Kura Oncology, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Sure. Yeah. Thank you, Lee. Thank you to you and Cantor for the invitation to participate in the conference. Kura is at a point where we think of the business as sort of 2 halves of a much larger whole. On the one side, you have our program for menin inhibition in acute leukemia. That's ziftomenib, where we're now leading new patient starts in the commercial setting in our labeled indication. We have a number of data updates coming here in the fourth quarter that will expand both the breadth and depth of what one can do with a menin inhibitor as monotherapy in combination. We have big 2 phase III's underway that are evaluating ziftomenib in the frontline setting with both intensive and non-intensive chemotherapy. Lee, that's all working toward top-line results for the first phase III in 2028.

Our estimates are a potential peak sales of $3 billion as part of a $7 billion TAM. We're really looking to transform the treatment of acute leukemia. That's one side of the house. The other side of the house is darlifarnib. The simplest way to think of darlifarnib is darlifarnib is a farnesyl transferase inhibitor that has the potential to make other targeted therapies better. We've now evaluated farnesyl transferase inhibitors in combination with KRAS inhibitors, with PI3 kinase inhibitors, as well as tyrosine kinase inhibitors. We have a 2-pronged development strategy currently underway. We're pursuing a phase I-B study of darlifarnib plus cabozantinib in kidney cancer. We will, next year, be pursuing the combination of darlifarnib plus the recently FDA-approved divarasib in pancreatic cancer.

The hope there is the message to patients is, if you like these therapies, whether it's cabo or divarasib, we think we can potentially make them better by combining with darlifarnib. That, Lee, is a similarly sized, probably peak sales, even an even larger TAM, obviously in kidney and pancreatic. But we're going to continue to push things. I suspect you'll ask more about it. We are the leaders, the pioneers in menin inhibition. Today, we proudly announced the creation of Caspian Therapeutics, and that is to pursue menin inhibitors as a potential disease-modifying therapy in diabetes. We're going to do that through a new company, a dedicated team, dedicated capital. But there's a lot of exciting things coming and all for the benefit of patients.

Yeah. It starts with menin inhibition. Menin is a target that keeps teaching us new things that it can do. As your audience probably knows, we obviously have a significant development and commercial effort underway in acute leukemia. We're evaluating menin in solid tumors, starting with gastrointestinal stromal tumors. To your point, there's very strong genetic and biologic data that supports using a menin inhibitor to selectively expand pancreatic beta islet cells. You can't create something out of nothing, but if you have some beta cell reservoir, by blocking menin, you actually selectively allow the pancreatic beta cells to enter the cell cycle and proliferate, and we're going to show preclinical data on the new Caspian compound, KO-7246. We'll show that data in Milan at the EASD meeting. From a Kura perspective, we have a lot to do.

Brian, Molly, Jennifer, our new CFO, we have a tremendous amount to do as a team. We can't do everything, so we wanted to make sure we put the diabetes and the cardiometabolic programs into a separate company. Again, we'll build a new team. We have fresh capital. I think that will become its own independent story over time. It allows us to really focus and apply our resources to being a best-in-class precision medicine oncology company.

Sure. Thanks, Lee, and appreciate the opportunity to be here. We're very pleased, as you said, with the launch of KOMZIFTI. The fact that, as we shared, we've reached the majority of new patient starts in only our second full quarter of launch demonstrates not just the strong commercial execution, but the differentiated profile of KOMZIFTI and the growing physician adoption. We've grown from the first quarter of the year to, I think we said we're about 40% of new patient starts. Now we announced that we're at the majority share. We've also seen growth in our TRX and overall revenue in that timeframe. I think the directionality of all these show that we're on track to be the market leader overall in the NPM1 mutated space.

We can't share details of where we are in terms of third quarter so far, but I can say that the profile has resonated of KOMZIFTI, showing that it's differentiated on efficacy, safety, combinability, and the simplicity of once-daily dosing. Those are what's resonating with physicians, with payers, and with pharmacists, and I think that's what's helping to drive the success we've had so far.

Sure. As we came into the launch, we have been guiding that this market is at the relapse refractory NPM1 mutated market, is about $350 million-$400 million TAM. That is assuming about a 6-month average duration of therapy. It is still a little too early for us to verify whether or not that is coming through, but I can say that everything is trending in that direction. We do need more time to be able to see that. As you mentioned, we have a significant amount of combination use. While our team is promoting on-label as a monotherapy, physicians want to have the opportunity and choice to be able to treat how they like to treat, which is often in combination with other standard therapies.

We anticipate that patients who would be getting treatment with KOMZIFTI in combination with venetoclax, azacitidine, or FLT3 inhibitors may be treated earlier in their course of disease, which could lead to a longer duration. It's something we're following and tracking, but of course, duration is a story that has to play out over time.