Yes, thank you operator and good morning to some and good afternoon to the rest. Before we start the presentation that will be conducted by President and CEO, Paul Chaplin; and Executive Vice President and CFO, Henrik Juuel, I would like to read the following statements in our disclaimer. This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ from the results discussed. Forward-looking statements include statements regarding our short-term objectives and opportunities, financial expectations for the full year and financial preparedness as of year-end, as well as statements concerning plans, objectives, goals, future events, performance and all other information that is not historical information. All such forward looking statements are expressly qualified by these cautionary statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. And with this, I will hand it over to you Paul.

Yes, thank you, Rolf, and welcome everyone to Q1 update. So if you go to Slide 3, Bavarian Nordic is a fully integrated vaccine company. And the beginning of last year, we set ourselves a new vision to become one of the largest pure play vaccine companies by 2025. And within just one year, we have really made huge progress towards that vision and in the execution of our strategy. So we’ve greatly expanded with a number of employees to more than 700 currently and that’s to help produce, distribute and sell our commercial portfolio of vaccines where we have currently four products around the world. We have built up a commercial infrastructure in key markets, which allows us to sell and distribute these products. And importantly, we are continuing to expand and build on our expertise of commercial manufacturing here in Denmark. Added to that we have a rather exciting R&D pipeline with two near-term assets, we have an RSV late-stage program that’s currently in the human challenge study with data coming later this year. And we have a COVID-19 vaccine, which we’re developing as a universal booster vaccine, hopefully providing a more durable and broader protection for the current first wave of vaccines, so really some exciting times and data points coming in the next few months. And added to all of that, we have our strong ambition to remain a profitable company and using those profits to develop more products in the pipeline, which we’ll add later to our commercial portfolio. If you turn to Slide 4, as I’ve just said, we have a vision to become one of the largest pure play vaccine companies, but we also recognize the importance of protecting and taking care of the world around us and so acting in a responsible way in all matters. Being a vaccine company, however, we are daily positioned to play an important role in ESG vaccine to become extremely topical in the last few months due to COVID-19 with a rollout. And it’s clear that vaccines are the really only hope we have of the world coming out of lockdowns and getting back to normal. However, vaccines have played an important role for more than the last 200 years, and it really improves the world health. And as you can see from the quote from Gavi, 14 of the 17 strategic goals can be achieved through vaccines. So that we are very well positioned to play an important role and others play out investors and stakeholders hopefully will join us in that journey. If you’d like more information on our work on ESG, you can see that in the CSR report that’s available on our website. Turning to Slide 5, we’ve had an extremely busy and productive Q1, while we still face some rather strong headwinds for our rabies franchise due to COVID and the travel restrictions and I’m sure Henrik will come to that in the coming slides, we are seeing some signs of stability on tick-bore encephalitis, despite COVID. Similar to last year smallpox contracts both with the U.S. but also with the new orders from EU countries have allowed us to record larger revenue Q1. And that leaves us with the confidence that we maintain a full-year guidance that we’ve set a few weeks ago. You have heard the news this morning and I’ll come back to that in the making the coming slides that we’re expanding our portfolio of commercial products in Germany with a collaboration to market and Dynavax’s innovative HEP-B vaccine. And I’ll come back to that in the later slides. But that is a very exciting development considering that we’ve only set up our commercial enterprise in Germany nine months ago. If we look at some of the orders, as I said, it’s interesting that we’re starting to see an expansion of orders outside of the U.S. for JYNNEOS, our smallpox vaccine, both in Europe and also in Canada. And as I’ve said, that’s allowed us to record slightly higher revenues in Q1 and Canada will probably be revenue recognized next year. The U.S. Government continues to honor its options of the order that was placed a few years ago was another $12 million exercise of an option. And only Ebola, we’ve seen some exciting news, where together with our partner Janssen, we’re going to manufacture additional doses which will help – be distributed and help with the current outbreak in central and Western Africa. And we’ve also announced the news that our vaccine is WHO pre-qualified, which will allow an easier distribution of these vaccines in areas that are desperately needing an Ebola vaccine in the current outbreak. On R&D and I’ll come back to this in the coming slides. We’ve probably seen the best preclinical data of any COVID-19 vaccine candidates. And I’ll walk you through that. The Phase 1 data from our partners without vaccine expression, and that you can solve them is confirming, the early data is confirming that those strong preclinical data. And we’re about to initiate a Phase 2 study, which I’ll come back to. And on RSV, as I said, we’re halfway through a human challenge study, where we’ll be reporting data from that exciting study later this year. So, if we turn to Slide 6, as I said this morning, we made an important announcement that we’ve come to the agreement with Dynavax where we will market and distribute the highly innovative two-dose vaccine against hepatitis-B, HEPLISAV-B. And that will be launched in Germany later this year. This will break the current EU monopoly, which is currently valued at about $27 million annually. And as you’ll see on the right part of that slide, this next year we’ll add to a very strong portfolio, all commercial assets that we will have in the largest EU market. And as I said, if you just go back nine months, we had no commercial presence, in Germany. And within that nine-month period, we are very proud to announce the Dynavax’s approach to Bavarian Nordic as the ideal company to distribute market, the innovative vaccine, which has an advantage over the current vaccine, in that is a two-shot vaccine providing a very strong efficacy within four months, would be not necessary, so actually three shots raising that’s currently been around for a number of years, that takes six months to complete. And as I said, this will add to a very strong portfolio we already have in the largest EU markets. Turning to Slide 7, so COVID-19, and one of the questions I often get is are you a little late and why are you developing the COVID vaccine when most of the world, particularly in Europe and the U.S. has already vaccinated or will be shortly? Well, there’s a couple of issues with the first wave of vaccines. Thank God that they are there and we can all get protected from COVID-19. However, the durability and the breadth of protection that they provide is a little unclear. So we don’t know how long they last or whether they truly protect against some of the more serious variants that are emerging and I’ll come back to that in the coming slides. It’s unlikely or most people in the community believe that COVID-19 can be eliminated through vaccination and it’s likely just like other infectious diseases that we’ll have to manage the burden of disease through vaccination and frequent or additional boosters are going to be required. Obviously, the bottlenecks that we’ve experienced in the last six months have highlighted the need that more vaccines are required, more vaccine manufacturers are required to meet the current demand. And lastly, the first wave of vaccines, there is a lot of question marks wherever they are really truly suitable as opposed to vaccines. So to the first wave vaccines are based on an adenoviral vaccine platform, it is known from the literature that they suffer from a pre-existing immunity generated to the viral vector itself, which may make frequent boosting, difficult or impossible or certainly reduce their efficacy. And with RNA, there is now growing concerns that there are some Grade 3 systemic adverse reactions that are in purity we will recruit with additional boosters. So some data that Moderna have published the Grade 3 AEs, or adverse reactions, systemic adverse reactions with 2.7% in the first vaccination going up to 9.7% up for the second and in their booster study, which they’ve reported is almost 15%. Clearly, increasing shot, after shot, after shot, and that raises questions is this platform really the ideal platform for regular boosters. So from acquisition with everything I’ve just said, there is a room and a need for improved vaccines both from a safety perspective and durability perspective and the breadth of protection perspective. If you go to Slide 8, as I said, we’ve probably published some of the strongest preclinical data for any COVID-19 vaccine and I will go through that in the next slide. Our platform, which is based on a VLP, or viral-like particle platform is relatively easy to produce and/or adapt – should there be a need to adapt the vaccine for new variants should there would be further mutations beyond what we’re already seeing. And as I said with our partners under the EU consortium are already in Phase 1 where we’re beginning to see some data confirming the preclinical data. And within a matter of weeks, we’ll be starting our Phase 2 study while we’re also in parallel gearing up production to potentially start a Phase 3 should we be able to secure funding in the coming weeks and months. So if we turn to Slide 9, I keep talking about the best preclinical data, so let’s talk about it. On the left hand side is the neutralizing titers that are induced in primates following two shots of a non-adjuvanted ABNCoV2 which is COVID-19 vaccine candidate. That was known from the literature that the level of neutralizing antibodies is predictive of the final efficacy that you may see in the clinic and that is by comparing to convalescent human sera. And many publications are saying that your clinical efficacy should be greater than 80% if you have a ratio of one or greater to the human convalescent sera. You can see in primates, we have a 50 fold higher neutralizing titers without vaccination compared to the high convalescent sera, which posed well to predicting a high efficacy in the clinic which of course still needs to be tested. In these animals there was complete protection following a challenge with SARS-CoV2, which again bodes well for strong efficacy in the clinic. On the right hand side, it’s some additional neutralizing data where we’ve looked at the sera from the primates and their ability to neutralize new variants, where some of them are quite old variants. So Wuhan is the main strain that obviously emerged from China and it is equivalents to the data on the left hand side of the graph. The middle is the British variants, which as you know who shown to be more infectious in the UK. And on the far last column, it’s the South African variant, which is causing issues around the world. And what we see is that we see exactly the same neutralizing titers, 50 times higher than human convalescent sera, and no difference between the variant in Wuhan strain. This is not the same data that others have published for current approved vaccines. For example, in a publication filed by [indiscernible] data shows that there’s almost a three-fold, lower neutralizing titer against the South African variant. The Janssen vaccine actually reported a 74% if I’m correct efficacy in the U.S., which is primarily at that time, Wuhan and only a 57% efficacy in South Africa. So again, a reduced efficacy probably associated with below neutralizing titer. So, these data really bode well, that have vaccine by generating such high neutralizing titers is going to give a broader protection against the current circulating variants than the existing approved vaccines. Slide 10, so as I said, we have Phase 1 trial ongoing sponsored by our partners and the EU consortium, that have already reported preliminary data showing that the vaccine is extremely well tolerated, particularly in its non-adjuvanted form and induce the high levels of neutralizing antibodies again supporting the pre-clinical data that I’ve just shown. In June just a few weeks away, we will be initiating a Phase 2 study, which has shown in the bottom half of this slide. It will be essentially two groups. One group will be sera negative i.e. not previously vaccinated or infected, and they will be receiving a primary vaccination regime of two vaccinations four weeks apart. And groups two will all be sera positive. So previously vaccinated. And these will receive a single booster with ABNCoV2 candidate, which is how we believe we will be developing the vaccine primarily in Europe and the U.S. And this will lead to data that we will be reporting mid of this year. Changing tracks a little bit and moving to Slide 11, talking a little bit about our RSV. As you are all probably aware, we announced at the end of last year, we will delay the initiation of our Phase 3, due to the low infection rates of RSV caused by the shutdowns, and the social distancing and all the other measures associated with COVID-19. We are, however, doing the human challenge, which is currently being conducted. And we will be able to report the data from this study later this year. That will hopefully give us added confidence that we are truly looking at a highly efficacious vaccine and that will hopefully allow us to initiate a Phase 3 study next year. So, on Slide 12, we’ve been investing quite heavily in a manufacturing plant adding a fill finish capability state of the art fill finish, manufacturing, which is now complete. We are actually in the process of transferring a number of products to the line. The liquid frozen formulation of JYNNEOS is very advanced, and we should be validating that process in the coming weeks. We’ve already initiated the first engineering runs also for the freeze-dried version of JYNNEOS. And I’m pleased to announce that we’ve also initiated the first engineering runs for Rabipur really indicating that our tech transfer activity from GSK remains completely on track. In addition to that, we’re expanding a bulk facility to allow us to produce the bulk, both Rabipur and Encepur. That is going extremely well, on track, on budget. And later this year, we will be shutting down at both facility, as we thought to reconnect both the expansion path that is ongoing right now with the existing building one, as we call it where we currently be manufacturing a smallpox vaccine. So as planned, there will be a shutdown of bulk manufacturing that, as I said, that’s all part of the plans. And when we finished all this work, we truly believe we’re creating a center of excellence for vaccine manufacturing based on stem cells. So we set highly productive, Q1 a lot happening, and there’ll be a lot more news flow coming in the coming months. But with that, I will hand over the presentation to Henrik.

Thank you very much, Paul. So on Slide 13, we will start the presentation of the financial results. But before we move into the hardcore financial numbers, let’s have a look at the performance of the market development for two vaccines the Rabies, Rabipur, RabAvert and our TBE vaccine in support in these markets. And on Slide 13, it’s all about our Rabies business as we have reached many times now, I think when we look at the Rabies market, I think we have to distinguish between the U.S. market and the German markets that have stay out very different markets. And if we start with the German market at the bottom of the slide, so the left, you will see that the German market has since first quarter of 2020 declined by more than 90%. This is due to the fact that the German market is nearly 100% a pre-exposure market, that meaning at travelers market. Rabies is not endemic in Germany. So the market – has travelers market, but people vaccinate when they go to all of the relevant countries. So the situation is that there’s nearly nothing lifts in the German market at the moment. And we are of course waiting travel pass on returning to a normality. And then we expect the market to come back full force again. I think what’s worth mentioning here is that when we are comparing to the first quarter 2020, we are comparing to a period just before the COVID-19 situation really started last year. So 91% down at the German market. And this is a good proxy for all that European Rabies markets unfortunately. If you look at the U.S. market, this is a very different story as the U.S. market consists of both the post exposure and the pre-exposure market as Rabies is endemic in the U.S. market, which makes it a much more resilient market to the COVID-19 situation. However, that said, we are still seeing a decline in the U.S. with the market being down 21% first quarter of this year compared to prior year. So how have you performed to under these conditions we can see that to the right side of the slide here. We delivered total revenue of DKK80 million for the first quarter against DKK218 million last year. So decline of 63% explained primarily by the COVID-19 impacts, but also by the fact that last year, the first quarter before COVID rollout, we had an extremely strong first quarter as we also faced a situation with our competitor being out of stock and adding to that also wholesalers stocking up to ensure that it could safely deliver into the market. So we are comparing against a very strong first quarter, but we also feeling the impact of the pre-exposure of segment both U.S. add Europe being significantly down. And I think the good key measure to take away here is that the whole markets here is still performing well. We have in the U.S. today approximately 73% of the market. We did lose some percentage points as our competitor came back. In the fourth quarter of last year, that was fully expected tax rate, but we are happy to say today that even today we have 5 to 6 percentage point higher than the average year in 2019 before we took over the responsibility of this Rabies business. So as well-positioned – and we are well-positioned to grab the market when it comes back and travel to resumes again. On Slide 14, let’s have a look at the TBE volume to the rises market was this – if you want European business and here we have shown the German market, as an example for how it’s a things are looking at Europe, we do not yet have the full consolidated the market takes the for all of Europe, but the indications we get that that’s also market in Europe is found in the first quarter compared to last year due to COVID. But actually with Germany being an exception, we have seen in the first quarter of 2021, an 8%, nearly an 8% growth compared to the same quarter last year with just a good sign, that things are with earnings some more normal situations in the German market. The TBE demand for TBE vaccines that stocks should not at all be impacted by the COVID-19 situation. But of course, the excess to your physicians, et cetera, has its own social impacts the social market, but with an 8% growth right now, I think that is a good sign for the current vaccination season. If you look to the right, you will see all numbers, we deliver revenue of DKK98 million for the first quarter against DKK103 million last year, so 5% down. This is caused by the total combined European market being somewhat down, the Germany being exception of cost and then it is also due to some inventory movements at the all statements. And again, key good takeaway here is that we have actually since we took over gain market share with our TBE business in Germany, I think we have gain here today, this year, whole country percentage points market share. So again, very well positioned to crack the market, when it comes back in Europe. And hopefully, I think maybe be seeing in the first quarter versus Germany leading the way. Next Slide 15, shows our profit and loss for the first quarter, where we deliver the strong top line with DKK535 million of revenue, driven by strong smallpox revenue, DKK336 million coming out of the smallpox business as you can see that the donor chart to the right, DKK246 million of that was revenue for products to BDS batches delivered to BARDA as part of the $202 million order we got last year, and the other part DKK19 million is related to the three European countries to whom we have supplied smallpox vaccines as well. This is a little more than the €11 million that we announced previously and simply due to somewhat better pricing terms. You can see the two products we already talked about Encepur coming into the DKK98 million in revenue and DKK80 million in revenue. And finally, a small piece of contract work coming from BARDA funding of all Phase 3 study and qualification of some of the work going on with all fully finished facility. Productions costs came in at DKK377 million. It’s gave us a gross profit of DKK158 million. R&D added up to DKK122 million, nearly twice as high as the level we saw in first quarter of 2020 and driven by RSV in the first quarter here, we have two into first quarter of manufacturing all the materials that we will need for a planned Phase 3 trial for RSV. And we have also started the human challenge trial. So quite a lot of FX has been spent on the RSV projects. This RSV manufacturing has actually also, in fact, in all production costs for the first quarter, as we are using our commercial facilities also to produce clinical material. And, of course, we allocate costs to those R&D projects and a lot of that has gone into the R&D line, but we are not allocating this on 100% basis, meaning there is some infrastructure costs, et cetera, which is not being excelled by commercial products when you manufacture for R&D. So there is also a negative impact on production costs for the first quarter, due to the manufacturing of the RSV material. SG&A costs came in at DKK124 million more or less at the same level, as we saw in the first quarter of 2020, but with several moving parts underneath that we have seen, for instance, some distribution, a significant saving as we had moved away from the GSK distribution network and now we started this home. On the other hand, we also have, particularly on admin, relatively low level of admin costs in the first quarter of 2020, as we’ve only starting up or ramping off the integration project for the Encepur and Rabipur products integrations. But all in all, adding that together SG&A costs slightly below the level we saw in prior year. All of this together gives us an EBIT for the first quarter of minus DKK88 million and depreciation and amortization or adding these back gives us an EBITDA for the quarter of DKK1 million. And I think with this situation again, strong revenue driven by our smallpox business this time we have gross profit and OpEx impacted by the RSV and manufacturing of Phase 3 material. And we still have cost associated with that. And with this, I think we are in a position where we can maintain our revenue and EBITDA guidance. Turning to Slide 16, quick update on our cash flow and balance sheet. If you look at the cash flow table to the left, net cash flow for the period of minus DKK43 million, this was of course driven by a negative net profit for the period and strongly supported by the proceeds from the private placements that we did raising approximately DKK1.1 billion. and then cash flow from investment activities reduced our core cash flow for the period by nearly DKK1.1 billion. Most of that was really related to placing of the liquidity in securities, but also some of its approximately DKK100 million was related to continued investments in our products and continued investments in our tech transfer. To revise, just a few selected balance sheet figures. I would just mention the VA procedure here. We have seen an increase to now nearly DKK6 billion and of course, positively impacted by the recent private placement we did. And then I think after the quarter and after this private placement, we have a very, very strong cash position of nearly DKK2.6 billion, allowing us the flexibility to move ahead with our strategy and our obligations to GSK during the next periods. So with this number, so this slide here, happy to say again, that we can also then say, cash guidance for the full year. On the next slide, we have an overview of our 2021 financial outlook and guidance. And as I said, we are maintaining this guidance on all aspects both on the top line where we are guarding a level of DKK1.9 billion to DKK2.2 billion and EBITDA of DKK100 million to DKK250 million and the cash position of between DKK1.4 billion and DKK1.6 billion. We are still seeing some uncertainties in the market and we haven’t seen the reopening as we had hoped for earlier this year. So therefore, we still stick to this way of guidance with using in sales. But of course, we do hope that we get some more clarity on the markets situation for the rest of this year, during the next quarter, we can come up with hopefully a more precise guidance in connection with our Q2 report later. And as we have said previously, I think of course, the little end of the guidance really reflects a delay to reopening. Whereas the offer really reflects that we should see the reopening happening now, basically, and affects that could mean already some traveling starting to occur late in this year. We’ve also previously said that the smallpox and Ebola business are not expected to be impacted by COVID-19, that’s still the case. But as you will have seen, we did announce the additional Ebola order of US$28 million. Recently we announced that, and we say that there would be no impact on our guidance from this as we absolutely will with all the customers to defer delivery of some of their products into the next year. Finally, on the right hand side of this slide, just a brief overview of what are the key exhibits and prices for the remaining part of the 2021. Within R&D, I think it is, of course, we have some very exciting period ahead of us in terms of the human challenge trial, where we expect to have readouts in September. We will continue to prepare ourselves for a initiating after Phase b trial next year on RSV. But of course, also continue to monitor on the market to see what is the prevalence of RSV? How feasible do we assess that it is to conduct a Phase 3, during the COVID situation. And then of course, also a lot of resources that put behind our COVID-19 vaccine candidates, which we are, as Paul said, we are accelerating into Phase 2 within a couple of weeks and proud that we are working to scale up manufacturing so that we can reduce volumes at Phase 3 levels. And then I think finally on R&D, I can mention also that we are continuing to work with our new construct setback, intravenous administration of brachyury will continue throughout this year. And then on the commercial side, of course, this is still to continue to drive the profitable growth. And the key activity will be to take over the remaining countries, in terms of marketing authorizations and distribution, we are nearly there now should be expect by the end of June. We had taken overall markets. One activity that we can now add to the list on commercial is of course, now we know, we have HEPLISAV on board from Dynavax and the key activity would [ph] be to launch have a successful launch for this product in the fourth quarter of this year. On the manufacturing sites, the fill and finish facility is up and running, construction complete qualification, nearly complete this year. We will pass the very important milestone as we will fill the first commercial product on the line. And then of course the manufacturing, I think it’s all about stay on the right path and complete the construction that we need, the amendments we need for the box facility to transfer manufacturing of the rabies and CpG products, and then of course, continue to stay on plan on the tech transfer of these products as well. So will that, I will give the work back to the operator for question-and-answer, please.

Thank you, sir. [Operator Instructions] Sir, your first question comes from the line of Michael Novod from Nordea Equities. Please go ahead. Your line is open.

Thank you very much. It’s Michael from Nordea. So three questions, please. First of all the preliminary data you’ve seen out of the first Phase 1 trial with ABNCoV2? Can you probably teach it a bit more on that? Is it for the year, the low dose cohorts, I would assume it, it is. And just maybe try to explain what you’re actually seeing in terms of neutralizing antibodies? And then secondly, I know it’s very difficult to comment on the sort of funding discussions, but it’s still the belief that the most likely funding should come from government funding or to also still pursue other avenues regarding funding for ABNCoV2? And then lastly, on the manufacturing temporary shutdown, you’re doing according to plan, maybe you could just talk a bit about sort of the structure of this, whether it would have any implications, whether you are sort of manufacturing in advance to meet demand, et cetera, just to get a bit more light on the potential impact from this.

Yes. Thanks Michael. So yes, the preliminary data from the Phase 1, is we’re using the lower doses. So, and if you remember, and partners are looking at both non- adjuvant and adjuvant vaccine, the main conclusions from the study apart from the tolerated is that the tolerability is better with non-adjuvant, which is expected what you’d expect. Not that it’s bad with the adjuvant, but it is improved without the adjuvant. And lastly in terms of the immune response, it’s kind of in line with what we’re seeing from preclinical. So we’re seeing superior titers compared to human convalescence serum, even at the very low doses. And the dose that we’re going to move forward with is much higher. So they’re now moving to the slightly higher doses in that trial, so really, really encouraging. I mean, it looks pretty good. In terms of funding, I think if they say it’s safe to say that – we’re are following a number of different tracks still, of course the risk what’s out there in the public in terms of the open discussions that we’re having apparently with the Danish government that’s public, so I’ve mentioned that. We’re also looking at other funding, CEPI and whatever, but that’s more early stages. So I think nothing’s really changed since the last time we talked. We’re talking to governments and we’re looking for funding from the usual sources. And in terms of manufacturing, our main goal right now is to scale up and manufacture the supply Phase 3, we are however, beginning to prepare for commercial production, but again as we said before, the commercial production phase really requires additional funding, well set for the Phase 3. So of course we’re not sitting on our hands doing nothing until we get funding, but the bulk of that activity really needs to wait for funding.

Yes, Michael, I think you had a question on the announced manufacturing shutdown as well. Maybe I can take that one. This is a planned shutdown, but something we wanted to hide out as well because of course it has implications. But I say this long planned, I think we have also planned the manufacturing schedules around, for instance we now manufacture all the – whole of assays that we need to deliver under the latest order. We managed to get all the RSV materials, Phase 3 material manufactured before we do this plant shutdown. So it’s simply a necessary thing to do to connect the two new buildings or to the new building to the old one, once the new one has been constructed, but of course it is something that we don’t want to drag on for too long. It does impact your flexibility to manufacturer both in this facility. And it does impact your financials when you’re not manufacturing commercial products in this facility. But as I said, it’s all planned and it’s factored into our guidance for this year. So there’s no additional impact. But – and I think one thing that will help us offset a negative impact of having sort of idle capacity in some quarters will be that we are actually for the first time this year, we are going to use our fill-in Finnish facility for commercial manufacturing. So you can see there we start having the opposite situation for the first time actually using one of our facilities for commercial use.

Okay. Thanks a lot.

Sir, your next question comes from the line of Boris Peaker from Cowen. Please go ahead. Your line is open.

Great. My first question is on the COVID vaccine, what’s the development timeline from today until approval. I’m just curious, what data do you need to see in order to decide to make a Phase 3 investment?

Yeah, so as I said, Phase 3 [indiscernible] initial data readout in August, again, if we just ignore the whole funding piece we’ve been talking about, we would be in a position to start Phase 3 by the end of this year. And again, if the regulators are still supporting accelerated reviews, we could see an approval mid of next year.

Got it. And maybe my second question is on the RSV. I’m just curious if you could set expectations for the human challenge study, specifically in terms of data that you need to see in order to move forward. And also you outlined a timeline starting an RSV study in 2022. I’m just curious with probably a lot of people still working from home and wearing masks. What do you need to see socially from social interaction to decide that 2022 is a good year to do an RSV study?

Yes. So first of all, the challenge component. So in the challenge study, we are obviously treating or vaccinating subjects either with a vaccine or with placebo. And then they will be challenged with RSV and they’ll be tracked for a number of – for a period post challenge. And we’re really looking for a significant reduction in the viral load in the blood. As you know, these are healthy individuals, and even in the placebo group, they will eventually clear the RSV. So you really looking for a delta or a difference between the vaccinated arm and placebo arm. We haven’t publicly said what the threshold is that we’re looking for, but no, I have publicly said before, if we don’t see an effect, and obviously the program is not going to move forward. In terms of the trigger to start a Phase 3 it’s a very good question. We are tracking incident rates of RSV and they remain extremely low. I don’t know whether you saw GSK has announced they’re initiating the Phase 3 and they updated their protocol from 18,000 subjects. I think it’s the 25,000 subjects just last week. My speculation on that is probably that’s due to the low rates of RSV. So I think our decision not move ahead this year has been endorsed as being far too risky, but we are monitoring it. But it’s a bit like exactly the same situation last year we were monitoring it. And at some point we had to make a decision, are we going or not going. But we’d certainly need to see the rates of RSV raised to more normal levels that we saw before the pandemic.

Got you. Okay. Thanks for taking my question.

Sir, your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Your line is open.

Hi, thanks for taking the questions. I’ve got a few. Firstly, just sticking on COVID-19, I’m curious that when you say for the Phase 2 study, that you’re planning that the – roughly, I think part of them are seronegative and part of them are seropositive or the serum negative subjects who have had a vaccine or an infection and test negative and a certain time post back event. And therefore, due to an underlying condition, I guess or due to time, or are they actually patients who have not yet been infected or not yet being vaccinated. And then also if you just outline what the end point is, please for the Phase 2 study that you’re looking at. And secondly, then just regards to Japanese encephalitis and cholera, appreciate yet to transfer [indiscernible] give us some idea of what you think the German market opportunity is currently for those that case from Valneva? And then finally, just on J&J, I’m just curious that if you can give us any updates on the status of any of the J&J collaboration vaccines whether or not there’s any news we can expect on those or any other progress you can report. Thank you.

Yes. Thanks Peter. So on the COVID Phase 2, the seronegative arm currently planned to be truly seronegative, so previously not vaccinated or infected, so that’s the group going forward and on the seropositive obviously people who have a proven vaccination and the fact that they actually have antibodies. And clearly, timing is important here, either kind of get the question, that’s why we’re starting in a few weeks and we’ll be conducting that study in both the Netherlands and Germany, and we believe it is doable to identify those subjects.

Okay. Just to be clear, what is presumably you test some of these patients for antibody at the start, because obviously there’s some percent here very symptomatic, and I guess I’m just thinking, it’s becoming increasingly difficult to necessarily know as well, who’s had a prior infection.

They will be screened and tested. Yes. But, it’s my guess it’s only those people who had a non-symptomatic infection that would they’re being infected, but then there are quite actually a few of those. So yes, they will be screened and they need to be negative serologically for SARS uptick.

Okay. Great. Sorry the endpoint?

Yeah. Sorry. So obviously safety is an important end point always. But the other endpoint is really looking for a significant increase in the neutralizing antibody parties.

That’s great. Thanks. And then, yes, Japanese is a brightest color and J&J, please.

I’d say J&J first. So J&J, unfortunately the other collaborative program that we have, they have been impacted by COVID. So the trials are either put on hold or have the delayed in the initiation simply because it’s just too difficult to recruit right now. So the other programs, we’re not expecting any news flow in the near term.

Yes. And two other products, Japanese Encephalitis and cholera product. I think we haven’t guided any specific things relating to our expectations for these products. But we can say is that we are taking all of these products in our markets from 1st of January 2022, and obviously I think they actually allow six to ten travelers vaccines. So that means they are negatively impacted as we speak here. So hopefully you can say, we can put COVID-19 behind us and the market is back from next year when we actually take – what marketing and distribution responsibility in Germany for these products. But as we get closer to that, I think we will come back and to make sure that the – you’re better equipped for gastric fixations on these products as well.

Thank you and sorry. Is it reasonable to assume – presumably, we should be thinking of these products and have largely been awaited cover cost of your sales force rather than perhaps looking at them as been a profit generator, so to speak, if that makes sense?

No, I think definitely I think with adding these three products now to our existing infrastructure and we are really leveraging the investment we have done there. So it’s not something that we’ll turn our P&L upside down, clearly not, but it is going to help us to cover that cost. And it will also make a process of contributions to our bottom line for these products. So I think it’s a good way of leveraging. You can say some ones have synergies that we assisting on with a full commercial infrastructure and only two products in the back so far in Germany.

That’s great. Thank you.

[Operator Instructions] And we got, another question comes from the line of Jesper Ilsøe from Carnegie. Please go ahead. Your line is open. Jesper Ilsøe: Thank you so much. A question on the COVID-19 vaccine development as well. So you have Phase 1/2 and Phase 2 data coming up. So besides safety data, what will you, do get when do you see? Can you hear me?

Yes Jesper Ilsøe: Okay. There was some disturbance on the line. So what will you look at in the Phase 1/2 data, as we read across into your own Phase 2 data also, considering that you would do Phase 2 with a higher dose versus the Phase 1/2, and the limitation seen in that Phase 1/2 study, and how certain is it that your vaccine can be a, one-shot also considering the much better neutralizing antibody titers preclinically with two shots versus one shot. Even tide that’s, what is the most, important sector in the datasets when thinking about Phase 3 funding discussions, possibilities, i.e. what are these, say organizations, governments really looking at to make your vaccine standouts, and perhaps you can also touch upon the data you saw from Medicago and GSK as a read across into your own vaccine and how you see cVLP based competition in COVID-19. Thank you.

Yes, let me see if I remember all those questions – see that, so the ongoing Phase 1/2 study is important because our collaborators are really looking at a range of doses starting low, which is the data I’ve indicated that we have now, but they’re also looking at to adjuvanted, non-adjuvanted, based on the pre-clinical data. It really looks as if we didn’t need an adjuvants. And that’s kind of the assumption that we had made already, to go into Phase 2. The encouraging thing is that already with the low dose data that we have now saying, the two things that we’re looking for is safety. Are there any signals that would be of a concern and so far, or be with a low number of subjects? It looks very promising from a tolerability point of view. And the other thing we really wanted to confirm was, do we need an adjuvant’s or not? That back in most of the data that they’ve generated pretty clear in the case, preclinically have always used an adjuvant. So we had little data to suggest to, support our assumption that we didn’t need it. So the, initial data that we’re saying has clearly shown that the adjuvant isn’t really adding anything in terms of the immunogenicity of our ABNCoV2. So actually as a fit now, I think, I already have the data. I need to proceed into Phase 2, which is exactly what we’re going to do. As I said, what we’re looking for in Phase 2 is a confirmation in large number of subjects with safety but we also want to make sure to your point that the single shot booster in people previously vaccinated is sufficient to generate, this strongly broad immune response. We are encouraged by the pre-clinical data where the second shots, really makes a big difference, in animals that are already primed. So we believe, that in patients previously vaccinated prime, they were boost the adenoviral platform or the RNA platform or any other platform that we will be able to boost those responses very strong, with this candidate, because it is clearly highly immunogenic and really generating strong immune responses. Just trying to remember some of your other questions? How many – safety data yes. I would say always encouraged to see positive data coming out. It’s a very healthy technology, but interestingly it is actually vented. So the data that they’re seeing requires an adjuvant. And again, I think what that points to me at least is that the platform we have, yes, it’s VLP, but it’s a superior VLP in my view, because we have a much denser expression or right of the RPD on the VLP. And we don’t need an adjuvant. And as I said, that’s confirmed now in the Phase 1, but also in preclinical. So not have management will reduce the COGS, reduce the reactogenicity that you’ll see when you get vaccinated and make app platform extremely competitive. But again, it’s really encouraging to see that VLP platform, it generating very positive data. Jesper Ilsøe: Perfect. Thank you so much. Perhaps, all to touch upon what the most important factors are, when taking discussion with say SEPI and the like, when they see your data. So what’s the most important factors there to make your vaccines stand out versus the compensation?

Yes. So on that, SEPI specifically has got a number of applications out there. One is specifically on new candidate vaccines generating a broader protection. And as I said, I keep saying it, I think we have the best preclinical data that anyone has. No one has shown the same neutralizing titers, particularly against the South African variants as ourselves. So that is putting us in a pretty strong position. The other application that SEPI is looking at is really for new candidate vaccines that can address the developing world. And again, I think there was the ease of production. We feel confident that we can even address that maybe through partnerships with others, but we can address that as well. I think when it comes to government, it’s really about hedging their bets, they used on a big deal, obviously on the RNA vaccines. There’s a lot of people writing concerns that maybe are we putting a lot into one basket. And as I said, there is now increasing data coming through where there is quite some alarming, adverse reactions, systemic adverse reactions on repeated vaccinations. And it’s also knowing the RNA platform that you really not getting the same sort of strong protection or immunity, I should say. You can see different variants. So I think we’re well positioned in our discussions, but on the day that we have, and it’s growing day by day, that we have a rather unique candidate that is addressing a lot of the concerns that exists right now, both from funding agencies offsetting, but also governments around the world. Jesper Ilsøe: Okay. Thank you so much, Paul.

[Operator Instructions] There are no more questions at this moment, please continue.

Okay, thank you. Thank you everyone for attending the call and for your questions. So have a great day and we’ll catch up next time.