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spk07: any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?
spk03: Thank you, Jen, and good morning, everyone. Thank you for joining us today as we provide an update from the second quarter, review our financial results, and outline our corporate milestones for the rest of 2022. We delivered a strong commercial performance with Kinloch in the second quarter, further entrenching this practice-changing medicine in the United States and building on our very successful initial launch in Germany, resulting in year-over-year quarter two product revenue growth of 43%. Beyond Kinloch, we continue to advance the development of our portfolio of product candidates with first-in-class and best-in-class potential. On today's call, Matt Sherman, our Chief Medical Officer, will review the progress we have made advancing our clinical stage pipeline, and highlight upcoming data milestones from the vinsultinib and DCC3116 programs. In the second quarter, we opened additional clinical study sites for the pivotal phase three motion study of vinsultinib as we focus our efforts on rapidly enrolling this registration-enabling study. We expect to present updated results from the phase one-two study of vinsultinib in tenosynovial giant cell tumor, or TGCT, at the ESMO Congress next month. We also announced today that we will present the initial clinical data from the phase one study of DCC3116, our first-in-class autophagy inhibitor, also at ESMO. This data presentation is the first report from our ongoing phase one study, and we're excited that the data was selected for an oral presentation as a proper paper. Finally, we anticipate nominating a potential best-in-class development candidate from our Pan-RAF research program by the fourth quarter. Dan Martin, our chief commercial officer, will share more details on the U.S. commercial performance for the quarter, and Margarita Duarte, our head of international, will provide an update on the momentum of Kenlock's fourth line launch in Europe, including, most notably, the recent major additional benefit rating Kenlock received in Germany and the successful post-approval paid access program in France. Both demonstrate the potential for Kenlock to transform the treatment of advanced JIS around the world. and underscore the sustained progress of our country-by-country market access strategy in Europe. This past quarter, we were also excited to welcome Kelly Deloy to our executive team as Chief Business Officer, who joined us from Novartis, where she served as the Vice President of Business Development for the Oncology Division. Kelly brings 20 years of life science leadership experience to the role, and her responsibilities will include developing and leading Decipher's business development efforts, as well as supporting corporate strategy initiatives. We're very excited to have Kelly at Deciphera, and I look forward to working with her to drive the company's next chapter of growth. I'll now turn the call over to Matt Sherman to provide an update on our R&D efforts. Matt?
spk12: Thanks, Steve. We continue to make excellent progress advancing our clinical and pre-clinical pipeline as we work to provide novel treatment options for patients with cancer. I'd like to start with DCC3116, our potential first-in-class O-conhibitor. We are leaders in exploring the role of autophagy as a broad resistance mechanism in cancer, and 3116 has the potential to benefit a significant number of cancer patients by targeting OAK, the initiating factor in the autophagy pathway. PCC 3116 is a potent and highly selective switch control inhibitor designed to inhibit the OAK1-2 kinases that activate the autophagy pathway. Autophagy is a key tumor survival mechanism and a potential mechanism of drug resistance in cancer cells. We've now generated a growing body of preclinical research, both independently and with academic collaborators, demonstrating the ability of BCC3116 to address autophagy-induced by a variety of RTK, RAS, and MAP kinase pathway inhibitors. And we have built an industry-leading position in targeting this pathway. BCC3116 is currently being investigated in the single-agent dose escalation portion of the Phase I study in patients with advanced or metastatic followed tumors with a RAS or RAS mutation. We are very excited that it was selected for an oral presentation at ESMO in September as a proffered paper, which is intended for original data of superior quality and includes expert discussion. The first readout will be focused on the overall safety and tolerability profile, as well as the pharmacokinetic and pharmacodynamic markers evaluated in the study. We expect to demonstrate targeted engagement through measuring levels of ACG14, a PD marker of ALT inhibition. Together with the initial PK and safety data, This will allow us to select the recommended dose that we will take forward into multiple combination dose exploration cohorts in the second half of this year. Based on our preclinical research and the mechanisms of action, we do not expect to see single agent activity as monotherapy. Our phase one study will include two cohorts in combination of MEK inhibitors, trimetinib and bidimetinib, as well as one cohort with dithoracin, an improved KRAS G12C inhibitor. Turning now to Vimseltamib, our CSF1 receptor kinase inhibitor that we believe has the potential to be a best-in-class treatment for tenosynovial giant cell tumor, or TPCT. With one approved treatment available for TPCT patients in the U.S. and none in Europe, there remains a significant unmet medical need for a highly effective therapy with a good safety and tolerability profile. We believe Vimseltamib is well-positioned to address this need. Based on the initial data from the ongoing Phase 1-2 study in GGCP patients, VinCeltinib has shown strong efficacy and durability with an excellent safety profile. We expect to provide updated results from the Phase 1-2 study next month and are delighted to have been selected for a closer presentation at ESMO. These results will include updated objective response rate data from the escalation and expansion phases of the study, longer-term safety, and initial secondary endpoint data based on patient-reported outcomes. We believe these results will continue to show that Zinfeltinib has the potential to become the standard of care drug treatment for patients with TTCP non-amenable to surgery. To that end, we continue to open sites and rapidly enroll our phase three registration-enabling motion study and plan to provide an estimate of timing of full enrollment in the coming months. Moving to our preclinical pipeline, We remain on track to nominate a development candidate from our pan-RAF research program later this year. This program is focused on developing a best-in-class dual inhibitor of BRAF and C-RAF kinases to address an unmet medical need in patients harboring class I, II, and III BRAF mutations, as well as BRAF fusions. Nomination of this development candidate highlights how our switch control kinase platform continues to drive portfolio growth through the discovery of innovative new molecules. We're proud to continue to expand our pipeline with potential best-in-class and first-in-class product candidates designed to improve the lives of people with cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to provide an update on our U.S. commercial efforts. Dan?
spk11: Thanks, Matt. In Q2, we continued to execute on our commercial goals for Kinloch in the U.S., reinforcing its position as a clear standard of care in fourth-line GIST while continuing to expand our prescriber footprint and physician experience with Kinloch. During the quarter, we achieved 23.7 million in total net product revenue in the U.S. Our key performance metrics continue to reflect strong commercial execution and highly positive product perceptions among JITS prescribers. We again delivered excellent results in terms of prescriber reach, share of voice, and product awareness. Importantly, JITS prescribers in both academic and community settings continued to rate Kinloch very highly across all key product attributes, including efficacy, safety, convenience, and payer access. At ASCO in June, we had the opportunity to sit down with many of the leading GIST KOLs to discuss their experience with Kinloch. Their feedback was extremely consistent, namely that Kinloch has provided tremendous clinical benefits for their patients and that they view it as an indispensable part of their treatment armamentarium in advanced GIST. In Q2, our sales and marketing teams drove strong unit demand volume across all business segments. Our launch-to-date prescriber base has continued to grow at a very consistent pace quarter over quarter and is now over 700 positions, with the majority of new prescribers again coming from the community setting. Our market access team has continued to deliver excellent payer access with 100% payable claims for on-label patients during the quarter. And we again saw strong persistency and time on therapy. As expected, the percentage of patients receiving free drugs under our patient assistance program, or PAP, increased in Q2 versus Q1. The PAP percentage was toward the higher end of our 20 to 30% estimated range. This quarterly trend is very consistent with what we saw in 2021. and is driven by patient affordability challenges that tend to increase as the year progresses due to the Medicare Part D drug benefit design. Consistent with what we saw last year, we expect the path percentage in Q3 and Q4 of this year to be at the high end or slightly above our estimated annual range of 20 to 30%. Turning to Vimseltinib, we are excited to see the continued progress of the motion study and are looking forward to the possibility of Vimseltinib becoming Decipher's second approved drug, which would offer substantial operational synergies given our existing sarcoma-focused commercial infrastructure. We have continued to deepen our understanding of the TGCT market opportunity through our market research, KOL engagement, and analysis of U.S. claims data. We believe Insultinib would be well-positioned to penetrate a potential addressable U.S. market of $850 million, given the high unmet medical needs as well as Vinsultinin's potentially best-in-class clinical profile. And this does not include the additional opportunity associated with a significant prevalent treatment-eligible population or the opportunity in Europe, where the unmet need is even greater, given that there are no approved therapies for TGCT. I will now turn the call over to Margarita Duarte, our head of international, to discuss the exciting results from our second quarter of the commercial launch of Kinloch in Europe. Margarita?
spk08: Thanks, Dan. We are very proud of Kinloch's strong entry into the European market, including our launch in Germany and the transition to the post-approval paid access program in France. As we work to ensure this important medicine reaches the patients around the globe who need it most. For the second quarter of 2022, we reported international KinlochNet product revenue of $7.8 million, most of which represents product revenue from Germany and France. These strong results in the second quarter reflect Kinloch's exceptional clinical benefits and demonstrate its growing position in the European GIST treatment landscape, addressing the high unmet needs of patients with forced-line GIST. We are honored to announce that Kinloch received on June 16th a major additional benefits rating in Germany for its indication in advanced GIST. This is an extraordinary achievement, as on these days, only approximately 1% of all oncology drugs have received the highest possible ratings. TINLOC is the first orphan oncology treatment to receive this rating for its lead indication and the only GIST treatment awarded with such recognition. Reimbursement submissions in Germany are known to be one of the most complex and comprehensive evidence submissions in Europe, and I am extremely proud of the dedicated cross-functional team that supported these impressive efforts. With the many traditional benefits, we have secured a favorable starting position from a price negotiation perspective, which we believe will result in a successful outcome. In France, we are also very well positioned thanks to Kinloch's positive AFMR3 ratings, a rating only achieved by a small number of orphan treatments, which underscores the recognition of the robust clinical value that Kinloch brings to eligible test patients. In addition to our ongoing efforts in Germany and France, we continue to pursue market access for Kinloch in the EU and the UK on a country-by-country basis. And I'm very pleased to share that we have recently submitted a reimbursement application tonight for access in England and Wales. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the quarterly financial results. Tucker?
spk10: Thanks, Margarita. I'd like to review the highlights from our second quarter financial results. Total revenue for the second quarter was $32.5 million, which includes $31.5 million in net product revenue of Kinloch and $1 million in collaboration revenue, which includes Kinloch supply and loyalty revenue under our agreement with Xilab for Greater China. Cost of sales for the three months ended June 30, 2022, was $1.8 million, which included approximately $1 million in cost of net product revenue and cost of collaboration revenue of $800,000. Cost of sales will not include the full cost of manufacturing until the initial pre-launch inventory is completed and additional inventory is manufactured and sold. We do not expect cost of sales and the percentage of net sales of Kinloch to increase significantly after we have sold all zero-cost inventories and commence the sale of inventories that will reflect the full cost of manufacturing. We expect to continue to sell the initial pre-launch inventory of Kinloch in the U.S. during 2022. Total operating expenses were $76.3 million in the second quarter, a decrease of 19% compared to operating expenses of 94.1 million in the same period in 2021. Research and development expenses in the second quarter were 44.9 million compared to 60 million in the same period in 2021. Selling, general, and administrative expenses for the second quarter were 29.6 million compared to 32.8 million in 2021. Cash, cash equivalents, and marketable securities as of June 30th was approximately 393 million. In April, we added approximately 163 million to our balance sheet through a very successful underwritten public equity offering. With our strength in balance sheet, we are well capitalized and believe that our cash together with anticipated product, loyalty, and supply revenue will be sufficient to fund our operations for the next three years into 2025. With that, I'll now turn the call back over to Steve. Thank you, Tucker.
spk03: Today's updates underscore the tremendous progress we have made during the first half of this year. We are proud of the momentum we have been able to sustain across our preclinical, clinical, and commercial programs so far this year, and look forward to an exciting second half. We anticipate a number of important milestones, including the presentation of initial data from the ongoing phase one monotherapy dose escalation study of DCC3116 at ESMO next month, and initiation of three combination cohorts with MEK and KRAS G12C inhibitors. Continued enrollment of the phase three motion study of imfaltinib and TGCT and the presentation of updated data from the ongoing Phase 1-2 study, also at ESMO next month, and finally, nomination of a development candidate from our PANRAC program later this year, all while we continue to cement the position of Kinloch as a standard of care for fourth-line GIST patients around the world. With that, operator, I'd now like to open the call for Q&A.
spk05: Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. Once again, please press star 1 and 1 if you would like to ask a question. We will now take our first question. Please stand by. Your first question comes from the line of Daniel Waller from JP Morgan. Please go ahead. Your line is open.
spk04: Good morning, everyone. Thanks for taking our question. A couple of high-level questions first. Looks like we've seen a couple of quarters of flattish revenue in the U.S. Is this market essentially full at peak penetration now and a high level? Should we think of this as a run rate going forward?
spk03: Hi, Daniel. Thanks for asking the question about Kenlock performance. As we noted in the prepared remarks, we're really excited about the number that we put up for the quarter, reflective of what we believe to be a very stable business here in the U.S., but of course now reflective of geographic expansion and the growth that we're seeing in Europe. Dan, do you want to comment specifically on some of the dynamics that we're seeing in the U.S. marketplace?
spk11: Sure, absolutely. Thanks, Daniel, for the question. So we have been really pleased with the launch and having established Kinloch as the clear standard of care in the fourth line setting, I think is really a testament to a couple of things. One is the significant unmet need that existed prior to Kinloch's launch in this setting, and also the really powerful clinical profile that Kinloch offers to these patients. We hear consistently from patients and providers that it's really been a tremendous benefit to these patients who, again, had significant unmet needs. As a result of that, we were really successful with the launch in penetrating the fourth line opportunities. So we do think that the fourth line opportunity is quite well penetrated. We think that the vast majority of patients who reach the fourth line receive Kinloch. And so we believe that looking ahead, while we will, of course, continue to look for opportunities for limited growth within our labeled indication, we've communicated that You know, we think growth opportunities beyond that would have to come from unpromoted off-label uses, such as the IPDE or BID use, as well as potentially use in earlier line settings. As we've communicated, we think that, you know, while that's possible, it's important to always underscore that these are off-label uses. So we can't promote those. We can't drive those. So those kind of uses would be dependent on NCCN listing, for example, but also spontaneous use within the provider setting. So when we think about growth moving forward, that's really how we think about the key dynamics.
spk04: Great. And then on Europe, when we think about peak Kinloch sales there, how would you compare that, what you expect there, to what you expect for peak sales in the US?
spk08: should it be similar or are there reasons europe will be larger or i guess smaller too margarita would you like to take that yes sure thank you for the question and thanks to you i let me start by saying that i'm very pleased with the strong launch momentum of pinlock in europe mainly in germany and with the progress that the team is making in terms of market taxes in the first european markets So when it comes to our launch trajectory in Europe, I would say it's still early days. We are still learning about launch dynamics and market dynamics. And it's difficult to know how the trajectory will evolve from here or when we will be fully penetrated in the market. So I would say that we need more time to consolidate learnings. Also take into consideration that summer, according to my experience in international markets, is historically a quiet and slow period in Europe. So we need to take that also into consideration.
spk04: Got it. And one more question on the clinical side. In terms of the development plans for DCC3116, is there a need to weigh the results from the combination trials to choose the recommended phase 2 dose, or is the recommended phase dose going to be solely based on the dose escalation study? Yeah, Matt, would you like to take that?
spk12: Yeah, thanks, Daniel, for the question. So, yeah, we're also very excited with the progress that we're making for our potential first-in-class autophagy inhibitor, DCCA3116, in combination with RAF and RAF inhibitors. And as you know, we initially, the study is monotherapy for dose escalation, and that dose level that we'll identify in the monotherapy part of the study will be taken forward in combination with multiple inhibitors in combination. Then once we'll continue with dose escalation in combination, and then choose a recommended phase two dose to take forward into expansion cohorts for determining the efficacy of the accommodation in the study. All right.
spk04: Got it. Thank you very much.
spk05: Thank you. We will take our next question. Please stand by. And your next question comes from the line of Chris Raymond from Piper at Sandler. Please go ahead. Your line is open.
spk06: Hi, good morning. This is Allie for Chris today. Thanks for taking our questions. So maybe one on on the motion trial. I know you're not guiding on your expected enrollment timelines, but could you maybe qualitatively sort of talk about the level of interest for you're seeing among prescribers and patients and how you think that could change after you present data from cohort B of the phase one to and maybe how that factors into your view of the TAM for this indication in terms of eligible, incident, prevalent TGCT patients. And then a separate question just on Kinloch. I think you mentioned the IPDE BID dosing as a potential growth driver in the U.S. this year. Could you just kind of talk to any changes you've seen since the NCCN just practice guidelines update in January? I think it was a little too early. for you to say too much on trends last quarter, but just wondering if you have any updates now six months after that NCCN update. Thanks.
spk03: Great, Ali. Thanks very much for the questions that you posed. So we'll take those in order. And what I would suggest, Matt, maybe you'd like to take the question about motion and about enrollment and any potential impact of data presentation at ESMO next month on the trajectory. of enrollment. And then, Dan, Martin, perhaps you'd like to take, then, the question with respect to the total addressable market and how we think about the opportunity in tenosynovir giant cell tumor for a potential best-in-class inhibitor like Vimseltinib. And then, Dan, you could also take the question with respect to off-label BID use that we see in the U.S.
spk12: Thanks, Stephen, and thanks, Ali, for the question. So, you know, going back to the first question you had about Vimseltinib and the motion study, so, yes, we're very pleased with the progress that we have currently enrolling the Phase III motion study. And as we've noted before, this is a global study in about 40 sites targeting 120 patients randomized to VimSultanib or placebo. And we're also, as we've announced today, we'll be providing an update on the Phase I-II study at ESMO next month. And this is additional follow-up and enrollment from our previous update at ESMO last year. And so we look forward to reporting both the dose escalation cohort in the Phase I study as well as the expansion cohorts in the phase one study. And also, as you know, there were two expansion cohorts. Cohort A was in previously untreated patients, and cohort B were in the patients who had been previously treated with specific CSF1 receptor inhibitor, such as texidartanib or other antibodies to the receptor. So with that presentation next month at ESMO, we do expect that there'll be continued enthusiasm for enrollment in the motion phase three study. And as we've noted, we're continuing to open up sites but currently open globally in the U.S., Canada, Europe, and Australia.
spk11: And hi, this is Dan. Thanks, Ali, for your questions. I'll just continue off of what Matt said as it relates to the TAM. You know, we view the progress that is being made with the motion study as really confirming, really very supportive of the way that we've laid out the market opportunity As you'll recall, we've broken that into a couple of components. One is the opportunity that relates to currently treated patients, which are claims analyses, which suggests somewhere in the order of 1,300 to 1,400 patients actively receiving systemic therapy for TGCT. And then an additional component, which could be a growth opportunity for us, given the patients who recur after their first surgery but may not go on systemic therapy today, given what we believe to be, you know, concerns over the available, you know, options. So, taking together that $850 million opportunity that we see in the U.S., just based on the incident population, not including what we think is a meaningful prevalent population, and then, of course, the opportunity in Europe. So, we obviously watch the motion progress with great interest and feel as though it's really supportive of the way we've laid out the opportunity in the U.S. and globally. As it relates to your second question, IPDE, yes, so as you'll recall, the guidelines were updated in January of this year to include IPDE after patients have progressed on QD. This is always underscore and off-label use, so not something that we're out there actively promoting. We've always heard real KOL interest in the IPDE data, and they view that as a really interesting data. And I think, you know, as underscored by the listing in the NCCN guidelines, view it as a really important treatment option in what becomes essentially fifth line. And we do see some of that use. I think it's still a bit early to know where the trends will go over time, because again, You would expect the dispersion of awareness of that data and potential use of that data to look differently than our launch because, again, we can't promote that data. But, and so, therefore, we continue to see the vast majority of use of the QD dose. But it is something that we're watching with interest, and we'll see how that unfolds in the coming quarters.
spk07: Thank you.
spk05: Thank you. We will take our next question. Please stand by. Your next question comes from the line of Bradley Canino from Stiefel. Please go ahead. Your line is open.
spk13: Thank you and congrats on the quarter. Two for me here. On Kinloch, do you have any updated timing for the NCCN meeting schedule to potentially take action on the second line GIST data And then on the ALK inhibitor, you've disclosed you're enrolling any metastatic solid tumor patient with a documented RAS, NF1, or RAF mutation. But based on the centers you've chosen and perhaps physician perception of the types of patients that might benefit from autophagy inhibition based on the case reports with hydroxychloroquine in the literature, Would you expect an over enrollment or a bias towards a particular solid tumor organ type in the dose escalation phase? Thank you.
spk03: Yeah. Hi, Brad. It's Steve. Thanks for the question. So I'll take the first question with respect to the NCCN guidelines and then ask Matt to comment on the Phase 1 study with DCC 3116. So we know that the NCCN, the next scheduled meeting for the GIST or SARCOMA panel is coming up in early September. It's September 13th. And so we would expect that that would be likely where the panel at least would have an opportunity to consider a submission of the Intrigue data and to evaluate that. Of course, as you know, this is an arm's length sort of process, so we don't have any insight as to what might be on the agenda for that meeting or if they will be reviewing the data from Intrigue at that meeting, but that would be the next opportunity, we believe, for the panel to review the data and then potentially take any action they choose to take. Matt, do you want to comment on the Phase 1?
spk12: Yeah, hi, Brad, and thanks for the question. And so, as you know, we're conducting the phase one first-in-human study of 3116 in patients with solid tumors to harbor a mutation in the RAF pathway. And the study's being done at a number of phase one sites across the country, and these are all experienced phase one investigators who have participated in similar studies in advanced cancer patients. You know, the spectrum of patients that are enrolled in these are ones who would be typically eligible for a Phase I trial that failed prior therapy, but in this particular case also carry these mutations. I don't expect there will be any bias to any particular tumor types, but more provide the opportunity for patients who have failed prior therapy to enroll onto this Phase I trial.
spk13: Great. Thank you.
spk05: Thank you. Once again, if you would like to ask a question, please press star one and one on your telephone keypad. We will now take our next question. Please stand by. Your next question comes from the line of Rennie Benjamin from JMP Securities. Please go ahead. Your line is open.
spk09: Hey, good morning, guys. Thanks for taking the questions. Maybe just starting off with 3116. You know, Maddy, you mentioned that you don't expect to see any monotherapy activity. So kind of outside of safety, what are the other metrics that you're looking at that help you, you know, to advance the program in the best way possible? And just related to that, about how many patients' worth of data, you know, should we be expecting to see?
spk12: Thanks, Randy, for the question, and we're really looking forward to the oral presentation, as we know, at ESMO next month. Thanks, Randy, for the question, and we're really looking forward to the oral presentation, as we know, at ESMO next month. The abstract was selected for a proffered paper, which is usually limited to very high-quality abstract submissions. And they'll also be followed by a discussion as well too. So we look forward to that next month. And this will be from the monotherapy dis-escalation cohorts in the study. And in this context, the presentation will not only focus on the safety of 3116 in these cohorts, but importantly also on the pharmacokinetics and the pharmacodynamics that were measured in this trial. And as we noted previously, the inhibition of the target kinase of kinases measured by decreases in ATG14 phosphorylation will be a key pharmacodynamic measure that we can look forward to presenting some data on next month. taking the totality of the safety, the PK exposure, and inhibition of the target proteins in the autophagy pathway. We look forward to sharing a very comprehensive package next month.
spk09: And will those metrics be measured from plasma, or do you have tumor biopsies? How should we be looking at that?
spk12: Yeah, the initial data for inhibition of ATG14 is done in peripheral blood mononuclear cells. They're obtained throughout the study for patients on a trial. So that will be part of the initial presentation in September. In terms of number of patients, we haven't provided a specific number of patients that will be presented in the presentation, but the study is designed as a 3 plus 3 study design, so you might think through that the number of patients per cohort is in that range of patients.
spk09: Got it. And just switching gears to Vimselta, you know, I know we've had prior updates, obviously, but, you know, in this case, I think, just confirm if I'm thinking about this correctly, the dose expansion courts, this might be the first time that we're seeing them. Can you just reconfirm? It seems like from the dose escalation part of the study, we should be seeing an update on follow-up and how long, you know, the durability of response. But the dose expansion, we might be getting first-time response rates as well?
spk12: Yeah, so good question. Let me just sort of walk through what the update will be also at ESMO next month. So, you know, first, the initial part of the study was dose escalation part of the study using three different cohorts of imsultinib, dose levels of imsultinib, And that enrolled 32 patients. We did provide the full enrollment of 32 patients at ESMO last year, but those patients now have much longer follow-up, obviously, a year more follow-up. And so there will be an update on those initial 32 patients. And then in the two expansion cohorts, cohort A was the expansion cohort of patients who were previously untreated, similar to the enrollment for the motion phase three study. That is fully enrolled with 46 patients. We had initially had efficacy last year at ESMO, but not all the patients were efficacy-available just because of their duration on the study. And now we have all those patients available for efficacy. And then cohort B is the cohort that's currently enrolling, and those are the patients who have been previously treated with specific CSF1 receptor inhibitor. And we have 13 patients of 20. who are currently enrolled into the cohort B. And so we'll also be providing an update on that cohort as well next month at ESMO.
spk09: Terrific. Great. Thanks for that. And then just finally, you know, you guys raised some significant capital in what was considered to be, you know, one of the worst biotech markets in quite some time. And so congratulations on that. Can you comment a little bit on what primarily drove that investment? What, you know, are investors most focused on Is it something about the pipeline? Any sort of commentary there?
spk03: Yeah, Ren and Steve, thanks for the question. I think interest certainly in the company continues to be built around the strong commercial franchise that we now have in Kinloch and GIST, which as we reported today, we're seeing really nice revenue growth based largely on the geographic expansion as our successful launch in Europe unfolds. So I think interest is really anchored around having a company that's generating meaningful revenue And behind that, of course, as we just talked about in answer to some of your questions, we have a really robust portfolio of either potentially first in class or best in class product candidates that have some meaningful data updates coming this year and have the potential to drive future growth for the company. And all of that is, of course, anchored by, if you will, a really productive research platform that has the potential to generate additional novel product candidates. So we think the profile of the company is unique in in the space and we think that was in part why we saw the strong investor interest that we saw earlier this year and we're now very well positioned with runway into 2025 to continue executing on our plans so we're very excited about the position that we're in and the opportunity to drive further growth terrific thanks for taking the questions thank you run thank you we'll now take our next question please stand by
spk05: Your next question comes from Shayzini from Barclays. Please go ahead. Your line is open. Hi.
spk01: This is Shay on for Peter Lawson. Thanks for taking the question. Congrats on the quarter. Just quickly then on to piggyback on there. Since it's now been another year since ESNA, should we be expecting to see durability data and what's that expectation there for what we could see? pending the motion data, is any sense of what the timing is for potential filing or approval and what the path to filing is? And then just a quick follow-up after that.
spk03: Sure. So, Matt, would you like to take the questions on Vimseltinib and also on motion?
spk12: Yes. Thanks for the question. So, you know, as we know, we'll have another year of follow-up from the initial presentation we had at ESMO last year. So, you know, that will provide not only, you know, an ongoing, you know, direct response rate that's being measured in the study, but duration of response and treatment duration as well in this study, and that's important because as we know, in this disease, patients are generally treated for long periods of time, and showing that there's large numbers of patients that can remain on study for longer periods of time, I think will be important observation to speak to the importance and the activity of Vimseltinib in patients with TGCT. In regard to an update on the phase three motion study, We do plan to provide an update later this year in terms of an estimate of timing of full enrollment and when we might expect to see results from the trial.
spk01: Great, thank you. Thanks for Kinloch. I know it's still early days for the Europe launch, but is there any way to add color to what we can expect for the launch in France compared to Germany, and how does that market opportunity compare? Thank you.
spk03: Yes, thanks for the question. With respect to Europe, Margarita, would you like to take that?
spk08: Sure. Just to double check, since my audio is not so good, was the question related to the market opportunity of Germany versus France?
spk01: Exactly. And what we could expect for your France launch.
spk08: Sure. Excellent. Thank you. So just to start with, you know, both Germany and France, they are definitely the largest European markets, and this is driven by population and market access considerations. Of course, some differences may apply in terms of products, but we believe that with Kinloch, this is where we are going to be. the biggest revenue for us. I should note that Germany has a larger population than France, so higher EPI, and this should be one of the main differentiators. I think it's also important to note that we have been selling in France for some time and have recently transitioned successfully, I should say, to the post-approval paid access program. So I expect the trajectory to be different versus what we are seeing in Germany since we started from scratch in Germany. last January, so early this year.
spk01: Great, thank you.
spk05: Thank you. We will now take our last question. Please stand by. And your last question today comes from the line of Andrew Behrendt from SVB Securities. Please go ahead, your line is open.
spk02: Hey, thanks for the question. This is Chris on for Andrew. Just two questions on Vimseltinib. Just wondering about how you got to the 150 million number and the assumptions for, you know, Vimseltinib in the incident population and TGCT. And then, you know, what can we think about for the size, for the additive size to the opportunity for the prevalent population and the EU?
spk03: Great. Thanks, Chris, for the question. So, Dan, why don't you, if you'd like to take the questions with respect to the market opportunity for Vimseltinib, both how we got to the TAM and then the additional question about the prevalent opportunity that we see.
spk11: Sure. Absolutely. Thanks, Chris. Appreciate the question. So, as we've laid out in the corporate deck, we have put a lot of effort into sizing the potential opportunity for Vimseltinib. certainly in the U.S., and then extending that globally. There are about 14,000 to 18,000 patients diagnosed each year with TGCT, but the real question is how many of those are likely to be newly eligible for systemic therapy. And so we've done a lot of work not only through the literature but also through claims data U.S. claims data. And multiple work streams that we've put toward answering these questions have resulted in very similar answers. And so it gives us great confidence in the numbers that we've laid out. And so the first component of the $850 million is made up principally of the 1,300 to 1,400 patients that we see starting on systemic therapy each year. So that's the incident component, incident treated component. The other component is patients who we can see have failed their first surgery but may not go on to systemic therapy currently within the treatment paradigm. Now, some of those patients may derive benefit from subsequent surgeries, but we know some of them also may just accommodate their lives and deal with the challenges of GCT because the options for systemic therapy today aren't great. We know that The one approved agent, pexidartinib, has some significant AE challenges, known hepatotoxicity, box warning, REMS program, extensive liver monitoring, for example. And so many patients today who receive systemic therapy actually receive famatinib, which is off-label. It's not been studied or developed for TGCT. is used off-label, and we believe largely because of the AE challenges with pexidartanib. So we think that the $500 million that we've laid out is sort of a floor, so to speak, to the opportunity in the U.S. because we can see those patients getting systemic therapy today. We think the additional $350 million growth opportunity is very real given we think that vinseltinib could offer a really best-in-class profile, something that patients just don't have access to currently, a real improvement in clinical profile in addressing that unmet need. Finally, how do we get to those numbers? Well, we look in the claims data to understand what duration of therapy patients seem to be deriving from principally on imatinib. We look to imatinib, and they get about 18 months total time on therapy. That's what we see in the claims data today. That's not the safe and self-nib or a better option. A best-in-class option might not offer more time on therapy, but that's what we use for the buildup to that TAM. So taken together, $850 million in the U.S., driven largely or entirely on what we see in terms of an incident opportunity. We haven't sized or laid out exactly how we think about the opportunity for the prevalent population. The math is a little bit different, but clearly, an 850 million opportunity in the U.S. without considering the approximately 8,000 estimate that we provided for prevalence. And then in Europe, where there are no approved agents, so really the unmet need is even higher. And we believe that the – there's no reason to believe the epi is different, so in Europe versus the U.S. So taken all together, it's not hard to imagine a billion-dollar-plus opportunity globally for bimseltinib in this space. Got it. Thank you very much.
spk05: Thank you. I will now hand the call back for closing remarks.
spk03: Great. Thank you very much, and thank you to everyone for joining us on today's call and for your continued interest and support of Decipher. We look forward to keeping you updated on our continued progress and look forward to seeing some of you at ESMO next month. Thank you very much, and have a great rest of your day.
spk05: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.
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