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All right. Thank you, everyone, for joining us. My name is Frank Tang, and I'm with the Investment Banking Division at Morgan Stanley. Thank you all for joining us today for the Fireside Chat with Cura Oncology. I am joined today by Chair and CEO Troy Wilson, Chief Commercial Officer Brian Powell, and Chief Financial Officer Jennifer Falk. Welcome, and great to have you all here today at our conference again. well we sat down last year Troy we were we were talking ahead of your Purdue for Day a lot has changed and for those less familiar with and new to Cora can you give us an overview of where the company sits today as a commercial stage business your pipeline and your priorities heading into the rest of 2026 and 2027 sure yeah and thank you Frank to you and the Morgan Stanley team for the invitation so it's been a year what a difference a year makes We are now a fully integrated research, development, and commercial company. In the last quarter, we announced our second full quarter of sales for ComZifty, which is our menin inhibitor approved in relapsed refractory NPM1 mutant AML. We were really pleased to say that we took leadership of new patient starts in our second full quarter. That's pretty unusual. we continue to push the launch and we have a large development program behind that initial approved indication we have two phase three trials ongoing in both the intensive chemotherapy and non-intensive chemotherapy settings with Ziftimenib which is ComZifty we also have trials underway to evaluate Ziftamenib with both as a monotherapy and in combination really throughout the treatment continuum them. Behind that, we have Darlafarnib, which is our farnesyl transferase inhibitor. There again, I think we've seen a lot of progress since we saw you last year. We are evaluating Darlafarib in a phase 1b study in advanced kidney cancer in combination with cabozantinib, and we expect to start a combination of Darlafrnib and daroxanracib in pancreatic ductal adenocarcinoma next year. Darla Farnab is the way that we describe it is it's a therapeutic target and a molecule that really augments a lot of other targeted therapies so we've got now two big drivers in the business we're well capitalized and a lot of exciting things to come rest of this year and into next year that's great last year you discussed ComZifty's differentiator profile and the abstract. Now that you've launched and you've generated 9 million sales and net product revenue in only your second quarter, and like you said, capturing the majority of new patients, what's driving that share capture and how durable do you think it is? Yeah, Brian? Yeah, absolutely. Thanks, Frank, for the question. Yeah, so as you said we talked coming into the launch and for some time around the four pillars that we saw that differentiate ComZifty from other competitors on the market, and those are the efficacy, the safety, tolerability, the combinability and compatibility with other agents, and the simplicity of a once-daily 600-milligram dosing. That's what we're actually hearing back from physicians now, that essentially ComZifty has more simplicity to use and has just become, we've seen quickly, the preferred agent. We talked about, as you said, $9.1 million in net revenue. We also had 115 new patient starts, 250 total prescriptions. And all of those metrics, which we think the new patient starts is kind of the leading indicator, but they're all growing in the right direction. And we expect to see that to continue. So we're very pleased with where we are now, and we expect us to continue to grow over time. Great. And then physician-initiated combinations, particularly with Vena and AZA and then for three inhibitors are already running 40-ish percent of new patient starts, even though you're only promoting monotherapy on the label, how do you read into that signal? What does that tell you about how the market is trending? Yeah, I think that that early signal, especially the combination, is a proof point that we've talked about, I take, that talks about the combinability and the ease of use. Physicians have told us, well, of course, we're promoting to the label as a monotherapy. Physicians have told us that they want to be able to use MEN inhibitors and COM-50 in particular in combination with their other standard of care agents. And we know that they're going to be trying to follow, you know, data on that. Our goal has been to present data and publish data to help to support their decision-making. We presented the Ven-Aza combination in the relapse refractory setting was published in Blood back in May of this year, which we think is also going to help patients or physicians make those choices. And from a FLT3 perspective, which, as you may remember, FLT 3 mutations occur, comutations with NPM1 occur about half of those NPM 1 patients. So it's about 30% of the population is NPM 2 mutant. Half of those are FLT 2, and we're going to be presenting data coming up later this year on combinations both with giltaritinib and quisartinib. So we're building the data set to support the physician's decision on that going forward. As you speak about that, the broad AML space remains large and competitive. Could you update us on how Zipto is now positioned relative to other competitors across MML refractory and NPM1 immune setting? Sure, sure. So as you know, our approval is in the NPM 1 population, which is, we said, about 30% of the overall relapsed refractory setting. We have a competitor on the market that also has an indication within the CAMT2A population. That is an area that we're pursuing in combinations, in our combination strategy that we've moved forward, because we think that's the best way to use COM-SIFTI when we're treating those patients, given the profile of COM-СИФТИ. We think that our I've had some conversations with some physicians recently that have told us the reason they're so excited about ComZifty and using Ziptomenib in multiple combinations and being able to build this essentially for moving into the front line is that it's rare that they've seen an agent that has the clinical activity with a good tolerability that oftentimes, and of course we know patients have side effects and leukemia, but they say it's It's such a well-tolerated agent that they want to be able to use it in the combinations as best they see fit. So our data generation strategy in the relapse refractory setting is going to support that. But we also think that as we move into the frontline settings with our COMET-017 studies that we'll be able use the relapsed refractory space as kind of a leading indicator for future success in that frontline opportunity, which has a much greater impact on patient outcomes and obviously our revenue as well. Yeah, just to add to that, Frank, I mean, the total addressable market in the front line is about 20 times what it is in the relapsed refractory setting. So I think what we're enthusiastic about is we're taking market leadership, right? We were second to market. We've taken market leadership in our approved indication. As Brian said, we have, we think, a superior agent in terms of tolerability, combinations, combinability of standard of care. That allows physicians to drive efficacy. You're also seeing that pull through in the frontline data that we're showing from the ongoing Phase 1Bs. This is all really giving physicians and patients experience as we work toward those significantly larger frontline indications. Speaking of that, last year you walked us through the two Phase III designs in Frontline. Where does COMET-017 enrollment stand today across the U.S. and worldwide, and how do you view the bar for success for your top-line data in 28? Sure. So there are – we have two trials ongoing under a single protocol. You referenced it as COMET-017. It has an intensive chemotherapy, randomized phase three, and it has a non-intensive chemotherapy, phase three. We put them together to make it easier for patients, for sites, and for physicians. So when a patient presents at a clinical site, the physician and the care team can decide, do I put them on the intensive or the non-intense regimen? We've found that really works well with the sites, And enrollment is right where we would expect it to be. It's right in line with our projections. We have guided to initial top-line results in the intensive chemotherapy combination in 2028. In terms of the bar, in intensive chemotherapy, we have both an endpoint that we think is appropriate for accelerated approval and then a survival-based endpoint for full approval. So the accelerated approval endpoint is an endpoint called negative measurable residual disease at complete response, MRD negative CR. The bogey there is about 44%. That's what chemotherapy will give you as measured in bone marrow. The data that we presented at the European Hematology Association meeting in June from the Phase 1B says we're running at about 59%. 55 to 59, that's clinically meaningful. That's 20% greater than what chemo would give you alone. We also then have an event-free survival-based endpoint, which would come later. On the non-intensive side, the accelerated endpoint is complete response. You would expect a CR rate for venasa being about 60%. We'd like to do better than that. Again, clinically meaningfully better than that 70% or more. And as Brian mentioned, we'll show data at the American Society of Hematology meeting, we hope later this year, where we give you an update on the ongoing Phase 1b study. Importantly, you know, we're running the largest Phase 1bs. Those are the trials that have informed the design and the execution of the Phase 3s. We have more than 200 patients that we've treated across those different regimens, that's given us a lot of confidence in terms of are we seeing the right patients, are we getting them on study, what to expect. So I think that's gone a long way toward de-risking those two phase threes, and, you know, everyone involved is very, very focused on enrolling those studies, and hopefully, you know, we have positive top-line results in 28. Yeah. Congrats on what you've shown at IHA and the de-risking that it leads to in 2017. What other frontline combination data should investors be watching for for the second half of this year? Yeah, I would say, so we showed the frontline intensive chemotherapy data at Iha in Sweden. Let me just spend a moment on that, because I think there's a development and a commercial consideration. From a development perspective, the OS rate at 12 months in that Phase 1B study was 94%. How do we think about that? What chemo alone would deliver in a 60-year and older population is about 45% to 55%. So you have 94% with the triplet versus 44% to 54%. So that's a good sign that you're driving clinical benefit for patients. Equally importantly, you have patients who are staying on 12, 18, 24 months. And that really speaks to the commercial opportunity and the total addressable market in the front line. There are about 11,000 patients, we think, who are MEN ineligible in front lines, about half of AML. If you can keep them on for 18 months, you're talking about a $7 billion to $10 billion market opportunity. So I think everything's tracking in the right direction. Now, to your question, we have the counterpart study, which is ziftamenib, venetoclax, and azacitidine, that frontline phase 1B. Hopefully, you'll see that later this year. The other frontline trial, Frank, that I would point people to is the one Brian mentioned, and that is ziptamenib and quazartinib in combination with intensive chemo in the NPM1 FLT3 commutated population. And as Brian said, the reason that's significant is 50% of your NPM1 patients have a FLT3 commutation. We've seen a lot of interest from clinicians to combine those two targeted therapies, a MENIN inhibitor and a FLTT3 inhibitor. The competitors in this space have not yet shown data that they can successfully combine with FLT2 inhibitors, so this will be, I think, an important update for the field for menin inhibitors and for what we might be able to do for that very significant patient population. That's great. That's a helpful data set to provide physicians. Next, could you refresh us on your cure-curing partnership, how the development and U.S. commercialized responsibilities are divided and how the economics affect you? Sure. Jennifer? Yeah, so we've had this partnership for a couple of years now, And at a high level, Cura maintains development decision-making rights, and we share kind of the profits 50-50. We anticipate, through the development of ZyftoMinib, from here to top-line results, about $180 million of milestones. So within the U.S., we retain decision- making rights on development and commercial and then worldwide. Karen leads development, and we share in the profitability there. Great. Thank you for the overview. Moving on a little bit to the rest of your pipeline, last year we were talking about your early FDI program. Today we can describe it as a second wholly owned franchise. Could you give us an overview of RCC, KRAS G12C data, and near-term readouts, and what investors should be watching for on Darla Farnib and FDI? Yeah, thanks for that. So maybe let's start with why should anybody care, right? As in leukemia, in solid tumors, increasingly you see a push toward combination use and toward earlier lines of therapy. If you want to drive the best outcome for patients, it's unusual in these tumor types, kidney cancer and KRAS-driven tumors, monotherapy is not going to get you there. People, let's take the kidney cancer side of the house first. You have checkpoint inhibitors, you have tyrosine kinase inhibitors and you have HIF-2-alpha. And we're seeing many, many combinations of those throughout the treatment continuum. The challenge is we're still not curing patients. And so what we've heard is there's a desire for new mechanisms of action. There's a design in particular for mechanisms of actions that can augment those individual components. We showed data at both IKCS and KCRS this summer, which is darlafarnib plus cabozantinib. And long story short, darlafarlib can augment the activity of cabozantonib in patients whose disease has progressed on Cabo. It can also augment activity of patients who are naive to Cabo, So Cabo remains the largest tyrosine kinase inhibitor by market share. It's the leader. It is the backbone of a number of regimens. Our intent is to show that darlofarnam can make it better. That's attractive to clinicians because there is likely to be a tyrosINE kinase inhibitor at some point in the treatment journey, and we're now at a point where if a patient's disease has failed those three therapies, physicians say, well, what am I going to do? and I think Darlifarnib helps to fill that need. We have an ongoing Phase 1b that's intended to select a dose of Darlfarnib and to really help solidify that we're driving a clinical advantage over Cabo alone. With that data, that data is expected. We'll give a data update probably second half of next year. Then we can decide where do we go. Do we go forward as the doublet, Cabo, Darlie, and if so, is it second-line or third-line kidney, and probably in parallel, do we consider a triplet? A triplet with HIF-2-alpha, a triplete perhaps with checkpoint inhibitor. You know, we're working all that through now. Fortunately, Darlie's very combinable, very easy to use. You know I think we have a lot of confidence. On the KRAS side, you know, sort of a different setup but the same theme. We've now seen Derox on Recib get approval and second-line PDAC, standing ovation at ASCO, well-deserved. That's the good news. The bad news is the median overall survival is still 13 months for pancreatic cancer patients. We think we can do better. We did a proof-of-concept study combining Darlaferna with Atagracib in a selected population. This was the so-called KRAS G12C mutant population. And what we saw was an increased response rate, better durability in lung, in colorectal, and in pancreatic patients. In particular, the pancreatIC data was interesting because adagracib alone has been reported to have about a 30% response rate. The combination with darlofarnib, admittedly, it's small numbers, but we had 67% response rate. And that's what you would expect from the mechanism. So now what we're doing is saying, okay, we've learned that we can combine using adagrasib. Let's now apply it to the newly approved deroxonrasib, and it's attractive to clinicians because, again, it's something that no one else is doing. People are bringing other RAS inhibitors forward and saying, how can we do better than deroxanrasib? But there's really only a couple of approaches, our farnesyl transferase inhibitor and maybe the PRMT5s that actually augment the clinical activity of Derox on Recib. So we're planning on starting a study in second-line PDAC next year. The hope would be that you can drive better clinical benefit than DeroX on ReCib alone. That's a very significant opportunity. I think, in addition, Frank, we could take either Deroxx or other RAS inhibitors into other places. It could go into colorectal or into lung. We can't do everything. We won't even try. I think if we can drive value in a couple of key areas, pancreatic and colorextal, for example, along with what I described in kidney cancer, you've got a very significant franchise coming along and, importantly, we'll be in a position to make later stage development decisions right around the time we're getting top-line readouts on the AML program. So from a company-building perspective, the two programs fit quite nicely together. Yeah, and it's great to see you guys continue to proceed with the combination strategy that you've been so successful with with Zipto as well. Yeah. And you've also continued to advance your next-generation menin inhibitor, particularly in diabetes and cardiometabolic diseases. Could you update us on your new co-strategy announcement? Sure, yeah. so again a lot has changed we announced last week the successful formation and financing of a new company called Caspian therapeutics thank you the relationship is the Kura River empties into the Caspians sea so it's sort of a continues that continues our aquatic theme Caspia is focused on the development of menin inhibitors in diabetes and metabolic disease. And we have, we, Cura, Caspian have upcoming data at the EASD meeting in Milan at the end of September. And what you'll see there is, we've done a lot of proof of concept studies with Ziftomenib just to show that there's a there there with menin exhibitors. But Caspin is starting with a brand new menin inhibitor. It's a new development candidate, a compound called 7246, and it was purpose-built for metabolic disease. So the pharmaceutical properties, the profile looks a little different than Ziftomenib and the other menin inhibitors in oncology. And we are going to at Caspian take it through a phase one, phase one 1A, 1B study, probably SADMAD, in both healthy volunteers and patients with diabetes, there's an opportunity in type 2. There's an opportunity in Type 1. There are other metabolic indications where either menin or menin NGLP1 could be quite significant. We helped to pull the syndicate together that included BVF, Invis, Montanova. Eli Lilly is an investor. The T1D Fund is an investigator. So, we're building an all-star team at Caspian to now really continue the journey and see what can menin inhibitors do for patients with diabetes and metabolic disease. We've separated it into Caspia because it allows us to focus, to recruit more resources, and to recruit a team that has experience in endocrinology and metabolic disease. Rob Spencer is the president and chief operating officer, and there will be additional hires to come. So I think we've gotten a lot of compliments that it's kind of a creative way to keep moving assets forward. Cura shareholders own approximately 50% of Caspian, so if Caspbian is successful, the intent is that the employees and the shareholders of Cura will benefit. That's great. Congratulations on that. Maybe moving over to the corporate side, you ended the quarter with significant cash, $519 million, and you guys have guided that roughly $180 million of anticipated milestones to come will fund AML programs through the first Comet 017 top line in 2008. Could you give us an overview of that runway and the balance, and what else does it cover? Jennifer? Yeah, so that remains true. We've got cash runway we've talked about through top line results in 2028 for Zifto-Menib, as well as funding the additional data sets that Troy and Brian were talking about that we're working on now. We have also, you know, just to separate for Darley Farnib, separate the two things. So one is the work that we are doing now both in kidney cancer and the additional look that we'll do in PDAC. We'll separate that from additional registration work that we will look at next year. Our intent is to leverage the data to look at those opportunities that are most value and retain the strategic flexibility to pursue those value opportunities. Strong balance sheet in this environment. Super helpful. Never have enough cash. that's all the questions I had on the main topics to close out maybe I would love for you guys to leave us with the most important milestones and updates that you would like investors to focus on for the rest of the year and for the next 12 months yeah thanks for that I would say continue to look at the launch I cannot say enough good things about our commercial team their execution the ability to continue to drive leadership in the commercial setting with MEN and inhibitors. There's a lot of data coming out. We have four presentations that we expect here in the fourth quarter with Zift-Amenib both as a monotherapy and a combination. That's important because those are proof points. Not everything we do with Zifta-Menib will be in a registration-directed setting. As Brian was saying, what we're hearing from clinicians is, just show us data that it's safe, it's well-tolerated, and it can drive better outcomes for patients. So we're going to continue to put that out. We're going places that I don't think our competitors can or are going, such as FLT3 combinations. As we look to next year, we will start the Darla Farnib PDAC study. We'll give an update on Darla Farinib and cabozantinib in kidney cancer. You'll also see, Frank, milestone payments, as Jennifer mentioned, that are getting paid, and those are tied to enrollment goals in the ongoing Phase 3s. So that's probably your best biomarker, that the Phase 3's are enrolling as expected. At this point, it's really, you know, trying to drive Ziftimenib as quickly as possible to take leadership in frontline AML and then to position Darla Farnib right behind it to be able, as Jennifer said, to make larger registration-directed decisions probably late next year or early 28. It'll be good timing. We've got $3 billion in peak sales that we've projected for Zipto. I think if we're successful in Kidney and PDAC with Darla, you're probably in that same zip code. Not a lot of companies that have the potential to drive six plus billion in peak sales, and we're clearly best in class on Mennon. We are only in class on FTIs, which is a good place to be because everybody wants to be in KRAS, right? Everybody's looking for an edge in KRS. We can potentially make all of those KRAS inhibitors better. We're not going to do everything with our balance sheet, but we're going to position it such that it's clear Darla Farnham can add value, you know, throughout the treatment continuum. We intend to keep the company well capitalized and just continue to execute on, you know, what we set out to do, research, development, commercial. You know, there's a lot of good stuff coming rest of this year and on into next year. And before we know it, we'll be, you know, we will have those top line results in AML. Congrats on all the progress and a lot of exciting news coming up in the next 12 to 18 months. Great. Thank you. Thank you for joining us today. Our pleasure. Thanks, Frank. Thank you, Frank, and thank you, Dr. Kahn.