Kura Oncology Q1 2026 Earnings Report

Kura Oncology EPS Results

• Actual EPS: -$0.83
• Consensus EPS: -$0.88
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: N/A

Kura Oncology Revenue Results

• Actual Revenue: $18.27 million
• Expected Revenue: $25.97 million
• Beat/Miss: Missed by -$7.70 million
• YoY Revenue Growth: N/A

Kura Oncology Announcement Details

• Quarter: Q1 2026
• Date: 5/12/2026
• Time: After Market Closes
• Conference Call Date: Tuesday, May 12, 2026
• Conference Call Time: 4:30PM ET

Kura Oncology (NASDAQ:KURA) is a biopharmaceutical company focused on developing precision medicines for the treatment of cancer. The company’s research programs target specific genetic and molecular abnormalities that contribute to tumor growth, with an emphasis on hematologic malignancies and selected solid tumors.

Kura’s leading program has been ziftomenib, an oral, selective menin inhibitor being developed for genetically defined forms of acute myeloid leukemia, including cancers with NPM1 mutations or certain KMT2A rearrangements. The company has also developed tipifarnib, a farnesyl transferase inhibitor investigated in several cancer indications, including diseases involving HRAS mutations.

Founded in 2014 and headquartered in San Diego, California, Kura has conducted clinical development activities through collaborations with academic institutions, research organizations and pharmaceutical companies. Its operations and clinical programs have been directed primarily toward patients and healthcare markets in the United States and other international regions where its investigational therapies are studied.

Kura Oncology Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: KOMZIFTI delivered a strong first full quarter of launch, with $5.8 million in net product revenue, 85 new patient starts, and nearly 160 total prescriptions.
• Positive Sentiment: Management said early launch trends show repeat prescribing, broad account uptake, and some physician switching from other menin inhibitors, suggesting KOMZIFTI is beginning to differentiate in the market.
• Positive Sentiment: Access is off to a strong start, with coverage at parity or better for more than 93% of covered lives and favorable formulary positioning for more than 12 million lives.
• Positive Sentiment: Clinical development remains on track, with KOMET-017 enrolling ahead of plan and multiple near-term data readouts expected this year, including updates at EHA and ASCO.
• Neutral Sentiment: The company ended the quarter with $580.8 million in cash and short-term investments and reiterated that this, along with expected Kyowa Kirin collaboration payments, should fund the AML program through the first KOMET-017 top-line results anticipated in 2028.

Presentation

[Operator]

Good day, everyone. My name is Layla, and I will be your conference operator today. At this time, I would like to welcome you to the Kura Oncology First Quarter 2026 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you have joined via the webinar, please use the Raise Hand icon, which can be found at the bottom of your webinar application. To allow everyone the opportunity to participate, we ask that you please limit yourself to one question and then re-enter the queue for any follow-ups. At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Kura Oncology. Please go ahead.

[Greg Mann, SVP of Investor Relations and Corporate Affairs at Kura Oncology]

Thank you, Layla. Good afternoon, and welcome to Kura Oncology's 1st quarter 2026 conference call. Joining the call today are Dr. Troy Wilson, President, Chief Executive Officer, Brian Powl, Chief Commercial Officer, Dr. Mollie Leoni, Chief Medical Officer, and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's discussion will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

[Troy Wilson, President and CEO at Kura Oncology]

Thank you, Greg. Good afternoon, everyone. Kura is at an inflection point. What we've been building over the last several years is now showing up clearly in the clinic, in the market, and in the way physicians are making treatment decisions. Our first commercial launch is off to a strong start. Our phase III programs are ahead of plan. Over the next 12-24 months, we expect a steady flow of data that we believe will define leadership in the menin inhibitor class. Most importantly, we're executing with focus, discipline, and a very clear strategy. Let me start with KOMZIFTI. In our first full quarter of launch, we generated $5.8 million in net product revenue ahead of expectations. What matters more to us is what's underneath those numbers.

[Troy Wilson, President and CEO at Kura Oncology]

We're seeing repeat prescriptions, we're seeing broad uptake and use expand across treatment centers, we're seeing increasing payer preference, and we're seeing early instances of physicians switching patients from other menin inhibitors to KOMZIFTI. That tells us something important. This is not just a class story anymore. Physicians are starting to differentiate based on product profile, and we believe KOMZIFTI is standing out. We see that differentiation coming from a combination of compelling efficacy, a predictable safety profile, simple and convenient dosing, and potential for broad combinability. In real-world practice, these things matter, and they're driving how physicians choose therapy. It's early, but based on what we're seeing, we believe KOMZIFTI is well-positioned to emerge as a leader in the treatment of adult patients with relapsed refractory NPM1 mutant AML. At the same time, we're not building this as a single indication product.

[Troy Wilson, President and CEO at Kura Oncology]

Our focus is to expand across the AML treatment continuum and establish it as a backbone therapy in combination. This year, we expect to generate multiple data readouts to support that strategy, including updated data from our 7+3 combination in newly diagnosed AML at EHA, publication of our venetoclax azacitidine combination, and initial data from our gilteritinib combination in relapsed and refractory AML patients with NPM1 and FLT3 co-mutations. Taken together, these datasets are designed to answer a simple question. Can KOMZIFTI be used broadly, safely, and effectively in combination across AML? Based on what we've seen so far, we believe the answer will be yes. In parallel, our frontline phase III program, KOMET-017, is progressing ahead of plan with strong enrollment for both studies across leading global sites. Our one-stop-shop design is doing exactly what we intended, accelerating execution without compromising rigor.

[Troy Wilson, President and CEO at Kura Oncology]

Beyond AML, we continue to build a broader pipeline with meaningful upside. darlifarnib is a good example. The data we've generated reinforce its mechanism and potential to overcome resistance to targeted therapies. We'll have additional combination data this year, including in KRAS G12C mutated cancers, where we think there's an opportunity to open up new treatment approaches across large solid tumor indications. When we step back, we think Kura is in a very strong position. We have a commercial product gaining traction and beginning to differentiate in the real world. We have a pipeline with multiple anticipated near-term clinical catalysts that can expand that opportunity significantly, and we have the balance sheet to execute our strategy and reach key value creating milestones. The menin inhibitor class in AML is still early.

[Troy Wilson, President and CEO at Kura Oncology]

The next year or two will determine how it evolves and who leads. Based on what we're seeing today in the clinic and in the market, we're confident in our ability to play a leading role in shaping that future. With that, I'll turn it over to Brian.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Thanks, Troy. We're very encouraged by KOMZIFTI's performance in the first full quarter of launch. Although we're pleased by the first quarter results, we're even more encouraged by the underlying trends driving that revenue. Our early momentum reflects three core strengths: strong preparation, an experienced commercial team, and most importantly, a clearly differentiated product profile defined by efficacy, safety, combinability, and convenient dosing. Our commercial strategy is focused on three priorities: drive broad awareness of KOMZIFTI's differentiated profile, deliver strong and consistent quarter-over-quarter growth, and establish relapsed refractory NPM1 mutant AML, a $350 million-$400 million market opportunity.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

In the first quarter, we generated $5.8 million in net product revenue, with 85 new patient starts and nearly 160 total prescriptions. Patients were treated across approximately 60 activated accounts, including ziftomenib trial sites, other menin-experience centers, and accounts new to menin inhibitors. More importantly, we are seeing clear signs of growing physician adoption. First, repeat prescriptions and expanding use across treatment settings indicate growing physician confidence with KOMZIFTI in real-world practice. Second, following our approval, we have observed physicians switching patients from other menin inhibitors to KOMZIFTI. Although still early, this is a meaningful signal that physicians are making active treatment decisions based on the product profile. Third, we are aware of early physician-initiated use of KOMZIFTI in combination with commonly used agents, including venetoclax azacitidine and with gilteritinib in FLT3 co-mutated patients.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

This physician-initiated use reinforces our belief that ziftomenib has potential to be a highly combinable backbone for use across AML patient populations. Feedback from physicians, pharmacists, and nurses consistently highlights the practical advantages of KOMZIFTI, particularly its dosing simplicity and convenience for patients, which we believe are important factors in real-world treatment decisions when monotherapy efficacy is viewed as similar. Collectively, these dynamics point to a clear conclusion. Increasingly, physicians, pharmacists, and nurses are selecting KOMZIFTI, which offers strong efficacy with a well-characterized and manageable safety profile and convenient once-daily dosing compatible with concomitant therapies, what we describe as efficacy without compromise. Turning to access, we've secured coverage at parity or better for more than 93% of covered lives, with no label restrictions. Achieving this level of access this early in launch, particularly as a second-to-market therapy, reflects the strong payer recognition of KOMZIFTI's value.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

We're also seeing favorable formulary positioning and step edit dynamics. I'm thrilled to report more than 10 plans covering more than 12 million lives have placed KOMZIFTI in a favorable policy position. These decisions reflect payer recognition of KOMZIFTI's differentiated profile and the predictability of its cost in managing patients in this setting. Operationally, execution remains strong. Time from prescription to patient receipt is approximately 3 days, ensuring rapid access to therapy. Our field teams, in collaboration with Kyowa Kirin, are driving strong engagement across both academic and community settings. Looking at the bigger picture, the combination of repeat prescriptions, broad access, payer preferences, expanding real-world use, and early instances of switching gives us confidence that KOMZIFTI is not just participating in the menin inhibitor class, but is increasingly defining its leadership position in the NPM1 market.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

The success we are seeing in this initial monotherapy setting is an important first step and reflects our foundational advantage of delivering strong efficacy with a predictable safety profile and convenient dosing that, in our view, represents efficacy without compromise. Importantly, this early momentum lays the foundation for our next phase of growth as we expand into combination and frontline settings. I'll now turn it over to Mollie.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

Thank you, Brian. In 2026, we expect a continued steady cadence of clinically meaningful data for ziftomenib and darlifarnib. Our strategy for ziftomenib is focused on one clear objective, establishing it as a highly active and broadly combinable backbone therapy across AML treatment landscape, supported by our registrational clinical programs spanning multiple lines of therapy and patient populations. As treatment paradigms evolve, physicians are increasingly looking for therapies that can be safely and effectively combined with existing standards of care, and ziftomenib is specifically designed to address that need. At the upcoming EHA meeting in June, we plan to present updated data from ziftomenib in combination with 7+3 in newly diagnosed NPM1 mutant and KMT2A rearranged AML. This updated data set will include extended follow-up with a median of approximately 16 months, including treatment course and response durability.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

We also expect to publish data showcasing venetoclax and azacitidine in combination with ziftomenib in relapsed or refractory NPM1 mutant AML. These data expand upon our presentation at ASH 2025, where we reported a striking 70% composite CR rate in patients without prior venetoclax exposure. This is an important regimen as ven-aza remains a widely used standard of care. In parallel, we are advancing combinations with FLT3 inhibitors. As a reminder, FLT3 mutations occur in approximately one-third of AML patients, and notably half of NPM1 mutant patients have FLT3 co-mutations. We anticipate preliminary data in the second half of the year from ziftomenib in combination with gilteritinib in relapsed or refractory NPM1 mutant FLT3 mutated AML. We are also evaluating ziftomenib in combination with quizartinib in the newly diagnosed setting. As a whole, these data are building a consistent picture.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

ziftomenib can be integrated across multiple treatment approaches without compromising safety or activity in clinical studies, an attribute we believe will be essential for long-term use in both relapsed and frontline settings. Turning to our frontline development program, our KOMET-017 trial is an innovative one-stop-shop design which enables simultaneous enrollment into two independent phase III trials at each activated site. This streamlined approach is a meaningful differentiator and operational advantage, allowing us to accelerate enrollment while maintaining rigorous study, design, and execution. We are very pleased with the progress to date. Site activation and enrollment are ahead of projections, with strong participation from leading academic centers across the U.S., Europe, and Asia. This level of engagement reflects both the clinical interest in menin inhibition and the confidence investigators have in ziftomenib's profile, particularly its potential to be combined with standard frontline regimens.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

Beyond AML, we continue to explore the broader opportunity of menin inhibition. Our study evaluating ziftomenib plus imatinib in GIST is progressing well, and we hope to provide updates when appropriate. In addition, we are evaluating the role of menin inhibition in other solid tumors. Turning to darlifarnib, which also continues to make important progress. Recent data presented at the International Kidney Cancer Symposium provided clear proof of mechanism, demonstrating activity in cabozantinib pre-treated clear cell renal cell carcinoma, a setting where clinicians would not typically expect to reintroduce responses with the same TKI after progression. These findings support the role of the RAS/mTORC1 resistance pathway and reinforce potential for darlifarnib to restore sensitivity to targeted therapies. Enrollment in the phase I-B portion of the darlifarnib plus cabozantinib trial is now underway.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

In addition, we intend to present an update on the full phase I-A data set later this year. We see combinations of FTIs and KRAS inhibitors as a potential next advance for patients. At ASCO, we will present preliminary data evaluating darlifarnib plus adagrasib in KRAS G12C mutated solid tumors, and we look forward to discussing that data at a virtual event on June third. I'm incredibly proud of our teams at Kura for the disciplined, focused execution behind these programs. Their cross-functional commitment and operational excellence are helping translate our strategy into meaningful clinical progress for patients. With that, I'll turn the call over to Tom for financial updates.

[Tom Doyle, SVP of Finance and Accounting at Kura Oncology]

Thank you, Mollie. I'm happy to provide a brief overview of our financial results for the first quarter of 2026. Our net product revenue from KOMZIFTI sales was $5.8 million, compared to none for the first quarter of 2025. Collaboration revenue from our Kyowa Kirin partnership was $12.5 million, compared to $14.1 million for the same period in 2025. Research and development expenses were $65.3 million, compared to $56 million for the first quarter of 2025. The increase was driven by ziftomenib's combination trials, including the start of enrollment in our COMET-017 trials in the second half of 2025. Selling, general, and administrative expenses were $31.6 million, compared to $22.8 million for the first quarter of 2025. This increase was driven by the commercial launch of KOMZIFTI.

[Tom Doyle, SVP of Finance and Accounting at Kura Oncology]

Net loss for the first quarter of 2026 was $73.3 million, compared to a net loss of $57.4 million for the first quarter of 2025. This includes non-cash share-based compensation expense of $8.4 million, compared to $7.8 million for the same period in 2025. As of March 31st, 2026, Kura had cash equivalents, and short-term investments of $580.8 million, compared to $667.2 million as of December 31st, 2025. We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 million-$55 million in 2026, $90 million-$110 million in 2027, and $90 million-$110 million in 2028.

[Tom Doyle, SVP of Finance and Accounting at Kura Oncology]

This revenue reflects non-cash based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. Current cash equivalents, and short-term investments as of March 31, 2026, together with anticipated payments of $180 million under our collaboration agreement with Kyowa Kirin, are expected to fund our ziftomenib's AML program through the first top line phase III results from COMET-017, anticipated in 2028. With that, I'll turn the call back over to Troy.

[Troy Wilson, President and CEO at Kura Oncology]

Thank you, Tom. As I said at the outset, company's firing on all cylinders. Our first commercial launch is off to a strong start. Our phase III programs are ahead of plan, and we expect a strong cadence of data over the next 12 to 24 months that will further define leadership for ziftomenib's and the menin inhibitor class. With that, we'll conclude our prepared comments, and we're happy to, Layla, to open the call up for questions.

[Operator]

We will now move to our question and answer session. If you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application. When you are called on, please unmute your line and ask your question. We will now pause a moment to assemble the queue. Again, we ask that you please limit yourself to one question. You're welcome to then re-enter the queue for any follow-up questions. Our first question will come from Lee Watzek with Cantor. You may now unmute and ask your question.

[Dan Bronder, Analyst at Cantor Fitzgerald]

Hey, team. This is Dan Bronder on for Lee Watzek. Thanks so much for taking our question, and congrats on the update and the commercial launch. Can you give us some color on how we should think about the duration of treatment with KOMZIFTI early on, given that it sounds like you have patients on monotherapy as well as some that might be receiving combination? We'd greatly appreciate it. Thank you.

[Troy Wilson, President and CEO at Kura Oncology]

Sure, Dan. Thanks for the question. Let me ask Brian if he can speak to that.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Sure. Thanks, Dan, for the question. I think it is difficult at this point to really give too much detail on duration of treatment, because, you know, we have one full quarter. We've reiterated before that our expectation is to get around six months of treatment. What I can say is that we're very pleased, of course, with the number of new patient starts. We think that's really the measurement at this early in the launch to measure how well we're doing, and I think the 85 new patient starts us off well. What we need to do is really track for several quarters to get a better sense of that.

[Operator]

Your next question will come from Peter Green with LifeSci Capital.

[Peter Green, Analyst at LifeSci Capital]

Hi, this is Peter on for Charles. Congrats on the results, team. You mentioned a few times, the frontline opportunity and also strong enrollment in KOMET-017 and in light of, sorry, EHA abstracts today, I have a question there. You know, I'm noticing from last year that complete response rates across both NPM1 mutant and KMT2A rearrange AML, and that's in the frontline, for ziftomenib in combination with 7+3. I'm noticing those CR rates are increasing. I'm also noticing that CR MRD negativity is, you know, in NPM1 occurring potentially out to 43 weeks in some patients.

[Peter Green, Analyst at LifeSci Capital]

I guess with all of that said, what have you learned from KOMET-007 about ziftomenib's profile in the frontline, especially over longer term use? Is there some response deepening happening or is this just kind of an artifact of increasing or of including kind of less adverse risk patients? Thanks.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

I think we've learned foremost that we're using it correctly, and that doing it with this staggered start and a start that enables patients to continue to remain on without having to interrupt or lower dose or discontinue for adverse events is a really powerful way to keep these patients both in a response, have that response deepen over time, and have these patients be able to continue on into some form of continuation treatment, whether that be post-transplant or post-consolidation. We continue to gather more data, and we continue to be extremely encouraged that the way we've designed KOMET-007, the data we continue to gather from KOMET-007, helps us to really reinforce that we've correctly designed KOMET-017, so that we can expect great outcomes for these patients in the frontline as well.

[Troy Wilson, President and CEO at Kura Oncology]

Yeah, Peter, this is Troy. Just to add to Mollie's comments, I agree with everything she said. One of the things you'll see at EHA is really this is probably the most mature set of data in the frontline, and it's really a story of durability and clinical benefit for patients. The data will be updated at the presentation, but response rate, MRD negativity are important. We'll really draw people's attention as well, as Mollie said, to the durability. We're really You know, this is this data's pretty unprecedented, and I think very encouraging for the promise of menin inhibitors and the 017 study, as she said.

[Peter Green, Analyst at LifeSci Capital]

Thank you.

[Operator]

Your next question will come from Jonathan Chang with Leerink Partners.

[Jonathan Chang, Analyst at Leerink Partners]

Hi, guys. Thanks for taking my question. On the KOMZIFTI launch, can you provide more color on what you're seeing in terms of initial combination use and instances of switching from other menin inhibitors? How common is combination use and switching? Thank you.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Yes, thanks for that question, Jonathan. What I can share about the combination use we'll get for this, of course, as you know, our promotional teams, our commercial teams are focusing on promoting on label as a monotherapy, but physicians are choosing to use in combination. The data we're seeing so far is that it's about probably about 40% of patients are getting used, using KOMZIFTI in combination either with ven-aza or in those FLT3 co-mutated also with Gilteritinib. That's what we're seeing early on. I think that, you know, getting to the expectation of how those patients will do is something we'll follow. Regarding your question around switching, that is something that we, as I said, we observed, you know, especially as two products then became available.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

It just kinda drove where physicians are choosing to use KOMZIFTI based on the profile. I think that's going to be probably less of a trend than the combination use that we expect to go forward. Nevertheless, it does demonstrate the strength of the KOMZIFTI profile and really I think supports the strong initial early momentum we've had in this first quarter of launch.

[Jonathan Chang, Analyst at Leerink Partners]

Understood.

[Operator]

Your nex-

[Jonathan Chang, Analyst at Leerink Partners]

Thanks for taking my question.

[Operator]

Your next question will come from Etzer Darout with Barclays. Etzer, feel free to unmute and ask your question.

[Etzer Darout, Analyst at Barclays]

Great. Thanks for taking the question. Congrats on the quarter. Just a follow-up on a question. If maybe you could comment on the primary reason patients have been switching from other menin inhibitors. Not sure how much data point you've gotten at this point, but just wondered if something you could comment on. Thank you.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

I don't think I can. Thanks for the question Etzer. I don't think I can go into the detail of each patient that switched really. It's probably more at a high level. We're seeing that physicians now, they have a choice between multiple menin inhibitors, and there have been physicians who've chosen to switch those patients from another menin inhibitor to give them the opportunity to benefit from KOMZIFTI. It's could be based on the profile, based on, you know, whatever the decision the physician feels, based on if it's efficacy, the safety profile, the simplicity of use. All of those things are what we've heard has resonated from a number of physicians.

[Troy Wilson, President and CEO at Kura Oncology]

Yeah, Etzer, just to jump in for a second, and build on that. I mean, the switching is to some extent what we expected. You know what? I agree with Brian Powl. I don't think it's probably the most significant aspect. What we draw your attention to is, as Brian Powl said in his prepared remarks, the new patient starts. You know, the other menin inhibitor had approximately 130 new patient starts. We've had 85 in our first full quarter. That's about 40%. Given that the story prior to this was kind of a winner take it all, we think we've got, you know, really strong momentum, to be able to take, you know, leading market share in NPM1. You are gonna see some switching.

[Troy Wilson, President and CEO at Kura Oncology]

I mean, as we've said, we think we have the superior overall profile, but where we really think you're gonna see it is in the new patient, you know, increased new patient starts. Again, use in combination, although that's not our labeled indication. You know, that's physician discretion. Those are some of the elements we draw folks' attention to.

[Etzer Darout, Analyst at Barclays]

Great. Thanks for the color.

[Operator]

Your next question will come from Reni Benjamin with Citizens.

[Reni Benjamin, Analyst at Citizens JMP Securities]

Hey, good afternoon, guys. Thanks for taking the questions, and congrats on the progress. Maybe just sticking with the new patient starts, you know, any other or additional color you can provide, anything regarding gross to net dynamics? When you talk about the 157 total prescriptions, are these you know, are the scripts typically like 1 month in average? Are they 3 months in average? Can you give us some sort of details there? Just, you know, if I can throw 1 more in regarding the commercialization. You said 60 activated accounts. Brian, what's kind of the total number of accounts that you're targeting? You know, just to give us a sense as to where we are in the cycle. Thanks.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Yeah, sure. Thanks for the question, Reni Benjamin. You know, with regards to these new patient starts, the color we're seeing, and I shared a little bit, these are, you know, the relapse refractory patients to kind of fit across we're seeing it across accounts that are either, you know, KOMZIFTI trial sites. We're seeing it from those who have experience with other menin inhibitors, as well as those who haven't had any experience.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

What we're seeing is, you know, a very strong start this early on that we're able to get, as Troy mentioned, you know, 40% of the kinda new patient starts in this first quarter alone, gives us a lot of confidence that there are patients out there who may benefit from KOMZIFTI, and we're very pleased with the opportunity we have to move forward with that at this point in time. We do said, and as I've mentioned in the remarks, we're gonna continue to see quarter-on-quarter growth. We'll continue to go deeper into other accounts and ultimately become the market leader in this space, you know, based on that menin class share. We're very encouraged by the start right now. We look forward to that in the future.

[Troy Wilson, President and CEO at Kura Oncology]

Ren.

[Reni Benjamin, Analyst at Citizens JMP Securities]

Just any-

[Troy Wilson, President and CEO at Kura Oncology]

the scripts are one month, right?

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Oh, yeah.

[Troy Wilson, President and CEO at Kura Oncology]

These are one-month scripts, so.

[Reni Benjamin, Analyst at Citizens JMP Securities]

Got it. The gross to net dynamics?

[Tom Doyle, SVP of Finance and Accounting at Kura Oncology]

Thanks, Ren, for this, that question. Those are within normal ranges, so in that 20%-30% range.

[Reni Benjamin, Analyst at Citizens JMP Securities]

Excellent. Thanks very much, guys.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Thanks, Ren.

[Operator]

Your next question will come from Roger Song with Jefferies.

[Nabil Belhadj, Analyst at Jefferies]

Hey, team. Thanks for taking our question. This is Nabil on for Roger. Encouraged to hear on the open label, the combo use at 40% in combination. I'm just kinda curious if you could give us color on how this looks in academic and community settings. As we get more data, the venetoclax publication and then the second-half data with the FLT3 combo, how do we expect this to sort of evolve, and does the KOMZIFTI have any advantage here?

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Yeah. I mean, I think that as we said, you know, this is our, the combination use is not what we're promoting actively, but it's based on a lot of the data. I think that in the remarks that, as we've shared here, Mollie's remarks around the combination use, this really shows that we have a potential to become that strong leader, both in the relapsed refractory, but in the frontline setting. The data that we'll be presenting in the publication with ven-aza will be coming, as we said, you know, in the first half of the year. We think that will help to draw momentum. Of course, our objective is to submit that to NCCN guidelines, but we can't determine whether or not that will be incorporated.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

We have heard feedback from physicians that the publication of the data are very important for them. We'll see that, plus the potential unique combination to be able to combine with the FLT3 inhibitor, I think also gives us a strong avenue to build strength in a market where there's 50% of the NPM1 patients who have a FLT3 co-mutation, which may be unique to KOMZIFTI's profile to be able to do.

[Operator]

Your next question will come from Philip Nadeau with TD Cowen.

[Philip Nadeau, Analyst at TD Cowen]

Good afternoon, thanks for taking our question, and congrats on the progress. In regards to the frontline data that's gonna be at EHA, we're curious to get your most recent thoughts as to what measures you think investigators and physicians are gonna look to when thinking of adopting the maintenance in the front line. Do you think ultimately the most powerful data will be the durability of the response? Could it be progression to transplant? Ultimately, overall survival? I guess in your conversations, what are physicians evaluating most prominently as they think about moving the maintenance forward? Thanks.

[Troy Wilson, President and CEO at Kura Oncology]

Um-

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

Yeah.

[Troy Wilson, President and CEO at Kura Oncology]

it's a-

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

Sure. I actually think it's a combination of all of those things you said. Ultimately, survival is the primary endpoint. You want these patients to live. There's some ability to get to curative intent with transplant. We want to be able to expand patients' ability to get to curative intent. The durability, I think, is going to be your best prognostic indicator for our ability to increase the survival. I think the MRD negativity is going to be what actually predicts the durability as well. All of them are extremely important. We're seeing extremely high response rates. You'd expect to see maybe 70%-80% of patients having a complete response with 7+3. We're seeing things in the high 90s.

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

You'd expect to see about 45% of patients have MRD negativity in the bone marrow, and we're seeing that in the 80s. Again, I think that all signs are pointing to these patients having really strong, really deep responses and a great chance of having an effect on survival overall.

[Philip Nadeau, Analyst at TD Cowen]

That's very helpful. Thank you.

[Troy Wilson, President and CEO at Kura Oncology]

Thanks, Will.

[Operator]

Your next question will come from Salim Syed with Mizuho.

[Salim Syed, Analyst at Mizuho]

Great. Congrats on the quarter, guys, and thanks for the question. I guess one for us on that 40% number, Troy, could you maybe comment on the cadence through the quarter? Is that something that is also representative of your exit MRD share for NPM1, or was it higher kinda coming out of the quarter? Similarly, I guess, is that similar to the dynamics you're seeing for this current quarter? Thank you.

[Troy Wilson, President and CEO at Kura Oncology]

Yeah, Salim. I mean, we're talking about small numbers. Our goal here is to be the market leader in relapsed refractory NPM1. You know, that's 51% or more. I think you're gonna see us push that as high as we can. You know, there's, as you know, I mean, you've been doing this a long time, there's a lot of variability week to week, month to month. What I think we're really encouraged by is, you know, we're second to market behind another product that's been on the market now for 15 months, and we've taken 40% of new patient starts in the first full quarter. That's what we set out to do. That's, you know, that's just the beginning. I think we're very optimistic.

[Troy Wilson, President and CEO at Kura Oncology]

You're hearing it, whether it's in the performance of the field force and the commercial team, whether it's the EHA abstract. This, you know, ziftomenib or KOMZIFTI in the commercial setting has a real opportunity. You know, look for us to build on that. As Brian said, I think we're just getting started. We're still learning. We're still educating. This is the first step, but I think a very, very encouraging first step.

[Salim Syed, Analyst at Mizuho]

Okay. Sounds good. Thanks so much.

[Troy Wilson, President and CEO at Kura Oncology]

Sure. Thanks for the question.

[Operator]

As a reminder, if you'd like to ask a question, please use the Raise Hand icon, which can be found at the bottom of your webinar application. Our next question will come from David Dai with UBS.

[David Dai, Analyst at UBS]

Great. Thanks for taking my questions, and congrats on the quarter. A few questions from me. One is on that $5.8 million revenue, how much of that is inventory stocking? How should we think about the combo use that could extend the duration of therapy beyond the 6 months on monotherapy? Lastly, do you think the patients would actually continue to use menin inhibitors beyond progression?

[Troy Wilson, President and CEO at Kura Oncology]

Just a reminder to everybody, David, I'm gonna I don't mean to single you out, but we're trying to limit people to one question. There isn't any meaningful stocking. I mean, this is You can see this in the numbers. Brian, maybe you can speak to durability, the question on durability of the combo.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

Yeah. I mean, I think that, as I said earlier, David, I think the duration of treatment is something we'll be seeing over time. It's difficult to say within a first full quarter of how much that duration is used. Our expectation is that patients who are on therapy in combination will likely have a longer duration. We need a little more time to play that out, 'cause you need to understand which type of patients are getting on therapy. Is it more the second line versus third or fourth line or something? Those are the things that we're tracking. We're pleased with where we're heading now. I could ask if we could get 2 more quarters under our belt to get a better sense on what that durability could be.

[Brian Powl, Chief Commercial Officer at Kura Oncology]

We would reiterate that we believe that this overall market opportunity in the relapsed refractory setting still remains around that $350 million-$400 million.

[Troy Wilson, President and CEO at Kura Oncology]

David, what I might add to that is we were not surprised to see some spontaneous combination usage. I think we were pleasantly surprised to see physicians choosing to combine with gilteritinib, given that we're not even planning to present that data until sort of toward the end of the year. Given the, you know, given the overall profile, the combinability of ziftomenib, it's nice that physicians have that option for their patients, and we're starting to see that kind of work its way into the commercial setting. That's very gratifying. It's not anything we're promoting, but it is nice to see.

[David Dai, Analyst at UBS]

I thank you so much for taking the time to ask my questions.

[Troy Wilson, President and CEO at Kura Oncology]

Sure.

[Operator]

Your next question will come from Daniel Brims with Lake Street.

[Daniel Brims, Analyst at Lake Street Capital Markets]

Thanks, thanks for taking my questions. Congratulations on the strong launch. For ASCO, I was just curious, will we be seeing any monotherapy data there or just combination data for darlifarnib with adagrasib?

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

We've actually previously presented the monotherapy data last year. To give you an idea of the really wide therapeutic window that we have with the monotherapy, balancing both efficacy and safety so that we'll be able to do an extensive amount of combinations over time. At the ASCO presentation, you're going to see it in combination with the KRAS inhibitor adagrasib. You will see dose escalation data. You will see it across multiple tumor types, including non-small cell lung, PDAC, and colorectal cancer. We're very excited to be able to share this with you, kind of our third installment of the RAS/mTORC inhibition pathway that is helping to overcome adaptive and innate resistance for these patients suffering from cancer.

[Daniel Brims, Analyst at Lake Street Capital Markets]

Thanks.

[Operator]

Your next question will come from Peter Green with LifeSci Capital.

[Peter Green, Analyst at LifeSci Capital]

Hi, this is Peter again on for Charles. Just wondering, you mentioned that the KOMET-017 trial is enrolling ahead of schedule. Just wondering if there's any more details on that, what you're hearing from investigators. And then remind me, does that change, you know, any guidance for a potential, you know, future readouts? Thanks.

[Troy Wilson, President and CEO at Kura Oncology]

Yeah, maybe Mollie can speak to anything we're hearing, Peter, then I can address your question about guidance. Mollie?

[Mollie Leoni, Chief Medical Officer at Kura Oncology]

All we hear is excitement. Excitement for new sites to get up and running, new regions to get up and running. I can tell you that participation both in the U.S., Europe and Asia is extremely strong and has come to that level of strength very quickly. I would say KOMET-007 was a great indicator of how quickly we could enroll, you know, 200 patients into a phase I trial. The phase III is going incredibly well, and it's really well-predicted by that enrollment rate we saw in KOMET-007.

[Troy Wilson, President and CEO at Kura Oncology]

On the guidance question, Peter, we haven't changed anything at this point. We've guided to the initial top-line results from the intensive chemotherapy combo in 2028. We haven't been more specific. You know, we might tighten that up as we get closer. I will highlight we're significantly ahead, as far as we can tell, the competition in that setting. Even in the ven-aza setting, which is the other side of KOMET-017, you know, the team is making just incredible progress. You know, really credit to Mollie for combining these two phase IIIs into a single protocol, such that every time we activate a clinical site, we're getting, you know, two phase III starts for the price of one.

[Troy Wilson, President and CEO at Kura Oncology]

I think you're gonna see that continue to get pulled through. The excitement has just been, you know, palpable. We did an investigator meeting recently and it was incredibly well-attended and well-received. Onward we go.

[Operator]

There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.

[Troy Wilson, President and CEO at Kura Oncology]

Thank you, Layla. Thank you all for joining us today. We're encouraged by the early performance of the KOMZIFTI launch, the momentum we're seeing across our clinical programs, the clarity of our strategy moving forward. With continued commercial execution, multiple clinical catalysts ahead, including EHA and ASCO, and a strong financial position, we believe Kura's well-positioned to drive meaningful impact for patients and to create long-term value. We look forward to updating you again soon and to engaging with many of you at our upcoming investor event later this month. Thank you all once again, and we'll adjourn.

Participants

Executives

• Brian Powl, Chief Commercial Officer
• Greg Mann, SVP of Investor Relations and Corporate Affairs
• Mollie Leoni, Chief Medical Officer
• Tom Doyle, SVP of Finance and Accounting
• Troy Wilson, President and CEO

Analysts

• Dan Bronder, Analyst at Cantor Fitzgerald
• Daniel Brims, Analyst at Lake Street Capital Markets
• David Dai, Analyst at UBS
• Etzer Darout, Analyst at Barclays
• Jonathan Chang, Analyst at Leerink Partners
• Nabil Belhadj, Analyst at Jefferies
• Peter Green, Analyst at LifeSci Capital
• Philip Nadeau, Analyst at TD Cowen
• Reni Benjamin, Analyst at Citizens JMP Securities
• Salim Syed, Analyst at Mizuho