Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) Q2 2022 Earnings Conference Call August 4, 2022 8:00 AM ET
Jennifer Larson - Senior Vice President, Finance and Investor Relations
Steven Hoerter - President and Chief Executive Officer
Matthew Sherman - Executive Vice President and Chief Medical Officer
Daniel Martin - Senior Vice President and Chief Commercial Officer
Margarida Duarte - Senior Vice President and Head of International
Tucker Kelly - Executive Vice President, Chief Financial Officer and Treasurer
Conference Call Participants
Daniel Wolle - JPMorgan
Allison Bratzel - Piper Sandler
Bradley Canino - Stifel
Reni Benjamin - JMP Securities
Good day and thank you for standing by. Welcome to the Deciphera Pharmaceuticals' Q2 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.
I would now like to turn the conference over to your first speaker today, Jen Larson, Senior Vice President, Finance and Investor Relations. Please go ahead.
Thank you, operator. Welcome and thank you for joining us today to discuss Deciphera's second quarter 2022 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations.
With me this morning to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer; Dan Martin, Chief Commercial Officer; Matt Sherman, Chief Medical Officer; Margarida Duarte, Head of International; and Tucker Kelly, Chief Financial Officer.
Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our commercialization of QINLOCK and 2022 guidance.
Forward-looking statements made on this call involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10-Q as well as our other SEC filings. We assume no obligation to update or revise 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 Hoerter, President and Chief Executive Officer of Deciphera. Steve?
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 QINLOCK 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 2 product revenue growth of 43%. Beyond QINLOCK, we continued 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 vimseltinib and DCC-3116 programs.
In the second quarter, we opened additional clinical study sites for the pivotal Phase 3 MOTION study of vimseltinib, as we focus our efforts on rapidly enrolling this registration enabling study. We expect to present updated results from the Phase 1/2 study of vimseltinib 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 1 study of DCC-3116, our first-in-class autophagy inhibitor, also at ESMO. This data presentation is the first report from our ongoing Phase 1 study, and we're excited that the data were selected for an oral presentation as a proffered 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 Margarida Duarte, our Head of International, will provide an update on the momentum of QINLOCK's fourth-line launch in Europe, including, most notably, the recent major additional benefit rating QINLOCK received in Germany and the successful post-approval paid access program in France. Both demonstrate the potential for QINLOCK to transform the treatment of advanced GIST 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 Kelley Dealhoy 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. Kelley brings 20 years of life science leadership experience to the role. And her responsibilities will include developing and leading Deciphera's business development efforts, as well as supporting corporate strategy initiatives. We're very excited to have Kelley 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?
Thanks Steve. We continued to make excellent progress advancing our clinical and preclinical pipeline as we work to provide novel treatment options for patients with cancer. I'd like to start with DCC-3116, our potential first-in-class ULK inhibitor. We are leaders of exploring the role of autophagy as a broad resistance mechanism of cancer. And 3116 has the potential to benefit a significant number of cancer patients by targeting ULK, the initiating factor in the autophagy pathway.
DCC-3116 is a potent and highly selective switch control inhibitor designed to inhibit the ULK1/2 kinases that activate the autophagy pathway. Autophagy is a key tumor survival mechanism and a potential mechanism of drug resistance in cancer cells. We have now generated a growing body of preclinical research, both independently and with academic collaborators, demonstrating the ability of DCC-3116 to address autophagy induced by a variety of RTK, RAS and MAP kinase pathway inhibitors. We have built an industry-leading position in targeting this pathway.
DCC-3116 is currently being investigated in the single agent, dose escalation portion of the Phase 1 study in patients with advanced or metastatic solid tumors with a RAS or RAF 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 that 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 target engagement through measuring levels of ATG14, a PD marker of ULK 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 escalation cohorts in the second half of this year. Based on our preclinical research and the mechanism of action, we do not expect to see single agent activity as monotherapy. Our Phase 1 study will include two cohorts in combination with MEK inhibitors trametinib and binimetinib, as well as one cohort with sotorasib, an improved KRAS G12C inhibitor.
Turning now to vimseltinib, our CSF1 receptor kinase inhibitor, that we believe has the potential to be a best-in-class treatment for tenosynovial giant cell tumor, or TGCT. With one approved treatment available for TGCT 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 vimseltinib is well-positioned to address this need. Based on the initial data from the ongoing Phase 1/2 study in TGCT patients, vimseltinib 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 poster 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 vimseltinib has the potential to become the standard-of-care drug treatment for patients with TGCT non-amenable to surgery. To that end, we continue to open sites and rapidly enroll our Phase 3 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 CRAF kinases to address an unmet medical need in patients harboring Class 1, 2 and 3 BRAF mutations as well as BRAF fusions. Nomination of this development candidate highlights 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 will now turn the call over to Dan Martin, our Chief Commercial Officer, to provide an update on our U.S. commercial efforts. Dan?
Thanks Matt. In Q2, we continued to execute on our commercial goals for QINLOCK in the U.S., reinforcing its position as the clear standard-of-care in fourth-line GIST, while continuing to expand our prescriber footprint and physician experience of QINLOCK.
During the quarter, we achieved $23.7 million in total net product revenue in the U.S. Our key performance metrics continued to reflect strong commercial execution and highly positive product perceptions among GIST prescribers. We again delivered excellent results in terms of prescriber reach, share of voice and product awareness. Importantly, GIST prescribers in both academic and community settings continue to rate QINLOCK 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 QINLOCK. Their feedback was extremely consistent, namely that QINLOCK has provided tremendous clinical benefit 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 physicians, 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 drug 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 past 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 Deciphera'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 vimseltinib would be well-positioned to penetrate a potential addressable U.S. market of $850 million, given the high unmet medical need as well as vimseltinib'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 Margarida Duarte, our Head of International, to discuss the exciting results from our second quarter of the commercial launch of QINLOCK in Europe. Margarida?
Thanks Dan. We are very proud of QINLOCK'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 QINLOCK net product revenue of $7.8 million, most of which represents product revenue from Germany and France. These strong results in the second quarter reflect QINLOCK's exceptional clinical benefit and demonstrate its growing position in the European GIST treatment landscape, addressing the high unmet need of patients with fourth-line GIST.
We are honored to announce that QINLOCK received on June 16 a major additional benefit rating in Germany for its indication in advanced GIST. This is an extraordinary achievement. And on this date, only approximately 1% of all oncology drugs have received the highest possible rating. QINLOCK 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 QINLOCK's positive ASMR III rating, a rating only achieved by a small number of orphan treatments, which underscores the recognition of the robust clinical value that QINLOCK brings to eligible GIST patients.
In addition to our ongoing efforts in Germany and France, we continued to pursue market access for QINLOCK in the EU and the U.K. on a country-by-country basis. And I'm very pleased to share that we have recently submitted a reimbursement application to NICE 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?
Thanks Margarida. 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 QINLOCK and $1 million in collaboration revenue, which includes QINLOCK's supply and royalty revenue under our agreement with Zai Lab of 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 depleted and additional inventory is manufactured and sold. We do not expect cost of sales as a percentage of net sales of QINLOCK to increase significantly after we have sold all zero cost inventories and commenced the sale of inventories that will reflect the full cost of manufacturing. We expect to continue to sell the initial pre-launch inventory of QINLOCK 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 30 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 strengthened balance sheet, we are well capitalized and believe that our cash, together with the anticipated product, royalty 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. 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 1 monotherapy dose escalation study of DCC-3116 at ESMO next month; and initiation of three combination cohorts with MEK and KRAS G12C inhibitors; continued enrollment of the Phase 3 MOTION study of vimseltinib in 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 pan-RAF program later this year. All while we continue to cement the position of QINLOCK 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.
Thank you. [Operator Instructions]
Your first question comes from the line of Daniel Wolle from JPMorgan. Please go ahead. Your line is open.
Hi. Good morning, everyone. Thanks for taking our question. A couple of high level questions first. It 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? At a high level, should we think of this as a run rate going forward?
Hi, Daniel. Thanks for asking the question about QINLOCK 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?
Sure. Absolutely. Thanks Daniel for the question. So, we have been really pleased with the launch, and having established QINLOCK 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 QINLOCK launch in this setting and also the really powerful clinical profile that QINLOCK 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 need.
As a result of that, we were really successful with the launch and 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 QINLOCK. 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 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 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 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.
Great. And then, on Europe, when we think about peak QINLOCK sales there, how would you compare that -- what you expect there to what you expect for peak sales in the U.S.? Should it be similar, or are there reasons Europe will be larger or, I guess, smaller too?
Margarida, would you like to take that?
Yes. Sure. Thank you for the question, and thanks Steve. Let me start by saying that I'm very pleased with the strong launch momentum of QINLOCK in Europe, mainly in Germany, and with the progress that the team is making in terms of market access in the first European market.
So, when it comes to our launch trajectory in Europe, I would say it's still early days. We are still learning about the 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.
Okay. Got it. And one more question on the clinical side. In terms of the development plans for DCC-3116, is there a need to wait 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?
Yeah. Thanks Daniel for the question. So, we're also very excited with the progress that we're making for our potential first-in-class autophagy-inhibitor DCC-3116 in combination with RAS and RAF inhibitors. And as you know, we initially did the study as 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. And then, once we'll continue with dose escalation in combination and then choose a recommend Phase 2 dose to take forward into expansion cohorts for determining the efficacy of the combination in the study.
Great. Got it. Thank you very much.
Thank you. We will take our next question. Please stand by. And your next question comes from the line of Chris Raymond from Piper Sandler. Please go ahead. Your line is open.
Hi. Good morning. This is Alli Bratzel on for Chris today. Thanks for taking our question. So, maybe one on vimseltinib. On the MOTION trial, I know you're not guiding on your expected enrollment time lines. But could you maybe qualitatively sort of talk about the level of interest for vimseltinib you're seeing among prescribers and patients, and how you think that could change after you present data from Cohort B of the Phase 1/2? 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 QINLOCK. 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 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 6 months after that NCCN update. Thanks.
Great. Alli, 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 tenosynovial 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.
Thanks Steven. Thanks Alli for the question. So, going back to the first question you had about vimseltinib in the MOTION study. So, yes, we're very pleased with the progress that we have currently enrolling the Phase 3 MOTION study. And as we've noted before, this is a global study in about 40 sites, targeting 120 patients randomized to vimseltinib or placebo. And we're also -- as we've announced today, we'll be providing an update on the Phase 1/2 study at ESMO next month. And this is additional follow-up enrollment from our previous update at ESMO last year. And so, we look forward to reporting both the dose escalation cohort in the Phase 1 study, as well as the expansion cohorts in the Phase 1 study.
And also, as you know, there are 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 pexidartinib 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 3 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.
And this is Dan. Thanks Alli for your questions. I'll just continue off of what Matt said. As it relates to the TAM, 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 suggest somewhere in the order of 1,300 to 1,400 patients currently receiving -- 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 concerns over the available 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, 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 -- I'll always underscore an 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 really interesting data.
And I think, 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.
Thank you. We will take our next question. Please stand by. Your next question comes from the line of Bradley Canino from Stifel. Please go ahead. Your line is open.
Thank you and congrats on the quarter. Two for me here. On QINLOCK, 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 ULK 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.
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, September 13. 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?
Yeah. Hi, Brad. Thanks for the question. As you know, we're conducting the Phase 1 first in human study of 3116 in patients with solid tumors who harbor mutation in the RAS/RAF pathway. And the study's being done at a number of Phase 1 sites across the country, and these are all experienced Phase 1 investigators who have participated in similar studies in advanced cancer patients. So, the spectrum of patients that are enrolled in these are ones who would be typically eligible for a Phase 1 trial that failed prior therapy, but in this particular case, also carry these mutations. I don't expect there'll 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 1 trial.
Great. Thank you.
Thank you. [Operator Instructions]
We will take our next question. Please stand by. Your next question comes from the line of Reni Benjamin from JMP Securities. Please go ahead. Your line is open.
Hey, good morning guys. Thanks for taking the questions. Maybe just starting off with 3116. Matt, 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 to advance the program in the best way possible? And just related to that, about how many patients' worth of data should we be expecting to see?
Thanks Reni 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. It'll also be followed by a discussion as well, too. So, we look forward to that next month.
This will be from the monotherapy dose 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've noted previously, inhibition of the target kinase -- or 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. So, 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.
And will that -- will those metrics be measured from plasma, or do you have tumor biopsies? How should we be looking at that?
Yeah. The initial data for inhibition of ATG14 is done in peripheral blood mononuclear cells. They're obtained throughout the study for patients on the 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 three plus three study design. So, you might think through that the number of patients per cohort is in that range of patients.
Got it. And just switching gears to vimseltinib. I know we've had prior updates, obviously. But in this case, I think -- just confirm if I'm thinking about this correctly -- the dose expansion cohorts, 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 the durability of response. But the dose expansion we might be getting first-time response rates as well?
Yeah. So, a good question. Let me just sort of walk through what the update will be on -- also at ESMO at next month. So, first, the initial part of the study was dose escalation part of the study using three different cohorts of vimseltinib, dose levels of vimseltinib, and that enrolled 32 patients. We did provide the full enrollment of 32 patients at ESMO last year. But those patients now are -- have much longer follow-up, obviously, a year or more of 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 3 study. That is fully enrolled with 46 patients. We had initially had efficacy last year at ESMO, but not all the patients were efficacy evaluable 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've 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.
Terrific. Great. Thanks for that. And then, just finally, you guys raised some significant capital in what was considered to be 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 -- are investors most focused on vimseltinib? Is it something about the pipeline? Any sort of commentary there?
Reni, it's 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 QINLOCK and just, 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 and answered 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 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 excited about the position that we're in and the opportunity to drive further growth.
Terrific. Thanks for taking the question.
Thank you, Reni.
Thank you. We will now take our next question. Please stand by. Your next question comes from Sean Feeney [ph] from Barclays. Please go ahead. Your line is open.
Hi. This is Sean on for Peter Lawson and thanks for taking the question. Congrats on the quarter. Just quickly then on vimseltinib to piggyback on there. Since it's now been another year since ESMO, should we be expecting to see durability data and kind of what's that expectation there for what we could see? And 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.
Sure. So, Matt, would you like to take the questions on vimseltinib and then also on MOTION?
Yeah. So, thanks for the question. So, as we know, we'll have another year of follow-up from the initial presentation we had at ESMO last year. So that will provide not only an ongoing drug response rate that's being measured in the study, but the duration of response and treatment duration as well in the 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 the 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 3 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.
Thank you. Then for QINLOCK, 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?
Yeah. Sean, thanks for the question. With respect to Europe, Margarida, would you like to take that one?
Sure. Just to double check since my audio is not so good, was the question related to the market opportunity of Germany versus France?
Exactly. And what we could expect for your France launch.
Sure. Excellent. Thank you. So, just to start with both Germany and France, they are definitely the largest European markets. And this is driven by population, market access considerations, of course. Some differences may apply in terms of products, but we believe that with QINLOCK, 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.
Thank you. We will now take our last question. Please stand by. And your last question today comes from the line of Andrew Berens from SVB Securities. Please go ahead. Your line is open.
Hey. Thanks for taking the question. This is Chris on for Andrew. Just two questions on vimseltinib. Just wondering about how you got to the $850 million number and the assumptions for vimseltinib in the incident population in TGCT. And then, what can we think about for the size -- for the additive size to the opportunity for the prevalent population and the EU?
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.
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 be -- may derive benefit from subsequent surgeries. But we know some of them also may just accommodate their lives and deal with the challenges of TGCT 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, boxed warning, REMS program, extensive liver monitoring, for example. And so, many patients today who receive systemic therapy actually receive imatinib, which is off-label. It's not being studied or developed for TGCT, is used off-label and we believe largely because of the AE challenges with pexidartinib. 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 vimseltinib could offer a really best-in-class profile, something that patients just don't have access to currently. A real improvement and address -- improvement in clinical profile and 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 looked 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 to say vimseltinib 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 the 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. That 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've provided for prevalent, 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 in Europe versus the U.S. Taken all together, it's not hard to imagine a $1 billion-plus opportunity globally for vimseltinib in this space.
Got it. Thank you very much.
Thank you. I will now hand the call back for closing remarks.
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 Deciphera. 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.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.