Kura Oncology, Inc. (KURA) September 2026 Conference Transcript

All right. Thank you, everyone, for joining us. My name is Frank Tang, and I'm with the Investment and 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 Folk. 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 Purdue for today. a lot has changed. And for those less familiar with and new to Quora, 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 CONZIFTI, 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 3 trials ongoing in both the intensive chemotherapy and non-intensive chemotherapy settings with Ziftomenib, which is ComZifty we also have trials underway to evaluate Ziftomenib both as a monotherapy and in combination really throughout the treatment continuum them. Behind that, we have darlafarnib, which is our farniciltransferase inhibitor. There again, I think we've seen a lot of progress since we saw you last year. We are evaluating darlafarnib in a phase 1b study in advanced kidney cancer in combination with cabozantinib, and we expect to start a combination of darlafarnib and daroxonrasib in pancreatic ductal adenocarcinoma next year. Darla Farnab, 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 the rest of this year and into next year.

Last year you discussed ComZifti's differentiator profile in 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?

Brian? Absolutely. Thanks, Frank, for the question. Yeah, so as you said, we talked coming into the launch and for some time around kind of 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 to see that.

And then physician-initiated combinations, particularly with venonazone and FLT3 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 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 MEN inhibitors and COMZIFTI in particular in combination with their other standard of care agents. And 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 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. Our physicians make those choices, and from a FLT3 perspective, which is you may remember FLT3 mutations occur, 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 quazartinib. So we're building the data set to support the physician's decision.

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 NPM1 population, which is, as we said, about 30% of the overall relapse 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 move forward because we think that's the best way to use ComZifti when we're treating those patients given the profile of ComZifti. We think that our, I've had some conversations with some physicians recently that have told us the reason they're so excited about ComZifti and using Ziptometib 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 the good tolerability that oftentimes, and 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. 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 Commodore 1-7 studies, that we'll be able to use the relapse 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.

Just to add to that, Frank, I mean, the total addressable market in the frontline is about 20 times what it is in the relapse refractory setting. So I think what we're enthusiastic about is we're taking market leadership. 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 1Bs. This is all really giving physicians and patients experience as we work toward those significantly larger front-line indications.

Last year, you walked us through the two phase three designs in front-line. 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 2018?

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-intensive 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, CR, 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 I-B 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 a 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 I-B study. Importantly, we're running the largest Phase I-Bs. 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 3s, and everyone involved is very, very focused on enrolling those studies and hopefully we have positive top-line results in 2018.

Congrats on what you've shown at EHA and the de-risking that it reached due to over 17. What other front-line combination data should investors be watching for the second half of this year?

Yeah, I would say... So we showed the front-line 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% to 55%. So you have 94% with the triplet versus 44% to 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 men ineligible in front lines, about half of AML. If you can keep them on for 18 months, You're talking about a $7 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 Ziftomenib, 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 Ziftomenib and Quisartinib 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 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, and important update for the field, for men and inhibitors, and for what we might be able to do for that very significant patient population.

So that's 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 Zifdomenib 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. Kieran 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 Dalek Varnib and FTI?

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. Let's take the kidney cancer side of the house first. You have immune, you have checkpoint inhibitors, you have tyrosine kinase inhibitors, and you have HIF2-alpha. And we're seeing, you know, many, many combinations of those throughout the treatment continuum. The challenge is, you know, 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 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 Darlafarnib plus Cabozantinib. And long story short, Darlafarnib 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 Darlafarnam 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 Darla Farnib helps to fill that need. We have an ongoing Phase I-B that's intended to select a dose of Darla Farnib 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-Darly? 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 triplet perhaps with checkpoint inhibitor? We're working all that through now. Fortunately, Darlie is 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 Daroxon Resib, 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 Darlaferna with Adagrasib 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 Adagrasib alone has been reported to have about a 30% response rate. The combination with Darlafarnib, 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 adagrassib. 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 deroxonrasib? But there's really only a couple of approaches, our farniciltransferase inhibitor and maybe the PRMT5s, that actually augment the clinical activity of Darrox 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 Darrox on Recib alone. That's a very significant opportunity. I think in addition, Frank, we could take either Darrox or other RAS inhibitors into other places. You 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 colorectal, for example, along with what I described in kidney cancer, you've got a very significant franchise coming along and, importantly, will 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. 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. Congratulations. Thank you. The relationship is the Kura River empties into the Caspian Sea, so it sort of continues our aquatic theme. Um, uh, Caspian is focused on the development of menin inhibitors in diabetes and metabolic disease. Um, and we have, we, Cura, Caspian have upcoming data at the EASB meeting in Milan at the end of September. And what you'll see there is, uh, we've done a lot of proof of concept studies with Zipto meninib, just to show that there's a there there with menin inhibitors. But Caspian 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 I, Phase I, 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 and GLP-1 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 investor. 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. um it's we've we've separated it into caspian because it allows us to to focus to recruit more resources and to recruit a team that has experience in uh endocrinology and metabolic disease rob spencer is the president and chief operating officer and there will be additional hires to come so it's uh i think it's a it's a 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 Caspian is successful, the intent is that the employees and the shareholders of Cura will benefit.

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 28. 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've also, you know, just to separate for Darlie Farnib, separate the two things. So one is the work that we're 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'll look at next year. You know, 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.

It's a 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 in the commercial setting with menin inhibitors. There's 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 a combination. That's important because those are proof points. Not everything thing we do with Ziftamenib will be in a registration-directed setting. As Brian was saying, you know, 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 Darlafarnib PDAC study. We'll give an update on Darlafarnib 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 3s are enrolling as expected. At this point, it's really trying to drive Zift Amenib 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 Zifto. I think if we're successful in Kidney and PDAC with Darley, you're probably in that same zip code. Not a lot of companies that have the potential to drive $6-plus billion in peak sales. And we're 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's looking for an edge in KRAS. 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 Darlafarnib 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's a lot of good stuff coming rest of this year and on into next year. Before we know it, we'll 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. Thank you for joining us today.

Our pleasure.

Thanks, Frank.