Y-mAbs Therapeutics, Inc.
Q4 2020 Earnings Call Transcript

Published: 26 Feb 2021

[Operator:]

Greetings, and welcome to Y-mAbs Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Thomas Gad, Chairman of Y-mAbs. Thank you, sir. You may begin.

[Thomas Gad:]

Thank you, and thank you, everyone. Good morning and thank you for joining us today. So 2020 was the year that we believe was truly transformational for Y-mAbs as we became a commercial stage company. We’ve made significant progress on executing our strategy and expanded significantly on our three pillars of business. First, our leading monoclonal antibodies, DANYELZA and omburtamab; second our bispecific compounds under the Y-BiClone tech platform; and finally, the SADA Technology platform. As you know, we received U.S. approval for DANYELZA in primary refractory and relapsed high-risk neuroblastoma on November 25, 2020. And from the beginning of February, we’ve been delivering DANYELZA, not only to MSK, but to hospitals throughout the U.S. So that’s very exciting.

[Claus Moller:]

Thank you, Thomas, and thank you everybody for deciding to – choose to spend the morning with us. During the fourth quarter, we have continued to work hard to ensure that our pipeline advances to what the market and our progress including having DANYELZA approved by the FDA, while at the same time making progress in the resubmission of omburtamab at BLA. In addition, we have initiated a Phase 2 study with nivatrotamab in small cell lung cancer under our own IND initiated two Phase 1/2 studies, one in medulloblastoma and one in B7-H3-positive CNS/leptomeningeal metastases in adult patients in the CNS and advanced our ongoing studies. We are also continuing to work on our new bispecific constructs and the SADA programs as well as our GD2, GD3 vaccine. Naxitamab, on November 25, the FDA granted us the approval of DANYELZA. DANYELZA is indicated in combination with GM-CSF for the treatment of pediatric patients one year of age and older, and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow, who have demonstrated a partial response, minor response or stable disease to prior therapy. This indication is approved on the accelerated approval regulation based on overall response rate and duration of response. The approval came a few days in advance of the PDUFA date, and we are thrilled to send out the first commercial vials to the treatment centers, including MSK across the country earlier this month. So that was really a major achievement for the team.

[Bo Kruse:]

Thank you, Claus. We reported a net loss for the full year ended December 31, 2020 of $119.3 million or $2.97 per share basic and diluted compared to a net loss of $81 million or $2.30 per share basic and diluted for the year ended December 31, 2019. We were happy to report the first revenues in the history of Y-mAbs in 2020. We reported net revenues of $20.8 million for the year ended December 31, 2020 related to our licensing arrangements in China with SciClone and in Israel with Takeda. There were no revenues reported in the year ended December 31, 2019. We incurred $2.2 million of royalty expense for the year ended December 31, 2020 related to our licensing revenue. There were no such royalty expenses reported in the year ended December 31, 2019. As we take a closer look at the operating expenses for the full year 2020, we note that R&D expenses have increased by $30.2 million from $63.5 million for the year ended December 31, 2019 to $93.7 million for the year ended December 31, 2020. This increase was primarily attributable to a $13.2 million increase in milestones and license related costs, primarily related to our acquisition of the SADA Technology from MSK, and the $13.4 million increase in personnel costs, the $1.6 million increase in outsourced services and supplies, and a $1.1 million increase in professional and consulting fees.

[Thomas Gad:]

Thank you very much, Bo, and thank you, Claus. This marks the end of our today’s prepared remarks and I’d like the operator to open up the call for questions now. Thank you.

[Operator:]

Thank you. We will now be conducting a question-and-answer session. Thank you. Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question.

[Alec Stranahan:]

Hey, guys. Thanks for the questions, and congrats on closing out a solid 2020. So first from me on nivatrotamab, how are you approaching the small cell lung cancer study given the various modifications that were proposed following the results last year from the past year trial? And I guess how do you see this asset sort of slotting into the treatment paradigm in both neuroblastoma and osteosarcoma given that DANYELZA may actually reach approval on these indications first? And I’ve got a follow up.

[Claus Moller:]

I’m not sure I got the last part, but you can get back to that. But for the small cell lung cancer study, the idea is to take patients that are second lines, mostly lung cancer patients, meaning patients that have relapsed after being treated in frontline or continue to progress. And then as you for sure also know some of the PD-1, PD-L1s in your oncology treatments are approved in second line small cell lung cancer are most likely the patients would also have seen these and potentially also additional chemotherapy before they came – come on to nivatrotamab. We are giving the product in combination with corticosteroids on a weekly basis – biweekly basis, sorry. And the idea is to give subcutaneous administration that should reduce further the side effects, potential side effect or risk of side effects from T cell activation systemically, cytokine release. So that was the answer to the nivatrotamab, I think. What was the other question?

[Alec Stranahan:]

Yes. And then just how do you see it slotting in maybe behind DANYELZA given they’re going after similar indications and a similar target?

[Claus Moller:]

Well, you can say in the neuroblastoma setting, we are treating patients in third line that have been exposed to DANYELZA. And as you can see also, when you look at the data from the 201 Study, we had a 68% overall response rate based on investigators, ORR evaluation leaving 32% of the patients not responding, and so there’s definitely still an unmet medical need in the neuroblastoma setting. So I don’t think it’s going to cannibalize in anyway the market for DANYELZA. And as I said also, this is a very early stage study in neuroblastoma setting. So I don’t think it’s going to – I think it’s way too early to start discussing whether one would substitute the other one. One is a commercial product and it’s on the market and available on the shelf. The other one is the development program that’s several years ahead of it before it could potentially get to a BLA approval.

[Alec Stranahan:]

Okay. That’s very helpful. And one more question, if I may, actually on the SADA platform. Yes, your ability to sort of confine the radiation to the target tissue in preclinical models is definitely encouraging, but could you maybe speak sort of the residency time in other organs as its excreted? And what will be done in patients to manage this as the first product and where’s the clinic date this year?

[Claus Moller:]

Yes. The actual construct per se is of course not a problem because it’s not toxic in anyway. So – and of course, if there is normal tissue expression of the target, the tumor binding part of the construct is binding to it. Then you may have some normal tissue binding out of the construct. The first one is for GD-2, and we don’t think that there’s an issue with the doses that we’re working on in terms of side effect profiles from the GD-2 planning to eventually no side effects. And we’re definitely now concerned about the radiation since we know that at MSK, they have given up to a very high doses of radiolabeled GD-2 antibody to patients in the past. So that are substantially higher than the doses we expect to use with the SADA. So then when we shoot in the DOTA molecules with the lutetium-177, that’s supposed to bind into the DOTA end of the SADA construct that’s bound to the tumor. Then you can say, but what about normal tissue toxicity from the DOTA molecules were lutetium caged in a molecule and that’s a very tiny little molecule. So, of course, it’s going to spread through the entire water phase of the patient’s body, which is typically 70% of an adult male and a bit less for an adult woman. But the thing is that this DOTA molecule will pass through the kidneys in circulation. And every time it passes through, half of it is going to leave the body through the kidneys and into the bladder. Now bladder radiation is of course not very comfortable and you make radiation cystitis in the bladder from the bladder. If you don’t put it in a catheter and make sure you continuously drain the bladder while the patient is having the circulating DOTA radiation construct in there, but I think that’s my only real clinical topic to focus on in terms of toxicity. And in the pre-IND discussions we have had with the agency, they don’t seem to be utterly concerned about that side of it either. So, we are quite comfortable that we will be able to move this towards the clinic in the first quarter of this year.

[Alec Stranahan:]

Perfect. Thank you, and congrats again on the progress.

[Claus Moller:]

Thank you very much, Alec.

[Operator:]

Our next question comes from the line of Robert Burns with H.C. Wainwright. Please proceed with your question.

[Robert Burns:]

Hi, guys. Thanks for taking my questions and congrats on the quarter. Just a few from me, if I may. So my first question is around the omburtamab resubmission. I just wanted to get a sense what remains to be done with completing the resubmission package to the FDA. And with regard to the Type B meeting, does Y-mAbs intend on issuing a press release on the results of that meeting? That’s my first one.

[Claus Moller:]

Okay. Yes. Well, I mean, we’re putting together all the data we have. One of the things that happened in December was there was a new paper published by SIOPE, the European Pediatric Oncology Organization, where they gave data from 63 patients with CNS/leptomeningeal neuroblastoma relapsed and shared all survival data that is precisely as rodent. And for us as for all the other studies that has been published. The good thing here is that there are some more granularity and details from that database than there was available initially from the central German cancer register database. So now we have two sets of historical controls. We have worked with SIOPE in January to make sure and agree with them that they would give us access to the data from that study, and we have gotten access to that, which the FDA seems to be very happy about. So now we have used that dataset also as second search historical control panel. So that has been put together and submitted to the FDA in preparation for the Type B meeting at the end of next month. When we have had that meeting and we received the minutes from the meeting that typically happens 8 to 14 days after the meeting, then of course we will come and guide what the outcome of the meeting was and what we expect that to mean in terms of the resubmission.

[Robert Burns:]

Okay. Awesome. Thanks, Claus. And my second question, so could you provide any additional color around the trial design for DANYELZA in the frontline neuroblastoma setting that sleigh to begin this year? For instance, I assume it’s going to be a non-inferiority trial against DANYELZA with event free survival being the primary endpoint. But are you writing into the protocol, the exclusion of ASCT in the naxitamab arm explicitly?

[Claus Moller:]

No, we’re not, because if patients have received bone marrow transplant, then they can come in still, but we are not requiring the bone marrow transplant. And as you have also seen previously, when Dr. Mora is treating patients, he doesn’t give them bone marrow transplant in the frontline setting. So, it’s not that, but we will put it into the analysis section of the protocol that we would do separate analysis of the patients with bone marrow and without bone marrow.

[Robert Burns:]

Okay. And considering the totality of the data since date for DANYELZA and neuroblastoma, at what time point do you believe you could potentially go to the FDA with some interim data to potentially request accelerated approval in the frontline setting?

[Claus Moller:]

It’s a little too early for us to say, but I’m hoping in the second half of this year that we can have a Type B meeting with the FDA to discuss this. We still have a breakthrough designation for this construct in neuroblastoma. So we’re eligible for additional meetings. And as you may recall, we have the 59 patients’ frontline study that was reasonably completed enrollment at MSK. And as soon as we have collected the data from that study, we would be most likely putting that together with the datasets from Dr. Mora study and asking for a Type B meeting. But I see – let me now, some of the patients that we are treating patients that are actually in frontline. And as I’ve said before, I mean, that definitely at MSK, they would – I mean, why would they not continue to treat patients in frontline with naxitamab. But it’s not an approved indication yet, and we are, of course, showing that.

[Robert Burns:]

Yes, that makes complete sense. Thank you so much, Claus, and congrats again on the quarter.

[Claus Moller:]

Thank you very much. Take care, Rob.

[Operator:]

Next question comes from the line of Etzer Darout with Guggenheim. Please proceed with your question.

[Paul Jeng:]

Hi, this is Paul on for Etzer. Thanks for taking our questions. For DANYELZA, hoping to get some additional comments on how you anticipate the launch trajectory to shape out in the coming months and maybe in context of current COVID dynamics. And also you’ve recently partnered with license and distribution partners in China, Israel, Eastern Europe. Can you help us understand the opportunity for DANYELZA and nivatrotamab in these particular regions and how applications might look? Thanks.

[Claus Moller:]

Yes. In terms of commenting on the launch, I can only say that, I mean, we will of course report on the first quarter sales when we get to our first quarter reporting. I’m happy to see that we have been able to ship to a number of sites outside of MSK also. But MSK managed to just shortly ahead of the two next hospitals to come in and place the first order. But we have seen a very positive line to what’s accepting the use of naxitamab. So very comfortable with the way this has panned out in the first three to four weeks, looking very much forward to report on the quarter when we have our first quarter conference call. In terms of partnering, obviously, the most interesting part here is the Chinese partnering because China will hopefully grant us approval based on the pre-BLA package we have submitted in China to file for approval with BLA package, primarily consisting of what we filed to the FDA. And if that’s the case, then hopefully in third quarter of this year, we can submit the Chinese BLA for naxitamab. And then what is the size of the market, as we speak now, that’s about 2,000 Chinese patients that each year received a diagnosis of neuroblastoma, and that’s very limited treatment available for these patients. Now, pricing wise, I mean, you’re probably not going to be able to get more than 15% to 20% of the U.S. price, but with a market that’s threefold as big as the U.S. market. It’s still a very interesting market, also from a financial perspective. In terms of Israel, Israel is a very small country, but they also do have quite a bit of medical tourism. I mean, it’s – I don’t think you’ll be able to see that the sales in Israel, hopefully – I hope you can see the sales in Israel as anything else, but a blip on our financial. Now the collaboration and distribution agreement with Swixx is addressing a relatively sizable market. And in particular, there is in Russia, a new system set up where, there’s allocated a significant amount of hundreds of millions of euro to pediatric oncology treatments. And we are of course, pursuing to try to get under that program. Did that answer your question, Etzer?

[Paul Jeng:]

That’s perfect. That’s very helpful. Thanks so much.

[Operator:]

Our next question comes from the line of David Lebovitz with Morgan Stanley. Please proceed with your question.

[David Lebovitz:]

Thank you very much for taking my question. You were talking earlier about the IND filed for omburtamab, targeting B7-H3 for adult indications. And that was just – I was a little confused when – because you initially had mentioned, I-omburtamab and then you transitioned to the Lu-omburtamab. Could you just run through that again, the nature of the IND and what that trial is going to be?

[Claus Moller:]

Yes. So the thing is that if we are going to address adults, and as I said, we have three to 25 adult patients with the iodinated version of the antibody. We needed a more, you can say easy quick way of being able to radiolabel the omburtamab construct. And therefore, we put a DTPA key data on the antibody. So instead of having to put the antibody on a column and iodinate and wash and elevate, and then we have to recheck the binding because some of the tyrosine inside the iodine binds to resetting close to the entity and determining side of the antibody. The whole process ends up taking between 60 and 100 minutes. Well, for a construct like the omburtamab-DTPA, the only thing I need to do is to pipe it off the amount of radioactive lutetium. So it takes me 10 seconds to radiolabel the antibody, because the isotope will bind only on DTPA and nowhere else. And you titrate, so you don’t put excess amount of lutetium, so everything will be bound with the antibody. So that’s why we created that to be able to address the tens of thousands of adult patients that every year dies from CNS/leptomeningeal metastasis that are B7-H3 positive. And that’s why we opened a separate IND for that, because now we’ve changed the isotope and we may be able to get higher than the 15 millicurie of radioactive iodine that we put into the heads of the kids and also used for the 25 adults we have treated with the existing omburtamab construct. We may be able to get up so maybe 80 or maybe even 100 millicurie per dose that we put into the CNS of the patients. Was that making it clear?

[David Lebovitz:]

Is there any I guess, reason why the efficacy would be different in adults than it would be in pediatric patients?

[Claus Moller:]

I think the only reason why it would be more efficacious is if we can get the radiation up to a higher dose level in the adult patients. But it simply, the key reason for going – since we are going after adult patients anyway, and we have to start with a Phase 1/2 dose escalation study anyway, rather than staying with the iodinated version, we felt that it was a relatively short delay to go for a DTPA conjugation and lutetium-177 labeling off of the antibody construct. So the antibody binds exactly as the existing antibody, it’s just radiolabeled with a different isotope and it’s much faster and easier and cheaper to radiolabel.

[David Lebovitz:]

Thank you for that. I guess, the other question is with respect to the upcoming FDA meeting, it sounds like you have the boxes checked off for the most part. I guess, is there a possibility that you could come out of this meeting with more boxes, you need to check?

[Claus Moller:]

What’s your experience with the FDA on such topics?

[David Lebovitz:]

I haven’t…

[Claus Moller:]

You never know. I crossed my fingers and hope that they see it as we see it, that these kids need this treatment and they need to get it approved for them as quickly as possible. So I certainly hope that, that they are not coming up with new boxes that we need to check. And if they do that, it will be post-marketing commitments and they will just give us an accelerated approval based on the tumor responses that we have seen among the first 24 patients.

[David Lebovitz:]

Thank you for that.

[Claus Moller:]

Thanks, David.

[Operator:]

Our next question comes from the line of Tessa Romero with J.P. Morgan. Please proceed with your question.

[Tessa Romero:]

Yes. Hey, guys, how are you? Thanks for taking the question. Just a quick one from me as we’re thinking about the launch for DANYELZA, I think you noted, you started delivering the product beginning in February. I guess, can you give us a little bit more of your sense on what metrics you’ll be providing the Street sort of to gauge the help of the launch? Is there anything beyond kind of sales top line that we should be thinking about?

[Claus Moller:]

I think it’s too early to say what we will actually be able to provide you with. But I would be surprised if we were not able to give you a bit of guidance on how many different centers that we – when we get first quarter results, of course, total number of vials that we have sold and total sales, and probably also the total number of sites that have started using DANYELZA for treating patients. But I think that’s – as I said, we are very early on, we’re few weeks into the first sites receiving the vials, and unfortunately also a few weeks into the first successful treatment outside of MSK. So we are very excited and very happy with where we have managed to get DANYELZA, but it’s a little early to give more details on the launch. So recently, what you were expecting to hear.

[Tessa Romero:]

Yes, no, no, that’s helpful. It sounds like there’ll be some color beyond DANYELZA, which will be helpful. And I guess, my second question is a bit broader. You guys have a lot of trial initiations coming up here this year, along with your ongoing studies. It would be helpful if you could sort of walk us through what data flow we should be expecting for the balance of the year, kind of for the key assets, for the key programs?

[Claus Moller:]

Yes. I mean, of course, if you look at naxitamab, we will be providing updates of course, on additional submissions in like the Chinese submission and the initiation of the two more studies we are planning to start this year. And hopefully, we should also see some data when we get to SIOP from the osteosarcoma study with naxitamab. In terms of omburtamab, of course, the resubmission to the FDA of the omburtamab BLA here in the second quarter, hopefully. We are still cautiously guiding that it could slip into third quarter, but my personal objective is definitely to get it done in the second quarter. And the submission to EMA on April 30 would clearly also be the one of the key things that we would be looking for. The other things with omburtamab would be of course, the initiation of the multicenter DIPG study and hopefully, also being able at ASCO to report on the ongoing of the DIPG Phase 1/2 at MSK. We are hoping to get an acceptance of a publication there. And then of course, the nivatrotamab, we hopefully will be able to give some update towards the end of the year, at our usual R&D Day in December on the status for the small cell lung cancer study and the status for the MSK study with nivatrotamab. Then there’s the second bi-specific antibody, the CD33/CD3. And hopefully, we can announce that we have gotten an approval to start the AML pediatric oncology study with the CD33/CD3 bi-specific in the second quarter. And then I think one of my real high hopes is that we managed to get this first out of construct into the clinic in the fourth quarter of this year, hopefully, in the beginning, but let’s see what happens when we file the IND and get all the stuff together. There are always some challenges when you start with a new type of molecules on the CMC side and to get it manufactured and purified the right way and – but I think we have come a long way and I think right now as we speak, I have 20 grams of rock available on the shelf to conduct the talk studies that we need in preparation for the IND filing. Was that kind of giving you a nice overview.

[Tessa Romero:]

Absolutely. That was great. Thanks so much, and thanks for taking our question.

[Thomas Gad:]

Absolutely. Have a good day Tessa.

[Operator:]

Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.

[Peter Lawson:]

Thanks for taking the questions and congrats on the initial shipments. Can you kind of perhaps give us any final detail around the number of sites that’s going out to beyond MSK? And any kind of initial feedback you’re getting from physicians about use of the product surprised you, either on the positive or negative side of things?

[Thomas Gad:]

I will give you more details when we report from the first quarter about number of sites et cetera. The only thing I can give of color is that I’m positively surprised that there have been absolutely no issues administering the product at sites that never have tried it before. But we also have a very strong team of research nurses and MSLs and back-office support that can help decide to make sure that they are probably trained and prepared for administering the first doses. Was that okay. Peter?

[Peter Lawson:]

Yes. That’s great to hear. That you look at the kind of issues around the drug. But do you think, like when we see 1Q, it will be predominantly MSK or is it kind of indicating to you from the initial shipments that it’s clearly breaking out of just MSK?

[Thomas Gad:]

I hope the trend continues and then it means that it’s breaking out from MSK, but let’s wait and see.

[Peter Lawson:]

Thank you. And then just for the resubmission of omburtamab, so what could be the potential outcomes there, what are the range of outcomes from the Type B meeting and associated kind of refilings? I know it’s – they want more data, they want a post-marketing commitment if you kind of run –

[Thomas Gad:]

Yes. As I’ve previously indicated, the FDA had two issues with the Refusal to File. The one was that they felt that the historical control group did not have sufficient granularity and they won’t in that propensity score analysis on the patients which requires you have a more granularity, of the individual patients and their previous treatments. We initially saw that would not be possible with the central German Cancer registered database. In between they have actually done a tremendous amount of collaborative work for us. And Germany had provided us with way more details and we had hoped they would be able to. And as I also mentioned earlier, unfortunately, there was this new study from SIOP that came out in December as a publication where they have granted us access to that database, including very granular datasets from the patients in that study. So I think we can address the FDA’s wish for additional granularity on the control group data for historical control. Should that not be the case, they have the other possibilities to say. But on the other hand, now you have 24 patients with six months follow-up full datasets, including 10 patients with tumor response data from the 101 multicenter study. What we could do is to call the historical data and the MSK study historical supportive data for an approval, based on the tumor response rate of 40% in your one-on-one study and then we would give you a post-marketing commitment to provide additional and progression-free survival, but that’s kind of like the two past they have to follow and we are suggesting that they continue with the original past when they I’ll have more granularity. The multicenter study is supportive and as well as the tumor response data are supportive and that new data controlled patients from the study together with the additional granularity from the German Cancer Register should be sufficient to support this. Is that clear.

[Peter Lawson:]

Yes, that’s definitely helpful and then just around kind of the OpEx, how should we be thinking that I think you mentioned that the cash burn and 21 remain in line with 4Q.

[Bo Kruse:]

Yes, roughly in line with what we were spending in the 4Q so mid-30s, maybe a little bit lower per quarter.

[Peter Lawson:]

And does that account for the like the vouchers just sales?

[Bo Kruse:]

No, that’s the operating cash burn. So any income would be deducted from that to get to sort of a net level.

[Peter Lawson:]

Got you, Bo.

[Bo Kruse:]

And the revenue partnerships mobile shares included in that spending.

[Peter Lawson:]

Great, thank you. So that’s kind of a clean them. Thank you so much.

[Operator:]

Our next question comes from the line of Sebastiaan van der Schoot with Kempen & Company. Please proceed with your question.

[Sebastiaan van der Schoot:]

Hi, Claus. Hi guys, congratulations on the full year results for 2020. I just have two questions, the first one is on omburtamab – you mentioned that you at the previous experience with iodine version. I was wondering what the clinical responses were in that certainly, with that particular agent in those patients.

[Claus Moller:]

In the medulloblastoma patients, we have had a number of patients that seem to stay in remission. Again this is given on the top of a standard regimen, including crane spinal radiation and induction chemo and for some of the patients, even some surgery. But it is clearly the – our opinion and also the investigators of MSK that this is contributing significantly to keeping these kids in remission. Unfortunately, we will not be able to put everybody into remission like and lasting remissions like it is within neuroblastoma, but if we can get to a 50% response for a long-term survivors situation in these patients. We have made a huge leap forward for these patients. But there has been very limited – Dr. Kramer presented a little bit in – at SIOP in 2019. There was a presentation, but it’s primarily safety data

[Sebastiaan van der Schoot:]

Okay. And then what’s for the adult population you were talking about?

[Claus Moller:]

The same for the adult 25 patients that there is limited information available. But there has been a number of patients that have responded positively, in particular recall a ovarian cancer patients that had 14 metastasis in the brain that had all of them shrinking or disappearing after the first cycle with impertinent, in spite of being treatment resistant to everything else that she had been receiving, and she lived for another 18 months, normally don’t live for 18 months with 14 brain meds from any cancer.

[Sebastiaan van der Schoot:]

Okay, great. Thank you. And then regarding , I was wondering whether you could comment on when we could expect to complete dataset for that trial and whether that will be enough, you think for accelerated approval in…

[Thomas Gad:]

Yes, as I told at the R&D Day in December, we had at that time point 31 evaluates patients and they’re still looking at least as promising as we would like it to look. And we have added two more sites . And we are looking when we have the first 39 patients, we will be looking at whether we should continue with a particular sub group of the patients where osteosarcoma relapse, i.e., where the majority of them is, and that’s the lung meds or whether we should continue with everybody. But that’s a little too early to say where we will end up, but hopefully we will have a dataset of the 39 patient, we can present at SIOP in October this year, alternatively, we will give an update at the R&D Day in December.

[Sebastiaan van der Schoot:]

Okay, great. Thank you.

[Thomas Gad:]

A formalized supplementary BLA for this, we need to see the data first.

[Sebastiaan van der Schoot:]

Okay. Thank you.

[Thomas Gad:]

You’re welcome, Sebastian.

[Operator:]

Thank you. We have no further questions at this time. I would now like to turn the floor back over to management for closing comments.

[Thomas Gad:]

Well, thank you everyone for listening today, and I hope you agree we had a very exciting 2020, and we look forward to 2021, and thank you Bo; and thank you, Claus. Have a great weekend everyone.

[Claus Moller:]

Thank you, take care everybody. Bye.

[Operator:]

Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.