Y-mAbs Therapeutics, Inc.

Good day, and welcome to the YMAB's Third Earnings Conference Call for the Fiscal Fall 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, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31st, 2021, as filed with SEC on February 24th, 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.

Thank you, Joe, and thank you, everyone. Good morning, and thank you for joining us for our earnings call today. During the year, we made significant progress on executing our strategy and expanded on all the three pillars of our business. First, our leading monoclonal antibodies, Danielle's hand on Bertramab. 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 Danielsa, the 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 Danielsa, and we are squarely focused on expediting Danielsa's adoption, continuous development, in expanded indications, and in parallel, we are leveraging our other platforms to generate groundbreaking data. After we launched Danielza 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 Onvirzumab 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 contract the GD2 SATA 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 SATA 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 Danielsa and the potential launch of UmbertoMap. as well as the advancement of our early stage programs, 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 Cruz, our Chief Financial Officer, will elaborate on later on this call. I entered into a loan agreement in 2019, at which point I pledged shares as a collateral. My pledge 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 forced 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 10B5 plan and Bo Kruse has done the same. In addition, our board has updated our insider trading policy and the new policy prohibits prohibits the pledging of company shares as collateral in the future and also adopts 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 Danielsa's sales increasing, the reimbursement BLA being on track, and the first SADA IND now submitted, and ongoing preclinical testing for additional SADA constructs. 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. Klaus Müller, our Chief Executive Officer. Go ahead, Klaus. Thank you.

Thank you very much, Thomas, and welcome to YMAT's 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 continue to optimize the value of our pipeline, And our progress included having launched Danielsa and reported increased sales for four consecutive quarters, while at the same time making progress in the resubmission of the ambertumab BLA. And we are also continuing significant investments in the potential game-changing SADA programs. Now turning to Anaxidamab or Danielsa 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 Danielsa net sales of 9.6 million in the fourth quarter, which reflects the strong 7% increase from previous quarter. We're also encouraged by the increase in number of treatment centers that have gained experience with Danielsa. We have now delivered Danielsa to 28 centers across the nation, We continue to be very pleased with the Danielsa 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 Strong Kettering. It is also notable that we are now seeing commercial uses of Danielsa 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 Danielsa and guided the many new treatment centers through their first experience with Danielsa. At our R&D day in December, Dr. Mora from Barcelona Children's Hospital presented compassionate use data from an investigational infusion protocol of Naxidimab, 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 the nerve fiber signaling 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 YMAPS, Dr. Mora, and Mora from 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 Nexidimab 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 DD2 therapies and believe this could open the door to exploring a number of DD2-positive indications in the adult field 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 Danielsa as underscored by clinicians' 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 Danielsa across the country. We expect YMAPS under SHU's commercial leadership to become a leader in the pediatric oncology field. On Bertamart, we are turning to now for the treatment of pediatric patients with CNS leptomeningo metastasis 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 ambertumab 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 ambertumab BLA by the end of next month's 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, imbertamab will be a significant benefit to patients with CNS leptomaniacal metastasis from neuroblastoma who are currently facing a major unmet medical need. If approved, 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 UmbertoMap was prepared in parallel with the USBLA and was submitted to 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 UmbertoMap for diffuse intrinsic pontine glioma, or DIPT, has paved the way for our Phase II study known 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 ambertumab 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 versatility of the SADA platform, we believe that SADA technology can be adapted for multiple tumor targets. We filed our first SATA-IND, the DD2-SATA, for treatment of DD2-positive solid tumors last December. We are also seeing significant partnership interest from the SATA technology, and we are well positioned to leverage the SATA platform in the coming months. We are truly excited about the potential of the SATA technology, which we have already shown great promise, and we believe that It can further unlock the potential of radiolabeled 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 YMAPS as a commercial states company. The Danielsa already being shipped to multiple treatment centers across the country and significant international progress being made, the Danielsa franchise continues on a growth trajectory that we believe is just beginning. We are anticipating a DLA resubmission of UmbertoMap soon, and we are leveraging our Danielsa experience to assure a successful launch of UmbertoMap 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, Klaus. We reported Danielsen 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 31st, 2021, related to our licensing agreement with Adium in Latin America, which compares to $20.8 million for the year ended September 31, 2020, related to our licensing agreements in China with Zycone and in Israel with Takeda. We did not have product revenues in 2020, and certainly also 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 half a million from 93.7 million for the end of December 31st, 2020 to 93.2 million for the year ended December 31st, 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 Naxizimab and Umbertovimab in 2020. and a $13.3 million decrease in milestones and license acquisition costs related to our acquisition of the starter technology from MSK back in 2020. These decreases were partially offset by increases in outsourced manufacturing costs of $6.2 million, clinical trial costs 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 non-cash 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 SDNA expenses primarily reflects an $8.9 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation, primarily for additional personnel related to the launch and commercialization of Danielson. We reported a net loss for the full year in the 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 Danielsa revenue stream and the net proceeds from monetizing the Priority Review Voucher, the PVE, associated with the FDA approval of Danielsa. we ended 2021 with a cash position of $181.6 million compared to $114.6 million at the end of 2020. The increase of $67 million reflects proceeds from the sales of our Danielsa 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 31st, 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 31st, 2021. We continue to believe that YMAT 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. Thank you.

Thank you.

Ladies and gentlemen, we will now begin our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and our confirmation tone will indicate your line is in the queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Alex Stranahan with Bank of America. Please proceed.

Hey, guys. Thanks for taking our questions. One on Danielza and then one on BurtonMap. So for the Danielza 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 updosing schema presented by Dr. Mora feed into this? Has the grade three pain been, you know, sort of a pushback from prescribers to date? And then I've got a follow-up.

Yeah, let's take that first on the Danielsa. And just to The next steps 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, Danielsa, Naxidimab, 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 Nexidimab 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 to help them getting access to our vaccine for a study they would like to initiate themselves. And so we are playing on a number of horses from the MSL side with the additional data that are also being generated directly by the sites where 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 Nexelamab combination, as well as we are hoping that Dr. Moore will be allowed to present his step-up protocol. Right now, we cannot use the data from Dr. Moore's step-up protocol in our sales and marketing activities, but Dr. Moore can talk to the sites. 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 Nexidimab. 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. Morris' experience has been with this. So those are, I think, some of the things that we are doing for Nexidimab. 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, Eric.

Yeah, yeah, that's helpful and definitely encouraging. Thanks, Klaus. And one more quick one on the EMBERT-MAB 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 things to actually complete the clinical section and the safety section of the BLA filing. So 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 Umberta MAP. 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 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 sorts of color around the questions that the EMA raised? Thanks.

The EMA questions have reflected almost precisely the questions that the FDA has raised in terms of comparison of data and propensity score 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 e-mail questions at the same time point as we are finalizing the amputament BLA resubmission.

So, it's basically the same types of questions.

Got it. Sounds great. And also, regarding your GD2 SADA, asset that sounds like it's heading to the clinic soon. 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. Thanks.

Yeah, 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 portable to have this Umberto map sorry, not a DOTA lutetium construct home to where the SADA molecule is sitting on the cancer. And we can see that on the SPECT scan we will be doing on the patients, basically from the first patient we are dosing. As soon as we see the SPECT 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 of lutetium-177, but the FDA has accepted that we are starting out with a total lutetium dosing of 200 milligray of the isotope. So we're giving a quite high dose of the isotope. The 200 milligray is the same amount of radiation that's put to the Lutacera product that is being given for treatment of neuroendocrine tumors. So the radiation dose is in the same magnitude as... 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 entire thing radiated? That's probably more up to the question, but there are some things also we will be exploring that. 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. I mean, unless I've completely misunderstood something about radiophysics, then if you put radiation to a cancer, it's going to kill it. Now, of course, there has to be enough of it. So if this works...

it really should have tremendous potential. So we'll get that answer very early on. Did you have a follow-up for this, Adam?

Yes, yes, thanks. Just one quick follow-up on that. So it does sound like, you know, you could potentially have some initial imaging data, you know, maybe at your R&D day by year end. I am kind of wondering, you know, like how should we think about, you know, I guess from a quantitative perspective, you know, like what the imaging data could tell us about, you know, dosimetry as well as localization, given that, you know, lutetium-177 isn't quite a purely diagnostic isotope, and you may be exploring some of the lower doses first. Thanks.

No, lutetium is a... It's 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 milligray of lutetium in DOTA molecules, is the same dose that is being used for Lutacera. And then Lutacera is given bimonthly for up to four doses of 200-milligray. But the total dose that we are sticking into the first patient that will receive a SADA molecule is also 200-milligray of lutetium-177. So it's potentially a treatment. Will there be enough protein sitting on cancers that the DOTA 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. But the spec scans that we'll be doing where you can image things that are 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 home 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 Oles with Morgan Stanley.

Please proceed.

Yep. Hi, guys. Thanks for taking the question. Just one on Danielsa and the label expansion strategy. Wondering 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 were 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? Thanks.

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. Moore'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 COG members. where more than 30 of the hospitals have said they want to participate in our frontline study where we're giving Daniosa together with chemotherapy in the induction setting before surgery and radiation and bone marrow transplant and additional chemo, etc., 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 dinotuximab and Nexidimab in frontline setting in patients that are in first complete remission.

Got it. Thank you. Our next question comes from Joseph Tomey with Cowan & 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 Daniela's launch, once some of these new centers do come online and get trial shipments or file shipments, Do they tend to be reorderers? Can you talk about the frequency there? Thank you.

Yeah, maybe I can answer Daniela first, and then Thomas can elaborate on the SATA 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 reorders. never actually accepted to see any of 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 states right now still. And as I said also, I had a call with one of the COG leaders recently And she said to me during that call that, hey, I mean, it's laborsome to give Danielsa. 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 Nexidimab. But, hey, trust me, it was exactly the same when we started out with Inotuximab. 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 dinatoxamab. They remembered how they needed to learn to give dinatoxamab also in the beginning. And now they have ended up with this humongous 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're handling all the practicalities around it pretty easily. And so the same goes for Danielle. So 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 these data and start implementing them on the sites. for the hospitals to have a lot easier access to treating these patients. But then with that, I'm going to let Thomas comment on the partnering plans for Stata. Thomas?

Yeah, yeah. Thank you, Klaus. So we are in discussions with multiple companies about our own targets, but also, importantly, third-party targets as our licensing agreement is structured 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, but also, importantly, talk to companies on their own targets.

Great. Thank you very much. Our next question comes from Tessa Romero with JP Morgan. Please proceed.

Hey, guys. I hope everyone is doing well. Thanks so much for taking our questions. So I think consensus for Daniela is getting around $78 million, which would imply, I think, about a doubling of sales versus 2021 sales. In your view, what are the levers for exceeding this number and what kind of keeps you up at night? Thanks so much.

Hey, Tessa.

Well, we haven't given any guidance for this year for sales of Danielsa. And a doubling 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 in 10% of increase in vials. We saw an increase from third to fourth quarter of about 7%. And that was in... The rebates in third and 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 which kind of patients that are actually being treated. So I think, Bo, do you have any comments also in terms of market expectations?

Yeah, I think, Cesar, you're right in that the average expectation is 78.2. 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 that it's maybe a little bit of a stretch for this year.

But we'll do our absolute best to see if we can live up to that, but I just don't want to give any guarantees.

Okay. Thanks, Klaus and Bo. I just One more, if I could squeeze one in. You noted a cash run right 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, like in 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. Okay. Thanks so much for taking our questions. Absolutely. Our next question comes from Sebastian Vendors Group with Kempin.

Please proceed. Hi, Tim.

Thanks for the update and taking my questions. The first one regarding the use of Daniela in the real setting versus the clinic. Can you expand on how many files are used per patient in the in the real world versus the clinical setting? And can you also maybe talk a little bit about the difference between MSK and other study centers? And then the second question is on the rest of the pipeline beyond Nuxetamab. Can you expand on what clinical data updates we are expecting in 2022?

Thank you, Sebastian. 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 12230, 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 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 spinotoximab and chemotherapy. And then rather than just sending them home with palliative therapy, then they try a couple of cycles of Nexidimab 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, the MSK have, I mean, like I just told you about the COT investigator I talked to that has many years of experience with dinotuximab 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 have 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 sides have to work a bit harder to get comfortable on how they handle their the reactions to the Danielsa product. And again, also, as I just alluded to with the number of vials, outside of MSK, the product is often being used at later stages, unless it's because the parent insists that they want their kid treated with Danielsa, which also happens. 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, et cetera. 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 Nexidimab. So that in itself is going to add another 15 to 20 sites that have never been practically using Nexidimab. 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 at ASCO to have some data presented on the chemo combination of Naxidimab with Irinotecan and Temazolamide 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. So there will be a number of additional data sets presented for Danielsa later this year.

Okay, thank you. And then regarding the rest of the pipeline, can you maybe, beyond Danielsa, do you have other clinical readouts? Yes.

For the rest of the pipeline, there will be definitely updates from our Onbertomat studies, both in the CNS leptomeningo-metastasis. We will be hopefully finding a suitable venue to present data from the 101 study, including tumor response and progression-free or event-free survival and overall survival from that study. And we will also be having, hopefully, additional data presentations on the DIPT study by Dr. Mark Swardain from Cornell MSK that have done the phase one, two 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 SARA at our R&D day, and hopefully also some additional update on our bispecific platform.

OK, great. Thank you, Klaus. 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 Gadd 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.