Kura Oncology, Inc. Morgan Stanley 24th Annual Global Healthcare Conference
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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 CEO, 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 daralfernib, 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 daralfernib in a phase I-B study in advanced kidney cancer in combination with cabozantinib, and we expect to start a combination of daralfernib and deruxtecan in pancreatic ductal adenocarcinoma next year. Daralfernib, 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 milligram 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.
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