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00:03 Good day, and welcome to the Y-mAbs Therapeutics, Inc.’s Third Quarter twenty twenty one 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 nineteen ninety five.

0:22 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 ten K for the fiscal year ended December thirty first twenty twenty as filed with the SEC on March one twenty twenty one and in the company subsequently filed SEC reports.

00:48 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..

00:55 Thank you, Hilary. And good morning, everyone, and thank you for joining us today for our third quarter earnings call. During the quarter, we made notable progress with DANYELZA and omburtamab, as well as our bispecific compounds traded under the Y-BiClone platform, and SADA platform, essentially constituting to three pillars of our business.

01:19 We had a strong twenty twenty one thus far and the resubmission of the omburtamab BLA is progressing well. We held a Type B meeting with the FDA in September during which we confirmed our path towards a pre-BLA meeting in January, potentially followed by a resubmission of that BLA.

Both DANYELZA revenues and the number of treatment centers have exceeded our internal expectation for the launch. So, we're very pleased with the initial adoption of DANYELZA. Claus Moller, will provide more details shortly.

01:53 I'm also pleased to report that we made additional progress in China this quarter, together with SciClone Pharmaceuticals our strategic partner for Mainland China, Hong Kong, and Macau.

The BLA for DANYELZA for treatment of patients relapsed and refractory high-risk neuroblastoma was accepted by to NMPA in China and subsequently granted priority review by the center for drug evaluation.

02:20 In addition it’s notable that DANYELZA has been prescribed for the first time in China and the first seven patients have received treatment in the Hainan Boao, Medical Tourism Pilot Zone. Notably, a significant number of new patients are lined up, and further SciClone plans to open up a second center in the [indiscernible] Pilot Zone.

02:44 The bispecific programs under the Y-BiClone platform continues to advance. We're now dosing patients in our Phase two small cell lung cancer study with nivatrotamab, a subcutaneous formulation.

The IND for our CD33 bispecific for pediatric AML has been submitted and this promising treatment will potentially address an important pediatric unmet need.

03:10 Our excitement over the SADA technology remains strong, as we continue to optimize the platform that potential will be able of deliver medicines to treat many cancers, and it moved closer to the clinic. We are on track to file the first IND for our GD2-SADA in the fourth quarter.

Next year, we are planning to file at least one more IND for the SADA construct. 03:34 We ended the third quarter with two fifteen million in cash.

So, we believe we have a strong balance sheet to normally support the continued commercialization of DANYELZA and the potential launch of omburtamab, but we are also advancing the Lutetium conjugated omburtamab-DTPA, and nivatrotamab into late-stage development.

03:56 At the same time, we continue to advance construct development on our Y-BiClone and SADA technology platforms. And we are actively working with both our platforms when the business development. We're very pleased with our current financial position, which Bo Kruse, our Chief Financial Officer will elaborate on later on this call.

04:16 And with that, I'm very pleased to turn it over to Claus. Thank you..

04:21 Thank you, Thomas and welcome to Y-mAbs Therapeutics’ third quarter twenty one earnings calls. We are very pleased that you have chosen to join us today. Let me start out with Naxitamab or DANYELZA.

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

04:50 We recorded DANYELZA net sales of nine million in the third quarter, which reflects a strong ten percent bio shipment growth over last quarter, offset by an impact of certain rebates reflecting a shift from both the treatment center mix and the patient mix from independent in-patient to outpatient.

We are particularly encouraged by the increase in the number of treatment centers that have gained the experience with DANYELZA. 05:17 At the end of the quarter, we had delivered twenty four centers across the nation.

We continue to be very pleased with DANYELZA, with the DANYELZA launch, while revenues look promising and the number of treatment sites are ramping up nicely. It is also notable that we have seen a more than forty percent increase in the number of vials delivered in the U.S. outside MSK compared to second quarter.

In other words, a significant increase in the business across the country. 05:47 The overall number of vials shipped in the U.S. increased as mentioned with approximately ten percent in the third quarter versus second quarter, and our gross revenue reflected that one to one.

We did however see a ship towards more patients being treated on an outpatient basis. 06:05 Some of which started as in-patient treatments in their first cycles, but then thereby becoming subject to available rebates as outpatient from the public health system or PHS.

This shift together with a significant increased share of vials being sold outside MSK has had an impact on the gross to net calculation, and this impacted reported growth in net revenues for the third quarter.

06:32 Going forward, I believe the increase in the gross to net calculation related to the PHS, eligible hospitals will subside, but the mix shift in favor of non-MSK institution is expected to continue into twenty twenty two as more and more centers outside MSK learn about and start prescribing DANYELZA.

06:53 We are very pleased to see DANYELZA get substantial traction in the market at this point. It is also notable that we are now seeing commercial uses at DANYELZA in early access programs in China, MENA, and LatAm.

Royalty income is obviously still very modest, but we have high hopes for future growth and are putting significant effort into expansion into additional international markets. 07:18 We recently held a key opinion leader webinar that included a detailed review of data from DANYELZA in first line, as well as HITS Data.

HITS refers to chemo immunotherapy for resistant high-risk neuroblastoma where DANYELZA is given in a combination treatment often referred to as HITS consisting of DANYELZA. Actually, humanized naxitamab, and thereby the 3F8, Irinotecan, Temozolomide and Sargramostim.

07:48 The key opinion leaders, as well as other medical doctors in the field appreciate the solid data that formed the basis for the FDA approval and the convenience of being able to offer an outpatient treatment, which brings new degrees of freedom to the table as opposed to watching the patient nonstop in the ICU day-in and day-out.

I'm very pleased with our commercial and medical affairs organization, whom has done an outstanding job of educating physicians and nurses about DANYELZA and guiding the many new treatment centers through their very first experience with DANYELZA during the quarter.

08:21 Our ongoing clinical trials for DANYELZA and Barcelona, Spain and MSK in New York for first line neuroblastoma maintenance treatment, as well as chemo combination trials for refractory and omburtamab patients are progressing nicely.

We are still in the process of initiating an international Phase II multicenter frontline trial and our multicenter chemo combination trial will start screening patients from next week. We also have a Phase II osteosarcoma trial ongoing.

08:50 Now, turning to omburtamab for the treatment of pediatric patients with CNS leptomeningeal metastases from neuroblastoma. Based on feedback from the FDA at a Type B meeting in September, where we provided the FDA with additional detailed data and statistical analysis plan.

09:08 We have recently requested a pre-BLA meeting, pending a positive pre-BLA meeting in January, we aim to initiate a resubmission of the omburtamab BLA shortly after the meeting, and we believe we are positioned to complete the submission during the course of first quarter twenty twenty two, potentially allowing for FDA approval of omburtamab in the first quarter of twenty twenty two.

09:31 Needless us to say, we are very pleased to be aligned with the FDA on next steps and believe that if approved omburtamab will be a significant benefit patients with CNS/leptomeningeal metastasis from neuroblastoma who are currently facing a major unmet medical need.

09:47 The European marketing application for omburtamab was prepared in parallel with the US-BLA and was submitted to EMA in April of this year. Preliminary feedback from EMA was received back in September and we are in the process of responding to questions raised by that agency. We believe the evaluation of our application is progressing as planned.

10:08 Furthermore, our interim Phase I dose escalation data for omburtamab for Diffuse Intrinsic Pontine Glioma or DIPG has paved the way for our multicenter Phase II study known as Study 101 for which we have filed in IND recently. We expect to administer up to three repeated doses of omburtamab in that study.

10:29 Now, turning to the lutetium labeled omburtamab. Our IND for 177 lutetium omburtamab need to pay for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children is now open and the first patient have been treated.

This multicenter Phase I/II trial is based on our clinical experience from treating medulloblastoma patients with Iodine-131 omburtamab and we are obviously excited to see 177Lu-omburtamab-DTPA make its way into the clinic to establish the safety profile and determine the maximum tolerated dose.

11:04 The FDA has granted us Rare Pediatric Disease Designation for the lutetium labeled omburtamab antibody program for the treatment of medulloblastoma, which makes us eligible for a priority review voucher, upon potential approval of the BLA for this rare pediatric cancer.

Among our leading compounds under development, four have now Rare Pediatric Disease Designation and this designation for 177Lu-omburtamab-DTPA further increases our chances of ultimately receiving multiple PREs.

11:37 In addition, we have opened the basket trial in B7-H3 positive CNS leptomeningeal cancers in adults where we hope to leverage our prior experience from treating adults with B7-H3 positive brain metastasis with Iodine-131 omburtamab.

The study has started screening patients and we hope to see the first adult patients treated with 177Lu-omburtamab-DTPA in late November. 12:03 We are thrilled to widen our clinical reach to include adult indications for the lutetium 177 omburtamab also.

Our Y-BiClone constructs, a new generation of T-cell engaging bispecific antibodies that may potentially destroy tumor cells by recruitment of host T cells. 12:23 The Y-BiClone formats contains two binding arms for the tumor target and two binding arms for the T cells.

The BiClone format was designed to have minimal binding affinity necessary to recruit T cells. We have expanded nivatrotamab’s clinical trial to include small cell lung cancer patients in our Phase two study with the subcutaneous administration and the study is now recruiting patients.

12:49 We also plan to expand the ongoing study of nivatrotamab at MSK into two separate Phase II arms one in neuroblastoma and one in osteosarcoma.

We have submitted an IND for our next in-line bispecific antibody, the CD33 bispecific generated on the Y-BiClone platform, and we have already experienced significant interest from multiple clinical sites to participate in this study. We hope to open this study for Pediatric AML patients within the next three to six months.

13:19 Turning to our SADA Technology, as you know, we are very excited about the prospect of this technology and we are making good progress. We are preparing a handful of SADA targets for clinical development. And as previously announced, the first SADA IND is expected to be against CD2 and plant for filing in December this year.

13:39 We are seeing significant partnership interest for the SADA technology and we are positioned to leverage the SADA platform in the coming months.

We believe the SADA technology has already shown great potential and that it can potentially improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents. We are truly excited about this platform. 14:04 Thus, let me finish off with some more general comments.

We believe we are well positioned to grow Y-mAbs as a commercial stage company, with DANYELZA already being shipped to multiple treatment centers across the country and significant international progress being made, the DANYELZA franchise is progressing even better than we had hoped for.

14:23 For omburtamab, the resubmission of the BLA is inside and the pre-BLA meeting has been requested. At the same time, we are widening and deepening our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the bispecifics, and the next generation of omburtamab radiolabeled antibodies.

14:44 In other words, we remain busy and we very excited to move forward to build the commercial business that helps patients and further elevates our continued development. 14:54 Now, let me invite Bo to share his remarks on this quarters financials. Thanks..

15:00 Thank you, Claus. We reported DANYELZA net revenue of nine million for the quarter ended September thirty, twenty twenty one. There were no revenues reported in the quarter ended September thirty, twenty twenty.

As we take a closer look at the operating expenses for the third quarter of twenty twenty one, we note that research and development expenses increased by two point one million from twenty one million for the quarter ended September thirty, twenty twenty to twenty three point one million for the quarter ended September thirty, twenty twenty one.

15:36 This increase was primarily attributable to a one point nine million dollar increase in clinical trial expenses and one point eight million increase in employee related costs, including salary, benefits and non-cash stock based compensation for personnel related to our expanding workforce.

These increases were partially offset by a one point four million dollar increase or decrease in outsourced manufacturing costs.

16:04 Selling, general and administrative expenses increased by two point four million from eleven point six million for the quarter ended December thirty, twenty twenty to fourteen million for the quarter ended September thirty, twenty twenty one.

The increase in selling, general and administrative expenses, primarily reflected two point one million dollar increase in employee related costs, including salary, benefits and non-cash stock based compensation for personnel related to the launch and commercialization of DANYELZA.

16:37 We reported a net loss for the quarter ended September thirty, twenty twenty one of twenty eight point nine million.

This corresponds to zero point six six dollars per share, basic and diluted, compared to a net loss of thirty two point eight million or zero point eight two dollars per share basic and diluted for the quarter ended September thirty, twenty twenty. The decrease in net loss was primarily driven by the DANYELZA revenues.

17:04 We ended the third quarter with a cash position of two hundred and fifteen point seven million compared to one hundred and fourteen point six million at year end twenty twenty.

The increase reflects proceeds from the sale of our DANYELZA product review voucher in January twenty twenty one where we netted sixty two million after sharing forty percent of the net proceeds from the sale with MSK as per our license agreement.

17:29 Our September thirty cash balance also reflect one hundred and seven point seven million dollars net proceeds raised in our public offering in February twenty twenty one, partially offset by the net cash used in operational activities of sixty point seven million for the nine months ended September thirty, twenty twenty one.

We continue to believe Y-mAbs remains in a healthy financial position. 17:56 Now, this concludes the financial update, and I'll now turn the call over to Thomas..

18:03 Okay. Thank you, very much, Bo. This marks the end of today's prepared remarks.

And at this time, I like to … You can’t hear me? Hello? Hello?.

18:19 Thomas, I can hear you fine..

18:24 Okay. Thank you, Bo. This marks the end of today’s remarks..

18:31 Bo, can you hear us?.

18:34 I think Bo, you need to mute. Well, I can hear you operator. So, we are going to open up the call for Q and A. Claus and Bo can you hear us? Okay. Thank you very much, Bo. This marks the end of today's prepared remarks. At this time, I would like to open the call up for questions.

Let's open the line now and perhaps I can ask the operator to remind you that the procedures – what the procedures are for submitting your questions. Thanks..

19:07 [Operator Instructions] Our first question is from Alec Stranahan of Bank of America. Please proceed with your question..

19:38 Hey guys. Thanks for taking our questions. So, two from me, both just trying to get a temperature on the DANYELZA launch.

So, I guess, could you speak to the timing of when patient started therapy in 3Q? Was it fairly evenly spread or was it more weighted to either at the beginning or the end? And is it possible that we'll see many of those patients carrying over into 4Q as well? And I guess of the patients that started therapy in 1Q in 2Q, how many completed therapy at this point and were there any, I guess discontinuations from treatment? Operator?.

20:25 Bo and Claus, can you hear us? Thomas, can you hear me?.

20:38 Yeah. We're going to try to redial and there's a problem with the lines..

20:42 Okay. [Operator Instructions] Hey, ladies and gentlemen, we are back. One moment while I reopen the question queue. Okay. All right. Our first question was from Alec Stranahan of Bank of America..

21:48 Hey, guys.

Can you hear me?.

21:51 Yeah, absolutely..

21:53 Perfect. Perfect. So, just trying to get a temperature on the DANYELZA launch.

I guess could you just speak to sort of the timing of when patients started therapy in 3Q, was it fairly evenly spread across the quarter? Was it more sort of weighted in the beginning or the end? And I guess of the patients that started therapy in 1Q or I guess mostly 2Q, how many have completed therapy at this point and where there any discontinuations? And I have a follow-up?.

22:27 Well, I mean, obviously, new sites, outside MSK, many of the first patient they try out is not primary or secondary refractory patients, but typically patients that have received chemotherapy in combination with dinutuximab and are still not coming into remission.

And many of these patients do not complete more than two or three cycles of DANYELZA. But as we see more and more sites retreating or treating new patients, we also see these sites starting to treat patients that are actually through primary secondary refractory patients.

23:06 As I said also, what we can see is that these patients after the first cycle where they often do it as in-patients treatment when they realize the patients are actually capable of moving out of the hospital the same day they received the treatment, a few hours later than they start converting to outpatient, but additional details on the distribution of type patients.

I think it's a bit too early to start giving out..

23:41 Okay. Okay. But would you say that, I guess most of the patients were sort of spread across the quarter in terms of treatment or maybe like a bolus towards the end of the quarter? That could….

23:53 Oh, it was pretty evenly spread around throughout the quarter. Yeah. No, it's….

24:03 Okay. And then my second question ….

24:08 July as a summer month was maybe a little bit more silent than August, September. It can also be reflecting other things..

24:20 Okay. That's helpful.

And then I guess looking to next year, how big a role do you see the EU and China playing into expanding the market for DANYELZA? And I guess, do you have any comments around your approach to the launch in the geographies?.

24:36 Well EU is probably going to be just early access programs for next year. China, we have quite good expectations for we see a very significant interest in China.

And as we previously have said, we expect based on the regulatory feedback that we have received that we could get a Chinese approval late first quarter or during the beginning of second quarter next year in China, which means that in second quarter, we could come to the Chinese market with DANYELZA and start expanding it.

And as Thomas mentioned, we are already treating commercial patients in China in some of these research areas where it's allowed to treat with products that are approved in EU or the U.S. 25:29 So, we have quite big expectations. So, it's a lot of patients that are available for treatment out there and need the treatment..

25:41 Thank you..

25:46 Our next question is from Joseph Thome of Cowen. Please proceed with your question..

25:52 Hi there. Good morning and thank you for taking the questions.

Maybe just a first one, in terms of bringing new centers online, can you just kind of walk us through what's next necessary? Do you have to work through like a formal P and T committee to get approval before bringing a new center [Technical Difficulty] and is that easing at all? And then maybe the second point on the SADA Technology, you indicated seeing significant partner interest, if you could just kind of qualify what you [indiscernible] geographic partner is this a combo partner or would you be put into license sort of individual? Thanks..

26:29 Sure.

So, I think the challenges we are seeing on activating new sites for DANYELZA is primarily getting education of the staff and making sure that they can make the staff available for the actual treatment because it's such a quick infusion, it does take more than one person to be a close to the patient and they need somebody manage the pain side of it also.

26:58 And, but in particular making sure that the staff is trained on handling the side effects. The pharmacy buying procedures and the reimbursement set-ups, etcetera is normally not giving any major hassles and problems. So, we have not experienced any in the size where we have actually sent the product too.

So, I think it's primarily getting the education. I think the MSL team is doing a great job there. 27:27 On the SADA BD side, what we can see now is that, and what we are looking for, you know SADA is a tech platform.

It's basically like when I was with [indiscernible] when we had a fully humanized antibody technology that there's no limit to how many SADA constructs you can make. There's no limit to how many different antibodies you can make.

27:50 So, if a company outside Y-mAbs has a target where they believe that they are antibody against this target, would be fantastic to have a way to conjugate against, but are concerned about the traditional problems with these, which is that you have these circulating anybody for such a long time.

The SADA would solve that problem and we could license the rights to use that particular target in antibody with our SADA technology to that company and we could do another platform deal with another company that has different targets.

28:26 So, there's basically no limits to how many different companies we can make partnerships as long as the targets that have not been you can say taken. And technically there's no problem.

So, it's two different partners who wants to make each of their own CD-20 or CD-39, whatever you can think of as potential targets for a SADA construct, then they can do them. And that's why I'm saying that we can do multiple partnerships where the partner gets the right to develop the SADA constructs for the entire world.

29:03 So, it's not regional for that generic spend. And of course, our own SADA constructs, including the first one will be filing the IND for the GD2-SADA in December. Potentially could be available for partnering also. I think one of our partners are those that we are talking to would be interested in that.

So, there's multiple possibilities for partnerships for the SADA platform..

29:29 Perfect. That’s very helpful. Thank you very much..

29:33 Thanks, Joseph..

29:36 [Operator Instructions] Our next question is from Tessa Romero of JPMorgan. Please proceed with your question..

29:56 Hey guys. Good morning. Thanks so much for taking our question.

So, my first question is about DANYELZA, you talked about the ex-MSK volume increase, but could you just clarify what portion of sales actually came outside of MSK? And how many sites have been activated at this point? I think you've talked in the past about a forty target for the year.

I guess how are you tracking towards that target? And I have a follow-up as well..

30:34 Yeah, okay. So, first, I said, we had twenty four sites by the end of the quarter that has received DANYELZA. And during the quarter, more than forty percent of sales is now outside MSK.

Was that what you asked?.

31:04 Yes.

So, I guess as we're thinking about, as we're thinking about sort of 4Q here Claus, how are you thinking about what target site number, you might be able to hit by the end of this year? Do you think it may take a little bit longer than originally anticipated to hit that forty target?.

31:29 I think it's a little early to say whether we – I mean maybe forty sites is on the high end, but we are making a good effort to visit sites every day to reach out to doctors to meet them at conferences, but when we get to forty sites, it seems like it's a stretch, since we on average have had eight new sites if you divide the three quarters up to the twenty four.

But let's see where we end up. 31:58 I think the important thing is that we continue to see an interest in learning about DANYELZA and trying it out on patients. And I think as I said, we are early into the launch with the launch starting in February this year.

So, we are looking at the first eight months right now, and let's see what happens in the rest of the year. 32:18 I'm still very positive on what we have seen. And I think we had not anticipated to see the level of say that we have actually reached this year. So, I’m positive and I still think that this makes a huge difference for a lot of patients.

But of course, it takes time to penetrate into a market where the existing product has been on the market for four to five years and that has been in a number of clinical studies at some of the leading sites.

32:50 So, that's of course making it, you can say, yeah, a lot of hard work quality to get in and have the doctors having practical experience with the product..

33:02 Yeah. That's helpful. And then if I could squeeze just a quick follow-up.

On the frontline MSK Phase II study, what is the latest on when we could see those results presented? I think you've talked about potentially presenting them at December R&D day, so just was wondering what the latest thought was there?.

33:29 Yes, I don't think we have said anything new. I still haven't seen the data. But as we said, the last patient came into the study in February. So, it's data collection. So, we're still hoping to have data available and give an update at the R&D day in December..

33:48 Okay, great. Thanks so much for taking our questions..

33:53 Thank you..

33:57 There are no more questions at this time. We have reached the end of the question and answer session, and I will now turn the call over to Thomas Gad for closing remarks..

34:07 All right. Thank you everyone for participating in today's call and have a great weekend. Thank you. Bye-bye..

34:15 This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation and have a great day..