Q1 2026 Kura Oncology Inc Earnings Call

May 12, 2026

Speaker #1: Good day, everyone. My name is Leila, 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.

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 Q1 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #2: Thank you, Leila. Good afternoon, and welcome to Kura Oncology's first quarter 2026 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer; Brian Powl, Chief Commercial Officer; Dr. Mollie Leoni, Chief Medical Officer; and Tom Doyle, Senior Vice President, Finance and Accounting.

Greg Mann: Thank you, Layla. Good afternoon, welcome to Kura Oncology's Q1 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: With that, I'll call the call over to Troy.

Speaker #3: 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.

Troy Wilson: Thank you, Greg. Good afternoon, everyone. Kura's 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, and over the next 12 to 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. We're seeing repeat prescriptions, we're seeing broad uptake and use expand across treatment centers.

Speaker #3: Our first commercial launch is off to a strong start. Our phase three programs are ahead of plan, and over the next 12 to 24 months, we expect a steady flow of data that we believe will define leadership in the metan inhibitor class.

Speaker #3: Most importantly, we're executing with focus, discipline, and a very clear strategy. Let me start with COM50. In our first full quarter of launch, we generated 5.8 million in net product revenue ahead of expectations.

Speaker #3: But what matters more to us is what's underneath those numbers. We're seeing repeat prescriptions. We're seeing broad uptake, and use expand across treatment centers.

Speaker #3: We're seeing increasing payer preference. And we're seeing early instances of physicians switching patients from other metan inhibitors to COM50. That tells us something important: this is not just a class story based on product profile and we believe COM50 is standing out.

Troy Wilson: 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. Our focus is to expand ziftomenib across the AML treatment continuum and establish it as a backbone therapy in combination.

Speaker #3: 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.

Speaker #3: It's early, but based on what we're seeing, we believe COM50 is well positioned to emerge as a leader in the treatment of adult patients with relapsed, refractory NPM1-mutant AML.

Speaker #3: At the same time, we're not building this as a single indication product. Our focus is to expand the demand across the AML treatment continuum and establish it as a backbone therapy in combination.

Speaker #3: 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 EHOP, publication of our Venetoclax, Azacitidine combination, and initial data from our Guilteritinib combination in relapsed and refractory AML patients with NPM1 and FLIP3 co-mutations.

Troy Wilson: This year, we expect to generate multiple data readouts to support that strategy, including updated data from our 7 plus 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. Beyond AML, we continue to build a broader pipeline with meaningful upside. Darlifarnib is a good example.

Speaker #3: Taken together, these data sets are designed to answer a simple question: can COM50 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.

Speaker #3: In parallel, our frontline phase three program, COMET 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.

Speaker #3: Beyond AML, we continue to build a broader pipeline with meaningful upside. Darla Farnab is a good example. The data we've generated reinforce its mechanism and potential to overcome resistance to targeted therapies.

Troy Wilson: 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 that is 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. The next year or two will determine how it evolves and who leads.

Speaker #3: We'll have additional combination data this year, including NKRAS, G12C mutated cancers, where we think there's an opportunity to open up new treatment approaches across large solid tumor indications.

Speaker #3: So, when we step back, we think Kura is in a very strong position. We have a commercial product that is beginning to gain, or that is gaining, traction and beginning to differentiate in the real world.

Speaker #3: 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.

Troy Wilson: 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. 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.

Speaker #3: The metan inhibitor class in AML is still early. 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.

Troy Wilson: 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.

Speaker #3: With that, I'll turn it over to Brian.

Speaker #2: Thanks, Troy. We're very encouraged by COM50's performance in the first full quarter of launch. And although we're pleased by the first quarter results, we're even more encouraged by the underlying trends driving that revenue.

Brian Powl: Thanks, Troy. We're very encouraged by KOMZIFTI's performance in the first full Q1 of launch. Although we're pleased by the Q1 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 leadership in relapsed/refractory NPM1 mutant AML, a $350 to 400 million market opportunity. In the Q1, we generated $5.8 million in net product revenue, with 85 new patient starts and nearly 160 total prescriptions.

Speaker #2: 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.

Speaker #2: Our commercial strategy is focused on three priorities: drive broad awareness of COM50's differentiated profile, deliver strong and consistent quarter-over-quarter growth, and establish leadership in relapse, refractory NPM1-mutant AML, a $350 to $400 million market opportunity.

Speaker #2: In the first quarter, we generated 5.8 million in net product revenue, with 85 new patients starts and nearly 160 total prescriptions. Patients were treated across approximately 60 activated accounts, including Ziftimenib trial sites, other metan experience centers, and accounts new to metan inhibitors.

Brian Powl: Patients were treated across approximately 60 activated accounts, including ziftomenib trial sites, other menin experienced 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. This physician-initiated use reinforces our belief that ziftomenib has potential to be a highly combinable backbone for use across AML patient populations.

Speaker #2: 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 COM50 in real-world practice.

Speaker #2: Second, following our approval, we have observed physicians switching patients from other metan inhibitors to COM50, although still early, this is a meaningful signal that physicians are making active treatment decisions based on the product profile.

Speaker #2: Third, we are aware of early physician-initiated use of COM50 in combination with commonly used agents, including venetoclax, azacitidine, and with gilteritinib in FLT3 co-mutated patients.

Speaker #2: This physician-initiated use reinforces our belief that Ziftimenib 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 COM50.

Brian Powl: 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. We're also seeing favorable formulary positioning and step edit dynamics.

Speaker #2: 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.

Speaker #2: Collectively, these dynamics point to a clear conclusion, increasingly physicians, pharmacists, and nurses are selecting COM50, which offers strong efficacy with a well-characterized and manageable safety profile and convenient once-daily dosing compatible with concomitant therapies.

Speaker #2: 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.

Speaker #2: Achieving this level of access this early in launch, particularly as a second-to-market therapy, reflects the strong payer recognition of COM50's value. We're also seeing favorable formulary positioning and step-edit dynamics.

Speaker #2: I'm thrilled to report more than 10 plans covering more than 12 million lives have placed COM50 in a favorable policy position. These decisions reflect payer recognition of COM50's differentiated profile and the predictability of its cost in managing patients in this setting.

Brian Powl: 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 insta-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.

Speaker #2: Operationally, execution remains strong. Time from prescription to patient receipt is approximately three days, ensuring rapid access to therapy. And our field teams, in collaboration with Keowa Kirin, are driving strong engagement across both academic and community settings.

Speaker #2: 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 COM50 is not just participating in the metan inhibitor class, but is increasingly defining its leadership position in the NPM1 market.

Speaker #2: 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.

Brian Powl: 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.

Speaker #2: 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.

Speaker #3: Thank you, Brian. In 2026, we expect a continued steady cadence of clinically meaningful data for Ziftimenib and Darlaparinib. Our strategy for Ziftimenib is focused on one clear objective: establishing it as a highly active and broadly combinable backbone therapy across the AML treatment landscape, supported by our registrational clinical programs spanning multiple lines of therapy and patient populations.

Mollie Leoni: 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 the 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, 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 dataset will include extended follow-up with a median of approximately 16 months, including treatment course and response durability.

Speaker #3: As treatment paradigms evolve, physicians are increasingly looking for therapies that can be safely and effectively combined with existing standards of care, and Ziftimenib is specifically designed to address that need.

Speaker #3: At the upcoming EHA meeting in June, we plan to present updated data from ziftimenib in combination with seven plus three in newly diagnosed NPM1-mutant and KMT2A-rearranged AML.

Speaker #3: This updated dataset will include extended follow-up with a median of approximately 16 months, including treatment course and response durability. We also expect to publish data showcasing venetoclax and azacitidine in combination with ziftimenib in relapsed or refractory NPM1 mutant AML.

Mollie Leoni: We also expect to publish data showcasing venetoclax and azacitidine in combination with ziftomenib in relapsed/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 venetoclax 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 H2 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.

Speaker #3: These data expand upon our presentation of ASH 2025, where we reported a striking 70% composite CR rate in patients without prior Venetoclax exposure. This is an important regimen as venazar remains a widely used standard of care.

Speaker #3: In parallel, we are advancing combinations with FLIP3 inhibitors. As a reminder, FLIP3 mutations occur in approximately one-third of AML patients and notably half of NPM1 mutant patients have FLIP3 co-mutations.

Speaker #3: We anticipate preliminary data in the second half of the year from Ziftimenib in combination with Guilteritinib in relapsed or refractory NPM1 mutant FLIP3 mutated AML.

Speaker #3: We are also evaluating Ziftimenib in combination with Quizartinib in the newly diagnosed setting. As a whole, these data are building a consistent picture. Ziftimenib can be integrated across multiple treatment approaches without compromising safety or activity in clinical studies.

Mollie Leoni: 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 US, 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.

Speaker #3: An attribute we believe will be essential for long-term use in both relapsed and frontline settings. Turning to our frontline development program, our common 017 trial is an innovative one-stop-shop design which enables simultaneous enrollment into two independent phase three trials at each activated site.

Speaker #3: 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.

Speaker #3: 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 metan inhibition and the confidence investigators have in Ziftimenib's profile.

Speaker #3: Particularly, its potential to be combined with standard frontline regimens. Beyond AML, we continue to explore the broader opportunity of metan inhibition. Our study evaluating Ziftimenib plus Imatinib in GIST is progressing well and we hope to provide updates when appropriate.

Mollie Leoni: 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 darlafarnib, 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 reinduce responses with the same TKI after progression. These findings support the role of the mTORC1 resistance pathway and reinforce potential for darlafarnib to restore sensitivity to targeted therapies. Enrollment in the phase I-B portion of the darlafarnib plus cabozantinib trial is now underway.

Speaker #3: In addition, we are evaluating the role of metan inhibition in other solid tumors. And turning to Darlaparinib, which also continues to make important progress.

Speaker #3: Recent data presented at the International Kidney Cancer Symposium provided clear proof of mechanism demonstrating activity in cabozatinib pretreated clear cell renal cell carcinoma a setting where clinicians would not typically expect to reinduce responses with the same TKI after progression.

Speaker #3: These findings support the role of the RevMTORC1 resistance pathway and reinforce the potential for Darlaparinib to restore sensitivity to targeted therapies. Enrollment in the phase 1b portion of the Darlaparinib plus cabozatinib trial is now underway.

Speaker #3: In addition, we intend to present an update on the full phase one A dataset later this year. We see combinations of FTIs and KRAS inhibitors as a potential next advance for patients.

Mollie Leoni: In addition, we intend to present an update on the full phase I-A dataset 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, we look forward to discussing that data at a virtual event on 3 June. 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.

Speaker #3: At ASCO, we will present preliminary data evaluating Darlaparinib plus Adagrasib and KRAS G12C mutated solid tumors and we look forward to discussing that data at a virtual event on June 3rd.

Speaker #3: 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.

Speaker #3: And with that, I'll turn the call over to Tom for financial updates.

Speaker #2: 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 COMZ sales was $5.8 million, compared to none for the first quarter of 2025.

Tom Doyle: Thank you, Mollie. I'm happy to provide a brief overview of our financial results for Q1 2026. Our net product revenue from KOMZIFTI sales was $5.8 million compared to 0 for Q1 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 Q1 2025. The increase was driven by ziftomenib combination trials, including the start of enrollment in our KOMET-017 trials in H2 2025. Selling, general, and administrative expenses were $31.6 million compared to $22.8 million for Q1 2025. This increase was driven by the commercial launch of KOMZIFTI.

Speaker #2: Collaboration revenue from our Keogh-Carron 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.

Speaker #2: The increase was driven by Ziftimenib combination trials, including the start of enrollment in our KOMET-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.

Speaker #2: This increase was driven by the commercial launch of COMZ. 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.

Tom Doyle: Net loss for Q1 2026 was $73.3 million compared to a net loss of $57.4 million for Q1 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 31 March 2026, Kura had cash equivalents, and short-term investments of $580.8 million compared to $667.2 million as of 31 December 2025. We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 to 55 million in 2026, $90 to 110 million in 2027, and $90 to 110 million in 2028.

Speaker #2: 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, cash equivalents, and short-term investments of $580.8 million, compared to $667.2 million as of December 31st, 2025.

Speaker #2: We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 to $55 million in 2026, $90 to $110 million in 2027, and $90 to $110 million in 2028.

Speaker #2: This revenue reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Keogh-Carron. Current cash, cash equivalents, and short-term investments as of March 31st, 2026, together with anticipated payments of $180 million under our collaboration agreement with Keogh-Carron, are expected to fund our Ziftimenib AML program through the first top-line phase three results from common 017 anticipated in 2028.

Tom Doyle: 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 31 March 2026, together with anticipated payments of $180 million under our collaboration agreement with Kyowa Kirin, are expected to fund our ziftomenib AML program through the first top-line phase III results from KOMET-017 anticipated in 2028. With that, I'll turn the call back over to Troy Wilson.

Speaker #2: With that, I'll turn the call back over to Shori.

Speaker #3: Thank you, Tom. As I said at the outset, companies firing on all cylinders are first commercial launch is off to a strong start. Our phase three 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 Ziftimenib in the metan inhibitor class.

Troy Wilson: 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 in 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.

Speaker #3: With that, we'll conclude our prepared comments and we're happy to Layla to open the call up for questions.

Speaker #1: 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.

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 Li Watsek with Cantor. You may now unmute and ask your question.

Speaker #1: When you are called on, please unmute your line and ask your question. We will now pause a moment to assemble the queue. And again, we ask that you please limit yourself to one question.

Speaker #1: You're welcome to then re-enter the queue for any follow-up questions. Our first question will come from Li Watsek with Cantor. You may now unmute and ask your question.

Daniel Brims: Hey, team. This is Daniel Brims on for Li Watsek. Thanks so much for taking our questions. 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 we have patients on monotherapy as well as some that might be receiving combination? We'd greatly appreciate it. Thank you.

Speaker #4: Hey team, this is Dan Brunder on for Li Watsek. Thanks so much for taking our question and congrats on the update and the commercial launch.

Speaker #4: Can you give us some color on how we should think about the duration of treatment with COMZIFT early on, given that it sounds like you have patients on monotherapy as well as some that might be receiving combination? That would be greatly appreciated.

Speaker #4: Thank you.

Speaker #2: Sure, Dan. Thanks for the question. Let me ask Brian if he can speak to that.

Troy Wilson: Sure, Dan. Thanks for the question. Let me ask Brian if he can speak to them.

Speaker #5: 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 we have one full quarter.

Brian Powl: 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 1 full quarter. We've reiterated before that our expectation is to get around 6 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 starts us off well. What we need to do is really track for several quarters to get a better sense of that.

Speaker #5: 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.

Speaker #5: 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 starts us off well.

Speaker #5: 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.

Speaker #1: Your next question will come from Peter Green with LifeSci Capital.

Peter Green: 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. 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.

Speaker #6: Hi, this is Peter on for Charles. Congrats on the results team. You mentioned a few times that the frontline opportunity and also strong enrollment in common 017 and in light of sorry, EHA abstracts today, I have a question there.

Speaker #6: I'm noticing from last year that complete response rates across both MPM1 mutant and CANT2A rearranged AML—and that's from the frontline for Zifto and in combination with 7 plus 3.

Speaker #6: I'm noticing those CR rates are increasing. I'm also noticing that CR MRD negativity is in MPM1 occurring potentially out to 43 weeks in some patients.

Peter Green: I'm also noticing that CR MRD negativity is, you know, in NPM1 occurring potentially out to 43 weeks in some patients. I guess with all of that said, what have you learned from KOMET-007 about ziftomenib's profile in the front line, 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.

Speaker #6: So I guess with all of that said, what have you learned from common 007 about Zifto's profile in the frontline, especially over longer-term use?

Peter Green: I guess with all of that said, what have you learned from KOMET-007 about ziftomenib's profile in the front line, 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.

Speaker #6: 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?

Speaker #6: Thanks.

Speaker #4: So 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.

Mollie Leoni: 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, 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 front line as well.

Speaker #4: We continue to gather more data and we continue to be extremely encouraged that the way we've designed 007, the data we continue to gather from 007 helps us to really reinforce that we've correctly designed 007 017 so that we can expect great outcomes for these patients in the frontline as well.

Speaker #2: Yeah, Peter, this is Troy. Just to add to Molly'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.

Troy Wilson: 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 front line, 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. You know, this data is pretty unprecedented, and I think very encouraging for the promise of menin inhibitors and the 017 study, as she said.

Speaker #2: 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 Molly said to the durability.

Speaker #2: We're really—this is—this data is pretty unprecedented, and I think very encouraging for the promise of MET inhibitor and the 017 study, as she said.

Speaker #6: Thank you.

Peter Green: Thank you.

Speaker #1: Your next question will come from Jonathan Chang with Lyric Partners.

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

Speaker #7: Hi, guys. Thanks for taking my question. On the COMZIFT launch, can you provide more color on what you're seeing in terms of initial combination use and instances of switching from other MET inhibitors?

Jonathan Chang: 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.

Speaker #7: How common is combination use and switching? Thank you.

Speaker #2: Yes, thanks for that question, Jonathan. Yeah, so what I can share about the combination use of for this, of course, as you know, our promotional teams, our commercial teams are focusing on promoting on label as a monotherapy.

Brian Powl: Yes. Thanks for that question, Jonathan. What I can share about the combination use will 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 probably about 40% of patients are 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.

Speaker #2: 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 COMZIFT in combination, either with veneza or in those flip-free co-mutated, also with kilteritinib.

Speaker #2: So that's what we're seeing early on. I think that getting to the expectation of how those patients will do is something we'll follow. And regarding your question around switching, that is something that we as I said, we observed especially as two products then became available.

Brian Powl: Especially as two products then became available, 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 Q1 of launch. Thanks for taking my question.

Speaker #2: It just kind of drove where physicians are choosing to use COMZIFT 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, but nevertheless, it does demonstrate the strength of the COMZIFT profile and really, I think, supports the strong initial early momentum we've had in this first quarter of launch.

Speaker #7: Understood. Thanks for taking my question.

Speaker #1: Your next question will come from Etcher DeRoot with Barclays. Etcher, feel free to unmute and ask your question.

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

Etzer Darout: Great. Thanks for taking the question. Congrats on the quarter. Just a follow-up on the 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.

Speaker #8: Great. Thanks for taking my question. Congrats to my quarter. Just a follow-up on a question. Maybe you could comment on the primary reason patients have been switching from other metan inhibitors.

Speaker #8: Not sure how much data point you've gotten at this point, but just wondered if something you could comment on. Thank you.

Speaker #2: Yeah, I don't think I can thanks for the question there, Etcher. I don't think I can go into the detail of each patient that switched really.

Brian Powl: Yeah. Thanks for the question, Etzer Darout. 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.

Speaker #2: It's probably more at a high level. We're seeing that physicians now, they have a choice between multiple metan inhibitors. And there have been physicians who've chosen to switch those patients from another metan inhibitor to give them the opportunity to benefit from COMZIFT.

Speaker #2: So it could be based on the profile, based on whatever decision the physician feels—based on if it's efficacy, the safety profile, the simplicity of use.

Speaker #2: All of those things are what we've heard is resonated from a number of physicians.

Speaker #8: Yeah, Etcher, just to jump in for a second and build on that. I mean, the switching is to some extent what we expected. I agree with Brian.

Troy Wilson: 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, I agree with Brian. I don't think it's probably the most significant aspect. What we draw your attention to is, as Brian 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 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.

Speaker #8: I don't think it's probably the most significant aspect. What we draw your attention to is, as Brian said in his prepared remarks, the new patient starts.

Speaker #8: The other metan 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 all, we think we've got really strong momentum.

Speaker #8: To be able to take leading market share in NPM1. You are going to see some switching. I mean, as we've said, we think we have the superior overall profile.

Troy Wilson: 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.

Speaker #8: But where we really think you're going to see it is in the new patient increased new patient starts again, use in combination, although that's not our labeled indication.

Speaker #8: That's physician discretion. Those are some of the elements we draw folks' attention to. Great. Thanks for the color.

Etzer Darout: Great. Thanks for the color.

Speaker #1: Your next question will come from Rennie Benjamin with Citizens.

Operator: Your next question will come from Reni Benjamin with Citizens.

Speaker #6: Very good afternoon, guys. Thanks for taking the questions and congrats on the progress. Maybe just sticking with the new patient starts. I guess any other or additional color you can provide, anything regarding growth to net dynamics, and when you talk about the 157 total prescriptions, are these are the scripts typically like one month on average?

Reni Benjamin: Hey, good afternoon, guys. Thanks for taking the questions, congrats on the progress. Maybe just sticking with the new patient starts. You know, I guess any other or additional color you can provide, anything regarding gross to net dynamics. When you talk about the 157 total prescriptions, 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 one 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.

Speaker #6: Are they three months on average? Can you give us some sort of details there? And just, if I can throw one more in regarding the commercialization—you said 60 activated accounts.

Speaker #6: Brian, what's kind of the total number of accounts that you're targeting? Just to give us a sense as to where we are in the cycle.

Speaker #6: Thanks.

Speaker #2: Yeah, sure. So thanks for the question, Rennie. So with regards to these new patient starts, the color we're seeing, and I shared a little bit, these are the relapse refractory patients to kind of fit across that we're seeing it across accounts that are either COMZIFT trial sites.

Brian Powl: Yeah, sure. Thanks for the question, Ren. 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 relapsed refractory patients that 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.

Speaker #2: We're seeing it from those who have experience with other metan inhibitors as well as those who haven't had any experience. What we're seeing is very strong start.

Brian Powl: What we're seeing is, you know, very strong start, this early on that we're able to get, as Troy mentioned, you know, 40% of the, kind of new patient starts in this Q1 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 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 the, 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.

Speaker #2: This early on that we're able to get is Troy mentioned, 40% of the kind of new patient starts in this first quarter alone. Gives us a lot of confidence that there are patients out there who may benefit from COMZIFT, and we're very pleased with the opportunity we have to move forward with that at this point in time.

Speaker #2: We do said, and as I've mentioned in the remarks, we're going to 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 based on that metan class share.

Speaker #2: So we're very encouraged by the start right now. We look forward to that in the future.

Speaker #8: And Rennie, the scripts are one month, right? These are one month scripts, so.

Troy Wilson: Reni,

Reni Benjamin: Just any-

Troy Wilson: The scripts are 1 month, right?

Brian Powl: Oh, yeah.

Troy Wilson: These are one-month scripts.

Speaker #6: Got it. And the growth to net, dynamics?

Reni Benjamin: Got it. The gross to net dynamics?

Brian Powl: Thanks, Ren, for that question. Those are within normal ranges, so in that 20% to 30% range.

Speaker #8: Thanks, Rennie, for that question. Those are within normal ranges. So in that 20 to 30 percent range.

Brian Powl: Thanks, Ren, for that question. Those are within normal ranges, so in that 20% to 30% range.

Speaker #6: Excellent. Thanks very much, guys.

Reni Benjamin: Excellent. Thanks very much, guys.

Speaker #8: Thanks, Brian.

Brian Powl: Thanks, Ren.

Speaker #1: Your next question will come from Roger Song with Jefferies.

Operator: Your next question will come from Roger Song with Jefferies.

[Analyst] (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'd give us color on how this looks in academic and community settings. Then as we get more data, the venetoclax publication and then the H2 data with the FLT3 combo, how do we expect this to sort of evolve, and does KOMZIFTI have any advantage here? Thank you.

Speaker #7: 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.

Speaker #7: So I'm just kind of curious if you could give us color on how this looks in academic and community settings, and then as we get more data, the Veneza publication, and then the second half data with the FLIT3 combo, how do we expect this to sort of evolve and does COMZIFT have any advantage here?

Speaker #2: Yeah, so I mean, I think, as we said, this combination use is not what we're promoting actively, but it's based on a lot of the data.

Brian Powl: 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 venetoclax will be coming, as we said, you know, in H1. 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.

Speaker #2: 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 relapse refractory but in the frontline setting.

Speaker #2: The data that we'll be presenting in the publication with Veneza will be coming as we said in the first half of the year. We think that will help to draw momentum.

Speaker #2: Of course, our objective is to submit that to NCCN guidelines, but we can't determine whether or not that will be incorporated. But we have heard feedback from physicians that the publication of the data are very important for them.

Brian Powl: 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.

Speaker #2: So 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 commutation.

Speaker #2: Which may be unique to COMZIFT's profile to be able to do.

Speaker #1: Your next question will come from Phil Nadeau with TD Cowen.

Operator: Your next question will come from Phil Nadeau with TD Cowen.

Speaker #9: Good afternoon and thanks for taking our question and congrats on the progress. In regards to the frontline data that's going to be at eHealth, we're curious to get your most recent thoughts as to what measures you think investigators and physicians are going to look to when thinking of adopting the metanins in the frontline.

Phil Nadeau: 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 frontline. 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.

Speaker #9: 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 metanins forward?

Speaker #9: Thanks.

Brian Powl: Um-

Mollie Leoni: Yeah. 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, 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% to 80% of patients having a complete response to 7 plus 3, and we're seeing things in the high 90s.

Speaker #3: 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.

Speaker #3: There's some ability to get to curative intent with transplant. And we want to be able to expand patients' ability to get to curative intent.

Speaker #3: So the durability, I think, is going to be your best prognostic indicator for our ability to increase the survival. And I think the MRD negativity is going to be what actually predicts the durability as well.

Speaker #3: So all of the more extremely important we're seeing extremely high response rates you'd expect to see maybe 70 to 80 percent of patients having a complete response to seven plus three.

Speaker #3: And we're seeing things in the high 90s. You'd expect to see about 45% of patients have MRD negativity in the bone marrow. And we're seeing that in the 80s.

Mollie Leoni: 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.

Speaker #3: So 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.

Speaker #9: That's very helpful. Thank you.

Phil Nadeau: That's very helpful. Thank you.

Speaker #8: Thanks.

Brian Powl: Thanks, Phil.

Operator: Your next question will come from Salim Syed with Mizuho.

Speaker #1: Your next question will come from Selim Syed with Mizuho.

Salim Syed: Great. Congrats on the quarter, guys, and thanks for the question. Just 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 NBRx 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.

Speaker #6: 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?

Speaker #6: Is that something that is also representative of your exit NBRX share for NPM1? Or was it higher kind of coming out of the quarter and similarly, I guess, is that similar to the dynamics you're seeing for this current quarter?

Speaker #6: Thank you.

Speaker #8: Yeah, Selim. I mean, we're talking about small numbers. Our goal here is to be the market leader in relapse refractory NPM1. That's 51% or more.

Troy Wilson: 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, 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.

Speaker #8: I think you're going to see us push that as high as we can. As you know, I mean, you've been doing this a long time.

Speaker #8: There's a lot of variability week to week, month to month. What I think we're really encouraged by is we're second to market behind another product that's been on the market now for 15 months.

Speaker #8: And we've taken 40% of new patient starts in the first full quarter. That's what we set out to do. That's just the beginning. I think we're very optimistic.

Speaker #8: You're hearing it, whether it's in the performance of the field force and the commercial team, whether it's the eHealth abstract, this ZIP to meta or COMZIFT in the commercial setting has a real opportunity.

Troy Wilson: 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.

Speaker #8: So 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.

Speaker #9: Okay. Sounds good. Thanks so much.

Salim Syed: Okay, sounds good. Thanks so much.

Speaker #8: Sure. Thanks for the question.

Troy Wilson: Sure. Thanks for the question.

Speaker #1: 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.

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.

Speaker #1: Our next question will come from David Dye with UBS.

Speaker #6: Great. Thanks for taking my questions and class on the quarter. So a few questions for me. One is on that 5.8 million revenue. How much of that is inventory stocking?

David Dai: 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 could extend the duration of therapy beyond the 6 months on therapy? Lastly, do you think the patients will actually continue to use menin inhibitors beyond progression?

Speaker #6: And then how should we think about the combo used to extend the duration of therapy beyond the six months on monotherapy? And then lastly, do you think the patients will actually continue to use meta inhibitors beyond progression?

Speaker #8: So just a reminder to everybody—David, I don't mean to single you out—but we're trying to limit people to one question. So there isn't any meaningful stacking.

Troy Wilson: Just a reminder to everybody. David Dai, I don't mean to single you out, but we're trying to limit people to 1 question. There isn't any meaningful stocking. I mean, this is you can see this in the numbers. Brian Powl, maybe you can speak to durability, the question on durability of the combo.

Speaker #8: I mean, you can see this in the numbers. But Brian, maybe you can speak to durability of the question on durability of the combo.

Speaker #9: 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.

Brian Powl: I mean, I think that, as I said earlier, David Dai, 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 because you need to understand what type of patients are getting on therapy. Is it more 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 a couple more quarters under our belt to get a better sense on what that durability could be.

Speaker #9: Our expectation is that patients who are on therapy in combination will likely have a longer duration. But we need a little more time to play that out because you need to understand what type of patients are getting on therapy.

Speaker #9: Is it more of 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.

Speaker #9: But I could ask if we could get a couple more quarters under our belt to get a better sense on what that durability could be.

Speaker #9: But we would reiterate that we believe that this overall market opportunity in the relapse refractory setting still remains around that 350 to 400 million dollars.

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

Speaker #8: Yeah. 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.

Troy Wilson: 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 Komzifti, 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.

Speaker #8: But given the overall profile, the combinability of ZIPTO, 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.

Speaker #8: That's very gratifying. It's not anything we're promoting, but it is nice to see.

Speaker #6: Thank you so much for taking the time to ask my questions.

David Dai: Thank you so much for taking the time to ask my questions.

Speaker #8: Sure.

Troy Wilson: Sure.

Speaker #1: Your next question will come from Daniel Brims with Lake Street.

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

Speaker #9: 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 Darla Farnett with Adagrasib?

Daniel Brims: 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?

Troy Wilson: Molly?

Speaker #8: So yeah. So we've actually previously presented the monotherapy data. Last year, and 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.

Mollie Leoni: We did. Yeah. 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, and 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 mTORC inhibition pathway that is helping to overcome adaptive and innate resistance for these patients with suffering cancer.

Speaker #8: At the ASCO presentation, you're going to see it in combination with the KRAS inhibitor, Adagrasib. You will see dose escalation data, and you will see it across multiple tumor types, including non-small cell lung, PDAC, and colorectal cancer.

Speaker #8: And we're very excited to be able to share this with you, kind of our third installment of the RevMTORC inhibition pathway that is helping to overcome adaptive NN8 resistance for these patients suffering from cancer.

Speaker #9: Thanks.

Daniel Brims: Thanks.

Speaker #1: Your next question will come from Peter Green with LifeSci Capital.

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

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

Speaker #10: Hi, this is Peter again on for Charles. Just wondering, you mentioned that the comment 017 trials involving ahead of schedule. Just wondering if there's any more details on that.

Speaker #10: What you're hearing from investigators and then remind me does that change any guidance for potential future readouts? Thanks.

Speaker #8: Yeah, maybe Mollie can speak to anything we're hearing. Peter, and then I can address your question about guidance. Mollie?

Troy Wilson: Yeah. Maybe Mollie can speak to anything we're hearing, Peter, and then I can address your question about guidance. Mollie?

Speaker #1: 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 US, Europe, and Asia is extremely strong and has come to that level of strength very, very quickly.

Mollie Leoni: 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 US, Europe, and Asia is extremely strong and has come to that level of strength very, very quickly. I would say double oh seven 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 double oh seven.

Speaker #1: So I would say 007 was a great indicator of how quickly we could enroll 200 patients into a phase one trial. The phase three is going incredibly well, and it's really well predicted by that enrollment rate we saw in 007.

Speaker #8: And on the guidance question, Peter, we haven't changed anything at this point. We've guided to the initial top-line results. From the first, from the intensive chemotherapy combo, in 2028, we haven't been more specific.

Troy Wilson: 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 2 phase III into a single protocol, such that every time we activate a clinical site, we're getting, you know, 2 phase III starts for the price of one.

Speaker #8: 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.

Speaker #8: But even in the Veneza setting, which is the other side of 017, we make the team is making just incredible progress. And really credit to Molly for combining these two phase threes into a single protocol.

Speaker #8: Such that every time we activate a clinical site, we're getting two Phase 3 starts for the price of one. And so I think you're going to see that continue to get pulled through. The excitement has just been palpable.

Troy Wilson: 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.

Speaker #8: We did an investigator meeting recently, and it was incredibly well attended and well received. So onward we go.

Speaker #1: There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.

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

Speaker #8: Thank you, Leila. And thank you all for joining us today. We're encouraged by the early performance of the COM50 launch, the momentum we're seeing across our clinical programs, the clarity of our strategy moving forward.

Troy Wilson: 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 is 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, we'll adjourn.

Speaker #8: We've continued commercial execution, multiple clinical catalysts ahead, including IHA and ASCO, and a strong financial position we believe cures well-positioned to drive meaningful impact for patients and to create long-term value.

Speaker #8: 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.