Y-mAbs Therapeutics Inc (YMAB) 2019 Q4 法說會逐字稿

Greetings, and welcome to the Y-mAbs' Full Year 2019 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Thomas Gad, Chairman and President. Please go ahead.

Thank you, Ashley. Good afternoon, everyone, and thank you for joining us on this particular day. So 2019 was the year that we believe we made significant progress on our strategy and took steps that positioned us very well for 2020, as we worked to complete 2 BLA submissions and prepare for 2 potential product launches while significantly expanding our clinical activities.

We ended 2019 with $207 million in cash. And as you know, in late October, we completed a secondary offering led by Morgan Stanley, JPMorgan and BAML, in which we raised approximately net proceeds of $135 million to the company. These proceeds have further strengthened our balance sheet for the potential launch of both naxitamab and omburtamab later this year, while at the same time, advancing our pipeline and should carry us through to the end of 2022 and that's without taking into consideration any product sales or any potential partnership revenue.

We are very pleased with our financial position as it is today. Naxitamab and omburtamab have both previously received rare pediatric disease designations from the FDA, and in December, our vaccine was granted rare pediatric disease designation as well. So that paves the way for a potential third priority review voucher.

Naxitamab and omburtamab continued to read out encouraging data, addressing clear unmet medical needs for neuroblastoma patients. And we have now shown that we are able to reproduce these results in multicenter trials. Today, naxitamab and omburtamab are treating children worldwide in clinical trials, including the U.S., Canada, Europe and Hong Kong, and we believe this global outreach is a major achievement for Y-mAbs.

We spent approximately $75 million on operations in '19, and we think our spending is a direct result of our highly dedicated teams who are very committed to making both naxitamab and omburtamab available to children everywhere. We are working hard on expanding our ongoing clinical activities for both these antibodies addressing osteosarcoma and DIPG, where clear unmet medical needs exists for pediatric patients. We are also working hard on opening up a global trial for our vaccine here in 2020 as an add-on to naxitamab in order to provide access to children worldwide.

Going beyond the naxitamab and omburtamab, we are advancing our 2 plus 1 bivalent low-affinity CD3 bispecific platform, which we are very excited about. Our first bivalent GD2-CD3 product is currently in dose escalation in a Phase I single-center clinical trial at MSK. It will be very interesting to see data from this study potentially validating our platform and expand into larger indications with future partners. We are also working hard on our second bivalent bispecific which we have announced, the CD33/CD3, focusing on potentially filing an IND this year and focusing on AML, again another unmet need for children.

As announced, we filed an IND for omburtamab conjugated with lutetium later -- late last year in order to get our next-generation omburtamab into the clinic. Here, we are working on a 2-part strategy, opening up multicenter trials, one for medulloblastoma pediatric patients who are faced with a clear unmet medical need and a second trial for B7-H3 primary tumors that metastasizes to the brain.

Taking out all our achievements into consideration, we believe Y-mAbs is very well positioned, and we are very excited to bring the company forward in 2020. And as a company, we always continue to stay through to work hard to position us as a leader in pediatric oncology addressing clear unmet medical needs and focus on advancing our therapies to reach the lives of children living with these rare cancers.

And with that, I'm very pleased to introduce to you Dr. Claus Møller, our CEO. Thank you.

Thank you, Thomas, and welcome to Y-mAbs Therapeutics 2019 Earnings Call. We are pleased that you've chosen to join us today. And during the fourth quarter, we had continued to work hard to ensure that our lead product candidates, naxitamab and omburtamab, advance towards completion of their respective BLA submissions. We submitted the first portion of the rolling BLA for naxitamab in November 2019, and we expect the submission to be completed within the next couple of weeks.

For omburtamab, we recently had a pre-BLA meeting with the FDA, and we were very pleased to have our plans confirmed by the agency. We expect to complete our rolling omburtamab BLA submission in May. Meaning that our projected overall commercialization time lines are unchanged. We will continue to keep you posted on our progress.

We believe that we have continued to demonstrate our ability to execute on our commercialization plans through the fourth quarter of the year -- this year. With the coronavirus being on everyone's mind these days, I want to stress that the company has taken what we deemed to be all necessary precautions to minimize the contamination risk at our facilities. This includes all sites in the U.S. and Denmark, and we believe that our contingency plan will enable us to ensure submission of both the naxitamab and the omburtamab BLA in line with the time lines I just mentioned.

Let me turn to naxitamab. In addition to the rolling BLA for naxitamab in relapsed/refractory neuroblastoma, we have some exciting news in frontline neuroblastoma. At our R&D day in December, Dr. Mora from Barcelona Children's Hospital, who has significant experience treating frontline neuroblastoma patients with both naxitamab and also a competing anti-GD2 antibody, dinutuximab, presented clinical data from both antibodies. This is the first ever naxitamab frontline data presented. Data from this investigator-sponsored naxitamab study of 34 patients with high-risk Stage IV neuroblastoma in first complete remission showed a 72% event-free survival rate at 24 months. This compares favorably with a publicly published data from The Lancet paper of 63%, 24 months relapse-free survival -- progression-free survival in 89 patients treated with the dinutuximab antibody.

The naxitamab treatment appeared to be well tolerated in the frontline study, and the infusion-related pain generally associated with the anti-GD2 antibody required significantly less opioids for naxitamab than with a -- the competing anti-GD2 antibody used by Dr. Mora. The use of morphica generally declined significantly after the first treatment cycle. And Dr. Mora's finding was that naxitamab only required less than 20% of the morphine dose required by the competing anti-GD2 antibody.

A second frontline study with naxitamab is currently ongoing at MSK in New York City, and we expect data from this study to be published later this year. We're also planning a multicenter frontline study, which we expect to start later this year.

At the International Society of Pediatric Oncology, or the SIOP, conference last October in France, a total of 6 presentations by MSK provided substantial exposure to naxitamab encouraging clinical data. Among the highlights was data from primary refractory high-risk neuroblastoma patients in Study 12-230. These patients are refractory to intensive induction therapy, and in addition, more than half of the patients were also refractory to second-line chemotherapy. In this subset of patients, we demonstrated a better-than-expected outcome, including a 78% overall response rate.

In another subset analysis, 35 patients with relapsed neuroblastoma who were resistant to salvage chemotherapy, 30 patients were evaluable, and also in these patients, we saw 1/3 of the patients had 2 or more prior relapses and 89% have previously received a GD2 antibody before they came on naxitamab. These patients coming on to naxitamab had a 37% overall response rate and a 36% progression-free survival rate at 2 years or 24 months, which indicated clinical benefit in this difficult-to-treat population.

We also presented data from high-risk neuroblastoma patients in second or later complete remission. 44 patients with no evidence of disease were treated with GM-CSF and naxitamab as maintenance therapy to keep them in remission. In this population, 88% of the patients had previously received anti-GD2 therapy and 30% had received 2 or more lines of anti-GD2 therapy before receiving naxitamab. A 2-year progression-free survival rate of 52% was observed. We believe these data are very encouraging since these patients are known to have short-lasting responses with 1-year progression-free survival of typically about 20%.

We also had data for patients with disease restricted to the bone marrow compartment which we deem very interesting as investigators assessed 100% curing of the bone marrow in this patient population. I don't believe that has ever been seen before in any neuroblastoma trial.

Now let me turn to omburtamab, our second lead compound. Omburtamab is a radiolabeled Iodine-131 antibody, and as previously disclosed, we are developing this compound for CNS/leptomeningeal metastasis from neuroblastoma, but also for diffuse intrinsic pontine glioma known as DIPG and desmoplastic small round cell tumors, also known as DSRCT. All of these tumors being B7-H3 positive.

In February, we had a pre-BLA meeting with the FDA, confirmed our plans for filing a BLA for omburtamab. We plan a rolling submission which we expect to complete in May. Completing submission for the BLA for naxitamab in late March and omburtamab shortly thereafter reflects an outstanding performance of our team, and we hope to see both compounds approved by the FDA before the end of the year.

In December, EMA agreed to our proposed pediatric investigational plan to omburtamab. As a part of the regulatory European process for registration of new medicine, companies are required to provide a PIP outlining their strategy for investigation of new products in pediatric populations. An approved PIP is prerequisite for filing a marketing authorization application for any new drug product in Europe.

We believe that there now is a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in Europe, and we plan to submit a marketing authorization application in the fourth quarter of this year. This is a vital step forward in our efforts to bring omburtamab to the European market, and it demonstrates the close constructive interactions that we have managed to establish with the European regulatory facilities.

Now turning to the data generated with omburtamab. In November last year, in the desmoplastic small round cell tumor, data was presented at the 2019 Connective Tissue Oncology Society, or CTOS, Annual Meeting in Tokyo, Japan. DSRCT is a malignancy that typically presents as intra-abdominal sarcomatosis in young males. Less than 100 patients are diagnosed each year in the U.S., and patients with DSRCT have very poor prognosis with a limited 5-year survival. So there's a clear unmet medical need in this population. Even the more fortunate DSRCT patient where it's possible to do gross total resection, the 5-year survival appears to be approximately 20%.

And based on observations from MSK, whole abdominal intensity-modulated radiotherapy may be advisable for those patients whose tumors can be resected. The data reported by Dr. Modak at CTOS was based on evaluation of 33 patients at MSK, a total of 24 patients from a Phase I study who received the radiation to the abdomen and in combination with intraperitoneally administrated omburtamab with iodine and 9 patients who just started the treatment with the abdominal radiation after total tumor resection, but no omburtamab. The study showed that a 41-month median overall survival for those who did not receive omburtamab and 59 months for those who received omburtamab. So the data presented at CTOS showed that adding iodinated omburtamab to standard radiotherapy was well tolerated and indicated, in our opinion, improved survival.

Furthermore, adding omburtamab to the resection improved the 5-year Kaplan-Meier estimated overall survival from the historically reported rate of approximately 20% to approximately 40%. So we are very pleased to see the survival data. Lack of evaluable disease means that survival is the only relevant end point in these patients. While this approach may not help patients who do not achieve gross tumor resection, we believe that it may help patients with microscopic diseases, which is exactly where this antibody has its strength. We believe that the data illustrates the width of compartmental use of radiolabeled omburtamab, which could potentially be applied to other peritoneal or compartmental medical disease.

We recently initiated a Phase II trial in DSRCT at MSK, and we are planning to open this study for a small exploratory group of both gastric cancer patients and also ovarian cancer patients.

At SIOP, we presented an updated omburtamab data readout from Study 03-133 at MSK where patients with CNS/leptomeningeal metastasis from neuroblastoma received 2 doses of radiolabeled omburtamab. Data showed that for the 107 evaluable patients, the median survival had decreased to 50.8 months with a final median not yet reached. This compares to the previously recorded 47.1 months when we had 93 patients in this study. So we are pleased with this update. Remember that historical median survival for these patients is approximately 6 months.

In addition, we had 68 patients diagnosed with other CNS cancers, including metastatic tumors who had received a total of 201 injections of omburtamab. The injections were routinely administrated primarily in outpatient setting. And the patient's primary CNS diagnosis included 8 different cancers, including 27 patients with medulloblastoma, 9 patients with ependymoma. Patients with metastatic tumors included 4 different primary cancers, including 9 patients with sarcomas and 5 with melanomas. As of today, 26 of these 68 patients with this highly lethal diagnosis are still alive. These results fueled our plans for lutetium-labeled omburtamab construct, for which we have filed an IND in December. The first study would be in medulloblastoma where we had the previous experience from 27 patients with the iodinated construct.

And in addition, we plan to submit a separate IND for our basket trial of B7-H3 positive CNS/leptomeningeal cancers in adults to leverage from our experience of treating more than 25 adults with the iodinated omburtamab. We expect to treat the first adults with the lutetium-labeled construct in the second half of 2020, and we are (inaudible) to widen our aim to include adults in these indications.

To support our growth plans, we increased our head count by approximately 16%, total of 65 employees during the fourth quarter. The increase is primarily due to the development team and the commercial team ramping up for the potential launch of naxitamab and omburtamab.

We continue to believe that we are well positioned to move both naxitamab and omburtamab through the FDA approval and commercialization in 2020 and concurrently increase our focus to our earlier-stage pipeline candidate, including, as I mentioned, the lutetium-labeled omburtamab-DTPA construct, the bispecific programs in the GD2-GD3 vaccine as well as the next in line indications for naxitamab and omburtamab.

Now let me invite Bo to share his remarks on the full year 2019 financial results. Bo?

Thank you, Claus. We reported a net loss for the year ended December 31, 2019, of $81 million or $2.30 per share, basic and diluted, compared to a net loss of $43.3 million or $1.50 per share, basic and diluted, for the year ended December 31, 2018.

We ended 2019 with a cash position of $207 million compared to the third quarter's ending cash position of $98 million. The increase of $109 million was primarily due to the net proceeds from our secondary offering of roughly $135 million net in November 2019, offset by fourth quarter expenditures.

As our work on the BLA submissions for naxitamab and omburtamab progresses and we accelerate the commercial ramp-up for the potential launch of the 2 lead compounds, we've seen our cash burn increase, and we expect the cash burn from operating expenses for 2020 to remain roughly in line with the first quarter of 2019.

Research and development expenses increased by $29 million from $34 million for the 12 months ended December 31, 2018, to $64 million for the 12 months ended December 31, 2019. This increase was primarily attributable to $17 million increase in outsourced manufacturing for our 2 lead product candidates, naxitamab and omburtamab; a $5 million increase in outsourced research and supplies to support expanding development activities; $3 million increase in personnel costs; and a $2.5 million increase in clinical trial expenses.

G&A expenses increased by $10.5 million from $9 million for the year ended December 31, 2018, to $19.5 million for the year ended December 31, 2019. The increase in G&A expenses primarily reflect a $5.1 million increase in personnel costs, a $2.8 million expense for the ramp-up of our commercial infrastructure related to the potential launch of omburtamab and naxitamab.

Cash flows from operating activities show that the cash burn increased by $32 million from $41 million for the year ended December 31, 2018, to $74 million for the year ended December 31, 2019. The increase was primarily caused by the increase in the net loss for the year. The net loss itself increased by $37.8 million for the year ended December 31, 2019, and was partially offset by a $5.5 million increase in accounts payable and accrued liabilities resulting from increased operations and an increase in noncash expenses, including stock-based compensation of $2.7 million. In addition, cash spending from investing activities increased by $1.7 million to $2 million in 2019 due to purchase of equipment primarily for the lab in New Jersey in 2019.

The net proceeds from the issuance of common stock increased by $36 million from $99 million in 2018 when we went public to $135 million related to our follow-on secondary offering that closed in the fourth quarter of 2019.

In terms of financial guidance, we've said since the secondary offering that the cash on hand plus the net proceeds from the offering would cover our operating activities and capital expenditures through the fourth quarter of 2022. And this still does not take into account any potential revenues from commercialization of naxitamab and omburtamab or the proceeds from any potential future partnerships. So we do believe Y-mAbs remains in a very healthy financial position.

This concludes the financial update, and I'll now turn the call over to Thomas.

Thank you, Bo. I think we'll now take some questions. Ashley, if you can control that?

(Operator Instructions) The first question is from Alec Stranahan of Bank of America.

Congrats on the completed '19 and the pre-BLA meeting for omburtamab. So just on that first, could you give us a sense of the additional studies, if any, that need to be done for the rolling BLA for omburtamab? And now with a clear picture of BLA submission time lines, following your interactions with the FDA, do you think it's still reasonable to assume commercial launch by the end of the year? And then I've got a follow-up.

Okay. Thanks, Alec. This is Claus. Yes. I mean just to be clear, for omburtamab, the FDA is not requiring any additional studies for the approval. What they're requiring is that the multicenter study be opened as a requirement from the FDA and where we have about 18 patients or so -- actually, we have almost 30 patients in the study now. But the first cohort of patients will be supporting the BLA, that will be completed in May. The FDA is giving us what they call an accelerated approval, which means that there will be a post-marketing commitment. And the post-marketing commitment is not requiring any additional study. It requires that the patients in the Study 101, where the first cohort of patients is a part of the first approval, should be followed for 3 years, and we have to come up with 3-year overall survival data that is significantly better than historical data, which is estimated to be about 10%.

So the number of patients that need to be for the 3-year follow-up is about 32 patients. And I think we are pretty close to having those 32 patients in the study already now. I think we have 28 or 29 patients. So we're pretty close to that. And as I said, it's not a requirement for the actual filing. We have all the information we need for the filing, and we are getting ready to submit everything before the end of May.

In terms of launch time, yes, we still believe that we can do that. For naxitamab, we expect to complete the rolling BLA before the end of this month, which we'll have a PDUFA date most likely in November, and we're ready to launch as soon as we get the approval from the FDA. If we file the omburtamab BLA in May, we should get a PDUFA date most likely in January 2021.

How can we then still believe there's a chance to launch it this year? Well, typically, the FDA, for these kinds of BLAs that addresses small life-threatening diseases, they typically approve the products 1 or 2 months early. So definitely, for naxitamab. Potentially, if the FDA use their standard time minus the typical 1 to 2 months early approval, we could also have the omburtamab on the U.S. market this year. Is that answering your questions?

Yes, that's very helpful. And one more from me. So assuming naxitamab gets approved in relapsed/refractory neuroblastoma by the end of this year, have you gotten a sense from the FDA what the expected regulatory path in frontline neuroblastoma would be? And how do you think the timing of the MSK study readout might influence the multicenter study design?

First of all, we don't have a discussion -- we haven't had a discussion with the agency about the frontline. And I have simply decided not to start discussing that until we get the approval in second line. We will have data out there from 2 individual single-center studies already this year. And we will be doing a multicenter study starting this year. And I think it's highly likely that the data will be out there. And I think we can see at least at some sites there's a clear interest in using naxitamab in frontline. Whether that will happen after the approval, I cannot give any guarantees, and we will work towards a formal regulatory approval to make sure that it's fully reimbursed also in frontline.

The next question is from Etzer Darout of Guggenheim.

Congrats on the progress. Just a couple of questions. I guess, one, maybe on sort of the data disclosures for 2020 given some of the disruption that we're seeing. And what your thoughts are around sort of maybe the venue or whether or not you sort of change the venue by which you dispose the data?

And then maybe on the sort of the global trial for the vaccine and maybe if you can sort of talk about what that pivotal trial could look like as far as design?

Well, in terms of venue, I mean I think we are all a little bit out in the woods right now on what's going to happen to various meetings. I think, for sure, very few larger meeting is going to happen in April this year. The meeting in May that we are planning to use as presentation for a number of our data sets that we've already submitted abstracts at the ANI in Amsterdam, let's wait and see. But we have the data, and of course, we'll make an effort to make sure we get data out as quickly as possible. So everybody is enlightened about what we have, yes, and that's completely sure. What was the other part of your question?

So yes, around sort of the trial for -- the global trial that you spoke about for vaccine and what that trial could like?

Yes. Well, I mean I think what we are doing is that we are following here. We have a lot of data in second remission patients. These are patients that have been in remission in frontline, then they relapse and become second-line patients. And we can put them back into remission with a combination eventually of chemotherapy and naxitamab or naxitamab alone. And so they are in second remission or later. And then we start vaccinating them. These patients have a tremendously poor prognosis. The numbers that we disclosed is a 20% 1-year progression-free survival and a 4-year 5% -- less than 5% progression-free survival. So if we can do anything to keep these patients at bay to prevent them from relapsing, which is what the vaccine seems to be able to do with that 2-year 50% progression-free survival in those that are in second or later remission, then we're doing something helpful.

I think for the second-line setting, the vaccination, we would go to the FDA and propose a uncontrolled fast-track accelerated type of approval with a post-marketing commitment potentially in a randomized frontline study. So we take patients in frontline, and as you also can see from the data I just disclosed, about 40% of the patients will relapse within 2 to 3 years typically in frontline. We may get that up to 30% relapse with naxitamab versus dinutuximab. But that's the ballpark we're talking about. So a number of patients in frontline is also relapsing, which dramatically decreases the prognosis of these patients. So you could imagine that we would try to discuss with the agency a strategy where we do get an approval in an uncontrolled setting in second line and then go for a post-marketing commitment to do a randomized frontline setting study. But this is speculative as we are right now. And I need to have the dialogue with the agency. And to be honest, we are working hard on getting the first BLA filed. And we'll take this dialogue with the agency up when we've gotten the approval for naxitamab and see what we can agree on. But I think those are kind of like the strategies that we are working along, but they are not...

The next question is from Robert Burns of H.C. Wainwright.

Congrats on all the progress you guys have made. So 3 questions from me, if I may. First one, for the naxitamab filing in Europe, could you provide an update as to when you believe you'll be able to file the MMA (sic) [MAA]? And what the time line would look like around the review period in Europe? That's my first one.

Okay. So naxitamab filing in Europe, we haven't given any final guidance. What we're saying is that we are discussing to get the PIP in place. When we have the PIP in place with EMA, we can give a more precise guidance. I would consider it unlikely that we'll be able to file in Europe until probably the beginning of '22, maybe late '21, but definitely not this year because we need to do another study in Europe. You know the regulatory situation is a little different. The standard approval time in the EU is 270 days from the filing, and then there can be various kinds of locksteps in between.

Okay. Great. My second question is, so switching back to the frontline setting, how long do you estimate that the multicenter trial that you're initiating this year will take to readout? And are you considering incorporating naxitamab into the induction portion of that treatment similar to the Firmin and colleagues paper that came out at the end of 2019?

It's still uncertain what it actually does to add a GD2 antibody in the induction setting. So we are not planning to do that. We are planning to use a setting where we put the naxitamab in as maintenance after standard induction therapy whether the patient had bone marrow transplant or not. We are not recommending a bone marrow transplant for these patients. We think it's an unnecessary toxicity to the [kids] and 80% of the patients in Dr. Mora's study who presented in frontline had not received bone marrow transplantation, and nevertheless, we got, if anything, at least as good and probably better progression-free survival data than we do when we give bone marrow transplantation and dinutuximab.

So what do we expect in terms of frontline data needed for a potential regulatory approval? I don't know for sure whether the FDA would be satisfied with 2 single-center studies and an ongoing multicenter study, but I would think that it would be sufficient, but we can't say anything until we've had a regulatory dialogue with the agency about this. But it would be hard for me to see that they would not at least be willing to look, I would say, objectively on whatever data is available as we have. It's data-driven. Honestly, it's so data-driven, it's -- and I mean I don't think anybody is going to ask you about the efficacy. Everybody will know that, hey, if we can take lots of patients that I just disclosed in my presentation, where 88% of the patients already received 1 or 2 other GD2 antibodies and relapsed or progressed, and then we give them naxitamab, and we put a large group of them into remission, this antibody is working very, very well.

So the key things will be safety. Is this antibody safer than giving dinutuximab with IL-2? I mean you can look up the black box warning yourself. I think safety is driving this, I think, more than -- I think the efficacy discussion is kind of like over with and done. There's a new paper that came out recently that they gave a combination of a humanized dinutuximab and IL-2 cobbled together and they give it to patients that have only disease in the bone marrow, 35 patients, and they get a 16% response rate. I just told you, we get 100% response rate in bone marrow patients, but if the disease is only in the bone marrow. Efficacy is not an issue anymore. Safety is the key issue. And I think the safety data presented by Dr. Mora was pretty clear.

Yes. No, I agree with you there. And then the last question -- no, it's all good, Claus. And then the last question for me is, so could you frame how you're thinking about the GD2 bispecific data that is supposed to be released in 2Q '20 from an efficacy and relative benchmark perspective?

Well, I haven't seen the data yet. So the only thing I can say is that we are thrilled that we're sitting here a year after we started the dose escalation study, and we haven't had any, you can say, events that gave us a clinical hold, which is unusual for a bispecific antibody. We have to wait and see the data when we get them. But it's definitely -- I'm very excited about this program, and then whether we need to get higher up on the dose or not -- or we can get higher or -- time will show. So it's still, you have to wait through. So it's not kind of like we can dose escalate every second week, but we have managed to dose escalate a number of times now. So we are in a pretty decent dose level. So let's see how it pans out. But hopefully, the ANI meeting will happen, and we'll get the abstract approval.

The next question is from Anupam Rama of JPMorgan.

This is Tessa on the call tonight for Anupam. First one on the pipeline. For the Phase II relapsed second-line osteosarcoma study, we have seen safety data, I think, for the study. Can you remind us of time lines for the efficacy update? And is there a specific medical conference you're targeting? And then I have a follow-up.

Sure. I mean this study is supposed to recruit 39 patients. And as soon as those 39 patients are in the study, we will find a suitable conference. I still cross my fingers and hope that we can present the data before the end of the year. But there's no guarantees from clinical trial. So let's cross our fingers and hope we get data from that study before the end of the year, that is in sarcoma.

Okay, that's helpful, yes. And then maybe a commercial one as well. So given potential approvals here later this year, 2 potential approvals, how are you thinking about initial sales infrastructure?

We have an MSL team in place already. We started putting together the MSL team about 8, 9 months ago. And so we will have an MSL team operating under the medical group in the company, and then they will have a quite extensive sales team, which most likely will consist somewhere between 5 and 10 sales reps and some regional sales heads and stuff. So -- but the whole commercial organization, including the back-office support, the marketing, the co-pays, the marketing analytics and all the other functions are put together, I think we're looking at a group of about 30 people.

The next question is from Boris Peaker of Cowen & Company.

The first one is on naxitamab. We talked a bit about the frontline strategy here. I'm just curious, if approved in the frontline, how much more use do you anticipate you would have with the frontline label versus just the second-line label? Would you have retreatment of patients? Or just kind of want to understand your estimated drug use in that setting.

Yes. I think in frontline setting, the patients are getting naxitamab or would be getting naxitamab and are getting dinutuximab as a maintenance treatment. And so there's no disease that you actually can see you're treating. You can only see the effect of the antibody by the increased progression-free survival. Would you then, if you have treated with the naxitamab in frontline, reuse naxitamab in second line? Definitely. Absolutely. I see absolutely no reason and we also know it from experience at MSK that patients that have been treated in frontline that have relapsed can respond to naxitamab in second line. So I think the frontline would not cannibalize any of the second line use.

Got you. Okay. That's good to know. So maybe -- just maybe a slightly broader question. For both naxitamab and omburtamab, obviously, you have extensive pipeline of various studies ongoing. So beyond the lead indications for both of these drugs which we talked about, what are -- what's the time line for the next BLA filing for -- or label expansion BLA filing for each drug?

Well, I think naxitamab in frontline depending on what we can agree on with the FDA, I think naxitamab for frontline could be in the end of next year. And in terms of additional indications, I think it's a little early to say whether we need to see the osteosarcoma data before we start discussing what is needed for a potential BLA. But frontline setting, the other indication I also reported a little bit about the data is those patients that come into remission in second or later line, for instance, by induction chemotherapy, we have treated them with maintenance therapy and prevented them from relapsing. So there's a number of potential indications. So that is NED patients, no evidence of disease patients. That indication is potentially for naxitamab.

For omburtamab, I think the first expansion indications could be with DIPG and the desmoplastic small round cell tumors. As soon as we get the approval in place with the agency, we're starting a multicenter DIPG study later this year. And we need to go and talk to the FDA. And we're looking at a group of kids here, 300 to 400 kids every year diagnosed and who actually have DIPG with absolutely no possibility for survival. They get radiation to their pons. And then they get the holidays in the disease of 3 to 6 months and it starts growing again and it kills them. There's a 10% 2-year survival rate and a 0% 5 year. I mean there's nothing for these kids out there yet. And we have an ongoing study now that has several patients, untreated patients from a bit more than 5 years now and we have patients that are in more than 5 years survival. We have numbers taken for more than 3 years. And we are planning to start a multicenter study for DIPG later this year.

For how long would you have -- how long is that?

I think estimate -- as I said -- well, that's a good question. I mean there's absolutely nothing for these patients out there as we already have cases. I will do my outmost to get a supplementary DIPG into the FDA as quickly as possible. There's no doubt the FDA would like to see a multicenter study, but I don't think I need to follow the multicenter patients for more than a year. So towards the end of next year, we could probably be ready, but that's very aggressive guessing from my side. But I'm always very optimistic in what we can do to help these patients. I want to do -- that's also why we're sitting here now less than 5 years after we started Y-mAbs and we are filing 2 BLAs. There's so much need for these treatments for these kids.

So I'm really going to make as significant effort as we can with the team to get the FDA to accept the data on DIPG based on what we have on MSK and multicenter study as little as possible. Then we can keep post-marketing commitments doing other things. But as I said, there's no alternative. All these kids, every single one will die, and they're dying today from their disease. We need to get something that can help them.

There are no further questions at this time. I would like to turn the floor back over to Thomas Gad for closing comments.

Yes. Well, thank you, everyone, for listening today on this particular day. And as you've just heard, Y-mAbs is in a great position for 2020, and we are moving forward with excitement. So I hope you have a great evening. Thank you. Thank you, Claus. Thank you, Bo.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.