Good morning, and welcome to Y-mAbs Therapeutics Third Quarter 2023 Earnings Conference Call. Please note that today's event is being recorded. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow the prepared remarks. I would now like to turn the conference call over to Courtney Dugan, Vice President, Investor Relations. Please go ahead. Thank you, operator, and good morning, everyone. Welcome to our Third Quarter 2023 Earnings Conference Call. We issued a press release with our results yesterday at market close. The press release and accompanying slides are available on the Investor Relations section of our website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, expectations with respect to early trial data, current and future clinical and preclinical studies in our research and development programs, expectations related to the timing of the initiation and completion of regulatory submissions, regulatory, marketing and reimbursement approvals, including statements with respect to future development of other development programs, potential for DANYELZA territory expansion and advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash burn rate, the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2023 and beyond and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements, and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future potential 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 quarterly report on Form 10-Q for the quarter ended September 30th, 2023, as filed with the SEC on November 15th, 2023. I would now like to turn the call over to our Founder, Vice Chairman of the Board of Directors, and Chief Business Officer, Thomas Gad. Thank you, Courtney. Good morning, everybody, and thank you for joining us today. I have with me today our Chief Financial Officer, Bo Kruse, our Chief Commercial Officer, Sue Smith, and our Chief Scientific Officer, Dr. Steen Lisby. I'm also very excited to welcome our newly appointed President and Chief Executive Officer, Michael Rossi. On today's call, Mike will begin by reviewing third quarter global highlights on DANYELZA sales, updates on our ongoing naxitamab clinical trials, and high-level updates around our SADA program. Sue will then report further insights into our U.S. DANYELZA sales in the third quarter. Next, Steen will provide further details on our phase I GD2-SADA trial currently underway, in addition to updates on our CD38-SADA program, for which we recently received IND clearance by the U.S. FDA. Bo will provide an overview of our third quarter financial performance, our cash resources, and our full year 2023 guidance before we open the line for Q&A. Before we get into the third quarter results, on behalf of the Y-mAbs Board of Directors and our senior leadership team, I want to extend a very warm welcome to our new President and CEO, Michael Rossi, who officially started on November 6th. Our board has conducted a careful search for the right dedicated leader of our company with deep commercial and radiopharmaceutical experience, and we are very pleased to have found that in Mike. Michael brings over 30 years of experience in the radiopharmaceutical industry. He joins us from Mirion Technologies, where he served as the President of the Medical Group. Prior to that, Mike was the Head of Radioligand Imaging at Advanced Accelerator Applications, better known as Triple A, a Novartis company, and before that, he led the growth of Jubilant Radiopharma into a vertical, integrated radiopharmaceutical leader. Early in his career, Mike spent over a decade at GE Healthcare, and he's also a certified nuclear pharmacist. As we continue our efforts to expand the geographic reach of DANYELZA and further our indication expansion initiatives to maximize the utility of this therapy, we are also incredibly excited about our novel two-step pre-targeted radioimmunotherapy platform, better known as SADA, and its potential to unlock the value of radiopharmaceuticals in the cancer treatment paradigm. After our reorg in the first quarter of this year, Y-mAbs has been positioned as one of the few independent commercial-stage biotech companies with sufficient financial resources to advance SADA through proof of concept. This is the right time for me to transition to a new role of Vice Chairman and Chief Business Officer, and I very much look forward to working closely with Mike and our board and the entire Y-mAbs team on our continued mission to bring novel therapeutics to cancer patients. With that, I'm very excited to turn the call over to Mike. Go ahead, Mike. Thank you, Thomas, for that introduction. It's great to be joining you all today for our Y-mAbs third quarter earnings call. As Thomas mentioned, I've built a 30+-year career in healthcare with a specific focus on radiopharmaceuticals. Y-mAbs is a pioneer in pre-targeted radioimmune therapy with its SADA technology platform, which is a key driver of my own personal excitement about joining Y-mAbs. SADA stands out as a highly differentiated, pre-targeted, two-step platform that is designed to enable precise radioisotope delivery. I truly believe that SADA has the potential to shift the treatment paradigm in radiotherapy. In addition, we have the promising DANYELZA franchise, where we expect to have a growing stream of revenue with our commercial product, DANYELZA, to independently support our clinical development work with SADA in a rapidly expanding radiopharma market. With our phase I GD2-SADA trial underway, and our phase I CD38-SADA trial anticipated to initiate next year, and several additional exciting targets currently in preclinical development, we believe we have a highly promising clinical pipeline ahead. Now, let's dive into the key highlights for the quarter, starting with DANYELZA. As a reminder, DANYELZA is approved by the U.S. FDA for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow of patients who have demonstrated a partial response, minor response, or stable disease with prior therapies. Neuroblastoma is the most common cancer in infants and the third most common cancer in children. In the third quarter of this year, we achieved $20 million in net product sales of DANYELZA, up 59% from what we recorded in the third quarter of 2022. We continue to make significant progress in our commercialization efforts for DANYELZA, and we are gaining momentum in the U.S. with a number of new accounts. We now have 57 sites activated across the U.S. since DANYELZA's launch, with nine new accounts so far in 2023. We continue to expand our global commercial footprint through partnerships and recently received regulatory approval of DANYELZA in Mexico, marking our second regulatory approval in Latin America with our partner, Adium. In addition, or as discussed last quarter, our partner, SciClone, successfully launched DANYELZA in China in June of this year. In terms of the number of vials used, in the first full quarter since the commercial launch in China, usage in China has been approximately 50% of the vials used in the U.S. during the quarter. While it's still early, we look forward to seeing the sales progress and trends in the region over the coming months. We see China as a key region for DANYELZA, and we look forward to providing an update in the coming quarters. We continue to be very pleased with the NPP program in Europe, with 19 patients treated with DANYELZA through the end of Q3. The continued geographic expansion of DANYELZA across these regions is an important step in our mission to enable broad global access for DANYELZA for patients with high-risk relapsed or refractory neuroblastoma. We remain encouraged by the expansion of DANYELZA, accumulating global net sales of more than $61 million in the first nine months of 2023, as we continue to gain further traction with physicians prescribing DANYELZA. We remain confident in our ability to continue to expand our global commercial market footprint and meet our full-year 2023 DANYELZA net product revenue guidance of between $80 million and $85 million. Excuse me, Sue will provide further color on DANYELZA sales in the quarter shortly. Now, let me briefly comment on our ongoing naxitamab clinical trials. We continue to make progress on our investigator-sponsored clinical trials in collaboration with leading KOLs to efficiently advance potential label expansion opportunities for DANYELZA. In the frontline high-risk neuroblastoma setting, we are partnering with the Beat Childhood Cancer Research Consortium, or BCC, in multicenter phase II trial, evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. To date, nine sites have been initiated, and six patients have been dosed. The study is expected to transition from a single-arm study with naxitamab added to the current standard treatment for induction, to a randomized study where the control arm will be the current standard of care for induction therapy, which is chemotherapy ± an ALK inhibitor, for which we plan to file an IND. As a reminder, the patient recruitment for the trial is projected over a span of 5 years, with an anticipated total trial sample size of approximately 282 patients. Our aim for the trial is to demonstrate a superiority in naxitamab arm versus standard of care. We expect to potentially initiate the new randomized study in the second quarter of next year. In osteosarcoma, we're continuing to work with Memorial Sloan Kettering Cancer Center, or MSK, on its multi-center investigator-sponsored trial for naxitamab. We anticipate MSK to provide a data readout from this phase I/2 trial in fourth quarter of 2024, and if positive, we hope to then begin recruitment for a pivotal randomized phase III trial. In addition, we are pleased with the publication of the study of naxitamab-based chemo immunotherapy HITS trial in patients with chemo-resistant, high-risk neuroblastoma in the journal, Cancers. In this trial, patients who received HITS immediately after induction had higher response rates, 47% versus 18% and superior, superior estimated 3-year overall survival, 85% versus 29%, compared with those who received the same combination regimen later in the course of treatment. These results further supported the utilization of naxitamab early during the course of treatment for patients with chemo-resistant high-risk neuroblastoma. We are continuing to work to unlock further value of naxitamab and truly believe in its potential to fill a much-needed treatment gaps in both pediatric and adult cancers for patients worldwide. Now, moving on to SADA. Our novel SADA technology platform is a key driver of my own personal excitement about joining Y-mAbs. Throughout my extensive career in various radiopharma leadership roles, I've had the privilege to witness the development of numerous breakthrough technological platforms. However, SADA, which is licensed by Y-mAbs from MSK and the Massachusetts Institute of Technology in 2020, stands out as a highly differentiated, pre-targeted, two-step platform that is designed to enable precise radioisotope delivery. We truly believe that SADA has the potential to shift the radiotherapy treatment paradigm and potentially be impactful in the fight against a wide variety of cancers. Steen will provide further color on our specific platforms later in today's call, but let me provide a high-level overview of where we currently are with our SADA pipeline. Our first program, GD2-SADA, began phase I development earlier this year. To date, we have completed dosing cohorts, cohorts 1 and 2, currently administering doses in cohort 3. Despite the limited patient sample size to date, we're very pleased with the positive progress we've seen so far, and we have decided to share early PK and proof of concept for our SADA platform during this call. Due to the progress we are seeing, we have elected to focus on a more mature phase I data readout at a major medical meeting next year in lieu of an R&D day event in December. Our second program, CD38 SADA, recently received IND clearance from the U.S. FDA to enter clinical development. We are particularly excited about the program, given our team's deep CD38 targeted drug development experience. We anticipate exploring potential partnership opportunities as this program advances. The phase I dose escalation, open label, single-arm, multicenter trial, evaluating the safety and tolerability of CD38 SADA in patients with relapsed or refractory non-Hodgkin's lymphoma, is anticipated to begin next year. We believe there remains a significant unmet medical need for these patients of both B-cell and T-cell origin, and we look forward to providing further updates as our program advances. In addition, we are continuing to advance multiple preclinical SADA targets and have made encouraging progress, especially on our HER2 and B7-H3 constructs. As we look ahead to the rest of 2023 and beyond, we believe we are well-positioned with $86.6 million in cash and cash equivalents as of the end of third quarter 2023, which now believe will extend our cash runway to support our business operations as currently planned into 2027. Of note, our use of cash was only $1.3 million in the third quarter of this year, a direct result of effective capital management strategy and action following our reorganization earlier this year. We believe we have the right strategy in place to drive further DANYELZA sales growth, which serves as the financial foundation to propel our SADA technology through clinical development with our two lead programs. We believe we're in a great position to bring forward additional novel therapeutics to cancer patients who need them, while at the same time delivering long-term value to shareholders. I am thrilled to be here at Y-mAbs during this exciting time and look forward to working with this entire team. With that, let me now turn the call over to Sue Smith, who will discuss our U.S. DANYELZA sales in further detail. Sue? Thank you, Mike, and good morning, everyone. I'm pleased to share the commercial progress of DANYELZA in the U.S. We increased DANYELZA sales 59% year-over-year compared to the third quarter of last year. Despite the unevenness from a quarter-over-quarter standpoint, this is not surprising in rare disease indications, particularly considering the ultra-rare indication of DANYELZA. We continue to see an upward trend of sales growth since the initial launch back in 2021. Our percent growth since launch is performing well above where Unituxin was at three-year post-launch, 45% versus 22% growth, and we believe we have room for continued growth. As Mike mentioned, we recorded $61 million in DANYELZA sales in the first nine months of 2023. We expect to meet our full year 2023 sales guidance of between $80 million and $85 million in DANYELZA sales. Let me review key highlights from DANYELZA US sales in the third quarter. At the close of the third quarter of 2023, we had a total of 44 new patient starts year to date. This brings the total of new patient starts since launch to 158. We continue to grow outside of MSK, with non-MSK vials sold, representing 63% of all DANYELZA demand in the US during the third quarter. With 57 accounts now having used DANYELZA around the US, we have seen 22 accounts treat 2 or more patients in the first nine months of this year. We believe physicians are getting more comfortable using DANYELZA, with 36 healthcare providers having prescribed DANYELZA in the first nine months of this year, including 7 HCPs starting 2 or more patients in the first nine months of this year. Since launch, a total of 88 doctors have prescribed DANYELZA, and 28 of them have started treatment on two or more patients as of September 30, 2023. Our U.S. commercial sales team has received increasingly positive HCP feedback on DANYELZA through over 2,500 customer interactions in the first nine months of this year, and over 6,400 interactions since our launch in 2021. We also continue to see institutional adoption of DANYELZA, which has been added to five hospital formularies in the first nine months of this year, bringing the total since launch to 41 hospital formularies. Y-mAbs remains a leader in the U.S. anti-GD2 market, a highly important area of pediatric cancer and a rare disease market with a flat incidence rate. Looking ahead to the fourth quarter of this year and beyond, we are intensifying our market efforts, and our commercial team is in the process of rolling out a brand-new DANYELZA campaign. The new campaign repositions and elaborates on DANYELZA's differentiating characteristics in the treatment of high-risk neuroblastoma for patients who have experienced incomplete response to induction therapy in their bone and bone marrow. Utilizing our pre-specified interim analysis data, which was consistent with our label, the campaign enables us to share our data for refractory versus relapsed patients separately, providing more detailed data regarding DANYELZA's performance in patients with an incomplete response, response to induction therapy, and also patients who are relapsed, which are two different patient groups. In addition, it demonstrates DANYELZA's response in children after prior anti-GD2 therapy. I am very proud of this team. They have been hard at work in the preparation and rollout of the new campaign, in addition to achieving year-over-year sales growth. We believe we will begin to see meaningful traction from the new campaign starting next year. Let me now pass the call to Steen, who will discuss the latest progress of our SADA platform in further detail. Thank you, Sue, and good morning, everyone. I'm pleased to provide you with an update on our SADA programs, beginning with the GD2-SADA. Our phase I trial evaluating the safety and tolerability of GD2-SADA in the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma, got underway in March of this year. This phase I dose-escalation, single-arm, multicenter safety study has 3 parts. Part A explores the dose finding of the SADA molecule itself and testing the dose intervals of 2-5 days between the protein administration and the lutetium DOTATATE payload. Part B will determine the optimal dose of lutetium DOTATATE, and part C evaluates the safety and initial signs of efficacy using repeat dosing. Dose escalation is based on 2 patients in a cohort 1 and 2, followed by a modified 3 + 2 design. It's important to emphasize that in each cohort, patient will be observed after dosing in a so-called 6 weeks dose-limiting toxicity period or DLT period. Currently, we are still in part A, and the trial is progressing very well. We have dosed 5 patients in the third quarter, and at present, we have 6 active sites, with further 3 sites expected to be activated during the fourth quarter of this year. We have advanced through the first 2 cohorts and allowed dosing patients in cohort 3. We now have more patients receiving the 200 milligram per repeat dose of lutetium DOTATATE. I would like to emphasize that we are still in part A, of this trial, which is essential to investigate the safety profile of the protein and to determine the optimal timing to administer the radionuclide. We are pleased with what we have seen so far. No patient has experienced any dose-limiting toxicities to date. Furthermore, no patients have experienced any related severe adverse event or serious adverse events. And of note, we can dose SADA protein with no severe or serious pain signals detected. Today, we also can announce that we believe to have demonstrated proof of concept for the GD2-SADA by demonstrating that the SADA molecules can find and bind to tumors, and that the radionuclide targets SADA as visualized on the SPECT-CT scans performed. It's important to note that these early data are not complete and are not necessarily indicative of the full results or ultimate success of the trials of SADA development program. As seen on next slide, we are in opinion that the exposure, the blood PK exposure on the patients look as expected. The data include 4 patients in each of the two treatment groups, so 8 patients in total. The patient dose with a 0.3 milligram per kilogram protein, represented here in blue, and the patient dose with a 1 milligram per protein, here, represented here in purple, are comparable and support the dose intervals of 2-5 days as being used so far. On next slide, we, for the first time, are showing a SPECT-CT scan demonstrating tumor uptake in one patient. This patient, this scan was conducted after an imaging dose of 30 millicurie only. We are, we are very encouraged by the data observed so far, and based on this, we're investigating the potential clinical expansion of GD2-SADA into pediatric development next year. We're also pleased by how our GD2-SADA program is progressing, and look forward to sharing further clinical updates anticipated next year at a medical meeting of choice. In addition, as Mike mentioned earlier, we are also excited by the FDA clearance of our IND for our CD38-SADA program in non-Hodgkin lymphoma, focusing on both B and T cell lymphomas, and expect to dose the first patient in this phase I trial next year. Now, with the addition of the CD38-SADA, we have reached the clinical development phase of our SADA platform in both solid and hematological tumors. We do believe in the potential for the novel SADA technology platform to become the targeted radiopharmaceuticals delivery platform of choice in the future, if approved, potentially altering the treatment landscape across a variety of cancers. I will now hand the call over to Bo Kruse, who will review our financials for the third quarter. Thank you, Steen, and good morning, everyone. DANYELZA net product revenues of $61 million for the nine months ended September 30th, 2023, represented an increase of 86% from the $32.8 million reported for the nine months ended September 30th, 2022. The increase of $28.2 million was primarily driven by an increase in new U.S. patients, and an incremental benefit from expanding international revenues. Our DANYELZA net product revenues of $20 million in the third quarter of 2023, represented a 59% increase compared to the third quarter of 2022, and a marginal decline compared to the second quarter of 2023, as we saw some unevenness in international revenues after a series of inventory stocking orders from our international partners, as reported in recent quarters. During the three and nine months ended September 30, 2023, we recorded $500,000 of licensed revenue in accordance with our sub-licensing, sub-licensing agreement with Adium, following the achievement of the marketing authorization for DANYELZA in Mexico in September. Now, moving to operating expenses. Our R&D expenses decreased by $7.1 million and $31 million to $15.4 million and $40.8 million for the three and nine months ended September 30, 2023, respectively, compared to the same periods in 2022. The net decrease was primarily due to the decrease in spending on deprioritized programs in connection with our restructuring plan announced in January 2023, which resulted in decreased outsourcing, outsourced manufacturing, outsourced research and supplies, clinical trials, and personnel related costs. The decrease was partially offset by a $4.1 million increase in accrued time-based clinical milestones related to our SADA technology. Selling general and administrative expenses decreased by $3.4 million and $16.4 million - $10.2 million and $33.7 million for the three and nine months ended September 30th, 2023, respectively, compared to the same periods in 2022. The decrease in SG&A for the three months ended September 30th, 2023, was primarily driven by cost savings in connection with our restructuring plan. The decrease in SCNA for the 9 months ended September 30th, 2023, was primarily attributable to a $10.9 million charge related to the departure of our former CEO in Q2 2022, and to a lesser extent, a $2.9 million decrease in commercialization expenses incurred in 2022, in anticipation of a potential omburtamab launch. Additionally, we recorded a restructuring charge of $1.1 million in SCNA during the 9 months ended September 30th, 2023, in connection with the restructuring plan. However, personnel-related costs inclusive of stock-based compensation actually decreased in the 3 and 9 months ended September 30th, 2023, compared to the corresponding period in 2022, due to the impact of the restructuring plan. We reported a net loss for the quarter, ended September 30, 2023, of $7.7 million, or $0.18 per share, basic and diluted, compared to a net loss of $27.5 million, or $0.63 per share, basic and diluted, for the third quarter, ended September 30th, 2022. The improvement in our net loss was primarily driven by the increased revenues and the growth of DANYELZA, coupled with decreased operating expenses in the third quarter of 2023. Additionally, we reported a net loss for the nine months, ended September 30th, 2023, of $20.4 million, or $0.47 per share, basic and diluted, compared to a net loss of $96.7 million, or $2.21 per share, basic and diluted, for the nine months, ended September 30, 2022. The decrease in net loss was primarily driven by higher product revenues, lower R&D expenses, and lower SG&A expenses, inclusive of the $10.9 million decrease for the charge related to the departure of the former CEO in Q2 2022. As mentioned earlier, we ended the third quarter of 2023 with cash and cash equivalents of $86.6 million compared to $105.8 million at year-end 2022. The decrease was $19.2 million year to date. Importantly, we reduced our quarterly cash use from $4.7 million - $1.3 million, or about 72%, during the third quarter of 2023 compared to the second quarter. We continue to demonstrate responsible cash management along with market expansion for DANYELZA, and we believe we're in position to reduce our projected full year 2023 operating expenses range from $115 million-$120 million to $110 million-$115 million, which together with working capital adjustments, leads to a reduction of the total expected cash burn range for the full year, 2023, from $40 million-$50 million to $27 million-$32 million. The consequential impact on our expected cash runway is that we now believe our cash and cash equivalents will sufficiently support our commercial operations and pipeline programs as currently planned into 2027. We continue to expect full year 2023 DANYELZA net product revenues to be in the range of $80 million-$85 million. As we noted in prior quarters, the underlying assumptions for this guidance are important to understand. No new partnerships or other new business development income is included in the assumptions. For the purpose of this analysis of runway only, the DANYELZA product revenues are assumed to increase by 10% each year from 2024 through 2026. We indeed hope to see a higher growth rate for DANYELZA as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs are assumed at this point for purposes of the analysis. No further development of the omburtamab program has been assumed for the purpose of this estimate, and we have not assumed any equity or debt offerings or borrowings. We believe Y-mAbs remains well positioned to execute our strategic mission, our priorities and to support the delivery of multiple milestones. This concludes the financial update, and I'll now turn the call back to Mike. Thank you for that overview, Bo. Now let's open the line for questions. Operator, do you have any questions? Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question 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 pull for questions. Our first question comes from Alec Stranahan from Bank of America. Please proceed. Hey, guys. Thanks for taking our questions. Just a couple from us. First, you know, I think Sue outlined some changes in the commercialization strategy for DANYELZA. And I know, Mike, you're probably still settling into the role, but any, you know. What would you say is the single biggest lever that you could pull to help drive growth for DANYELZA? And you know, how does that compare to the 10% year-over-year growth that Bo outlined? And then I've got a follow-up. Well, Alec, thank you for your question. I will pass that to Sue. Sue has a robust plan for our expansion of DANYELZA and is in the best position to discuss that. Sue? Thanks, Mike. Thanks, Alec, for your question. There are a couple of really important levers that we're able to pull with this campaign. It actually parses out our efficacy data in frontline part, in the patients who are in the frontline, partial response to induction. This is consistent with our label, but our current label blended in our relapse and refractory data together. By our ability to parse out the efficacy, we are able to demonstrate that a patient who has incomplete response to induction still can have a 46% response rate. So that really enabled us to move the conversation earlier in the patient journey to just after that induction treatment. So we anticipate that as an important growth lever. Currently, about half of our sales are actually in the third line treatment setting after relapse. So, this is a significant movement and opportunity. And we also are excited because we have new data that shows our benefit after failing at prior anti-GD2 therapy. Another important area when you think of the Unituxin users, we still have a 31% response rate after prior anti-GD2 therapy, and some of those patients were able, 17%, to go and get a complete response. So those are two really important new pieces of data that have been resonating very well as we talk to customers, and the team is very excited to be rolling out that campaign. Okay, great. Thanks, thanks for that. And just one follow-up on CD38-SADA. As you've been thinking about pushing this one into the clinic, have there been any lessons learned from GD2-SADA, you know, dosing or, you know, design of the molecule or the clinical study? Thanks. Yeah, Alec, I appreciate the question on that. I'm going to pass it over to Steen, who can discuss what we've learned from GD2 as we move forward next year into CD38. Steen? Thank you. I think what we learned so far, as I also alluded to earlier, is that it's, until now, it has been quite safe to administer the SADA program and the SADA protein in particular. So we have seen no serious adverse events related to the protein, and we see no grade III plus adverse event related to the protein. And I think that is something that we bring into the next program when we discuss starting dose of the molecules. We also use, of course, our experience with the non-clinical tox package to bring over to a CD38 program, and we're very happy that the FDA have accepted that program, and now we have to have an open mind. So, I think we are more confident administering the SADA protein into use now than we were before. And as such, we hope to a little bit more quick dose escalation in the first part of that trial. Thank you. Thank you, Steen. Next question, operator? Our next question comes from Charles Zhu from Guggenheim. Please proceed. Hey, good morning, everyone, and thanks for taking our questions. And, Mike, congratulations on the new role, and also very encouraged to see your excitement over the SADA platform. On that note, regarding the GD2-SADA, given your intent now to put out a more substantial data readout, if I heard that correctly, in a 2024 medical meeting as opposed to the year-end R&D day, what quantity as well as types of data could you potentially present? Could we, for example, see things like additional whole body planar images or organ and tumor dosimetry data, or how are you thinking about that? Thank you. Charles, thank you for your question. I'm going to pass this off to Steen to discuss what information potentially will be available and what we expect to be able to present at a medical meeting this coming year. Steen? Thank you. So for the 2024, we still are in the early part of this first human dose escalation study, so this is a safety study, as discussed prior. But definitely we now already, as discussed, have dosed 9 patients, and we continue enrollment. So we will be able to share both PK data, biodistribution data, as initial also tumor imaging, which we shared the first picture with you today. So these kind of information will be ready to be shared during the next year. Thank you. Thank you, Charles. Yeah, and if I could squeeze in one follow-up on that, if you don't mind. So, you know, just looking at some of the, you know, the initial data that you've presented so far in the GD2-SADA, maybe something a little bit more granular, but, you know, noticed that your PK data appears to be on the injected protein concentration. But, you know, just also how any color you can provide on a radioisotope uptake into the tumor upon, you know, the 200 millicurie administration. Thank you. Thank you, Charles. Steen? This is early days. As I discussed, we have more patients now receiving the 200 millicurie. Most of the tumor uptake and the biodistribution data is collected on the 30 millicurie dosimetry dose. But we also are planning to include scans after the therapeutic dose going forward. For now, it looks fine. We are still looking for the scalability of the protein. We are dose escalated from 0.1 microgram only, so we are still continuing the dose escalation of protein. So I think we need to await more robust protein data before we disclose and discuss methodology. Excellent. Thanks for taking the questions, and definitely look forward to that readout next year. Very good. Next question, operator. Our next question comes from Bill Maughan from Canaccord Genuity. Please proceed. Hey, good morning, and welcome, Mike. So two questions from me. When you cite the 57 accounts for DANYELZA, is that all that have written and currently set up to write DANYELZA? Or is there sort of a time cutoff to weed out any who may be inactive? And then a question on the SADA platform. Looking forward to potentially trying to read through the GD2 targeting to the CD38 targeting, are there any unique challenges to targeting CD38 versus GD2 that might prevent a seamless read-through from that data? Thank you. Bill, thank you. I appreciate the question. We'll take the first part of that, and I'll ask Sue to address the accounts that are set up for DANYELZA. Sure. Thanks. Thanks, Bill, for the question. So those 57 accounts are set up to use our product. And to give you some perspective, in the United States, only 152 accounts have ever used any anti-GD2 therapy. So, you know, we're well on our way to over a third of those accounts who are using DANYELZA. And, as we mentioned before, we're seeing deeper penetration of those accounts and also the repeat use in 22 accounts with two or more patients. We're also seeing an increase in the Tier 1 accounts. So we're making good headway from a breadth and a depth standpoint. And Bill, as far as your second question goes on the GD2 versus CD38, I'm gonna pass that to Steen, but understanding that our team has a very deep in-domain knowledge in CD38, which actually makes it very interesting for us moving forward and being able to target the CD38 receptor. So, Steen? Yes, thank you. Yes, there are some differences between the two. Of course, going to the CD38, we are entering the hematological space. And of course, with a two-step procedure, we also need to make sure that we don't have too much bone marrow involvement, which is part of the protocol development, that we have some limits on how much bone marrow involvement the patient can have in order for us not to put radioactivity directly on the progenitor cells. So there are some slight difference in the protocol development and the inclusion, exclusion criteria, but else, most of those lymphoma patients also have, like, the lymph nodes, of course, involved, in which we are quite comparable, reaching those areas as compared to the solid tumors we are seeing now with GD2. Very good. Thank you. Thank you for your questions, Bill. Operator, next question. Our next question comes from Etzer Darout from BMO Capital Markets. Please proceed. Great. Thanks for taking the question, and Mike, congrats on the role here as CEO. Just one quick question for me, going back to some of the comments in the 10-Q around the interval of dosing of 2-5 days for GD2-SADA, and what you ultimately think would be an optimal dosing schedule for the technology, sort of moving forward as you kind of go through to sort of Part A into potentially the Part B expansion. Thank you. Etzer, thank you for your call, your question, and I will pass that to Steen as he's doing the majority of the work on the targeting. Thank you, Mike. So I think it's too early to say what you could see on the curves I shared with you earlier on this call. There was a slight shift to the right when you went up in the protein concentration. So likely, the dose interval will be longer than the two days, depending on how high we can dose up the protein, and this is a safety precaution. So we will have to wait until we see the three and 10 milligram dose cohorts to see how the blood PK behaves. This will also, together with the absorption into the tumor, so biodistribution, tumor symmetry, will dictate the sweet spot where the best relationship between the free drug in the blood and tumor uptake will be found. So for now, at least we can say that we actually were in a good position here in the early part of the trial, but likely they could be longer than two days. Great. Thank you. Thank you, Etzer. Next question, operator? Our next question comes from Mike Ulz, from Morgan Stanley. Please proceed. Good morning, and thanks for taking the question. Maybe just a follow-up on the SADA program. You're in the process of advancing the CD38 program, but just curious, thinking about advancing some of those earlier programs, such as the HER2 program, and will you be waiting to see more data from GD2, potentially before deciding to advance some of those programs? Thanks. Mike, I appreciate the question. You know, as we start looking at this, we've committed to submit an IND every year, and we are going to continue to do that and advance some of the early, early programs on. We're extremely confident in SADA and what it can do and, and the problems that it actually addresses in the regulatory pharmaceutical therapeutic market. So we are going to continue to invest in the early programs and, and look to introduce INDs on an annual basis in order to continue to advance the overall SADA platform. Yep. Great. Thank you. Thank you, Mike. Next question, operator. Our next question comes from Robert Burns, from H.C. Wainwright. Please proceed. Hey, guys. Congrats on the quarter, and congrats, Mike, on your appointment as CEO. Just two questions, maybe two and a half I should say, from me. So since the point of the SADA platform is to reduce radiation-associated toxicities and enable greater doses of radiation to be received, I was curious to know at what level of radiation would you start seeing those DLTs and, you know, toxicities that would, you know, put patients off of therapy if you weren't given the SADA platform, specifically associated with the lutetium? I'm essentially trying to get at, well, what's the incremental dose level you think you could get, given a base level radiation without SADA? Oh, yeah, Robert, thank you for the question. As we're looking at these safety studies and moving forward, on a new platform on specific targeting, we're going to be able to really work with these to tailor make what that response looks like, and also leveling out what some of the patient individual responses look like. I'll pass it to Steen for some additional color. But as we look at these, our primary goal now is to balance the safety and then move into the efficacy as we move forward with the clinical trials. Steen? Thank you, Mike, and I thank you. I have not much more to add to this because what's really is important for us now, and the potential benefit of the SADA platform is that you administer the radioactive nuclei when the majority of free protein is out of the system. So the whole goal here is to differentiate from the one-step radionuclei out there in order for us to spare normal tissue. And then we will see from there on how much we can add onto the tumor space, and that's the data. Awesome. Thank you. Second follow-up from me. So, you know, when we think about the CD38-SADA, specifically in the multiple myeloma context, what are you viewing as the benchmark there? Are you viewing the benchmark as just what Darzalex did back in the day? Or are you looking at these new CD38-targeted agents, such as like Modakafusp alfa and HexaBody-CD38? And then are you also enabling prior Darzalex utilization in those patient populations? Robert, thank you for your question on that, and I'll pass it over to Steen for what the plans are for the phase I and as we move forward. So as discussed earlier on this call, we are starting the phase I program in non-Hodgkin lymphoma, so we're actually not dosing multiple myeloma initially. That's in order for us to quite quickly create the safety benefit of that molecule. And I do agree that there's a lot of competition on the CD38 molecule, but this is predominantly in multiple myeloma space. And I think what we do have here is completely different mode of action as compared to the competitor. So I'm quite confident we will later go there, but we will initially start the development plan to start the development here in both the B and T cell space in non-Hodgkin lymphoma. Awesome. Thanks, guys. Thank you, Robert. Operator, are there any other questions? This concludes our question-and-answer session. I would like to turn the floor back over to Mike Rossi for closing comments. Thank you, Operator, and thank you everyone for your participation on today's third quarter earnings call and for your continued interest in Y-mAbs. We believe we're in a strong position as we work to deliver multiple potential value-creating milestones with our novel SADA technology, while continuing to drive adoption, growth, and expansion of the DANYELZA franchise. Let me say it again, I'm thrilled to be part of this special company and look forward to working as one team with a patient-first mindset in our mission to fight cancer. Thank you, everyone, and have a great day. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.