Bavarian Nordic A/S (CPH:BAVA)
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Earnings Call: Q2 2019

Aug 15, 2019

Operator

Ladies and gentlemen, thank you for standing by. Welcome to today's half year report 2019 conference call. As you some all participants are in a listen only mode. There will be a presentation followed by a question and answer session, at which time, if you wish to ask a question, you will need to press star 1 on your telephone and wait for your name to be announced. I must advise you that this conference is being recorded today, Thursday, the 15th August, 2019. I would now like to hand the conference over to one of your speakers today, Rolf Sass Sørensen. Please go ahead.

Rolf Sass Sørensen
Vice President, Investor Relations and Communications, Bavarian Nordic

Thank you. Welcome to this Q2 call. My name is Rolf Sass Sørensen. With me today, I have Chief Financial Officer, Henrik Juul, as well as President and CEO, Paul Chaplin. Before we start the presentation, I need 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 could 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. All forward 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 back to Paul Chaplin.

Paul Chaplin
President and CEO, Bavarian Nordic

Thank you, Rolf. Welcome everyone to our Q2 report. The first 6 months of 2019 have been very eventful for the company. We've had strong performance in our pipeline. We remain on track for all our key milestones in the second half of this year. The BLA for the approval process for our MVA smallpox vaccine is going according to plan. We still expect an FDA decision in September. Our fill and finish facility, which is in the construction phase, is also progressing according to plan and budget. This is a key activity upon completion should return the company to profitability under our existing order with the U.S. government. As I said, we've seen key progress in our pipeline. We've initiated our Phase III freeze-dried MVA trial, which was initiated earlier this year.

It's a $30 million phase III study, which is fully funded by the U.S. government under our existing order. Our discussions with the FDA on the phase III design for our RSV prophylactic vaccine are still ongoing. I'll touch on that in the coming slides. Our partner programs are progressing. Our Ebola vaccine in combination with Janssen has entered a new, large phase III study in Uganda, and our HPV vaccine, again, together with Janssen, has entered the clinic and is undergoing enrollment as we speak. In terms of our immune oncology, we've seen progression earlier than anticipated for our BN-Brachyury study. We've seen a partial response with one of the first patients that we enrolled.

That triggered moving into the second stage of that clinical study, we're currently enrolling another 19 patients, we anticipate more data in the next 6-12 months. In addition, we should be seeing some of our new concepts in immune oncology entering the clinic later this year. Strong pipeline performance, as you'll hear from Henrik later, our financials are fully in line with our own internal expectations, of course, we maintain our guidance for 2019. Turning to slide 4, our vision at Bavarian Nordic is to become a leading and profitable biotech company, that through harnessing the power of the immune system, will develop, manufacture, but also commercialize products for infectious diseases and cancer within the next 5 years. To achieve this aspiration, we have 4 main goals.

One is to maintain our global leadership, our smallpox vaccine business. To do this, we need to finalize the development, not only of the approval of the liquid-frozen in the coming weeks, but also the freeze-dried and to secure broader sales. We also want to expand and rapidly advance our pipeline for infectious disease programs. We need to move forward and launch our RSV vaccine in the next 5 years, advance our partner programs with Janssen, and bring more programs through into the clinical pipeline in the years ahead. Thirdly, we want to establish a broad and deep cancer immunotherapy portfolio. We want to continue our current strategy of combining various vaccines with either standard of care, including checkpoint inhibition, but we want to explore more advanced combinations and treatments which will be initiated later this year.

Lastly, we want to expand the commercial footprint and our capabilities. One of our key strengths is our ability to manufacture, and we want to build upon that, look to expand our capacity and to potentially manufacture for others. We want to build a commercial infrastructure to drive profitable growth, potentially accelerating our ambition by looking for M&A opportunities that may be out there. On slide 5, I talk a little bit about our ambition to maintain our global leadership role in smallpox. Essentially, we have the only company providing a safer alternative vaccine, smallpox vaccine, that's safe for the entire population. We've had a very strong relationship with the U.S. government and have received funding to the tune of almost $1.8 billion.

That has allowed us to complete 22 clinical studies, deliver 28 million doses to the Strategic National Stockpile, and we have now submitted the BLA, our first BLA, for the initial liquid-frozen formulation. Currently, by year-end, we'll have bulk valued at $33 million in our facility. We expect the approval of liquid-frozen in September this year. This should also come with a priority review voucher, which we intend to sell, and we've initiated, as I already said, our freeze-dried Phase III study. What the future brings is that on completion of our fill and finish facility, we will convert all this bulk that we're storing into freeze-dried doses, and that will trigger the $300 million or the $299 million option that's existing in the current order.

This order is awarded in 2017, is a 10-year contract. We've already negotiated additional pricing for liquid-frozen, freeze-dried, and bulk, and we fully anticipate new orders. Upon approval of the liquid-frozen, we believe it will open up new opportunities beyond the stockpiling, which many of you come to recognize us for. For example, 50,000 soldiers are currently vaccinated against smallpox each and every year. That's 1 opportunity. If more soldiers were to be vaccinated, such as all recruits, that would be 400,000 personnel vaccinated each and every year, and there is currently a policy from the CDC stating that up to 5 million people should actually be vaccinated against smallpox before an outbreak, which becomes possible when you have an approved, safer alternative. We truly believe there's been great historical business in our smallpox franchise.

There is great current business. We will be returning to profitability with a current order. There are many new opportunities ahead of us. Slide six, a little update on Ebola. Obviously, the Ebola current outbreak is continuing in the Congo. Unfortunately, just under 3,000 cases have been reported. This comes with a 60% or greater than 6% fatality rate. This has led the WHO in July to declare this a public health emergency of international concern. The WHO, earlier this year, also recommended the use of Janssen's BN vaccine. That's led to the initiation by Janssen of a clinical study in Uganda in 800 healthcare workers, which obviously, neighbors the ongoing outbreak in the Congo. Slide seven, talks about our RSV ambitions. We are still in dialogue with the FDA.

However, we've had very fruitful discussions that are in the Phase II meeting, and there are one or two aspects that still remain outstanding, particularly the rules about stopping after season one. It's essentially a 2-season design that we're in discussions with the FDA. It's between 12,000 and 14,000 subjects split, as I said, over 2 seasons. The first season, we will enroll 6,000, and then there will be a futility analysis, which will determine whether we continue into season 2, with potentially an adaptive design if we're underpowered based on the incident rates of RSV. We do anticipate that this will be finalized in the coming weeks, of which we will then, obviously, inform the market of the final design and the statistical plan.

The budget for this study is well within our reach. It's in the region of $80 million–$120 million, obviously split over 2 years. It's well within our reach and something that we can fund. As I said, we have probably the best RSV candidate vaccine in the pipeline, and one that we're eager to get into Phase III. Slide 8, we talk about our fill and finish facility. This is the single largest CapEx investment that Bavarian Nordic has entered in our history. However, it's one that will return the company to profitability. It will allow us not only to manufacture the bulk vaccine, which we've been doing for more than a decade, but will now allow us to both freeze, dry, and fill liquid-frozen products.

This will be important for our current order, unlocking that option of $299 million. It will also allow us to launch our RSV vaccine upon completion of Phase III. It also allows us to potentially look at bringing in other products that fit our profile and our key set of skills that allow us to expand our commercial activities. It's really an investment for the future that will allow Bavarian Nordic to return to profitability. Slide 9, our immunotherapy strategy is basically on three legs. We currently are looking at the combination of our vaccines with standard of care, and the best example there is our BN-Brachyury and chordoma.

We're also looking at vaccine combinations with checkpoint inhibition, as we believe cancer vaccines will stimulate T cells, and obviously, checkpoint inhibition allows those T cells to become more powerful to eliminate tumors. I'll come back to the BN-Brachyury study in a minute, but we have three ongoing studies of CV301 in combination with different checkpoint inhibitors in different indications. The ongoing bladder study, together with Roche's anticancer treatment, will actually be reporting data in the second half of this year. We, however, are not resting on our laurels on this strategy, even though we believe there's great merit in evaluating these in the clinic. We have, for more than a decade, been looking at ways of making our platform even more immunogenic, allowing us to hit the tumors with many more arms of the immune response.

These concepts will be initiating Phase 1 studies later this year. On Slide 10, a chordoma study. We completed enrollment in the Stage 1, which was to enroll 10 patients. We were looking for an objective response in at least 1 patient, trigger moving into Stage 2, which to enroll another 19 patients. These are cancer patients which are treated with radiation, which is the standard of care, together with our experimental vaccine, BN-Brachyury. We had very positive and encouraging data earlier than anticipated, as 1 of the first patients enrolled actually had a partial response, meeting the threshold of a greater than 30% shrinkage of their tumor, which had been irradiated. That allowed us to initiate earlier this year, the enrollment in Stage 2. The Stage 2 enrollment is going extremely well.

We're about halfway through that enrollment, we anticipate finalizing enrollment later this year, meaning that as these patients are evaluated at their 3, 6, and 12-month periods, we will have the opportunity to obviously, hopefully, see more data. We're looking for a total of 4 objective responses to have a meaningful result from this study, which will allow us to open dialogue with the FDA on the next steps. With that quick tour of what we've done in the pipeline, I'll hand over to Henrik, who will give you an update on the financials.

Henrik Juul
CFO, Bavarian Nordic

Thank you very much, Paul. First of all, I'm very pleased to report financial results that are fully in line with our expectations and our guidance. I would like to start taking you through the lower right corner table, which shows that for the first six months of this year, we delivered revenue of DKK 228 million. The doughnut chart to the right show that that is composed of $49 million from our smallpox bulk manufacture under the contract with BARDA. These are three batches that were revenue recognized already in the Q1 of this year.

We have previously guided that we will revenue recognize 20 batches. We are fully in line with our manufacturing plans to deliver on that promise, which of course, means, again, that our revenue will be skewed towards the second half of the year for the smallpox business. I'm very pleased to report that when you look at the breakdown of the revenue, we have first six months, DKK 179 million coming from contract R&D work. As we have said previously, this year, we are blessed with the fact that we are actually playing on more different horses. This DKK 179 million actually comes from our contract with BARDA on the CMC. It comes from our contract as a sponsored Phase III trial that we have initiated this year.

There is income from our agreement with the Department of Defense on the equine encephalitis, there are still income from our Janssen agreement included there as well. All of our revenue in the Q2 , which was 101 million, actually comes from R&D contract work under these four contracts. This revenue line and our progress on projects and our general spend, et cetera, translated into an EBIT loss of DKK 201 million. Fully in line with our guidance again. With the investments that we are this year doing with primarily within our establishment of the fill and finish facility, we are ending first six months with a cash preparedness of nearly DKK 1.9 billion.

Again, in line with our expectations and which enables us to confirm and maintain our guidance for the full year. I will just here remind you of our guidance. We are guiding a revenue level of DKK 600 million for the full year and an EBIT loss of DKK 360 million and a cash preparedness of DKK 1.6 billion by the end of the year. Let's turn to the next page, where we will see a breakdown of our financial position. You will recognize the nearly DKK 1.9 billion in current cash preparedness. That consists of, first of all, of our cash and the investments we have done in low-risk securities.

It also includes a loan from the European Investment Bank of EUR 30 million, which we have not drawn down yet. Below that table, you will see the breakdown of our current debt that we are carrying. That's a small mortgage loan of DKK 26 million, and then an older European Investment Bank loan of DKK 372 million. Again, all in all, we have a very strong financial position that enables us to continue the execution of the current strategy. As said, we are guiding a cash preparedness of DKK 1.6 billion by the end of this year. By the end of this year, we will also have finalized the biggest part of the investment in the fill and finish facility, so giving us a very strong position. Let's turn to the next slide.

Given our progress that we have seen during the first half-year, we are able to confirm the exciting news flow we have ahead of us for the second half of this year. If we look at those, I think within our smallpox vaccine business, that is, of course, the expected approval of the liquid-frozen smallpox product by the U.S. FDA, which triggers the award of a priority review voucher, which we intend to sell. On the other infectious disease programs, here, the big thing, of course, will be to finalize the RSV development plan. As Paul said, we are in the final discussions with the FDA, and we'll be able to share relatively soon an update on that program.

We are also working already on the study of equine encephalitis virus program, sponsored by the Department of Defense, later this year, we are going to initiate a Phase 1 study here. Amongst the Janssen programs, we are expecting Janssen to initiate a Phase 1/2a study of the HIV vaccine later this year as well. Within our cancer immunotherapy business, we have already this year, as Paul said, reported the initial objective response rate from our BN-Brachyury study and have started the recruitment of stage 2. We are also, later this year, expecting to report on the CV301 bladder study. Also this year, expecting to initiate studies to test new routes of administration. More specifically, that will be a Phase 1 study, testing BN-Brachyury intravenously and CV301 intratumoral.

Again, exciting news to happen also within the cancer immunotherapy portfolio. Finally, within the fourth strategic objective, the plan this year is to finalize the full construction of the fill and finish facility that will really enable us to return to a more stable revenue level in the future and return to profitability as well. An exciting news flow ahead of us, which we are very pleased that we can confirm again, given the progress we have seen, both financially, but also on all our projects during the first 6 months of this year. With that, I will ask the operator, please, to open up for question and answers.

Operator

Thank you. Ladies and gentlemen, if you wish to ask a question, please press star and one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, please press star and one if you wish to ask a question. Your first question comes from the line of Chad Messer. Please ask your question. Your line is now open.

Chad Messer
Analyst, Needham & Company

Great, thanks. Appreciate you taking my question, and congrats on all the, all the progress. As usual, a lot going on. Just for the chordoma study, I'm wondering what we should expect in terms of reporting on that. Are you gonna sort of report responders as they occur, or will you let us know when you hit 4, or are you just gonna wrap the whole study up before we, before we'll get a report?

Henrik Juul
CFO, Bavarian Nordic

Mm-hmm.

Paul Chaplin
President and CEO, Bavarian Nordic

Yeah. Hi. Thanks, Chad. Yeah, obviously, just to explain how the study goes, obviously, we've enrolled 10. We completed enrollment in February. Their first scans are 3 months post the initiation of radiation, then 6 months and 12 months, which is the period that we evaluate. Obviously, early next year, those first 10 will be fully evaluated. Obviously, we started enrolling the next 19 in June. As I said, we're about halfway there, approximately. Depending on when we complete enrollment, let's say we complete enrollment in October, for the sake of timing, that means we would complete the whole study by next October. That's the sort of timeframe we're looking at. Obviously, your question relates to if we see more objective responses, we'll report them.

I think we'll probably report them in the quarterly announcements, but obviously, if and when we hit 4, which of course could happen between now and the last patient, we would obviously report that.

Chad Messer
Analyst, Needham & Company

All right, great. Yeah, no, very, very exciting. We will stay tuned for that. Then on MVA-BN or PROSTVAC, I don't know when we stopped calling it that, I must have been asleep. How long do you think it'll take to run the freeze-dried study? And if that's not something you can provide, maybe just remind us how long the liquid-frozen study took.

Paul Chaplin
President and CEO, Bavarian Nordic

Yeah. The freeze-dried phase 3 is just in over about 1,000 subjects with 3 arms. We expect recruitment to be finalized towards the end of this year, kind of on track for that. The study itself won't be completed until early 2021.

Chad Messer
Analyst, Needham & Company

All right. Great. Thanks.

Operator

Your next question comes from the line of Thomas Bowers. Please ask your question. Your line is open.

Thomas Bowers
Senior Equity Analyst, Danske Bank

It's great. Thank you. Just on, first of all, on the RSV, it seems like you narrowed in the number of patients from 12,000-18,000 to down to 12,000-14,000. I'm just wondering what this adjustment account for? Is it just a continued dialogue with the FDA, or is there anything else that you are considering here? Then, on the Ebola vaccine, just remind me, do you have any regulatory milestones agreed with Janssen? I'm just thinking that you should be quite close with a filing to the European authorities. Is there anything we could expect here in before the year ends?

Also on the Ebola, anything pending, any additional WHO meetings that needs to be completed before you think that Janssen is given the green light to potentially deliver vaccines to DR Congo? Just on the chordoma, so I guess given that you state that you will probably report any partial responders in the quarterly updates, I guess you're still at 1 PR. Is it fair to assume that you have 6 or 7 patients through the, at least the first and maybe even a few patients on the second analysis? Thank you.

Paul Chaplin
President and CEO, Bavarian Nordic

Thanks, Thomas. I'll try and remember all those questions. That was a bit of a barrage. Your first question related to the RSV, and you're correct. You're very quick at seeing that we narrowed the total number of subjects, 12-14. It's just a reflection of the status of where we are with the FDA. It's, you know, as I said, I think the trial design, there should be no surprise when we come out and announce it, that the trial design, as it's depicted on that slide, is basically what we're in discussion with the FDA. It's 12,000-14,000 subjects. It'd be 6,000 subjects in the first season. The things that are outstanding with the FDA are some of the definitions of the endpoints.

How do you measure lower respiratory tract infections and acute respiratory disease? Some of those discussions are still ongoing. Primarily, the big discussion is really on the stopping rules after season one, which is to do with obviously the stats plan, which is outstanding. The trial itself is pretty much, design is shown in that slide, but there are a couple of outstanding points that still need to be put at home, put to bed with the FDA. The second question related to Ebola and other regulatory milestones. There are regulatory milestones, but I don't believe we've actually disclosed what they are, but there are regulatory milestones. Regarding that whole process, you know, Janssen, our partner, is in discussions both with the FDA and the European authorities on filing, and what will it take.

I can't really comment on the timing of when that will be. We have a lot of clinical data, as we've shown in the slide. We're currently validating the process, so we are moving towards filing, but as I said, that's in the hands of Janssen. Again, I think one other question you have related to potentially supply with the WHO of the vaccine to the Congo. You know, those again, are lengthy, ongoing discussions between our partner, Janssen, the WHO and various other bodies and authorities, and they've been going on for some time. Let's see what comes out of that. As I said, I can't really comment on that either. The last question related to chordoma. You're correct. A lot of the patients have gone through screening.

Obviously, if we'd seen more partial responses, it would be in the quarterly. I would say that there are some encouraging signs in what we see, in that we have actually, at the first 10 patients, quite a number of patients with stable disease. Now, that's also kind of expected with a slow-growing tumor, but it's encouraging that there are still patients to evaluate in that first 10 that were enrolled.

Thomas Bowers
Senior Equity Analyst, Danske Bank

When you say stable patients, so do you see any tumor reduction or?

Paul Chaplin
President and CEO, Bavarian Nordic

Well, the definition of stable is either that there is a tumor reduction that is less than 30%, obviously, because obviously if you hit 30%, it would be a partial response, or there's no growth of the tumor. I'm not really going to say what it is, we are encouraged by what we're seeing. Again, you know, our feet are on the ground here because it's a slow-growing tumor. We've seen one partial response, which is highly encouraging, we are seeing some encouraging results, we haven't met the threshold of a reduction in 30% in another patient.

Thomas Bowers
Senior Equity Analyst, Danske Bank

Okay, got it. Then just quickly on the one patient that had a partial response or the first patient. What's your consideration here, given that partial response came very fast? It was the first analysis after three months post-treatment. What do regulators say and how to interpret that response? Is that likely to be related to the radiotherapy? I guess given that the vaccines are well known to have a delayed effect. What's your consideration here?

Paul Chaplin
President and CEO, Bavarian Nordic

You know what? It's a very small data set of one, right? I think it's dangerous to speculate too much. As I said, I think we're encouraged that we've seen a response. Clearly, we can't start attributing that response solely to the vaccine. It could be radiation, it could be the vaccine, we could just be lucky, it could be random. I mean, you know, we have to keep our feet on the ground, and that's why the trial was designed the way it was. One response was statistically then worth expanding the number of patients, and that's what we've done. We need to see four responses to be convinced that we're seeing a signal from the vaccine in combination with radiation.

Thomas Bowers
Senior Equity Analyst, Danske Bank

Great. Thank you very much.

Operator

Your next question comes from the line of Peter Welford. Please ask your question. Your line is now open.

Peter Welford
Senior Research Analyst, Jefferies

Hi, yeah, thanks for taking my questions. Just coming back to RSV, just curious to understand, is the debate here around the allocation of alpha for the interim analysis, or is this a case of debate whether there should be an interim analysis, or is it rather based on the hierarchy of the endpoints and which endpoints are considered at the interim? I guess, just curious, is it essential that the interim analysis triggers filing of the RSV, or is it that actually the interim analysis you would still continue with the second season irrespective of what happens at the interim, i.e., it is a 12,000-4,000 patient study irrespective, but the question is whether or not that first stage could potentially hit the primary endpoint?

Just turning back to brachyury, I'm just curious here, are you able to disclose how many patients of the original 10 have had an evaluation? Presumably now all 10 have had the first evaluation, or are some of those 10 still awaiting even their first evaluation after receiving RT in the vaccine? Thank you.

Paul Chaplin
President and CEO, Bavarian Nordic

Thanks, Peter. As usual, quite good questions there. On RSV, it's kind of all of the above of what you said, to be honest. It's on the definitions of some of the endpoints and the hierarchy of those endpoints. It is around the interim analysis. It's not really on the power because we won't be utilizing any power on that analysis. However, it is really about the stopping rules on, you know, on that analysis, what would trigger a stop and what would trigger a continuation. I would say none of this is alarming or shouldn't be. It's pretty standard, and we're very happy with the dialogue we're having with the FDA, and I, you know, I really think we're just waiting for some feedback on our last proposal that we've submitted.

Your other question related to how many patients. I think I'm right in saying that of the first 10, all have gone through their first evaluation. As I said, we do have quite a few patients that have stable disease, so they're still being evaluated in or, well, obviously, being evaluated in their follow-up, visits, but they have not progressed, so we're encouraged by that.

Peter Welford
Senior Research Analyst, Jefferies

Thank you.

Operator

Ladies and gentlemen, once again, if you wish to ask a question, please press star and one on your telephone. To ask a question, star and one. Your next question comes from the line of Boris Peaker. Please ask your question, your line is now open.

John Scotti
Analyst, TD Cowen

Good morning, this is John Scotti on for Boris. Thank you for taking my questions. First, with the PDUFA date coming up for Imvamune, do you anticipate having a black box warning on the label based on the safety profile you've seen in your trials? On the cancer immunotherapy program, you mentioned some additional combinations are being considered. Would that continue to be combinations of your virus with a drug that already has an approved indication, or are you looking potentially at combinations of multiple novel agents? Thanks.

Paul Chaplin
President and CEO, Bavarian Nordic

Thanks. No, we certainly don't anticipate the black box warning. You know, the safety profile that we've seen with our smallpox vaccine is one that you typically see with live virus-based vaccines. Some local swelling and redness, but nothing at the injection site, but nothing alarming. We've obviously also given the vaccine to people with HIV, who are actually considered severely immune compromised, and haven't seen any safety issues. We don't anticipate a black box warning. I think your other question was relating to some of the new studies that we're planning on with our new approaches. Those approaches are administering the vaccine by different routes, either directly into the tumor or intravenously.

We're excited by those concepts because they're stimulating different arms of the immune system that potentially down the road, will allow us to look at other combinations other than just checkpoint inhibition, such as antibodies targeting the tumor, such as an anti-Herceptin or Herceptin targeting HER2. However, the initial studies we'll be doing will be initially safety studies with the current vaccines we have before we move forward next year, hopefully with some of the more optimal constructs, which we'll be announcing, hopefully later this year.

John Scotti
Analyst, TD Cowen

Okay, thank you very much for taking my questions.

Operator

Your next question comes from the line of Jacob Lademann. Please ask your question, your line is now open.

Jacob Lademann, you can ask your question, your line is open.

Jacob Lademann
Analyst, Carnegie Investment Bank

Yeah. Hi, thank you. A clarifying question here for the next generation VN vaccines. Just wanting to make sure that I'm understanding correctly, that these are actual new constructs and not just different routes of administration or different sites of administration. Maybe if you could also expand a little bit about the overall strategy of the cancer immunotherapy portfolio. You have currently ongoing phase 2 trials, I guess I'm sort of trying to gauge how many of how many of these, you could say, strategies are you actively interested in moving forward, maybe all of them? If you could sort of narrow the scope a little bit for me here. Thank you.

Paul Chaplin
President and CEO, Bavarian Nordic

Thanks. Just to clarify, Well, let me talk about the overall strategy, and then I can clarify your first question about the construct. Basically, you're correct. We have multiple strategies in immuno-oncology, which is in line with our overarching strategy to build a portfolio. You know, cancer vaccines and curing cancer is gonna be a tough nut to crack. We currently have a number of concepts which are combinations with radiation or combinations with checkpoint inhibition, which isn't anything really novel. Many other people are trying it. It is supported by strong preclinical evidence that those combinations may be synergistic and merits being evaluated.

How we're evaluating them is in a careful fashion, in that we're doing smaller studies, looking for signals, and then expanding those studies, as we've done with the chordoma and with the bladder study, or potentially could with the bladder study if we see those signals. We're looking for signals, expanding those cohorts to generate proof of concept that these strategies bear fruit. They will lead, if they're positive, most likely to more confirmatory clinical studies, which of course we will follow, because obviously, that will be because we have strong clinical data and a headwind, tailwind, I should say, behind us. The other new strategies that we're evaluating are because it doesn't mean that we don't believe in the current strategies.

It means that the new strategies, in terms of going intravenously and into, directly into the tumor, offer new paths to stimulate the immune system, which we're not currently evaluating in the current strategy. As I tried to indicate in the last question, could open up new combinations which currently don't match when you go sub-Q, as we currently are with CV 301 and Brachyury. Again, what we're doing initially is Initially, for the studies we're starting this year, they're the current constructs of BN-Brachyury in CV 301. We're trying to generate safety with those constructs, allowing us to come with optimal new constructs later, for one, definitely next year, where we will be doing follow-on studies.

Again, we're looking for signals, proof of concept of efficacy, where we can expand the cohorts and then follow the signals wherever we see them.

Jacob Lademann
Analyst, Carnegie Investment Bank

All right, thank you.

Operator

Devan, no further question at this time. Please continue.

Paul Chaplin
President and CEO, Bavarian Nordic

Okay. Well, thank you everyone for your time and joining the call. Have a great day. Bye.

Operator

This does conclude our conference for today. Thank you for participating. You may all disconnect.

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