Y-mAbs Therapeutics - Q2 2024

Transcript

Operator (participant)

Good morning, and welcome to Y-mAbs Therapeutics Inc.'s Earnings Conference Call for the second quarter of 2024. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow today's prepared remarks. As a reminder, today's conference will be recorded. I will now hand it over to Y-mAbs's Head of Investor Relations, Courtney Dugan. Please go ahead.

Courtney Dugan (Head of Investor Relations)

Thank you, operator, and good morning, everyone. Welcome to the Y-mAbs second quarter 2024 financial results conference call. We issued a press release with our results this morning before the market opened. 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, 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's territory and label expansion, and potential of an advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash runway and cash burn, and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2024 and beyond, and our financial performance, including our estimates regarding revenues, expenses, 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 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 previously filed annual report on Form 10-K for the year ended December 31, 2023, quarterly report on Form 10-Q for the quarter ended March 31, 2024, and the company's quarterly report on Form 10-Q for the quarter ended June 30, 2024, to be filed with the SEC today. I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Mike Rossi (President and CEO)

Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Chief Commercial Officer, Sue Smith, our Chief Medical Officer, Dr. Vignesh Rajah, and our new Chief Financial Officer, Pete Pfreundschuh. This morning, I will begin by reviewing key financial and operational highlights from the second quarter of 2024, including DANYELZA sales performance and the clinical progress of our radiotherapy clinical programs, utilizing our Self-Assembly Disassembly Pretargeted Radioimmune Therapy, or SADA PRIT technology platform. Next, Sue will provide details around our global DANYELZA sales in the second quarter. Vignesh will then provide updates around our ongoing naxitamab ISS clinical trials. Pete will then review our second quarter of 2024 financial performance, our cash resources, and provide an update to our full year 2024 guidance before we open the line for Q&A.

Let's begin with key highlights for the second quarter of 2024, starting with DANYELZA. As many of you know, neuroblastoma is the most common cancer in infants and the third most common cancer in children. Our commercial drug, DANYELZA, is a leading anti-GD2 therapy in the U.S. and remains critically important therapy for children with relapsed, refractory, high-risk neuroblastoma. DANYELZA is humanized and is the only FDA-approved immunotherapy for high-risk neuroblastoma that is specifically designed for children who have an incomplete response to induction or relapse therapy, and also have disease in the bone and/or bone marrow. Importantly, DANYELZA can be administered either outpatient or inpatient, depending on the specific needs of the child and his or her family. In the second quarter of 2024, we achieved total DANYELZA net product revenue of $22.8 million, up 10% from the second quarter of 2023.

The increase was primarily driven by a boost in international orders from our partners, WEP in Western Europe and Adium in Latin America, which includes the commercial launch in Brazil and Mexico. For the first six months of the year, we achieved total DANYELZA net product revenues of $42.2 million, up 3% from the same period in 2023. The increase was primarily driven by an increase in U.S. revenues in the first half of 2024 compared to the year prior period. We are continuing to drive DANYELZA forward and are penetrating more centers. In the second quarter alone, DANYELZA has been added to 2 new hospital formularies. Well, we saw increased market and clinical trial competition for patients in the U.S. during the second quarter. We view this as a net positive for patients and families.

As a company, we are driving investments around direct-to-parent educational efforts focused on DANYELZA differentiators in bone and bone marrow. The Y-mAbs team has deep knowledge of the market and is specifically dedicated to pediatric neuroblastoma. ex-U.S., we saw a boost in orders in the second quarter of this year as compared to the first quarter of this year. Our partner, Adium, executed the DANYELZA commercial launch in both Brazil and Mexico. We're very pleased with how these launches are progressing and look forward to providing further updates in future quarters. In Asia, our SciClone partner continues to expand the use of DANYELZA in China. Additionally, we're thrilled to have received approval for DANYELZA in Hong Kong and look forward to working with our Eastern Asia partner, SciClone, in anticipation of their commercial launch of DANYELZA in Hong Kong.

Our European named patient program with WEP Clinical is also continuing to progress as we support the needs of children with high-risk relapsed refractory neuroblastoma in Western Europe. In addition to our new approval in Hong Kong, we entered into distribution agreement with TR Pharm for named patient program distribution of DANYELZA in Turkey. We also plan to submit a BLA for DANYELZA in Argentina later this year. We remain confident in our U.S. commercial strategy and trajectory, and in the continued ex-U.S. expansion of DANYELZA. Vignesh will provide updates on our investigator-sponsored trials of naxitamab later during this call. Let me now shift to our clinical progress of our SADA PRIT programs.

We are currently in Part A of our GD2-SADA phase I trial, evaluating the safety and tolerability of the SADA PRIT in the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma. As a reminder, this phase I dose escalation, single-arm, multicenter safety study, has three parts. Part A, which we are currently in, is structured to demonstrate the safety profile of the protein while it explores dose finding for the GD2-SADA molecule and testing of dose intervals of two to five days between the protein and the Lutetium-177 DOTA payload. Part B determines the optimal dose of Lutetium-177 DOTA, and Part C evaluates the initial signs of efficacy using repeat dosing. We are pleased with how the trial is progressing and have advanced through cohort 4. We are currently in cohort 5.

We have dosed a total of 17 patients to date in Part A of this trial. We currently have 6 sites open and plan to continue adding additional sites. We are encouraged by what we've seen so far. To date, no patients in the trial have experienced any dose-limiting toxicities, and there have been no instances of treatment-related serious adverse events. Based on the SPECT/CT scans and PK activity we have seen to date, we believe we have demonstrated a proof of concept in humans that GD2-SADA can both find and bind to tumors. It is important to note that these early data are not complete and not necessarily indicative of full results or ultimate success of the trials or the SADA development program.

We expect to complete Part A of the phase I study by the end of this year, and look to present the full data set from Part A at a medical meeting in early 2025. In the data readout from Part A of the trial, our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radionuclide, all of which will inform Part B. In addition, we plan to show additional scan images and PK data. Our second SADA PRIT program is CD38-SADA, which we plan to first study in the treatment of non-Hodgkin's lymphoma, focusing on B and T cell lymphoma. This will be our first SADA program in circulating tumors. Our planned phase I follows a comparable design to our GD2-SADA phase I trial, which you can see here.

We have selected the first six sites and expect to dose the first patient in the second half of this year. We strongly believe SADA PRIT has the potential to shift the radiotherapy treatment paradigm across a variety of cancers and potentially even in indications beyond oncology, all while avoiding many of the infrastructure, manufacturing, and administration challenges many other technologies are facing. We look forward to providing further updates on our SADA PRIT programs going forward. Our team remains steadfast in our collective commitment to improve patient lives, and I'm very proud of the progress we continue to make to advance our novel therapies through clinical development. I will now pass the call over to Sue Smith to provide further color on global DANYELZA sales for the second quarter of 2024.

Sue Smith (Chief Commercial Officer)

Thank you, Mike, and good morning, everyone. As you heard from Mike, we're pleased with the commercial traction of DANYELZA, both in the U.S. and across our ex-U.S. markets. As more competition arises in the form of new market entrants and clinical trials, we're continuing to sharpen our strategic commercial efforts and remain confident in the unique features and benefits DANYELZA is bringing to neuroblastoma patients. In the second quarter of 2024, total worldwide DANYELZA net product revenues were $22.8 million, a 10% increase compared to the same period last year, primarily driven by an increase in international orders. Breaking out U.S. and ex-U.S., in the U.S., our second quarter 2024 DANYELZA net product revenues were $15.2 million, a decrease of 4% compared to the second quarter of 2023.

The Q2 softness was driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activity. Ex-U.S., our second quarter 2024 DANYELZA net product revenues were $7.6 million, a 55% increase compared to the second quarter of 2023. In the U.S., our dedicated team is continuing to advance our new DANYELZA campaign, aimed to reposition and elaborate on DANYELZA's differentiating characteristics in the treatment of high-risk neuroblastoma for patients who are refractory or have experienced incomplete response to induction therapy in their bone and bone marrow. The critical piece of this new campaign highlights DANYELZA's performance in two different patient populations. Those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy. This campaign also highlights DANYELZA's response in children who had previously received anti-GD2 therapy.

Additionally, we recently rolled out a new direct-to-consumer campaign that specifically speaks to the needs of parents. As Mike mentioned, competition is good for patients, particularly in a rare disease space that predominantly impacts young children. The treatment approach for each individual patient may be different. We have seen the positive impact DANYELZA has had on children with high-risk, relapsed, refractory neuroblastoma in the bone and bone marrow, and believe we are only at the beginning of unlocking the potential of DANYELZA in our mission of improving the lives of patients and their families. A total of 65 accounts have now used DANYELZA around the U.S. since its initial launch in 2021, with 7 new accounts added in the first six months of 2024. DANYELZA's total share of the U.S. anti-GD2 market is currently at approximately 17%. Physician utilization of DANYELZA continues to grow.

30 healthcare practitioners started patients on DANYELZA in the first half of 2024, with 4 physicians starting treatment on 2 or more patients. Since launch, a total of 108 healthcare providers have prescribed DANYELZA, and 31 of those have started treatment on 2 or more patients. Our dedicated U.S. commercial sales team continues to receive positive healthcare provider feedback on DANYELZA through ongoing customer interactions. In addition, we continue to see institutional adoption of DANYELZA, which was added to 2 hospital formularies in the second quarter of 2024, bringing the total since launch to 46 hospital formularies as of June 30, 2024. Now turning to our ex-U.S. commercial progress. We saw a boost in international orders in the second quarter versus the first quarter of this year, driven by recent launches and the continued traction our ex-U.S. distribution partners are gaining across their markets.

This second quarter marked the first quarter of DANYELZA sales in Brazil and Mexico, led by our South America partner, Adium. We expect to see additional adoption over the coming quarters and learn more about market dynamics in these regions. In Asia, our SciClone partner continues to expand use of DANYELZA in China. Additionally, we're thrilled to have received approval for DANYELZA in Hong Kong and look forward to working with our Eastern Asia partner, SciClone, in anticipation of their commercial launch of DANYELZA in Hong Kong. Despite variability in orders, particularly in the U.S. during the summer months, we have continued to see an overall upward trend of sales growth since the initial launch back in 2021. We look forward to providing further updates throughout the year. I will now pass the call to Vignesh.

Vignesh Rajah (Chief Medical Officer)

Thank you, Sue, and hello, everyone. I'm pleased to provide a brief update on our ongoing investigator-sponsored naxitamab clinical trials. We continue to evaluate potential label expansion opportunities for DANYELZA in collaboration with several leading KOLs and institutions. Let me begin with an update on the multicenter investigator-sponsored trial for naxitamab in patients with second-line relapsed osteosarcoma, led by Memorial Sloan Kettering Cancer Center. In late June 2024, we received a preliminary draft abstract of certain results from MSK on this trial. For the 39 patients in the study with pulmonary-only recurrence, the summary stated there were 14 event-free patients at 12 months, rather than MSK's primary endpoint of 16 event-free patients at 12 months. Analysis of the full study results is still underway.

Once we obtain the full dataset from MSK, we plan to undertake further analysis of efficacy, including primary and secondary endpoints, evaluate tumor GD2 expression in study subjects, and the degree of correlation with clinical response. We intend to use the results of such further analysis to inform our determinations with respect to potential further development of naxitamab-based immunotherapy in patients with relapsed osteosarcoma. The complete results from this trial are expected to be presented by MSK investigators later this year at a medical meeting. In the frontline high-risk neuroblastoma setting, our partner, the Beat Childhood Cancer Research Consortium, or BCC, is leading a multicenter phase II trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. 17 sites have been opened, and 10 patients have been treated to date, with recruitment ongoing.

The amended protocol for the transition to a randomized trial is currently in process and being evaluated. The BCC continues to expect the trial to transition from a single-arm trial, with naxitamab added to current standard of treatment for induction, to a randomized trial later this year, where the control arm will be the current standard of care for induction therapy, which is chemotherapy, for which we plan to file an IND. Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the naxitamab arm versus the standard of care. In triple-negative breast cancer, we are partnering with the Ohio State University on a Phase Ib/II trial investigating TGF-beta, NK cells, gemcitabine, and naxitamab in patients with GD2-positive metastatic breast cancer. 2 patients have been enrolled, and both have been treated with initial combination of gemcitabine and NK cells.

The study is designed to evaluate safety in the first three patients treated with gemcitabine and NK cells. If this combination is well tolerated, naxitamab will be added to the combination treatment for subsequent patients. We expect the first patient to be treated with the addition of naxitamab by the end of this year. Upon the outcome of this trial, if the data supports doing so, we would consider moving forward with a multicenter phase II trial. In addition, we are in discussions with the MD Anderson Cancer Center to initiate a multicenter phase I/II study, with a phase I run-in that seeks to test the hypothesis that the addition of naxitamab to current standard of care will increase the objective response rate in patients with metastatic triple-negative breast cancer, who have received at least one prior line of systemic therapy for metastatic disease.

The study, which is anticipated to start in mid-2025, will further inform us on a future phase II program in triple-negative breast cancer. In patients with refractory Ewing sarcoma, the Institute of Mother and Child in Poland is leading a randomized phase II trial evaluating the efficacy and safety of naxitamab. This trial was initiated during the fourth quarter of 2023. 3 patients have been dosed in the naxitamab arm to date, and recruitment is ongoing. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028. We believe a significant treatment gap remains in this anti-GD2 space, in both pediatric and adult cancers. We are committed to supporting the advancement of these investigator-sponsored studies through clinical development and working to unlock the untapped potential of naxitamab. Let me now hand the call over to Pete Pfreundschuh.

Peter Pfreundschuh (CFO)

Thank you, Vignesh, and good morning, everyone. As you heard earlier from Mike and Sue, total DANYELZA net product revenues of $22.8 million in the second quarter of 2024 represented a 10% increase compared to $20.8 million total DANYELZA net product revenue in the second quarter of 2023, primarily driven by increased international revenues. The increase of total DANYELZA net product revenue net in the quarter ended June 30, 2024, compared to the quarter ended June 30, 2023, was a result of increased volume from Western Europe, as well as commercial launches for Brazil and Mexico and Latin American region. U.S. DANYELZA net product revenues were $15.2 million and $15.9 million for the three months ended June 30, 2024 and 2023, respectively, representing a 4% decline.

Our total DANYELZA net product revenue was $42.2 million for the six months ended June 30, 2024, an increase of 3% as compared to $41 million in the comparable period in 2023. The increase in total DANYELZA net product revenue was primarily driven by a $1.2 million increase in U.S. DANYELZA net product revenue in the six months ended June 30, 2024, while ex-U.S. net product revenue was relatively flat. We did not have licensing revenue for the three months ended June 30, 2024, and 2023. We reported $25 million of licensing revenue in the six months ended June 30, 2024, and did not have licensing revenue for the six months ended June 30, 2023.

Moving to operating expenses, our research and development expenses were $12.3 million and $25.6 million for the quarter and six months ended June 30, 2024, which were relatively flat compared to $12.1 million and $25.5 million for the quarter and six months ended June 30, 2023. Selling general and administrative expenses increased by $5.9 million and $5.1 million to $17.2 million and $28.7 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023....

The increase in selling, general, and administrative expenses for the 3 and 6 months ended June 30, 2024, were primarily attributable to a net impact of $3.8 million in charges related to 2 legal settlements that were finalized in the second quarter of 2024, which is net of anticipated insurance proceeds. We reported a net loss for the quarter ended June 30, 2024, of $9.2 million, or -$0.21 per basic and diluted share, compared to a net loss of $6.3 million, or -$0.14 per basic and diluted share for the quarter ended June 30, 2023.

In addition, we have reported a net loss for the six months ended June 30, 2024, of $15.9 million, or -$0.36 per basic and diluted share, compared to a net loss of $12.7 million, or -$0.29 per basic and diluted share for the six months ended June 30, 2023. The increase in net loss for the three and six months ended June 30, 2024, was primarily driven by the previously mentioned two legal settlements with a net $3.8 million impact. As mentioned earlier, we ended the second quarter of 2024 with cash and cash equivalents of $77.8 million, compared to $78.6 million at year-end 2023. The decrease was $0.8 million year-to-date.

Importantly, we continue to maintain a strong balance sheet, reporting $2.1 million in cash inflows for the second quarter of 2024, an improvement from $5 million cash burn in the same period in 2023. Turning now to our full year 2024 guidance. We are revising our full year 2024 total net revenue to be in a range of between $87 million and $95 million from our previous guidance in the range of between $95 million to $100 million. Although our current guidance is reduced for 2024, we believe that DANYELZA will return to higher growth rates in the second half of 2024 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.

We continue to anticipate operating expenses to remain in the range of between $115 million and $120 million, which is consistent with our prior guidance. We expect our cash burn for the full year 2024 to remain in the range of between $115 million and $120 million, which is consistent with our prior guidance. We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of this specific analysis of cash runway only, minimal growth in DANYELZA net product revenues is assumed to be part of the analysis.

Although we are seeing slower single-digit growth for the first half of 2024 than previously anticipated and communicated, primarily driven by competition for patients as a result of increased clinical trial activity in the U.S., we believe DANYELZA will continue to grow in future periods, and this will not have a material impact on our cash flow guidance. We believe that DANYELZA will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that potentially could lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that all of our programs will be advancing at our own expense. No new programs other than the ones that are planned and in studies and trials are assumed at this point for the purposes of this analysis.

With a strong balance sheet and a focused strategy, we believe Y-mAbs is well positioned to execute on our strategic mission and priorities, and to support the delivery of multiple anticipated milestones as we move ahead. This concludes the financial update, and now I will turn the call back over to Mike.

Mike Rossi (President and CEO)

Thank you for that overview, Pete. Now, let's open the line for questions. Operator?

Operator (participant)

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 that your line is in the question queue. You may press star two if you would like to remove your question from the queue. We ask that analysts limit yourselves to one question and a follow-up, so that others may have an opportunity to ask questions. You may re-queue if you have additional questions. For participants using speaker equipment, it may be necessary to pick up your handsets before pressing the star keys. One moment please, while we poll for questions. Our first question comes from Etzer Darout with BMO Capital Markets. Please proceed with your question.

Etzer Darout (Managing Director and Senior Biotechnology Analyst)

Great. Thanks for taking the questions. First one I had was on sort of the frontline BCC study. Just wondered if you could talk about how many patients maybe you anticipate enrolling in the randomized portion of that study. And I had a follow-up on SADA.

Mike Rossi (President and CEO)

Great. Thank you, Etzer. As far as the BCC study, I'll pass that off to Vignesh. So Vignesh can inform you a little bit more on the study. Vignesh?

Vignesh Rajah (Chief Medical Officer)

Yes. Thank you, Mike. Yes, so the current study, ongoing single-arm study, as Mike mentioned, enrolled 10 patients, so far, and we're anticipating transitioning to a randomized study, where the design is still being evaluated. At the moment, I don't, I can't give you an exact figure of how many patients that is expected to be, but as soon as we get further details later this year, we will share that.

Etzer Darout (Managing Director and Senior Biotechnology Analyst)

Great. Thank you. And then, for the Part A of the SADA study, just wondered if you could learn enough about GD2 expression in the various tumor types you're exploring, to start maybe thinking about expansions into specific tumors in Part B or C, or are we still sort of too early kind of in the process to get to sort of tumor-specific evaluation, if you will, in sort of the subsequent cohorts that you'll be enrolling on Part B, C and beyond?

Mike Rossi (President and CEO)

Well, that's a good question, Etzer. As we look at this, we opted to go with a wide basket looking at different tumor expressions, and we'll collect that data. I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one, but we will take all that into account as we move into Part B.

Etzer Darout (Managing Director and Senior Biotechnology Analyst)

Great. Thank you.

Mike Rossi (President and CEO)

Thank you.

Operator (participant)

Our next question comes from Nicole Germino with Truist Securities. Please proceed with your question.

Mike Rossi (President and CEO)

Nicole?

Nicole Germino (Biotech Equity Research Analyst)

Hi, sorry about that. I was on mute. Thanks for taking the question. For GD2-SADA, can you walk us through the cadence of data milestones and roughly when we could get some efficacy data from potentially Part B? I have a quick follow-up.

Mike Rossi (President and CEO)

Yes, Nicole. As we look at the drug study itself, the work we're not designed for efficacy in Part A. So what we're looking for is really the safety of the protein and making sure that we can continue to move on to Part B, where we do a dose escalation. Secondary to that, we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope. So from our Part A, as we conclude it later this year, is really focused on the safety of the protein, with the additional data coming in from the interval, as well as the overall protein load that we'll use to move forward in Part B.

Nicole Germino (Biotech Equity Research Analyst)

Okay, got it. And then just more broadly in SADA. The SADA administration has a cold protein infusion that can be administered by the treating oncologist before the isotope infusion. While this may be a bit early, can you help us understand how reimbursement work would work out for both the med onc and for the rad onc?

Mike Rossi (President and CEO)

Yes, that, you know, again, that's a good question. This is a novel approach in better utilizing the overall infrastructure in both oncologist offices as well as in nuclear medicine. So we know there's challenges today with having enough theranostic suites to do long isotope infusions, as well as enough nuclear medicine physicians, authorized users, to be able to take the time to do that. So as we move forward, going into our registration trials, we're looking at different opportunities for reimbursement and what that may look like, but that overall is not driving our strategy. Our strategy is to be able to more effectively dose patients, to better utilize those resources from both infusion centers as well as nuclear medicine departments, and ultimately be able to treat more patients in an effective manner.

Nicole Germino (Biotech Equity Research Analyst)

Great. Thank you.

Mike Rossi (President and CEO)

Thank you, Nicole.

Operator (participant)

Our next question comes from Justin Walsh with JonesTrading. Please proceed with your question.

Justin Walsh (Director and Equity Research Analyst)

Hi. Thanks for taking the question. Can you provide any color on your timeline expectations for GD2-SADA going forward? Do we have a sense of how long Part B and C might take relative to Part A?

Mike Rossi (President and CEO)

You know, that's as we have it laid out today, we expect to conclude Part A later this year and move right into Part B. Now, we've been increasing the speed of our recruitment in our trials, so we've been able to recruit rather quickly in Part A, as we've progressed this trial. So looking at Part B, as we take the information from Part A, my expectation would be that we would be able to start treating patients in 2025, early 2025, with the potential to close that out in 2025 or early 2026. Vignesh, anything additional on your side?

Vignesh Rajah (Chief Medical Officer)

.Nothing to add on matter. I think that is a reasonable timeframe based on what we've seen so far. Obviously, it's very, very dependent on what results and dosimetry we see along the way, but I think that's about as best estimation we can make at this stage.

Justin Walsh (Director and Equity Research Analyst)

Great, thanks for taking my question.

Mike Rossi (President and CEO)

Thank you.

Operator (participant)

Our next question comes from Alec Stranahan with Bank of America. Please proceed with your question.

Alec Stranahan (VP of Biotechnology Equity Research)

Hey, guys. Thanks for taking our questions. Maybe a quick follow-up on the last question that was asked. Maybe walk us through how recruitment has gone versus your expectations for the GD2-SADA studies so far, and any other unique logistical considerations you'd flag to getting these studies, either for GD2 or for CD38 off the ground, especially thinking as you move to parts B and C. Thanks.

Mike Rossi (President and CEO)

Thank you, Alec. As far as recruitment goes, it was slow at first as we're getting the sites up. Now we've seen an increase in speed and recruitment in our 101 trial for GD2. I'd expect to see that continue. As far as our 1201, we've recently initiated the first site with the second one right behind it, so we're actively seeking the first patient for our 1201. But you know, as we look at this, I would expect, as you dose proteins in patients for the first time, for physicians to really be judicious in who they select and how. But once you start seeing the safety data rolling in and the lack of DLTs, we see an increase overall in the speed of the trial.

I'm happy with the speed of recruitment, but again, first in humans, you do see some lag time. Vignesh, anything additional?

Vignesh Rajah (Chief Medical Officer)

Yeah, just to add, as you know, as Mike mentioned earlier on, this is a complex part of the phase 1 study, where we set out to test different sort of dose levels all the way from 0.3 up to much higher doses, up to 5 to 10 milligrams, was the original protocol, including testing dosing intervals of 2 to 5 days. So we're still in that process at the moment, so it's too soon to determine the optimal combination or permutation. But this is kind of the stepwise process where we're taking to actually determine the optimal dose before we get onto part B.

Alec Stranahan (VP of Biotechnology Equity Research)

Great, makes sense. Thank you.

Mike Rossi (President and CEO)

Next question, operator.

Operator (participant)

As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Mike Ulz with Morgan Stanley. Please proceed with your question.

Mike Ulz (Executive Director of Biotechnology Equity Research)

Hey, guys. Thanks for taking the question. Maybe just a follow-up on GD2-SADA. Can you remind us for cohort 5 in part A, just, you know, what dose you're at, if you can, and then are there any plans to go to a cohort 6, for example, or dose higher? Thanks.

Mike Rossi (President and CEO)

Well, Mike, good question. Vignesh, address the,

Vignesh Rajah (Chief Medical Officer)

Yeah

Mike Rossi (President and CEO)

cohort 5.

Vignesh Rajah (Chief Medical Officer)

Yes, we're currently in cohort 5, where we are testing 1 milligram per kilo at a 4-day interval. Whether or not what cohort 5 patients look like will determine how we proceed, based on whether a cohort 6 is required, will really depend on the dosimetry. So at the moment, we don't have any immediate thoughts on what that will look like. We'll wait to see what the results show in this cohort 5. So at the moment, it's 1 milligram and 4-day interval.

Mike Ulz (Executive Director of Biotechnology Equity Research)

Got it. Thank you.

Mike Rossi (President and CEO)

Thank you, Mike.

Operator (participant)

Our next question comes from John Newman with Canaccord Genuity. Please proceed with your question.

John Newman (Managing Director of Biotechnology)

Hi, guys. Good morning. Thanks a lot for taking my question. Just curious, with the ongoing DANYELZA's launch, obviously, you're seeing some expansion internationally, but I'm wondering if you could comment on whether you're continuing to see the duration of therapy mature in the United States, and whether going forward that could make a meaningful contribution to growth. Thank you.

Mike Rossi (President and CEO)

Thank you, John. For DANYELZA's specific growth, I'll pass this to Sue.

Sue Smith (Chief Commercial Officer)

Great. Thank you. Yeah, we have seen some duration increase, actually, with some older patients that are added. And in general, we're actually seeing more continued use as our new campaign has data showing efficacy if someone has been on a prior GD2 therapy and has not progressed well on that. When switching over to our product, we have data showing now that patients with bone or bone marrow involvement actually can get a disease response if they've been on a prior GD2 therapy. So we're seeing an increase in uptake among physicians in that setting as well.

Etzer Darout (Managing Director and Senior Biotechnology Analyst)

Great. Thank you.

Sue Smith (Chief Commercial Officer)

Sure.

Operator (participant)

Our next question comes from Justin Walsh with JonesTrading. Please proceed with your question.

Justin Walsh (Director and Equity Research Analyst)

Hi, thanks for taking the follow-up. I'm wondering if you can remind us how you view the relative market opportunity for DANYELZA in frontline induction and high-risk neuroblastoma and osteosarcoma versus the currently approved relapsed refractory indication.

Mike Rossi (President and CEO)

Thank you, Justin. Again, Sue?

Sue Smith (Chief Commercial Officer)

Sure. So currently, the bulk of our use is in the relapse setting in the U.S., and, the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting. And actually, the data that is in our new campaign does a nice job of separating this out and actually showing that a patient with an incomplete response after any treatment, who has residual disease in the bone or bone marrow, this is precisely where we were studied. So we're starting to see, and we've heard from physicians with the new campaign, that they intend to, increase their use in both of those settings based on the new data.

Etzer Darout (Managing Director and Senior Biotechnology Analyst)

Great. Thanks.

Operator (participant)

There are no further questions at this time. I would now like to turn the floor back over to Mike Rossi for closing comments.

Mike Rossi (President and CEO)

Thank you all for joining us today to discuss the progress made during the second quarter of this year. Y-mAbs is supported by a strong financial foundation, driven by the growing commercial success and geographic expansion of DANYELZA. We believe we're uniquely positioned to continue growth while advancing the clinical development of our differentiated radioimmune therapy platform, SADA PRIT, to potentially deliver better and safer therapeutic options in the treatment of a variety of cancers. We look forward to seeing many of you at upcoming investor and medical meetings throughout the fall. Have a great day.

Operator (participant)

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.