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Operator
Welcome to the YMABS Therapeutics Incorporated's first quarter 2021 earnings conference call. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements. as defined in the Private Security Liquidations Reform Act of 1995. Because forward-looking statements involve risk 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 the fiscal year ended December 31st, 2021, as filed with the SEC on March 1st, 2021, and in the company's frequently filed SEC reports. At this time, I would like to turn the conference over to Thomas Gad, the company's founder, chairman, and president. Please go ahead, sir.
Thomas Gad
Thank you, Latonya. Good morning, everyone, and thank you for joining us today for our first quarter 21. So during this quarter, we have continued our execution of our strategy and expanded on all three pillars of our business, which is first, our leading, Monoclonal antibodies, secondly, our by specific compounds develop under the white platform. And finally, the start of technology platform, which we also refer to as liquid radiation. We've had a strong start to 2021 and we are thrilled to submit a marketing authorization application for. For the treatment of pediatric patients with CNN. CNS metastases from high-risk neuroblastoma in Europe. We submitted that last week on April 27th. Further, we gave an update on UmbertoMap in the U.S. and after our Type B meeting with the FDA on March 26th. And here we are continuing to working hard towards being able to resubmit the BLA for UmbertoMap late in this second quarter or in the third quarter of this year. We believe these important achievements as on birth map can potentially address a significant unmet medical need and therefore have a substantial impact on the treatment landscape for CNS metastases where there's currently no standard therapy today. As you know, we received U.S. approval for Danielsa in relapsed primary refractory high-risk neuroblastoma in November last year. delivering Danielsa in the beginning of February and saw demand from hospitals throughout the U.S., so this is very exciting. The first quarter net sales of 5.4 million represents less than two months of commercial sales, and we are pleased to report these first revenue numbers. Although we have not provided guidance on Danielsa sales, I'm pleased to note that despite COVID-19 forcing us into a partial virtual launch mode, both revenues and reach exceeded our internal expectations for these first few months, and we could not be more pleased with that. Going on, the SADA technology continues to look very promising. We recently had positive feedback from the FDA on our pre-IND package on our DD2 SADA construct and expect to file an IND in the fourth quarter of this year. In addition, at ACR in April, we reported that pre-targeted radio immunotherapy against GPA 33 in a center graph model of colon cancer demonstrated a high therapeutic index, a favorable tumor to tissue ratio showing radioactivity uptake of 122 measured 24 hours after injection. GPA 33 is expressed on 95% of all colorectal cancers and the IND for the GPA 33 SATA is targeted for next year. So very exciting. The bispecific programs under the Y-Biclone platform continue to advance. Our IND for nevartrotumab was cleared last year, and we are getting ready to dose the first patients in our small cell lung cancer study this quarter. In addition, we are planning for a phase two expansion in neuroblastoma and osteosarcoma later this year. Our CD33 bispecific for pediatric AML is scheduled to enter into the clinic in late 2021 and will potentially be addressing an important pediatric unmet medical need as AML remains one of the most challenging hematological malignancies for children. I'm pleased to note that Cyclone Pharmaceuticals, our strategic partner for mainland China and Hong Kong, received a clinical trial waiver for Danielsa in March which should accelerate our time to market, and we continue to view this opportunity as significant for YMAPs, potentially serving a large unmet medical need in China. We are very pleased with our progress so far in China. I can also note that Takeda filed a BLA in March of this year for Nasitimab in Israel. So overall, we are very pleased with the continued interest in both Danielsa and on Bertamab globally. We ended the first quarter with approximately 252 million in cash after having closed the sale of our Danielsa Priority Review Voucher for 105 million. Under our agreement with MSK, we received 60% or 62 million of proceeds of that sale. In addition, we completed an oversubscribed secondary offering led by J.B. Morgan, Morgan Stanley, and Bank of America. in which we sold approximately 2.8 million shares of our common stock, including the full exercise of the over-allotment option at $41 a share, resulting in net proceeds of approximately 107 million. So we believe we have a strong balance sheet, not only to support the continued commercialization of Danielsa and potential launch of UmbertoMap, but also to advance our lutetium-conjugated UmbertoMap DTPA construct and NivatrotoMap into late-stage development. At the same time, we continue to advance our two platforms, the Wi-Fi clone platform and the SATA platform. We're very pleased with our current financial position, and Bo will talk more about that later in this call. Taking our achievements into consideration, we believe YMMT is very well positioned to expand on our commercial activities while at the same time advancing our clinical pipeline to continue to address unmet medical needs, and we are very excited to continue to do so. And I'm pleased to hand over the call to Dr. Murlau, Chief Executive Officer. Thank you.
Latonya
Thank you, Thomas, and welcome to YMAP's first quarter 2021 earnings call. We're very pleased that you have chosen to join us today. During the first quarter, we have worked hard to ensure that our pipeline advances towards the market. Our efforts included initiating commercial sales of Danielsa in the U.S., as Thomas just alluded to, while at the same time making progress with the resubmission of the ambertumab BLA and submitting the European marketing authorization application for ambertumab. In addition, we have initiated a Phase II study with nevotrotumab in small cell lung cancer under our own IND and initiated two Phase I-II studies with lutetium-177 ambertumab DTPA in medulloblastoma and in B7H3-positive CNS-leptomynical metastasis tumors in adult patients. and advanced our ongoing studies in other areas. We are also continuing to work on new bispecific constructs in our SADA programs. Now let me turn to Nuxetamab. Thanielsa is indicated in combination with DMCSF for the treatment of pediatric patients one year of age or older and adult patients with relapse or refractory high-risk neuroblastoma in the bone or bone marrow, who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved by the FDA under accelerated approval regulation based on overall response rate and duration of response. We were thrilled to send out the first commercial vials to treatment centers, including MSK, across the country in early February. The total net sales of 5.4 million, as Thomas just mentioned, we are very pleased with the launch. As you would expect, MSK is our largest customer to date. But vials have been shipped to more than 10 other cancer centers across the country now. And our highly targeted commercial and medical affairs organization has done an outstanding job in educating physicians and nurses about Danielsa. Many treatment centers have had their first experience with Danielsa, and we believe that treatments have gone generally very well. In addition, we have had pre-BLA meetings in China, and together with Cyclone, we expect to submit the Chinese BLA in third quarter this year, which hopefully will lead to a 2022 approval and launch in China. Our clinical trials ongoing with Anielsa in Barcelona, Spain, and at MSK in New York for our first-line neuroblastoma maintenance treatment, as well as chemotherapy combination with Naxidimab, for refractory and over-stomach patients are also progressing nicely. We are working to initiate an international phase two multi-center trials for Danielsa in both frontline and with chemo combination treatments, and we also have a phase two osteosarcoma multi-center trial ongoing. Now, turning to UmbertaMap, on March 26th, we had a Type B meeting with the US FDA to discuss the road towards resubmission of the BLA of for treatment of pediatric patients with CNS leptomaniacal metastasis from . We are maintaining a very close and open dialogue with the FDA regarding the resubmission and have scheduled a second type B meeting on June 1st, where we hope to reach final agreement with the agency on the remaining details concerning the granularity of the data from our identified historical control groups and how we would work forward with this. In order to agree on the statistical analysis plan, this additional granularity data was submitted to the FDA in late April. We still aim to resubmit the UmbertoMap BLA in the form of a rolling BLA by the end of second quarter or insert quarter of 2021. The European marketing application for UmbertoMap was prepared in parallel with the U.S. BLA and was submitted to the European Medicines Agency EMA last week on April 27th. The evaluation of our application is scheduled for 210 days. However, the review clock stops whenever we respond to any questions posed by the FDA, the European regulatory authorities, and the clock resumes only once we have submitted our responses. So the 210 days is without any responses from our side. In addition, we have begun staffing for our European commercial organization this quarter, and we are excited to prepare for our first European product launch. As previously disclosed, We are also developing ombertumab for diffuse intrinsic pontine glioma, known as DIPG, in a Phase I study at MSK, and we are planning to open a multi-center Phase II study for DIPG patients later this year. For desmoplastic small round cell tumors, known as DSSICT, we have a Phase II study ongoing at MSK. Then turning to the lutetium-labeled version of our ombertumab B7H3 antibody. In October 2020, the FDA cleared our IMD for the 177-glutisimum vertum of DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children. Medulloblastoma are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain and the spinal cord. Our international multi-center phase 1-2 trial is open for pediatric patients with medulloblastoma And based on our clinical experience from treating 27 patients with medulloblastoma with our iodine-131 ambertumab construct, we are very enthusiastic about this new trial. And to see this construct moving into the clinic and to get started on establishing safety profiles to determine the maximum tolerated doses in this mode of using the ambertumab antibody. In this study, known as TRIO-1, we hope to leverage our prior clinical experience from the iodine-131 ombrotumab, once again giving the infusion through an Amaya-Casiton reservoir. In addition, our basket trial in B7H3-positive CNS leptomeningo cancers in adults, known as study TRIO-2, where we hope to leverage our prior experience from treating more than 25 adults with the iodinated version of ombrotumab, is now open for the first adult patients to be screened and treated with the 177 Lutetium and Bertramot DTPA. And we are thrilled to widen our clinical reach to include adult indications. On our bispecifics, we're also excited to widen the Nebotrosomat clinical reach to include adult cancer patients in our phase two study with subcutaneous administration of the bispecific. We also plan to expand the ongoing Nevotrotumab at MSK into separate phase two arms, one in the oblastoma and one in osteosarcoma. In addition, we are preparing an IND for the next in-line bispecific antibody, the CD33 bispecific generated on our Y-Biclone platform. And the IND for pediatric AML is scheduled for second quarter this year, which is the current quarter. Now turning to our starter technology, As you know, we are very excited about the prospects for this technology, and we are making good progress on preparing our four disclosed SATA targets for clinical development. At the AACR annual meeting in April, we presented our first animal data for the DPA33 SATA. In a xenograft model of colorectal peritoneal carcinomatosis, DPA33 SATA showed a favorable tumor-to-blood radioactivity uptake of 122 measured 24 hours after injection. DPA-33 is expressed on 95% of all colorectal cancers, and we are targeting an IND for the DPA-33 next year. Our other publicly announced targets includes DD2-SATA for potential use in DD2-positive solid tumors, for which we expect to submit our first IND in the fourth quarter of 2021. We also have a B783 SADA for the intended use in treatment of prostate cancer, and we have a HER2 SADA for potential use in breast cancer. We believe the SADA technology can potentially improve the efficacy of radiolabeled therapies in tumors that have not historically demonstrated meaningful responses to radiolabeled agents. And we are truly excited about our SADA technology, or liquid radiation technology. With the launch of Thanielsa, already leading to deliveries to multiple treatment centers across the country and internationally, and the planned resubmission of the Ombrtima PLA coming up. We believe that we are well-positioned to continue the development of YMAX as a commercial stage company. Concurrently, we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the bispecifics, and the next-generation Ombrtima PCPA radiolabeled antibodies. In other words, we remain busy, And we are very excited to move forward and build a business that helps patients and elevates our continued development. Now, let me invite Bo to share his remarks on this quarter's financials.
Thomas
Thank you, Klaus. We reported net income for the quarter ended March 31st, 2021 of 33.4 million, corresponding to 80 cents per basic share or 75 shins on a fully diluted basis. This compares to a net loss of 26.6. 6.2 million or 26 cent per share basic and loser for the quarter ended March 31st, 2020. The main reasons for the net income to go up is revenues and other income. We reported that net revenues of 5.4 million for the quarter ended March 31st, 2021 representing the sales of Danilza. And there were no revenues reported in the quarter ended March 31st, 2020. We also recognized 62 million from monetization of the Danielsa PFE as other income in the quarter ended March 31st, 2021, whereas there was no other income in the quarter ended March 31st, 2020. As we take a closer look at the operating expenses for the first quarter of this year, we note that R&D expenses have increased by 3 million from 18.6 million for the quarter ended March 31st, 2020, to $21.6 million for the quarter ended March 31, 2021. This increase was primarily attributable to a $2 million increase in outsourced manufacturing expenses, $2.5 million increase in employee-related costs, and $0.8 million increase in the clinical trials in the first quarter of this year. The increases were partially offset by a $3.1 million decrease in outsourced research and supplies. Selling, general, and administrative expenses increased by $3.9 million from $8.1 million in the quarter ended March 31, 2020 to $12 million for the quarter ended March 31, 2021. The increase in selling, general, and administrative expenses primarily reflects a $3.3 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation for personnel. We ended the first quarter with a cash position of 252.3 million compared with the 2020 year-end cash position of 114.6 million. The increase was driven partly by the completion of the sale of our Danilza PFE in January, and partly it reflects the 107.7 million net rates in conjunction with our secondary offering in February. Cash used in operating activities show that the cash burn increased by $10.1 million to $31.9 million for the quarter ended March 31, 2021. The increase was primarily caused by the increase in operating expenses for the period as our work on the Alberta Map BLA resubmission has progressed. We will continue to accelerate the launch activities of the Nielsa and Alberta Map if approved, which has also caused our operating cash burn to increase. the cash burn from operating activities for 2021 to remain roughly in line with the rate of the first quarter of 2021. We continue to believe that YMAS remain in a healthy financial position. This concludes the financial update, and I'll now turn the call over to Thomas.
Thomas Gad
Thank you, Bo, and thank you, Klaus. Latonya, I think we can open up the lines for Q&A at this point. Thank you.
Operator
Thank you. At this time, we will conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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. Once again, that's star 1 at this time. One moment while we pull for our first question. Our first question comes from David from Morgan Stanley. Please proceed.
David
Thank you very much for taking my question. Congrats on the nice launch. My question is on the launch itself. Are there any specific dynamics regarding the initial uptake aside obviously from Memorialstone Kettering being the largest customer? Is there any stocking that some hospitals might do to prepare? Will there be a lumpiness that we might see as the year goes on, just given the nature of the small population? Any insight you might provide there would be helpful.
Latonya
Yeah, absolutely. Thank you, David. And I think, of course, there were a number of patients that was converted special license use or compassionate use when the product became commercially available that that was converted at msk but i don't think you'll see any stocking of this so it's that's just reflecting you can say maybe a quicker ramp up than than you could have expected but but i definitely don't can foresee that that from the ordering that we have seen that that sites are stocking up anything typically The site will be using two vials per infusion per patient and typically doing four cycle, three infusion Monday, Wednesday, Friday. So if they're planning to treat the patient next week, they would have ordered the product by yesterday, this week, six vials for the next week. And we can see that's the pattern we see from both at MSK and also sites outside MSK. They order for the patient that they're planning to treat the following week. and because we can ship basically on a day-to-day, and it's a relatively expensive product. So I don't think there's any stocking issue, and I think, as I said, we are very comfortable with the initial loans. We are, in particular, very pleased to see that a number of sites, as I said, more than 10 sites outside MSK have started using Damiosa, and I think some of them have treated actually quite a bit of patients now, and are continuing to put new patients on treatment. So very good start for us, very happy with the sales teams.
David
But that's helpful. As far as the special license use being converted, is that mostly done at this point, or should we expect more of those patients to convert as the year progresses?
Latonya
No, that happened in February. So that's done. So nobody, no more patients had early access And I think the last clinical trial patients, so there was still a few study patients that needed to go into our clinical trials, but that's also happened in first quarter. So we don't have any additional clinical trial recruitments ongoing in the U.S. for Nexedema. So I think we are no more early access patients and no more clinical trials.
David
Thank you very much for taking my questions. And again, congrats on the first quarter launch.
Operator
Thank you very much, David. Our next question comes from Alex Stranahan with Bank of America. Please proceed.
David
Hey, guys. Thanks for taking our questions, and I want to offer my congrats on the launch so far as well. Two from me. So, the first, United Therapeutics posted better-than-expected sales for Unitoxin 1Q, and they pointed to the fact that kids are starting to come back for treatment as the pandemic abates. So, I'd be interested to hear whether your seeing similar market dynamics for Danielza. And then any feedback you're receiving on clinical experience and treatment sites outside of MSK that are maybe using Danielza for the first time would be great. Thanks.
Latonya
Thanks, Alec. And I think it's difficult for us to say anything about whether patients are coming back from COVID-19. I would say the number of patients we see on the site we know the best, which is, of course, MSK, is pretty stable, was stable last year, and doesn't seem to have changed a lot. I think what the increased sales number for United Therapeutics, to the best of my knowledge, is two things. It's a plus 13% price increase by January 1st, which always helps a bit, but it's also the fact that United Therapeutics, as you may also have seen in their report, decided to abandon their attempt to get a supplementary BLA for the relapsed refractory setting, where we have an approval And I think that made them stop sponsoring clinical trials in the relapsed refractory setting. And therefore, those trials are continuing on the COG auspicious, and they probably now have to buy the product. So I think it's a combination of those things. But it's great to see that the market has that size because it's reinforcing us and that we have a fantastic opportunity for these patients in the relapsed refractory setting that is offering a treatment that doesn't necessitate hospitalization for eight days in the context of administrating this product, and that it's not a 10- to 20-hour infusion, but just a median time to infusion is about 37 minutes for Nexetamab, while we're still giving two and a half times as much antibody. So I think we are very satisfied with the situation, but of course also with the fact that the United States gave up getting a Uh, the approval for a supplementary and with actual factory setting.
David
Did that answer your question now? Yeah, the feedback on the, um, on maybe sites that are using Daniel for the 1st time, just their clinical experience.
Latonya
Yeah, I think we have been positively surprised, but I also know that our research nurses and MSLs are doing a great job in making sure that the centers are comfortable. I mean, I'm not saying that nobody is seeing any side effects or having any infusion issues. You always have that, in particular with a product like a DD2 antibody, but it's gone very well. And as I also mentioned, we have sites that have treated more than four patients already. So that's been very encouraging. So most of the experience has been very positive.
David
Okay, great. Thanks, and congrats again on the progress. Thank you very much, Anik.
Operator
Our next question comes from Edson DeRuyt with Guggenheim. Please proceed.
spk09
Great. Thanks for taking the questions and offering up congrats as well on sort of the early launch for Danielle's, I guess. And first question is, are you seeing enough maybe data week to week to gauge sort of demand beyond MSK at this point? I know it's fairly, and I guess, you know, as you think about sort of the second quarter and beyond, and then I have a second question.
Latonya
Well, I mean, I think it's way too early for us to start guiding on anything. We are satisfied with what we saw in the first quarter. If you were broadening it to say, would I expect that we would be able to beat first quarter sales in the second quarter? I certainly hope so. But I think we are at a very early stage now. But that's also kind of like responding to the issue about the stocking. I don't think what we saw with the $5.4 million net sales in first quarter was a reflection of somebody stocking the product. So I would definitely expect us to be able to exceed that sales number for the second quarter. But right now, to start predicting anything, I think it's too early.
spk09
Great, great. And I've been getting questions around sort of going back to sort of the bystander effect with antibody drug conjugates. And, you know, we talked about this earlier on. Just wondered if you could maybe sort of compare and contrast, if you will, with sort of the radionucleotide and its ability in terms of sort of the bystander effect, just given sort of the interest that we see sort of coming in from investors to this point.
Latonya
Yes, I mean, there's no doubt that the interest in radioconjugated antibody construct is increasing also from big pharma. I think everybody is paying attention to Roche that recently presented new data with their three-step technology for basically a similar type of technology. The only thing to our startup, they're just using full antibodies and a clearing agent. And then instead of using a beta emitter, they're using an alpha emitter. But with our technology, we can also use alpha emitters. I'm a strong believer in alpha emitters. We're just not at the point where we have a construct that I'm ready to push formally into preclinical development. But we believe that our protease technology for using alpha emitters with our SatoTech will be ready within the next 12 to 18 months to initiate a formalized development. So we do see a lot of interest. We also see a lot of interest from potential pharma partners to work with us on this technology. For everybody that looks carefully at the SATA check, it stands out compared to anything else that's out there in the radioconjugated field, and that's also the feedback that we start getting from potential partnering. Did that answer the question?
spk09
Yeah, just maybe more specifics around sort of the bystander effect with radionucleotides compared to sort of what we see with ADCs.
Latonya
Well, I mean, the challenge with the radionucleotides is that if you don't get rid of them, they keep circulating through your bone marrow, and your bone marrow is the most sensitive organ. You can also see something in the liver and the heart and the kidneys, but the bone marrow is typically where people is limited, and of course also the blood. And with the technology we are using, because we give the isotope capes in a donor molecule that is very tiny, it leaks out through the kidneys within hours after the administration. And there's one thing that is the primary, there's actually two things that drives the radiation damage you get to other tissues, and that is the duration of the exposure, and then of course also the intensity. But you can, with those few hours of circulation of our isotope, you can get to quite extensive amounts of radiation. You may remember that Lutocera, for neuroendocrine tumors is given as 200 milligrees on a peptide that is having a relatively short circulation time, but 200 milligrees is a relatively high dose. That's four times as much as we're giving for the umbertumab. So I think we will see, and I think that's also reflected with the data from the TPA33 that was presented at ACR with 122-fold as much radiation to the cancer cells as we got to the blood in those animals. I think that is what we can show that nobody else can show. The only other data in this ballpark you can see is coming out from the tree-step procedures where you use a dextron-like molecule to eliminate all circulating full antibodies. But for a cancer patient to lose all your antibodies is probably not an optimal setting. It works fine in an animal, but I would be cautious on it. on exposing cancer patients for the risk of losing all their circulating antibodies, including potential anti-tumor antibodies. But that's a completely different discussion. The time will show.
spk09
Right. Great. Thank you, and congrats again on the progress.
Latonya
Thank you very much.
Operator
Our next question comes from Joe Thome with Cowan. Please proceed.
Joe Thome
Hi there. Good morning, and thank you for taking my question. Um, just a couple of the launch, if you could just walk us through a little bit, um, the process of bringing new centers on board. Is there a, um. Duration that's associated with that you have to work through any sort of kind of committee approval in order to get Danielle on board broadly. And then 2nd, from a reimbursement perspective, have you seen any pushbacks from any centers outside of and how much time will it take if there is any to stabilize that? Thank you.
Latonya
Sure. So we have a pretty clear setup for this, and we also have a hub where we can help getting patient registered and help also getting reimbursement in place. Typically what happens is, first of all, we haven't incurred any problems getting permission at sites to actually bring the product into the hospitals. So that has been operating pretty smoothly. Almost everybody has been interested in getting practical assistance in terms of talking to research nurses that know about the practicalities around the administration of the antibody and our MSLs about the potential side effects, et cetera. So that has been quite smoothly. Reimbursement, of course, we were very interested and excited about how that would actually go. And I can say until now we have not had a single patient that was refused reimbursement. And most, I would say more than 90% of the patients get the reimbursement in place within one to two weeks after the doctor suggests that they should have Nexedema. We've only had one patient where it took four weeks, and that was the only time we've had that insurance company into the process. And they gave in and accepted reimbursement. There was no issues with that in the end. So that has been very nice and very successful. So we were pleased with that. There's no doubt in my mind that we are addressing an unmet medical need. And I also have heard about the first cases of patients where the parents have actually pointed to the possibility of rather than in this laboratory setting treating their kids with dinotoxin map and chemo asked for Nexonimab. So I think we are making good progress.
Joe Thome
That's great and very helpful. Thank you very much.
Operator
Our next question comes from Robert Burns with HC Wainwright. Please proceed.
Robert Burns
Hi, guys. Thanks for taking my questions, and congrats on the launch as well as the quarter. Just one for me, if I may. So I'm curious as to how many of the Tier 1 prescribers has your commercialization team been able to make contact with to date, and does the rate of contact track with your own internal expectations, or has the pandemic affected it?
Latonya
Well, I can say that I don't know what the rate in terms of Tier 1 customers that we have actually made contact with, but I would guess that we have made contact with about two-thirds at least of them. And I can also see that among the sites that we have started shipping product to, there's a couple of the really big Tier 1 hospitals that have started trying to use Nexetamab.
Robert Burns
Okay, that's completely fair. One additional follow-up. I'm sort of curious as well, since you've, you know, you've made contact with two-thirds of the Tier 1 prescribers. You know, what is the average timing between contact and actual ordering of Danielle's? And have there been any gating factors on the prescriber end outside of the frequency that these patients are seen that has limited Danielle's?
Latonya
Rob, I think it's way too early to have thought that. elaborating on that. Of course, we have a lot of statistics on this now, but it's only for two months. And as I said, actually, as we are speaking now, it's for three months. But I would say I've not heard about any site, Tier 1, Tier 2, Tier 3, that has said, you know, this is not relevant. I mean, some doctors of the attitude, especially if they were principal investigators of the Naxidimab or the Ombritumab clinical trial, not Ombritumab, the Unitoxin clinical trials, that they can do everything they need for these patients with unitoxin, but in reality, it's not the truth. I mean, it gives all by itself that if you have a clinical study where only 42% of the patients come into remission, you have 58% of your patients that has an issue. But, you know, We are very early into the launch. We are very happy with what we have seen, and I'm in particular very happy that we have been able to get actual commercial sales to more than 10 sites outside MSK. So this early on in the launch process, and we keep pushing out there and are seeing, I would say, continued strong interest in the product.
Robert Burns
No, I completely agree. Thank you for the clarity, Klaus. Thank you. Have a good day.
Operator
Our next question comes from Peter Lawson with Barclays. Please proceed.
Peter Lawson
Hey, thanks for taking the question. Just as we think about the sales over the last quarter or part quarter and how they've trended and what's that look like going into April?
Latonya
Well, I think it's very early for us to give any indications. I think I've stretched myself as far as I can when I said I I certainly foresee that we would be able to outperform the sales of first quarter and the second quarter. So definitely, we have no indications that what we saw in the first quarter is not reflecting real sales or use of the product. As I said, we can see the sites are actually ordering when they have a patient. They're getting ready to treat the patient the next week. They order before the end of the previous week. So nobody is stocking up. You know, if you look at our clinical trial data that has been published, the median or the average number of doses or cycles, sorry, the average cycle number per patient in this relapsing factor is 5.3 cycles of antibody. And so that takes into consideration that some patients drop off after one cycle and some patients progress after three or four cycles and therefore drop off. But you end up with an average, because we say we give five cycles after you come into remission, and that typically happens after one, two, or three cycles. And so if you are in remission after three cycles, you end up with eight cycles. So the median is expected to be 5.3 based on our clinical trial data. And that means that all the new patients that started in February and in March and in April, they will continue for an average of 5.3 cycles, which means the February patients will on average finish their treatment in July. And so that means that we have a number of patients that come back right now for re-treatment every month. Did that answer the question?
Peter Lawson
Yes, that's really helpful. What percentage of the sites do you think are treating more than one patient or have had, I guess, discontinuations or? Just the kind of the pros and the cons.
Latonya
I don't think we have any sites that have said, well, this was such a bad experience. I'm never going to use Nexidimab again. I don't think that has happened yet. It may happen at some time point, but, you know, it hasn't happened yet. And I think there's definitely a number of sites that have, as I said, reported positively back and started treating not only one patient but several patients. But as I said, we are very early into the launch. We're talking very preliminary data. I certainly hope when we have the second quarter call that we will be able to give a bit more details. But I think typically you want to have at least three or four quarters before you start feeling more comfortable about treatment and retreatment and how many patients actually completed all the cycles that were intended, and to see whether the 5.3 average number of cycles that we saw in the clinical trials is also reflected on what's happening in the clinic. So I think we are very early on, and I hope that gives you some clarification, Peter.
Peter Lawson
Yes, that's correct. Have you had any sites that have converted from United Stroke that have got SARS-CoV-2?
Latonya
Well, it's two different indications. I don't think any of the sites outside MSK that are using unitoxin would stop using unitoxin because it's approved in patients that are in complete remission and frontline. So many of them would probably continue with that for a while until the parents say, hey, come on, I don't want my kid in the hospital. I want my kid to be treated with a new outpatient treatment, but more data needs to be reported and Hopefully, we at some time point can get a supplementary BLA for the frontline indication. But I think we are, as I said, very early on now. And so we are approved in an indication where nothing else is approved. Our United Therapeutics just told us that in their quarterly report that they are not pursuing a supplementary BLA for those patients.
Peter Lawson
Perfect. Thank you so much. Congrats.
Operator
Thank you. Once again, ladies and gentlemen, to ask a question, that's star one on your telephone keypad. Our next question comes from Tessa Romero, JP Morgan. Please proceed.
Tessa Romero
Good morning, guys. Thanks for taking our question and congrats on the initial progress here. Switching gears to a pipeline question from me, a question actually on the upcoming ASCO presentations. I think you will be giving an update on the phase one DIPG study. How should we be thinking about a win scenario for this update? And then can you remind us what are the next steps in the DIPG and DSRCT indications? Thanks so much.
Latonya
Yes, so the DIPG is an update presentation from what was presented two years ago in 2019 by Mark Svodane. So you'll see data from a higher dose cohorts and you'll see data on more patients, and you'll see additional follow-up on the survival. As you may recall, the survival in these patients is typically less than 10% after two years, and very, very rarely you see patients surviving five years. So that's what you could expect. And in terms of continued planning for the DIPD, it's our intention to initiate later this year a multi-center phase two study that potentially could support a supplementary BLA for ombertumab iodine in the indication DIPT. So, but first we need to get the approval for ombertumab in the CNS leptomeningolobastoma indication, and then with the data from that phase two study, hopefully we can get a supplementary BLA, or as a minimum together with the phase one study from MSK, generate enough data to support reimbursement or compendia listing for umbertumab iodine in the DIPG setting. On the DSS-RCT, as you may also recall, that's a very tiny little indication. It's maybe 150 young adults and teenagers every year in the U.S. that's diagnosed with this horrible sarcoma in Tapir-Tuneli. And there we give the umbertumab iodine as an IP administration in 250 mLs of saline solution to these patients. And they first started the Phase I study where data was presented at CTOS in 2019. We had shown the safety and clear indication of treatment benefit in the Phase I study where patients only were given one dose. And now we have expanded into a Phase II study where patients received two doses. Again, as I said, I think the regulatory pass for these patients is still a little uncertain in the current setting. As I said, it's an ultra-orphan indication. Would it be sufficient to have data published just to see any uptake in that? We'll have to wait and see until the product comes to the market and more data is generated and what the FDA attitude would be to this. But it's definitely the data that's being generated in that setting also.
Tessa Romero
Okay, great. Thanks. And then 1 clarifying question. Hopefully it's quick. It's just. Have you guided to a number of sites. For Danielle's up by the end of this year, I'm just wondering if is that you have internal we haven't given any guidance at all.
Latonya
I think what we have said is that I think, uh. Oh, remind me, the media and analyst expectation for sales is for Daniela this year. What is that? Is that 2013? Sorry. That's in the mid-20s.
Tessa Romero
Clouds, not sales, just sites.
Latonya
Yeah, but that was my point. We haven't said anything about sites. We have said that... We are very comfortable with the median sales estimation by the analysts and feel comfortable that we can definitely reach and most likely also exceed that median. But we are still very cautious in what we are. We need to learn more about what's happening out there and also to see how well the centers, and as I said, until now we have been very positively surprised at how well the centers is managing the administration of Nexidimab. So they are definitely doing a good job, but we are early on in this process, but very positively surprised about how things have been going.
Tessa Romero
Okay.
Latonya
I hope that was a little helpful, not too helpful.
Tessa Romero
No, no, that's great. I just wanted to clarify. Thanks so much.
Operator
Yeah. Thank you. At this time, I would like to turn the call back over to management for closing comments.
Thomas Gad
All right. Well, thank you, everyone, for joining us today, and we look forward to continuing working on maps and expanding our pipeline and launches. Well, thank you. Have a great weekend. Thank you.
Operator
Thank you. This does conclude today's teleconference. You may disconnect your lines at this time, and thank you for your participation, and have a great day.
Tessa Romero
Thank you.
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