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spk04: Hello, and welcome to Epizyme's first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. Following the prepared remarks, there will be a question-and-answer session. Please be advised that this call is being recorded. I would now like to turn the call over to Kristen Hilton, Investor Relations. You may begin.
spk02: Thank you, Operator. This morning, Epizyme issued a press release providing a business update in addition to first quarter 2022 financial results. The press release can be found in the investor section of the company's website at epizyme.com. On the call today are Grant Vogel, President and CEO, Dr. Shefali Agarwal, Senior Medical Advisor and Interim Chief Medical and Development Officer, and Joe Bollier, Senior Vice President and Head of Finance. Gerald Korn, our recently appointed Chief Operating Officer, will join us for the Q&A session. As a reminder, today's discussion will include forward-looking statements related to Epizyme's current plans and expectations, which are subject to certain risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the risk factors section of our most recent forms 10-Q, 10-K, and other SEC filings. These forward-looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date. We undertake no obligation to publicly update these statements. At this time, I would like to turn the call over to Grant Vogel. Grant?
spk05: Thank you, Kristen, and good morning, everyone. It's great to be here with you today and to provide an update on our first quarter 2022 results. On today's call, I will provide our commercial overview and performance at TASVERIC. Shefali will speak to our clinical development progress for Tazometastat and EZMO414, our investigational SETD2 inhibitor. And Jill will cover our financials for the quarter. Following our remarks, we'll open the line for questions. During the first quarter, TASVERIC generated net product revenue of $8.7 million, including $0.5 million related to the sale of TASVERIC commercial product for a third-party pharmaceutical company use in clinical trials. Tasveric commercial net sales in the first quarter of 2022 were $8.1 million, representing an increase of approximately 10% when compared to the fourth quarter of 2021. Free goods from our patient assistance program represented approximately 15% of total demand for the first quarter of 2022, a rate consistent with Q1 of 2021. Commercial demand increased 16% in Q1 2022 versus Q4 2021, while total demand, which, as a reminder, is commercial demand plus free goods provided through our patient assistance program, was similar to the fourth quarter 2021 levels. These fluctuations in total demand and commercial demand are directionally consistent with prescription dynamics we saw at the end of 2020 and into 2021. We believe these fluctuations are a result, in part, of the Medicare Part D drug benefit design and year-end prescription patterns that impact Q1 demand. As in the prior year, TASVERIC demand rebounded in March and reached its highest monthly level since launch. While more time will be needed to understand the impact of seasonality on the relapsed refractory FL market, and TASVERIC demand in particular, I am encouraged by this demand growth. We continue to be optimistic about prescription growth for TASVIRIC based upon physician feedback, data from our ATU survey, and recent changes in the FL treatment landscape and subsequent updates to treatment guidelines. Recent market research suggests that TASVIRIC market share continues to grow. In the third line, we lapse refractory FL setting for both wild-type and EZH2 mutation-positive populations, consistent with the company's commercial focus, messaging, and our prescribing information. Following the recent changes in the FL marketplace, Tasveric is now the only oral treatment alternative approved in the third-line plus setting for relapsed refractory FL patients. And based on physician-reported prescribing behavior from our tracking studies, physicians we sampled reported they intend to increase prescribing of Tasveric in patients in both wild-type and EZHT mutations in the third-line plus setting. NCCM recently updated its guidelines on B-cell lymphomas. The updated guidelines for grade 1, 2 follicle lymphoma now include Tazometastat as a suggested second-line treatment regimen and FL for elderly or infirm patients with EZH2 wild-type or unknown root-optifractory disease with no satisfactory alternative treatment option. Tasmetastat remains a suggested treatment in the third-line FL and subsequent lines of therapy consistent with our label. The inclusion of Tasmetastat in the second-line setting is an exciting update that reinforces our confidence in Tasveric's potential to reach many more patients. In addition to the NCCN guidelines update, we're also witnessing the FL treatment landscape changing in real time. with a voluntary withdrawal of PI3 and K inhibitors from the relapse refractory FL marketplace in recent months. In December, Secura Bio announced it was withdrawing Copetra from its approved FL indication. This was followed by Gilead's decision in January of this year to withdraw Zydelic from its approved FL indication, and TG Therapeutics' decision in April to stop selling Uconic in all of its approved indications. The FDA is also looking closely at the risk-benefit profile of PI3K inhibitors in FL, as seen with the recent ODAC meeting on the topic, in which the FDA asked advisors to specifically discuss the observed toxicity of the PI3 class and whether randomized data in this class of therapies are warranted to support the evaluation of benefit-risk in patients with hematologic malignancies. Our internal market research has consistently shown that the PI3K class accounts for approximately one-third of the FL market share. For physicians seeking an alternative to PI3Ks, Tasveric is now the only other oral therapy approved in the third-line plus setting. Combined with the NCCN guidelines update, we believe this presents a significant opportunity for future prescription growth. and corresponding commercial sales. At this time, I'd now like to turn the call over to Shefali. Shefali?
spk01: Thank you, Grant, and good morning, everyone. I'll begin our clinical update with tazometastat. As shared on March 15th, we dosed our first patient in the Phase III portion of the Symphony I study, a confirmatory study assessing tazometastat in combination with rituximab plus lenandamide compared with R-squared plus placebo in patients with relapsorefractic follicle lymphoma, previously treated with at least one systemic therapy, including those who are rituximab refractory and or have experienced progression of disease within two years of receiving their last treatment. We are proud to share that the randomized phase three portion of the study is open globally, and we are actively screening and enrolling patients in both Europe and the U.S. We are happy to share the data from the Symphony 1 study has been accepted for a poster presentation at the upcoming American Society of Clinical Oncology annual meeting in Chicago in June. The poster will include updated safety and activity data from the Phase 1B portion of the study, specifically updated overall and complete response rate, and a subgroup analysis of rituximab refractory and POT24 patients, which, as you know, represent about 30% to 40% of the relapsed refractory FL population in the real world and in which new, more effective treatments are needed. As a reminder, recent safety and activity data from the Phase 1b portion of Symphony 1 were presented at ASH in December 2021. We continue to follow this cohort of 40 patients and report additional updated data from the Phase 1b safety-running portion of the study later this year. We have finalized plans to begin a natural history study called Viola, evaluating R-squared in second-line relapsed refractory FL patients. Given the lack of the real-world data evaluating R-squared outcomes in the second-line relapsed refractory population, which includes rituximab refractory and POT24 patients, our goal is to design a prospective natural history study to better understand the outcomes of R-squared usage in this patient population. The study is designed to create a synthetic control arm with R-squared to compare the outcomes to the Symphony I Phase Ib activity data in a matched patient population which may allow us to mimic a randomized study. Our goal is to submit data from this study for publication in a peer-reviewed journal in 2023. Turning to the LISA study, progress is being made towards complete enrollment. LISA has fully enrolled the FL arm and is near complete in the DLBCL arm. As a reminder, this is a large Phase II study evaluating RCHOP and tazometastat in 62 high-risk frontline FL patients and 122 high-risk frontline DLBCL patients. Lysa, in collaboration with Epizyme, anticipates presenting top-line results from the Phase II portion of the study in the second half of 2022. Moving to our solid tumor program, CHEL-1, an open-label randomized Phase Ib2 study evaluating tazometastat plus enzutamide compared to enzutamide monotherapy in metastatic castration-resistant prostate cancer patients continues to progress nicely. The study is approximately 85% enrolled in the randomized portion toward a target of 80 patients. In 2022, we expect to complete enrollment in the randomized Phase II portion of the study and present updated data from the safety-running portion as well as interim data from the Phase II portion of the study, including radiological PSS and PSF50 in the second half of 2022. We continue to screen patients in ARIA, otherwise known as EZH1501, the Phase Ib2 Tazometastat Hematological BASC Study, as well as SET-101, which is first-in-human Phase Ib1 study of EZM-0414, represents novel first-in-class oral SET-D2 inhibitor in adult patients with relapsed refractory multiple myeloma and relapsed refractory DLBCL. For Aira, the bispecific of the Phase Ib2 Hematological Study will combine Tazometastat with mesotunizumab, Roche's investigational CD20-CD3 T-cell engaging bispecific antibody for patients with relapsed refractory FL who have received two or more prior lines of therapy. For SET101, the company expects to enroll between 30 to 36 patients in the Phase I dose escalation portion of the study. We plan to provide updates on both of these programs in the second half of 2022. As you can see, we continue to advance our development program for tazometastat and EZM-405 and anticipate a steady cadence of data in the second half of this year and through the coming years. Our post-marketing FDA commitments are also on track. We plan to leverage the Symphony 1 confirmatory trial and the ongoing post-marketing commitments to fully expand the TASVERIC label. We have several post-marketing studies underway intended to inform aspects of the label. These include clinical pharmacology evaluations to assess the effect of tazometastat on liver function, and the effect of CYP3A inhibitors and inducers on tazometastat for patients with solid or heme malignancies. We have also expanded enrollment in a cohort of our Phase II study in adults with INR1-negative tumor to enroll a total of at least 60 ES patients. The cohort is a paired biopsy designed to assess potential immune biomarkers. I would be remiss if I didn't share my excitement as a clinician in terms of the recent update to the NCCN guidelines that Grant referenced previously. These changes, which are more closely aligned with our current label in relapsed refractory FL, will support physicians making informed decisions as they consider appropriate treatment options for the patients regardless of mutation status in relapsed refractory FL. At this time, I'd like to pass the call to Joe, Senior Vice President and Head of Finance.
spk03: Thank you, Shefali. We ended the first quarter with approximately $200 million in cash, cash equivalents, and marketable securities. We continue to guide our cash runway into the third quarter of 2023. Total GAAP operating expenses were approximately $60 million for the first quarter of 2022. Total non-GAAP adjusted operating expenses were approximately $53 million for the first quarter of 2022. As you may recall, last quarter we revised our full-year 2022 operating expense guidance based on expense reduction measures and operational efficiency. We continue to expect 2022 total non-GAAP adjusted operating expenses of between 160 to 180 million. I would now like to turn the call back to Grant for closing remarks. Grant?
spk05: Thank you, Joe, and thank you, Shefali. This was a very good update, and I look forward to questions. In the Q&A session, we'll be joined, obviously, by Joe and Shefali, but also Gerald Korn, our new Chief Operating Officer. So I'll serve as kind of the emcee, and as we open the line to questions to them, I'll turn them to the appropriate person, okay? So why don't we open the line right now?
spk04: Thank you, sir. As a reminder, to ask a question, you would need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. I show our first question. It comes from the line of Peter Lawson from Barclays.
spk09: Great. Thank you so much. Thanks for taking the questions. I guess the first question is the confidence you have around essentially a rebound in revenues for Q2. That would be anything. Details around that would be great. Thank you.
spk05: You know, Peter, we're one month in, and we haven't reported on that. We did see a very strong rebound, as I said, in March. That continued into April, but the quarter's not done. But, you know, I think that the broader scope of change is this is – there's been more change in this market in the last quarter, I think, than there probably have been in many, many years. And I think physicians are just processing that information. And in terms of what the future holds, that's obviously something that's difficult to predict. What I can tell you is from what our market research has shown and what we hear from physicians is this is a significant opportunity for TASVIRIC. There'll be patients that are put on other therapies as well. But for many patients, especially in the third line plus setting, which is where the PI3Ks were used the most, we're the only oral agent that is now approved in that setting. And because of our profile, not just being oral, because of the safety profile, because of the tolerability, because of the efficacy, quite frankly, what I'm most excited is the growth that they're projecting is not in the mutant population. It's actually in the wild type or unknown population. And so for those reasons, along with the NCCN guidelines, I'm quite encouraged. I would say this is more of a back half and into 2023 when it starts because you've got to build patients, and then the life of therapy component of that would kick in. Does that make sense, Peter?
spk09: Yeah. That was actually my follow-up question. So you think that's more of a back half because of the you're waiting for patients to come off the PI3Ks. That's where you get that.
spk05: Yeah. Remember, most of, so if you take, with the exception of Econic, all of these drugs remain available on the market. And I'd like to ask you to follow here, but I can tell you my experience from working with physicians for many years at U.S. Oncology, if you've got a patient that is doing well, it's generally not an immediate change, especially if the drugs are still available. But I think each clinician is probably weighing the changes, and as things like NCCN guidelines get pulled through, pathways get updated, all those various types of things, it pulls through the system. But you're following?
spk01: Yeah, absolutely right, Grant. I think, as you know, follicle lymphoma is an indolent tumor, and patients actually do well. And if the patient is not symptomatic, physicians tend not to change the therapy if they're continuing, for example, on PI3Ks or any other therapy. I think important to see, Peter, is that, you know, that point that Grant made, that we'll be the only oral-approved therapy in third line and beyond. And now with the NCCN update, with availability in second line as well, although it was our label but now aligned with our label, we believe there's a great potential for Tazveric. And additionally, as we talk about all the great trials that we are doing and additional data that we will be generating, not only in FL, but also in other heme malignancy and solid tumors, we really substantially add to the value of TASVERIC in terms of potential of TASVERIC in combinations as well.
spk09: Thank you. And just a final question on the weakness at the beginning of the year. Is there any way of breaking out any COVID or Omicron effect that you may have seen in first years first few months of the year?
spk05: You know, like all of the things, Peter, short answer is I can't really quantify that. There were portions of the country that were enrolling, you know, lockdowns and so forth. But I would say that my experience in other drug classes, as well as what we saw last year, I really think this relates to two factors. One is the design of the Medicare drug benefit, which, as you know, as you get to the end of the year and the re-upping and the donut hole and all these things that affect how prescriptions are dispensed towards the end of the year. And the second aspect is that given that this is a tumor, a lot of patients, to be honest with you, decide to, you know, they travel south or they do different things that impacts the refills and so forth. So I can't tease out everything, but those are the, and since we've seen it Similarly, last year, I've seen it in other classes, not all of orals. That's what I think it was predominantly. I can't rule out that there was a COVID effect, though.
spk09: Okay. Thank you so much.
spk05: Thanks, Peter.
spk04: Thank you. Thank you. I'm sure our next question comes from the line of Peyton Bonsack from Callen. Please go ahead.
spk07: Hey, good morning, guys. This is Peyton on for Joe. Thanks for taking our questions. I guess the first one, hey. Could you elaborate or provide any additional details on the prescriber base for TASBERIC and how that's evolved since launch? Specifically, what are the number of new prescribers versus pre-prescribers and how that's changed over time? And then also, any additional information on the number of hospitals integrating TASBERIC into the amount R you can give? And I have a follow-up. Thank you.
spk05: Okay. Okay. So let me just talk a little bit about how it was introduced, and maybe, Shefali, you can comment on that since you were here and I was on the board. But predominantly at the start, given our patient population, which was an ES to begin with, epithelioid sarcoma, plus the fact that familiarity with TASVERIC was not broadly distributed in the United States when it launched, it was predominantly taken up in the academic setting. And what we've seen is a migration and greater uptake in the community over time. And today, roughly the split of volume between the community and the academic setting is roughly 45 to 50% community in the balance in the academic environment. And it goes up and down in that environment. There's probably more patients in the community than there is in the academic environment, but you have greater concentrations of physicians that all they do is treat follicular lymphoma in the academic environment than in the community. So you get some different dynamics going on in that environment. In terms of growth of That's something that we have a really difficult time assessing because, as you know, 60% of our volume goes to the specialty distributor channel. If they order through the specialty pharmacy, of which we've got one, we understand it's Dr. Smith, and it's a patient that's either ES or FL. We can track that. But that's only 40% of our prescription volume. When drug is sent from the distributor to Memorial Sloan Kettering or sent to Minnesota Oncology, we can't tell from once that drug is dispensed from the pharmacy, whether it's a new patient, a refill, which doctor, so forth. So we don't have visibility with that. What I will tell you is... We are continuing to see growth in new accounts coming on board. Many times these are satellite accounts of a parent account that has already ordered in the past. However, recently we did see some accounts that had never ordered, and we can't be for sure because I don't have direct access into those accounts, but this timing was coincident with a lot of the issues around the PI3Ks, and some of the challenges they had, so one could speculate that it might be related to that, but I view that as a positive sign. So I think physicians are rethinking how to position Tasveric, especially in light of the NCCN guideline changes, our change commercial strategy, in terms of simplifying the message and really focusing on the broad population, and expanding our use in the wild type setting. So I think those changes are having an impact. Did that answer your question?
spk07: Yeah, thank you. That was really helpful. Thanks for all the color on that. And then I guess kind of secondly, due to the recent CRL issued to HushMed, due to the FDA rejection clinical trials data generated in China and the U.S. for gene studies, does this have any read-through to enrollment in the phase-through portion of the symphony study or any planned combination studies with TAS and HushMed assets? Thank you.
spk01: I think, you know, I really think it is a big thing with VI3Ks and really, you know, although there's a discussion about China, but I don't think that's specific to China. I think there's still a question about, you know, VI3Ks overall. Overall, for Simply One Design, as you know, we have 180 sites globally, right? Our focus is to really get patients in the U.S. and many other sites in Europe. China, as you know, with our partner, we have 20%, you know, in terms of sharing of patients, but that's not just that 20%. Our goal is to enroll the study as quickly as possible globally, and currently we are working to open the sites. We are currently screening and enrolling patients globally as well. So although I do see, you know, I kind of understand your question about CRL, but I don't see an impact on Symphony 1 because we do have many sites that can be able to enroll this trial.
spk07: All right, perfect. Thank you very much.
spk04: Thank you. I show our next question. It comes from the line of Michael Yee from Jefferies. Please go ahead.
spk05: Hey, Mike.
spk04: Hey, good morning.
spk06: This is Sid on for Michael Yee. Congrats on getting into the NCCN guidelines and Q1 revenue. I just have a few questions. This time a lot. My first question revolves around a set D2 inhibitor. You said that we can expect data sometime second half. Could you give us any more guidelines as to, you know, can we expect it at ASH and what kind of data we're expecting to see, and, you know, what do you expect to see as a good result?
spk01: Yeah. So, you know, as you know, the CETD2-EZM-0414 is the first clinical CETD2 inhibitor, and we are very excited about that. You know, as such, in terms of the Phase I trial, it's the first in-human trial. We are doing dose escalation for six dose levels, and the goal is to escalate and really get into a maximum efficacious dose, or an MTD, We are screening patients. We are, you know, we have sites open. And in terms of the data, because it's open label, it's dose escalation, we'll be presenting data, not just at certain time, but at any time as we can. You know, eventually, I think the important thing is that specifically SETD2 inhibitor is very important for the T414 translocation multiple myeloma. And that's a big unmet need. So our goal is to enrich for that patient in first in humans. And as a result, we are not only doing that, but also non-T414 and DLBCL. That's our first in human design of the trial. But once we have a dose, then we would expand it, add additional patients on that dose, and eventually have cohorts that are specifically for T414, about 20 patients, non-T414, and then DLBCL. In terms of what is considered, like I would say, a win-win, I would really think there's an opportunity in T414, multiple myeloma, because there's a big unmet need, and we know that, as we've heard, the therapies don't work well in that particular subset of patients, and the prognosis is poor. So there's an opportunity to study monotherapy in that population and possibly a registration path. Now, we do have to discuss with the agency about the path as well. But our goal is to enroll that trial as quickly as possible, get that data done, you know, possibly second half of this year. And as we progress, we will provide more guidance on when we'll be able to present that data. But, you know, eventually, first in human, open label, as we get data, biomarker data, activities, safety, we'll be presenting. Thank you for that.
spk06: And the second question I had revolves kind of just overall commercial strategy. You know, we've seen kind of modest quarter-on-quarter growth for TAS. What's kind of your, you know, your commercial strategy moving forward? You know, is it dependent on EZH2 screening status with physicians? Is it a market access strategy? You know, what are you trying to focus on to just generate increases in your quarter on quarter revenue?
spk05: So, great question, and I'm glad you asked that. It's really pretty straightforward. We don't have access issues, and I mean from a payer's standpoint. There continue to be challenges just in terms of nature of how oncology has evolved in terms of access to providers. I mean, they're busy, and quite frankly, in some areas, they kinda like the fact that they locked down in a COVID environment, and they're not opening up. But I would say in the vast majority of cases, Offices are opening up, we're getting access, but we're meeting physicians and engaging with other caregivers on their own terms, and if they prefer to do that electronically, we can do that. But in terms of the strategy, it's really pretty straightforward. We're simplifying our message. We're focusing on the broad patient population. We are appropriately leveraging the changes in the marketplace as well as the NCCN guidelines to continue to educate on our label, which as you know from launch was not exactly the most intuitive in terms of understanding the full potential. And it's really then pulling that through from a systems of care standpoint into the order sets, into the pathways, driving it through education, driving it through physician interactions. So I wish I could, you know, there was some secret sauce here. This is just about education. I think that the resounding feedback we get from physicians, and we just had an advisory board here in Boston a couple weekends ago. Shefali was at it with me along with many other colleagues here. Physicians have really just... Believe it or not, at this point in time, new physicians that have used TASVERIC a fair amount are just appreciating the data, the depth of the data, how the drug performs, the fact that patients can tolerate this, the data behind the wild type, not just the mutant population. So there's a lot of factors that have taken time. I wish it had been faster, but that's really the focus. Shafali?
spk01: Yeah, I think there's an important thing as you think about TASVERIC. You know, one of the things that, you know, was a challenge initially is understanding of the label. And then, of course, COVID, you know, just reaching to the physician. Now, you know, as Grant mentioned, that's not the challenge. It's just educating physicians of the importance of wild-type data. And as we saw when we discussed with the agency and talked about that, it works in both. The durability is the same. The PFS is the same. There's a difference in absolute response rate. However, that may be due to the patient population demographics as well. So the goal is to really educate physicians about that data, understand that data, so it could be used, you know, overall in broad population. But the important thing is also create as much data as we can in combination. And that is what our focus is. So we started with monotherapy, but we are moving towards combination. We have this great data with Symphony 1 that is 40 patient data that, as I mentioned in the script, we actually – are going to do a real-world study to create a synthetic control, then we will have CELLO1 solid tumor data. We have Lysa data in frontline high-risk patients and other combinations as well. So constant cadence of data to realize the value of Tazveric, not only as monotherapy but also as combination. Although we understand we cannot promote that, but we can talk clinically and medically about that data, and I think that would be our goal.
spk05: And I'll just ask Gerald to comment on this, and I'm sorry this is a long answer. One change we have made, as you know, we restructured the commercial organization. We brought in new leadership. We worked on simplifying the message. There's been a lot of changes. There are new skill sets that understand systems of care. We've also increased the size of our medical affairs group, and I'd like Gerald to just touch on that briefly to talk a little bit about how that group is changing in light of the additional data that Shefali mentioned to you. We think that there's a real opportunity and a need to educate in an appropriate way based on all this data. Joe?
spk08: Thanks, Grant. Yeah, you know, we think this education is critical. You know, as we've talked about this morning, a lot of the treatment occurs in the community setting. But while that treatment is occurring broadly in the community setting, many individual community oncologists see only a small number of follicular lymphoma patients per year. And when you combine that with the indolent nature of the disease and the overall quantity of oncology developments that come out annually, keeping up with developments can be challenging for some physicians. So it's incumbent on us to identify and reach those physicians so we can ensure they're aware of all the changes in the marketplace and appropriately educate on updates to the NCCN guidelines as well as our Tadveric data. So we've put a lot more resources into this. and making sure that we can go out and identify those community physicians across the country. And that's really the focus of our medical affairs team at this time.
spk05: Thank you, Drew.
spk06: Thanks for that. As somebody that worked in market access, I can understand those challenges. If we have time, just one last quick question. You know, it seems for the phase three portion of Symphony 1, much of the enrollment will be in China. Due to the lockdowns, are you seeing any slowing down of enrollment? And lastly, do you expect any milestone payments from HutchMed for clinical developments in that phase three portion? Thank you.
spk01: Yes. Let me just clarify. Actually, it's on the contrary. We don't have our patient expecting from China. We have 180 sites globally, and only a very handful of them would be in China. The majority of them are actually in Europe and U.S. About 75 to 80 sites are in U.S. So the goal was to really enroll the study across globally. It's not specifically in China. You know, as you know, there are about 500 patients, so we would, you know, use U.S. sites, all ex-U.S. sites, and China as well to enroll. You are absolutely right. There is challenges in terms of, you know, lockdown in China, and we are working with our partner, Hajmed, to make sure that we can start those activities in China. But overall, we are not dependent on just that. We have all these sites that we continue enrolling across the world.
spk05: And, yes, related to the milestone payments, there are milestone payments. I don't believe we disclosed what they are or the amounts, but they are some clinical milestone payments. But there's also some important expense offsets. As you know, Symphony 1 is, you know, for us, it's a large randomized global trial, so there's a fair amount of expense there. And And as part of our agreement, HutchMed has agreed to pick up the portion of that for the patients that are enrolled in China. And that's not an insignificant amount, although that's not the majority of patients, as Shefali said.
spk01: And I just want to add to that is the Symphony 1 Phase 3 is open. It's open now in many sites in the U.S., ex-U.S. We are screening patients and globally enrolling. We are really working very hard to get this trial enrolled as quickly as possible.
spk06: Wonderful. Thank you for your time. I appreciate it.
spk00: Thank you.
spk04: Thank you. As a reminder, to ask a question, you would need to press star 1 on your touchtone telephone. To return your question, please press the pound key. I'm showing no further questions in the queue at this time. I'd like to turn the call back to Mr. Grant Bogle, CEO, for closing remarks.
spk05: Thank you, Glenn. This is very helpful. And I want to thank everybody for joining us today. We're available for follow-up calls as needed. I would also like to point out that we have revised and updated our corporate deck, which is now on the website. I'd encourage you to download it. And, of course, this meeting will be recorded as well and posted shortly. So with that, I thank you, and I hope everybody has a great rest of the day.
spk04: This concludes today's conference call. Thank you for participating. You may now disconnect.
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