Good day and welcome to the Y-mAbs Therapeutics, Inc.'s Earnings Conference Call for the Fiscal Full Year of 2021. 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 that 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, 2021, as filed with SEC on February 24, 2022.

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

first, our leading monoclonal antibodies, DANYELZA and omburtamab; second, our bispecific compounds under the Y-BICLONE platform; and finally, the promising targeted radiopharmaceutical SADA technology platform.

It's been almost exactly a year since we launched DANYELZA, a much needed treatment for children with relapsed/refractory high-risk neuroblastoma. We delivered not only an innovative treatment but also demonstrated our commitment to develop better and safer products addressing the medical needs of these children.

We are encouraged by the benefits of DANYELZA and we are squarely focused on expediting DANYELZA's adoption, continue it's development in expanded indications. And in parallel, we are leveraging our other platforms to generate groundbreaking data. After we launched DANYELZA in the U.S.

in February 2021, we've seen a nice ramp up of sales and we ended the year recording net revenue of $9.6 million in the fourth quarter, corresponding to a 7.1% increase over the third quarter and total product revenues of $32.9 million for the full year. The resubmission of omburtamab BLA is progressing as planned.

We held a pre-BLA meeting with the FDA in January which confirmed our path towards a BLA resubmission in March. Summarizing on our two bispecific programs, we are continuing to dose patients in our small cell lung cancer study and the IND for our CD33 bispecific for pediatric AML has been submitted.

And we believe that this promising treatment can potentially address an important pediatric unmet medical need. With SADA, we are entering into a new frontier of radiotherapy with the ability to precisely target multiple tumors.

Our excitement over SADA technology grows as we work to optimize that platform that we believe will be able to deliver medicines to treat many cancers. During the fourth quarter, we filed the IND for our first construct, the GD2-SADA for GD2-positive solid tumors and are looking forward to treating the first patients this summer.

We are scheduled to file at least one more IND for a new SADA construct later this year and we plan to file at least one IND per year moving forward.

We ended the year with $181.6 million in cash, so we believe we have a strong balance sheet to support both the continued commercialization of DANYELZA and the potential launch of omburtamab as well as the advancement of our early-stage program such as the new constructs developed under the SADA technology platform.

We are also actively working with our SADA platform within business development. We are very pleased with our current financial position which Bo Kruse, our Chief Financial Officer, will elaborate on later on this call. I entered into a loan agreement in 2019, at which point I placed shares as a collateral.

My place of shares was disclosed in our prospectus filed in February 2021, so over a year ago. At that time, our insider trading policy allowed for such transactions to occur after approval by our General Counsel.

Due to the various market factors, including the biotech industry falling out of investors' favors in 2021, our stock price has declined from a high of approximately $55 to where it sits today. The decline in our stock price triggered four sales by my bank in January and February 2022 to repay that loan.

The loan has now been repaid in full and no additional sales under this pledging agreement are coming. In addition, I've terminated my current 10b-5 plan and Bo Kruse has done the same.

In addition, our Board has updated our insider trading policy and the new policy prohibits the pledging of company's shares as collateral in the future and also adopt some of the proposed SEC amendments to Rule 10b-5. This new policy will be posted to our website.

In summary, we are very proud of the progress we made in 2021 and we are very optimistic and excited about DANYELZA's sales increasing and omburtamab BLA being on track and the first SADA IND now submitted and ongoing preclinical testing for additional SADA construct.

I would also like to take the opportunity to acknowledge the effort of our ambitious team which we recently expanded by hiring our new Chief Commercial Officer, Sue Smith. Sue brings extensive commercial experience, including several recent successful product launches within cancer and rare disease.

We are pleased to have her joining our leadership team and are already benefiting from her prior experience, as we continue to optimize our commercial franchise in order to leverage potential future products driven from our core platforms. And with that, I'm very pleased to turn over the call to Dr. Claus Møller, our Chief Executive Officer. Dr.

Claus? Thank you..

Thank you very much, Thomas and welcome to Y-mAbs Therapeutics' Fourth Quarter and Full Year 2021 Earnings Call. We're very pleased that you have chosen to spend this morning with us. During the year, we continued to optimize the value of our pipeline.

And our progress included having launched DANYELZA and reported increased sales for our -- for four consecutive quarters, while at the same time, making progress in the resubmission of the omburtamab BLA and we're also continuing significant investments in the potential game-changing SADA programs.

Now turning to naxitamab of DANYELZA, that is approved for 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 and was approved by the FDA under the accelerated approval pathway.

We recorded DANYELZA net sales of $9.6 million in the fourth quarter which reflects a strong 7% increase from previous quarter. We're also encouraged by the increase in number of treatment centers that had gained experience with DANYELZA. We have now delivered DANYELZA to 28 centers across the nation.

We continue to be very pleased with the DANYELZA launch and the traction we are getting in the market at this point. The increase corresponds to four new centers since the last quarter and approximately 40% of the vials sold in the U.S. are currently sold outside Memorial Sloan Kettering.

It is also notable that we are now seeing commercial usage of DANYELZA in early access programs in China, MENA and LATAM. Royalty income is still modest. But given the incident rates in these regions, we have high hopes for future growth and are putting significant effort into expansion into additional international markets with our partners.

And I'm very pleased with our commercial and medical affairs organization which has done an outstanding job of educating physicians and nurses about DANYELZA and guided the many new treatment centers through their first experience with DANYELZA. At our R&D Day in December, Dr.

Mora from Barcelona Children's Hospital presented compassionate use data from an investigational infusion protocol of naxitamab, where he systematically increased the infusion rate during the treatment. By starting dosing at very, very low infusion rate and gradually increasing the rate, Dr.

Mora was able to exhaust and verify the signaling without -- within approximately 60 minutes, thereby allowing for a substantial increase of the infusion rate during the remaining infusion. Using this new revised infusion scheme, for which a provisional patent application has been filed by Y-mAbs, Dr.

Mora and Memorial Sloan Kettering, it was observed that the protocol may help reducing grade 3 and grade 4 adverse events. We believe this new insight can help us refine the naxitamab dosing regimen and thereby improve, not only the safety profile and, therefore, the duration of therapy but also further reduce the frequency of dosing.

We consider this to be a strong competitive advantage over other approved GD2 therapies and believe this could open the door to exploring a number of GD2-positive indications in the adults need also. And we are in the process of planning clinical trials for a number of such indications.

To summarize, we are very optimistic about the long-term opportunity for DANYELZA as underscored by clinician's feedback. Our focus remains on continued accelerated adoption. And looking ahead, we plan additional medical educational training to broaden site activations.

Sue Smith, our new Chief Commercial Officer, will execute a marketing strategy aimed at increasing market awareness, utilization and duration of therapy of DANYELZA across the country. We expect Y-mAbs on the Sue's commercial leadership to become a leader in the pediatric oncology field.

Omburtamab, we are turning to now for the treatment of pediatric patients with CNS/leptomeningeal metastases for neuroblastoma. We had a pre-BLA meeting with the FDA on January 13, 2022 and we are working closely with the FDA on the resubmission of the omburtamab BLA.

The agency had some final questions regarding access to the audit of historical data from the German database which we use as a control group and we have been working with the doctors responsible for the database to provide clarification on this matter.

We are working diligently to meet all requirements from the FDA and expect to resubmit the entire omburtamab BLA by the end of next month, first quarter 2022.

Needless to say, we are very pleased to be aligned with the FDA on the next step and believe that if approved, omburtamab will be a significant benefit to patients with CNS/leptomeningeal metastases from neuroblastoma. We are currently facing a major unmet medical need.

If approved, it will be -- it will also be a welcome addition to our commercial franchise as the second BLA approval in as many years and will leverage our investment in our commercial organization in the U.S. The European marketing application for omburtamab was prepared in parallel with the U.S. BLA and was submitted through EMA in April 2021.

Preliminary feedback from EMA has been received and we are in the process of responding to questions raised by that agency. The evaluation of our applications is progressing as planned.

In addition, interim Phase I dose escalation data for omburtamab for diffuse intrinsic pontine glioma, or DIPG, has paved the way for our Phase II study note as Study 102, for which we filed an IND in October. We are excited and hope to initiate this multicenter study in DIPG later this year.

We expect to administer up to three repeated doses of omburtamab in that study. Turning to the SADA technology. As you know, we are very, very excited about the prospects for this technology and we are making good progress preparing additional INDs and identifying additional SADA targets for clinical development.

As a reminder, the SADA technology platform allows for targeted delivery of radioisotopes and could potentially improve the efficacy and also reduce the toxicity of radio-labeled therapeutics. Additionally, given the versatile -- versatility of the SADA platform, we believe that SADA technology can be adapted for multiple tumor targets.

We filed our first SADA IND, the GD2-SADA for treatment of GD2-positive solid tumors last December. We are also seeing significant partnership interest from the SADA technology and we are well positioned to leverage the SADA platform in the coming months.

We are truly excited about the potential of the SADA technology which we -- has already shown great promise and we believe that it can further unlock the potential of regulated therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents.

Thus, in general, we believe that we are well positioned to continue 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 continues on a growth trajectory that we believe is just beginning.

We are anticipating a BLA resubmission of omburtamab soon and we are leveraging our DANYELZA experience to assure a successful launch of omburtamab if approved.

At the same time, we are expanding our pipeline by advancing our constructs through the clinic, predominantly the SADA constructs, While we believe the best is yet to come, the fiscal year 2021 has certainly been a significant year for us.

We are excited to move forward and unlock long-term shareholder value by continuing to build a commercial business that helps patients and further elevates our continued development across each of our platforms. Now let me invite our Chief Financial Officer, Bo Kruse, to share his remarks on the financials.

Bo?.

Thank you, Claus. We reported DANYELZA net product revenue of $32.9 million for the first year of sales.

In addition, we reported license revenues of $2 million for the year ended December 31, 2021, related to our licensing agreement with Adium in Latin America which compares to $20.8 million for the year ended December 31, 2020, related to our licensing agreement in China with SciClone and in Israel with Takeda.

We did not have product revenues in 2020 as DANYELZA did not receive FDA approval until late November 2020. As we take a closer look at the operating expenses for the full year of 2021, we note that R&D expenses decreased by $0.5 million from $93.7 million for the year ended December 31, 2020, to $93.2 million for the year ended December 31, 2021.

The decrease was primarily attributable to a $4.8 million increase in regulatory affair expenses associated with costs incurred for the BLA submissions for naxitamab and omburtamab in 2020 and a $13.3 million decrease in milestones and license acquisition costs related to our acquisition of the SADA technology from MSK back in 2020.

These decreases were partially offset by increases in outsourced manufacturing costs of $6.2 million, clinical trial cost of $3.9 million, consulting services of $1.2 million, expenses for premises of $1.4 million and employee-related costs of $4.1 million, including salaries, benefits and noncash stock-based compensation for personnel related to our expanding workforce.

Selling, general and administrative expenses increased by $9.8 million from $44.8 million for the year ended December 31, 2020, to $54.6 million for the year ended December 31, 2021.

The increase in SG&A expenses primarily reflects an $8.9 million increase in employee-related costs, including salary, benefits and noncash stock-based compensation, primarily for additional personnel related to the launch and commercialization of DANYELZA.

We reported a net loss for the full year ended December 31, 2021, of $55.3 million or $1.28 per share, basic and diluted compared to a net loss of $119.3 million or $2.97 per share basic and diluted for the year ended December 31, 2020.

The decrease in net loss was primarily driven by the DANYELZA revenue stream and the net proceeds for monetizing the priority review voucher, the PRV, associated with the FDA approval of DANYELZA. We ended 2021 with a cash position of $181.6 million compared to $114.6 million at year-end 2020.

The increase of $67 million reflects proceeds from the sales of our DANYELZA priority review voucher in January 2021, where we netted $62 million after sharing 40% of the net proceeds from the sale with MSK as per our license agreement.

Our December 31, 2021 cash balance also reflects the $107.7 million net proceeds raised in our public offering back in February 2021, partially offset by the net cash used in operating activities of $102.6 million for the full year ended December 31, 2021. We continue to believe that Y-mAbs remains in a very healthy financial position.

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

Okay. Thank you very much, Bo. This marks the end of today's prepared remarks. And at this time, we can turn over the call to the operator to start Q&A..

[Operator Instructions] Our first question comes from Alec Stranahan with Bank of America. Please proceed..

Hey guys, thanks for taking our question. One on DANYELZA and then one on omburtamab.

So for the DANYELZA launch, I guess, what are the next steps, in your view, to driving further access and/or utilization, particularly at the new treatment centers or ones that have recently been activated outside of MSK? And I guess how does the up-dosing schema presented by Dr.

Mora feed into this? Has the grade 3 pain been sort of a pushback from prescribers to date? And then I've got a follow-up..

Yes. Let's take that first on the DANYELZA. The next step is that we continue what we have been doing. We are reaching out to sites. It has been a little tricky during certain parts of 2021 to actually get in-person meetings. That seems to have opened up now here in February this year and we will continue expanding on that.

We are also receiving interest from sites on providing product DANYELZA, naxitamab, for investigator-sponsored studies.

And in particular, we are sponsoring an induction treatment study where the patient, shortly after diagnosis, is receiving chemotherapy in combination with naxitamab instead of just receiving chemotherapy prior to their surgery and radiation.

So we are working with a number of sites on this and there's also an increased interest from a number of the sites to work with us on the vaccine and we're working with the children's oncology group, among other two, help them getting access to our vaccine or for a study they would like to initiate themselves.

And so we are playing on a number of horses on the MSL side with the additional data that are also being generated directly by the sites, we're in the studies they want to start. We are continuing to inform them about the data that we are generating and that will be coming out.

We are hoping to present at ASCO some data from our chemotherapy and naxitamab combination as well as we are hoping that Dr. Mora will be allowed to present his step-up protocol. Right now, we cannot use the data from Dr. Mora's step-up protocol in our sales and marketing activities. But it can -- Dr. Mora can talk to the site.

So not until he has presented data at ASCO, we have a more formalized package that hopefully we can be allowed to use unless the FDA agreed to let us do that first. But there's no doubt that the step-up procedure is simply facilitating the staff need for the infusion of naxitamab.

So instead of having a couple of nurses and a doctor bedside, while the infusion goes on for about an hour, then you can have the infusion maybe for two hours but then only one nurse. That's how Dr. Mora's experience has been with this.

So those are, I think, some of the things that we are doing for naxitamab and in addition to, you can say, the more traditional stuff. We're also expanding activities on patient identification so we can do more targeted approach but we are continuing to expand to new sites.

And we continue to see also in the new year that additional new sites have shown interest in ordered product for treating patients. I hope that answers your question, Alec..

Yes, yes. That's helpful and definitely encouraging. And one more quick one on the omburtamab refiling, if I may.

Could you just talk to any remaining list items you maybe need to check off in the FDA's view or the tumor response data and the CMC discussion you provided, sufficient for them?.

To the best of my understanding, all the information that we need, we have. And what we are doing right now is we are finalizing what's called final study reports on -- thanks to actually complete the clinical section and the safety section of the BLA filing. So there's no -- we're not waiting for additional stuff to come in. There's some discussion.

The FDA wants to understand how they can actually -- to which degree they can verify the historical control data in the central German cancer registry in Cologne but that's not something that is holding up the submission of the BLA filing..

Thank you..

Our next question comes from Charles Zhu with Guggenheim Securities. Please proceed..

Hi, everyone. Thanks for taking my questions and Happy Friday. First one regarding omburtamab. So it sounds like the FDA refiling is going quite well and as planned. I had one question regarding the EMA feedback that you received. I think you mentioned that your -- that you received some feedback and questions from that agency.

I guess, to what extent can your activities in addressing FDA questions throughout 2021, be potentially applied to addressing the EMA questions that you raised? And could you provide any sort of color around the questions that the EMA raised?.

The EMA questions have reflected almost precisely the questions that the FDA has raised in terms of comparison of data and propensity for balancing of patient cohorts. And so I mean maybe they just are thinking along the exact same lines or they have been talking together.

So that's also why, I mean, we are expecting to answer the EMA questions at the same time point as we are finalizing the omburtamab BLA resubmission. So it's definitely the same type of question..

Got it. Sounds great. And also regarding your GD2-SADA asset, that sounds like it's heading to the clinic sooner. How should we think about near-term milestones and data releases coming out of that asset? And I might have a follow-up on that as well..

Yes. I mean the beauty of this SADA technology is that we can immediately get the first very important answer to the question on this technology. Is it actually possible to have this omburtamab -- sorry, not -- builder Lutetium construct home to where the SADA molecule is sitting on the cancer.

And we can see that on the spec scan we will be doing on the patients basically from the first patient we are dosing as soon as we see the spec scans, we can see does this actually work.

Now, I cannot guarantee that the first patient will be getting enough SADA to cover the entire tumor tissue with sufficient amount of lutetium-177 but the FDA has accepted and we are starting out with a builder Lutetium dosing of 100 -- sorry, 200 millicurie of the isotope.

So we're giving a quite high dose of the isotope, 200 millicurie, the same amount of radiation that's put to the LUTATHERA product that is being given for treatment of neuroendocrine tumors. So the radiation dose is in the same magnitude as what is normally being used with curative intent per dose.

And now will the amount of protein that we can give for the first patient be enough to cover sufficient amount of the tumor to actually also get the enticing. That's probably more a bit to the question. But there are some things also we'll be exploring that.

So -- but very early on and I hope definitely at our R&D Day later this year that we'll be able to share with you some of the first data findings from this study and the scans from these patients. I'm very, very excited about this. And it -- I mean, unless I completely misunderstood something about radio physics.

And if you put radiation to a cancer, it's going to kill it. Now of course, there has to be enough of it but -- so if this works, it really should have tremendous potential. So we will get that answer very early on.

Did you have a follow-up for the SADA?.

Yes. Yes. Just one quick follow-up on that. So it does sound like you could potentially have some initial imaging data, maybe at your R&D Day by year-end.

I am kind of wondering how should we think about, I guess, from a quantitative perspective, like what the imaging data could tell us about dosimetry as well as localization, given that the lutetium-177 isn't quite a purely diagnostic isotope? And you may be exploring some of the lower doses first?.

No. Lutetium is a curative isotope. It's a beta-emitter with a half-life of about six days and a pretty high energy that will be killing cells up to one millimeter from where it's sitting. And as I said, the dose of Lutetium we are using which is 200 millicurie of Lutetium and beta molecules is the same dose that is being used for LUTATHERA.

And then LUTATHERA is given bimonthly for up to four doses of 200 millicurie. But the total dose we are sticking into the first patient that will receive a SADA molecule is also 200 millicurie of lutetium-177. So it's potentially a treatment.

Will there be enough protein sitting on cancers that the beta molecule can bind to, that is probably problematic since we are dose escalating on the protein on the antibody construct also. And we may have to go to higher doses of antibody before we get sufficient amount of binding.

So -- but the spec scans that we'll be doing that where you can image things with that beta radiation emitting, then they should show and we can superimpose those spec scans on the MR scans from the patient and see does the technology actually work? Will it actually hone to the cancer.

So, I think we will get some quite important information early on..

Understood. Thanks for that color and clarification..

Thank you, Charles..

Our next question comes from Mike Ulz with Morgan Stanley. Please proceed..

Yes. Hi guys, thanks for taking the question. Just one on DANYELZA and the label expansion strategy. I wonder if you can give us an update on the frontline neuroblastoma study in terms of where you are in enrollment? I think at the R&D Day, you're also considering adding a new cohort with the new dosing protocol.

Just curious if you made a decision there.

And is it possible that we might see some data from this study later this year?.

I think it's highly likely that the frontline study from MSK will be published later this year. It's 59 patients in the frontline setting that has not yet been published. The only data we have published in the frontline setting is the data from Dr. Mora's site in Barcelona.

And as I said, we are working also with the Beating Childhood Cancer group which is a consortium of more than 40 sites in the U.S.

And more than half of them are also CoD members, where more than 30 of the hospitals had said they want to participate in our frontline study really giving DANYELZA in the -- together with chemotherapy in the induction setting before surgery and radiation and bone marrow transplant and additional chemo, etcetera.

And in that study, we are also considering, since it's an investigator-sponsored study, it's at the discretion of the investigators but to randomize between dinutuximab and naxitamab in frontline setting in patients that are in first complete remission..

Got it. Thank you..

Our next question comes from Joseph Thome with Cowen & Company. Please proceed..

Hi, there. Good morning and thank you for taking our questions. Maybe on the SADA platform. I know you mentioned potential partnership strategies there.

So can you talk about that a little bit? How many deals are you looking to do for the SADA platform? And maybe what targets or indications do you want to keep fully in-house? And then second, on the DANYELZA launch, once some of these new centers do come online and get trial shipments or vial shipments, do they tend to be reorders? Can you talk about the frequency there?.

Yes. Maybe I can answer the DANYELZA first and then Thomas can elaborate on the SADA partnerships and what we're doing there. But yes, we are definitely seeing reorders and it's a little varying. I think our third biggest site in the U.S. right now has never actually accepted to see enough for our sales team.

But nevertheless, had been ordering and reordering for a number of treatments. So yes, we are definitely seeing that. But I think we are in the early stages right now still. And as I said also, I had a call with one of the CoD leaders recently. And she said to me during that call that, "hey, I mean, it's labor-some to give DANYELZA.

I'm the only doctor here at this hospital that can sit bedside when we give it." And therefore, we need to get the system up and running but I'm definitely continuing to use naxitamab. But hey, trust me, it was exactly the same when we started out with dinutuximab. And I've been involved in that development all along.

But now everything is running because we've been doing it for so many years now. And so this will come. So it's just to say that, yes, there are some hurdles but the doctors are not stupid. They also remember most of those that are, you can say, long-term users of dinutuximab.

They remember how they needed to learn to give dinutuximab also in the beginning. And now they have ended up with this humongous labor-some process where it takes almost a week to treat a patient and they have to be in the hospital, intensive care unit admitted all along, although they are handling all the practicalities around it pretty easily.

And so the same goes for DANYELZA. They need to get used to it. The nurses need to get used to kind of like handling the patients and the infusion.

I think with the step-up dosing, we are really making a significant leap forward to helping when we can publish this data and start implementing them on the sites for the hospitals to have a lot easier access to treating these patients. So then with that, I'm going to let Thomas comment on the partnering plans for SADA.

Thomas?.

Yes. Yes. Thank you, Claus. So we are in discussions with multiple companies about our own targets but also importantly, third-party targets as our licensing agreement and structures in a way that we can talk to partners about other targets, their own targets and we can optimize our platform for these targets.

So the strategy is to definitely talk about partnerships for large adult indications, maybe carve out the pediatric patients populations and -- but also importantly, talk to companies on their own targets..

Great. Thank you very much..

Our next question comes from Tessa Romero with JPMorgan. Please proceed..

Hey guys. I hope everyone is doing well. Thanks so much for taking our question. So, I think consensus for DANYELZA is getting around $78 million which would imply, I think, about a doubling of sales versus 2021.

In your view, what are the levers for exceeding this number? And what kind of keeps you up at night?.

Tessa, well, we haven't given any guidance for this year for sales of DANYELZA and adopting from last year would be 64-point-something million. But I think we have given absolutely no guidance in that direction. And I think it's still too early. I mean we saw an increase from second to third quarter and 10% of increase in vials.

We saw an increase from third to fourth quarter of about 7%. And that was in -- the rebates in certain fourth quarter were basically the same. So it's also reflecting a similar increase in sales of vials. I still think this is still so early on in terms of adoption and kind of patients that are actually being treated.

So I think Bo, do you have any comments also in terms of market expectations?.

Yes. I think, Tessa, you're right in that the average expectation is $78 million is true. If we narrow it down to just look at the analyst reports most recently updated, it's quite a bit lower than that.

So what I'm trying to say is that in the average number, there are some quite updated reports in there, not that we will get to $78 million but it's just a -- may be a little bit of a stretch for this year..

But we will do our absolute best to make -- to see if we can live up to that but I just don't want to give any guarantees or guidance..

I just -- one more, if I could squeeze one and you noted a cash runway through the end of 2023.

Are you able to provide any kind of rough guidance on expenses in 2022? And how that breaks out between SG&A and R&D?.

We haven't provided any guidance for '22 but I would expect it to be reasonably in line with what you've seen last year. And even if you look at the year before that, again, 2020, we had operating expenses of $141 million. And then in '21, we had $150 million. So it's not that you would expect to see some sort of a dramatic increase.

I would assume it to be reasonably flat..

Okay. Thanks so much for taking our questions..

Absolutely..

Our next question comes from Sebastiaan van der Schoot with Kempen. Please proceed..

Hi, team. Thanks for the update and taking my questions. The first one regarding the use of DANYELZA in the real setting for the clinic.

Can you expand on how many vials are used per patient in the real world versus the chemical setting? And can you also maybe talk a little bit about the difference between MSK and other resellers? And then the second question is on the rest of the pipeline beyond naxitamab.

Can you expect expense on what clinical data updates we are expecting in 2022?.

Thank you, Sebastiaan. We don't -- we haven't given any numbers on the number of vials per patient. What I can say is that in the clinical study 201 and 12-230, the average number of cycles of treatments per patient was about 5.6.

And what we are seeing is that in patients that are -- equivalent to the patients in these two studies, the number of vials -- or the number of cycles are the same. But we also see many new sites that are starting out with patients that are way later in their disease development than the patients in those studies.

And that means that they are actually progressing after having received a number of cycles of dinutuximab and chemotherapy. And then rather than just sending them home with a palliative therapy, then they try a couple of cycles of naxitamab on these patients and that becomes then their first experience.

And obviously, then the number of vials and the number of cycles goes down.

In terms of the difference between MSK and the rest of the sites, the MSK sites or the MSK have -- I mean, like I just told you about the CoD investigator I talked to that has many years of experience with dinutuximab and said that in the beginning it was really a major effort for us to treat those patients.

And now everything is standardized and we're so used to it and it's no longer considered an issue. The MSK side had been dealing with this product for so long time, so they don't need a doctor bedside just because they're dosing. They have several patients being dosed at the same time with some nurses looking after it.

And of course, there is the ability to get a doctor in the room if needed but very rarely that is needed. So for them, it's just a normal day on the job, whereas the new sites have to work a bit harder to get comfortable on how they handle the reactions to the DANYELZA product.

So, there -- and again, also, as I just alluded to with a number of vials, Outside of MSK, the product is often being used at later stages unless it's because the parent insist that they want their kid treated with DANYELZA which also happens. And so that is another difference between MSK and the sites outside.

And that will change as we continue to work with the sites and they get more experience, etcetera. And I think -- I hope my point was well taken about the Beating Childhood Cancer study that is expected to start this summer. That's including 30 sites, more than 30 sites, of which no more than 10 of them have previously been using naxitamab.

So that, in itself, is going to add another 15 to 20 sites that have never been practically using naxitamab and then they get clinical trial experience and they can also use it at the same time with patients on the commercial side. So that's really a major important thing for us.

In terms of data, I just alluded to that we expect that ASCO to have some data presented on the chemo combination of naxitamab with irinotecan and temozolomide from a data compilation made by MSK and Dr. Mora. And we also expect Dr. Mora's study to be presented there.

And then later this year, we expect also to have data from the 59 patient frontline study at MSK. And then there may be something else but those are the ones that we are right now focusing on. But so there will be a number of additional data sets presented for DANYELZA later this year..

And then regarding the rest of the pipeline, can you maybe, beyond DANYELZA, do you have other clinical....

The rest of the pipeline, there will be definitely updates from the -- from our omburtamab studies, both in the CNS/leptomeningeal metastases, we will be hopefully finding a suitable venue to present data from the 101 study, including tumor response and progression-free inventory survival and overall survival from that study.

And we will also be having, hopefully, additional data presentations on the DIPG study by Dr. Mark Souweidane from Cornell MSK that have done the Phase I/II dose escalation study there.

And that's -- I think, in line with what I've said earlier also, we are hoping to have the first data from the SADA at our R&D Day and hopefully also some additional update on our bispecific platform..

Okay, great. Thank you..

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session. I'd like to turn the call back to Thomas Gad for any closing comments..

Thank you very much, everybody, for joining today. This concludes our earnings call and have a great weekend. Thank you..

This concludes today's conference. You may now disconnect..