Good morning, and welcome to the Y-mAbs Therapeutics, Inc. Second Quarter 2020 Earnings Conference Call. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995.

Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31, 2019, as well as with the SEC on March 12, 2020, and in the company's sequentially filed SEC reports.

At this time, I would like to turn the conference over to Mr. Thomas Gad, the company's Founder, Chairman and President. Please go ahead, sir..

Thank you, Donna. Thank you, everyone, and good morning, and thanks for joining us today. I hope I go through loud and clear. I know we had a storm, but the lines are up and running. So despite the COVID-19, the second quarter of 2020 has been very strong for Y-mAbs.

We believe we've made significant progress on executing our strategy and taking steps that will position us very well for the potential product launches of our two lead product candidates, naxitamab and omburtamab. As you know, we have completed the submission of the naxitamab BLA in March and received a PDUFA date for November of this year.

And in addition, the submission of the omburtamab BLA to the FDA was completed earlier this week. We ended the second quarter with approximately $158 million in cash. So we believe we have a strong balance sheet to support the potential launch of both naxitamab and omburtamab, while at the same time achieving our development pipeline.

We believe that our cash position will carry us through the end of 2022 without taking into consideration any product sales or potential partnership income. And we're very pleased with our financial position, which Bo will talk about later on this call.

As a company, we always work very hard to stay tuned to our position as a leader in pediatric oncology, addressing clear unmet medical need and focusing on advancing our therapies to reach the lives of children living with these rare cancers.

Concurrently, it's pleasing to see our pipeline and technology platform widen its reach into adult patient populations, with lutetium-labeled omburtamab will soon be tested in adult B7-H3-positive cancers and the GD2 biospecific scheduled to enter Phase II in small cell lung cancer later this year.

We're also very excited about our new licensing agreement with MSK and MIT, which we entered into in April to expand our antibody platform with the SADA technology. We believe the SADA technology represents a new approach to pre-targeted radioimmunotherapy, which we refer to as liquid radiation.

And SADA may have potential to improve the current treatment landscape in oncology since it appears to enhance the therapeutic index of payload delivery.

We believe SADA's technology appears to be very promising and may be able to take radio-conjugated antibody constructs to a new level and potentially open up for much broader usage than any other radiolabeling technology in the antibody area. We expect to deploy the SADA technology in a range of adult tumors as well as pediatrics.

And our targets include in HER2 for breast cancer, B7-H3 for prostate cancer and GPA33 for colon cancer, thereby adding further exposure for the company in adult patient populations. I'm also very happy to announce that Laura Hamill has joined our Board of Directors.

Laura has extensive experience in the industry with over 30 years of global commercial experience and a rarity of executive leadership position, most recently as Executive Vice President at Gilead.

Laura adds significant commercial expertise to our Board, which will be a great value to our plans for commercial organization and bring our product candidates to patients. And today, obviously we'll hear remarks from Dr. Claus Moller, our CEO; and Bo Kruse, our Chief Financial Officer. And I will hand it over to Claus now. Thank you..

Thank you, Thomas, and welcome again to Y-mAbs Therapeutics Second Quarter 2020 Earnings Call. We are very pleased that you have chosen to spend this morning with us. Let me start by saying that we continue to closely monitor the impact of COVID-19 on our business.

We have implemented a number of measures to protect the health and safety of our employees, while also taking steps to mitigate potential disruption to our supply chain and continue our clinical trials and planning of commercial activities.

While we have seen some near-term impact on clinical trial site initiation and patient enrollment, we have not changed our guidance for key anticipated 2020 clinical data readouts. To date, we are pleased with the continuity of our business and our ability to support the critical need of cancer patients in our ongoing trials.

We will keep you updated as appropriate going forward. During the second quarter, we have continued to work hard to ensure that our two lead product candidates, naxitamab and omburtamab, advance towards the market.

For naxitamab, as you will recall, we completed the BLA for naxitamab in March this year, and we have now received the PDUFA date November 30 this year. And had a number of dialogues with the agency and are still confident that we will be able to stick to this plan.

The BLA is for treatment of patients with relapsed/refractory high-risk neuroblastoma in bone and bone marrow. The BLA submission is based on the safety and efficacy results of the pivotal studies called 201 and 12-230, which we expect to present data from at a suitable venue later this year.

In terms of post-marketing commitments, we are aiming for a two year progression-free survival for the planned patients from the Study 201, and in addition to the ones that were in the filing.

In addition to the BLA for naxitamab, we have trials ongoing in Barcelona and at MSK for first-line neuroblastoma as well as chemo-combination trials for refractory neuroblastoma patients.

During the remainder of 2020, we expect to initiate an international Phase II multicenter trial for naxitamab in both frontline and with chemo-combination treatments. Now let me jump to omburtamab, our lead our second lead compound.

We had the pre-BLA meeting with the FDA in February this year, and we're very pleased to have our plans confirmed by the agency for the BLA. We initiated the rolling BLA in June and completed the BLA submission earlier this week for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.

This is a few weeks later than we had originally anticipated back in February after the pre-BLA meeting, but before the COVID-19 started to affect our activities.

However, we are very pleased to have the in-house competence to work and coordinate the submissions of another BLA filing only four months after the completion of the submission of the naxitamab BLA, and we will continue to keep you posted on our progress.

We are hoping to confirm a post-marketing commitment showing three year overall survival from 32 patients from the Study 101 to be significantly better than a 10% overall survival reported historically. We will present preliminary data from the pivotal 101 study in CNS/leptomeningeal metastases from neuroblastoma at SIOP later this year.

That's in October. In addition to the U.S. development program, we are making good progress in Europe and we plan to submit a marketing authorization application for omburtamab within the next six months. This is a vital step forward in our efforts to potentially bring omburtamab to the market in Europe in 2021.

As previously discussed, we're also developing omburtamab for diffuse intrinsic pontine glioma, known as DIPT, in a Phase I study at MSK, and we are planning to open a multicenter Phase II study for DIPT patients in 2020. For desmoplastic small round cell tumors, also known as DSRCT, we have recently opened a Phase II study at MSK.

For our lutetium-177 labeled omburtamab-DTPA construct, we are planning to open a multicenter Phase I/II study in pediatric medulloblastoma next month. And we also plan to open a second Phase I/II study, which will be a basket study for B7-H3-positive CNS/leptomeningeal metastases in adult patients later this year.

For both studies, we hope to utilize our prior experience of treating patients these indications with the iodinated 131-iodine omburtamab. I'm very pleased to see the second-generation omburtamab entering the clinic very soon.

On the commercial standpoint, we believe that we are very much on track to build the rightsized, best-in-class commercial organization in time for the potential approvals of both naxitamab and omburtamab. Should the potential naxitamab approval even come before the PDUFA date, we will also be prepared for that.

Given the small universe of pediatric cancer centers that treat the majority of the neuroblastoma patients, we believe that we can build a lean and highly targeted commercial organization and launch both compounds ourselves. Our commercial team is largely in place.

As many of you know, we hired our Chief Commercial Officer, Phil Herman, more than two years ago, and we have been building his team ever since. In addition, we have medical science license and medical affairs groups in place, so we believe we are positioned very well for the potential the launch of naxitamab and omburtamab in the U.S. market.

Since European marketing application for omburtamab is potentially only about six months behind the U.S., we plan to begin staffing our European commercial operations towards the end of 2020. The SADA technology that Thomas also mentioned briefly was licensed in April.

It's an agreement with Memorial Sloan Kettering Cancer Center and Massachusetts Institute of Technology for a worldwide exclusive license and research collaboration to develop the antibody construct based on the SADA molecule self-assembling/disassembling antibody constructs. It's a radioimmunotherapy platform.

We also refer to the SADA platform to as liquid radiation. The SADA platform operates in a two-step manner. In the first step, a saturating dose of tumor-targeted, unlabeled, bispecific antibody fragment is injected.

These bispecific antibody fragments are self-assembled in-vitro prior to the injection into tetramers and subsequently bind to the tumor cells.

After a few hours, excess tumor-targeted antibody constructs that have not bound to the targeted tumor cells disassemble due to the dilution in serum into smaller antibody fragments that are then subsequently excreted quickly through the kidneys.

In the second step, the next day, when the concentration of antibody constructs not bound to the tumor is at its peak and much higher than in normal organs, a radiolabel compound that binds to the other end of the bispecific constructs, the DOTA binding part, is injected.

In published papers utilizing similar approaches, data indicate that this two-step process results in a much higher tumor/non-tumor concentration ratio, which we believe is favorable for radiotherapy since it substantially minimizes the radiation damage to healthy tissues.

We believe SADA potentially could improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents, i.e., tumors with multiple microscopic lesions, larger than three or four centimeters in diameter, as it appears to subsequently allow a higher radioactivity level to be injected without impairing the hematological toxicity.

We have initiated development of a number of SADA-based constructs created by MSK, including GD2-SADA for GD2-positive solid tumors, a GPA33-SADA for potential use in colon cancer and HER2-SADA for potential use in breast cancer.

And we expect to advance a series of proprietary constructs as well as we were very pleased to designate the B7-H3-SADA for potential use in prostate cancer as the first of these constructs a few weeks ago.

We plan to file the first IND within the next 12 months for a SADA construct and hope to start treating patients with this exciting technology shortly thereafter.

We believe the SADA technology platform makes tremendous sense for Y-mAbs, and it could potentially allow us to unlock even further potential in the field of regulated antibodies, both for specialty oncology indications and also in larger adult indications.

The platform is also available for sublicensing, and we hope to see the SADA technology make significant contribution to improve the treatment landscape in radioimmunotherapy in the coming years. To support our growth plan, we have increased our headcount to a total of 89 employees during the second quarter of the year.

Due to the COVID-19, the increase is modest compared to prior quarters, and the growth represents addition to the development team as well as to the commercial team that is ramping up for the potential commercial launch of naxitamab and omburtamab.

With the PDUFA date in late November 2020, we continue to believe that we are well positioned to move naxitamab to FDA approval and commercialization later this year. For omburtamab, we believe that we are well positioned for the potential FDA approval and commercialization in the beginning of 2021.

Concurrently, we plan to increase our focus on constructs generated by the SADA technology and the earlier-stage product candidates in our pipeline, including the lutetium-label omburtamab and the bispecific antibody programs, as well as the next-in-line indications for naxitamab and omburtamab.

Now let me invite Bo to share his remarks on the second quarter financials..

Thank you, Claus. We reported a net loss for the quarter ended June 30, 2020, of $40.4 million or $1.01 per share, basic and diluted. This compares to a net loss of $18 million or $0.53 per share basic and diluted for the quarter ended June 30, 2019.

We ended the second quarter with a cash position of $158 million compared with the 2019 year-end cash position of $207 million.

As our work on the omburtamab BLA submission has progressed through the quarter and as we continue to accelerate the commercial ramp up for the potential launch of both naxitamab and omburtamab, we have seen our cash burn increase.

We expect the cash burn from operating expenses for the remaining quarters in 2020 to increase slightly, but remain roughly in line with last couple of quarters. With respect to the recent announcement of the SADA license, we do not expect this to have a material impact on our spending in 2020.

As we take a closer look at the operating expenses for the second quarter, we note that R&D expenses have increased by $15.6 million from $14.5 million for the quarter ended June 30, 2019, to $30.1 million for the quarter ended June 30, 2020.

This increase was primarily attributable to a $1.8 million increase in personnel costs and a $13.3 million increase in milestones and license fees as per the SADA agreement. In the second quarter, most of the SADA-related expenses were noncash items.

G&A expenses increased by $6.3 million from $4.1 million for the quarter ended June 30, 2019, to $10.4 million for the quarter ended June 30, 2020.

The increase in G&A expenses primarily reflects a $1.9 million increase in personnel costs, a $3.5 million increase in expenses for the building of our commercial infrastructure related to the potential launch of our two lead product candidates, naxitamab and omburtamab, and a $0.9 million for business insurance and professional fees.

Cash used in operating activities in the first half of 2020 show that the cash burn increased by $21.9 million from $27.5 million for the period ended June 30, 2019, to $49.4 million for the period ended June 30, 2020. The increase was primarily caused by the increase in net loss for the period.

The net loss itself increased by $32.6 million for the period ended June 30, 2020, and was partially offset by an increase in noncash expenses, including depreciation and stock-based compensation of $11.7 million.

In terms of financial guidance, since the secondary offering last year, we've said that cash on hand plus net proceeds from the offering would cover our operating activities and capital expenditures through the fourth quarter of 2022.

This does not take into account any potential revenues from commercialization of naxitamab and omburtamab or the proceeds from any potential future partnerships. So we believe that 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. Thank you, everyone. So Donna, if you would open up for Q&A and just go through the process of how that will work..

[Operator Instructions] Our first question is coming from Alec Stranahan of Bank of America. Please go ahead..

Hey guys, thanks for taking our questions. Two from me. My first question is on the GD2-GD3 bispecific.

In the first indications of relapsed/refractory neuroblastoma and osteosarcoma, is the hopes here that we'll see better safety in naxitamab in terms of the grade three pain? Or do you think we could also see a boost in efficacy given the higher potency in preclinical models? And in terms of timing of the data, I think I recall you mentioned we might see early efficacy at SIOP in the fall, but I didn't see it in the titles you listed.

So any additional color there on time lines for data release would be great. And then my second question is on the commercialization front. I know launch is still a few months away and things could change.

But given the situation with COVID, how are you building the potential for extended social distancing and mobility issues into your approach to marketing naxitamab and omburtamab? And how are you weighing boots on the ground versus virtual interactions in your launch preparations?.

Thanks, Alec. Just your first question to the bispecific antibody. We are still hoping that during the fall we will be able to come out with some preliminary data from the Phase I/II dose-escalation study on the bispecific antibody. And hopefully also some preliminary indication of both safety and efficacy.

The idea is that due to the lower doses that we are using that we potentially could see less pain side effects with this.

The patients that we are putting on study is patients that have already progressed while having received GD2 antibody, although we have a fantastic naxitamab GD2 antibody, you will recall for second-line patients that are secondary refractory, we only have about if you include those, we can put in remission in combination with chemotherapy, about 60% of the patients to come into remission, which also tells you that the remaining 40% are still not in remission.

So there is a significant unmet need still for those patients. And of those 60% that does come in to remission approximately, if you look at Dr. Kushner's data from SIOP last year, you will see that the two year progression-free survival for those that are coming to remission are about 37%. So there's clearly still more to be done for these kids.

So if the bispecific antibody could help out, initially, it will be developed for those that are not staying in remission after first or second relapse.

And then, of course, you would try to advance it and see if you use it in earlier stage, you can actually keep patients more patients in remission for a longer time and put more patients in remission with the product.

And for the osteosarcoma patients, the thing is, today, there's nothing approved for patients that are beyond frontline treatment in osteosarcoma. So, that's definitely an unmet medical need there. And then and I know we have at least three or four osteosarcoma patients on the study, and we are looking very much forward to see how that progresses.

In terms of the commercialization, well, we're definitely paying attention to the issue with COVID-19, and we are preparing to do a virtual launch. Right now, there's a limit to how much that can be done.

It seems to be our experience monitoring what other people are doing that physicians are very open, in particular, to new products coming to the market to do virtual interviews and presentations. So we are preparing for that situation that we may not be able to put feet on the ground in the hospitals, but have to do the launch virtually.

So I was discussing this and have been discussing this a number of times with Phil heading the commercial team. So he's perfectly prepared for that situation also.

Did that answer your question?.

Yes, that's perfect. And congrats on all the progress..

Thank you..

Thank you..

Our next question is coming from Etzer Darout of Guggenheim. Please go ahead..

Hi, thanks for taking the question. I guess the first one on just Danyelza and Omblastys. If you could maybe provide some commentary on access, pricing and reimbursement, conversations that you're having with payers and how sort of you're kind of communicating what you've kind of characterized as optimal pricing.

And then just secondly, if you could maybe give a little bit more color on the data you've seen for omburtamab in adults and sort of how that may be kind of read through to the lutetium product that you're advancing in adult patients..

Well, thanks for the questions. And in terms of pricing, it's difficult for me right now to give you any details on the pricing. We have previously discussed some ballpark figures where you could expect the pricing to end.

But I think I have nothing further right now until but I would in terms of price resistance, I have to say that we're not meeting any. And it doesn't matter which kind of price level we are discussing within the levels where other people for these very expensive niche products are selling right now. So I don't foresee any issues with pricing.

Remember, for omburtamab, we are taking a group of kids where everybody is historically expected to die from the disease and we cure 50% of them. I think it's very hard not to start arguing about pricing as long as you stay within a reasonable amount of cost. In so that's as much on the pricing. And the other question was omburtamab in adults.

And we presented some preliminary data from the iodinated version. I mean many of these patients that went on the iodinated omburtamab for CNS/leptomeningeal metastases for ovarian cancer and for melanoma and sarcomas, etc. that we have on the study, were really terminal when they came on to the protocol.

I remember the woman with the ovarian cancer had 14 metastases that was visible on her scans when we put on. And nevertheless, she lived for 1.5 year, which is, I would say, unprecedented. There's no doubt that you need to come as quickly as possible if you want to get full benefit of a treatment like the omburtamab lutetium.

So like for the kids we put on this treatment, where we get these fantastic results, remember, before they come on the treatment, they receive standard of care, which is induction chemo, surgery and radiation to their tumors in the brain.

After that, their expected median survival is six months from diagnosis of CNS disease and their expected three year overall survival is 10%. So these patients are receiving optimal treatment.

If I'm the patients that we will put on the adult protocol will be those that say, that have a melanoma relapsing in the brain, they will also receive induction chemo with temozolomide and maybe some irinotecan. And then they will get surgery for the lesions that are visible, and then they will get whole brain radiation probably 25 grade total.

And after that, most of the patients will be NED. And nevertheless, the likelihood that they will be alive 12 months later is 15%. So those patients just after they finish that would be optimal to put on this. Based also on the experience we have, we have treated a number of melanoma patients.

And again, as I said, most of them come at a time point where there's no other alternatives and they have received whatever palliative care they could receive. I hope that answers your question to the extent....

No. Great, yes. And congrats on all the progress..

Thank you very much..

Thank you..

Our next question is coming from Robert Burns of H.C. Wainwright. please go ahead..

Hi guys, thanks for taking my questions and Congrats on the progress. Just a few from me, if I may.

So since you're advancing both the GD2 bispecific and GD2-SADA assets, could you discuss the potential overlap of these assets? And in what setting do you believe each is likely to be preferentially used? As well as whether you see any profitability for cannibalization of the others' revenue potential, particularly in SCLC? And then I have one more after that..

Okay. So first, well, of course, there is a potential that one of them could cannibalize the other one. But remember, one is right now in the early preclinical testing, meaning we are getting ready for tox studies. It will probably enter clinic by the middle of next year, third quarter next year. That's the SADA construct.

The other one is ready to start three Phase II studies later this year. And when we started this development, we didn't have the SADA technology, and we don't know how the SADA technology will work in patients. Remember, it's never been in patients before.

But if the SADA technology works, the way I believe it's working, it's going to be the biggest game changer that we have seen in oncology for the last 30 years. And then it's going to completely compete out the bispecifics. Then it has the potential to compete out basically anything.

The SADA constructs are only dependent on the receptor on the cancer cells. As long as you can identify something that is selectively, to some degree, expressed not even on all the cancer cells because radiation from lutetium penetrates like one to 1.5 millimeters in cancer tissue.

So, you get a ton of bystander effect from these radiolabeled constructs. Whereas a bispecific antibody is dependent on T cell activation, a naked antibody like naxitamab is dependent on NK cells and macrophages and ADCC activation.

These constructs, even if I take a late-stage patient that have been through four, five different regimens of cancer therapy, has no immune system that's really working anymore, but the cancer is still expressing the target and the patient has hundreds of micrometastases, my SADA construct will still work, it's just going to go in there and eat it.

So if the SADA works, I would agree that it could potentially cannibalize anything that naxitamab and the bispecific GD2. But I've been long enough in this industry to know that you should not abandon the stuff that you have coming to the market just because you believe that something in your research lab looks more interesting.

But it shouldn't stop us from pushing that forward. And I have to say, and I've said it many times already now, I'm extremely excited about our SADA technology. It is really the best stuff I've seen since I started working with antibodies back in the 1980s in a different venue.

Did that answer the question?.

It certainly did. I certainly look forward to the whole SADA constructs. One more from me.

So considering that Y-mAbs is eligible to receive a PRV upon approval of naxitamab and omburtamab, have you already lined up potential buyers for them?.

We have lined up some people that will help us make sure we get the best possible price for it. So but I know also from one of these said that the last two ones that they were involved in selling took three to four weeks to sell. And you may have seen that there was another one that was sold about a week ago for $100 million..

Yes, that seems to be what they're going for, roughly. Claus, congrats again on the progress..

Thanks a lot, Rob..

Thank you..

Our next question is coming from David Lebowitz of Morgan Stanley. Please go ahead..

Thank you very much for taking my question.

Given that you have two BLAs that are currently in progress, have you had any discussions with the agency regarding how facility inspections will be conducted for both applications?.

Yes. I don't foresee any problems in that context, and they have also been monitoring sites and haven't seen any issues in that context either. But there is that there could potentially be a challenge if the FDA cannot go and inspect the omburtamab facility in France in the first quarter next year. But I would be surprised if that's not the case.

I mean we are then at a time point where at least a lot of the big pharmas have promised that there will be vaccines available in the hundreds of millions of doses. So but for naxitamab, I don't foresee any issues..

Excellent. And one additional question. With respect to radiolabeled products, how will you, I guess, juxtapose the U.S.

market versus the European market in how such therapies are used and delivered?.

The first commercial delivery site we had was in South Bend, Indiana in the U.S., and we are planning in the next 12 months to open a second site in Europe. In addition to that, we're also working on an additional U.S. site. So but we have the site that is basically a part of the BLA is in the U.S.

and the European approval will not come until probably towards the end of 2021. So we should be up and running with the European site at that time point also. But we can ship you from the site in Indiana. It's no problem for us to ship. We're already doing that, shipping from U.S.

to Europe for the clinical trials and having the product available at the hospital in due time for use..

Thank you for taking my question..

Thanks, David..

Thank you..

[Operator Instructions] Our next question is coming from Peter Lawson of Barclays. Please go ahead..

All right, thanks for taking my questions. Just on the data for naxitamab, it that looks really encouraging.

Just what's the pushback that you've had outside MSKCC? And how do you overcome that?.

Well, I would say, I don't think we have had any significant pushback. It's I mean, it's really hard to push back when you have a treatment that you right now, inside outside of MSK and if they're not in our clinical trial, they will use dinutuximab in second-line patients together with chemotherapy. And that gives about a 40% response rate.

And we come here with a naked antibody therapy in an outpatient setting without chemotherapy, and we get much better responses. So I mean, I haven't heard any real qualified arguments why you would not use this in second line.

And it's hard for me to imagine that any doctor would not use naxitamab in primary or secondary refractory patients according to indication and rather go for something else. And you can argue if they say. But I want to use the antibody in combination with chemotherapy.

We have two studies out there where we use it in combination with chemotherapy, and we're getting very nice results there also. And we are starting a multicenter study very soon this year, also in chemo combination. So I haven't heard any concrete arguments against it.

As I said, there's a lot of people that are happy that they have access to dinutuximab and are using it, both in front and second line, but it doesn't mean that they will then when there's something that can be used in an outpatient setting with less side effects, why wouldn't they?.

Good. Okay, and then....

With pediatric oncology, a lot of the treatment is driven by the parents. So the parents will also have a lot of saying about this.

If the doc tells you I'm going to treat your kid in the intensive care unit for eight days in combination with chemotherapy and there may be some significant side effects, but I think it's a good treatment for your second line patient here.

And the parents know that there's an FDA-approved product for second-line patients that can be done in an outpatient setting without chemotherapy. I mean, they're going to ask the doctor why on earth you would not be using that. So....

And how much work do you have to do with patient advocacy groups?.

Well, I mean, of course, we are in dialogue with them and talking to them, and they are definitely aware of it. We have been in dialogue with them since we started working with Y-mAbs five years ago. I mean this all came to some degree out of the patient advocate groups. So but we have a very close dialogue with many of them.

But it's not kind of like that. But they are independent groups and, of course, we fully respect that. But of course, we have a dialogue with them and they are fully aware of that treatment..

Good. And then the pivotal 101 study at SIOP later this year.

What should we expect to see in that data? What should we be looking for?.

Well, I mean, for the omburtamab, we definitely would be planning to present some of the data from the Study 101, the multi-center study and also the survival data that we have available at that time point. And for the 201 study, again, the data used for the FDA filing and the updated data from that study.

So whatever is available in terms of updated data. Remember, the data set that was last presented from the 101 study was with a cutoff date that is almost a year ago. And the same goes for the 201 data. The data cutoff for the 201 study was in July 1, 2019. So we have more than a year of additional follow-up on the data there..

Great. And then, the bispecific, that was I thought that was going to be at SIOP. Has that been delayed kind of COVID-related issues or....

Yes. Well, I mean, the thing was that we have decided not to stop dose escalating. And the requisite for a late-breaking abstract is that the study is not ongoing. So since it's still dose escalating but I have to say that we're not beyond the cohort 6. Also, we need to we're working with some ways to handle some of the side effects that we are seeing.

So but it's not that we are expecting it to delay any of the time lines. We're still planning for going into the Phase II studies. But of course, we want to make sure that we are at a higher dose level as we can be and to see if we can get beyond the cohort six level..

Great, thank you so much. Thanks for taking my questions..

Much appreciated..

[Operator Instructions] Our next question is coming from Anupam Rama from JPMorgan. Please go ahead..

Good morning, guys. This is Tessa [ph] on the call this morning for Anupam. The rolling submission for omburtamab is now you just announced was complete yesterday.

What are some of the next steps and key interactions with regulators as we head towards a potential approval?.

Well, the FDA now has 60 days to make up their minds whether they believe that the BLA is complete or whether it's faulty and therefore should be returned or refused to file. And typically so then you receive what's called a day 75 letter, which means that the FDA typically 75 days.

So if you don't get a refuse to file within 60 days, you get a day 75 letter that includes your PDUFA date, which will then be six months after the 60 days, i.e., eight months after you filed or completed your own BLA.

But the day 75 letter doesn't necessarily come 15 days after the day 60, it can come a month after if they have some questions and stuff. And also for the naxitamab, we had an interaction with the FDA already in the first 60 days where they asked us for what they called an application orientation meeting.

And where they had a ton of people available to get to make sure that they had a complete understanding of the various parts of the filing. So there's going to be, I think, already from within the next two to three weeks, beginning correspondence with RFIs, request for information from the agency.

So as for the naxitamab, since we completed the rolling BLA in March, we have had a number of conference calls and discussion meetings, etc. with the agency. So this is a continued dialogue. You just you don't just sit down and wait six months and then cross your fringes and hope that they are happy with everything. There's a lot of dialogue.

And very constructive. And I think also because we have breakthrough designation, the FDA has, also before we filed, given us a lot of constructive advice for both filings. So we have I think we have a great and very constructive dialogue with the agency on these two filings..

Great. Thank you for taking our questions..

Thank you..

Our next question is coming from Peter Lawson of Barclays. Please go ahead..

Right. Thanks for taking the follow-up. Just on the SADA construct for B7-H3 in prostate cancer. Look, we see the initial data and why do you think it works in prostate cancer.

And is that based on your own data or peer data?.

Well, there's a lot of documentation that B7-H3 is highly expressed on prostate cancer. And the construct that we are using here remember, the omburtamab antibody is a murine antibody IgG1. And the construct, the binding single chain, if we, again, see the B7-H3 that we are using for the SADA, is a humanized version of the antibody that's modified.

So it doesn't seem to cross-react with any liver tissue, which can be the issue with some bispecific or some B7-H3 antibodies. So it's a modified version that we at least based on what we have seen in the research, do not expect to cross-react with liver issue. And the reason for going for this, I mean, prostate cancer is a huge indication.

And with the SADA technology, a part of that technology package the other part of this SADA construct binds DOTA molecules. And DOTA is obvious for lutetium because it works as a key later. But we also, as a part of the package, have a technology we call Proteus. And the Proteus is a benzyl binder that can carry actinium linked to the DOTA.

So that means that and you know that prostate cancer is very sensitive to alpha emitters. And one of the ideas is that we want to use the Proteus construct as an alpha-emitter against the prostate cancer. And the nice thing here is that it's just going to find any micrometastasis expressing B7-H3.

And even if it's only one in 10 prostate cancer cells that's expressing it, whereas we normally know that it's more than 90%, it's going to kill all of them. Because although the alpha-emitter is not penetrating a millimeter, but maybe just 0.1 or 0.2 millimeters, it's still extremely lethal to the cancer cells.

So it's it just made a lot of sense for us with the knowledge that's out there about prostate cancer and B7-H3 expression.

And since we had the construct to start working on it, and of course, we started working on it quite a while ago and just kept pushing it until we had a construct that we felt comfortable moving forward to actual cGMP production for.

Did that answer the question?.

It did.

Other than that, when could we see data?.

I don't know, Peter. As soon as we can get some, we'll present them..

But you've kind of pushed to have some preclinical data out there or kind of hold that back..

Well, I mean, yes, some. But we don't we would have to put together a paper. It's not something that would go for an oral presentation. So we could put together for a paper for it.

But honestly, I think the interesting thing here is because even if I showed you a ton of animal data that this works perfectly in the mice, let's get it into patients, that's what matters. And happy to see whenever we have tox data available also to share that whatever we see there and get in there.

But the key thing that drives this is actually having a cGMP production available and approved IND, and get the stuff in the patients..

Got you.

And then the bispecific data, would you end up just press releasing that? Or you want to try and find a venue?.

I'll get back to you whether we do one or the other..

But it's still kind of year-end we should see bispecific?.

Yes. Yes. We have some plans, but they're not final. Not yet. So and it's definitely our intention to present data before the end of the year..

Okay. Thanks much..

Thank you..

At this time, I would like to turn the floor back over to management for any additional or closing comments..

Thank you. I mean thank you, everyone. Thank you, Claus. Thank you, Bo. Thank you for all the great questions. And this concludes our call then. Have a great day..

Ladies and gentlemen, thank you for your participation, you may disconnect your lines at this time and have of wonderful day..