Bo Kruse; Executive VP, Secretary, Treasurer & CFO; Y-mAbs Therapeutics, Inc.
Michael Rossi; CEO, President & Director; Y-mAbs Therapeutics, Inc.
Steen Lisby; Senior VP & Chief Scientific Officer; Y-mAbs Therapeutics, Inc.
Susan Smith; Senior VP & Chief Commercial Officer; Y-mAbs Therapeutics, Inc.
Alec Warren Stranahan; Associate; BofA Securities, Research Division
Etzer Darout; MD & Senior Biotechnology Analyst; BMO Capital Markets Equity Research
Michael Eric Ulz; Equity Analyst; Morgan Stanley, Research Division
Robert John Burns; MD & Senior Healthcare Analyst; H.C. Wainwright & Co, LLC, Research Division
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 Subsidies 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 and 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 advanced east, collaboration or strategic partnerships and the potential benefits thereof; expectations related from our anticipated cash coorefficiency of our cash resources and assumptions really there to 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 30, 2023, as filed with the SEC on November 15, 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. And 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 Daniels sales. updates on our ongoing necitumab 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 thing we'll provide further details on our Phase I DDII 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. Then Bo will provide an overview of our third quarter financial performance, our cash resources and our full year 2023 guidance before we open the lines 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 6.
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 Merian Technologies, where he served as the President of the Medical Group. Prior to that, Mike was the Head of Radioligand Imaging and Advanced Accelerated Applications better known as AAA in Novartis company. And before that, he led the growth of Jubilant radiopharm into a vertical integrated radiopharmaceutical leader. Earlier in his career, Mike spent over a decade at GE Healthcare, and he's also a certified nuclear pharmacists.
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 2-step pretargeted radioimmunotherapy platform, better known as SADA and its potential to unlock the value of rated pharmaceuticals in the cancer treatment paradigm.
After a 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. And 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 YmAbs third quarter earnings call. As Thomas mentioned, I've built a 30-plus year career in health care with a specific focus on radiopharmaceuticals.
Y-mAbs is a pioneer of pretargeted radioimmunotherapy with the SADA technology platform, which is a key driver of my own personal excitement about joining Y-mAbs. SADA stands out as a highly differentiated, pretargeted 2-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 the patients 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. and DANYELZA's launch with 9 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 [indiscerninble] successfully launched DANYELZA in China in June of this year.
In terms of the number of aisles 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 WEP 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/refractory neuroblastoma.
We remain encouraged by the expansion of DANYELZA, accumulating global net sales of more than $61 million in the first 9 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. Sue will provide further color on DANYELZA's 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 and multicenter Phase II trial evaluating naxinimab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma.
To date, 9 sites have been initiated and 6 patients have been dosed. The study is expected to transition from a single-arm study with naxitamab added to 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 plus or minus 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 M&A on its multicenter investigator-sponsored trial for naxitamab. We anticipate MSK to provide a data readout from this Phase I/II trial in fourth quarter of 2024. And if positive, we hope to then begin an improvement for a pivotal randomized Phase III trial.
In addition, we are pleased with the publication of the study of naxitamab-based chemoimmunotherapy HIS trial in patients with chemo-resistant high-risk neuroblastoma in the journal cancers. In this trial, patients who received HIS immediately after induction had a higher response rates, 47% versus 18% and 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. From my extensive career in various radiopharma leadership roles, I've had the privilege to win this development of numerous breakthrough technological platforms. However, SADA which is licensed by BIMAS from MSK and the Massachusetts Institute of Technology in 2020 stands out as a highly differentiated, pretargeted 2-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.
Steve 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 or cohorts 1 and 2, currently administering doses to cohorts 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're 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 2 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 be with the commercial -- 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 3-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 9 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's in U.S. sales in the third quarter. At the close of the third quarter of 2023, we had a total of 44 new patient stats year-to-date. This brings the total of new patient stats since launch to 158. We continue to grow outside of MSK with non-MSK vial sold, representing 63% of all DANYELZA demand in the U.S. during the third quarter.
With 57 accounts now having used DANYELZA around the U.S., we have seen 22 accounts treat 2 or more patients in the first 9 months of this year. We believe physicians are getting more comfortable using DANYELZA with 36 health care providers having prescribed DANYELZA in the first 9 months of this year, including 7 HCPs starting 2 or more patients in the first 9 months of this year. Since launch, a total of 88 doctors have prescribed DANYELZA and 28 of them have started treatment on 2 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 9 months of this year and over 6,400 interactions since are launched in 2021.
We also continue to see institutional adoption of DANYELZA, which is -- which has been added to 5 hospital formularies in the first 9 months of this year, bringing the total since launch to 41 hospital formularies. YmAbs remains a leader in the U.S. anti-GD2 market, a highly important area of pediatric cancer in 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 prespecified 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 to induction therapy and also patients who are relapsed, which are 2 different patient groups. In addition, it demonstrates DANYELZA's as 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 evaluated 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 away 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 self and testing the dose intervals of 2 to 5 days between the protein administration and the lutetium data payload. Part B will determine the optimal dose of lutetium data and Part C evaluates the safety and initial signs of efficacy using repeat dosing.
Dose escalation is based on 2 patients in cohort 1 and 2, followed by a modified (inaudible). And it's important to emphasize that in each cohort, patients will be observed after dosing in a so-called 6-week dose limit 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 presite expected to be activated during the fourth quarter of this year. We have advanced through the first 2 cohorts and are now dosing patients in cohort 3. We now have more patients receiving the 200-(inaudible) therapeutic dose of lutetium data.
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 often the timing to administer the lutetium drug. We are pleased with what we are seeing so far. No patients have 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 start approaching 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 SADA molecules can find and binds to tumors and that the ready nuclide target SADA as visualized on the spec city scans count.
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 tires of SADA development program.
As seen on next slide, we are in an opinion that the exposure of the -- but exposure in the patients look as expected. The data includes 4 patients in each of the 2 treatment groups, so 8 patients in total. The patient dosed with a 0.3 milligram per kilogram protein represents here in blue, and the patient dosed with a 1 milligram per protein represented here in purple are comparable and supported those intervals of 2 to 5 days as being used so far.
On the next slide, we, for the first time, are sharing a spec CT scan, demonstrating tumor uptake in one patient. This scan was conducted after an imaging dose of 30 millikilli only. We are very encouraged by the data observed so far. And based on this, we investigated the potential clinical expansion of GD2-SADA into pediatric development next year. We're also pleased to how GD2 start-up from is progression 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 heart failure lymphoma, focusing on both B and T-cell lymphomas and expect to dose the first patient in this Phase I trier next year.
Now with the addition of the CD38 SADA, we have reached the clinical development phase of our SADA platform in both sides and hematological tools. We do believe in the potential for the novel SADA technology platform to begin the targeted radiopharmaceuticals delivery platform of choice in the future, if approved, potentially algin the treatment landscape across the variety of (inaudible).
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 9 months ended September 30, 2023, represented an increase of 86% from the $32.8 million reported for the 9 months ended September 30, 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 '22 and a marginal decline compared to the second quarter of '23 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 3 and 9 months ended September 30, 2023, we recorded $0.5 million of license revenue in accordance with our sublicensing 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 3 and 9 months ended September 30, 2023, respectively, compared to the same periods in '22. 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 to $10.2 million and $33.7 million for the 3 and 9 months ended September 30, 2023, respectively, compared to the same periods in 2022. The decrease in SG&A for the 3 months ended September 30, 2023, was primarily driven by cost savings in connection with our restructuring plan. The decrease in SG&A for the 9 months ended September 30, 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 SG&A during the 9 months ended September 30, 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 30, 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 30, 2022. The improvement in our net loss was primarily driven by the increased revenues and the growth of the DANYELZA coupled with decreased operating expenses in the third quarter of 2023.
Additionally, we reported a net loss for the 9 months ended September 30, 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 9 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 to $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 a position to reduce our projected full year 2023 operating expenses range from $115 million to $120 million to $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 to $50 million to $27 million to $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 in June 2027.
We continue to expect full year 2023 DANYELZA net product revenues to be in the range of $80 million to $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, with DANYELZA product revenues assumed to increase by 10% each year from '24 through '26. 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 assumed at this point for purposes of the analysis. No further development of the embertimab program has been assumed for the purpose of this estimate, and we have not assumed any equity 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 margins. 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.
Question and Answer Session
(Operator Instructions). Our first question comes from Alec Stranahan from Bank of America.
Alec Warren Stranahan
Just a couple from us. First, 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 -- what would you say is the single biggest lever that you could pull to help drive growth for DANYELZA? And 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. We still have a robust plan for our expansion of DANYELZA is in the best position to discuss that. Sue?
Thanks, Mike. Thanks, Alex, 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 -- 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 relapsed 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 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 2 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.
Alec Warren Stranahan
Okay. Great. 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 dosing or design of the molecule or the clinical study?
Yes, 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. Steen.
I think what we learned so far, as I also alluded to earlier, is that it's -- until now, it has been quite safe and SADA program and a SADA protein in particular. So we have seen no serious adverse events related to the protein, and we see no grid 3-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 nonclinical tox package to bring over to a CD38 program, and we were happy that TFA have accepted that program, and now we have to have an OND. 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.
Our next question comes from Charles Zhou from Guggenheim.
Mike, congratulations on the new role. And also very encouraged to 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 the 2024 medical meeting as opposed to the year-end R&D day, what quantity as well as types of data could you potentially present? Can we, for example, see things like additional whole body planar images or organ in tumor dosimetry data? Or how are you thinking about that?
Charles, thank you for your questions. 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 the 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, bio distribution data as initial also tumor imaging, which we shared the first picture we you today. So this kind of information will be ready to be shared during the next year.
Yes. And if I could squeeze in one follow-up on that, if you don't mind. So just looking at some of the initial data that you've presented so far in the GD2-SADA, maybe something a little bit more granular, but I noticed that your PK data appears to be on the injected protein concentration. But just also how -- any color you can provide on a radioisotope uptake into the tumor upon the 200-mile administration?
Thank you, Charles, Steen.
This is early days. As I discussed, we have more patients now receiving the 200 (inaudible). Most of the tumor uptake and the biodistribution data is collected on the 30-(inaudible) dosimetry dose, but we're also planning to include scans after the therapeutic dose going forward. So for now, it looks fine. We are still looking for the scalability of the program. We have dose escalated from 1 multigram only. So we are still continuing the dose escalation of protein. So I think we need to wait more robust protein data before we disclose and discuss targeting.
Definitely look forward to that readout next year.
Very good. Next question, operator?
Our next question comes from Bill Morgan from Canaccord Ingenuity.
Welcome, Mike. So 2 questions from me. When you cite the 57 accounts for DANYELZA, is that all that have written and currently set up to right DANYELZA? Or is there sort of a time cutoff to read 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?
Bill, thank you. I appreciate the question. Well, I'll take the first part of that, and I'll ask Sue to address the accounts that are set up for DANYELZA.
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 we're well on our way to over 1/3 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 2 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 going to pass that to Steen, but understanding that our team has a very deep domain knowledge in CD38 which actually makes it very interesting for us moving forward and being able to target the CD38 receptor. So Steen?
Thank you. Yes, there are some differences between cost going to the CD38, we are entering the hematological space. And of course, with a 2-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 that use can have in order for us not to put ready activity directly on the penta sales.
So there is some slight difference in the protocol development and the inclusion exclusion criterias. But else, most of those lymphoma patients also have like the lymphos of course, involved in which we are quite comparable reaching those areas as compared to solid tumors we've seen now in GD2.
Very good. Thank you for your questions. Operator, next question.
Our next question comes from Etzer Darout from BMO Capital Markets.
And Mike, congrats on the role here as CEO. Just one quick question for me going back to sort of the -- some of the comments in the 10-Q around the interval of dosing of 2 to 5 days for GD2 where you ultimately think would be sort of 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.
Etzar, thank you for your question, and I will pass that to Steen as he's over joining the work on the targeting.
Thank you, Mike. So I think it's too early to say. What you could see on this, 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 2 days depending on how high we can dose of the protein. And this is a safety precaution. So we will have to wait until we see the and 10-milligram dose cohorts to see how the blood PK behaves. And this will also together with the absorption into the tumor, so biodistribution, tumor tesemetry, we dictate the sweet spot where the best relationship between 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 year in the early part of the trial, but likely they would be longer than 2 days.
Our next question comes from Mike Ulz as from Morgan Stanley.
Michael Eric Ulz
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 of insured data from GD2 potentially before deciding to advance some of those programs?
Mike, I appreciate the question. 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 programs on. We're extremely confident in SADA and what it can do and the problems that it actually addresses in the radiopharmaceutical therapeutic market. So we are going to continue to invest in the early programs and look to introduce SADA on an annual basis in order to continue to advance the overall SADA protocol. Thank you, Mike. Next question, operator?
Our next question comes from Robert Burns from H.C. Wainright.
Robert John Burns
Congrats on the quarter and congrats, Mike, on your appointment as CEO. Just 2 questions, maybe 2.5 for 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 whether or at what level of radiation, would you start seeing those DLTs and the toxicities that would put patients off of therapy if you weren't giving the SADA platform, specifically associated with the lutetium. I'm essentially trying to get at what's the incremental dose level do you think you could get given a base level radiation without SADA?
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 thank you. I had that much more to add to this because what's really it's important for us now and the potential benefit of the SADA platform is that you administer the radioactive nuclear when the majority of free protein is out of the system. So the whole goal here is to differentiate from the one-step radio nuclear eyes out there in order for us to spare normal issue. And then we will see from there on how much we can add on to the tumors based on that SADA data.
Robert John Burns
Awesome. A second follow-up from me. So when we think about the CD38 SADA, specifically in the multiple myeloma context, what are you viewing as a 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 that look like (inaudible) 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 in Italy. 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 a 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 competitors. So I'm quite confident we will later go there, but we will initially start the development plan to start the developing here in both the and TC space in non-Hodgkin's lymphoma.
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 Rose 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. We 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.