Y-mAbs Therapeutics, Inc. (YMAB) Earnings Call Transcript & Summary

Welcome everyone to the 39th Annual JPMorgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at JPMorgan. I'm joined by Tessa Romero and Matt Bannon from the team. Our next presenting company is Y-mAbs, and speaking on behalf of the company, we have CEO, Claus Møller. Before I turn it over to Claus, I just want to remind those on the webcast that you can submit a question via the ask the question feature in the portal, and I'm happy to ask a question on your behalf. With that, I'll turn it over to you, Claus.

Thank you very much, Anupam, and thank you, everybody, for listening into today to our company presentation for the JPMorgan Conference, January 2021. You should have access to the slide deck, and I'm going to go to the disclaimer and make sure that you have all paid attention to that. Our mission in Y-mAbs is to become the world leader in developing better and safer antibody-based oncology products addressing clear unmet, pediatric and adult medical needs. We started out with a technology platform from Memorial Sloan Kettering, focusing on pediatric oncology about 5.5 years ago, and we have moved on from there. But our first pediatric asset, DANYELZA product was approved by the FDA November 26 last year. So we have moved a long way in the first 5 years for this company. And going to Slide #4, the investment highlights of the company. As I just mentioned, DANYELZA approved by the FDA here in November 2020. We also received a priority registration voucher together with that. And many of you may have seen that we actually sold that in December for $105 million. 60% of those money will end up in Y-mAbs' bank account and 40% goes back to Memorial Sloan Kettering as a part of the licensing agreement we made with them when we got the technology out of Memorial Sloan Kettering. We also have our second product that is very close to the market, the omburtamab radiolabel antibody that is used for CNS/leptomeningeal metastases for neuroblastoma. We are planning after a refuse to file from the FDA in October last year to resubmit the BLA for omburtamab in this quarter 2021, with the potential of having the product on the market in the end of this year as our second product. And then we have also recently filed INDs for our second-generation omburtamab, where we instead of using Iodine-131 can radio label the construct with lutetium-177 because it's conjugated with the DTPA molecule [indiscernible]. That construct is in development, both for the pediatric indication medulloblastoma but also for a basket trial in adult patients with CNS/leptomeningeal metastases from solid tumors expressing B7-H3. And then we have a bispecific antibody platform, the Y-BICLONE platform we call it. The first of these constructs from this bispecific CD3 activating -- T-cell activating construct platform is in the clinic in a Phase I/II study, it's called nivatrotamab. It's a TD2 CD3 bispecific. And we also have our second bispecific, the CD33/CD3 for AML in both in pediatric and in adult patients approaching towards IND filing in the midst of this year. And then we have our very, very interesting SADA tech platform that I will also come briefly into in my presentation today. And a very nice financial position, which was further strengthened, as I just mentioned, with the sales of our priority registration voucher, which added another $60 million when the deal is finally closed. And we also did a licensing agreement in January that added another $20 million to our cash position as an upfront payment from SciClone for the Chinese market. Our pipeline, as you can see on the next slide, is very extensive. We have the 2 lead candidates DANYELZA and omburtamab. We have our vaccine that is in a Phase II study. We are starting a multicenter Phase II shortly. And we have the 2 bispecific antibodies. And then we have the second-generation omburtamab construct. And then we have 4 SADA constructs that we have publicly disclosed that we are formally moving forward towards IND filing. The first one we expect to have in the clinic by the end of this year with a planned IND filing for the TD2 SADA construct in the end of third quarter this year. Going to the next slide, we'll talk a little bit about our commercial readiness. As I mentioned, we have one commercial product on the market, DANYELZA. you will soon have pending, we get approval for everything and [ blastoma ] omburtamab coming to the market in the end of this year. These 2 first products is addressing relatively small orphan oncology markets in the pediatric setting. DANYELZA is approved for the second line of blastoma indication treatment, which is about 300 patients a year in the U.S. market. We are continuing to develop this for the front-line treatment also, we have 2 ongoing single centers for that indication, one in Spain, an investigator-sponsored study by Dr. Mora and one at Memorial Sloan Kettering, and we are starting a multicenter study later this year. We also have a study in second-line Osteosarcoma patients that have been put into complete remission for the second time, but well knowing that about 85% will relapse within 12 months. We try to treat the microscopic remaining disease, preventing them from relapsing within 12 months using the antibody here. And we just presented a little data set from this, 31 patients in -- at our R&D Day, showing that it may very well be able to keep more than 50% of the patient in remission for 12 months. If this holds up in a multicenter setting, it would be the first great news for patients with Osteosarcoma in the last 30 years. Omburtamab is also moving forward. As I said, we have tiny little indication for the first indication that we will be applying for approval for, which is about 80 patients per year. And then we also have a second indication where we have a study ongoing at MSK, where there's currently about 50 patients in the study in diffuse intrinsic pontine glioma patients. Also a very lethal disease with a median duration of survival of about 8 to 11 months, depending on which studies you are looking at. We already now can see that we are in the ballpark of about 17 months, but also that we are still dose escalating and expect to get even better results with higher doses. We are opening a multicenter study in this indication and foresee that, that could be bringing this patient population for the omburtamab to maybe another 300 to 400 patients a year. And we also have data from our Phase II study in desmoplastic small round cell tumor, the sarcoma, very rare, but still potentially another 100 to 150 patients per year in the U.S. So altogether, these treatments could be addressing respectively 1,500 patients in just the indications where we are currently pursuing development. DANYELZA, if we go to the next slide, is, as I mentioned, approved by the FDA here in November. It has a lot of advantages to the extent that there is another TD2 antibody approved in frontline dinutuximab. The infusion with our antibody is about 30 minutes, median intrusion time is about 37 minutes or so. So whereas for dinutuximab, you typically spend between 10 and 20 hours. It's an outpatient treatment, and thereby, very, very few hospitalization days, which is in contrast to the 35 to 40 days of hospitalization with dinutuximab when you're giving that product as 5 cycles and the necessary outpatient treatment. So for these patients with neuroblastoma, which is clearly one of the most devastating pediatric oncology indications, this is a major step forward that patients not only at Memorial Sloan Kettering, but throughout the entire U.S. now can have access to naxitamab. And as I said, the U.S. commercial launch is underway. We expect to start shipping the first commercial vials to the sites already by the end of this month, beginning of February. Of course, we couldn't start packing commercial product until we got the licensing number. We got that in the end of November, then we printed the packing and labeling materials and did the first commercial batch packing just before New Year. And there, we are now doing the quality control. And as soon as our QP has accepted the quality control documentation, we will be able to release from [ quarantine ] in the first commercial batch and start shipping it out to the sites. So very shortly, we should have our first sales and expect to be able to see a very nice pickup of the product from the beginning. What we have shown with this for this group of patients where there is no approved therapy before DANYELZA is that both in the study 12-230, which was a single center study at Memorial Sloan Kettering, we had an overall response rate of about 78% as estimated by the investigators at Memorial Sloan Kettering. And in the study 201, again, we had an independent review assessment of the response rates in the first 25 patients enrolled in that study. And that was a 68% overall response rate. So here we have a treatment that can put about 2/3 plus of the patients into remission and many of them into complete remission in an indication where there's no approved therapies. And these remission seems to be of significant duration. But we will be reporting back with more data from that. In the front-line setting, as I mentioned, we are also going forward with this. When you use dinutuximab in front line, it's an 8- to 20-hour infusion given Monday recovery in the intensive care for the patients on Tuesday and then infusion again for 8 to 20 hours on Wednesday, Thursday and Friday. We do the same. In the beginning, we do induction chemotherapy for these high risk neuroblastoma patients. We do stem cell collection and we do surgical [indiscernible] of primary tumor. Then there's a consolidation therapy with high-dose chemo, which we also do. If you are planning to use the patient -- the dinutuximab for the patients as maintenance, you have to give a bone marrow transplantation and then radiation therapy. We skip the bone marrow transplantation. We also give radiation therapy. And then as maintenance treatment, we give the antibody together with cis-retinoic acid and GM-CSF. Whereas with dinutuximab, you give again the dinutuximab immunotherapy with the cis-retinoic acid, but also with IL-2, and they also typically use GM-CSF. So it's a much simpler treatment, our treatment. And if you look at the outcome for these patients that did not have to go through a bone marrow transplantation, we are seeing a 2-year event-free survival in the ballpark of 74% compared to what was in the original dinutuximab approval study, which was also about 60% to 70%. And the 2-year overall survival, we are looking at about 90%, 2-year overall survival. And for dinutuximab in the original study also a ballpark of 80% to 90%. So we are definitely not having less efficacy, but we don't have to give a bone marrow transplantation, IL-2 and 40 days of hospitalization. So huge benefit to these patients if they can get a naxitamab versus dinutuximab. We are expanding our clinical programs. And as I said, we have, through the accelerated pathway on the basis of data from 2 studies, gotten the approval. We're now expanding into frontline, and we are also expanding into chemo combination, and as I said, relapsed second line Osteosarcoma patients. What we also do for these patients that actually get a complete response, we have seen that some of them generate their own immune response and create their own antibodies against GD2. Those patients, which is about 10% of them, that does that seem to have a better prognosis long term. So Dr. Cheung developed at Memorial Sloan Kettering a vaccine to have everybody develop their own immune response after being put into remission. So this is an add-on treatment. As we speak now, more than 300 patients has been exposed to the vaccine, and we are starting a multicenter Phase II study later this year with this vaccine. But it clearly indicates that you can have more patients staying in remission for a longer time when we treat them with the vaccine, which is our third product addressing the neuroblastoma patient population. So key takeaway is that we're addressing a significant unmet need in high-risk neuroblastoma patient and potential to expand into broader populations. This takes us to the omburtamab, where we have regulatory path to BLA approval, which is to update the clinical package that we had in the original filing for the BLA with the tumor response data that we have now collected plus adding another population control group and some propensity score analysis based on the preliminary discussions we have had with the agency. We have additional discussions with them this month. And I hope by the end of January that we will be coming to an agreement with the FDA about the full content of the refiling package and expect to be able to refile the omburtamab BLA by the end of the first quarter of this year. What we do here is that we take patients that have relapsed in the brain from their neuroblastoma. So they -- many of them, about 2/3 of them are systemically free of disease but have relapsed with multiple metastasis in the brain. This is typically a death sentence. 5-year overall survival for these patients is typically around 0% and 3-year overall survival 10% and median survival 6 months. What we do for these patients, standard of care is that we give them induction chemosurgery and radiation, and then they go home. And unfortunately, almost none of them will be able to survive. There was a recent study by the SIOPEN where they managed to among 63 patients find 3 patients that had lived for 2 of them 4.7, 4.9 months and one -- years and one had lived for 10 years. So 3 out of 63 patients seem to achieve some level of long-term survival. What we are doing here is that after the standard of care, we put in Ommaya catheter and reservoir and give them 2 doses of a radiolabeled B7-H3 antibody that will only bind to tumor cells that's left in the brain after the induction therapy. So very, very selective therapy. And it spreads throughout the CNS compartment in a couple of hours. We can get a very high concentration of the radiolabeled antibody in here. And then the antibody will radiate the tumor cells and kill them. And as you can see on the next slide, Slide 17, this will give a 51-month median overall survival with 52% of the 107 patients still being alive when we did that evaluation and comparing very nicely to the historical data. One of the things that is also interesting that we implemented in the multicenter Study 101 is to look at those patients, which is about 40% of the patients that we are treating that have some measurable disease left when they come onto omburtamab treatment. Is there a direct antitumor effect of the omburtamab? That has been a question from the FDA all along. And we seem to be able to answer that now that among the first 24 patients in Study 101, 10 of the patients had an objective radiographic structure that could be evaluated when they entered the study. And of those 10 patients, 4 of them got either complete or partial response, 2 complete, 2 [ partial ]. Furthermore, 5 of them had stable disease and one patient, unfortunately, had progressive disease. Now these responses were maintained at 26 weeks follow-up. If you have a stable tumor in the brain for half a year, it means that it's not growing, it's under control. It's definitely responding to treatment. So for this construct, as I mentioned, we are also pursuing additional indications. We are pursuing the DIPG indication and we are starting our multicenter study later this year with a lot of participation in the U.S. and we also have a Phase II desmoplastic small round cell sarcoma study ongoing with this construct. This takes us to the new construct we have created, where we used the lutetium-177 instead iodine to radio label the constructs. And in this situation, we can clearly see that it's a lot easier for us to radio label. The DTPA act as a magnet for the radioisotope and as soon as we mix them, it takes a few seconds, the antibody is radiolabeled. When we use iodine for the radiolabeling, it typically takes about 1.5 hour to do the radiolabeling procedure. So much easier to radiolabel and thereby much easier to address tens of thousands of adult patients with CNS/leptomeningeal metastases issues. And that takes us to Slide #20. The key takeaway is, of course, for omburtamab that we are addressing a significant unmet need, and there's potential to expand into a number of broader populations. There are no approved products for neuroblastoma patients who have CNS/leptomeningeal metastases. And the goal of treatment right now is generally palliative. We can change that to a potentially curative treatment, seems to be able to cure about 50% of the patients we put in our trial. We have a demonstrated overall survival of 51 months, which is unprecedented to the historical 6-month median survival. So -- and for this product, we will also get a PRV when we get it approved. And which is nice external dilutive cash for the company. Yes, it should take us to our bispecific antibody slides, Slide 22. And here, you can see nivatrotamab is our first bispecific antibody construct in the clinic. We have an ongoing basket trial at Memorial Sloan Kettering, Study 18-034, and then we are starting our Study 42 very shortly. We filed the IND December 22. So unless something stops it or delays it further, it should be ready to go into formal clinical testing in small cell lung cancer here at end of January of this year. You can see our bispecific antibodies are different from what most other people are using. We have kept the original structure of the ITT backbone. So we have 2 binding sites to the tumor targets. And then at the end of the light chain of the fat part of the antibodies, we have put a slow affinity -- low affinity anti CD3 binder. So very different constructs, very excited to see these progress and see how this will work. And our own second construct, as I mentioned, will come into the clinic by the mid of this year in AML. And then I'm just going to talk shortly about our SADA tech platform or what we also call liquid radiation, and go to Slide 24. There, you can see that these constructs here, typically, if you do a radiolabeled antibody constructs, you can see that you end up -- even if you have an antibody that can bind a lutetium [ cate ] DOTA molecule, you end up getting a lot of radiation spread not only to the tumor, which is on the right side of the picture, just behind the 4 leg of the mice, but it spreads through all the central organs of this little animal. When we give an animal that has a similar-sized tumor, again, just on the right flank of the mouse, just behind the right 4 leg of the mouse. We give them the SADA construct, this tetrameric construct that we inject that will bind very heavily without any radiation to the tumor side, then everything that's injected will fall apart and become monomers. And the monomers will leave the body within 24 to 48 hours if it's not bound to the target. And then the orange part of the antibody bind the lutetium DOTA we then inject. And therefore, you will not see any left circulating immune global in antibodies picking this up because all the tetramers are bound at the tumor and the rest is left. So the only place for the DOTA to bind is at the actual tumor. So very, very specific binding. If these constructs work, just nearly as good in humans as they do in the mice, we have a very nice nontoxic treatment to cure cancers, both solid tumors and hematological cancers. And as you can see on the next slide, it's outlining just an animal experiment where we eradicate completely established tumors, which are between half a cubic centimeter and 1 cubic centimeter in the flank of the mice with 3 single doses of SADA and followed by the DOTA dosing. And that is sufficient to basically cure these kids, oh, not kids, sorry about that, these mice. With no liver toxicity, no kidney toxicity, no bone marrow toxicity. So we get between 100 and 500 full more radiation to the tumor than we do to the actual bone marrow of these mice. That means that we can come back and retreat again and again, it's not like when you have been exposed to normal radiation, that's a once in a lifetime event. So with that, it takes me to our short financial summary on Slide 27. And as you can see, at the end of third quarter last year, we had $131 million in the bank. And as I just mentioned initially, in December, we did a licensing agreement with SciClone for China that gave us another $20 million cash upfront. And we also managed to sell our PRV, which is going to give us another about $60 million on the top of that. So although we have spent some money in the fourth quarter, we also managed to allocate another $80 million to our cash position. So very well financed, and we believe that we have sufficient cash in the current situation to take the company through the end of 2022 without taking into account that we will also have commercial sales and potentially additional partnering agreements. Thank you very much. With that, I open this presentation for questions.

And just for all of the listeners on the line, if you would want to submit a question in the portal, I'm happy to ask on your behalf. Maybe we'll start off with the recent approval of naxitamab in relapsed/refractory high-risk neuroblastoma. How are you thinking about the launch curve here in the U.S.? And what are some of the key metrics we should be monitoring?

Well, I mean, first of all, I would say that we know, of course, that Memorial Sloan Kettering is going to be one of our most important centers for DANYELZA. They are treating about 15% of all the neuroblastoma kids in the U.S. So they all by themselves will, of course, start putting patients on naxitamab as soon as it becomes commercially available towards the end of this month, beginning of February. And the reason why I can't say precisely when it's released, and normally, I would be able to say, but it's a 6-day procedure for the QC lab to do this. But right now, a lot of people tend to not show up to work for the recent COVID-19. So even the QC labs have problems actually doing things during the time period they are supposed to do it. But I feel quite comfortable that by the end of the month that we will have all the documentation in place, and we have sufficient product on shelf to be able to provide whatever need the market may have. I would say, if we do not have enough product, we have a different issue, which is that our sales is going to be way beyond what market is expecting right now. So we would probably be able to handle that also. But we will be able to provide what is needed. And as I said, that means that we know right now that in the U.S., there's way more than 20 patients that is on SPU, and these patients, of course, will go from treatment on SPU to commercial product as soon as commercial product becomes available.

We've got a question in the portal here, which is, will the restricted FDA label to relapse/refractory setting with bone marrow involvement impact your launch curve?

I don't think so. As I said, it's -- that's -- the first market we are going for is the 300 patients that are relapsed/refractory patients. And will there be some pickup in front line? Most likely. I mean remember, this is pediatric oncology. The parents are extremely active in most cases. And following what's happening and you can imagine, if it was your kid that was supposed to get a treatment where you find out that there's a treatment that's an outpatient treatment at 37 minutes average infusion time versus an 8- to 20-hour infusion in the hospital intensive care unit, it's a no-brainer. I mean I wouldn't take my kid to the intensive care unit for those 4 days of 10- to 20-hour infusions if there was an alternative, which was 3 days with a 30-minute infusion and then come home and sleep in your own bed. And the data is not in any way indicating -- if it's indicating anything, it's superiority in terms of efficacy. So I mean it should be a no-brainer.

Yes. And you've talked about this in your slides as well with how to think about it relative to Unituxin. But I guess from the Unituxin sort of launch curve dynamic, is there anything you can talk about in terms of broader adoption beyond MSK? And then what you're doing there to kind of get docs educated and get docs signed?

Yes. We have -- the Study 201 has been ongoing at a number of sites outside of MSK also. And we also have seen SPU [indiscernible] sites outside MSK after we got the approval. So there's a lot of awareness. And what may happen is that some of the patients that in the past where parents decided they couldn't get naxitamab locally, they took the kids to Memorial Sloan Kettering. I think some of these parents will just stay locally and tell their doctor to get naxitamab for that patient. And we have the necessary setup also, even if it's the first time that the doc is treating the patient with naxitamab, we have MSLs that are ready to go up. We have research nurses that are ready to go out and work with the sites when they treat the first patients. So I think we are pretty well set for that setting.

Let me see if Tess from the team has a couple of questions.

I just had sort of one question. You made some comments about sort of being confident that the BLAs resubmission will be -- will happen later this quarter. I guess I know you're in active regulatory dialogue. Have you confirmed that, that clinical module is kind of sufficient for the FDA? And then...

You never get a final confirmation from the FDA. I mean I went to a pre-BLA meeting with the FDA and agreed what I was going to put into my package, and I put that into my package and they decided in the end, no, we probably need something more. And in particular, when you're dealing with something like an ultra-rare orphan oncology indication, where the data is substantially less than what you normally would create, if this was a new antihypertensive product, I would know precisely what I would need to deliver. So I would say that it's going to be -- I'm not going to get a very specific indication from the FDA. But I think we are getting there on the most recent discussion last week with the FDA. I think we got the most clear guidance that I've been looking for, for quite a while, and I think we will be able to come to a final agreement. I want to make sure that we have minutes and things like that in place and before we put together the refiling package and send it to them. But I'm as confident as you can be in this environment, that we will be able to complete and submit by the end of this quarter, resubmit the BLA, but I mean with all the precautions in this environment that you need to have.

Okay. And then that -- and then I was just going to ask, you'll file the same package with the EMA, right?

Yes.

And so that should follow subsequently from the FDA refile.

Yes. I would say what we are offering the FDA is essentially what we are also putting into the EMA filing. So -- and then what happened recently was there was a new paper coming up out from SIOPEN requesting, as I mentioned initially, that if we could look into trying to get detailed patient data from the SIOPEN study, which we are working on right now to add as a force control group to support that this patient population has such a dire prognosis. As I also indicated that they are not getting among the 60-some patients with CNS/leptomeningeal, they had 3 long-term survivors there, and only one of them exceeding 5 years of overall survival, where we have 45% 10-year overall survival in the 107 patient population that we have. I mean you can imagine it shouldn't be possible to find 50 10-year surviving patients if they -- among 2,000 patients with 63 relapsing in the brain find 3. If it wasn't because there was something in the 3, physically completely impossible.

Yes. And then just one more question, I guess, on EU, U.S. dynamics. So I guess we know, Claus, that the EU requires some different clinical data when it comes to DANYELZA or naxitamab. Can you just remind us of exactly what you're doing to support an EMA filing? And what data you need to gather there?

No, and the reason is I can't get a straight answer from EMA. So we are still struggling with them to try to come to an agreement. But I'm quite confident that this is changing now, and we are scheduling a new meeting in the next 2 months. And there, we will be discussing. But I think the environment changed after we got the approval from the FDA as long as the product was not approved anywhere. But now the FDA has approved, and they are under pressure from European parents also that, hey, well, I'll comment, a U.S. kid can get dosed dinutuximab and naxitamab and here we can only get dinutuximab. I mean it's -- I think it's going to come. We will come to an agreement with them now. And I think we will have a fair and good discussion with them. And as I said, we have come to a completely clear agreement of the omburtamab and we are getting that filing. And -- so but best case scenario, I would think we have the documentation for naxitamab in Europe available by the end of this year, maybe beginning of next year.

We've got a question in the portal, which says, can you comment on the time lines for the first results in patients with your bispecific?

Yes. We disclosed some information at our R&D Day in December and also that because we have changed the drop product that we are using from a manufacturing batch that was done by MSK to one that we have done, which is the same one we are using in the small cell lung cancer study. And therefore, we started dose escalating again from cohort 4 level in the MSK study. And we are using a different dose escalation schedule for the small cell lung cancer study that will start this coming month, spending -- then there's going to be a waiting time for IRB approval. But if IND opens 22nd of January, then we can file for IRB approval and then 4 to 8 weeks after that, we should have the first site open for patient recruitment for small cell lung cancer. When we will have data from that is a little bit out in the woods, depending on how quickly we can actually dose escalate, but somewhere between 12 and 18 months out. And we may have, in the end of this year, additional update data from the MSK dose escalation study also when that's rolling into the 2 Phase II studies in neuroblastoma and osteosarcoma.

Maybe a question on naxitamab and Osteosarcoma. We got an update there in -- at the R&D Day in December. So what are the next steps here? And it seems like there could be a regulatory pathway here that may emerge?

Next step is to get the last patient into the study, so we are up to the 39. I meant the protocol allow for additional patients to come in, go to the FDA and present the data we have from the 39 patients and say, compare to historical what is needed for a supplementary BLA. So most likely, in about 6 months, we should be able to go to the FDA and discuss a supplementary BLA for Osteosarcoma. And then it may be that they'd say -- but it's fine, you have 3 sites in this study now, and you call it a multicenter, but the 2 new sites only took 3 patients out of 39. So if you want to call them multicenter, make sure that the new sites also have 20 patients. But then at least we have an opening, we can start discussing how many patients do they need to see at sites outside MSK before -- and under which circumstances would they let us file for a supplementary BLA here.

And maybe final question here. What are some of the preclinical activities going on with this SADA technology platform in terms of progress to getting to the clinic?

Well, we have put together some very clear tox programs and the whole manufacturing process is running. I'm quite comfortable about the production side of it. We are putting together a package to have a pre-IND meeting with the FDA in the next couple of months to make sure that the whole tox program that we have put together, and our ideas for how to get in the clinic and dose escalate and the levels of radiation that we need will be acceptable to the agency. So we will have a pre-IND meeting. And based on that, we will adjust, if needed, the tox program that we have ongoing. And then we should be ready by the end of third quarter to submit an IND, maybe running a little bit into fourth quarter, depending on the timing of eventual modifications. But I'm quite comfortable that we will start treating the first patient this year. One of the things that you could think about is that the first SADA is a GD2 SADA and if it's binding heavily to nerve fibers because it's the same binding [indiscernible] on DANYELZA. And although, it's different dosing, smaller doses, et cetera, but could you think about eventually radiation damage to nerve fibers. And we found out that previously at MSK, they have tested the 3 of 8 the predecessor of naxitamab with radioactive iodine on the antibody in patients systemically third-line neuroblastoma patients, and seen that it was tolerated with doses of up to about several hundred, 300 to 400 millicuries of radiation on the antibody given to the patients. So I'm not concerned that just because I use SADA and then I stick in maybe 20 millicurie that then -- I'm going to burn all the patient's nerves, it's not going to happen. Not for sure that's not the case. And we will also have program addressing this issue. So I feel that we have this pretty much under control, and I'm extremely excited to see this because this -- I don't think we need to have dramatic dose escalations before we start seeing direct effect treatments.

All right. Claus, thank you so much for this super productive session.

Thanks, Anupam. Thanks, Tessa.

I hope you have a good meeting.

Thank you. Take care, everybody.