All right. Thank you everyone for joining us. My name is Frank Tang, and I am with the investment banking division at Morgan Stanley. Thank you all for joining us today for the fireside chat with Kura Oncology. I am joined today by Chair and Chief Executive Officer, Troy Wilson, Chief Commercial Officer, Brian Powl, and Chief Financial Officer, Jennifer Fulk. Welcome, and great to have you all here today at our conference again. When we sat down last year, Troy, we were talking ahead of your Kura LIVE Day. A lot has changed, and for those less familiar with and new to Kura, 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 has 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 KOMZIFTI, 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 is pretty unusual. We continue to push the launch, and we have a large development program behind that initial approved indication. We have two phase III trials ongoing in both the intensive chemotherapy and non-intensive chemotherapy settings with ziftomenib, which is KOMZIFTI. We also have trials underway to evaluate ziftomenib both as a monotherapy and in combination, really throughout the treatment continuum. Behind that, we have darlifarnib, which is our farnesyl transferase inhibitor. There again, I think we have seen a lot of progress since we saw you last year. We are evaluating darlifarnib in a phase I-B study in advanced kidney cancer in combination with cabozantinib, and we expect to start a combination of darlifarnib and deruxtecan in pancreatic ductal adenocarcinoma next year. Darlifarnib, the way that we describe it is it is a therapeutic target and a molecule that really augments a lot of other targeted therapies. So we have got now two big drivers in the business. We are well-capitalized and a lot of exciting things to come rest of this year and into next year. That is great. Last year you discussed KOMZIFTI's differentiated profile in the abstract. Now that you have launched and you have generated $9 million of sales and net product revenue in only your second quarter, and like you said, capturing the majority of new patients, what is driving that share capture, and how durable do you think it is? Yeah. Brian? Yeah, absolutely. Thanks, Frank, for the question. Yeah. As you said, we talked, coming into the launch, and for some time around the four pillars that we saw that differentiate KOMZIFTI 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 mg dosing. That's what we're actually hearing back from physicians now that essentially, KOMZIFTI has more simplicity to use, and it's just going to become, we've seen, quickly the preferred agent. We talked about, as you said, that $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 the leading indicator, but they're all growing in the right direction, and we could expect to see that to continue. We're very pleased with where we are now, and we expect to see that continue to grow over time. Great. Physician-initiated combinations, particularly with venetoclax and azacitidine and then FLT3 inhibitors are already running 40%-ish on 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's trending? Yeah, I think that early signal, especially the combination, is a proof point that we've talked about. I think that talks about the combinability and the ease of use. Physicians have told us, while of course we're promoting to the label as a monotherapy, physicians have told us that they want to be able to use menin inhibitors and KOMZIFTI in particular, in combination with their other standard of care agents. We know that they're going to be trying to follow data on that. Our goal has been to present data and publish data to help to support their decision-making. We presented the venetoclax and azacitidine combination, and the relapsed refractory setting was published in Blood back in May of this year, which we think is also going to help physicians make those choices. From a FLT3 perspective, which as you may remember, FLT3 co-mutations with NPM1 occur about half of those NPM1 patients. So it's about 30% of the population is NPM1 mutant. Half of those are FLT3, and we're going to be presenting data coming up later this year on combinations both with gilteritinib and quizartinib. So we're building the data set to support the physician's decision on that going forward. Yeah. As you speak about that, the broad AML space remains large and competitive. Could you update us on how ziftomenib is now positioned relative to other competitors across AML refractory and NPM1 mutant settings? Sure. As you know, our approval is in the NPM1 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 KMT2A population. That is an area that we're pursuing in combinations, in our combination strategy that we moved forward, because we think that's the best way to use KOMZIFTI when we're treating those patients, given the profile of KOMZIFTI. I've had some conversations with some physicians recently that have told us the reason they're so excited about KOMZIFTI, and using ziftomenib in multiple combinations and being able to build this essentially for the moving into the frontline, is that it's rare that they've seen an agent that has the clinical activity with a good tolerability that oftentimes. Of course, we know patients have side effects in leukemia, but they say it's such a well-tolerated agent that they want to be able to use it in the combinations as best they see fit. Our data generation strategy in the relapsed refractory setting is going to support that. But we also think that as we move into the frontline settings with our KOMET-017 studies, that we'll be able to 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. Okay. Just to add to that, Frank, the total addressable market in the frontline is about 20 times what it is in the relapsed refractory setting. 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 with 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 I-B's. 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 KOMET-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 2028? Sure. We have two trials ongoing under a single protocol. You referenced it as KOMET-017. It has an intensive chemotherapy randomized phase III, and it has a non-intensive chemotherapy phase III. We put them together to make it easier for patients, for sites, and for physicians. 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-intensive regimen? We found that really works well with the sites, and enrollment is right where we would expect it to be. It is 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. 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 is 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 I-B says we are running at about 59%, 55%- 59%. That is clinically meaningful. That is 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 venetoclax and azacitidine being about 60%. We would like to do better than that. Again, clinically meaningfully better than that, 70% or more. As Brian mentioned, we will show data at the American Society of Hematology meeting, we hope later this year, where we give you an update on the ongoing phase I-B study. Importantly, we are running the largest phase I-Bs. Those are the trials that have informed the design and the execution of the phase IIIs. We have more than 200 patients that we have treated across those different regimens. That has given us a lot of confidence in terms of, are we seeing the right patients? Are we getting them on study? What to expect? I think that has gone a long way toward de-risking those two phase IIIs, and everyone involved is very focused on enrolling those studies, and hopefully, we have positive top-line results in 2028. Yeah. Congrats on what you've shown at EHA and the de-risking that it reads through to KOMET-017. What other frontline combination data should investors be watching for the second half of this year? Yeah, I would say, we showed the frontline-intensive chemotherapy data at EHA 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 I-B study was 94%. How do we think about that? What chemo alone would deliver in a 60 year and older population is about 45%-55%. So you have 94% with the triplet versus 44%-55%. 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 menin eligible in front lines, about half of AML. If you can keep them on for 18 months, you're talking about a $7 billion-$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 ziftomenib, venetoclax, and azacitidine, that front-line phase I-B. Hopefully, you'll see that later this year. The other front-line trial, Frank, that I would point people to is the one Brian mentioned, and that is ziftomenib and quizartinib in combination with intensive chemo in the NPM1 FLT3 co-mutated population. As Brian said, the reason that's significant is 50% of your NPM1 patients have a FLT3 co-mutation. We've seen a lot of interest from clinicians to combine those two targeted therapies, a menin inhibitor and a FLT3 inhibitor. The competitors in the space have not yet shown data that they can successfully combine with FLT3 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 Kura/Kirin partnership, how the development and U.S. commercial responsibilities are divided, and how the economics affect you? Sure. Jennifer? Yeah. We've had this partnership for a couple of years now, and at a high level, Kura maintains development decision-making rights, and we share the profits 50/50. We anticipate, through the development of ziftomenib, from here to top-line results, about $180 million of milestones. Within the U.S., we retain decision-making rights on development and commercial, and then worldwide. Kirin 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 FTI 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 darlifarnib and FTI? Yeah. Thanks for that. Maybe let's start with why should anybody care, right? 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. Let's take the kidney cancer side of the house first. You have checkpoint inhibitors, you have tyrosine kinase inhibitors, and you have HIF-2α. We're seeing many combinations of those throughout the treatment continuum. The challenge is we're still not curing patients. What we've heard is there's a desire for new mechanisms of action. There's a desire, in particular, for mechanisms of action that can augment those individual components. We showed data at both IKCS and KCRS this summer, which is darlifarnib plus cabozantinib. Long story short, darlifarnib can augment the activity of cabozantinib in patients whose disease has progressed on cabo. It can also augment activity of patients who are naive to cabo. 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 darlifarnib 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?" I think darlifarnib helps to fill that need. We have an ongoing phase I-B that's intended to select a dose of darlifarnib 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/darali, and if so, is it second-line or third-line kidney? Probably in parallel, do we consider a triplet? A triplet with HIF-2α, a triplet perhaps with checkpoint inhibitor. We're working all that through now. Fortunately, darali's very combinable, very easy to use. I think we have a lot of confidence. On the KRAS side, sort of a different setup but the same theme. We've now seen adagrasib get approval in 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 darlifarnib with adagrasib in a selected population. This was the so-called KRAS G12C mutant population. 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 adagrasib alone has been reported to have about a 30% response rate. The combination with darlifarnib, admittedly, it's small numbers, but we had 67% response rate. That's what you would expect from the mechanism. 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 adagrasib." 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 adagrasib?" There's really only a couple of approaches. Our farnesyl transferase inhibitor and maybe the PRMT5s that actually augment the clinical activity of adagrasib. 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 deruxtecan alone. That's a very significant opportunity. I think in addition, Frank, we could take either deruxtecan or other RAS inhibitors into other places. You could go into colorectal or into lung where 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 colorectal, 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. From a company building perspective, the two programs fit quite nicely together. Yeah. It's great to see you guys continue to proceed with the combination strategy that you've been so successful with ziftomenib as well. Yeah. 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. Again, a lot has changed. We announced last week, the successful formation and financing of a new company called Caspian Therapeutics. Congratulations. Thank you. The relationship is, the Kura River empties into the Caspian Sea, so it continues our aquatic theme. Caspian is focused on the development of menin inhibitors in diabetes and metabolic disease. We, Kura Caspian, have upcoming data at the EASD meeting in Milan at the end of September. What you will see there is, we have done a lot of proof-of-concept studies with ziftomenib, just to show that there is a there there with menin inhibitors. Caspian is starting with a brand-new menin inhibitor. It is a new development candidate, a compound called KO-7246, and it was purpose-built for metabolic disease. The pharmaceutical properties, the profile looks a little different than ziftomenib and the other menin inhibitors in oncology. We are going to, at Caspian, take it through a phase I-A, I-B study, probably SAD/MAD in both healthy volunteers and patients with diabetes. There is an opportunity in Type 2, there is an opportunity in Type 1. There are other metabolic indications where either menin or menin and GLP-1 could be quite significant. We helped to pull the syndicate together that included BVF, Invus, Montanova. Eli Lilly and Company is an investor, the T1D Fund is an investor. We are 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 have separated it into Caspian 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. I think we have gotten a lot of compliments that it is a creative way to keep moving assets forward. Kura shareholders own approximately 50% of Caspian, so if Caspian is successful, the intent is that the employees and the shareholders of Kura will benefit. That is great. Yeah. 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 will fund AML programs through the first KOMET-017 top line in 2028. Could you give us an overview of that runway and the balance, and what else does it cover? Yeah, Jennifer? Yeah. So, that remains true. We've got cash runway we've talked about through top-line results, in 2028 for ziftomenib, as well as funding the additional data sets that Troy and Brian were talking about that we're working on now. Just to separate for darlifarnib, separate the two things. So one is the work that we're doing now, both in kidney cancer, and an additional look that we'll do in PDAC. We'll separate that from additional registration work that we'll 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. A strong balance sheet in this environment- Yeah Super helpful. Never have enough cash. That is 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, right? I cannot say enough good things about our commercial team, their execution, the ability to continue to drive leadership in the commercial setting with menin inhibitors. There is a lot of data coming out. We have four presentations that we expect here in the fourth quarter with ziftomenib, both as a monotherapy and in combination. That is important because those are proof points. Not everything we do with ziftomenib will be in a registration-directed setting. As Brian Powl was saying, what we are hearing from clinicians is, "Just show us data that it is safe, it is well-tolerated, and it can drive better outcomes for patients." So we are going to continue to put that out. We are going places that I do not think our competitors can or are going, such as FLT3 combinations. As we look to next year, we will start the darlifarnib PDAC study. We will give an update on darlifarnib and cabozantinib in kidney cancer. You will also see, Frank, milestone payments, as Jennifer mentioned, that are getting paid, and those are tied to enrollment goals in the ongoing phase IIIs. That is probably your best biomarker that the phase IIIs are enrolling as expected. At this point, it is really trying to drive ziftomenib as quickly as possible to take leadership in frontline AML and then to position darlifarnib right behind it to be able, as Jennifer said, to make larger registration-directed decisions probably late next year or early 2028. It will be good timing. We have $3 billion in peak sales that we have projected for ziftomenib. I think if we are successful in kidney and PDAC with darlifarnib, you are probably in that same zip code. Not a lot of companies that have the potential to drive $6+ billion in peak sales, and we are clearly best in class on menin. We are only in class on FTIs which is a good place to be because everybody wants to be in KRAS, right? Everybody is looking for an edge in KRAS. We can potentially make all of those KRAS inhibitors better. We are not going to do everything with our balance sheet, but we are going to position it such that it is clear darlifarnib can add value throughout the treatment continuum. We intend to keep the company well-capitalized and just continue to execute on what we set out to do, research, development, commercial. There is a lot of good stuff coming rest of this year and on into next year, and before we know it, 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- 18 months. Great. Thank you. Thank you for joining us today. Thank you. Our pleasure. Thanks, Frank.