Kura Oncology, Inc. Wells Fargo 21st Annual Healthcare Conference

Sure. Yeah, and thank you, and apologies for the delay. We're trying to get down on the elevators. Kura has two major pillars to our business. On one side, we have our product for acute leukemia, ziftomenib or KOMZIFTI. As you said, we're off to a very strong launch in the initial relapsed/refractory NPM1 mutant setting. We have a number of data catalysts coming here in the second half of the year, both as monotherapy and in combination, in frontline and in later lines. We have two large randomized phase III studies underway, and if those are positive, and we've guided to initial top-line results in 2028, we think that could unlock a multibillion-dollar opportunity. So that's the acute leukemia side. On the other side of the house, we have darlifarnib. Darlifarnib is a farnesyltransferase inhibitor.

We have shown data with it in combination with both cabozantinib in kidney cancer, as well as adagrasib in KRAS G12C mutated solid tumors. We're doing a sort of a two-prong strategy. We're moving it forward in kidney cancer. We're in a phase I-B study with cabozantinib. We think that could open up opportunities in the second or third line in kidney cancer, either as the doublet or potentially as a triplet. We also expect to begin dosing next year patients with daraxonrasib, recently approved in pancreatic ductal adenocarcinoma and darlifarnib, looking really to extend what we've done so effectively with adagrasib, but now do that with the approved standard of care. The easy way to think about darlifarnib is darlifarnib is an agent that makes targeted therapies much better.

We should see phase I data leading up to potential registrational studies right around the time that the AML studies we're beginning to get the results from those phase IIIs. So it's a nice setup between the two sides. We had $518 million in cash as of our last quarterly update. We expect $180 million in additional milestones from our partners, Kyowa Kirin, tied to ziftomenib development. The company is in a strong capital position, and we think we could develop two potential blockbusters, one in liquid tumors, one in solid tumors, which should position us really well the rest of this year, next year, and on into 2028.

Yeah, absolutely. Thank you. We reported in the second quarter that we had $9.1 million in net revenue. That was in our second full quarter of launch. That was a growth of about 57% quarter-over-quarter, where we had $5.8 million in that first full quarter in Q1. We also had an increase in new patient starts. We had 115 new patient starts, about 250 total prescriptions in the quarter. The new patient starts to us is really the story when you're coming into a launch because that really signals where market leadership may be possible and how we've been able to achieve that. So in this last quarter, we achieved the majority share of new patients that started in the NPM1 mutant population. We expect to see that to grow.

I think the reasons why we have those expectations is that the profile of KOMZIFTI is something that has been resonating with physicians, with payers, with pharmacists, that KOMZIFTI is viewed as the differentiated menin inhibitor based on its efficacy, its safety and tolerability, the ability to combine with other agents, both concomitant medications and other therapeutic agents, and also the simplicity of a once-daily dose that makes it easier for patients to potentially benefit.

Yeah. Since we are in a launch phase, we are expecting the leading indicator right now is to get new patient starts and to build that leadership in new patient starts. For the relapsed/refractory NPM1 mutant population, we have guided that the market size is about $350 million-$400 million per year. That is assuming patients get about six months of therapy, five and a half to six months of therapy. So it is going to take some time for us to get a better sense as to where that will even out. But we do anticipate that the patients that are on therapy who are new patients throughout the quarter will stay on and be able to help ultimately get us to the duration of what we have expected to guide so far.

Yeah, absolutely. Yeah, so our commercial team, of course, is focusing on promoting per label, which is as a monotherapy. But physicians that treat AML patients, especially the relapsed refractory, have their discretion as to what they will treat. We have seen in the second quarter, we saw about 40% of patients receive KOMZIFTI in combination with other standard therapies. Largely, the majority of those have been in combination with venetoclax and azacitidine, which is a therapy that if they did not receive in the first line, that would be a second line setting. Then we have seen mostly in that, as I said, about 75% or so are ven/aza. The remaining are pretty much in the FLT3-mutated population with gilteritinib. The FLT3 population, when you think about the overall market within AML, 30% of patients have an NPM1 mutation.

Just 30% of patients who have a FLT3 mutation, about half of the NPM1 patients also have a co-mutation for FLT3. There is a significant overlap, given that physicians see an opportunity to combine with the two, that enables patients to get treated earlier in the course of disease rather than later on in third, fourth, fifth line. We do have data that we are expecting to present later this year in combination with FLT3 inhibitors. We have not published anything to this point yet, but physicians are starting to use that.