Good day, and welcome to the Y-mAbs Therapeutics Inc. Second Quarter 2021 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 in 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 risk factors discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as filed with the SEC on March 1, 2021, and in the Company's subsequently filed SEC reports.

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

Thank you very much. Good morning, everyone and thank you for joining us today for our second-quarter earnings call. During the second quarter of 2021, we continue to make notable progress across all three pillars of our business. First, our leading monoclonal antibodies, then the also an omburtamab.

Secondly, our bispecific compounds developed under Y-BiClone platform and finally the SADA platform, which also we refer to as liquid radiation. We had a strong start to 2021.

We were very thrilled to submit the Marketing Authorization to EMA for omburtamab for the treatment of pediatric patients with CNS leptomeningeal metastases from high-risk neuroblastoma back in April.

Also after our Type B meeting with the FDA in June, we believe, we now have a clear path towards resubmission of the omburtamab BLA in the form of a rolling submission. We intend to initiate this by the end of this year. As you know we started delivering DANYELZA in the beginning of February and we are seeing demand from hospitals across the US.

Second-quarter net sales were $9 million, up 67% as compared to first-quarter net sales of $5.4 million. During the second quarter, we have roughly doubled the number of treatment centers that have gained experience with DANYELZA. And we have now delivered to approximately 20 centers across the nation.

Although we have not provided guidance on DANYELZA sales, I'm pleased to note that both revenues and the number of treatment centers have exceeded our internal expectations for the first two quarters, so, we could not be more pleased with that.

I'm also pleased to report the progress we've made so far in China together with SciClone Pharmaceuticals, our strategic partner from Mainland China, Hong Kong, and Mecca. In June, SciClone Pharmaceuticals held a pilot launch presentation of GD2 therapy for Neuroblastoma in the tourism pilot zone in Boao Hainan and on also known as Boao Hope City.

Thanks to the drug approval process in Boao Hope City and strong support of the local medical institutions. We believe that cyclone will soon be able to provide DANYELZA to neuroblastoma patients in China.

You'll recall that in March SciClone received a clinical trial waiver for DANYELZA and in July, the BLA for DANYELZA for the treatment of patients with relapsed and refractory high-risk neuroblastoma was submitted to NMPA in China.

We are also very excited to [indiscernible] an exclusive distribution agreement with Adium Pharma, also known as Techno Pharma, a company with significant oncology and rare disease businesses and a commercial presence in 18 countries across Latin America.

Techno Pharma will employ its sales and marketing expertise to Distribute DANYELZA and omburtamab if approved in that region. Techno will also submit registration files on our behalf in this territory. The SADA technology continues to look very promising and Dr.

Nikon Chong from the Memorial Sloan-Kettering Cancer Center recently gave a presentation of PEGS and Boston to demonstrate how cancer therapeutics often sale on development because of dose-limiting toxicities of sub-therapeutic dose and as a consequence of insufficient therapeutic in Texas.

Our two-step SADA technology uses unique pharmacokinetics to potentially improve therapeutic index of oncology therapeutics. The bispecific programs under the Y-BiClone platform continue to events R&D for nivatrotamab was clear last year and we are getting ready to dose the first patients in our small cell lung cancer study as we speak.

Phase II expansions with nivatrotamab in neuroblastoma and osteosarcoma are also planned for later this year. The R&D for our CD-33 bispecific for Pediatric AML has been submitted and this promising treatment will potentially address a very important Pediatric unmet need.

As AML remains one of the most challenging hematological malignancies for children today. We ended the second quarter with $233.6 million in cash. So, we believe we have a strong balance sheet.

I support the continued commercialization of DANYELZA and the potential launch of omburtamab, but also to advance both our Lutetium conjugated omburtamab-DTPA, and nivatrotamab into late-stage development. At the same time, we continue to advance our Y-BiClone and SADA technology platforms.

So, we are very pleased with our current financial position which Bo will elaborate on later on this call.

Taking our achievements into consideration, we believe Y-mAbs is very well positioned to expand our commercial activities, while at the same time, advancing our pipeline to continue to address unmet medical needs and we are very excited to continue to do so. And with that, I'm very pleased to hand over the call to Dr.

Claus Moller, our Chief Executive Officer. Thank you..

Thank you, Thomas, and welcome to Y-mAbs Therapeutics second quarter 2021 earnings call. We are very pleased that you've chosen to join us today. During the second quarter, we have worked hard to ensure that our pipeline continues to advance toward the market.

DANYELZA for the treatment of patients with relapsed-refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy was approved by the FDA on the accelerated approval pathway.

We were - told to ship the first commercial borrowers to treatment centers across the country during the first quarter and I'm very pleased with the launch to date and as you would expect MSK is our largest customer at this stage, but with the continued addition of new sites using DANYELZA during second quarter, we expect that in the third quarter almost 50% of the virus will be sold to other cancer treatment centers across the US.

Our commercial and medical affairs organization has done an outstanding job educating physicians and nurses about DANYELZA and many Treatment Centers have now had their first experience with DANYELZA. Our understanding is that these treatments have generally gone very well.

In front-line updated clinical data for DANYELZA and GMC SF from the consolidation of high-risk neuroblastoma patients in complete remission was presented at the American Society of Clinical Oncology, also known as ASCO Annual Meeting in June 2021.

Patient received five cycles of DANYELZA and GMC SF in a compassionate use setting for consolidation of high-risk neuroblastoma in first or subsequent CR. The three-year event-free survival for patients in first CR was 74% and 19% for second or latest CRs.

The three-year overall survival for patients in first CR was 92% and 66% per second or latest CRs. Two-year event-free survival and overall survival was previously presented at our R&D Day in December 2020 and those data points are now poised for the three-year follow-up.

I'm very pleased to see how well both duration of response and survival rates seem to be holding up. Our ongoing clinical trials for DANYELZA in Barcelona, Spain, and MSK in New York City for the first-line neuroblastoma maintenance treatment as well as chemo combination trials for refractory in neuroblastoma patients are all progressing nicely.

We are working to initiate international Phase II multicenter trials for both frontline and chemo combination treatments and we also have a Phase II osteosarcoma trial ongoing.

Now, turning to omburtamab on June 1, we had another Type B meeting with the FDA to discuss the route towards resubmission of the BLA for omburtamab for the treatment of pediatric patients with CNS leptomeningeal metastasis from neuroblastoma.

We are maintaining a very close and open dialog with the FDA regarding the resubmission and hope to reach a final agreement with the agency for the remaining details shortly. We aim to resubmit the omburtamab BLA in the form of a rolling BLA by the end of this year.

If approved, we strongly believe that Omburtamab will represent a very significant advancement in the treatment landscape for CNS metastasis when no standard therapy exists today. The European marketing application * for omburtamab was prepared in parallel with the US BLA and was submitted to EMA in April of this year.

The evaluation of our application is expected to take 210 days plus potential clock stop addition of days.

In addition, interim Phase I dose escalation data for omburtamab for diffuse intrinsic pontine Glioma known as DIPG US presented at ASCO in June and showed that dosing of omburtamab radiolabeled with eight milligri of Iodine-124 appear to be well tolerated and proved distribution volume to potentially cover tumor volumes of up to 200-cubic centimeters.

The median or survival of all 46 patients in the dose-escalation study increased by three to four months as compared to the historical control group. The study will continue dose escalation for both infused volume and dose. We are excited to share these results that significantly broaden the potential reach of omburtamab.

The results have also paved the way for our multi-center Phase II study in DIPG later this year, where we expect to administer up to treat repeated doses of omburtamab and thereby further hopefully improve efficacy.

As previously discussed, we are also developing omburtamab Desmoplastic Small Round Cell Tumors known as DSRCT, and we have a Phase II study ongoing at MSK. The FDA has also cleared our IND for 177 lutetium omburtamab DTPA for the treatment of medulloblastoma which is the most common type of primary brain cancer in children.

Our international multi fits in the Phase I, II clinical trial is now open for pediatric patients with medulloblastoma and the study is based on our clinical experience from treating 27 medulloblastoma patients with the Iodine-131 omburtamab construct.

We are obviously excited to see 177-lutetium omburtamab DTPA make its way into the clinic to establish the safety profile and to determine the maximum tolerated dose. In this study, known as study 301, we hope to leverage our prior clinical experience with Iodine-131 omburtamab and we will once again be giving the infusion to in Ommaya reservoir.

It is also notable that in June, the Committee for Orphan Medicinal Products also called COMP of the European Medicines Agency has recommended an orphan drug designation in the EU for 177 utetium omburtamab DTPA for the treatment of medulloblastoma.

In addition, our basket trial in B7-H3 positive CNS leptomeningeal cancers in adult patients known as Study 3 or 2, while we hope to leverage our prior experience from treating more than 25 adults with B7-H3 positive brain metastasis with Iodine-131 omburtamab is now also open for the first adult patients to be screened and treated with 177-lutetium omburtamab DTPA.

We are thrilled to widen our clinical reach to include adult patients also now and then turning to the Y-BiClone, we have expanded nivatrotamab's clinical reach to include small cell lung cancer patients in our Phase II study with subcutaneous administration of the bispecific antibody.

We also plan to expand our ongoing study of nivatrotamab at MSK into two separate Phase II studies, one arm in neuroblastoma and another in osteosarcoma.

In addition as planned during the second quarter, we submitted an IND for the next in-line bispecific antibody in the CD-33 bispecific generated under Y-BiClone platform during the quarter as we had planned. We hope to open the study for pediatric AML patients within the next six to nine months.

Turning to our SADA technology as you know, we are very excited about the prospect for this technology and we are making good progress. We are preparing our four disclosed [ph] for clinical development. The first our IND is expected to be against GD2.

We expect to file this IND in the fourth quarter of this year and we have recently received what we believe to be positive feedback on our pre-IND package from the FDA.

In addition at American Association for Cancer Research AACR in the conference in April, we reported that Pretargeted Radioimmunotherapy against GPA33 in a xenograft model for colon cancer had shown, a tumor to blood ratio, radioactivity uptake of 122 measure 24 hours after injection. GPA33 is expressed on 95% of all colorectal cancers.

And in IND for GPA33 SADA is targeted for the end of next year. Our other publicly announced targets includes B7-H3-SADA intended for the treatment of prostate cancer and HER2-SADA for potential use in breast cancer.

We believe the SADA technology can potentially improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents and we are truly excited about this platform.

Looking at some more general aspects, we believe that we are well poised to continue to grow Y-mAbs as a commercial-stage company with any - also already being shipped to multiple centers across the country and significant international progress being made on the DANYELZA franchise, this promising even better than we had hope for.

From omburtamab the pass to resubmission of omburtamab PLD - Omburtamab BLA is much clearer after our recent meeting with the FDA and we now have an understanding of the deliverables that are required by the FDA prior to initiating the resubmission.

At the same time, we are widening and deepening our pipeline by advancing our antibody construct through the clinic, predominantly the SADA constructs the bi-specifics and the next generation omburtamab DTPA radiolabeled antibodies.

In other words, we remain busy and we are very excited to move forward to build a commercial business that helps patients and further elevates our continued development. Now, let me invite Bo to share his remarks on this quarter - for this for financials..

Thank you, Claus. We reported net revenues of $11 million for the quarter ended June 30, 2021, representing DANYELZA sales of $9 million and license revenues of $2 million. There were no revenues recorded in the quarter ended June 30, 2020.

As we take a closer look at the operating expenses for the second quarter of 2021, we know that research and development expenses decreased by $10.3 million from $30.1 million for the quarter ended June 30, 2020 to $19.8 million for the quarter ended June 30, 2021.

This decrease was primarily attributable to a $13.1 million decrease in milestone payments and license acquisition cost patients with the SADA license agreements, which were incurred in the second quarter of 2020.

Selling general and administrative expenses increased by $3.1 million from $10.4 million for the quarter ended June 30, 2020, to $13.5 million for the quarter ended June 30, 2021.

The increase in selling general and administrative expenses primarily reflects a $3.1 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation for personnel related to the launch and commercialization of DANYELZA.

We reported a net loss for the quarter ended June 30, 2021 of $22.9 million and this corresponds to a $0.53 per share basic and diluted compared to a net loss of $40.4 million or $1.01 per share basic and diluted for the quarter ended June 30, 2020.

We ended the second quarter with a cash position of $233.6 million compared to $114.6 million at year-end 2020. The increase reflects the proceeds from the sale of our DANYELZA Priority Review Voucher in January, where we need $62 million, up 40% of the net proceeds from the sale license agreement with MSK.

Our June 30 cash balance also reflect $107.7 million net proceeds raised in our public offering in February 2021, partially offset by the net cash used in operational activities of $50.6 million for the six months ended June 30, 2021. We continue to believe Y-mAbs remain in a very healthy financial position. This concludes the financial update.

And I'll now turn the call over to Thomas..

Thank you, Bo. This marks the end of our prepared remarks for today. And I'd like to open up the call for Q&A right now. Thank you..

Thank you. [Operator Instructions] The first question comes from Alec Stranahan with Bank of America. Please go ahead..

Hey guys, thanks for taking our questions. Just a couple on DANYELZA from us.

First, when you look at ways to grow market share in neuroblastoma I guess at this point, how much is adding new treatment centers versus shifting patients over from DANYELZA that would have otherwise got unit toxin sort of your focus at this point? And how much do you think positive chemo combo data could feed into uptake in the relapsed refractory setting? And then my second question, I believe you mentioned that we could see osteosarcoma data at a conference in the fall.

So, if you could just help us frame the extent of data and ballpark on sample size, we should expect that in the update, that'd be great. Thanks..

Thanks, Alec. Well, I mean, it's too early to say anything about what kind of market share we are taking into, but it's pretty clear to us that - of course at MSK they are doing, as they've been doing all along, where we develop this using it and numerous lines of treatment of neuroblastoma patients.

But I think what we are seeing is on the new sites that have previously been using Dinutuximab.

They are primarily using it for patients where they have tried Dinutuximab eventually Dinutuximab in combination with chemotherapy, which is the most common and not achieved sufficient response in the patients and then some sites have also started using it in the primary refractory, secondary relapsed patients.

So, but the most of that treatment we are seeing on this side is kind of like - that's - but also typically happens when you have a new product entering the market. So, there is definitely lots of space for additional growth. And we continue to see very high levels of interest.

Also I can say that our EMA sales, and our research nurses, and our sales teams have had hundreds and hundreds of meetings with, and interactions with both physicians and other hospital professionals at sites outside of MSK. So, we continue to see a strong interest in understanding how to use DANYELZA besides.

Your last question about the eventual presentation of osteosarcoma data. I think it's most likely that you will be seeing the data presented at all our R&D Day in December, but it's, - I think it's too early yet because study is still missing one patient for recruitment and then we can do the analysis afterwards.

I think was that the answer to your questions?.

Yes. Yes, that's perfect. And if I could just allow another one in..

Sure..

Could you maybe talk about - from omburtamab? Your go-to-market strategy in the EU, assuming approval comes I guess later this year or early next?.

Yes. It's more likely since we submitted in April, 210 days. I know that it has been normal easy calculation seven months that would take us to November, but then you have this clock stop situation. So, most likely EMA will come back to us in September with a bunch of questions up their qualified review of the file.

And then, we will be probably spending somewhere between 30 and 90 days depending on how detailed questions they have.

On putting together the responses and then the clock stops while we are putting together this, then the clock starts again when we have submitted the responses then if they have additional questions to that responses then the clock stops again.

So, although it's called a 210 day review period, its means that - that's in an ideal situation without any clock stop. But having said that, I think it's highly likely that we would be on the market in second quarter next year pending approval.

And we are already now in the process of building up a European organization that can handle the sales and distribution of omburtamab in Europe.

Was that answering your question?.

That's perfect. Thank you..

Thank you. Have a nice day, Alec..

The next question comes from David Lebowitz with Morgan Stanley. Please go ahead..

Thank you very much for taking my question. First on DANYELZA in the quarter, you seem to say that next quarter MSK would be about 50% of sales.

I'm just curious as to, is that kind of the run rate we should expect from MSK going forward as a contributor? It seems that there has been upper limit from one hospital as far as how much it can contribute to sales. That's my first question..

Yes.

Absolutely, I understand the question, I mean that I don't think MSK is going to be much bigger than we are now, where we would see the growth is from outside MSK and then where we are also continuing to add new centers basically every month new centers are joining and working with them we can see several of the sites that started using Omburtamab, naxitamab at DANYELZA early on have treated more than one patients.

I think the highest numbers up to six patients outside MSK. So, definitely the growth will come from outside MSK..

That's helpful. And with respect to the omburtamab submission given that the FDA has already substantial parts of the submission before.

What do you anticipate to review process would be like this time? Would they ultimately leave the full six-month review period or could it be more abbreviated given that they have probably seen a lot of the data in the past?.

I tend to agree with you that most likely it will be abbreviated. But I think it's highly likely, - it's unlikely they will not give us the traditional eight-months fast track review PDUFA date. But most likely they will be able to approve before the end of that eight-month period.

But let's see how it goes when we get it submitted, but we definitely hope and expect to be on the market next year with omburtamab in the US also..

Thank you. Thank you for taking my questions..

Thank you, David..

The next question comes from Robert Burns with HC Wainwright. Please go ahead..

Hey, guys. Thanks for taking my questions and congrats on all the progress. Just two from me if I may. First CSR, you stated in your prepared remarks that DANYELZA has been shipped roughly 20 centers as of today.

I was just curious as we think about the rest of this year, what are you thinking about from an internal metrics sort of benchmark? Where do you think you'll be able to get to by year-end with regards to the number of centers actually prescribing DANYELZA? And then my second question; so, I know that there's going to be a subsequent Type B meeting with the FDA this quarter.

I was just curious whether there are any other points of alignment that you're seeking with the FDA or to move forward with that rolling submission.

And if so, what were those points that you are still seeking alignment on?.

Well, to finish off the first one, the last one first. I think we have everything aligned, the FDA has asked us to prepare some analysis and then will be discussing those data points and how we are doing them and the update is statistical analysis plan. And I think we should then be ready to resubmit.

So, but then they would ask us to have a formal pre-BLA meeting and to take it and most likely it can even be written response to that. So, I think we are not expecting any additional alignment except for making sure that we have understood precisely what the FDA asked us. And they want to make sure that we understood that.

So, - but I think we are pretty much on track with that. In terms of additional sites, I mean, I think it's, - as I previously said, there is about 160 sites in the US that on a more regular basis of on rare location treats patients with neuroblastoma.

And I think if we can penetrate into of these sites, especially if we can penetrate into some of the more important ones that the biggest sites in the first year. I think we have done a pretty nice job and I think, we hopefully can see a bit more acceleration in that.

But until now, I would have to say that I'm very pleased to see that we have managed to get, almost 20 sites in addition to MSK to start using the product. I think it's been a very positive uptake.

And - you know in the beginning, there were some concerns that many doctors will say we have what we need with dinutuximab, but that's definitely United to this change in many places. And also that it seems that the sites are better than we had been concerned about them - they have been concerned about themselves to actually use DANYELZA.

That it is not as complicated as somebody might have tried to convince them it was to use DANYELZA. So, I think it would be a very positive about the continued development..

Awesome. Thanks for the clarity, Claus. Congrats, again..

Thanks a lot..

The next question comes from Joseph Thome with Cowen & Company. Please go ahead..

Good morning. and thank you for taking my questions. If you - just the first one on the omburtamab re-submission.

Are you able to provide just maybe a little bit more context around kind of what the additional detailed data the agency requested, sort of after the last meeting ahead of the next Type B? And then end of the rolling BLA submission is targeted to begin at the end of this year.

Are there additional modules that we need to be resubmitted next year to sort of complete the submission? And then, I have a follow-up on DANYELZA as well..

Well, I think it's too early now to say when we will be able to finalize the clinical study report based on the statistical analysis plan that we hopefully get a green light from the FDA on at this meet - upcoming meeting.

But having said that, it was pretty clear that the FDA wanted to make sure that the analysis what we compare the data from Study 133 or 0133 with the data from the historical control groups that dose to patient cohorts were made comparable.

And we are using what's called a synthetic control arm after having discussed this forward and backward with the FDA. So, we are putting that together and that data set we have agreed with the FDA about also how to generate the synthetic control arm based on the available historical patient data.

So, that's what has been going on and we are building that database or actually, we have done it and the whole dataset will be submitted and results to the FDA very shortly. So, I think that's as far as we can get it now. When it comes to, when we will be having everything ready for completing the rolling resubmission.

I think we will take that when we have had the pre-BLA agreement in place with the FDA..

Okay, perfect.

And then, just in terms of DANYELZA in new centers, can you give a little more information around how these new sites roll on? Do they take sort of an initial pilot dose and then choose to expand it more broadly to sort of their individual center? Or is it sort of ordering pattern increase on kind of the individual patients?.

Yes. What's presently is happening and that's happening for all sites. Is that they typically if they have a patient and they screened the patient find out, they want to put the patients on DANYELZA, then the treatment would be Monday, Wednesday and Friday for the first treatment cycle. So, they would order drug for those three treatments.

And then, if the patient does well and they want to continue then four weeks after the first cycle, then they start the second ones they will order then, so they have product for the next one. Nobody orders for five cycles and then leaves it and we can see that also.

So, that's why I mean we receive orders almost than a weekly basis from MSK and we receive orders from most of the other sites that are treating more patients also on a weekly or biweekly basis. So, I think that's how also adds do because it's an expensive therapy.

So, if you buy six and - also if they buy and you only end up spending six of them and you pay $20,000 per [indiscernible]. And then, you have a pretty expensive inventory..

Yes, that makes a lot of sense. Great, thank you very much..

Thanks..

The next question comes from Etzer Darout with Guggenheim Securities. Please go ahead..

Great. Thanks for taking my question. Just one question for me on DANYELZA. So, recall sort of conversations around increasing engagement with the FDA on the front line setting as at post-launch and is with a couple of quarters under your belt, just wondered if you have initiated those conversations.

Or if not, when do you plan to start to have dialog and sort of buy-in if you will into sort of the plans for our frontline setting for put on the other? Thanks..

I think, I've been saying before that we expect to do that in the beginning of next year. We are waiting for the MSK closed in the first quarter of this year, their frontline study. And then, we need some follow-up on the last patients in that frontline study with naxitamab.

So, when we have those data towards the end of this year together with the dataset with three years follow-up from Dr. Mora study, I think we have sufficient material to approach the FDA early next year and have the discussion on what additional data could eventually be necessary if we wanted to a supplementary BLA approval.

So, we are continuing to collect the data from the MSK study and then together with the data from Dr. Mora study as I think we have a nice dataset to discuss with the agency..

Got it. Thank you. Congrats on the progress..

Thank you, Etzer..

The next question comes from David Nierengarten with Wedbush Securities. Please go ahead..

Thanks for taking my question. I have a couple. First on DANYELZA, it is part of the appeal or we've talked in the past about part of the appeal being maybe less of a required metric for a patient to a larger center for treatment and things like that.

So, is that part of this kind of the right word to diffusion into or they diffusion in the smaller centers, diffusion into use in centers that would otherwise be referring to MSK? I'm just kind of curious if part of the selling point here is that, and that's part of the strength in the prescriptions.

And then, on lutetium on the DTPA Omburtamab; I think you commented that the - you expected the first patient and in Q3 this quarter, the IND was submitted a few months a while late year, part of that gap getting sites signed up for kind of or trying to find qualified patients.

I'm just curious why it's taken may be off the time - why it is taking a little bit of time there? And if we could expect for enrollment trends so going forward? Thanks..

Sure. I mean I think for the DANYELZA, what we are seeing is that definitely sites that might not have treated patients in the past with just refer them can now because it is an easier to handle product treat patients with DANYELZA.

But I also think that's actually driving some of the bigger sizes that could have been showing more resistance to what's moving from what they have been heavily involved in developing themselves Dinutuximab to move towards being open to actually treat with Danyelza because some parents and simply will state it, but then we go to another site that actually will be using DANYELZA.

We want to have treatment as an outpatient treatment. We want to have this new antibody approved by the FDA. So, but I think that's helping to open up. But again, that it's very limited knowledge we have until now and we are still learning every day. But in the very positive that we have been seeing until now.

Also, that some of the bigger COD sites have started using Naxitamab. In terms of the starting of recruitment of patients with omburtamab DTPA, Lutetium-177, it has taken a while to get through all the approval processes in the institutions.

But both studies are open for recruitment and I know they are actually be screening patients and I know that they are planning to start treating the first patients also now. So, it did take some time.

Was it caused by, I mean, everybody is blaming COVID-19 for everything, so, I'm happy to do that here also? But I think it's - that has been a little bit delayed in those settings but, but it's a complicated treatment and with the indwelling catheters and the radiolabel the lutetium we have the radiopharmacy security group involved in addition to IND at the hospital.

So, there is a long process of activities going on. So, typically from when you get an IND approved today, it is a minimum of six months before you see the first patients entering the study simply because most institutions do not want to sign a contract they may tell you that they want to work with you and do this.

But until the IND is approved and the protocol is comp and stone [ph], they're not signed into the contract earlier. So, and then it - then you need to go to IND also so things take a little time. I hope that explained.

was that answered?.

Yes, it's understandable. I was just curious if there was a particular arm factor beyond that, like again as you mentioned the radiation arm approval or if it was patient availability; but it sounds like all of the above..

Yes. No, patient availability doesn't seem to be an issue..

Okay, great. Thank you..

Thanks, David..

The next question comes from Tessa Romero with JP Morgan. Please go ahead..

Hi, guys. Good morning, and thank you for taking our question here. And so my first one is kind of around what your latest thoughts are on how we should be thinking about the accuracy of tracking with third-party vendors, such as Symphony? Should these services need over time, we expect it to be tracking DANYELZA accurately? And then I have one more..

Well, I mean I'm actually amazed that they were this close and I think they were pretty close. I think there were about 10% below our actuals.

But having said that I think based on the way they are actually collecting the data there is definitely a high risk of some uncertainty, but we are trying to find out precise to how they are collecting the information. But definitely, they did a good job this time..

Okay..

It's hard to be, but sorry, Tessa..

No problem. Thanks, Claus. That's helpful.

And then I guess my next question is just - I think we've discussed this before kind of how has reimbursement in formulary access has been going as you move into more sites and new treatment centers? And I think we've talked about, kind of 10% of use going into the frontline in this kind of what you're seeing as you're kind of moving forward here about right or how is it looking?.

Well, I think as we grow sales outside of MSK more and more sales or in the second-line and third-line setting. And I would say we actually seeing way more sales and sort of fourth-line setting than we had expected because that's where many sites would start treating patients. But having looked at reimbursement issues there is absolutely no issues.

We haven't seen any issues with reimbursement and that's been very positive..

Okay, great. Thanks for taking our questions..

Thank you very much. Have a good day, Tessa..

The next question comes from Arlinda Lee with Canaccord. Please go ahead..

Hi, guys. Thanks for taking my questions. I guess I had another one on the market.

Can - you just talked about how as states start gaining experience with this attendant go in a later line? Can you maybe talk about the 20 sites that are open right now? What proportion of the population do you think that covers? And then, the larger sites that you're most interested in what proportion of patients, do those cover and what do you think your penetration is right now? Thanks..

Well, I think it's very difficult to give anything precisely here. And as I said that initially, there is 160 sites treating patients with Neuroblastoma in the US on a more or less regular basis. 50 of those sites are treating probably 70% to 80% of all the patients.

And I would say a lot of the sites we have been shipping through is belonging to the medium-sized sites, whether there is 10 times that it really top note site and until now, I think we are in two or three of these top sites.

But a lot of it is also to get into the formulary in detail, which is more labor some in the bigger hospitals than it is in the smaller hospital. And I see that we are making good progress there also.

If the first site of the big ones starting to use it and even till that I think it's still going to ask over to Andrew announced that they had been treating, we are planning to treat their first two patients for the naxitamab and they also had an experience treating patients offset of promo, which I know for true-- for sure is true, gets a part of our osteosarcoma study.

So, I think we will see this spreading out, but it takes a little time to get on the formulary in these bigger sites and it takes a little longer than in the smaller sites..

Great. Thank you. Now, that makes sense. It's great progress. On the ex-US market, can you maybe talk a little bit about what the normal timelines are for the China market? And then I think you previously mentioned that some of the, - that this is a pretty large market.

Can you provide additional color on how they do you think the China market is? And whether that impact anyone that have been traveling to other places to get treatment? Thanks..

Yes. I would say most of the Chinese patients that we have treated have been treated at Dr. Mora site in Barcelona. I think he is up to about 100 Chinese patients that he has treated until now in the last three years, but the approval part is in China is not something where you can get a clear guidance that now you don't get a PDUFA date like we do.

But I think it's a qualified guess is that sometimes in the end of first half of next year, we should be able to get an approval in China, that's our initial expectation. Having said that initially, you will be on the Chinese market approved and you can sell without reimbursement.

Then it takes a while to get government-funded reimbursement and that could be another year so, but that also would require you to go to the crisis. But having said that, it is our estimation that the Chinese market is at least two to three times as taken in numbers of patients as the US market.

And - but it's also we are estimating that we will probably not be able to give more than about 20% to 25% of the price in the US. So, value-wise, the Chinese market is anywhere between, half of the value of the US market and up to same value of the US market.

But it's depending on where pricing and reimbursement end up, but we are definitely very excited about this. And as you can see with the most recent data from that United Therapeutics where they had sales of about $53 million in second quarter of treating with naproxen, it is estimated at about $40 million to $44 million of those sales was in the US.

That means that combined with our KOLs that we are looking right now at a $200 million US market, but the price per patient and drop cost for dinutuximab is about 40% of [indiscernible] other to be looking at in DANYELZA supply this a market that potentially could be more than $200 million per year. So, the US market in itself is interesting.

Then with the Chinese market if that turns out to be in the ballpark of a couple of hundred million also. Then we really got into some very interesting markets here; and also with - in countries covered by our Latin American partner, Techno Pharma, and this mix in Europe, Eastern Europe, and Russia.

I think we are pretty well placed for - in nice growth in the coming years..

Great. Thank you very much..

You're welcome, Arlinda..

This concludes the question-and-answer session. I would like to turn the conference back over to Thomas Gad for any closing remarks..

Thank you everyone for joining our call today, and we hope you have a great day. And look forward to speaking to you soon. Thank you. Bye..

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day..