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spk02: Good morning and welcome to the YM Labs Therapeutics, Inc.' 's earnings conference call for the second quarter of 2023. At this time, all participants are on a listen-only mode. Instructions for the question and answer session will follow after the prepared remarks. As a reminder, today's conference will be recorded. I will now hand it over to YM Labs Head of IR, Courtney Dugan.
spk01: Thank you. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, 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 Danielsa territory expansion and advancement of FATA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and 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 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 factors discussed in the company's quarterly report on Form 10-Q for the quarter ended June 30th, 2023, as filed with the SEC on August 10th, 2023. With that, I'd now like to turn the call over to our founder, president, and interim CEO, Thomas Gad.
spk14: Thank you, Courtney, and good morning, everyone, and thank you for joining us today. Today I have with me our Chief Financial Officer, Bill Cruz, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vinesh Raja. On today's call, I'll begin by providing a review of our second quarter product sales and then also highlights, updates on the additional Nacitimab research currently underway. I'll also touch on key clinical highlights from the quarter and an update on our novel retargeted two-step radiopharmaceutical platform. the SADA white print. We next will then discuss further details, our ISS programs under Danielsa, as well as our progress on our SADA Phase 1 study, followed by Sue Smith, who will report further insights into our Danielsa U.S. and ex-U.S. sales. Sue will then provide an overview of our second quarter financial performance, our cash position, and reiterate our full year 2023 guidance. And then we'll open up the line for Q&A. Let me begin with a high-level update on the year so far. As you know, we successfully implemented a strategic repatriation of our pipeline, focusing on Danielsa and the SADA platform earlier this year. Our execution has been swift, as our first half financials demonstrate, allowing us to extend our estimated cash runway into 2026. I'm incredibly proud of our team's resilience over the past several months, and their steadfast dedication to realizing our mission of providing innovative therapeutic options in the fight against cancer, particularly pediatric cancers. As we look ahead to the rest of 2023 and beyond, we are in a healthy financial position with 87.9 million in cash and cash equivalents at the end of the second quarter of 2023. We have a firm strategy in place that focuses on growing Danielsa's net sales which we believe will enable us to continue to advance our SADA platform through clinical development while being disciplined on our R&D spend, and at the same time deliver long-term value to both patients and investors alike. Let me turn to the highlights on our Danielsa franchise. As a reminder, Danielsa is approved by the US FDA for the treatment of relapsed and refractory high-risk neuroblastoma in bone and bone marrow for patients but demonstrated a partial response, minor response, or stable disease prior therapies. Neuroblastoma is the most common cancer in infants and the third most common cancer in children. In the second quarter of this year, we achieved 20.8 million in net product sales of Danielson, more than double of 112% from what we recorded in the second quarter of 2022, and up 3% from our previous quarter. Additionally, we made significant progress on our commercialization efforts for Danielsa and continue to gain momentum in the U.S. with a number of new accounts. We now have 56 sites activated across the U.S. We've been making significant progress outside the U.S., marked by the recent regulatory approval of Danielsa in Brazil. In May, we received approval in Brazil, where we have partnered with Adium, also Technopharma. for marketing in the region. Additionally, Cyclone launched Danielson in Greater China late June, early July, further solidifying our presence in the Asian market. We firmly believe that the Asian market holds a great potential as an important revenue driver for Danielson, and we look forward to updating you on the progress of these launches over the coming quarters. We also continue to see progress with our partnerships in Central Eastern Europe through Swix Pharmaceuticals and Takeda in Israel, and our distribution program through WEP in Europe. We continue to seek partnerships to expand our global commercial footprint even further, aiming to enable any patient who may benefit from Danielsa to access it. This is the backbone of our mission at YMAPS, to support children and families in their fight to beat cancer. We couldn't be more pleased with our first two quarters of Danielsa, creating net sales of more than $40 million in 2023 already and gaining market share in the US. We remain confident in our ability to continue to grow our commercial market footprint and meet our full year 2023 Danielsa net product revenue guidance. Sue will provide further call on Danielsa sales for the quarter shortly. In addition to our partnering strategy for Danielson, we continue to collaborate with leading KOLs on investigator-sponsored clinical studies to efficiently advance potential label expansions opportunities for Danielson. We next will provide an update on our ongoing clinical trials with thought leaders at the Beat Childhood Cancer Resource Consortium, MD Anderson Cancer Center, and Ohio State University and Memorial Sloan Kettering Cancer Center. Now let's turn to SADA. On to SADA, our novel and highly differentiated pre-targeted two-step radiopharmaceutical platform in development that we licensed from Memorial Sloan Kettering and MIT in April 2020. With SADA, we are working to pre-target the tumor with a protein-only dose with rapid clearance of any unbound protein from the bloodstream, followed by a radioactive payload. we believe this mechanism offers the potential to substantially increase the amount of radioactive payload delivered to tumors while simultaneously limiting normal tissue uptake and thus resulting in significantly higher therapeutic indices by potentially maximizing on-target efficacy while minimizing off-target side effects. Further, our two-step dosing separates protein dose from the hot payload dota case lutetium dose. simplify our supply chain and facilitate the use of SADA in large infusion centers if approved. The payload is not patient-specific, making it possible to use the same payload for different SADA patients and different SADA constructs, potentially increasing the platform's accessibility and efficiency. We believe our SADA WiPAR theranostic platform, if approved, has the potential to drive significant supply chain improvements. Our first, hopefully, of many SADA constructs targeting GD2 entered the clinic this March. We are pleased to report that we have closed cohorts one and two, and we are currently administering doses in cohort three at one milligram per kilo. I can further say that we have now administered a 200-millimeter therapeutic dose, and we have not seen any pain signals when dosing GD2 SADA. We anticipate sharing PK and imaging data at our annual R&D day in December. Our second development program derived from this platform is the CD38 construct. We have already conducted our pre-IND meeting with the FDA, and we anticipate submitting an IND application for this program in the third quarter of this year. Additionally, we are advancing a number of preclinical target, and have made good progress on both our HER2 and B7H3 constructs, on which we plan to provide an update on our IND day later this year. Lastly, a short update on our business development activities. As mentioned, we remain dedicated to expanding the global commercial footprint of Danielsa through potential partnerships and ISS strategies. Regarding SADA YPRIT, our current approach is multifaceted. We aim to advance internally some of the SADA constructs to at least phase two, while in parallel seeking to out-license other targets. Additionally, we see an important opportunity to collaborate with third-party and their targets to introduce to the SADA platform, and to explore targets from previously unsuccessful phase threes as we seek to maximize the potential of our platform. And with that, I would like to turn this call over to Dr. Ines Raja. Thank you.
spk10: Thank you, Thomas, and good morning, everyone. I'll first provide an overview of our ongoing NACCIDIMAP investigator-sponsored studies, ISS's, And then I will discuss the latest updates on our SADA platform. So in the frontline high-risk neuroblastoma setting, we are excited about our collaboration with Beat Childhood Cancer Research Consortium for a multicenter phase two trial, evaluating Nexidimab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. Currently, nine sites have been initiated and five patients have been dosed. Study will, however, transition from a single-arm study with Naxidimab added to current standard treatment for induction to a randomized study where the control on the current standard of care for induction therapy, which is chemotherapy plus or minus ALK inhibitor. The clinical rationale for this study is based on the fact that patients who have a favorable response at the end of induction treatment have a much better prognosis. By increasing the number of patients who achieve a complete response following induction treatment, we can potentially improve overall survival outcomes. The purpose of this randomization is to compare the end of induction complete response rate between the two arms. Our aim is to show superiority in the Naxidimab arm versus standard of care. We intend to engage with the FDA to gain their insights on the study design and endpoints and hopefully get their alignment. We're also considering an interim analysis and its impact on the sample size. Patient recruitment for the trial is projected to start years, but there's an anticipated total trial sample size of approximately 270 patients. This will include BCC centers in the US, Canada, and Europe. At the moment, we're in the midst of updating the trial protocol, preparing for IND submission, and working to schedule a regulatory meeting. We anticipate the new study to be initiated in quarter one, 2024. Moving to osteosarcoma, We are continuing to work with Memorial Sloan Kettering Cancer Center on its multicenter investigator-sponsored trial for Nexidimab. We expect data from this Phase I-II trial in Quarter 3 of 2024. And if positive, we hope to then begin recruitment for a pivotal Phase II trial. At ASCO in June of this year, we presented the pre-specified interim clinical data on Nexidimab in combination with GM-CSF. in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to the bone and or bone marrow. The overall response rate was 50% and complete response rate of 38% as per INRC criteria. For the subset of patients with refractory and relapsed disease, the overall response rates were 58% and 42% respectively. There were clinically meaningful reductions in QI scores ranging up to minus 18 in patients, regardless of baseline disease status. At the AACR meeting in April of this year, we presented data on preclinical study conducted by MD Anderson Cancer Center, showing that GD2 was upregulated in positive breast cancer, and its high expression is associated with a poor prognosis. This data led to our ISS study with Ohio State University for advanced breast cancer, whereby Naxidimab will be dosed combination with gemcitabine and NK cells. Our strategy is to generate proof-of-concept data in humans with the aim to establish a solid tumor breast cancer franchise that could potentially attract strategic partnerships. We firmly believe in the potential of Nexidimab to aid the treatment of a variety of cancers with significant medical needs, both in pediatric and adult cancers. And we plan to execute and build upon the large commercial opportunity of Nexidimab worldwide. Now turning to the latest updates on our SADA WIPRIT Theranostic platform. In June, we presented our phase one clinical study design, evaluating SADA WIPRIT for the treatment of certain GD2 positive solid tumors, including small cell lung cancer, sarcoma, and malignant melanoma at ASCO. To reiterate, the phase one dose escalation, single arm, open label, non-randomized multicenter study had three parts. Part A explores dose finding for the GD2 SADA molecule and testing of dose intervals between the protein and the 177 lutetium DOTA payload. Part B determines the optimal dose of 177 lutetium DOTA. And Part C evaluates safety and initial signs of efficacy using repeat dosing. Dose escalation is based on two patients in cohorts 1 and 2, followed by a classic 3 plus 3 design. The study is progressing well. We currently have six active sites and patient recruitment is ongoing. Particularly exciting is the news that we shared today that we have advanced through the cohorts to the point we have now given a 200 millicurie therapeutic dose of 177 lutetium dota using the dosing interval of two to five days based on optimal timing coming from our animal studies. We are pleased with what we have seen so far, noting that we are still in early days but are looking forward to providing an interim data update at our R&D day later this year. Additionally, we remain on track to file an IMD for our CD38 SADA program in non-Hodgkin's lymphoma, focusing on T cell lymphoma, where an unmet medical need exists with the FDA in the third quarter of this year. We believe in the potential for SADA WiPRIT 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'll now hand the call over to Sue Smith to provide further color on our continued Danielsa growth.
spk09: Thank you, Vignesh, and good morning, everyone. I'm pleased to be speaking with you this morning about our commercial progress of Danielsa. Our revenues in the second quarter reflect the team's execution on the strategic commercialization plan in action as we further expand our market footprint. The feedback we receive from physicians is truly remarkable, and as Thomas mentioned earlier, we are very pleased to see more and more physicians and new centers gaining experience with and seeing the benefits of Danielza for their patients. The strategic commercialization plan we have put in place includes three key initiatives, and I'll speak to each one. First, we keep the patient at the center of everything we do. Our team has built upon the strong momentum from the first quarter of this year and continued to put initiatives in place to further educate the market about the safe and effective use of Danielza. During the second quarter, we continued to build upon our work to identify and support new patients, and as a result have had three consecutive months of more than 30 patients in our hub. We added three new accounts using Danielza during the second quarter. Twelve physicians have prescribed Danielza, and 12 new patients started treatment in the second quarter. Additionally, we launched a strategic social media initiative to specifically target the average parent age of a child with neuroblastoma, which is typically a parent in their 20s or 30s. The launch of our Instagram in particular has been noteworthy as we roll out a steady stream of new and informative content to caregivers. Second, we demonstrate focused account teamwork. Following our restructuring announced earlier in the year, we've really seen what our realigned team can accomplish. And since the initial launch, and as of June 30th this year, we've delivered Danielza to 56 centers across the U.S., a sequential increase of 6% in the number of centers versus the last quarter. During the second quarter, 61% of vials sold in the U.S. were sold outside of Memorial Sloan Kettering. consistent with our split in the first quarter of 2023. Our team continues to demonstrate professionalism and commitment to our mission of making Danielza accessible to patients. Third is our ongoing commitment to customer support. We believe the increase in physician experience with Danielza that I mentioned earlier is in part due to the clear and consistent administration experience our team has put in place. This has led to 30% of our accounts having had two or more patients on Danielza since launch. Consistently executing against our strategy and demonstrating a high level of excellence has led to YMABS being recognized as the most committed pharmaceutical company in the high-risk neuroblastoma space, with 88% of physicians treating pediatric neuroblastoma in the U.S. associating YMABS with a true commitment to the disease based on a recent survey we conducted among 17 physicians. We are a leader in this highly important area of pediatric cancer, and we have a 17 percent share of the U.S. anti-GD2 market as of the second quarter of this year. I'm very proud of this commercial team, and I look forward to sharing our continued progress in future quarters. Let me now pass the ball to Bo, who will discuss our second quarter financial results in more detail.
spk03: Thank you, Sue, and good morning, everyone.
spk11: Our net product revenues of 20.8 million in the second quarter of 23 increased by 3% sequentially compared to the first quarter of 23, which has revenues of 20.3 million. The increase was driven by international revenues and related royalties, including a $3.5 million commercial launch inventory stocking order from Cyclone, which we do not anticipate recurring at this level each quarter. Also, the increase was partly offset by a softening in the number of new U.S. patients in the second quarter and our $2.5 million inventory stopping order from WEP in the first quarter this year. Daniela, net product revenues of 20.8 million and 41 million for the quarter and six months ended June 30th, 2023 represented increases of 112% and 102% respectively over the 9.8 million and 20.3 million reported in the comparable periods of 2022. The respective increases of 11% and 20.7 million were primarily driven by an increase in the number of new US patients and an increments of benefit from expanding international markets. Moving to operating expenses. Our research and development expenses decreased by 14.3 million and 23.8 million to 12.1 million and 25.5 million for the second quarter and six months in the June 30th, 2023 respectively. compared to the same periods last year. The net increase was primarily due to the decrease in spending on deprocessed programs in connection with our restructuring plan, which resulted in decreased outsourced manufacturing, outsourced research and supplies, clinical trials, and personnel-related costs. Selling general and administrative expenses decreased by 11.8 million and 13 million to 11.3 million and 23.5 million for the second quarter and the six months ended June 30th, 2023, respectively, compared to the same periods last year. The decreases in SDNA for the three and six months ended June 30th, 2023 were primarily attributable to a $10.9 million charge related to the departure of the company's former chief executive officer in Q2 2022. Additionally, we recorded a restructuring charge of $1.1 million in SDNA during the six months ended June 30, 2023 in connection with the restructuring plan. Personnel-related costs, inclusive of stock-based compensation, decreased in the three months ended June 30, 2023 compared to the corresponding period in 2022 due to the impact of the restructuring. We reported a net loss for the quarter in the June 30th, 2023 of 6.3 million, or 14 cents per share, basic and diluted, compared to a net loss of 41.1 million, or 94 cents per share, basic and diluted, for the second quarter in the June 30th, 2022. The improvement in our net loss was primarily driven by the increased revenues and growth of Danielsa, coupled with decreased operating expenses in the second quarter, 2023. Additionally, we recorded a net loss for the six months ended June 30, 2023 of $12.7 million, or $0.29 per share, basic and diluted, compared to a net loss of $69.2 million, or $1.58 per share, basic and diluted, for the six months ended June 30, 2022. The decrease in net loss was primarily driven by higher net product revenue, lower R&D expenses, lower SG&A expenses, inclusive of the $10.9 million decrease for the charge related to the departure of our former CEO. As Thomas mentioned, we ended the second quarter with cash and cash equivalents of $87.9 million compared to $105.8 million at year end 22. the decrease was 17.9 million years to date. Importantly, we reduced our cash use from 13 to 5 million or by 64% during the second quarter of 2023 compared to the first quarter. We continue to demonstrate responsible cash management along with market expansion for Danielsa and our total cash burn for the full year 23 is expected to be between 40 and 50 million. We believe Our cash and cash equivalents will be sufficient to support our commercial operations and pipeline programs as currently planned into 2026. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. No new partnerships or other new business development income are included in the assumptions. For the purpose of this analysis of cash runway only, The Danielsa product revenues are assumed to increase by 10% each year in 2024 and 2025. We indeed hope to see a higher growth rate for Danielsa as we execute our refined commercial strategy and work to deliver the 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 would 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 EmbedderMap program has been assumed for the purpose of this estimate, and we have not assumed any equity debt offerings or borrowings. We continue to expect to achieve the financial guidance announced during our Q1 report, as we anticipate full-year, and also net profit revenues to be in the range of 80 to 85 million with a projected cash burn of 40 to 50 million for the full year. And we continue to expect operating expenses between 150 and 120 million. We believe YMAS remains a healthy financial position to execute our strategic mission, our priorities, and to support the delivery of multiple milestones. Now, this concludes the financial update, and I'll now turn the call back to Thomas.
spk14: Thank you, Bo. Thanks for the overview. Let's open up the line for questions, Alberto, please.
spk02: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2. if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.
spk03: And our first question comes from the line of Alec Stranahan with Bank of America.
spk02: Please proceed with your question.
spk12: Okay, great. Hey, guys, thanks for taking our questions. Just a couple from us. Maybe first for Sue. Could you give us a sense of the patients coming on therapy versus coming off therapy in 2Q? And as we look to the back half of this year, essentially, if you want to meet guidance, you just need to sort of flatline that $20 million or so per quarter. So is the expectation that the on-off rate will be roughly equal in the second half? And then just to follow up, on the July symphony data from Bloomberg. Any guidance you can give around that? I noticed it was down sequentially month over month. And then I've got a follow-up. Thank you.
spk09: Okay. Thanks, Alex, for the questions. In terms of the patients coming on and off treatment, we are looking to drive patients earlier to the induction failure. And so in terms of the right now, the majority of our patients are relapsed. And we anticipate the on-off rate to shift slightly to a more an earlier patient based on induction new induction failure data that we hope to roll out. So that is a new marketing effort that we're working on and we hope to roll that out later this year and pending FDA approval of that. And secondly, in terms of the July symphony data, we did see a little softening in the second quarter. I think really now after being here for a year and a half, you know, we see a little seasonality in the spring. I think that truly what we hear from customers is the spring holidays and then the end of school time in June. Some people kind of tap the brakes on treatment a little bit to have some normalcy. And I really do think that's what it is in terms of the softening that we saw. But I remain confident that we have a real stable inflow of 30 plus patients per month in the hub over the past three months and a growing XMSK outside where 61% of our sales now are outside of MSK. A year ago, 60% of our sales were at MSK, right? So we've done a flip. So I think that's really the perspective to take that the foundation is strong, but we saw some seasonality.
spk12: Okay. Okay, that's helpful. And then one quick one, if I may, just on the China launch. Could you give us a sense if any of the 3.5 million sales from Cyclone, if any part of that was repeatable royalties yet?
spk03: Thomas, do you want to speak to that one?
spk14: Well, I think, Beau, do you want to speak to that one?
spk11: Yeah, I can. Well, it's very early days with Cyclone. And what they obviously faced their launch order with us here during the second quarter is quite substantial. Sold a little bit. So it's a combination of us selling wild to them and they sending us some royalties. And I think that's just an important point that with that transaction during the second quarter and the inventory stocking at web during the first quarter then essentially we're seeing 20 of the revenues coming from outside the us during the first half and that's a quite substantial um share and and and it's hard to imagine that we will see exactly the same or more in in terms of international um revenues in the second half and that's really why we maintain the guidance Of course, we're expecting international income during the second half, but I think it would be maybe a little bit too optimistic to say that it will continue at 20% of the total product revenues.
spk03: Okay. So that's how it comes about. Got it. All right. Thanks, and congrats on the progress. Thank you. Our next question comes from the line of Charles Su with Guggenheim Securities.
spk02: Please proceed with your question.
spk05: Hey, good morning, everyone, and thanks for this call and for taking our questions. Regarding GD2-SATA, correct me if I misheard, but it sounds like you've hit positive imaging data and have subsequently dosed a patient at the therapeutic level of 200 millicuries. One clarifying question on this, are you imaging only at the imaging dose, or are you also re-imaging at 200 millicuries? And if you're not, is there sufficient resolution at the imaging dose to generate clear SPECT images and possibly insights into on-tumor dosimetry? Thank you.
spk03: Yeah, thank you, Charles.
spk14: So, I'll just say that, yeah, you know, When we see tumor uptake, the protocol has been designed to move the patient to a repeat protein dose and then a 200-milligram dose. So that's what happened with the patient. But I would like to relay this question over to you, Vinesh, and then try a little more product and then look forward to the more detailed update.
spk10: Yes. By inference, when we say the patient has been dosed with tumor millicurie, That's on the basis that a patient has shown positive imaging uptake as per the protocol. So as you mentioned earlier on, we've gone through cohorts one and two, and we are now in cohort three with a higher dose of SADA protein at one milligrams per kilo. In terms of your other question, the imaging dose of radioisotope is 30 millicurie, and the therapeutic dose for this pathway at least is 200 millicurie. There is no planned imaging straight after the therapeutic dose, but there's sufficient granularity and imaging quality coming from the 30-millikuri dose, at least to address the question that we have in terms of uptake in the vital organs and also clearance from the system. So again, we're all evaluating this as we go forward. It's still very early stages, and we'll provide more data when we provide more mature information at the end of this year and the R&D day.
spk05: Sounds great.
spk03: Thanks for that color, and thanks for taking our questions, and happy Friday. Thank you.
spk02: Our next question comes from the line of Mike Bowles with Morgan Stanley. Please proceed with your question.
spk08: Hey, guys. Thanks for taking the question. Maybe just a bit of a follow-up on the launches outside the U.S., and maybe you could talk about your thoughts on those market opportunities relative to the U.S., you know, over the long term. Thanks.
spk14: Yeah. So, um, talking about Cyclone, our partnership in China and the approval that we got back in December, they have now announced they launched the product over there, I think, uh, late June, early July. So it's obviously very, very new for us. Uh, but, but, you know, we, we do think that there's, uh, going to be a material market for us going forward. But it's too early to get some call on how that's going to work. So we look forward to having two or three quarters. We know it's initially a 40 hospital campaign with dedicated 15 FTEs. So we are quite excited about it. And DD2 in that market is obviously fairly new. I think the first GD2 antibody was introduced nine months ago, and we are the second on the market shortly thereafter, so that's exciting as well. Okay, thank you. With Brazil, we are currently in negotiations on pricing, and once that settles, we look forward for ADM to launch there. You know, Brazil is approximately 50% of South America. That is also an exciting market for us. And our I think we are very pleased with the progress of our WEP name patient program in Europe and as well with Takeda in Israel and Swix Pharmaceuticals in Eastern Europe. So it's nice to see actual sales also gaining momentum.
spk03: Great. Thanks. Our next question comes from the line of Bill Maughan with Canaccord Genuity.
spk02: Please proceed with your question.
spk04: Good morning and thanks. So, looking down the line at a first line indication for Danielza eventually. So, if the study, if the induction study is positive and eventually you have a label, obviously you'll be one of two GD2s in the first line, but there'll be different settings in the first line, induction versus consolidation. So, given that it's not just two options in a head-to-head competition for treatment, all else being equal, I just want to get your, your, um, commentary on how you see the competitive dynamic playing out when you have two different drugs or kind of two different, um, two different, uh, uh, strategies for attacking first line, uh, neuroblastoma.
spk14: Yeah, thanks. I mean, I can, uh, high level and then Vanessa, maybe you can follow up. So, uh, I think, uh, I think the market is currently looking at introducing GD2 antibody up front and at the same time discussing the need for bone marrow transplant. So I think maybe the whole GD2 market is swearing towards induction. And I will let Vanessa talk a little bit about more of the trial design and how it positions versus the traditional front line.
spk10: Yes. I mean, the clinical landscape is definitely moving towards looking at the combination of chemo immunotherapy, both at the induction as well as a consolidation state, partly to maximize the efficacy or the response seen at the end of induction, which as I alluded to earlier, this has been correlated with a positive survival outcomes or improved survival outcomes. And in the consolidation setting, there is increasing awareness and consensus that potentially, combination of anti-GD2 plus current standard treatment of chemotherapy may be as good as or equivalent to stem cell transplant. So these are discussions still very early at this stage, but I think the scientific community is now looking to see how that landscape of anti-GD2 entering in the both induction and consolidation setting in order to improve the safety profile and the safety outcomes of patients is definitely there. And as far as Nexidimab is specifically concerned, we are definitely prioritizing the development of Nexidimab as we're in a randomized study looking at how the combination of Nexidimab plus standard induction chemo compares to just standard induction chemo. This seems to be the way forward now, and the aim is, of course, to maximize the complete response rate A recent COG study report confirmed as a publication, which showed how a combination of, well, not a combination, but at least maximizing treatments in these settings led to superior event-free survivals based on looking at QE scores before and after. And they go on to conclude that further improvements in survival outcome will depend on improved induction therapy regimens with agents like anti-GD2 antibodies. So the landscape is definitely evolving in that direction. And yes, I can't say anything more specific than that because trial discussions still ongoing with the COG and the BCC.
spk04: Understood. And as a quick follow up, so looking at the Brazil launch, from having seen other drugs that are reimbursed in Brazil, sometimes just given the government pay dynamics, the ordering and revenue can be very choppy. Is that what you expect out of Danielza in Brazil, or do you expect more of a curve where volume and demand matches revenues?
spk14: Yeah, no, we expect pending successful negotiations with CMAT on pricing. We do not expect any choppy reimbursement, and
spk03: But it's still ongoing. Okay. Great. Thanks.
spk02: Our next question comes from the line of Tess Romero with JPMorgan. Please proceed with your question.
spk07: Good morning, guys. Thanks so much for taking our question. In terms of the US-XUS split here to reach your 80 to 85 million guidance, What is your current expectation as to how this will split out? Do you still think it should be kind of in the mid-70s in the U.S. here? And then another launch follow-up for us. To be clear, July symphony was down 47% month over month. Are you suggesting that you think this will pick back up in August? And even last summer, we didn't see any seasonality in Daniela based on the symphony data that is available to us. Thanks so much.
spk14: I guess I'll take the first. Yeah, I do think we are comfortable in seeing mid-70s in U.S. and then the remainder from ex-U.S. sales. I don't know, Bo, Sue, if you want to comment on the .
spk09: Yes. This is Sue. Yeah, I think we do. I think that the stability is there. and that we do expect it to pick back up. We also have some new campaigns in development that we're very excited about. So, you know, I'm anticipating we will hit this number this year with the things that we have in place.
spk03: Okay, great. Thanks so much for taking our questions. Mm-hmm.
spk02: Our next question comes from the line of Edser Daroud with BMO Capital Market. Please proceed with your question.
spk13: Hi, this is Luke Chamoyang for Edser. Thanks for taking my question. Just one for me. Looking at the PK and imaging data for SADA later this year, how should we think about benchmarking that, and what are you thinking about as the go, no-go for that program?
spk14: So, thanks, Edser. So what we are trying to achieve by December is we are trying to see PK curves and imaging data, meaning we are trying to validate the mechanism of the SATA platform in terms of having the protein find a tumor while rapidly clearing unbound proteins from the bloodstream and at the same time being able to validate and the tumors with the 30-millicure isotope dose. I think that's what we're aiming at for December, and I think that would be a success internally for us.
spk03: Okay, thank you.
spk02: And our next question comes from the line of Sebastian with ChemPen. Please proceed with your question.
spk06: Hi, everyone. Thanks for taking my questions. I'm just wondering if you can comment on the type of centers that are going to enroll the frontline study in neuroblastoma. How many patients are those centers treating on an annual basis? And you already said something when you would expect data from that group. Thank you.
spk14: Hi, Vinesh. Why don't you take that?
spk10: Yeah, I didn't catch that question clearly. Can you repeat that, please?
spk14: He was asking about the PCC study, Nambak Center's potential data readout and patient numbers? Yes.
spk10: So as I mentioned earlier, we have a current ongoing study, which is a single-arm phase two, which we are aiming to transition to a study that could potentially lead to a label expansion. And that transition we anticipate to take place in quarter one next year. So what will happen to the patients in the current ongoing recruitment study will, of course, contribute safety evaluation of the combination and induction. But the proposed new randomized study will include a number of sites which are affiliated with the BCC network, which is currently about 50 sites in US, Canada, and also they have sites in Europe. They're also very keen to expand it out to other centers internationally outside of the US to accelerate the recruitment for this randomized study. The protocol is still in draft stage at the moment, but as I mentioned earlier on in the presentation part, we are looking at approximately 270 patients in total to be randomized in this study. We anticipate that will take anywhere between four to five years to complete enrollment. And based on the data, and we're also looking at the possibility of interim analysis and how that will impact as well. All of this is subject, of course, to discussions with the FDA, which we are planning later this year. And subject to all this data coming through being positive, yes, as I mentioned, we hope this will lead to sufficient data to expand our label on axonimab in induction treatment. Does that answer your question?
spk06: Yeah, great. Thank you very much, and have a nice weekend.
spk02: And we have reached the end of the question and answer session. I'll now turn the call back over to management for closing remarks.
spk14: Thank you, and thank you everyone for joining us today. Happy Friday. Have a great weekend.
spk03: Let's conclude our call. And this does conclude today's conference, and you may disconnect your lines at this time. Thank you for your attention.
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