Thank you for standing by. My name is Bella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Kura Oncology and Kyowa Kirin Strategic Collaboration Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Troy Wilson, President and CEO of Kura Oncology. Please go ahead.
Thank you, Bella, and good afternoon, good evening, everyone. Welcome to our call. We are thrilled to share with you the news that Kura has struck a strategic collaboration with Kyowa Kirin for the development and commercialization of ziftomenib. We're going to talk more about the details of the collaboration, what it means for Kura, and we're also delighted to have two members of Kyowa Kirin's senior leadership team here on the call with us to introduce themselves and tell you a little bit more about Kyowa Kirin and how ziftomenib fits into their strategy. I will say there are slides that accompany this call. I'm now turning to slide two, which is a forward-looking statement. We will be making forward-looking statements during this conference call. I'll just remind you that these forward-looking statements are associated with certain risks and uncertainties of an investment in Kura.
We would refer you to information either on our website or the website of the Securities and Exchange Commission for more information. Thank you. Turning to slide number three. Before we get into the details of this transformative strategic collaboration, let me just use this as an opportunity to summarize what we see as now the investment thesis for Kura Oncology. This allows us to really focus and extend what we think we do well, which is to develop potentially blockbuster product opportunities in hematologic malignancies, in solid tumors, and of course, in the area of menin inhibition, also in diabetes. We could not be more proud and more thrilled to have Kyowa Kirin as our strategic collaborator. As you'll see, this collaboration accelerates both the global development and commercialization of ziftomenib, and it allows us, in our view, to really maximize the potential benefit for both patients and shareholders.
Importantly, this is an unusual deal, and again, great credit to our colleagues at Kyowa Kirin. This collaboration allows Kura to retain program leadership in the U.S., the key market, and certain key strategic rights that give us strategic optionality and flexibility. Importantly, looking beyond ziftomenib in hematologic malignancies and solid tumors, we also retain our pipeline in totality, which is now funded through key value inflection points in the next couple of years, including, again, our next generation menin inhibitors targeting diabetes, certain other oncology indications, and metabolic disease, as well as our work on KO-2806 and tipifarnib and the farnesyltransferase inhibitor combinations.
Perhaps very importantly for the analysts and the investors on the call, one of the really noteworthy aspects of this collaboration is that between the upfront payment, near-term milestones, and our current cash balance, we believe we now have the resources to fund our ziftomenib AML program all the way through to commercialization in those critical frontline combinations. That we believe will really enable ziftomenib to become the market leader, not only in the relapse refractory setting, but potentially in the frontline and, as you'll see, in the post-transplant maintenance setting. Turning to slide number four, a little more detail on the aspects of the strategic collaboration.
So I think we would be challenged to find a partner that has better alignment with us around the development, the operational, and the commercial expertise needed to really maximize the value for ziftomenib, as well as a long-term vision to capitalize on the promise of ziftomenib for patients with AML and potentially GIST and other solid tumors. As you'll see, this collaboration allows us. We're going to initiate trials in both the fit and unfit frontline populations. We will start a trial in the post-transplant maintenance setting. And if the data continues to support further development, we'll advance into combinations with certain targeted therapies. And by that, we're, of course, referencing the critically important FLT3 combinations in that frontline setting. Importantly, as I indicated, while this is a global strategic development and commercial collaboration, Kura retains certain leadership and key strategic rights in the US.
That allows us to retain our strategic flexibility, and it really accelerates our path now toward becoming a fully integrated commercial-stage biopharmaceutical company. We've talked about the fact that we retain our pipeline programs in full. You'll see more data on those, hopefully, next year and the following year. And as I said, along with our current cash balance, the collaboration positions Kura well to be able to execute all the way through to commercialization to the frontline combinations. An opportunity that, as you've seen in our press release, we believe is up to $3 billion annually, the frontline opportunity in the United States. Turning now to slide number five, just to share a summary of the collaboration terms, and you may have seen much of this from the press release.
As indicated, this is really a very comprehensive development and commercial collaboration for ziftomenib, initially in acute leukemias, with a broad mandate to develop frontline indications, post-transplant maintenance, and potentially combinations with targeted therapy. Kura is on track to receive $330 million upon closing. We anticipate that that will be before year-end. And importantly, if we continue to execute, we stand to receive $420 million in near-term milestones, including milestones associated with the NDA submission and first commercial sale of ziftomenib in that critically important relapse refractory monotherapy setting. In totality, the deal value is $1.16 billion in total development, regulatory, and commercial milestones. That's in addition to the $330 million for the upfront. As far as the development and commercial rights, Kura's leading global development and taking the lead in the US in terms of regulatory and manufacturing.
Our colleagues at Kyowa Kirin will lead the regulatory efforts in the ex-US territories. In the US, the deal is structured as a 50/50 US co-commercialization profit and loss share, with Kura booking revenue and Kyowa Kirin being the lead party for regulatory and commercialization outside the US. With respect to GIST and potentially other solid tumors that can be treated with ziftomenib, Kyowa Kirin has the ability to opt in to development and commercialization in those indications upon Kura delivering a data package from the ongoing study, the phase I study of ziftomenib plus imatinib in GIST. If Kyowa Kirin were to do that, it triggers up to an additional $228 million in upfront and milestone payments. And the deal is structured in the same way as it is structured for the acute leukemias, with the respective sharing of roles and responsibilities between the parties.
Then, of course, there's a royalty component associated with Kyowa Kirin's commercial efforts outside the US, and Kura is set to receive tiered double-digit royalties. Pausing now to go to slide number six, it's my pleasure to introduce two members of the Kyowa Kirin leadership team, Dr. Abdul Mullick, who is the Managing Executive Officer and Chief International Business Officer, and Yasuo Fujii, who's the Managing Executive Officer and Chief Strategy Officer for Kyowa Kirin. Gentlemen, over to you.
Thanks very much, Troy. And good afternoon, good evening, everyone. It's a pleasure to join you here today from Tokyo. What I'd like to do over the next few minutes is really give you a flavor of who we, Kyowa Kirin, are, why we are such a good partner for Kura, and the importance of Kura and ziftomenib to our own future aspirations and ambitions. So I will give you a flavor of why this is such a good collaboration. Let's go to number seven. Who are we? We're a Japan-based global specialty pharma. We have a presence across 50 markets globally, importantly in North America and Europe. More than 65% of our revenue is now derived from outside of Japan. And that revenue is really driven by our global strategic products, of which one is in the hematology-oncology space, where we've built significant capabilities over the past years.
I'll come back to that in a moment. We have 6,000 amazing employees across the world, driving an annual consolidated revenue last year of $3.1 billion. Really, what's special about our company is this passion and history of applying high science to underserved patient populations. Clearly, this collaboration allows us to continue to do precisely that. Let's go to slide number eight. Talking about the history and the science, we have a history of over 60 years in the hematology-oncology space, bringing numerous products to the market through our own laboratories and also through partnerships such as the one we've had for over 40 years with Amgen. Most notable to this collaboration is the product highlighted in the box, Poteligeo. We launched this product in Japan in 2013 and then ex-Japan from 2019 for cutaneous T-cell lymphoma in North America and Europe.
This is a product, a monoclonal antibody directed against CCR4, which has strong synergy with ziftomenib and is an important growth driver for our future also. Let's go to slide number nine, please. So you see the fit between ourselves and Kura. But if we look to our own future ambitions, earlier this year, we communicated what we call is our story for Vision 2030. It's a way of kind of articulating how we'll deliver our vision, which is simply to create and deliver life-changing value, to develop and bring to underserved populations medicines which make a meaningful difference. In this communication, we articulated our focus areas. These are areas where we would look to provide value across the whole value chain from discovery through to commercialization. One of those areas is hematology-oncology.
Of course, developing assets in this space ourselves is important, but also within the story for Vision 2030, we highlight the importance of strategic collaboration, and clearly, this fits in with that, so what you see really is, from all fronts, the basis of a very good partnership between ourselves and Kura for the future, so with that, I'll hand back to Troy. Thanks, Troy.
Thank you, Abdul. We can go to slide 10. So now we're going to just, with this collaboration in mind, talk about the present and then the future value for Kura Oncology. So turning to slide number 11, this is a slide that you've seen from our corporate presentation. It describes the development strategy for ziftomenib in acute leukemia with the frontline populations on the left and, of course, the relapse refractory populations on the right. Importantly, you can see now an entry for COMET-017, where we have the frontline zifto plus Veneza and the frontline zifto + 7+ 3. Turning to the next slide, our pipeline chart here, this doesn't yet have COMET-017 introduced, but what's shown in the red box are the trials, the initiatives that will be part of the strategic collaboration with Kyowa Kirin.
Importantly, if Kyowa Kirin opts into the GIST trial, we'll bring that box down and include COMET-015. Turning now to slide 13, this is something that many of you have asked about, and now I think we can be more granular with what we're going to be doing. This is now a fully funded global pivotal trial. It's called COMET-017. It builds on the work that is currently underway with COMET-007, and it includes two independently powered phase III randomized double-blind placebo-controlled studies. One, of course, in the non-intensive therapy context, where we are looking at ziftomenib or placebo in combination with Venetoclax and Azacitidine. The second study in the intensive therapy setting, again, ziftomenib or placebo combined with, of course, daunorubicin and cytarabine or 7+3.
The benefit of running these studies together is that we believe, number one, we can be the most attractive study to global sites because nearly any patient in the frontline can come into COMET-017, and as you'll see, it's intended to cover approximately 150 sites in more than 20 countries. Given that we've seen a competitive cooperative group study from the HOVON group, we think we're very well positioned with two company-sponsored trials to be able to get ziftomenib to the frontline populations to enable it to be both first-in-class and, we believe, best-in-class in this important frontline opportunity. Turning now to slide 14, this collaboration has taken a tremendous amount of work between our two organizations and our teams over the past year, and from Kura's perspective, we believe that it accomplishes all of the goals that we set out to do.
Most importantly, with the help of Kyowa Kirin, we believe we can now maximize the value for patients and really capitalize on the promise of using ziftomenib to treat up to 50% of patients with AML. Moving to the right, as you'll see, we are going to very aggressively invest in both the frontline opportunities as well as, if you look in the lower left, the post-transplant maintenance and targeted therapy populations. We recognize it's going to be a competitive market, and with our combined commercial teams, we think we'll be very ready to compete in the relapse refractory population here, looking toward a launch for ziftomenib in the relapse refractory setting in 2025.
Then, importantly, again, moving to the right and the lower part of the slide, it allows us to invest in our pipeline programs, which for shareholders and for patients, we believe can really continue, excuse me, continue to create meaningful value. These programs now are funded to some very important value inflection points. Then last but not least, from the standpoint of being a public company, this puts us in a very, very strong cash position and allows us to retain some important strategic optionality. Really allows our teams together to focus on, again, on execution and on maximizing the value for patients and, by extension, for shareholders. Taking us to the final slide, the forecasted milestones and financial highlights. We're looking forward to presenting updated data sets from the COMET-007 study at ASH.
Importantly, you'll see that frontline data for the 7+3 adverse risk population that I think will help folks understand why we are moving so aggressively to invest in those frontline indications. We're looking forward to sharing top-line results in early 2025 from the ongoing COMET-001 registration-directed trial. We would look forward to providing additional updates from the COMET-007 study. I'll remind you that that study is now enrolling in a number of expansion cohorts at the 600-milligram dose. That will continue to give us data to support our discussions with health authorities and the launch of the COMET-017 study in the middle of next year. We're also on track to nominate and then develop a menin inhibitor development candidate, which we've said we're taking forward into diabetes. There are a number of additional important milestones for our pipeline programs, which we'll talk about another time.
And then, of course, you see it on a pro forma basis. Well, as of September 30th, our last earnings call, with the upfront payment of $330 million, Kura now has pro forma cash of $785 million. And of course, you can see the shares outstanding. With that, Bella, I'm happy to conclude the presentation, and we're happy to take questions.
At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Jonathan Chang of Leerink Partners. Your line is now open. Please go ahead.
Hi guys. Congrats on the deal, and thanks for taking my questions. I guess just what I want to understand is, can you discuss the higher-level rationale behind this partnership versus other potential avenues, Troy, and I guess why now versus later?
Yeah, Jonathan, thanks for the question. So the rationale is pretty simple. The data supports the emerging data, both monotherapy and combination supports a significant investment in frontline and post-transplant maintenance studies to support the further development of ziftomenib. Those investments have to be made six to 12 months in advance of ever dosing a patient. And we, along with Kyowa Kirin, believe now is the right time to make that investment, looking toward initiation, again, of that critical 017 frontline study middle of next year. As we considered potential partners, Jonathan, we sought to maintain meaningful development and commercial rights to continue to create a strong investment thesis for our shareholders and then to invest aggressively to make ziftomenib the market leader. We recognize we're competing not only with the product that's recently received approval in the KMT2A population, but potentially other programs in development.
This deal allows us to build a co-promotion agreement where we book sales and take a lead role in the U.S., allowing us to retain key rights and strategic optionality, but recruiting the resources and the expertise of a multinational pharma. And then finally, Jonathan, to the second part of your question, as we look at different financing options, and as I like to say, we run all the options all the time, the upfront and the potential near-term milestones from this deal, along with the cash on hand, allow us to have this AML program fully funded through to launch in the frontline populations. And that, in our mind, as we continue to approach that inflection point, we think you're going to see value for both patients, as you'll see hopefully at ASH, and then one again next year, and then for shareholders.
And then finally, just as Abdul mentioned in his presentation, we were impressed by Kyowa Kirin's ability as far as building an organization that is focused on hematology-oncology. Their expertise, particularly in patient identification, we think is going to be critically important in this relapse refractory setting. And their willingness to work with us shoulder to shoulder to simultaneously do the frontline development, post-transplant maintenance, and targeted therapies, we just think is a win-win-win relative to other financing options.
Understood. Thanks for taking the questions.
Sure.
Your next question comes from the line of Li Watsek of Cantor Fitzgerald. Your line is open. Please go ahead.
Hi, this is Alexa Deemer on for Li Watsek. I just wanted to start off by saying congratulations on this exciting opportunity, and my question is, for the $420 million in near-term milestones, can you elaborate a little more on the breakdown of approval milestones versus launch milestones?
Yeah, Alexa, thank you for the congratulations. And unfortunately, no, we're not at this point going to be more granular. We have classified those milestones as near-term milestones, which I think speaks both to the temporal nature and to the more near-term nature of the structure. But at this point, can't be more specific on the breakdown.
Okay, thank you.
Your next question comes from the line of Roger Song with Jefferies. Your line is now open. Please go ahead.
Great. Congrats, adding our congratulations to the deal. Maybe two quick questions from us. The first one is, given the last time you showed us some data is early this year, and then you were about to show the data at ASH. So how much of the data sharing you have gotten with the have shared with Kyowa Kirin, the partner? And the second question is, given Kyowa Kirin has a very strong presence ex-US, how should we think about the ex-US sales versus US sales in the future, the potential? Thank you.
Sure, Roger. Thanks for the questions. I think we can say that Kyowa Kirin has seen enough data to have conviction to forge a very innovative partnership and justify an eventual investment of up to $1.5 billion. They've also reviewed our submission to the FDA regarding our breakthrough therapy designation. Importantly, I think they also, Roger, share our conviction around the emerging data in the frontline opportunities. I have reiterated to a number of you that safety, tolerability, and combinability are important, and I think you'll see that as these frontline profiles of the different drug candidates begin to emerge. With respect to your second question, Roger, I don't know that we've broken it down yet really between the US and the ex-US business. We at Kura are comfortable forecasting that we think it's up to $3 billion annually in the US in the frontline population.
But I don't believe that we've given any more color on the ex-US business. That's something we'd look to do in the future.
Great, thank you.
Your next question comes from the line of Peter Lawson with Barclays. Please go ahead.
Great. Thank you so much. I guess a couple of questions. Firstly, with the funding, Troy, if this has accelerated any programs or if you kind of view this as a way of kind of accelerating enrollment and how you think this has kind of changed your ability to get to market?
Yeah, Peter. So absolutely. I mean, we continue to be very encouraged by the pace of enrollment across the trials. That's continued in the 007 trial. The cohorts enroll at different rates depending on the unmet need and the population, but enrollment continues to be very strong. What I think is important is AML is a disease where if you want to maximize the value of the asset, you have to simultaneously take on development and commercialization in multiple different areas. And that is intensive and non-intensive therapy in the frontline, which is, we think, a multi-billion-dollar opportunity. The post-transplant maintenance setting, which again, we think could be a meaningful commercial opportunity. And then the FLT3 setting, which I'll remind everyone is the same size as NPM1. And there's a reasonable rationale to think that one could use a menin inhibitor in that population.
What this allows us to do, Peter, is exactly what you said, to accelerate all of those as quickly as they can be operationalized. And in addition to the financial resources, I mean, those are important, but the operational resources, the people on the ground, the regulatory expertise, as well as the commercial insights, now we can maximize the value of zifto, not only in the U.S., but KK is very focused on Japan, Europe, and the ex-U.S. markets. That's something that we just couldn't do on a standalone basis. And we think, again, as this frontline data begins to emerge, you have the real potential to transform the treatment of AML and thus to transform the commercial opportunity. And we were thrilled that Kyowa Kirin had a similar vision for where that commercial opportunity could be in three to five years.
Okay, perfect. Thank you, and Troy, I apologize, I may have missed this, but your partner, Kyowa, what did they see? Did they see the frontline or the pivotal data?
Yeah. What I said in response to the last question, Peter, was they've seen we haven't been specific, but they've seen enough data to have conviction to, I think, to make a very unusual deal, I think a very attractive deal to Kura shareholders. Deals that look like this, in my experience, you can kind of count on one hand, beginning with Janssen Pharmaceuticals and Legend, and sort of working backward. They've seen enough data, Peter, to say that they have conviction about ziftomenib's potential to be best in class.
Great. Thank you so much.
Your next question comes from the line of Ren Benjamin with Citizens JMP. Please go ahead.
Hey guys, thanks for taking the questions. And congratulations on a really nice deal and having the funding now available to run all your studies. A couple of questions for me, Troy. I guess one, you had mentioned in your prepared remarks that you're retaining key strategic rights of zifto in the US. But by looking at the deal, it seems like everything has kind of been given out. So I'm kind of curious if you can provide some more color as to what those key strategic rights are. And maybe just related to that, will there be a joint committee that you can utilize Kyowa Kirin's expertise in designing new clinical trials going forward? Or is it really kind of a silent partner who's kind of letting you run the studies here in the US?
Yeah, Ren, let me take those questions in the reverse order. Thank you for the congratulations. So I wouldn't describe Kyowa Kirin as a silent partner. They have been a very engaged partner throughout our due diligence and negotiations. I expect them to continue to be a very engaged partner. Our commercial organizations will be working very closely together to maximize the value initially in the relapse refractory setting. And I think it's likely, Ren, that they may take on responsibility, for example, for running the post-transplant maintenance study. That's something that we need to spend more time talking about. But certainly, they have the capability, the resources, the expertise to do that. That way, we don't have to build that capability at Kura. With respect to your first question around key strategic rights, so you're always giving up something, right?
Anytime you do a deal, whether you're selling equity to shareholders or you're doing royalty financing or you're doing a deal such as this, you've got to give something to get something. The rights that we think are important that we've retained are the lead development and commercial partner in the U.S. and the ability to book sales. That's of strategic importance. We're not today, Ren, focused on a downstream strategic transaction. I want to very much keep the focus on the relationship with KK and the value I think we can create together. But the potential for a larger company to look at this and say, "This is attractive," I think those are some of the key strategic rights that we're referring to. So I hope that that's helpful to answer both questions.
Yep. No, that was. Thank you for that. Maybe just a quick question for the Kura team. Can you talk a little bit about what your plans are for ex-US trials? When do you think they start? And would you be able to comment on what you think might be the first ex-US countries for potential commercialization? Thank you.
Yeah.
Absolutely.
Thanks for the question.
Troy, maybe you can take the development plan one.
Yep. Yep. Yeah, I would say on the development plan one, Ren, we're really focused at this point on getting the 017 operationalized. We'll provide more detail on the size, the powering, the endpoints after we've had a chance to engage with health authorities. But when you compare and contrast that to what our competitors are doing in the frontline with a cooperative group study, this is just a much larger and more muscular study that's going to be a company-sponsored study, and with everything that goes along with that. We'll control the timing. We'll control the data. We'll control the design. We'll control the submissions. All of those advantages. We'll provide additional detail, Ren, in the time to come on the future sort of development activities, but maybe I can ask Abdul to speak to how they view the ex-U.S. market.
Abdul, I don't know if you can make a comment to that.
Yeah, sure. Absolutely. I mean, I think first and foremost, one of the reasons we did this deal was because AML is a really underserved patient population with limited therapeutic options. And we really think zifto is going to bring tremendous value to this patient group. And that's important. Those of you that are familiar with the ex-US market, Europe in particular, know that pricing and access are really dependent upon the ability to demonstrate value. And so really, that's the kind of algebra we'll have to work through now. The launch sequence really depends on multiple things. But over the past years, with our experience in this space, we built the capabilities around being able to convince payers of the value of medicines like this. So we're pretty confident that the opportunity outside of the US is pretty significant too. I hope that answered your question.
Thank you, Abdul. That's great.
Thank you.
Your next question comes from the line of Joe Pantginis with H.C. Wainwright. Please go ahead.
Hey, everybody. Nice job. I just want to leave it there. But I guess two questions if you don't mind. So looking forward right now with regard to some of the use of the upfronts or what have you, as you approach COMET-017, where do you stand on your manufacturing needs? And then I have a follow-up.
Yeah, Joe. First of all, thank you. Thank you for the comment.
These things are a huge amount of work, and this, we couldn't be more thrilled. As far as manufacturing, we're prepared or we will be prepared, I should say, to be able to go to market in the relapse refractory monotherapy setting if the 001 trial supports approval with the FDA. We're also, and this is something that our colleagues at Kyowa Kirin spent a lot of time on, we will be prepared to support global development of these different trials in a timely fashion. When you're supplying 150 sites in 20 countries, you really have to be on your game. And that was an important and very extensive part of the diligence by Kyowa Kirin. And I think the current team stood up to that. We are the lead party on manufacturing, and we will continue to be.
We'll speak more to that, Joe, as we approach the market. But I think as it stands now, we're in great shape.
No, I appreciate that. And I don't know if you could give any details here, but with regard to the opt-in for solid tumors, can you talk about what would be needed to trigger the opt-in? Is it after a time after a particular data release? And let's just say if Kyowa Kirin does not opt in, it's then available for others?
Yeah, that's right. So the opt-in is triggered after Kyowa Kirin has had an opportunity to review the data really from expansion cohorts, Joe, in the phase I study. As you know, there's a dose escalation portion where we're escalating zifto on top of Imatinib at the recommended dose of Imatinib. And then there will actually be, I think, two expansion cohorts. Once we have that data and we're able to make an assessment of what's the magnitude of clinical benefit and what's the corresponding potential development path and commercial opportunity, at that point, Kyowa Kirin has the option of electing to be our partner there as well. And we'd be thrilled by that. As you've seen, we've already hardwired the deal to do that.
If, however, they elect that's not what they would like to do, then those rights within solid tumors revert back to Kura on a worldwide basis.
Understood. Thank you very much for the details.
Our pleasure. Thank you.
Your next question comes from the line of Phil Nadeau with TD Cowen. Please go ahead.
Good afternoon. Thanks for taking our questions and letting us add our congratulations on the deal. Actually, a couple for Abdul if that's okay. Abdul, we're curious to get your assessment of the menin opportunity. The slides today talk a lot about the frontline opportunity. Is that really the driving force behind the deal and the valuation? I guess what's the relative contribution of frontline versus the relapse refractory space as you size the opportunity? That's first. And then second, as I'm sure you're aware, the investment community has a multi-year debate about the competitive position of all the different menin that are in development. We're curious to get your assessment of why zifto. How do you see the competitive environment? Thanks.
Great. Thanks for the question.
Abdul.
I think.
Yeah.
Please, Troy, go ahead.
No, no. I was going to say, Abdul, if you're comfortable taking those questions, please.
Yeah, absolutely. As I alluded to before, I think from our perspective, one of the driving forces of this transaction was really the unmet need in this patient population, and that unmet need, of course, extends across frontline and relapse refractory. I do think, though, that there's clearly an opportunity in the relapse refractory, but where we see the real significant potential in the future for this class and zifto in particular is that frontline opportunity. That's where the unmet need is greatest and where we believe the long-term value could be highest. Now, in terms of the weighted contribution of each, that's something that we've got to work on in more detail, but we believe both have an opportunity, but the frontline for sure could be a game changer for the future.
In terms of the competitive profiles, I mean, we understand and believe that this class really is going to make a meaningful difference. And looking at the profile of zifto versus others, as Troy said, we believe this has the potential to be the best in class. And the reason we think that is that, of course, the efficacy is important. But as we talk about the use of combinations, the safety and tolerability profile takes on more importance. And clearly, that looks extremely good if you look at the profile of zifto and the data that is available. So hopefully, I've addressed both your questions there.
That was very helpful. Thanks for taking our questions. Congrats again on getting the deal done.
Thank you, Phil.
Your next question comes from the line of Justin Zelin with BTIG. Please go ahead.
Thanks for taking our questions. And congrats on the partnership as well. Troy, I just wanted to ask about the development costs here. It looks like Kura is funding development costs through 2028 and 2029 onward. It'll be split at a 50/50. And just which trials you think might be in that 2029 onward timeframe? I think you mentioned post-transplant maintenance might be one candidate there.
Yeah, Justin, thank you. So that's the frontline studies, the 017 intensive and non-intensive therapy. That's the post-transplant maintenance study, as well as the, I would say, the early work on the FLT3 inhibitor combinations. We don't yet have enough data to really do a full sort of study design concept for a registrational study in the FLT3 frontline population. That would be outside of that, Justin. But otherwise, it encompasses all of the other development as well as much of the ongoing development that you see on the slides that I walked rather quickly through.
Understood. With this deal, you mentioned that you're funding the rest of the pipeline. Any particular program or milestone that you're most excited about near term that you think investors should focus on?
That's a great question, Justin. It's kind of hard to choose. And I'll say this, we'll see. The translational data for GIST looks as good as any I've ever seen. I find it hard to believe a menin inhibitor isn't going to work in diabetes. Is it going to be a drug? I think that depends on the safety profile. But I think there's a very high probability that you see us recapitulate what we showed in the American Diabetes Association poster earlier this year. And then you know I always root for the underdog. I think there's some interesting surprises coming with 2806 in the combination studies. Those studies are sort of quietly enrolling. And we obviously know that class better than anyone. And I would say stay tuned. That last one, Justin, is probably more of a second half of the year type of thing.
But I think Kura's really set up to just keep developing innovative medicines. It's hard to say you love all your children equally. I think in this case, that's really the truth.
Thanks for taking our questions. And congrats again.
Thank you.
Your next question comes from the line of George Farmer with Scotiabank. Please go ahead.
Hi. Thanks for taking my question. Troy, I was wondering if you could comment on your plans to run the COMET-0 17 as a company-sponsored trial. Your competitor's going or one of your competitors is going with a cooperative group to do this. Why? I mean, what are the different pluses and minuses when choosing between one or the other?
Yeah. I mean, the pros of a cooperative group study and cooperative group studies have their place. Absolutely. And we are using investigator-sponsored studies now. You see them on our website. We've talked about them. You'll see trial-in-progress posters at ASH from a couple of our ISTs. No company can do everything. And these cooperative groups have incredible expertise. But as Abdul mentioned in his comments, and I think we wholeheartedly agree, the biggest opportunity in near term is that frontline. And many people are like, "Look, I don't know if there can be a blockbuster drug in AML because I have yet to see one." But as we've talked about, as I've talked about to many of you, it's about clinical benefit, safety, tolerability, combinability, and time on therapy.
And pay attention to that last one, time on therapy, the ability to keep patients in a response or to maintain that response post-transplant. In our calculus, the ability to design the study to push ourselves and the health authorities on the potential for accelerated endpoints, the ability to go as fast as possible, this is where everything matters. People have spent a lot of time about who's first to market in relapse refractory. A company-sponsored study will almost always outperform a cooperative group study because a cooperative group study, these people have other things to do. And that's not a criticism at all. That's just the reality. We took a different path. We are making a significant investment in three, possibly four, company-sponsored studies to really try to drive ziftomenib to not only first to market in that frontline setting but blockbuster status and we think best-in-class market leader.
In our view, and I think KK shares this, that if one can do it, company-sponsored studies are the way to go.
Okay. Great. That's very helpful. And then one more, if I may, maybe Abdul from Kyowa Kirin here can respond. You mentioned this frontline opportunity is really where the heart of this deal comes from. Are there plans to develop the drug in the relapse refractory setting as a single agent outside of the US?
Abdul, are you comfortable answering that?
Sorry, maybe.
Yeah. So I'll.
Sorry, maybe.
Yeah. Let me take that. I think at this point, we're going to keep the monotherapy global development a little close to the vest for now. We'll have more to say when the time is right. But we want to maximize the value for patients. We also want to be careful not to give away too much on our strategy.
Sure. Okay. Thanks very much.
Pleasure. Operator, do we have anyone else? All right. I think we're done with Q&A. I want to thank my colleagues from. I'm sorry. I want to thank my colleagues from Kyowa Kirin for their gracious willingness to join this call and to talk about why they're excited about this partnership. I want to thank everyone for your time and attention. We look forward to following up with you. ASH is right around the corner, and we're going to be sharing some important data. And this is just, we think, the next important step toward the further development of ziftomenib for the treatment of patients. So I want to thank all of you, and we'll adjourn the call. Thanks very much.