Good morning, everyone. My name is Daniel, I'm one of the analysts on this mid-cap biotech teams. It's my pleasure to introduce Steve Hoerter from Deciphera. We don't have to go to a different room for the breakout session, so post the presentation, there'll be mic runners if you wanna ask questions, or you can ask questions through the portal, and I'll be able to ask questions of that. Without further ado, Steve. Great. Thanks, Daniel, very much for the kind introduction, and I'd like to thank the team at JP Morgan as well for the invitation to present at this year's conference. I'm excited to have the opportunity to share with you the outstanding progress we've made at Deciphera over the course of the past year, and to share with you the 2023 milestones, which put us firmly on the path to being a company with multiple approved medicines around the world. As you know, I'll be making forward-looking statements during the course of our time together this morning, and I'd ask that you refer to the set of risk factors shown on this slide, and also available at deciphera.com. At Deciphera, we're focused on discovering, developing, and commercializing important new medicines for the treatment of cancer. Our first medicine, QINLOCK, is now approved for 10 jurisdictions around the world. We achieved significant revenue growth in 2022 versus 2021 based on our existing fourth-line label and driven by very strong performance in the U.S. as well as launches outside of the U.S. Just last week, we announced our plans to initiate a new pivotal phase III study of QINLOCK in selected second-line GIST patients, which, if successful, has the potential to double the U.S. revenue opportunity for QINLOCK. Vimseltinib, our potent and selective CSF1 receptor inhibitor for the treatment of tenosynovial giant cell tumor or TGCT, has demonstrated very clear and compelling clinical proof of concept from a phase I/II study, I'll share those results in a few minutes. We expect the phase III MOTION study of vimseltinib in TGCT to complete enrollment in the coming months, which will enable us to read out top-line results from this pivotal study in Q4 of this year. Taken together, we believe that QINLOCK and vimseltinib have the potential to generate in excess of $1 billion in annual revenue. We are also leaders in the field of autophagy in cancer, we reported initial phase I results from the DCC-3116 program at ESMO last year, showing that this first-in-class ULK inhibitor is well-tolerated as monotherapy, has dose-dependent PK, with strong target engagement at all doses studied. Just last week, we announced a new clinical trial collaboration and supply agreement with Pfizer for a new combination cohort with DCC-3116 and encorafenib and cetuximab in colorectal cancer. We're excited about the potential for DCC-3116 to broadly impact the treatment of cancer, which represents a multi-billion-dollar peak revenue opportunity. Our highly productive research engine continues to generate new product candidates. We're looking forward to advancing our next candidate into the clinic later this year. As I noted, we're excited about the potential for our deep pipeline to make a difference for people living with cancer. The programs that you see here listed on the slide and that I'll speak about today are nearly all the result of our own proprietary research engine and our expertise designing kinase inhibitors with unique properties targeting the switch region of the kinase. We've accomplished now something that few biotech companies have been able to accomplish, which is to build a fully integrated company with capabilities from research through to commercialization, with products all generated from our own platform. Now, with the pivotal phase III MOTION study scheduled to read out at the end of this year, we have the potential to become a company with multiple approved products. Our strategic priorities are shown on this slide. For QINLOCK, in addition to driving adoption of this practice-changing medicine in fourth-line GIST in the U.S. and executing on launches outside of the U.S., we plan to initiate the new phase III INSIGHT study in selected patients in second-line GIST. For vimseltinib, as I noted, we're rapidly enrolling the phase III registration-directed study, and we're on track to report out results in Q4 of this year. For the phase I of DCC-3116, this is actively enrolling now across a number of combination dose escalation cohorts, we plan to initiate one or more expansion cohorts later this year. In addition, we plan to initiate the new dose escalation combination cohort with encorafenib and cetuximab. Finally, we both expect to file the IND for our pan-RAF inhibitor and to declare our next new development candidate. Now turning to QINLOCK. QINLOCK, our first approved medicine, was designed specifically for the treatment of GIST and is now the standard of care in its approved fourth-line indication in the U.S. We've now achieved regulatory approvals around the world, including in the E.U., in the U.K., and in Switzerland, our team in Europe has achieved strong launch momentum in Germany and in France, where QINLOCK is available through a post-approval paid access program. We expect the new phase III INSIGHT study in a selected second-line population to serve as the basis for additional regulatory approvals around the world and as a source of significant future potential revenue, approximately doubling the peak revenue opportunity in the U.S. for QINLOCK. Now, one of the hallmarks of this disease is the clonal heterogeneity of GIST, with multiple primary and secondary resistance mutations resulting in disease progression. Early disease in GIST is driven by primary mutations in KIT exon 9 and 11, and resistance post imatinib is driven by secondary mutations in KIT exon 17, 18 and/or 13, 14, as you can see on this slide. The data supporting the initial approval of QINLOCK in fourth-line GIST was striking and underscores the benefit this medicine can provide to patients. In the pivotal INVICTUS study, QINLOCK nearly tripled the median overall survival versus placebo, as you can see on the right panel of this slide. The PFS benefit in patients was striking as well and across all mutation subgroups, as you can see in the forest plot on the left panel of this slide, with hazard ratios ranging from 0.16 to roughly 0.19 across mutation subgroups. QINLOCK has really transformed the way fourth-line patients are treated, and due to these exceptional results, they've also really transformed the commercial picture for QINLOCK around the world. As you can see here, QINLOCK achieved approximately 40% revenue growth in 2022 over 2021, driven both by growth in our U.S. business and reflecting our successful geographic expansion as we've brought QINLOCK to patients in Europe and in other territories around the world. Since launch, QINLOCK has generated approximately $250 million in global net product revenue, establishing a strong foundation as we continue to expand access for patients around the world. As I mentioned a few minutes ago, our analysis of circulating tumor DNA or ctDNA from the second-line INTRIGUE study has allowed us to identify a group of patients who derive substantially greater benefit from QINLOCK in the second-line setting versus SUTENT. ctDNA is rapidly being adopted across oncology to conduct mutational profiling of patients' tumors to enable treatment with precision medicines. We disclosed last week our analysis from the INTRIGUE study, which support our planned phase III INSIGHT study in second-line GIST in patients with KIT exon 11 + 17/18 mutations as detected by ctDNA. Now I'd like to briefly walk you through the data that we disclosed last week. QINLOCK showed a striking benefit compared to SUTENT across all efficacy measures, starting with objective response rate. As you can see on this slide, patients on the QINLOCK arm had a confirmed objective response rate of 44% compared to 0% of patients on the SUTENT arm. All patients on the QINLOCK arm had either a partial response or stable disease, resulting in 100% disease control rate. In contrast, as I noted, there were no objective responses in the SUTENT arm. Similarly, QINLOCK demonstrated dramatically improved progression-free survival relative to sunitinib, with a median PFS of 14.2 months versus 1.5 months for sunitinib. The associated hazard ratio of 0.22 translates into QINLOCK offering a 78% reduction in the risk of progression or death versus sunitinib. Finally, median overall survival for patients treated with QINLOCK was not reached, while the median for patients on the SUTENT arm was 17.5 months. We conducted a landmark analysis showing that twice as many patients on the QINLOCK arm as the SUTENT arm were alive at 2.5 years. The hazard ratio for overall survival was 0.34, which implies a 66% reduction in the risk of death for patients on the QINLOCK arm. Based on these compelling results, we announced last week our plans to initiate a new pivotal phase III study, the INSIGHT study, which will compare QINLOCK to sunitinib in second-line GIST patients harboring mutations in exon 11, 17/18 only. This new pivotal study capitalizes on our understanding of the secondary mutations driving GIST in the second-line and may, for the first time, allow us to select the right drug for the right patient at the right time. We're very excited to launch this study later this year. The development and approval of QINLOCK in the fourth-line setting in GIST addressed a very significant unmet medical need in that setting and really has transformed how the disease is treated. Since approval and launch in the U.S. in 2020, academic and community physicians have consistently cited QINLOCK as the clear standard of care in these fourth-line patients across all mutation subgroups. With the second-line study, the INSIGHT study, we're excited now to advance the GIST treatment paradigm yet again. With our fourth-line business as a strong foundation, we believe an expanded second-line label would add significant incremental peak revenue, driven by more QINLOCK-treated patients with longer average duration of therapy. We estimate that a potential expansion into second-line based on INSIGHT would double U.S. peak revenue potential for QINLOCK, generating between $350 million-$400 million in peak revenue in the U.S. alone. We're extremely excited about the compelling data that I just walked through and summarized on this slide from our analysis from the INTRIGUE study. By all measures of efficacy, whether objective response rate, progression-free survival or overall survival, QINLOCK delivered striking benefit for patients. The results from this analysis will be presented later this month on January 24th at the ASCO Plenary Series session. As I noted, we look forward to kicking off this next phase III study later this year. As we initiate one phase III study, we're preparing to read out yet another phase III study this year, but this time for vimseltinib. Vimseltinib is our potent selective CSF1 receptor inhibitor that's currently being evaluated in the phase III MOTION study in TGCT. There remains a significant unmet medical need for patients with this disease for an effective and well-tolerated systemic treatment, we're excited about how rapidly this program has advanced in the phase III study. As I mentioned earlier, we expect to complete enrollment here in the coming months, which will enable us to read out top-line results in Q4 of this year. In a few minutes, I'll outline our view of the commercial opportunity for vimseltinib in this disease, which we believe to be a total addressable market opportunity of $850 million in the U.S. alone. At ESMO last year in September in Paris, we presented these updated efficacy data from the ongoing phase I/II study in TGCT, demonstrating clear and compelling clinical proof of concept. Across both the phase I dose escalation cohorts, as you can see here on the left, and the two phase II expansion cohorts A and B, vimseltinib delivered between a 46%-69% response rate in these patients, demonstrating 100% clinical benefit, with all patients achieving either a CR, a PR, or stable disease. We think these data reflect how potent and selective vimseltinib is for the target and the potential for this drug to be best in class. Despite not being approved by the FDA for the treatment of this disease, the most commonly used therapy for systemic treatment in patients with TGCT is imatinib. In the pie chart on the left panel of this slide, you can see data or results from our analysis of U.S. medical claims showing that 70% of patients in fact receive imatinib today, and only 15% of patients receive the only approved therapy for this drug, a drug called pexidartinib, which is viewed by clinicians as having significant liabilities due to the off-target and potentially fatal hepatotoxicity that can be seen with this drug. Due to those risks, pexidartinib was approved with a REMS program and a black box warning to help to mitigate patient safety and ensure patient safety. Given this landscape, we believe there remains a very significant unmet medical need for a new agent that is both well-tolerated and also effective for these patients. Again, based on our analysis of U.S. medical claims, the potential number of incident patients eligible to receive systemic therapy in the U.S. is between 2,000 and 2,400 patients, which would translate into a total addressable market of approximately $850 million. In the U.S. today, there are 1,300 to 1,400 new patients each year who are treated with systemic therapy. In addition, there are another 700 to 1,000 patients who recur after their first surgery and may be eligible for systemic therapy. Beyond the newly diagnosed patients or the incident patients, there are 8,000 patients that we see in the claims analysis in the prevalent population who may also be eligible for treatment. None of these estimates include estimates for Europe either, where there is no approved therapy today for the treatment of this disease. Based on the compelling clinical proof of concept data that we've presented, we launched this phase III study of vimseltinib called the MOTION Study, shown on this slide. This is a randomized placebo-controlled double-blind study of vimseltinib versus placebo in patients not amenable to surgery. The primary endpoint of the study is objective response at 25 weeks. As I noted, we expect to complete enrollment in the coming months, enabling a readout of top-line results later this year. If successful, vimseltinib would be our second approved medicine around the world and would allow us to leverage our existing infrastructure in the U.S. and in Europe. In the U.S., we believe there is approximately 90% overlap between the physicians who treat GIST and physicians who treat patients with tenosynovial giant cell tumor. All right, now switching gears and turning to DCC-3116. We're leaders in the field of autophagy and understanding the role of autophagy as a broad resistance mechanism in cancer. Next, what I'd like to share with you is the progress we're making in this area and the broad potential applicability of our first-in-class ULK inhibitor, 3116, which targets the initiating factor in this pathway. At ESMO last year, we reported the initial phase I monotherapy data with 3116 demonstrating that this potent and selective ULK inhibitor is well-tolerated, has dose-dependent PK, and achieves strong target engagement even at the lowest doses that we studied. We've rapidly moved now into the combination dose escalation portion of the phase I. We're actively enrolling patients in both the MEK and sotorasib KRAS G12C inhibitor combination cohorts. We were excited, as I mentioned earlier, to announce last week a new clinical trial collaboration and supply agreement with Pfizer for yet another combination cohort, which will be in combination with encorafenib and cetuximab. We expect to initiate that cohort later this year. In the second half, we also expect to present updated data from the phase I and initiate the MEK and G12C expansion cohorts. There's now very significant scientific evidence that the inhibition along the MAP kinase and PI3 kinase pathways elicits an increase in autophagy and protects cancer cells from the cytotoxic effects of targeted inhibition along either pathway. On the left panel of this slide, you can see the multiple nodes along the MAP kinase pathway, where we have now demonstrated preclinically the potential for 3116 in combination with other agents to effectively shut down autophagy-related resistance. We look forward to presenting additional preclinical data in the coming months with additional combinations, further demonstrating the broad applicability of autophagy as an escape pathway and how 3116 can shut down this mechanism of escape. As I mentioned a few minutes ago, we were excited to present the initial phase I data at ESMO last year. The drug was well-tolerated at doses ranging from 50 mg to 300 mg BID at exposures preclinically that were associated with preclinical activity in combination with MEK inhibitors. Treatment-related adverse events were mainly grade 1 and 2. We did not reach an MTD in the dose escalation part of the study. Importantly, we saw strong target engagement across all dose levels. We have now moved into the combination dose escalation portion of the study. With the broad potential role of autophagy as a resistance pathway in up to 70% of human cancers, we believe there's a significant opportunity for DCC-3116 to address some of the most commonly occurring solid tumors. Our proven discovery engine has delivered all of the product candidates that I've discussed this morning. I'm really excited about the potential for our team to deliver additional differentiated new medicines for patients. The next program slated to enter the clinic is DCC-3084 from our pan-RAF research program. We expect to file an IND for this program later this year. In addition, we'll present preclinical data from our DCC-3084 program in the coming months, also data from additional undisclosed research programs as well. That will include data to support the nomination of our next new development candidate. We've made very significant progress throughout the company during the course of 2022 and even already in 2023, outlining a very clear path to drive significant shareholder value with the potential to become a company with multiple approved medicines around the world. I've outlined here our planned 2023 corporate milestones for QINLOCK. In addition to presenting the results from the phase III INTRIGUE study coming up at the ASCO Plenary Session later this month, we look forward to launching QINLOCK in key European markets over the course of this year, and importantly, initiating the new phase III INSIGHT study. For vimseltinib, we plan to complete enrollment in the MOTION study in the coming months and report out top line results in Q4 of this year. For 3116, we'll present updated clinical data later this year from both the monotherapy as well as the combination dose escalation cohorts, and initiate the MEK G12C expansion cohorts, along with the dose escalation study with encorafenib and cetuximab. Finally, we plan to submit the IND for 3084 and nominate a development candidate later this year. In summary, we're looking forward to a transformative year for the company in 2023 as we continue our work to benefit patients with cancer. We're well capitalized with $339 million as of the end of last year, which provides us with a cash runway into 2025. Finally, I'd like to thank the amazing team here at Deciphera for their dedication and hard work as we work together to develop new medicines for the treatment of cancer. I'd like to thank the patients, their caregivers, and the healthcare professionals who have participated in our clinical studies. Thank you very much. You wanna take the photo? Sure. Come on, guys. Yeah. Steve will be joined by Dan, Bart, Matt and Tucker. Are Are you staying there? Okay. As I said, you can ask questions through the portal, or we can make it lively and just ask here questions, the audience. I'll just start, ask all the questions, but that would not be fun. I can take the first crack at it. Just, you know, you mentioned this opportunity in second-line last week. How should we think about the potential for further QINLOCK growth in the U.S., you know, besides that opportunity, just looking at fourth-line alone? Yeah, sure. Thank you for the question. We've been really pleased, continue to be really pleased with the performance of QINLOCK in the U.S., in the fourth-line setting. By any measure that we look at to track the performance, continues to be really strong with physicians clearly stating QINLOCK as the standard of care in the fourth-line, irrespective of mutational profile. We saw really nice growth year-over-year. We saw about 20% net revenue growth from 2022 over 2021. About 1/2 of that was from volume growth, and with the other half coming from net price growth, as well as a lower percentage of patients receiving free drug under our patient assistance program. We were really pleased to see that volume growth that I mentioned came principally from an increasing average duration of therapy, as the real world persistency curve better reflects patients who receive a prolonged benefit from QINLOCK. Taken together, really pleased with the performance and look forward to continued success as we move forward. To continue, y ou've also mentioned the opportunity in Europe. Maybe could you give us an update on the progress there in terms of reimbursement negotiations as well as, you know, launch progress with the country by country basis? Sure. Danny, I'll be happy to take that. We're really pleased with how the launch is going in Europe. As I mentioned a few minutes ago, we launched initially in Germany, where we have the ability to price freely, at least it was at the time we launched for 12 months. Now it's been shortened a bit. We're really pleased with the good volume growth that we're seeing in Germany. We're also participating in this post-approval paid access program in France, we've seen a strong adoption in France as well, despite not being able to promote there. Those are the initial two markets really where we're generating revenue. What we have in view later this year is finalization of reimbursement negotiations in a variety of different markets across Europe. The best way to think about trajectory for revenue and for growth in Europe over the course of this year is that it will be staggered based on when we get pricing and reimbursement authorization in each of those markets. That could include finalization of the process in Germany, for example, the process in France, the process in Italy, potentially in the U.K. A variety of additional markets have the potential to come online over the course of the year. During your prepared remarks, you mentioned something, I don't know, a key point is the extension of duration of treatment in fourth-line, which you've observed, but also something that will apply to second-line. I think last week you sort of provided us the sort of 20 months duration of treatment that can be potentially achieved in second-line. Can you give us the rationalization behind that number and how you're seeing this continued increase in duration of treatment over even after launch of the drug? Yeah, absolutely. So again, we've been really pleased to see that as the treated population within the U.S. has matured over the last 2.5 years, the average duration of therapy has grown. It's grown beyond the median PFS seen in INVICTUS. That's not a surprise to us because there's actually quite a bit of evidence to suggest that this is typical, not only with QINLOCK but with products more broadly in oncology. Number one, we saw a similar dynamic in our phase I study across each of the cohorts, irrespective of line of therapy. Number two, we've been seeing this dynamic play out in our commercial data in the U.S., as I mentioned. Number 3, we actually saw a great study, a wealth of data laid out in a publication from 2019 in The Oncologist, where approved products across oncology were evaluated to understand the relationship between average and median. Very commonly, the average time on therapy was about 1.4x the median seen in clinical studies. This is a very common thing that we see. For all of those proof points, we feel really confident, not the least of which is seeing it in our own data in the fourth-line, that in the fourth-line, we would ultimately see a average duration of therapy in the 8 to 8.5 month range. By extension, for the second-line, based on the ctDNA analysis that we presented last week, where there was a 14-month median PFS, we would expect a similar 1.4x ratio of median PFS to average duration at peak. That's how we get the 1.4 x, the 14 months gets us to approximately 20 months peak average duration. I'll just underscore again that, you know, that's part of the major driver of why we think the second-line indication opportunity is so valuable to us and can drive this incremental revenue that we've talked about. While the indication itself is a relatively small percentage of overall second-line patients, the duration of therapy is so long, given how effective QINLOCK is in these patients, that it becomes a very valuable opportunity. Are there any plans to move to first line in that group of population? We haven't announced any different or additional development plans for QINLOCK, aside from the phase III INSIGHT study in this selected population in the second-line. Do you guys know how many the percentage of patients in the fourth-line fit your criteria of the KIT exons that you're going after in the second-line? Yes, we do. Based on the analysis and the data that we reported last week, which is the results of a very thorough analysis of the ctDNA data from the INTRIGUE study, we know that there are approximately 15% of patients in a second-line setting that would have a KIT exon 11 + 17/18 only mutation. That's the target population for the phase III study. 15%? That's correct. Yes. 15. Yeah. Again, just that was my point earlier about how although that sounds like a relatively modest overall percentage of GIST, because of the dramatic treatment effect and the prolonged duration of therapy that we expect, it becomes a very valuable opportunity for us to add to our existing fourth-line business. Sorry, I might have missed it. In the fourth-line, patient population, do you know how many of those patients fit the second-line KIT exon mutations that you're going after in the second-line? We reported out on the ctDNA analysis from the fourth-line INVICTUS study now, Matt, what, two years ago- Mm-hmm. ... roughly. Do you wanna speak to the fraction of patients that we saw? Yeah. We did look by ctDNA in the INVICTUS fourth-line trial, and what we were able to show across all mutational subgroups, that there was a very strong benefit of QINLOCK versus placebo, based on the reduction in the risk of progression. Those were the data. In fact, Steve summarized one of those slides this morning. We also know that it's probably accumulation of some of these mutations, so there was a slightly higher percentage of the patients with 17/18 in the fourth-line study, probably just due to the accumulation of secondary mutations as the patients progress with their disease. Theoretically, do you think, when we move to the second-line, that it will be possible to retreat in the fourth-line or, they will develop a resistance? Yeah, I think it's, Matt, maybe you wanna comment. I think it's probably too soon to know how the treatment algorithm may evolve over time, given these data, given a potential approval based on the INSIGHT study that we're going to conduct. Up until now, the way the disease has been treated has been really just line by line based on what's been approved. I think the advent of the data that we reported last week and the selected population and the potential for an approval in that population m ay change how physicians choose to treat patients in the future. Whether patients experience benefit by retreatment on QINLOCK, we've not generated data in that setting. The only data that we have generated, which is very meaningful, is actually dose escalation upon progression. This isn't within our approved labels around the world, but we did in INVICTUS and in the phase one study, allow physicians to dose escalate patients from 150 once daily to 150 mg twice daily. We saw an incremental benefit in PFS 2 for patients who were dose escalated. [audio distortion] That's right. It does. Yes. The safety profile of the drug remains quite attractive, whether at 150 mg once daily, which is our approved dose, or at the 150 mg twice daily, given the experience, and we've reported on that in the literature, it's been published, the BID experience. You're welcome. Maybe if I could ask a quick question on the phase III INSIGHT study. Can you maybe go a little bit over the study design and your confidence in the powering behind the study's design, given that you're expecting to enroll 54 patients? Sure. Thanks, Daniel. The new study that we're really excited about starting in the second half of this year based on these really dramatic you know, data that we showed from this ctDNA analysis in the INTRIGUE study, the INSIGHT phase III study, will be a pivotal registration-driven study in 54 patients. It will be a randomization between QINLOCK and Sunitinib in a two-to-one randomization. Patients who progress on Sunitinib have the opportunity to cross over to QINLOCK at the time of their progression. The study will be very similar to the INTRIGUE study. We have a strong belief of the, you know, high degree of confidence in the success of this study. We, you know, we've been very rigorous about the powering of the study, and we know that patients can have a doubling of the hazard ratio that we observed in the INTRIGUE data of 0.22, and we'll still have a statistically significant study. We also designed the study to have very similar features to the INTRIGUE study. In terms of the sample size, it's similar to what we just presented for the ctDNA analysis. The eligibility criteria and endpoints will be the same as the INTRIGUE study. Of course, you know, there's been strong investigator and patient interest in this type of study, you know, really moving just to this, you know, precision medicine realm of obtaining a specific mutational profiling. With our experience in conducting now just trials across the globe, you know, we feel that we have a great degree of confidence in the success of the phase III INSIGHT trial. Maybe moving to vimseltinib, with potential enrollment completion first half, data is expected in 4Q. While it may be a bit away, what should we expect with initial readout from that trial? Also very excited about the progress we've had on our phase III MOTION study for vimseltinib in patients with TGCT, and that's also a registration-driven study. We've been very pleased with the enrollment that we've had to date, and as we've said, that we'll be completing enrollment in the coming months this year and have top-line results from this trial in the second half of this year. This is a randomized phase III trial with patients being randomized to vimseltinib versus placebo. The primary endpoint of the study and the top-line results will be focused on the 25-week objective response rate. This is, you know, bolstered also by the data we reported at ESMO last year, showing a 53% objective response rate in the similar population of patients previously untreated. Of course, we'll be incorporating a number of secondary endpoints in the trial as well, because it's very important not just how the tumor responds, but how the patients feel and function. Both pain and stiffness, for example, will be secondary patient-reported outcome measures. We also had the opportunity to report those in the update at ESMO last year from the ongoing phase I/II study, and patients had about a 50% improvement in their worst pain and in their stiffness. Again, a very significant benefit for these patients with this chronic disease. There are approved products for this indication in the U.S. Given the profile of your product, where do you expect vimseltinib to fit in with the treatment landscape of TGCT? Yeah, it's a great question. I think we've learned an awful lot about TGCT over the last few years. As Steve presented in his prepared remarks earlier, we've done a lot of U.S. claims analysis, really sort of rigorous analysis to understand exactly how patients are treated today. I think one of the really important insights is that the products, the two primary products that have been used in TGCT are imatinib, off-label, and pexidartinib. You know, we'll often get the question, "Well, how do you think about the market opportunity if pexidartinib hasn't really been able to penetrate, hasn't really delivered revenue growth that one might expect?" Actually, it's all of this analysis that's really helped put this in context for us. I think now that we've been able to lay this all out, it's becoming much more appreciated that, you know, imatinib is used. Approximately 70% of patients treated for TGCT with pexidartinib being used in only approximately 15%. That very small degree of penetration, coupled with some other factors, relatively short time on therapy and a lot of down dosing without a flat pricing schema, has really undermined their revenue for pexidartinib. When we look at our opportunity to deliver a potentially best in class profile with a significant duration of therapy, we see a really significant opportunity. You know, it's important that obviously that we feel really confident in that, but it's also really important to understand what prescribers are saying. We recently took the data that Steve presented today that we read out at ESMO out to TGCT treaters. In short, their response to the data in a blinded product profile relative to pexidartinib and to imatinib really helped to validate very, very clearly that this drug, vimseltinib, has the opportunity to deliver what they've been looking for, which specifically is a product with great potency, great efficacy, but without the adverse event profile that pexidartinib has had to deal with. Taking together, we feel like vimseltinib has the potential to really be the best in class agent in this space. Okay. Maybe with a, with a minute and a half remaining. Moving on to DCC-3116, what are you looking for in terms of efficacy and safety from the dose escalation evaluating the combination, so that you can be able to, you know, inform the recommended phase II dose, and then you can start one or more expansion cohorts? Right. For DCC-3116, our, you know, potential best in class inhibitor of the autophagy pathway. You know, we're very excited last year also to present the first in -human experience with this. As Steve also indicated, as monotherapy, the drug was very well tolerated. We were able to get good dose dependent pharmacokinetics and exposure. Importantly, also we had target engagement with inhibition of the autophagy pathway as monotherapy across a wide range of doses. We took the 50 mg twice a day dosing level into escalation with three combination partners, and that's actively proceeding now. The objective here is to look at the safety as well in combination with these three different MAP kinase inhibitors, both trametinib and binimetinib as MEK inhibitors and sotorasib as a KRAS G12C inhibitor. Once we complete the dose escalation of the combinations, we'll take the totality of the data and then move into the expansion cohorts of the study. The expansion cohorts are tumor-specific indications. Well, with that, thank you, Steve, Dan, and Matt. Great. Thanks, everyone. Thanks, Daniel. Mm-hmm.
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