Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to today's 2019 Q1 interim report. At this time, all participants are in a listen-only mode. There will be a presentation followed by a Q&A session, at which time, if you wish to ask a question, you will need to press star and one on your telephone keypad and wait for your name to be announced. I must advise you, this conference is being recorded today, Wednesday, the 22nd of May, 2019. I would now like to hand the conference over to your first speaker today, Rolf Sass Sørensen. Thank you. Please go ahead, sir.
Yeah, thank you, operator. My name is Rolf Sass Sørensen, VP, Investor Relations. With me here in the room, I have Paul Chaplin, President & CEO, and Henrik Juuel, Executive Vice President, CFO. Before we begin the presentation, I would like to read the following statements. This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside our control, that would cause actual results to differ materially 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 our plans, objectives, goals, future events, performance that is not historical information. 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. With this, I will hand the line over to Paul.
Thanks, Rolf. Welcome everyone to our Q1 report. If you go to slide three, we've had an extremely productive first three months of 2019, really setting up an exciting year ahead. Our BLA for our MVA smallpox vaccine is on track, we still anticipate our first U.S. approval later this year. As I'm sure many of you know, that will also come with a Priority Review Voucher with our intention to sell. We continue to invest for the future in expanding our manufacturing footprint, earlier this year, the U.S. government is chipping in with that, with a $44 million option to support the tech transfer of the manufacturing process to our new facility.
Everything is going according to plan, nudging us every nearer to return to profitability in the near term. In terms of RSV, we're extremely excited about the opportunity that we have ahead of us, and we're finalizing our discussions on the phase III design, and we will be coming back to the markets later this year. With our partnership with Janssen, we've seen two significant events. We've entered a phase I, 2A for our HPV vaccine, treating chronically infected women to prevent cervical cancer. We've seen development in Ebola, with the WHO advisory group recommending a combination vaccine to be used in the current outbreak. In cancer immunotherapy, we've completed enrollments in our pivotal chordoma study, that will have an exciting readout later this year.
In terms of financials, we remain on track, but I'll leave that for Henrik to discuss later in the presentation. Going to slide four, we aspire to be a leading and profitable biotechnology company that, through harnessing the power of the immune system, will develop, manufacture, but also commercialize products for both infectious diseases and cancer. This vision is underpinned by four strategic objectives. One is to maintain our global leadership of our smallpox vaccine business, and to do this, we want to finalize the development not only of the liquid frozen, but also the freeze-dried and secure broader sales, which I'll come to in the coming slides. We want to expand and rapidly advance our infectious disease programs.
By that, we want to launch our RSV program, advance our partner programs with Janssen, but also bring some exciting new opportunities from preclinical into the clinical pipeline in the months, years ahead. We also want to establish a broad and deep cancer immunotherapy portfolio. We want to explore the current strategy of combining our vaccines with checkpoint inhibitors and other standard of care. Later this year, we'll also bring in some new, exciting opportunities and different therapies that will hopefully help patients in the near term. Finally, we want to expand our commercial footprint and capabilities. What do I mean by that, is that we want to harness one of our key strengths, which is our manufacturing capability. If you look at most manufacturers of live virus vaccines, they have difficulty in providing the market, there's stock outs.
We've had a continuity of supply for the last 10 years. We believe that's a true asset for us. We want to harness that, both through the expansion of our facility, but also in our current capability. We also want to build a commercial infrastructure in the years ahead that will help us commercialize the business. On slide five, I want to talk a little bit about our global leadership in smallpox vaccines. Obviously, we've had a very strong presence in this arena for the last 10 years. The reason we believe we're a global leader is we're the only company that is currently providing a safer alternative smallpox vaccine that's suitable for the general population....
We've been extremely successful over the last 10 years, securing nearly $1.8 billion in both investment in R&D, but also in acquisition of the product. In the past, we've completed 22 clinical studies. That's one of the reasons that the approval date of our product was extended. It's a vast amount of data that we've generated. Currently, we'll have bulk vaccine by the end of this year of $333 million. We expect our first U.S. approval later this year, which will be coming with a Priority Review Voucher. We'll also be initiating our phase III freeze-dried trial, fully funded by the U.S. government later this year. In the future, of course, we see huge potential.
There is currently, in the current order, $299 million to convert all this bulk that we've manufactured over the last three years into approximately 13 million doses. That will return the company to profitability once the facility is up and running. With a safer alternative vaccine that is likely to be approved later this year, there are new opportunities to start vaccinating first-line responders, military, and the like. That will expand the opportunity well beyond the current stockpile that you've seen over the last few years. Talk to that point on slide six, mpox has been, it is a growing threat. There's been a number of cases. There's a current, serious outbreak of mpox in Nigeria, and there's been recent cases in the U.K., Israel, all from people returning from those areas.
What this highlights is that there's a true need for better preparedness by governments around the world, because what's happened here is healthcare workers have also been infected, who've had to deal with these infected patients, and we see a huge opportunity in the better preparedness against monkeypox, but also smallpox in the years to come. On Slide seven, we have a very exciting asset in that we have a completely differentiated RSV vaccine, targeting the elderly. We have a very exciting phase II data, where we've shown that our vaccine concept induces very broad antibody T cell responses against RSV, which, as I said, is a completely differentiated approach to anyone else. We're currently in the process of finalizing the discussions with the authorities on a phase III design, which we plan to initiate next year.
Currently, a concept that we're trying to push through is a two-season design with a futility analysis after season one. That would be in 2021, if we start the study in 2020, as planned. If it's obviously positive, we will continue to go into season two with a very high degree of certainty if we first, if we pass that futility analysis. As I said, we need to finalize our discussions on the exact size and the exact strategy moving forward, which we'll come back to the markets sometime in the summer. On slide eight, as you all know, we're investing $75 million in a state-of-the-art fill finish facility, which will allow us for the first time to really take full control of our manufacturing.
Not just manufacturing the bulk vaccine, but be able to fill either liquid or freeze-dried versions. This is really a game changer for us. The investments in this facility are gonna peak this year, meaning that everything, all being equal, meaning that the cash burn should reduce next year. This is a state-of-the-art facility. It will allow us to return to profitability with the current order we have. Obviously, we've been encouraged by the U.S. government to make this investment, which is not about the existing order, but is about future orders and future supply. On slide nine, to just give you an update of our pivotal trial in chordoma, our BN-Brachyury vaccine is being evaluated in an ultra-rare indication.
Chordoma is unique in that it expresses brachyury throughout the tumor and makes it an ideal indication to test the brachyury-based vaccine. We enrolled 10 patients ahead of schedule, which I guess highlights the interest that there is by chordoma patients in this study. This is in combination with radiation, and we should start to see the first results later this year, which will be, hopefully, the first indication that our strategy in oncology is along the right lines, in that in combination with standard of care, vaccines can actually improve the efficacy and prolong survival. Likewise, on slide 10, we have three ongoing phase II studies looking at CV301, which is targeting MUC1 and CEA, which are two tumor-associated antigens in three different indications, all with different checkpoint inhibitors.
The concept here is that checkpoint inhibitors obviously work in about 20% of the patients who have an existing immunity against the tumor, but the majority of patients don't respond because their immune system has not recognized the tumor. We believe that with CV301, we can stimulate an immune response and make that immune response a lot more effective with the standard of care in many of these indications. In terms of bladder, we're well on track to complete enrollment in the first stage, and we would expect data from this interesting and important study later this year. We have an exciting year ahead based on a solid foundation of the first three months.
We're looking to have our first approval of our smallpox vaccine, but also some pivotal data from our oncology programs as well. With that, I'll hand over to Henrik to walk you through the financials.
Thank you very much, Paul, welcome to all the listeners to this conference call. On slide number 11, I just want to reiterate our message that we are right now in a phase where we are investing for the future. I believe this is best illustrated by the graph below here, showing how much we are currently investing in our pipeline, our R&D assets. In 2019, we expect DKK 570 million invested in R&D, with the majority of that going towards our infectious disease programs and a smaller part to our oncology business, where we are very cautious on our spending, using adaptive trial designs, et cetera.
Besides the R&D investments, we also, as Paul alluded to, we are investing significantly in expanding our manufacturing capabilities, which again, will be one of the means to for us to return back to profitability in the near term. 2019 will be the peak year in terms of investing in our fill-finish plant, as we are planning to actually to finalize the construction of the plant this year, ready for the qualifications to start the qualifications of the plant next year. Let's turn to slide number 12.
Looking at the results for the first three months of 2019, if you look at the lower left table, you will see that we reached a total revenue level of DKK 127 million, comprised of DKK 49 million from revenue recognition of three IMVAMUNE batches. Remember, we have previously guided that this is the second tranche of the contract we have, $50 million, or 20 batches of IMVAMUNE, to be recognized this year. We also have, as part of the revenue, we reached DKK 78 million of revenue from our R&D contracts. During the first three months, we saw contributions from our agreement with the Department of Defense on the equine encephalitis vaccine development.
We saw contributions from our BARDA agreement on the tech transfer that Paul alluded to previously. We also have some contribution from our agreements with our partner, Janssen. Looking at the EBIT for first three months, we saw a loss of DKK 104 million. Finally, after the investments that we conducted during the first three months as well, we ended up with a cash preparedness of nearly DKK 2.2 billion. Cash preparedness, defined as our cash and securities, plus some unused credit facilities. All in all, I think we have delivered on our own expectations and our guidance. We are maintaining the guidance for the full year.
Again, I just have to state here, for the sake of clarity, that any potential income from our Priority Review Voucher, which we expect to be awarded after approval of our IMVAMUNE product in September, is not included in any of these guided numbers. Turning to slide number 13. I think this slide we have included, again, just to help provide a little more clarity on the what we call the cash preparedness. Here, you will see the approximately 2.2 billion Danish kroner in cash preparedness, broken down by the amount you will find in the balance sheet, the 1.9 billion Danish kroner of securities, cash, and equivalents.
We have DKK 244 million in unutilized credit lines, primarily the EUR 30 million loan we have from the European Investment Bank. In the table below, you will see an overview of our current total debt. Primarily the European Investment Bank loan that we have utilized. The first one, we got DKK 372 million, we have a smaller mortgage in our facilities here in Kvistgård, Denmark. That was the breakdown of the financial position. I think, again, the conclusion is here, yes, we are investing in the future, but we are making very deliberate investments, both in our R&D and in our fill and finish plant, we are very well prepared to continue executing on the strategy.
We are, as you will remember, we have guided that we expect to end 2019, even despite these significant investments, with a cash preparedness of DKK 1.6 billion. Let's turn to the next slide, which is basically a summary of some of Paul's presentations, focusing on our priorities and goals and the expected news flow for 2019, and here again, grouped by our key strategic objectives. Within our smallpox business, very obviously, I think the big thing to happen this year will be the approval of the first product in the U.S., which we anticipate in September, with the following award of a Priority Review Voucher, which we are intending to sell. Secondly, we also are planning to start the initiation of phase III study of our freeze-dried version later during this quarter.
Within the other infectious disease programs, big thing here, naturally, will be to go out to the market and announce our development plans for RSV, which we expect to be able to do around mid this year. We are also to start phase I dose-finding study of equine encephalitis. This is our agreement with the Department of Defense, and we expect actually to initiate that study during the second half of this year. Finally, within this strategic objective, we also expect Janssen to start their phase I/ phase II study of HIV later this year. Within our cancer immunotherapy portfolio, I think we have an exciting time ahead of us as two of our currently running studies will have the first readouts.
As Paul mentioned previously, this is in the chordoma study, where we could expect first results in the fourth quarter of this year. Secondly, it's also in our CV301 project in combination with checkpoint inhibitors in bladder cancer, where we also expect to have the first readouts later this year. Besides the running trials, we are also, this year, going to test new routes of administration, planning to initiate a phase I intravenous administration study of BN-Brachyury and a phase I intratumoral administration using CV301 in solid tumors. Also an exciting time ahead of us within the cancer immunotherapy area.
Finally, within our ambition to expand the commercial footprint and capabilities, we are still on track to finalize the construction of fill and finish facility by the end of this year. With that, I will hand the word back to Paul.
Thanks. I think we'll open up the call for Q&A.
Thank you, sir. Ladies and gentlemen, as a reminder, if you wish to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. If you wish to cancel that request, please press the hash key. That's star and one, if you wish to ask a question. Your first question comes from the line of Chad Messer of Needham & Company. Please ask your question.
Great, thanks. Appreciate the opportunity to ask some questions here. First, just on the equine encephalitis program, I just wondering if you could give us an idea of what the ultimate opportunity here might be. I guess the U.S. government would be your major customer here. Any idea, you know, how big of an opportunity to sell this to them? I mean, what revenues potential might be, outside of obviously them funding the program to begin with?
Thanks, Chad. The opportunity right now is obviously, DoD is very interested in developing a vaccine, primarily to vaccinate military personnel, because it's a potential biological threat. They've actually evaluated a number of different vaccine platforms in preclinical studies. In fact, our platform came out on top, and that led to the initial award to evaluate the safety immunogenicity of our current construct. That's basically the concept of the contract we have to date. However, obviously, if we show that it's immunogenic, as we believe it will be in the clinical studies, there's potential that this is gonna lead to a much larger contract to develop this all the way through to licensure. That in itself could be a substantial contract award.
Of course, post successful licensure of the product, we're really looking at a DoD supply. Again, the opportunity there is potentially quite substantial if you look at other vaccines that have been sold to DoD for new recruits. It is potentially quite a big opportunity, both in the near term in terms of new contracts, but also in the longer term, in adding to the top line in sales to the U.S. military.
Great, great to see you guys leveraging the platform and some of your relationships to expand business. Another one on the brachyury readout. I know what you're looking for is at least one objective response out of the 10. Just wondering how the, you know, sort of conclusion of the dataset or what triggers the readout. When you get a response, is that does that trigger it, or is there some kind of amount of follow-up on the last patient that we're waiting for?
Actual fact, if you look at if you go back to slide nine, we actually show the course of events in terms of the trial. We start vaccinating prior to the standard of the care, which is radiation. And then the first MRIs in terms or CT scans, in terms of having a look at the tumor lesions, is actually some time later in the normal course of events. Of course, as you mentioned, we're looking for one objective response. We've enrolled 10 patients ahead of schedule. However, I believe we only have one or two patients that are currently being evaluated at their first CT scan.
If one of those scans shows, a potential positive response in terms of, objective response, it would go to the independent DSMB charter, who would look at the data independently, and they would actually request a confirmatory CT scan four weeks later. Once that's been confirmed, then obviously we would have our first objective response, which would trigger going into stage two. We're anticipating, the data readout will be in the second half of this year, simply because of the time course of, the treatment and the standard of care.
All right. Very, very exciting. And then, Paul, I just got to ask, I was a little surprised to learn about the departure of Tommi Kainu, especially ahead of all the exciting cancer immunotherapy readouts that we're expecting. You just got to ask, does this affect you guys at all? Are there plans to get another chief medical officer? If so, what would the profile of that person ideally be?
Yes. Yeah, you're right. Chris has left us, which is obviously a shame because Chris is a great guy, has really contributed a lot, even in the short term he was here. But as I'm sure you're very aware, it's a very highly competitive market to retain attractive talent like Chris in terms of oncologists. You know, he's gone with our best wishes, and I'm sure he'll do great where he's gone. Of course, we're gonna replace him, even though that's a difficult task, but we will. Again, we're looking for someone who has got industry experience in clinical development, both in oncology but also infectious diseases.
All right. Thanks, Paul.
Thank you. Your next question comes from the line of Michael Novod of Nordea. Please ask your question.
Thank you very much. Just a question to the RSV program. In terms of the Phase III trial, I know you're still working with the FDA to determine the final design, but can we conclude that if the full trial, the cost is DKK 80 million-DKK 20 million, it's gonna cost you DKK 40 million, DKK 50 million to take in the data for the fertility analysis? Just to get a feeling for, say, the cost to go there, because DKK 40 million, DKK 50 million would be quite easy, I guess, for you guys, also with the PRV in mind that you can sell.
Secondly, on chordoma, maybe I missed it, but just try to describe a scenario for us. Now, you need four responses or one response out of the first 10 patients, one OR, and then you need four out of the total 29, if you can progress it into the Stage Two. What happens? I know it's, it might be an unrealistic scenario, but what happens if you get four responses out of the first 10 patients? Maybe you can just elaborate a bit on that for us.
Sure. Thanks for the question. Yes, I think your assumption on what the Season One would cost is in the ballpark. The reason, again, we're not giving clarity right now is we really don't know the total number of subjects that we're looking at, which is all to do with the statistical plan. Yes, I would say, to help you guide, a figure of DKK 40 million-DKK 50 million for Season One is in the right ballpark. In terms of chordoma, it's an interesting question. What happens if we see four already in the first 10? That would be unprecedented, unheard of in this situation, and that would certainly accelerate our discussions with the authorities on how to proceed.
You know, typically, when the FDA already knows you know, 10 would be a very small number, and when they already know you're enrolling more, they would probably want to see what the outcome is. If we got four out of 10, it would be unprecedented in this indication and would really stimulate a lot of discussions with the authorities on how to move forward.
What about if you get, if you get two? Would that qualify also for this to potentially get a Breakthrough designation? What, what should be, say, required for this to be qualifying for a Breakthrough designation with the FDA?
Well, we believe the four out of the total number of patients, it would also be an outstanding result. Again, you know, if we got something in the first 10, you know, it would be a strong indication, but it's only 10 patients, right?
Yeah.
Although I know we're only gonna be enrolling 29 in total, which is still very small, 10 is a relatively small sample size to draw strong conclusions on a breakthrough. However, as I said, let's see what the data reads out and, what the discussions with the authorities entail.
Okay, just one more follow-up, if I may. I just came back from seeing JNJ at the CMD in the U.S., and they clearly have revisited their RSV strategy to make a write-down on one of their assets they bought in, and now they're running a new phase or phase II or phase IIb with the one they call RSV senior vaccine, so for the elderly. They are in phase II, phase IIb. Maybe you could just say, elaborate a bit on the competitive environment, because it seems like also with the recent failures, that you're actually ahead of, say, the pack now, or do you see someone, say, moving in, say, in front of you on the vaccine side?
I know there are other approaches, antibodies, et cetera, but on the vaccine side, maybe you could just give us a bit on your thoughts on the competitive environment?
Sure. you know, who's in the lead is always subjective of where you're sitting, but I would say that we're definitely in the lead. When I look at the competition, including Janssen, or J&J, their concept is to use the fusion F protein within their vaccine platform, which is adenovirus, as you know. They have a slightly different concept in that they're using one form of the F fusion protein, which is believed to give you stronger neutralizing antibodies, but it is basically based on initiating neutralizing antibodies. This concept of using F, whether it's the pre or the post, has failed for numerous companies. In our hands, when we use F alone in our platform, we can't protect animals in the relevant animal models, which is why we have developed our concept to have five encoded antigens.
One of the reasons that a lot of the competition don't go for the same strategy is their vaccine platforms don't allow them to encode five antigens, which is the advantage we have. You know, who is right at the end of the day? We're gonna find out pretty soon, because, you know, we plan to start phase III next year, and we'll have a readout in 2021. You know, I'm confident in our approach. It's rare, I would say, in vaccine development, that you design a vaccine to do something that actually does exactly what you designed it to do in the clinic. You often design a vaccine, and it does some of the things you want it to do, and you convince yourself that that's good enough.
This is doing exactly what we want it to do. I believe it's worth evaluating in the clinic.
Thank you so much.
Thank you. Your next question comes from the mind of Nick Nieland of Citi. Please ask your question.
Hi, thanks for taking the question. Firstly, with the news flow regarding the outbreaks of mpox infection in various countries, has that directly led to any orders of IMVAMUNE from governments outside the US? Secondly, you mentioned in your release that HIV vaccine is expected to initiate later this year. Is there a milestone associated with that initiation similar to the HPV? Do you see any of the healthcare reform in the U.S. as a and potential budget cuts as a threat to your long-term IMVAMUNE revenues?
Thanks, Nick. Your first question was related to the outbreaks of mpox that we've seen, has it led to any orders outside the U.S.? Well, yes, small orders in the U.K., where we supplied our IMVANEX, as it's licensed in the EU, to vaccinate those who were already exposed and others dealing with the infected patient. Interestingly, in the U.K., they actually have a licensed replicating smallpox vaccine, which is stockpiled, but they actually requested the safe alternative from us. We do anticipate that the mpox indication or the mpox situation is actually generating a lot more discussion in various governments, but we'll have to see how that market develops. Your other question related to the initiation of HIV, would it stimulate a milestone payment?
We haven't revealed any milestone payments on that program. We'll probably make that clearer when that study gets initiated. Your other question related to budget cuts and the like in the U.S., how could that affect us? Of course, you know, it could affect us. I can't deny it, that there are cuts. Having said all of that, over the last two administrations, or in fact, I should say three or four administrations, where there have been budget cuts and constraints and even shutdown of the government, the one thing that remains funded at the levels that's requested or even above, is biodefense. Independent of which party is in, is sitting in the White House, it seems to be universally well-funded. That's certainly been our experience over the last decade.
Okay, thank you.
Thank you. Once again, ladies and gentlemen, that is star and one if you wish to ask a question. Your next question comes from the line of Boris Peaker of Cowen. Please ask your question.
Good morning, this is John Scullin for Boris. I had a question on RSV. Would that interim analysis be powered for efficacy for a potential early stop in filing after one season of data, or is this strictly to stop the trial only if there's unlikely to be a benefit?
Thanks for the question. How to answer that? I think most likely it is futility, but again, it just depends on just how efficacious the vaccine is. As you know, when you do an efficacy study, you make certain assumptions, and you power it for those assumptions. If the vaccine is a hell of a lot more efficacious than your assumptions, it could, but most likely, I wouldn't be promoting that as a likelihood. The way we're trying to power the study, if we pass the futility analysis, at least the way we're discussing it with the FDA, it would really increase the chances of success in the second season. Again, these details I would rather leave until they are really confirmed in the protocol design that we're discussing with the FDA.
Okay, thank you. On smallpox, you've discussed some additional settings for healthcare and military personnel. Would the first step in that process be responding to a request for a proposal from the U.S. government, or can you approach healthcare providers directly for their workers once there's an FDA approval?
let's see after the FDA approval, but it's our working hypothesis that we will be able to directly approach healthcare workers once we have an approved product. Of course, one of the customers outside of BARDA, who are stockpiling it, is DOD. Of course, there are ongoing discussions already with DOD as, obviously, changing their policies or ordering vaccines, is a relatively slow process. Yeah, we see really good opportunities once we have a safer alternative that's suitable for the general population.
Okay. Thank you for taking my question.
Thank you. Your next question comes from the line of Jesper Ilsøe of Carnegie. Please ask your question.
Yes. Hello. Thanks for taking the question. My question is around CV301 and your new administration methodology. Could you update us if you have any further preclinical results, and what is the current plan to take it into the clinic also in relation to ongoing CV301 phase II studies? Thank you.
Yes. We've reengineered CV301, so we start with a priming dose of MVA-BN, encoding the relative antigens and TRICOM. We do it in a slightly different way than we've done in the past, in that we give the highest dose possible, and to achieve that, we vaccinate high doses in each limb, so both legs, both arms, and we repeat that vaccination four weeks later. We're giving a lot more vaccine than we've previously done in terms of priming. The reason we go in each limb is that we have some evidence that that's a great spot in terms of the draining lymph nodes, which is where all the immune activation occurs.
We follow up with fowlpox boosters at relative different intervals, but throughout the entire length of the standard of care, whether that's with a checkpoint inhibitor or with radiation. There is some data that NCI have already generated, indicating that this approach, both for BN-Brachyury and also CV301, is a lot more immunogenic than the previous approach with PROSTVAC, which is great, it is really encouraging. We'll have to wait and see whether those greater immune responses bear out in a larger number of patients in the ongoing studies and of course, whether those immune responses can lead to clinical responses in combination with the standard of care.
We have three ongoing studies, as I indicated in the presentation, and importantly, we will have data readout from one of those in terms of the first data readout, in bladder later this year, which will hopefully confirm that our strategy is going in the right direction. Similarly, with chordoma, as I've said, with a similar, vaccination regimen, we should have data readout, later this year, which will again, hopefully confirm that the new approach is working.
Thanks. I was actually thinking about the intrathecal and intratumoral injections.
Okay.
guess you're discussing what you're currently doing in the current clinical trials, right?
Yep. We have a couple of studies planned where, we want to vaccinate both directly into the tumor. Again, the preclinical evidence there is that we can really change the tumor microenvironment. We make it much more inflammatory, which is great for, the T cell responses to be effective. We have some really exciting preclinical data, that it's not only changing the tumor microenvironment, but it's also stimulating, great T cell responses that are attacking and killing the tumor. While CV301 and Brachyury may not be the optimal constructs, both for intravenous or intratumoral, which we'll be testing, these are gonna be important studies for safety and also for some initial, indications of efficacy.
While we come, hopefully next year, with the more optimal constructs, once we've already established the safety, with Brachyury and CV301.
Just a final follow-up here. Would that mean that if you, for instance, if you observe one objective response in Brachyury here in the first stage of the trial, would you then consider switching to a new construct, or is this too long into the future that you rather prioritize moving forward what you currently have in the clinic?
You know, once the study is ongoing, it's difficult to swap and change about what you're doing. You know, we have, I know it's a number of people have criticized it, but we actually have multiple strategies moving in parallel. It's a difficult nut to crack, as you all know, in oncology. It doesn't mean that we don't believe in CV301 or Brachyury with checkpoint inhibitors or radiation. We still believe in those concepts. We have a lot of solid data suggesting that that is a good strategy. We have other strategies as well, which indicate that they may work in different indications with other products that we're also pursuing. We're pursuing multiple strategies in parallel.
Again, we're doing it in a very cost-effective way, that hopefully will bear fruit in the months and years ahead.
That's clear. Thanks.
Thank you. We have a follow-up question from Michael Friis Jørgensen of Nordea. Please ask your question.
Yep. Thank you very much. Just a Question to your comments on the investing for the future slide regarding manufacturing for partners and or collaborators. I was just thinking, how much can you actually do in terms of contract manufacturing when everything is up and running and ready in 2021? We have seen other companies, even also here in Denmark, Lundbeck, generating a lot of income from contract manufacturing. Is there gonna be a specific strategy that you're gonna allocate some of your capacity for contract manufacturing, and how much can you actually do in terms of capacity for others?
Yeah. Thanks. you know, having manufacturing capabilities is both a blessing and a noose around your neck in some ways, in that it's a blessing that we have the capabilities. However, of course, the infrastructure for manufacturing live vaccines is very costly. Nonetheless, the best way of utilizing that expertise, is to utilize the capacity the best you can. We are looking at opportunities both to do contract manufacturing, I would say more strategically for certain partners, both on the bulk, potentially, but also on the fill finish. Again, the mix of how much contract manufacturing do we do versus how much of our own filling, depends really on what's on the order books. We're looking to optimize the facility costs by filling the facility, both with our own products and with strategic partners.
If you have.
I know that there's a specific answer around-
Maybe also asking in, also in a different way. If you had the capacity today, would you be able to have contracts already? I mean, is the interest there?
There's a lot of interest. I can tell you already, we haven't even finished building the building. There's already a lot of interest. There is a shortage of filling capability, both for liquid and freeze-dried, for live viruses, for starters, and or specialty filling, and this is a state-of-the-art facility for live viruses. Of course, we can fill other things. There is a lot of interest, yeah.
Super. Thanks. Super. Thank you.
Thank you. There are no further questions at this time, sir. Please continue.
Thank you. Thank you everyone for your time today and for your questions. Thank you very much, and goodbye.
Thank you, ladies and gentlemen. That does conclude our conference for today. Thank you all for participating. You may now disconnect.