial.

On the infectious disease side, our jointly developed flu construct is currently in preclinical testing and will enter the clinic in the first half 2022. Let me now briefly go into the preclinical data of Cv2CoV, demonstrating the strong potential of our second-generation messenger RNA. I now move to Slide 7, which represent an excerpt from a large preclinical data set in nonhuman primates generated in collaboration with Harvard Medical School, published online in Nature yesterday. The preclinical study initially uploaded to the bioRxiv's pre-print server features a direct comparison of CV2CoV and CVnCoV fully utilized animals.

In the study, Cv2CoV exhibit significantly improved utilizing antibody levels compared to CVnCoV, which range about 50 times higher one week after second vaccination. Faster onset of neutralizing antibodies led to meaningful titers just two weeks after the first vaccination, seven times higher when compared to CVnCoV, which was still at baseline. Consistently higher antibody titers for CV2CoV were also observed in response to relevant COVID-19 variants, including the delta variant. We recently extended the comparison data shown here on Slide 8, in nonhuman primates by a direct comparison of CV2CoV with the licensed Pfizer BioNTech vaccine Comirnaty.

Neutralizing antibody titers were measured following full vaccination of animals with either 12 micrograms of CV2CoV or the standard dose of 30 micrograms of Comirnaty. At peak immunity at week five, utilizing antibody titers induced by CV2CoV cock were highly comparable to titers induced by the licensed vaccine. In summary, the CV2CoV data demonstrate how targeted optimization of a non-chemically modified messenger RNA construct can substantially improve immunogenicity in preclinical study. The data, thereby, demonstrate the overall relevance of the unmodified approach for our understanding of the potential of messenger technology as a whole.

Let me move to Slide 9 to describe the oncology part of our pipeline. I would like to update you on the progress on our lead candidate CV8102, currently under evaluation in a Phase 1 clinical trial. Let me briefly remind you that CV8102 is a noncoding RNA optimized to activate RNA receptors that normally detect viruses, including toll-like receptors seven and eight as well as RIG-1. When injected directly into the tumor, CV8102 mimics a viral infection of the tumor, which can activate the immune new system to reject the tumor.

It is hypothesized that the locally induced immune response in the injected tube is amplified throughout the party based on the release of tumor antigens and the activation of tumor-specific T cells that are able to clear tumor cells at the injected site, but also at distant non-injected tumors called metastases. The Phase 1 clinical trial is evaluating administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin and head and neck cancers, or adenoid cystic carcinoma. Patients received CV8102 as single agent or in combination with anti-PD-1 therapy. The trial is a two-part study, a dose-escalation part has already been completed, an expansion part of the study initiated in February this year, specifically evaluate CV8102 in 40 additional patients with advanced melanoma.

If we move to Slide 10, you can see the latest update on CV8102 efficacy from the dose-escalation part of the study. The data represents a [Inaudible] update from June this year and were presented earlier this year at the ESMO conference in September. On the left, evidence of single-agent activity can be observed in one patient with a complete response and one patient with a partial response in melanoma as well as one patient with a partial response in cutaneous squamous cell carcinoma. Overall, the patient experienced a stabilization of disease, including same shrinkage of non-injected lesion in some patients.

The combination group on the right includes more heavily pretreated patients who were indicated for anti-PD-1 therapy and who did not respond or slowly progressed on anti-PD-1 therapy. So far, two melanoma patients could be observed with a partial response and two further melanoma patients experienced stable disease as well as one patient with head and neck cancer. Moving on to Slide 11. At the recent SITC conference last week, we presented additional details in muni profiling data from the CV8102 Phase 1 dose-escalation part.

The data is based on blood samples from all patients as well as tumor biopsies of injected and noninjected tumors from four of the patients. The data support the hypothesis that the local injection of CV8102 into a single tumor is able to produce a systemic response, leading to an immune effect against both injected and non-injected tumors. Tumor biopsy data confirms strongly increased T cell infiltration by both CD4 and CD8 T cells and a corresponding decrease of the tumor cell content. Blood samples of patients in order to further confirm broad activation of the innate immune system within 24 hours after injection, mainly characterized by interferon alpha and interferon gamma.

In the expansion part of the Phase 1 study, patient enrollment was completed in October. Data, including biopsies for over 20 patients is expected to be reported in the second half of 2022 and will further complement our understanding of the therapeutic effects of CV8102. Let me turn to Slide 12 and transition into the third therapeutic area in our pipeline, protein therapy, or as we have recently renamed it molecular therapy. As Franz has already highlighted, our development efforts in molecular therapy target disease is characterized by missing our inactive proteins to provide optimized messenger RNA that can restore or replace these proteins.

In this area, we recently published promising preclinical mouse data in liver fibrosis, a disease that contributes to millions of debts annually. The study was carried out in collaboration with the research center at the Hannover Medical School. Progression of liver fibrosis is associated with a gradual decrease of HNF4 alpha, a protein essential for liver development and metabolism. The data shown on the left illustrate reduced HNF4 alpha levels in fibrotic versus healthy mice.

To circumvent this decrease, we developed and optimized messenger RNA encoding for HNF4 alpha that was able to induce production of the missing protein inside cells, as shown in the middle graph. Correspondingly administration of HNF4 alpha messenger to fibrotic animal was indeed able to restore HNF4 alpha level and significantly reduced liver injury. This is illustrated on the right by the reduction of ALT, an indicator of liver damage. Overall, this study demonstrates the potential of messenger RNA technology in molecular therapies and provides the first experimental proof that messenger RNA therapeutics can serve as a potential treatment option for liver fibrosis.

With this, let me hand the call back to Franz.

Franz-Werner Haas -- Chief Executive Officer

Thank you, Klaus. I'm now on Slide 13 to give you an overview of the current plans for our manufacturing capacities. We are continuously adjusting our capacity projections to ensure that we can rapidly and flexibly deliver potential second-generation vaccines in line with the anticipated volumes. The switch of the manufacturing setup from the production of first to second generation construct at our in-house GMP three facility and the facilities of our European network partners is progressing.

This includes the implementation of processes for flexible adoption to new variant specific constructs as well as processes for the production of modified mRNA construct, which we explore as part of the second-generation development program. For CV2CoV, we have already produced material for the upcoming Phase 1 clinical trial in our in-house plans, GMP one and two. The buildup of our commercial-scale manufacturing plant GMP four is also progressing as planned, representing an important factor in our setup to efficiently deliver on future public health needs and pandemic preparedness initiatives. Let me now hand over to Pierre for a review of our financial data.

Pierre Kemula -- Chief Financial Officer

Thank you, Franz, and good morning and good afternoon to everyone on the call. We are successfully progressing in the transition from our first to second-generation vaccine program while executing on our financial strategy. Early in September this year, we have set up an at-the-market financing, which, subject to market conditions, may provide us with the option to offer the future shares worth up to $600 million over a period of several years. If we are able to use the at-the-market tool in the future, we expect to use the proceeds to provide further means to fund the transition from first to second-generation vaccines as well as accelerate the momentum of our mRNA technology across the therapeutic areas.

Before we go into the cash and P&L discussion on Slide 15, let me briefly update you on the anticipated financial impact of restoring CVnCoV from the regulatory review, with a focus on the advanced purchase agreement that we have with the European Commission that signed in November 2020. The European Commission and CureVac has structured the APA to share the financial risk of our accelerated efforts to develop a safe and efficacious vaccine by providing a EUR 450 million upfront payment. According to the EU APA, we must only return the unspent amount of the prepayment. And we are in the process of submitting to the European Commission reported expenses or expenses committed to the using of the upfront payment.

At this stage, we do not expect that we will be required to return any portion of it. The value of certain assets, semifinished and finished goods that will have -- that will have no future use will be assessed in the fourth quarter of 2021. We are currently coordinating with the European Commission to evaluate whether it will exercise its options to recover some raw materials or primary components paid for with the upfront has allowed under the APA. With that, let me resume the financial review.

Looking at our current cash position, we closed the third quarter of 2021 with a favorable cash position of EUR 1.06 billion. Over the first nine months of 2021, the development of our cash position was mainly driven by the raising of EUR 404 million in net proceeds from our follow-on offering in the Q1 in the first quarter, a EUR 75 million upfront payment following our collaboration extension with GSK and a EUR 38.3 million tranche from the grant from the German Federal Ministry of Education and Research. Cash was used mainly for the development of CVnCoV. Moving on to our profit and loss statement.

Revenues increased EUR 24.1 million to EUR 29.3 million for the third quarter of 2021, and EUR 19 million to EUR 61.8 million for the first nine months of the year compared to the same periods in 2020. The increase was mainly driven by revenues from our GSK collaboration, which provided EUR 49.6 million in revenues for the first nine months of 2021. In addition, termination of the Boehringer Ingelheim collaboration agreement for our legacy clinical candidates in non-small cell lung cancer became effective on November 17 of this year. The remaining contract liability related to the upfront payment is now fully recognized.

For the first nine months of 2021, this led to a EUR 10 million being recognized as revenue, compared to EUR 1.4 million in 2020. These increases were partly offset by a EUR 33.1 million onetime effect in the second quarter of 2020. Operating loss was EUR 143.1 million for the third quarter, representing a EUR 106.4 million increase compared to the same period in 2020. For the first nine months, operating loss increased by EUR 443.5 million to an overall EUR 406.7 million.

The strong increase was in line with high CVnCoV development costs throughout 2021. These were mainly driven by higher R&D expenses as well as increased general and administrative expenses and cost of sales, the latter resulting from CVnCoV manufacturing activities, including the termination of several CMO contracts within our European manufacturing network. Overall, the increase in expenses was partially offset by a strong increase in other operating income based on our grants from the German Federal Ministry of Education and Research. Financial results for the third quarter decreased by EUR 0.4 million and increased by EUR 8.2 million to EUR 1.2 million over the first nine months of 2021.

Net loss was based on negative interest on cash held in liquid funds to support development and manufacturing activities of CVnCoV and CV2CoV. It was almost fully offset by foreign exchange gains. Pretax losses were EUR 143.5 million in the third quarter and EUR 407.9 million in the first nine months of 2021. With this, I would like to hand back to Franz for today's key takeaway messages.

Franz-Werner Haas -- Chief Executive Officer

Thank you, Pierre. Let me quickly summarize the key messages from today's presentation. CureVac remains fully committed to the global fight against COVID-19. We will now focus our priorities and resources with the goal of delivering advanced second-generation vaccines together with GSK, addressing global pandemic and post-pandemic healthcare needs.

Further on, between the two companies, priorities for our broad infectious disease program, we are fully aligned to accelerate the development of a future pipeline of mRNA vaccines, including COVID-19, supported by a large number of dedicated experts on both sides. Being dedicated to this common goal, we will take an unrestricted technology approach to advance our entire platform and ensure data-driven selection of the best candidate. Highly relevant preclinical data of second-generation candidate Cv2CoV has recently shown the potential of competitiveness of an unmodified mRNA approach, which will be assessed in parallel to the modified mRNA constructs. Learnings and infrastructure from our first-generation candidate are expected to be leveraged to accelerate momentum across the entire pipeline and technology platform and to deliver advanced vaccines and therapeutics in oncology and molecular therapy.

With this, we conclude our presentation and would like to open the webcast to your questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] Our first question comes from the line of Manus Masteracus with Deutsche Bank. Please proceed with your question.

Manos Mastorakis

Yes. Hello, and thank you for taking my question. The main question I wanted to ask is what is the expected run rate of [Inaudible] in 2022? And what are the implications for the funding outlook for the business moving forward?

Pierre Kemula -- Chief Financial Officer

Yes. So Pierre speaking, happy to take the question. So I think let me try to answer it this way because we are still very much in the budget phase. So we don't have final figures yet to be able to provide you a bit more color.

But what you should think is to spend all the cash -- I mean, the cash spend that we've had over 2021 was only decline next year, right? And so we feel that, for the time being, our cash position is comfortable. But of course, as I said, we put in place this ATM and, at some point, indeed, if there's an investor interest, we will be happy to use it.

Operator

Thank you. Our next question comes from the line of Evan Wang with Guggenheim Securities. Please proceed with your question.

Evan Wang -- Guggenheim Partners -- Analyst

Hi, guys. I want to clarify some aspects of the nature of publication. Do you guys plan to kind of share additional data in terms of the comparison between CV2CoV and Comirnaty? When will we see the kind of whole kind of time lines in terms of neutralizing antibodies response? And can you clarify a little bit where the Comirnaty monkeys dosed in the same pay [Inaudible] schedule or renew [Inaudible] 28? And how do the kind of peak there compare? And then I have a follow-up.

Mariola Fotin-Mleczek -- Chief Technology Officer

OK. Mariola speaking. In this study, we have just one data set showing how antibody titers compared by using vaccination schedule, which is typical for Comirnaty and vaccination schedule we used for our candidate. There will be a separate study coming here on in the future are on -- from Ten Lab, yes.

But this is not a collaboration with us here. So we will have more data coming soon.

Evan Wang -- Guggenheim Partners -- Analyst

Great. And as a follow-up, what level of confidence does this study give you given the -- I mean, the comparable results there? And I guess, what are the remaining hurdles before starting the clinical trial?

Klaus Edvardsen -- Chief Development Officer

Hey. Hello. [Technical difficulty] Can you hear me?

Franz-Werner Haas -- Chief Executive Officer

Yes, please proceed.

Klaus Edvardsen -- Chief Development Officer

Yeah. I mean, in essence, there are no hurdles there is, as we have alluded to under the presentation that we are going to go into the second generation effort with a combination of approaches -- And therefore, it's not a hurdle. It's just simply to be ready to test out the different modalities that we would like to test out.

Franz-Werner Haas -- Chief Executive Officer

And we are in preparation to start the clinical trials within the next months to come in collaboration with GSK.

Mariola Fotin-Mleczek -- Chief Technology Officer

And the data for [Inaudible], if that -- also our Cv2CoV construct has a good chance to be also a good solution. As we always mentioned, yes, we will face different constructs modified, unmodified knowing that the mechanism of action is not exactly the same, and this is exactly the beauty of the trial look on the four immune response, memory responses and then decide on the data which construct could be the solution for future -- for our development.

Evan Wang -- Guggenheim Partners -- Analyst

Thank you.

Operator

Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Please proceed with your question.

Jonathan Miller -- Evercore ISI -- Analyst

Hi, guys. I am also excited to see the second-gen trial gets started there. And I guess, just following on, on that previous question, you mentioned you have unmodified, modified you're going to try multiple things. I guess, have you said what the modifications you're using are? And I guess what's your clarity or what's your comfort level around your freedom to operate in what is usually a very locked down IP space in modified mRNA?

Mariola Fotin-Mleczek -- Chief Technology Officer

So I can comment here on this modification that we also consider use different modifications, it will be not just one. And also use different variants delta, etc., this will be tested as well.

Franz-Werner Haas -- Chief Executive Officer

And then certainly, on the IP field, if there are certain licenses to be needed, then certainly, we'll deal with the situation as well as we, of course, [Inaudible] operate is certainly an important part.

Jonathan Miller -- Evercore ISI -- Analyst

OK. I guess that makes sense. I guess the follow-up there is, if you have not yet pursued licenses on important modifications that have IP overhangs, what's your confidence that you'll be able to get licenses at this point?

Franz-Werner Haas -- Chief Executive Officer

We are quite confident as, of course, we are talking with relevant parties.

Jonathan Miller -- Evercore ISI -- Analyst

OK. Thank you.

Operator

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

Zhiqiang Shu -- Berenberg Bank -- Analyst

Great. Thank you. So a couple of questions around -- also around modified, unmodified. I guess in this collaboration with GSK, what are they contributing to the second-gen effort? And just on that modified, would they be working on the unmodified MRE together with you guys? And then I have a follow-up.

Thank you.

Mariola Fotin-Mleczek -- Chief Technology Officer

So as you know, we started our efforts on the second generation already in 2020. So we designed the same constructs -- a lot of the same construct, not just this one, yes? And when we generated data in different technical models. And based on this data, then GSK step in, and we closed with collaborations. So the initial effort and the design is coming from CureVac, and therefore, we invest further this approach.

And for sure, also knowing the results coming from outside what we see with competitors, the obvious question is whether this approach or how this compared to the modified, yes? And we don't want to exclude any options. As I said, the mechanism of action are not identical. That's what we want to learn, and that's what we included this as well in our trials, and this is absolutely also the intention and goals from our partner, GSK, as really to be data-driven and to make our decision based on the data.

Franz-Werner Haas -- Chief Executive Officer

Perhaps to add to this one is just two or three weeks ago, we had a broadening or intensening of our collaboration with GSK, and we had a webcast for this as well, and it was quite from GSK's part as well. To the question, what are they adding into it? It's not only just to have a monovalent vaccine to compete with the current situation, with the current vaccines, which are in the market. It is also how to deal with the entire pandemic, which is turning into endemic right now. So thinking about -- not only about the antibody titers and the monovalent, it's also to put other variants on the same backbone, same backbone with a longer protection life.

Then also thinking about multivalent that you have got a cocktail of different vaccines into the same short or -- and, on the long run, then also combine it with other mRNA-based vaccines. So that are lot of questions to be tackled, where certainly GSK, with all the understanding of the immune system of the virology and also how this develops, they're certainly adding a lot on top to changing an organization from a biotech company into a commercial company and by that, also broadening the technology. On the technology level, there are a lot of things to be done with immunomodulators, not only the one what Mariola was saying before as well with this one chemical modification, which is known, but also have other elements to play with on the RNA level, on the formulation level, but also on the antigen level. And all of this tells you quite a bit.

Broadening the pipeline -- broadening the technology is also then contributing outside the field what we are working with GSK for immuno-oncology and molecular therapies. So that is really what they bring to the table, what we alone could not be because there is also a time aspect which we need to accelerate.

Zhiqiang Shu -- Berenberg Bank -- Analyst

Got it. Thank you. And my second question is around the clinical development strategy here. I know it's probably early, but I'd like to ask probably for your second generation, you're looking at the booster market.

I guess, in this market -- in this asset, when you run clinical trials, are you looking to vaccinate people with two doses? Or are you looking for people who have been vaccinated and give them a booster? And then also related to that, I know your first generation is primarily for the European market. Now with everything exchanged that are you looking at both the U.S. and the Europe market at this point?

Klaus Edvardsen -- Chief Development Officer

I can start with the last part of the question first. Yes, we are also looking at the U.S. market. And the clinical development plan for the second-generation COVID program has been structured to both look into the booster setting.

And I think scientifically, it is interesting and important to understand whether you will get a different level of efficacy, or potentially even more important, a different level of reactogenicity by doing boosting with [Inaudible] principle. So that's one element of the program. There's certainly also an element of the program of being prepared with other variants and certainly the delta variance for a priming concept. It, I guess, implied in your question about the geography, there's obviously an ongoing speculation on how do you conduct a trial in this setting as of today, where you have a significant proportion of the world being vaccinated or infected.

And there are obviously speculations on how do you conduct the trial with correlates of protection and discussions on how that should be structured. But it is not only a European effort, it's a global effort. Thank you.

Franz-Werner Haas -- Chief Executive Officer

Perhaps to add to this one because you asked a question for the market there as well. I mean, as a pandemic now shows you with increasing incidences and the markets are still tender markets for governments to buy into, and there is a huge interest, what we see to be prepared coming into the future because there are still a lot of people who are not vaccinated. So to be priming vaccinated and others to deal with boosters and most probably also in the changing environment, also perhaps the new variants coming in. And again, what we, today, see in the vaccines are certainly vaccines for pandemic situation.

So there's a lot of need to work on stability and this kind of question as well.

Zhiqiang Shu -- Berenberg Bank -- Analyst

Great. Thanks very much.

Operator

Thank you. [Operator instructions] Our next question comes from the line of Geoff Meacham with Bank of America. Please proceed with your question.

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

Hey, guys. It's Aspen on for Geoff. Thanks for the question. Just kind of want to follow up on the last one.

Maybe you can discuss your strategy for contract agreements for CV2CoV and what the time line for that might be in some of the more, I guess, target regions that you're looking at? And maybe just help us -- help characterize some discussions you've already had with government bodies regarding CV2CoV? Thank you.

Franz-Werner Haas -- Chief Executive Officer

Yes. Thanks for the question. Well, in the details of discussions, we, unfortunately, cannot go in because this is all under confidentiality. But what one really can see is perhaps in twofold.

The one, there is a clear need for a decentralized available manufacturing capacity in the different locations, which is of utmost importance to take the lessons learned because I think no government wants to enter into the situation where we have been in 2021 -- 2020 and beginning of 2021. With the increasing incidence certainly, there is an understanding for more vaccines and most probably also flexible vaccines if there is a variant which is not that well covered by the current vaccines. And even with the current vaccines, you see that the intensive care units are going to be filled, but good that we have got the vaccines because, otherwise, the world would look different. So there is a need from this one, how this translates then into products to be prepurchased like it has been in the beginning, and in Europe, this is also still ongoing.

So this is a clear tendency what we see also in international level. What you see also in the international level is like the G7 and G20 come up and say how can we accelerate regulatory approval processes to -- for not only the current pandemic, but also what else is going to come that something can come and has a horrendous effect, not only on the world economy and the global health but on the entire social community. This is what we have been seeing. So there is, even beyond the current situation, a willingness and a clear interest to work on platforms.

And as we have seen, technologies like ours have to be built on 20 years. Now they are in a state where, at least in prophylactic vaccines, are exploitable. But also if you see this technology, which can be rather soon produced from target to fill and finish mine so to speak. There is a clear tendency to make it much faster, which then would contribute, for example, in a flu-like situation as well that you're coming much closer to the real season and now have a much better understanding on the pathogen in question.

So, therefore, there is a huge interest, as I said, about a concrete discussion and negotiations, I, unfortunately, cannot talk about.

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

Thank you.

Operator

Thank you. Our next question is a follow-up from the line of Manus Masteracus with Deutsche Bank. Please proceed with your question.

Manos Mastorakis -- Deutsche Bank -- Analyst

Yes. Thank you for taking our question. Basically, I wanted to ask around time lines for [Inaudible], you mentioned it would be next year. But beyond that, do you think there will be a need for a full Phase 3 head-to-head study for U.S.

approval? Is that something that you've thought about already?

Klaus Edvardsen -- Chief Development Officer

I think this is too early to say. I'm fully aware of the FDA notion that they are not, at this stage, accepting correlates of protection. And I think that there is obviously a necessity for an ongoing conversation as to whether you can conduct your trial in a different scheme. I think it's obvious that if you are talking about a year from now, to conduct a trial in the U.S.

that could be the traditional Phase 3 design with two groups, one vaccinated and one nonvaccinated, and then wait until you see the infection rates in the two groups is going to be increasingly difficult to conduct in the country like U.S. and obviously, also in countries around the world. So I withstand from especially FDA at this stage, I am absolutely confident will have to be revisited because it will slow down advances in current vaccines if you are not willing to open up for a different way of assessing efficacy in these trials and then obviously, the whole feasibility aspect that if you cannot find people that are [Inaudible] so to speak because they are either vaccinated before or they have naturally been infected, it will come into more difficulties doing it in the traditional way. But right now, it is correct that from an FDA perspective, they have taken a strong stand.

Operator

Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Ms. Fakih for any final comments.

Sarah Fakih -- Head of Corporate Communications and Investor Relations

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

Thank you, and goodbye.

Operator

[Operator signoff]

Duration: 50 minutes

Call participants:

Sarah Fakih -- Head of Corporate Communications and Investor Relations

Franz-Werner Haas -- Chief Executive Officer

Klaus Edvardsen -- Chief Development Officer

Pierre Kemula -- Chief Financial Officer

Manos Mastorakis -- Deutsche Bank -- Analyst

Evan Wang -- Guggenheim Partners -- Analyst

Mariola Fotin-Mleczek -- Chief Technology Officer

Jonathan Miller -- Evercore ISI -- Analyst

Zhiqiang Shu -- Berenberg Bank -- Analyst

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

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