U.S. Markets closed

Edited Transcript of YMAB.OQ earnings conference call or presentation 14-Aug-19 8:30pm GMT

Q2 2019 Y-mAbs Therapeutics, Inc Earnings Call

NEW YORK Aug 16, 2019 (Thomson StreetEvents) -- Edited Transcript of Y-mAbs Therapeutics, Inc earnings conference call or presentation Wednesday, August 14, 2019 at 8:30:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* Thomas Gad

Y-mAbs Therapeutics, Inc. - Chairman, President, and Head of Business Development and Strategy

* Claus Moller

Y-mAbs Therapeutics, Inc. - CEO

* Bo Kruse

Y-mAbs Therapeutics, Inc. - CFO, Treasurer, and Secretary

================================================================================

Conference Call Participants

================================================================================

* Alec Stranahan

BofA Merrill Lynch - Analyst

* Boris Peaker

Cowen and Company - Analyst

* Robert Burns

H.C. Wainwright & Co. - Analyst

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Greetings and welcome to the Y-mAbs Therapeutics Inc. second-quarter 2019 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Thomas Gad, Chairman and President of Y-mAbs. Thank you, Mr. Gad. You may begin.

--------------------------------------------------------------------------------

Thomas Gad, Y-mAbs Therapeutics, Inc. - Chairman, President, and Head of Business Development and Strategy [2]

--------------------------------------------------------------------------------

Thank you, Terry. Hello, everyone, and thank you for dialing into our second-quarter earnings call. Today we will hear remarks from our Chief Executive Officer, Dr. Claus Moller, and our Chief Financial Officer, Bo Kruse.

Overall, we are very pleased with our second-quarter results. Our reported spending of $27.5 million year to date is really a direct result of our highly dedicated and productive team effort to prepare Y-mAbs to be ready to submit two BLAs in 2019.

We ended the quarter with $120 million in cash. And taking into consideration our potential approval timelines of Q3 2020 for naxitamab and omburtamab, and also taking into consideration that each product has rare pediatric disease designation from the FDA, which should entitle both products to a priority review voucher, we are very pleased with our financial position.

As a company, Y-mAbs continues to work very hard to solidify our position as a leader in pediatric oncology, focusing on rare pediatric cancers with clear unmet medical needs.

And with that, I am very pleased to give the word to Dr. Moller. Thank you.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [3]

--------------------------------------------------------------------------------

Thank you very much, Thomas, and welcome to Y-mAbs' second-quarter conference call. This is our first ever earnings call after our IPO in September last year and we are pleased that you have chosen to join us.

Since our IPO, we have worked hard to make sure that our lead product candidates, naxitamab and omburtamab, continue to advance through the clinic towards the BLA submissions, as Thomas just mentioned. We are planning to initiate this informs of rolling BLAs before the year-end for those assets. And as you previously heard, November is the target timeline for naxitamab and the following months is most likely going to be the omburtamab start.

We started Y-mAbs in April 2015. And since then, we believe that we have demonstrated a strong track record of execution and improve the ability to innovate, compete, and grow. Since our IPO, we have increased our headcount with about 65% to a total of 48 people by the end of the quarter. And we feel that we are well positioned to move naxitamab and omburtamab to approval and commercialization next year and to capitalize on the growth opportunities presented by our earlier stage pipeline.

We advanced our bispecific GD2-CD3 antibody in the clinic earlier this year and expect the IND for the omburtamab DTPA to be filed later this year. That is the antibody we are planning to radiolabel with Lutetium-177.

We have recruited all the patients in the study 201 that we need for our BLA filing for the treatment of relapsed/refractory high-risk neuroblastoma. And we also held the promising pre-BLA meeting with the US FDA. At the meeting, we reached alignment with the FDA on accelerated approval pathway for naxitamab along with a rolling BLA submission.

The Company expects to submit the clinical and safety portion and the nonclinical portion of the BLA in November 2019. For the CMC portion, the Company believes it will have sufficient data from the PPQ batches to complete the CMC portion in early 2020, most likely in February.

Under naxitamab's breakthrough therapy designation, the compound qualifies for a rolling BLA, which enables individual modules of the application to be submitted by the Company and reviewed by the FDA on a rolling basis rather than waiting for all sections to be completed before submission. The rolling application process will provide the Company with the opportunity for ongoing discussions with the Agency. And during this rolling process, the Company anticipates that it will be able to address whatever matter may be raised by the Agency during their evaluation after the filing.

At this year's ASCO conference in June, naxitamab data from 24 patients with primary refractory neuroblastoma enrolled in the study 12 through 30 was also presented. These 24 patients had bone marrow disease and all of them managed to get a complete response on a naked antibody alone.

In addition, 22 of the patients also had neuroblastoma in their bone and as shown by MIBG scans. The MIBG scans after treatment showed other parts of a complete remission in 19 of 21 patients, corresponding to 90%. So we are still seeing very nice dramatic response within these patients. 12 patients maintained progression-free survival from 2 to 56 months after enrollment with a median progression-free survival of 29 months, more than 2 years. As a reminder, naxitamab is still an outpatient treatment. In addition, recruitment of the Phase 2 frontline study in high-risk neuroblastoma patients continues as -- and progress as anticipated at MSK.

The naxitamab Phase 2 study for patients that do not respond to chemotherapy and do not respond to naxitamab, which is basically double refractory patients, is also ongoing. We call the protocol HITS; it is the combination of the humanized antibody irinotecan, temozolomide, and sargramostim, the GM-CSF.

At ASCO, we presented data from 46 heavily pretreated patients with a median age of 6.6 years and a median 2 prior relapses was presented. At enrollment, seven patients had high-risk neuroblastoma refractory to induction chemotherapy, and while 39 had prior relapses. Early responses after two cycles was documented in 39% of the patients and were evenly split between complete responses and partial responses.

Later this year, we also expect to have interim data from the Phase 2 study in naxitamab for the treatment of osteosarcoma. The data is planned to be presented at SIOP in Lyon in France in October.

With the naxitamab anti-GD2 antibody, we believe we might be well positioned to develop treatments for a range of GD2-positive cancers, including both pediatric and adult indications. In addition, as you probably have already seen, we have announced back in May a development update on our cancer vaccine program with a vaccine against GD2 and GD3 proteins.

The vaccine was originally developed also by Memorial Sloan Kettering. To date, more than 230 patients have been treated with the GD2-GD3 vaccine at MSK in New York under an MSK-sponsored IND.

And the Advances in Neuroblastoma Research conference in San Francisco in May 2018, we presented Phase 2 data for Stage IV high-risk neuroblastoma patients, in particular, a Phase 2 trial of 84 patients vaccinated with the GD2-GD3 vaccine. We saw that these patients actually had a 51% progression-free survival at 2 years and also a 90% overall survival at 2 years. And it is very well tolerated with no reported Grade 3 or Grade 4 toxicities.

Since we inlicensed the vaccine in June 2018, we have explored our options to establish commercial scale cGMP production of the vaccine. And we believe we now have a viable route forward for manufacturing and plan to begin using the newly manufactured cGMP product in the clinic at the end of this year.

Establishment of a clear development path towards approval has been our prerequisite for advancing the GD2-GD3 vaccine program and we are excited to move the program forward now. We believe the GD2-GD3 vaccine for relapsed high-risk neuroblastoma may offer meaningful improvement in long-term treatment paradigm for pediatric patients and serving as a natural add-on to the naxitamab treatment of the patient. So first, we put the patients into remission with naxitamab and then we vaccinate them to prevent them from relapsing.

Now turning on to omburtamab, our second lead compound that is also planned for BLA filing later this year. Omburtamab is a B7-H3 monoclonal antibody that is developed for use with radiolabeled Iodine-131. We are developing the compound initially for CNS/leptomeningeal metastases from neuroblastoma. The next indication will be diffuse intrinsic pontine glioma, also known as DIPG, and then also desmoplastic small round cell tumors known as DSRCT, all of which are highly B7-H3 positive tumors.

We completed the enrollment of the 18 patients with CNS/leptomeningeal metastases from neuroblastoma as needed for our filing of the BLA. And we believe that we are on target to submit the first portion of the rolling BLA to the FDA under our breakthrough therapy designation before the year end.

For DIPG, we recently shared positive interim data from the ongoing dose escalation Phase 1/2 study presented at ASCO. A total of 37 kids were treated, with 34 of them being evaluated for primary and secondary endpoints. The median age at enrollment is 6.8 years of age and there was no dose-limiting toxicities in the study. Among adverse events that were at least possibly related to the treatment, there were no Grade 4 or Grade 5 events and only four reversible Grade 3 events in four patients.

The overall survival rate at 12 months was 64.7% or 22 of the 34 patients. And we are very excited about these data, all derived from the first cohorts of the DIPG study. As a reminder, historical median survival from diagnosis in these patients are 9 to 11 months with only 10% of the children surviving for 2 years following their diagnosis and less than 1% for 5 years. And we are looking at a 15% median survival in the dose escalation study already.

In the field of bispecifics, our GD2-CD3 bispecific antibody entered clinical testing early this year in a Phase 1 study at MSK. And the dose escalation part of the study is progressing as planned. We expect to have an update on this trial towards the end of the year or beginning of next year, depending on how the continued dose escalation is going.

We expect the next bispecific antibody we are working on to be our CD33 CD3 antibody and expect that to enter clinical development during 2020 for the potential use, of course, CD33-positive hematological cancers.

We have received rare pediatric disease designations, one for each of naxitamab and omburtamab, which entitles us to a priority review voucher upon FDA approval of our products, assuming the drugs are approved before October 1, 2022, where the program currently is scheduled to expire. The term of our MSK license provides that MSK is entitled to receive 40% of the income generated from the sale, and therefore Y-mAbs 60%. And for the second PRV, they will get 33% and Y-mAbs will get the remaining 66.6% from the sale of the PRV.

So with this, I would now invite Bo to share his remarks on the second-quarter financials. Bo?

--------------------------------------------------------------------------------

Bo Kruse, Y-mAbs Therapeutics, Inc. - CFO, Treasurer, and Secretary [4]

--------------------------------------------------------------------------------

Thank you, Claus. For the second quarter, we report a cash spending of $14.1 million, corresponding to a 4% increase in our spending compared to the first quarter this year, which means that we ended the second quarter with a cash position of $120 million.

As our work on the BLA submissions for naxitamab and omburtamab progresses, and the commercial ramp-up for the potential launch of the two lead compounds accelerates, we are seeing that the [rent] will increase. And we expect an additional increase in the second half of 2019.

R&D expenses increased by $6.2 million from $8.3 million for the three months ended June 30, 2018, to $14.5 million for the three months ended June 30, 2019, which was primarily due to a $2.9 million increase in manufacturing expenses from naxitamab and omburtamab.

In addition, expenses for outsourced research and supplies increased by $2.2 million for the three months ended June 30, 2019, due to our increased need for clinical trial support, with clinical expenses increased by $1.2 million for the three months ended June 30, 2019, due to an increased labor [chemical] activities.

G&A expenses increased by $2.1 million from $2 million for the three months ended June 30, 2018, to $4.1 million for the three months ended June 30, 2019. The increase in G&A expenses was primarily attributable to a $1.4 million increase in employee-related cost, including salaries, benefits, and non-cash stock-based compensation for personnel related to our business activities.

In addition, costs for setting up commercial infrastructure increased by $0.5 million for the three months ended June 30, 2019. The increase in G&A expenses overall primarily relates to the infrastructure and administrative cost of being a public company.

In total, the net loss increased by $7.7 million from $10.3 million for the three months ended June 30, 2018 to $18 million for the three months ended June 30, 2019. For the six months ended June 30, the net loss increased by $16.2 million to $34 million compared to $17.8 million for the corresponding period in 2018.

The cash flows for the first half of 2019 show that the cash burn increased by $7.4 million from $20.3 million for the six months ended June 30, 2018, to $27.7 million for the six months ended June 30, 2019. The increase in net cash used in operations was primarily due to an increase of $10.3 million in our net loss for the six months ended June 30, 2019, partly offset by stock-based compensation to employees, which increased by $0.7 million.

In terms of financial guidance, we have said consistently since the IPO that the net proceeds would cover our operating activities and capital expenditures through the fourth quarter of 2020. Now, this number does not take into account the potential proceeds from monetization of the PRV, which Claus mentioned, revenues from commercialization of naxitamab and omburtamab, all the proceeds from any potential partnerships that we may enter in the future. So we do believe Y-mAbs remain in a healthy financial position.

Now this concludes my financial update and I will now turn the call over to Thomas.

--------------------------------------------------------------------------------

Thomas Gad, Y-mAbs Therapeutics, Inc. - Chairman, President, and Head of Business Development and Strategy [5]

--------------------------------------------------------------------------------

All right, thank you, everyone. I think this takes care of our remarks and I'd like to open up the call for any questions. So if you can ask the operator to conduct the call from here. Thank you, Terry.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Alex Stranahan, Bank of America.

--------------------------------------------------------------------------------

Alec Stranahan, BofA Merrill Lynch - Analyst [2]

--------------------------------------------------------------------------------

Hey, guys. Thanks for taking my questions, and congrats on your first earnings call as a public company. Just a couple from me. The first from me is regarding your GD2-CD3 bispecific. Could you give us a sense of what percentage of the study has accrued at this point? And I guess how do you see this asset fitting into the treatment paradigm if naxitamab gets approved? And then I have another.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [3]

--------------------------------------------------------------------------------

Okay, well, I mean, we hadn't disclosed any details on the recruitment. But obviously, this is a dose escalation study, so we go from cohort to cohort. And we have been through I think at least the first three cohorts now, but we haven't disclosed, as I said, any details from this.

We have to wait between each cohort to see if 30 days out the last patients have any side effects before we can dose escalate. But we haven't seen anything that gives us any concern for now. We still probably need to get up another group of cohorts before we can expect to release without seeing serious effect, although we should be close to what that level would be.

So I think that basically takes care of that. We have said we would come with an update on the study towards the end of the year or early next year, depending on where we are in the dose escalation. The good news is that we haven't received any chemical hold yet, so it is still safe.

--------------------------------------------------------------------------------

Alec Stranahan, BofA Merrill Lynch - Analyst [4]

--------------------------------------------------------------------------------

Great. And sort of how do you see the asset fitting into the treatment paradigm alongside naxitamab if it is approved?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [5]

--------------------------------------------------------------------------------

Well, I think we have something that works; that is naxitamab. If it turns out like five, six years from now, maybe even seven, eight years from now, that we get fantastic data in pivotal studies with the bispecific antibody in the neuroblastoma setting and osteosarcoma setting without any pain issues, which is the key challenge with GD2 antibodies, then this would naturally migrate into that setting also.

But remember that hundreds of thousands of patients that have GD2-positive tumors including, including all the small cell lung cancer patients. A lot of melanoma patients, triple negative breast cancer patients. So I think you should think more like the bispecific antibody in the context of the adult potential indications.

Right now, the dose escalation study is basically for anybody with a GD2-positive cancer. We will continue exploring this, of course, in the pediatric indications, which is our primary mission as a company. But definitely also in the adult setting.

And my first shot would probably be to go for a small cell lung cancer when we have established the safe dose. And probably also Ewing sarcoma, which is clearly an unmet medical need that also seems to be expressing GD2s. So there's ample possibilities also outside the field.

The pain is basically what is limiting the dosing of GD2 antibody. And I think the tolerability to the pain is less in the adults that we have seen previously than it is in the kids. So obviously a GD2-bispecific would really be potentially very attractive for a number of indications.

--------------------------------------------------------------------------------

Alec Stranahan, BofA Merrill Lynch - Analyst [6]

--------------------------------------------------------------------------------

All right, great, thank you. And then my second question is on your manufacturing agreement with SpectronRx. How long do you expect it will take to get them online for the radiolabeling of omburtamab, particularly at the level of commercial production? And I guess along those lines, how do you plan to split up manufacturing amongst your various TMOs?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [7]

--------------------------------------------------------------------------------

Well, I think first of all, Spectron will definitely be ready in the next three to six months to deliver. And initially, they will just be delivering for clinical trial purposes. So we don't have any problems there.

And I think what we initially will be doing is that for patients here in the US, we will be using the two facilities here in the US that can actually do radiolabeling for us. And the European ones will be ready for delivery for the European site.

But the good thing is that we can ship, and we have also right now we are currently shipping from the US to Europe because the European sites are not operational yet. So we know that's possible. And the product is usable within 72 hours of release from the labeling facility, so you have ample time to get it to the site. And it is working.

--------------------------------------------------------------------------------

Alec Stranahan, BofA Merrill Lynch - Analyst [8]

--------------------------------------------------------------------------------

Great, thanks.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [9]

--------------------------------------------------------------------------------

Does that answer the question?

--------------------------------------------------------------------------------

Alec Stranahan, BofA Merrill Lynch - Analyst [10]

--------------------------------------------------------------------------------

Yes, that's perfect. Thanks.

--------------------------------------------------------------------------------

Operator [11]

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [12]

--------------------------------------------------------------------------------

Great. And I'd like to add my congratulations on having you guys -- hearing you for the first time on an earnings call.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [13]

--------------------------------------------------------------------------------

Thanks, Boris.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [14]

--------------------------------------------------------------------------------

So first question is on naxitamab. Can you comment on the osteosarcoma data? Specifically, what should we be expecting and when?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [15]

--------------------------------------------------------------------------------

Well, I mean, I haven't seen any yet, so it's difficult for me to comment on. You see that whatever we have available in terms of PFS on the patients that have been treating, what we have available in terms of tolerability, safety, etc.

And I think most likely the patient cohort is going to be in the magnitude of about 30 patients or so. We are not doing any analysis until we get a bit closer to the conference so we have as much information available as possible. So honestly, I haven't seen the data yet, except for I know the safety part is fine.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [16]

--------------------------------------------------------------------------------

No, but that's what I wanted to hear. So it sounds like, just so I am clear, roughly 30 patients we will see later this year.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [17]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [18]

--------------------------------------------------------------------------------

Okay. Fantastic. Actually, maybe a similar question on DIPG and DSRCT. What should we be expecting and when?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [19]

--------------------------------------------------------------------------------

DIPG, we presented some very nice update data at ASCO. I think the expectation you can have is that if this continues to look positive, as it is right now, we would definitely go ahead and do an update again at ASCO 2020. Since this was the only study with a positive indication for anything in DIPG, everything else has not shown anything. And if it continues to look like this, we are definitely planning to give another update next year.

The other thing relating to this is that there is clear interest in expanding the study. So we are trying to see if we can before next summer open additional sites or open a separate study on other sites for the DIPG patients.

For the desmoplastic small round cell tumors, we would expect to have a presentation later this year for an update on the desmoplastic small round cell tumor. I think it is in November we have an abstract approved for a conference.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [20]

--------------------------------------------------------------------------------

And what conference would that be at?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [21]

--------------------------------------------------------------------------------

Bo, do you recall the name of the conference in Japan? Did we send out a press release about it? I think we did.

--------------------------------------------------------------------------------

Bo Kruse, Y-mAbs Therapeutics, Inc. - CFO, Treasurer, and Secretary [22]

--------------------------------------------------------------------------------

Yes, it's CTOS.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [23]

--------------------------------------------------------------------------------

CTOS. Yes.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [24]

--------------------------------------------------------------------------------

Great. I will take a look if you guys -- maybe I have forgotten. I guess then lastly on the priority vouchers, is there a way potentially you can monetize them before actually receiving them?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [25]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [26]

--------------------------------------------------------------------------------

And are you doing anything -- is that a direction you are considering?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [27]

--------------------------------------------------------------------------------

Well, anything is a possibility. It will definite be something we are looking at. If we get a sufficiently attractive term, say, we find a pension fund that is tired of only getting minus 0.5% interest on their bonds and say hey, maybe we can make 15% on -- what do I know? But we are definitely considering the possibility as a potential to have non-dilutive cash into the Company.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [28]

--------------------------------------------------------------------------------

Great. Well, thank you very much for taking my questions.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [29]

--------------------------------------------------------------------------------

If we feel it's needed.

--------------------------------------------------------------------------------

Boris Peaker, Cowen and Company - Analyst [30]

--------------------------------------------------------------------------------

Thanks for taking my questions.

--------------------------------------------------------------------------------

Operator [31]

--------------------------------------------------------------------------------

(Operator Instructions) Robert Burns, H.C. Wainwright.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [32]

--------------------------------------------------------------------------------

Hi, Claus. Great hearing you on the first earnings call again. I have three questions for me. So I guess the first one is I just want to confirm from you that we are going to be seeing efficacy data at SIOP in osteosarcoma as an abstract. As well as the [timing] don't seems to imply that there is going to be efficacy data in it. That is my first one. And then the second one is what sort of steps are you taking --

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [33]

--------------------------------------------------------------------------------

Well, why don't I answer the first one? First, we take the second one so I don't forget the first one and the second one, give me the third question. We haven't said for sure there will be efficacy data, but we are trying to see if we can get the PFS data for the patients.

And therefore, there is nothing in the abstract because when the abstract was submitted, there was no evaluation of PFS at that time point. So I haven't seen the presentation yet, as I said, since it is not made yet. But we will see if we can get data out of there. It is in the MSK database, the data, so it is not in Y-mAbs database.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [34]

--------------------------------------------------------------------------------

Okay. So my second question is I've noticed that you said multiple times that you are trying to accelerate the CMC portion of the filing. What steps are you taking to try and accelerate that portion? How feasible is it that we might see an accelerated timetable for that portion? You said that you might be able to (multiple speakers) but -- yes.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [35]

--------------------------------------------------------------------------------

It is hard to accelerate something from November to two months. But we are doing what we can in terms of understanding what precisely it is that the FDA wants in addition to what they already know about on the PPQ filing. So we are doing what we can terms of communicating with the Agency.

But besides that, we are just following track and moving along. And I think at the end of the day, you also know that when we file the clinical part of the BLA, they are going to start evaluating that immediately. They are not going to sit on it until they get the last part in February. That is the whole idea of the rolling BLA.

So typically for these compounds that are filed with rolling BLAs, instead of getting the typical six months from the PDUFA date approval, you typically see like one to two months early approval of products that has been filed with rolling BLAs that are addressing unmet medical needs in oncology.

I think in reality, we are not really looking at any significant later date than we would otherwise get if we filed the CMC packets one or two months earlier than February. But we are looking into try to understand it why it wouldn't be sufficient what we have.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [36]

--------------------------------------------------------------------------------

All right, sounds good. My next question so you are going to be submitting the clinical data portion in November. Can you just remind us as to what you anticipate the timeline would be for the pivotal top-line date release for naxitamab and omburtamab?

And then a follow-up to that is can you sort of update us as to the status of the frontline naxitamab program in patients with first-line remission? And what does the pathway look like for adding HIPS verticals and naxitamab [really in secondary] --

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [37]

--------------------------------------------------------------------------------

How many questions was that? Could you start with the first one? What was the first question?

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [38]

--------------------------------------------------------------------------------

So just can you remind us about the timeline for pivotal top-line release for naxitamab and omburtamab, considering that you are submitting (multiple speakers)?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [39]

--------------------------------------------------------------------------------

So the 24 patients for naxitamab that will go into the BLA filing, of course we will have the data in November. We may have a suitable venue before ASCO, but we will find a suitable venue. And depending on what we decide, it may even be that we can agree with the investigators to -- since this is a part of the study that since it is in the BLA we can release the data before that. But we will have the data. We will find a venue.

For the omburtamab data, it is 18 patients with pharmacokinetic and dosimetry data. So there is no efficacy in the 18 data from the 101 study. So hereafter, the pre-BLA meeting that, if the FDA is okay with letting us file that we will have data that we have shared with the Agency and that the pharmacokinetic and dosimetry data looks comparable at MSK and outside MSK and comparable to the data from the study 03133. And that is basically it.

Then as you may recall, we are adding another 14 patients on top of the 18, so a total of 32 patients. And we have discussed with the Agency that our post-marketing commitment after the accelerated approval next year will be to provide the Agency from these 32 patients with six months' progression-free survival and two-year overall survival.

Now, that is discussion topic, so the Agency can decide all the way up to they give us the approval what our post-marketing commitment will be. But it is highly likely that it is going to look like that. And those data, of course, especially the progression-free survival data, should be available probably by the middle of next year or on the second half of next year.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [40]

--------------------------------------------------------------------------------

Okay. That sounds good. And then with the HITS protocol, is there a pathway that that will be added into the naxitamab label in secondary refractory patients?

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [41]

--------------------------------------------------------------------------------

Yes, I think what we most likely will do is now, we will get the first approval. I'm not going to rock the boat and start talking about any additional indications or modifications.

But then I would go ahead and ask for a Type B meeting with the Agency and say, hey, look at we take patients in second-line that are refractory to chemotherapy and then they get naxitamab and they are refractory to naxitamab. And then we put them on this HITS regimen and then we put 40% into remission.

And you see now say we at that time point have 85 patients and you can see if we do this, we get 45% or whatever it is into remission, why don't you give us the indication in these patients? And why don't you say that it could be recommended to use this upfront? I mean, why would you not use this? Before you give salvage chemotherapy, before you give naked antibody, give the combination.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [42]

--------------------------------------------------------------------------------

No, it makes complete sense from (multiple speakers).

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [43]

--------------------------------------------------------------------------------

That's the question we'll take. And then you asked about the frontline study. And what we have said is that we have about at least 50 patients or more in that study now. That's a single center study. We are planning a multicenter study to start in the first half of 2020.

And again, when we have the approval for the second-line, I would go and talk to the FDA about a potential approval in frontline and find out what do they need from a multicenter study, what is the safety data needed, are they satisfied with whatever efficacy data we can agree with them on. And get a regulatory strategy in place after the approval, but not rock the boat right now and start talking about additional indications.

But we hope to be able to present data. And again, I do not decide what is being accepted for presentation at ASCO, but we would hopefully be able to present at ASCO next year data from our frontline study with the patients. And some of the patients will at that time point will have been at the study for more than 2 1/2 years.

So hopefully we can present both safety data, hospitalization data, and progression-free survival data from the first cohort of patients. And so more than 50 patients, most likely less than 100 patients.

--------------------------------------------------------------------------------

Robert Burns, H.C. Wainwright & Co. - Analyst [44]

--------------------------------------------------------------------------------

Awesome. Sounds good. I look forward to it. Thank you so much, Claus.

--------------------------------------------------------------------------------

Operator [45]

--------------------------------------------------------------------------------

There are no further questions at this time. I'd like to turn the floor back over to management for closing remarks.

--------------------------------------------------------------------------------

Claus Moller, Y-mAbs Therapeutics, Inc. - CEO [46]

--------------------------------------------------------------------------------

Thank you. Well, thank you, everybody, for joining us today. It has been a real pleasure to have our first quarterly earnings call and I look forward to the next one. Have a good day, everybody. Bye.

--------------------------------------------------------------------------------

Operator [47]

--------------------------------------------------------------------------------

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a good evening.