Excellent. Good afternoon, everyone, and it's welcome to the JMP Securities Hematology and Oncology Summit. Very, very happy to have Deciphera Pharmaceuticals as the next presenting company. Presenting for the company is Tucker Kelly, CFO. Welcome, Tucker. Thanks for joining us. Great. Ren, thank you for hosting us today. Appreciate it. Thank you. I never know exactly who's in our virtual audience and whether or not they know Deciphera, so I always like to start these fireside chats off before we get into the details with, asking you to provide maybe a two- to five-minute overview as to what Deciphera is all about. Sure. Happy to do that, Ren. So we are a fully integrated oncology company with capabilities from discovery all the way through commercialization, both in the U.S. and in Europe. And we'll talk a little bit more. We're on the cusp of becoming a multi-product company as well, with a recent phase III readout. All our drugs are developed in-house, and we've built a really great business that I think is quite distinct in today's market environment. So, we're a really key inflection point in the company, as we move one commercial product entity to one that has multiple products. And we think that puts us on a path to being a self-sustaining biotech company. So QINLOCK, which is our first approved product, is now approved in 42 countries, and we think that, combined with our next product called vimseltinib for tenosynovial giant cell tumor, we think those two drugs at peak can do $1 billion in revenue for the company. Then again, as I mentioned, becoming a self-sustaining company on the back of those two drugs alone. So QINLOCK is now the standard of care in fourth-line GIST. We've marketed it in the U.S., in Europe, and 42 countries around the world, and with partners as well. And we think there's a significant upside from its current labeled indication in fourth line into a portion of the second-line population, which we think can double the size of the US market. We're on a really great trajectory now with the launch in the U.S. being about three years old now and being almost two years into our European launch as well. In Q3, we did $43 million in revenue, which is driven by continued growth in the US based on increased demand as well as geographic expansion and further penetration into the fourth-line in Europe. It's a 30% year-over-year product revenue growth. We're really excited about the current base business with QINLOCK and we continue to think that the fourth-line business can grow based on geographic expansion, as well as increasing duration of therapy. Beyond that, we think the second-line opportunity that we'll touch on today, Ren, provides significant upside from the current trajectory in fourth-line. That's really gonna be based on data that we generated out of our initial all-comers population in second line, what we call the INTRIGUE study. Looking back at that trial, which did not meet the primary endpoint, but which we did a subset analysis of patients with a specific mutation, that was exon 11 primary and exon 17/18 secondary. We saw a significant outsized benefit relative to sunitinib, which is the comparator, in that trial. We think that data is really compelling and is the basis for our ongoing phase III INSIGHT trial to replicate that in a prospective manner. With a labeled approval and at peak, we think that the second-line and fourth-line opportunity in GIST in the U.S. alone could be $350-$400 million, again, not including any ex-US revenue there as well. As I mentioned, we had a second product that we just read out, our pivotal phase 3 study. The drug is called vimseltinib, and the disease is called tenosynovial giant cell tumor, or TGCT. We think this is a great next fit for us. It's a drug that has a high unmet medical need, and where the prescriber base is a fantastic fit for where we call on today, with GIST and with QINLOCK. So, the positive MOTION data that we'll touch on, we think sets us up really well for an approval in the U.S. and Europe. We'll file the NDA in the second quarter of next year and the MAA in the third quarter. And we've got fantastic phase I and II data backing up the 25-week endpoint data for MOTION, with really long treatment duration and great long-term safety and tolerability profile, as well as great efficacy, that we think can make this really best-in-class product. Again, as mentioned, there's a high unmet medical need in TGCT, and we think that it represents, in the U.S., at a minimum, a $500 million initial market opportunity, and ways to grow that franchise over time, as well as obviously outside the U.S. You know, beyond that, we've got a really exciting rich pipeline that we're developing. We have an ULK inhibitor, best-in-class, first-in-class agent right now in a dose escalation combination, designed to treat autophagy, which is a resistance mechanism in cancer. Similarly, we have a pan-RAF inhibitor that one of our final goals for 2023 is to file that IND before the end of the year, and we're well on track for that. Next up, we've got a next-generation pan-KIT inhibitor that we'll file the IND for, in the first half of next year. And more programs and activities underway in our research engine as well. So we're well-capitalized to cap it off, $377 million at the end of Q3, and that takes us into 2026, into a really exciting time period, where hopefully we'll have two products on the market, a launch with them, and moving toward readouts and label expansions for QINLOCK. So we think a really exciting, differentiated profile. Excellent. Thank you for that overview. Let's jump into some of the details, I guess, right? Sure. So maybe starting off with, you know, this genetically defined subset. You know, can you talk to us a little bit about, like, how did you find it? You know, how did you know to target, you know, even look for it? Or was this something that, you know, when you're going through the entire INTRIGUE study, you know, it's something that just kind of popped out at you? And I guess, what is the current registrational study designed to show? Like, what kind of delta are we looking for here? And you mentioned already that it's a sizable opportunity. I think it doubles the current opportunity, but maybe I heard that wrong. Just if you can help us with the opportunity. ... Sure, absolutely. So great question. So let me just back up for folks who hadn't followed us over the last couple years. So, after we got approval in the fourth line, we were looking to get an all-comer second-line indication. Current standard of care today in second line is sunitinib. So we ran an all-comer study called INTRIGUE. We read that out, just over two years ago now, and while we didn't meet the primary endpoint, the data was quite similar. So we had a PFS of eight months, versus 8.3 months for sunitinib, but with a much better safety and tolerability profile. What we knew going into it was that they had differential activity against some of the key KIT mutations that drive GIST. So we knew that, for instance, regorafenib would typically be better against exon 11 primary mutations where sunitinib would be better against exon nine. And then importantly, we also knew was that we were a much better inhibitor of exons 17 and 18, which are key secondary resistance mutations, and that sunitinib was stronger in exons 13 and 14, which are key secondary mutations as well. So it wasn't a surprise that we had the data that we did coming out of INTRIGUE. It was a surprise, probably the magnitude of the benefit. So what we saw when we did the analysis using ctDNA from the INTRIGUE study, was that patients who had the exon 11 primary and exon 17 and 18 secondary, had a significantly outsized benefit. So we saw a 44% response rate versus 0 for sunitinib. We had a PFS of 14.2 months, and the PFS was 1.5 months for sunitinib. And for overall survival, even with crossover, we didn't have with crossover, but with subsequent therapies, apologies, we saw at 30 months that twice the number of patients in the QINLOCK arm were alive, 60% versus 30% in the sunitinib arm. So really compelling efficacy and again, a much better safety and tolerability profile. So we weren't surprised that we saw a difference, but it was a very large difference. So we took that data and announced that earlier this year and also announced that we were going to be running a label-enabling study called INSIGHT, and that's designed to replicate what we saw in the INTRIGUE trial. And the INSIGHT study, which is now up and running, is designed to basically replicate in a prospective manner the same data. We're using effectively the same number of patients. We saw our subset analysis in 52 patients, the INSIGHT studies in 54 patients. We're using the same primary endpoint, which is PFS. And again, based on the strength of the data, we have a I think a very strong belief that we're going to have a positive study. So, we're very excited to get that up and running. There's a lot of enthusiasm amongst investigators. We think it's a great option for patients. And we're excited to get our commercial teams down the line an expanded label for QINLOCK so that they can promote this data and provide what we think is really practice-changing benefit for these patients. You know, from a commercial standpoint, what that means is that, you know, we can have, a small portion of the second-line population with this expanded label, but that provides a significant revenue opportunity. And that's because, one, the patient population second line, is double overall what we see in fourth line. Unfortunately, a lot of patients never make it to fourth line GIST, because it's a really pernicious disease, and a lot of patients end up succumbing, to their cancer before they reach fourth line. In addition, what we saw again, with the PFS and the extended treatment duration in this, patient population second line, is a really, long duration of therapy that we think in real-world practice can be even longer than the 14 months of PFS that we saw, from INTRIGUE. So it can double the US opportunity is what we've said, and, and in total, we think just in the U.S., with an expanded label of peak, could be a $350 million-$400 million opportunity. And a really great benefit for patients with a practice-changing therapy that now gives patients a new option, hopefully in second line, to try and treat their disease in a much more targeted and effective manner. So you're in a very select group of biotech companies in that, you know, you've been able to successfully develop a drug, get it through the regulatory agency, and get a commercial product with a run rate, you know, roughly of about $160 million right now, and the potential to even grow that. That itself is unique. But now, you just recently announced positive phase 3 results for a second drug, vimseltinib. So congratulations on that. I think it really puts you guys in a very unique position. Maybe just, you know, for our investors, can you summarize the key data highlights here? But also, I expect some of our investors to know this already, there's an approved drug that's already out there for TGCT, TGCT, always do that, pexidartinib, as well as off-label imatinib. And so I kind of would love to get your thoughts on, you know, how you plan on competing in that market environment. No, absolutely. Thanks, Ren. You know, we think it's a great testament to both the strength of our discovery engine, we discovered both drugs in-house, our ability to develop it in the clinic to run, you know, registration trials internationally. Obviously, we've got approval in our marketing in the U.S. and Europe with QINLOCK, and we're really well-positioned to set up for marketing vimseltinib upon approval in the U.S. and Europe as well. So we were thrilled by the data that we announced at the end of October. At the same time, we announced the phase III MOTION readout. We also had updated phase I/II data, which we thought was really compelling and speaks to the overall profile of the drug, as well as its potential to help patients over a really extended time period. But the phase II results we reported for vimseltinib were to the trial called MOTION. This was a study in 120 patients, randomized 1:1 against placebo. And it was a week 25 endpoint of PFS. What we saw was a resounding success. We not only met the primary endpoint, but we met all key secondary endpoints, of which there were six, and we've disclosed the first two of those in the hierarchy. And that's important because this is a disease where certainly shrinking tumors by RECIST is important, and from a regulatory standpoint, that is the primary endpoint. But it's really important for these patients and physicians to have good quality of life benefits. So TGCT is a non-malignant disease. Patients don't die from TGCT-... They're diagnosed much earlier than a lot of other solid tumors or places like GIST. So typically, in their thirties, forties, and fifties. So for these patients, a good safety and tolerability profile, good efficacy that doesn't trade off for them against the disease burden that they suffer with from today, is really important. You know, for our primary endpoint, we had a 40% response rate at week 25, compared to 0% for placebo. And we had a tumor volume score reduction of 67%, versus zero for placebo. And that's important in this disease because people may not be as familiar with TVS, or tumor volume score, but it's another way to measure the size change in these tumors for TGCT patients, which are distinct and different from what you see in a lot of other solid tumors. They've got a lot of irregular shapes and patterns to them. So, the KOLs like to look at another measure, which is sort of what is the reduction in the overall volume of the tumor, or TVS, as a really compelling way to understand what the drug is doing. So, there, you have to have a 50% or greater reduction in order to qualify for a response. So we're really thrilled with that. And then in addition, we had all the other secondary endpoints hit. We haven't disclosed others, except for the first one in the hierarchy after TVS, which is range of motion. And there we saw a 5 times improvement in range of motion relative to placebo, which provides really significant functional benefit for patients. So, we'll publish the, the balance of the data. It's all clinically significant, statistically significant, and we think a really great data set to go to the regulators with, and to approach patients and physicians upon approval for... We think it's gonna be a great, great drug to help patients. As you mentioned, there is one drug that's approved in the U.S. today. It's called pexidartinib. There are no drugs approved outside of the US Pexidartinib was brought to the European regulators, but was not accepted for approval. It has done very poorly in the U.S. in terms of uptake. So what we see in claims data analysis is that it's not really become the standard of care, and that's because while it has decent efficacy, it has a significant, even though low frequency, safety issue. It's a hepatotoxicity that resulted in fatality in one of their clinical studies, as well as significant rates of severe hepatotoxicity, about 5% in their TGCT studies. So again, these patients, you know, that are looking to have symptomatic relief, that are in their thirties, forties, fifties, and are going to live with this disease potentially for the rest of their lives, that's a really scary thing to address. It's even if it's a low risk to have that as one of the possibilities of taking this therapy. So what we see today is that more patients tend to get imatinib, which is... well, it's a CSF1 inhibitor. And so we think that provides a really great opening for us to come to the market with a drug that has great efficacy, really good safety, in a prospective study, and something that patients and physicians can hopefully access, well and doesn't have the REMS and black box warnings that pexidartinib has. So, we think we're in a great position to get an approval in the US and Europe, and look forward to bringing it to patients, you know, following approval. If we think about regulatory interactions, and I believe you mentioned in your prepared, you know, kind of summary or overview of the company, an NDA by the second quarter of next year, MAA in the third quarter. Can you take us through, like, what are kind of the gating steps? I guess, you know, with the reporting of the data, right, I would have thought, like, "Hey, you'd be able to submit an NDA kind of right away." How do you think about, you know, once it's submitted, you know, is this a large unmet need and a priority review, or since there's a drug already out there, it's a normal review? How are you thinking about that? Sure. So we think we've got a really great package from the phase III study to the phase I and II study, where we've got really long duration data. We've got patients in the phase I out almost four years, and we've got really good efficacy and safety data to complete the package with FDA and EMA. It does take a while, obviously, to compile that data, to get all the modules that you need for the submissions together. And we're excited to have the NDA submission, that we've targeted for Q2 of next year. And then importantly, the EMA submission, you know, just that next quarter, which wasn't the case for us with QINLOCK and GIST. I think that's a sign of our maturity as a company. You know, we just had a team that was smaller and had worked together for a short amount of time and didn't have as much bandwidth to try and get that NDA and EMA submissions together more close in time. So, I think it's a great testament that we're able to try and file them pretty sequentially next year, and look forward to that. But it's nothing out of the ordinary. We'll have the, you know, pre-NDA meetings with FDA. We'll continue to compile the data and submit that to the regulators. And in terms of whether we get a priority review or not, we don't know. So we certainly will advocate for that. We think the data is really compelling and strong to support that, but that'll be part of the review discussions with the, the regulators. Pexidartinib did have a priority review on their, submission, so that's one data point, but that'll be a topic of conversation. We'll, advocate as best we can on behalf of, of the product. But we, we think we've got a great data package to bring to, to the regulators and look forward to doing that, next year. Got it. One final question on vimseltinib in terms of the treatment paradigm. We already talked about pexidartinib, and we talked about, you know, imatinib. You know, where do you think vimseltinib fits in, right, to this therapeutic paradigm, if and when approved? And so, you know, do you think docs can just, you know, make a switch, even though there's no head-to-head study? I'd love to know, you know, if, if you're already hearing that from your key opinion leaders that you, that you talk to. And I guess importantly, do you think the current sales force is enough to address, the potential for you to reach peak market penetration? Or, or do you think that, you know, or are the physicians different enough that you need to, you know, hire a lot more people? Sure, no, great question. So let me just back up and just talk a little bit about TGCT for folks who may be listening that aren't familiar with the disease. So, tenosynovial giant cell tumor has an incidence rate somewhere in the 14,000 incidence in the U.S. Thankfully, for patients, a lot of those patients can be cured by surgery. So orthopedic surgeons are typically the treating physicians when patients get to the point of understanding their diagnosis and are looking for an intervention of some sort. And as I mentioned, for a lot of them, patients can have that fully resected and not have to suffer with TGCT anymore. There are, however, a good number of patients for whom surgery is just not possible upfront, so they're just not amenable to surgery at the outset because of where the tumors are located, its involvement with nerves and other areas of the joints, and surgery just isn't a practicable or, or safe option. In addition, there are patients who unfortunately will have a surgery and, for a variety of reasons, can't be fully cured, and so the disease will recur. So for us, the study with MOTION and for the, the label, we would expect to be for patients who are not amenable to surgery. And what we see is in the U.S., on an annual basis, so incidence basis, we see about 1,400 patients who are newly at an oncologist and being treated for the first time. And that's important because that's where our sales force calls on today. So there are even more patients who maybe have had recurrent disease and are still being seen by an orthopedic surgeon or elsewhere, but aren't at the oncologist. But we know that 1,400 patients from our claims data are actually being treated by an oncologist today, for TGCT, that they may not have surgery for, and they're getting polypharmacy. So these are patients that are probably getting most often pain and steroid medications, and in about half the cases, they are getting a TKI. Most often, as I mentioned, what we see is they're getting imatinib off-label, in about 60% of cases. And about 25-26% of cases, patients are getting pexidartinib. So our go-to-market strategy is initially to focus on these oncologists, who are already treating and seeing TGCT patients. Certainly on an incidence basis, you know, converting the people who are today getting a TKI, either imatinib or pexidartinib, and getting those converted to vimseltinib. In addition, as I mentioned, there are half of those patients today that aren't getting the TKI and are getting probably pain and steroid medication. We think they're great candidates also for systemic therapy with a TKI. They may have chosen not to today because they are worried about the side effects with pexidartinib, or, you know, they don't think the trade-off is worth it with imatinib because of the lower efficacy. So we think that's a great opportunity with a strong label, to provide physicians and patients with that option. In addition, what we see in our claims data is that there's 9,000 prevalent patients that have been seen by an oncologist in the last few years, that we think also could be brought back into the treatment funnel, and re-engaged with an oncologist, if there's a better option that's out there. So, you know, our core market opportunity, that 1,400 incident, we think alone in the U.S., is a $500 million opportunity. And the way we get there is those 1,400 patients, get treated with a TKI, then we use the current pexidartinib pricing, which is just over $20,000 a month, and we think that could be a floor for us. Certainly, they've set up a low floor for what you might be able to price an even better agent at. And we use the imatinib duration of therapy, which we see in claims data is 18 months, versus the 10 months that we see in the claims data today for pexidartinib. And from our phase I study, we saw treatment duration, median being 25 months. So we think there's a good chance to keep these patients on drug for a long period of time. So just that 1,400 incident patient population, we think, is a TAM of $500 million, excluding the prevalent patients, excluding another 1,300 patients we see incident that aren't being seen by an oncologist, but most often by orthopedics and others, as well as the global opportunity in Europe and elsewhere. So we think it's a great fit, for us and a really strong market opportunity. Excellent. So before we talk about, you know, kind of the upcoming milestones as we see it, and maybe I'll ask you to, you know, weigh in on which ones you think are the most important that will drive shareholder value. A question we get from investors is, you know, like, "Hey, the company has a significant burn rate. Revenues are increasing slowly," right? 'Cause you guys got to fourth-market peak penetration very, very quickly. Like, almost right off the bat, everyone was using it. You know, and vimseltinib is likely, you know, going to come in, call it end of next year or later in 2025. How do you bridge that gap to profitability? How are you thinking about partnerships, you know, versus raising capital? Yeah, no, it's, it's a great question. So, you know, we think we're anchored by our business with QINLOCK. We do think we've penetrated well the fourth-line opportunity. We've seen a, you know, a acceleration of the growth rate on the last two quarters. We haven't touched on that today, but what we have seen, when we said on the Q3 call, was in addition to the continued growth in the U.S. and fourth line as well as in Europe, in the U.S., we think we've seen an uptick based on off-label, unpromoted, usage in the second-line, based on either the eleven seventeen data we talked about, or the fact that QINLOCK was included in the NCCN guidelines in March, for second-line for patients who are, intolerant to sunitinib. So again, we don't promote to it, we don't have perfect visibility of the channel, but we saw a significant trend shift, that resulted in the U.S. in quarter-over-quarter growth in Q2 and Q3 that was, significantly above what we'd seen over the last couple of years. So we saw 17% quarter-over-quarter growth in Q2, and another 13% in Q3. So, we have seen a nice trend line, in the base business with QINLOCK, but obviously, we'll really be able to, maximize that opportunity when we have a label that we can promote to, and that'll be on the back of the INSIGHT study. You know, we think we're well capitalized, as I mentioned, and we do think that, you know, Qinlock and vimseltinib, once approved, can be two drugs that will get us to be self-sustaining. Again, we think at peak, we can do $1 billion between those two products. But today, we've got $377 million in cash in Q3. That cash takes us into 2026, so we're not yet guiding that our current resources would get us to break even or profitability. But we are very much on a path toward becoming self-sustaining now with the data out of MOTION, and with an approval and a launch there, we think that really sets us up on a great trajectory toward that. You know, we'll continue, like all biotechs in this market environment, to look at, you know, how to do a couple things. One, continue to manage our resources really well. So we've got a great pipeline we've touched on very briefly, and we know that, right now, our commercial and late-stage products are the ones that get the most investor attention and focus. So we're gonna be really thoughtful about how we continue to invest in our discovery and clinical pipeline, and obviously continue to resource the opportunities for QINLOCK and ripretinib to try and get those, you know, approved and through studies. So, we think we're well-positioned. We think we've got lots of ways to continue to finance the company, and feel good about our position, but, you know, that's certainly one of the challenges of being a company that, you know, is not yet break even or profitable. But we think we're in a great position relative to a lot of development-stage companies, you know, who don't have the QINLOCK revenue to help mitigate the investments we're making elsewhere. And the opportunity in hopefully the not-too-distant future, to have a second product that can really give us a lot of synergy. We haven't really talked about that, but the prescriber base is a big overlap, 70%-80% in the US. So we'll have to make minimal investments really to try and get them commercialized, and that we think provides a lot of upside from our commercial investment that we've made. Excellent. I guess in 30 seconds, these are the milestones, you know, that we have, you know, for you guys, and if I had to pin you down, do you think there's any one that you think is a real, you know, driver of shareholder value or, you know, how do you view these? Yes, I think there's sort of the two big buckets. One is just the continued quarterly revenue results for QINLOCK, and how that continues to to develop over the coming quarters. We we certainly have seen positive momentum based on the last two quarters in terms of the stock reaction and investor enthusiasm around the momentum we have there. So that's certainly one thing as we expand in other countries in Europe and continue to commercialize here in the U.S. And the second thing obviously is, you know, getting the NDA and the MAA filed. So those are obviously key events that I think are are super important for the company's future development, and we really look forward to to having those over the coming quarters. Excellent. Tucker, thank you very much, as always, for your time. Congratulations on all the progress and the positive phase III. Look forward to a productive 2024. Great. Thanks for hosting us today, Ren, thanks all for joining. Take care. Thanks.