Hey there. Good afternoon, everyone. My name is Jessica Fye. I'm a senior biotech analyst at J.P. Morgan, and we're continuing the 42nd annual Healthcare Conference today with Deciphera. I'm joined by the company's CEO, Steven Hoerter. He's going to give a presentation on the business, and then we're going to go right into Q&A. If you're in the room and you want to ask a question, you can raise your hand, someone will bring you a microphone, or you can submit questions through the portal, and I'll read them off the iPad. So with that, let me pass it over to Steve. Great. Thank you, Jess. Good afternoon, everybody. It's really exciting to be here back at the conference, and I want to thank Jess and the team at JP Morgan for the very kind invitation to join again for this year's conference. And I'm excited as well to provide an update on the great progress that we're making at Deciphera. We had a fantastic year in 2023, and during today's remarks, I'll outline our milestones for 2024, as we are now on the cusp of transitioning to a company with multiple approved medicines and on a path to becoming a self-sustaining, fully integrated biotechnology company. So as you know, I'll be making forward-looking statements during the course of my remarks this afternoon and would just ask that you refer to the set of risk factors in very small print shown on this slide and also contained in our most recent SEC filings, which you can find at deciphera.com. At Deciphera, we're focused on discovering, developing, and commercializing important new medicines for the treatment of cancer, and our portfolio is the result of our own proprietary research engine and our expertise designing kinase inhibitors with unique binding properties. Our first medicine, QINLOCK, was approved in the U.S. in 2020 and is now approved in 40 countries around the world, and we're focused on continued commercial execution here in the U.S., while we expand our geographic reach based on QINLOCK's approved fourth-line GIST label. A new pivotal Phase III study of QINLOCK in a selected second-line GIST patient population, the INSIGHT study, is also now underway, and this study has the potential to dramatically expand the use of QINLOCK to benefit patients with GIST and could also double the peak revenue opportunity for QINLOCK in the U.S. alone. Vimseltinib, our potential best-in-class CSF1 receptor inhibitor for the treatment of TGCT, or tenosynovial giant cell tumor, recently achieved the primary endpoint and all six key secondary endpoints in the pivotal Phase III MOTION study, and we now expect to file both an NDA and an MAA in the coming months. Vimseltinib, if approved, will be our second medicine, leveraging our proven commercial capabilities both here in the U.S. as well as in Europe. We announced plans yesterday to pursue a new clinical study of vimseltinib in chronic GVHD, an opportunity to benefit the thousands of patients with this debilitating condition and for which CSF1 receptor inhibition has demonstrated the potential to provide clinical benefit. So together, we believe that QINLOCK and vimseltinib have the potential to generate more than $1 billion in peak global revenue. And with an outstanding IP runway for each of these two lead molecules, we're also excited about the opportunity to pursue label expansion opportunities for each of these two medicines. In addition, we're making focused investments in our earlier stage pipeline, which we expect to fuel our future growth. Finally, we are debt-free. We're well-capitalized with cash that takes us through multiple milestones and into the second half of 2026. So our strategic priorities for 2024 are outlined on this slide. For QINLOCK, in addition to driving the adoption of this practice-changing medicine in fourth line just in the U.S. and expanding our global reach, we're focused, as I mentioned, on continuing enrollment in the phase III INSIGHT study. Last week, we announced publication in Nature Medicine of the results from the ctDNA analysis from the INTRIGUE study, which were the basis for this new phase III INSIGHT study. For vimseltinib, as I just noted, we'll file the NDA and the MAA based on the positive phase III study, and we'll present additional results from the MOTION study at a major medical meeting, as well as updated results from the ongoing phase I/II study later this year. As I also noted, we plan to initiate the phase II POC study in GVHD by the end of the year, and we'll continue our strategic investments in the pipeline that will allow us to advance the ULK inhibitor DCC-3116 into potential expansion cohorts while we advance both the pan-RAF and pan-KIT programs into the clinic. All right, so now turning to QINLOCK. Yesterday, we announced yet another strong quarter and full year of performance for QINLOCK, with approximately $162 million in revenue for the year and $47 million in revenue for Q4 2023. In Q4, the net product revenue was $46 million for QINLOCK, and that represents 40% growth year-over-year versus Q4 of 2022. Since launch, QINLOCK has generated over $400 million in net product revenue. So QINLOCK revenue growth in the U.S. during the course of 2023 and outside of the U.S. was driven by strong demand during the year and our continued geographic expansion outside of the U.S. We expect to see continued growth in the business in 2024, driven by QINLOCK's position as the standard of care in fourth-line GIST, potential unpromoted off-label use based on physician decision in earlier lines of treatment, as well as increasing average duration of treatment and net average price. Our success with QINLOCK has created a very strong foundation for our business, which we expect to leverage as we transition to a multi-product company. The data supporting the approval of QINLOCK in this initial fourth-line label is shown on this slide and is really striking. So on the left panel, you can see the progression-free survival data and the 84% reduction in the risk of progression or death that we showed in that study with QINLOCK versus placebo in the fourth line. And in the right panel, you can see the overall survival data showing a tripling of overall survival at the median. Really impressive data that's now transformed the treatment of fourth line, fourth line GIST and made QINLOCK the clear standard of care in this setting. We've built an agile and focused commercial organization here in the U.S. and in the major markets of Europe to support commercialization of this practice-changing medicine. Outside of countries where we commercialize on our own, we work with a growing network of partners, including Zai Lab in Greater China, and we're very, proud and pleased with the relationship that we have with Zai. They've done an outstanding job commercializing QINLOCK in Greater China. Just yesterday, we announced a new distribution agreement with a party for Central and Eastern Europe, so we can expand the geographic reach of QINLOCK in a territory where the drug already has regulatory approval. And we plan to leverage this strong set of commercial capabilities as we launch vimseltinib in TGCT, because we believe there's a 70%-80% overlap in the prescriber base for these two products and two different diseases. Now, as you may recall, we previously published at about this time last year the initial analysis from the ctDNA analysis of the INTRIGUE study, where we showed that patients with a specific mutation profile derive substantially greater benefit from QINLOCK treatment than they do from sunitinib treatment. The KM plot that you see here on this slide is the progression-free survival from the ctDNA analysis, where we showed a 14.2-month PFS at the median for patients on the QINLOCK arm versus only 1.5 months for patients on the Sutent arm. So that translates into a 78% reduction in the risk of progression or death. We've received U.S. FDA breakthrough therapy designation for based on these data, and we've now initiated the new phase III study, the INSIGHT study, in second-line GIST in these patients. So with our fourth-line business in GIST as a very strong base, we expect an expanded label in the second-line setting based on the INSIGHT study would offer significant incremental peak revenue simply based on additional patients with GIST being treated by QINLOCK with a substantially longer average duration of treatment. And we estimate that that potential expansion, label expansion into second-line GIST based on INSIGHT, would double the peak revenue potential for QINLOCK in the U.S. alone. So we have strong momentum with QINLOCK commercially, and we're really just getting started building this franchise to benefit patients with GIST around the world. And our strong commercial performance based on the fourth line label and our strategy of expanding geographically has generated very positive returns on the investment that we've made in our global commercial business and capability. We have significant growth potential, looking to the future based on the phase III INSIGHT study and second-line GIST. Together, we believe that these growth drivers have the potential to generate even further revenue growth in the franchise as we prepare for the potential launch of vimseltinib. Now I'd like to turn your attention to vimseltinib, our potential next approved medicine. Vim is a potent and selective CSF1 receptor inhibitor that we're developing in TGCT. There remains a significant unmet medical need for an effective and well-tolerated systemic therapy for these patients, and we were thrilled to report the exceptional data from the phase III MOTION study in quarter four of last year. We believe the market opportunity for vimseltinib in TGCT is a significant one, and we believe the total addressable market in the U.S. alone, based only on the incident patients, is approximately $700 million. We're on track to file the NDA in quarter two and the MAA in Q3 of this year. In addition, as I mentioned a few minutes ago, we are now initiating a new phase II clinical POC study of vimseltinib in chronic GVHD. Based on the strong clinical data that we generated from the ongoing phase I/II study, we initiated the phase III MOTION study shown on this slide. MOTION is a randomized, placebo-controlled, double-blind study of Vim versus placebo in patients with TGCT who were not amenable to surgery. The primary endpoint in the study was objective response rate at a time point, which is 25 weeks, as measured by RECIST. We had a number of key secondary endpoints in the study, including response as measured by tumor volume score and a series of other patient-reported outcomes, which we believe are particularly relevant and important in this disease to help characterize the patient benefit and really translate what tumor shrinkage means for patients on a daily basis. As I noted, the phase III MOTION study achieved the primary endpoint, demonstrating a 40% response rate as measured by RECIST versus 0% in the placebo arm, and this was highly statistically significant with a p-value of less than 0.001. MOTION also achieved all of the key secondary endpoints, which were both statistically significant and clinically meaningful. The first of those secondary endpoints was shown here on this slide on the right panel, is responses measured by tumor volume score. You may be aware that in this disease, in TGCT, tumors are not spherical. They weave into the joint space, making it more challenging, perhaps, to measure response by a two-dimensional measure like RECIST. This is where tumor volume scores, so a volumetric measure of tumor size, can be particularly relevant.... The threshold for calling a response by TVS is 50% tumor shrinkage or greater. So we demonstrated in 67% of patients on the vimseltinib arm, the ability to shrink their tumors as measured by TVS at the 50% threshold or greater. This, again, was highly statistically significant. When we reported out the top line results, we also reported out on, on this secondary endpoint, which was the change in active range of motion. So patients on the Vim arm experienced a 5x improvement in range of motion at week 25, relative to placebo, which is incredibly, incredibly meaningful. So this suggests that patients were able to increase the range of motion of their joint, which could make the difference between a patient being able to move from a sitting to a standing position or even to climb stairs, for example. So this translates, we think, quite meaningfully the benefit of Vimseltinib in this disease beyond just tumor shrinkage, but really showing a really remarkable benefit in terms of improvement of range of motion and therefore improvement in activities of daily living. The drug was very well tolerated in the MOTION study. Only 6% of patients discontinued treatment due to a treatment emergent adverse event, and all of the adverse events noted here in MOTION were very consistent with what was previously reported from the ongoing phase I, II study of vimseltinib. Importantly, there has been no evidence of the off-target cholestatic hepatotoxicity, which is an adverse event that occurs with the only approved agent here in the U.S., a drug by the name of pexidartinib, and that is the reason that PEX has a black box warning and a REMS, which we believe is a significant headwind to utilization in the U.S. PEX was not approved for use outside of the U.S. and Europe specifically. So based on the totality of the data shown here, so the phase I,II data summarized on the left and the phase III data from the MOTION study summarized on the right, we're on track, as I mentioned, to file the NDA and the MAA later this year. Importantly, in the phase I,II data update from this study of vimseltinib in TGCT, we updated the much more mature median treatment duration from the phase I,II study, now showing that across the phase I part of the study and cohort A in the phase II, approximately two years median duration of treatment on the study, which demonstrates, we think, the positive impact this drug is having in terms of managing a tumor, shrinking tumor, as well as how well tolerated the drug is. The patient who's been treated the longest in the phase I study is now out on treatment over four years. There's a significant opportunity, we believe, for a new therapy with a profile like the one we've demonstrated based on the MOTION study, to benefit patients with the disease and also to generate a commercial opportunity. So based on our estimates in the U.S. today, there are approximately 1,400 new patients each year who are treated with systemic therapy for their disease and are being seen by an oncologist. And we estimate the total addressable market based on the incident population alone to be approximately $700 million. In addition to those incident patients, there are 9,000 prevalent patients who have engaged with an oncologist and are receiving some form of systemic treatment and therefore may be eligible for vimseltinib therapy. We believe there are a comparable number of patients in the five largest European markets where there are no approved treatments, and they are waiting, most certainly more urgently for a new treatment option, in Europe, where there are no approved treatment options. We've conducted extensive market research in the U.S. and now in Europe to better understand the patient journey with this disease, and we've tested a blinded product profile of vimseltinib versus pexidartinib, and versus imatinib, which is used quite commonly off-label to manage patients with this disease. As you can see on the heat map on the left panel of this slide, the results from the qualitative market research show very clearly that vimseltinib is rated the highest across all of these measures of efficacy and tolerability that physicians tell us are important as they select an agent to treat patients with this disease. On the right panel, you can see that in this same market research study, that all of the physicians surveyed, 100% of these physicians, selected the vimseltinib profile as their preferred agent for managing their patients with TGCT. Now with our regulatory filings for vimseltinib and the near-term horizon expected here in the coming couple of quarters, we also announced yesterday our plans to expand the vimseltinib development program into chronic GVHD. We know that targeting CSF1 receptor expressing macrophages, both pro-fibrotic and pro-inflammatory macrophages, has the potential to offer meaningful benefit for patients with GVHD, and we expect to initiate this study here by the end of the year, putting us on the path to potentially expanding the utility of vimseltinib for patients. So lastly, I'd like to turn to our early stage pipeline. Our proven discovery engine has delivered on all the product candidates that I've discussed this afternoon. So these are all internally generated molecules, and we're excited about the potential for our team in research to deliver additional differentiated new medicines for patients. We have a total of three additional programs that are either in the clinic or expected to enter the clinic later this year beyond QINLOCK and beyond vimseltinib. DCC-3116 is our potential first-in-class ULK inhibitor, targeting the autophagy pathway, which is a broad mechanism of resistance in a variety of commonly occurring solid tumors. We're working toward clinical proof of concept with this drug in combination with the KRAS G12C inhibitor, sotorasib, and in combination with our own TKI, ripretinib. DCC-3084 is a potential best-in-class pan-RAF inhibitor, and we expect to initiate the first-in-human study in the first half of this year. For DCC-3009, our pan-KIT inhibitor, we expect to file the IND in the first half of this year and initiate the phase 1 study in the second half of this year. Lastly, we disclosed at AACR last year the next program coming out of research, which is an exciting program, the GCN2 activator research program, targeting the integrated stress response pathway. And we're advancing this program during the course of 2024 as we make our way towards a potential IND for this program. So we're really excited about the depth and the breadth of this early-stage portfolio that we have here at Deciphera, and it's really reflective of how productive our research engine has been and the expertise that we have internally designing differentiated kinase inhibitors. So building on the really exceptional 2023 that we just reported out, where we saw record revenue for QINLOCK, and we reported exceptional data, as I noted earlier, for the phase III MOTION study. We're really excited about now about the potential to transition to a multi-product company. So we're focused on the milestones outlined on this slide, and that includes continuing enrollment in the phase III INSIGHT study. I should note that just last week, we published in Nature Medicine the findings from the ctDNA analysis from INTRIGUE, which is great visibility for those data in Nature Medicine. And then we plan also this year for QINLOCK to continue our geographic expansion in fourth-line GIST. And I noted earlier the new distribution agreement that we've now signed for Central and Eastern Europe, and we expect to increase that list during the course of 2024. For vimseltinib, we're on track to submit the NDA, as I noted, and to prepare for commercial launch. So those are key milestones for us for the year. We'll present additional updated results from the phase I/II study in TGCT with longer-term follow-up, and then we'll pre-present the MOTION study results at an upcoming medical meeting, including reporting out on the whole host of secondary endpoints that we achieved in that study. And then finally, we plan to initiate the POC study in GVHD. And I believe I've already noted the early-stage pipeline milestones that we expect for the balance of this year. So in summary, we're looking forward to really a transformative year for the business in 2024, as we advance to our goal of having multiple approved products around the world. We're well-capitalized with approximately $352 million as of the end of 2023, which provides us with cash runway into the second half of 2026. Importantly, to note, we have no debt on our balance sheet. So we're excited with the cash runway that we have and the ability to achieve the milestones that I outlined in my presentation today. So finally, I'd like to thank the amazing team here at Deciphera for their dedication and hard work as we're focused on developing important new medicines for the treatment of cancer. And I'd like to thank the patients, importantly, their families and the healthcare professionals who have participated in our clinical studies. So thank you very much, and I'd be happy to open the floor for Q&A. Jess? Great. Thanks for the presentation. I think some other members of the team are going to come up for Q&A. So just give that a moment. And as a reminder, if you have a question in the room, you can raise your hand or, you can send me questions through the portal. I'm gonna start out, just with a high-level question. On that $1 billion peak revenue potential for QINLOCK and vimseltinib, can you just talk about what indications that does and doesn't contemplate? And maybe talk about the pushes and pulls that would land you, you know, potentially above or below that target. Yeah, it's a great question, Jess. So that, that billion-dollar peak global revenue opportunity is really focused on the totality of the QINLOCK business, both in the fourth-line label as well as the Phase III INSIGHT study in the second line, in addition to vimseltinib in TGCT. So we've not articulated the size or scope of the opportunity in chronic GVHD yet, so that would be an opportunity above and beyond the billion-dollar peak revenue estimate that we've put out there. I think you mentioned a number of different potential sources of growth for QINLOCK in 2024 and going forward. Can you just remind us what you see as the duration of therapy for QINLOCK today and where, where you see that going? Sure. Dan, would you like to take that? Sure. Thanks for the question. So in the U.S, what we've said is that, when we look back to 2022, we saw the average duration of therapy grow beyond the median PFS that we saw in the INVICTUS study. We expected this. We've seen this phenomenon in all of our clinical studies. It's just as the active treated population more fully reflects the impact of patients who have very long time on therapy, that average duration of therapy grows. In 2023, we saw that push beyond seven months, and we have an expectation that that would reach eight-eight and half months at peak, and that's just for the core fourth-line business. Of course, over the last number of quarters, as we've shared, we believe that we've seen an increase in unpromoted earlier line use, as a result of both the ctDNA analysis that was presented last year at ASCO and published in Nature Medicine, as well as the NCCN listing of ripretinib in the second line for patients who are intolerant of sunitinib. As those patients get put into the mix, it gets a little murkier to be able to discern exactly, which patients are getting what line of duration of therapy, excuse me. But we would, for multiple reasons, expect to continue to see that duration of therapy be a growth driver for us in 2024. ... Is that to say that to the extent some of these second-line patients trickle into the overall pool, that duration of therapy could even exceed eight-eight and half months months? Exactly right. We would expect that earlier line patients would benefit more on the drug, have longer time on therapy. And so as those get mixed in, it's possible that the average duration would push beyond the 8 to 8.5. It's difficult for us to discern exactly what proportion of patients who are on therapy today come from what line of therapy. The data is just not great to enable us to do that, so it does become a little bit tricky to guide to a specific revised duration number, but it's something we'll continue to monitor and provide updates as appropriate. Got it. So then this question might also be tricky to answer, but, how should we think about, or is it possible to quantify the amount of QINLOCK use in the second line? And how do you think about that changing over the next few years? Yeah. Go ahead. Yeah, I can go ahead and take that as it relates to the U.S. business. So it is really difficult to estimate with any degree of precision what proportion of patients are in what line of therapy. What we do know is that when we look at the quarter-over-quarter growth that we've seen, going back to 2022 and then comparing that to our growth in 2023, we saw an acceleration of that growth. And so we are confident that that acceleration is coming from this increased use. We also have some anecdotal evidence and various pieces of intel that, you know, we triangulate. But I think the most clear view of the fact that we've seen this increased use is that acceleration of the business, on top of a foundation that was a highly penetrated fourth line opportunity. When we think about what would we expect moving forward, I want to underscore that this is unpromoted, off-label use, so it's not something that we promote, not something we can drive or control. That makes it that much trickier to predict, or exactly what the trend will look like. Moving forward, we may see some quarter-to-quarter variability, but more than anything, what is going to impact the second line use for this drug is a positive INSIGHT study. We think that if we can deliver a positive study that replicates the data we saw from the ctDNA analysis, it will be truly practice-changing and will drive significant use in that setting and double the peak revenue opportunity for ripretinib in the U.S. So, while we're on that, how is enrollment going in the INSIGHT trial, and when could we see the data? Yeah. So the INSIGHT trial is the confirmatory phase III trial that is based on the analysis we did from the ctDNA subset in the second-line INTRIGUE trial. As Steve mentioned in the presentation, we had an outstanding and consistent benefit across all 3 endpoints, including the progression-free survival, the objective response rate, as well as overall survival. So the phase III INSIGHT trial is the confirmatory trial. It's a small trial in 54 patients, so two to one randomization, and it's small because the treatment effect is so profound in these patients, it doesn't take a lot to show statistical significance. So we activated the trial last year, and we're actively enrolling patients and opening up new sites for the trial globally. And we haven't commented yet on the completion time for the trial. As we get further along in terms of where we are in the enrollment, then we can provide an update at that time. Great. And just while we're on this topic, can you also touch on the diagnostic needed to test for mutations in KIT exon 11 and 17, 18, and how that might impact uptake in the real-world setting? Yeah. So it's based on the ctDNA analysis, and this is just a simple blood test that's taken. It's a liquid biopsy, and it reflects the heterogeneity of the mutations that patients express. And it's actually better than a tumor biopsy, which is only selected for one lesion within the patient, but they may have multiple lesions, and those lesions overall could have different mutational genotypes. So by doing this simple test, we're able to identify the patients that harbor the mutation in exon 11, as well as the resistant mutations in exons 17 and 18. And this is being incorporated broadly in solid oncology, and other tumor types. Standard of care now for non-small cell lung cancer, recognizing that there's different treatment options for which genetic driver mutation there is in lung cancer. You know, today that has been actionable in just tumors, but now with the data that we've been able to publish now in Nature Medicine as of last week, these results, I think, will be practice-changing for the field for the treatment of GIST. Jess, I'd just add that this is a commercially available assay today, so physicians, if they decided to, could order a blood test based on the Guardant360 platform or the FMI platform and have an answer to that question in seven-10 days. We don't view it as being a barrier to eventual future adoption. If you think about this in the commercial setting, just given how easy it is, given that we're not asking for a fresh tumor biopsy, this is about drawing an additional tube of blood and waiting seven-10 days for that result. Got it. So I think you showed on one of the slides kind of how the ex-U.S. revenue for QINLOCK is ramping. How should we think about the U.S., ex-U.S. split kind of evolving over time? Yeah. Margarida, do you want to take that? Sure. ... So if we look at 2023, ex-U.S. revenue, including collaboration from Zai Lab in Greater China, was approximately 25% of total revenue, which is notable given the longer time for market access and also a longer time for launches and the price difference. So we believe there is still significant value to be captured globally, and the deal that Steve just mentioned in his presentation with Genesis Pharma, where we announced yesterday for Genesis to supply and distribute QINLOCK in 14 markets in Central and Eastern Europe, where QINLOCK is already approved. These are European Union countries with a combined population of 118 million people. It's a good example of the transactions that you can expect from us as we continue our efforts of geographic expansion to bring QINLOCK to more patients across the globe. So ultimately, Jess, you know, where, where do we land in terms of the split when you think about peak? You know, there certainly large companies are able to achieve pretty even splits on a global basis in terms of where revenue comes from. We don't of course know or can't predict at this stage where we might end up with QINLOCK, but the work that we're doing outside of the U.S. has borne a lot of fruit so far, in terms of the expansion into other territories and the work through distributors. And we'll continue chipping away at that, given that we have many parts of the world still where we don't have... patients don't have access to QINLOCK, and there's an opportunity. Okay. Maybe switching to vimseltinib, can you walk through the timelines around launch? Can you talk about which TGCT patients you expect would initially go on therapy? Yeah. So I'll take the first part of that question and then ask Dan to comment about potential launch in the U.S. and what sorts of patients might be an initial targets for initiating treatment. So as I noted, you know, the NDA will go in in quarter two, so ultimately the launch timeline in the U.S. will be dependent upon whether we receive a priority review for the application. That will set what the end date might be for a review, and then it just really depends on the agency in terms of what else they have in front of them to review as to what the timeline might be. We believe the data set is comprehensive, very straightforward in that it is very uniform. So having achieved the primary endpoint so clearly and all six of the key secondary endpoints, as I was saying earlier, really confirming that tumor shrinkage with this drug translates into other benefits for patients, draws a very clear picture in terms of how the drug may benefit patients. It's also very consistent with the phase I, II experience. And it's not a large data set in the sense that, you know, it's 120 patients in the MOTION study data set with clear and convincing data. So we'll have to see first whether we receive priority review for the package, and that will then determine, you know, what the earliest possible date might be for a potential launch. And that's why one of our key milestones for the year, in addition to getting the file in to the FDA and also to the EMA, is to begin the commercial preparation for a potential launch. Dan? As it relates to your question about patients and how that might grow over time, we have invested and spent a lot of time analyzing U.S. claims data to help really understand this market. This market is unique. It's a non-lethal patient population. It's a lifelong journey for these patients. There's no clear ICD-10. So we've spent a lot of time, and we have really created some extremely valuable insights that are guiding our launch preparation. Most importantly, we've defined the patient population as those target patient population as those who are diagnosed who are currently receiving systemic therapy today, which could be a TKI, or it could be prescription pain and/or steroid medications, and that they have engaged with an oncologist. We also see 9,000 prevalent patients that meet those same criteria. We think that's really important that they've reached an oncologist, because we think that's representative of where they are in their journey and what their mindset is in terms about seeking out additional treatment options. The 1,400 incident treatment-naïve patients alone, as Steve mentioned in his presentation, we calculate a $700+ million total addressable market in the U.S. alone. We think that, over time, there's even opportunity for growth because we see additional patients out there who have just not yet made it to the oncologist. They're diagnosed, and they're receiving systemic therapy, in this case, often prescription pain or steroid medications, but they haven't made it yet to an oncologist consult. We think through patient education over time, we can get more of those patients to raise their hand and request a consult with an oncologist to explore additional options. We think that there are a lot of different ways to bring value to patients here in the short and long term, and a lot of different ways for us to win with our second commercial product. Great. Thinking about potential additional indications and moving into phase II in GVHD, what needs to happen before you start that trial? And is there any reason to think you wouldn't show a profile at least on par with axatilimab? Yeah. So we're also very excited about our our milestone this year to initiate a phase II proof of concept study with vimseltinib in- ... chronic GVHD. Of course, we understand that the macrophages play a role in creating an environment of chronic inflammation in patients with GVHD, and inhibition of those macrophages with vimseltinib can reverse perhaps some of the complications of GVHD related to fibrotic diseases, such as in the skin or in the lung. There's been clinical validation of CSF1 receptor inhibitor with axatilimab in GVHD to date. But that's an IV infusion given every two weeks, and the backbone of therapy for treatment of this disease is with oral therapies. Using an oral agent, such as vimseltinib, could add very nicely into the treatment paradigm for treating GVHD. The work we do is to develop a protocol and do all the standard activities to initiate a trial. So that's in our plans to initiate and start treating patients in the second half of this year. Great. Maybe coming back to TGCT, can you talk a little bit about how we should think about duration of therapy initially and whether you see that sort of evolving over time? Dan? Yeah, I think our claims analysis has been really instructive here, and as has the data as it has matured in our clinical trials. GIST... I'm sorry, TGCT, unlike GIST, is a non-lethal disease. It's a lifelong challenge for these patients to deal with what it can be an extremely locally aggressive and really debilitating disease, impacting their... How they feel and how they function. If surgery is not an option or if the patient recurs, you know, they immediately know that they're gonna be in a lifelong struggle with the disease. Highly effective and tolerable product could be a tool for these patients throughout their journey over their lives. We see 18-month duration of therapy for imatinib in the claims data. We believe that we can extend that considerably. The data from our most recent update late last year of our most mature data set, our phase I and II data set, showed 25.1 months of median time on therapy. And we think that in the real-world setting, over the course of a patient's life, their use of vimseltinib may have different episodes over time. But given the fact that there is no resistance mechanism in TGCT, we expect that a product with a best-in-class profile like vimseltinib could be a really critical tool for these patients throughout their life and throughout their journey. Great. With the remaining time, just one on DCC-3116. Can you recap what combinations you're prioritizing with that product and why? Yes, we made the decision this year to prioritize the combination studies with our ULK kinase inhibitor, DCC-3116, with two other partner agents, so sotorasib in non-small cell lung cancer and our QINLOCK in GIST patients. This was to give us the best activity, the best opportunity to get to proof of concept quickly. We believe that those two indications could lead to, you know, synergistic treatment effects and combination of inhibition of autophagy. Great. I think we're about out of time, so thank you. Great. Thank you.