At this time, I would like to welcome you to the Kura Oncology FDA Approval conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question, please use the raise hand function at the bottom of your Zoom screen, which can be found at the bottom of your webinar application. To allow everybody 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 from Kura Oncology. Thank you, Operator. Good day to all. I'm Greg Mann, Senior Vice President, Investor Relations and Corporate Affairs at Kura Oncology. Welcome to our conference call to discuss the FDA approval of ziftomenib. Today's press release, the U.S. prescribing information, and the slides we'll be reviewing today are available on our website, www.kuraoncology.com. Joining our call today are Dr. Troy Wilson, President and Chief Executive Officer of Kura; Dr. Mollie Leoni, Chief Medical Officer; Brian Powl, Chief Commercial Officer; and our guest speaker, Dr. Eunice Wang, Chief of Leukemia Service and Professor of Oncology at the Roswell Park Comprehensive Cancer Center. Before beginning our prepared remarks, we remind you that today's call 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 could 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 now turn the call over to Troy. Thank you, Greg. Today, FDA granted full approval of KOMZIFTI, or ziftomenib, a groundbreaking once-daily oral menin inhibitor for treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, or AML. We believe KOMZIFTI has a best-in-class benefit-risk profile for patients and marks a significant step toward transforming AML treatment. It's noteworthy that KOMZIFTI's PDUFA target action date was November 30th, 2025. The fact that FDA approval came early speaks to the compelling benefit-risk profile for patients. The approval is a pivotal moment for Kura Oncology. With this milestone, we transition into a fully integrated commercial-stage company as we advance the development of KOMZIFTI as well as our robust pipeline of therapeutic programs. Together with Kyowa Kirin, we're committed to delivering KOMZIFTI and improving the lives of patients. We're thrilled for the approval and confident in KOMZIFTI's potential to make an impact for patients. Its favorable benefit-risk profile positions it as a best-in-class menin inhibitor by delivering meaningful efficacy with a differentiated safety profile. KOMZIFTI did not require a box warning for QTc prolongation or Torsades de Pointes. In addition, the KOMZIFTI prescribing information does not require dosage reduction when KOMZIFTI is concomitantly administered with CYP3A4 inhibitors. Although this initial approval in the relapsed refractory setting is an important first step, we believe the greatest potential impact for KOMZIFTI lies ahead. KOMZIFTI is being studied across a range of AML treatment settings, including frontline therapy and combinations with 7+3, venetoclax/azacitidine, as well as FLT3 inhibitors. Supported by its best-in-class balance of safety and efficacy, we believe KOMZIFTI has potential to serve as a foundational therapy for acute leukemias, marking a significant step in redefining the standard of care in AML. I'll now turn it over to Dr. Mollie Leoni, who will review the U.S. prescribing information and key clinical data supporting KOMZIFTI's approval. Following her, Dr. Eunice Wang, Lead Investigator on the KOMET-001 study, will share her insights on the approval's significance for the clinical community. Brian will outline our commercial strategy. Over to you, Mollie. Thank you, Troy, and hello, everyone. At Kura Oncology, we are proud and grateful for the opportunity to deliver KOMZIFTI to our patients. Our heartfelt thanks go to the patients and their families, investigators and their teams, FDA reviewers, our partners and collaborators at Kyowa Kirin, and the dedicated Kura teams whose efforts made the KOMZIFTI approval possible. Relapsed refractory NPM1-mutated AML has been a disease with limited treatment options and poor outcomes, underscoring our determination to make KOMZIFTI available to patients in urgent need. Approximately 20% of patients are refractory to frontline treatment, and 50% of those who do achieve a complete remission will relapse. Despite recent advances, fewer than 10% of these patients will survive five years. NPM1 mutations represent about 30% of AML cases and are among the most common genetic alterations in AML. KOMZIFTI's approval introduces a new once-daily oral treatment offering hope for patients with NPM1-mutated AML. KOMZIFTI is approved for adult patients with relapsed refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Treatment for at least six months is recommended for patients without confirmed disease progression or unacceptable toxicity to allow sufficient time for a clinical response. The recommended dosage is 600 mg once per day, making KOMZIFTI the first and only approved once-daily oral menin inhibitor. The approval of KOMZIFTI is based on data from the KOMET-001 clinical trial, which evaluated KOMZIFTI in 112 patients with relapsed or refractory NPM1-mutated AML at the 600 milligram dose. I'll now summarize some key data from the KOMZIFTI label as shown on slide seven. In 112 patients treated, KOMZIFTI demonstrated a 21.4% complete remission plus complete remission with partial hematologic recovery rate. The median duration of that response was five months, with a median time to response of 2.7 months. Of the patients who achieved a response of CR or CRh, 88% of those patients responded within six months of starting KOMZIFTI therapy. Almost 50% of patients maintained or achieved transfusion independence. Results from KOMET-001, which were recently published in the Journal of Clinical Oncology, provide further insight. Of patients who achieved the response, the median overall survival was 18.4 months compared to 3.5 months for non-responders. A pre-specified subgroup analysis showed consistent response rates across age, performance status, types, and number of prior therapies, and co-mutations. The patient population in KOMET-001 reflects real-world clinical practice, and the consistency of clinical activity underscores KOMZIFTI's broad applicability, offering hope to diverse patient groups within relapsed refractory NPM1-mutated AML. Safety data from the KOMET-001 trial in 112 patients show KOMZIFTI was generally well tolerated, with most adverse reactions being grade one or two. Serious adverse reactions are occurring in more than 5% of patients, including infection without identified pathogen, febrile neutropenia, bacterial infection, differentiation syndrome, and dyspnea. Similar to other differentiating agents, the KOMZIFTI label does include a box warning for differentiation syndrome, or DS. Low frequency and duration of QTc prolongation were observed in the KOMET-001 trial. Importantly, the data did not meet criteria for a box warning. Grade three QTc prolongation of any cause occurred in 8% of patients with no grade four or grade five events. NPM1-mutant patients tend to be older in age at diagnosis. Notably, only 10% of patients over the age of 65 experienced a QTc prolongation of any cause. The mean change in QTc interval across the study population was 7.7 ms, even when including patients on concurrent QTc prolonging drugs such as azole antifungals. While the upper bound of that confidence interval crosses FDA's 10-millisecond threshold for inclusion as a precaution on the label, this degree of change remains well below the 20-millisecond level generally associated with a clinically meaningful increase in cardiac risk. We're already in dialogue with FDA about potential steps post-approval that could help refine the labeling, as some of the observed QTc changes appear to be influenced by concomitant medications rather than by KOMZIFTI itself. KOMZIFTI has no significant drug-drug interactions or DDIs and does not require dosage reduction when concomitantly administered with strong CYP3A4 inhibitors. Patients with AML are often prescribed agents that interact with CYP3A4, such as azole antifungals and calcium channel blockers, as part of supportive care. The absence of significant DDIs is important because a competing menin inhibitor is a sensitive CYP3A4 substrate and requires careful titration and monitoring. KOMZIFTI's lack of clinically meaningful drug-drug interactions enhances its compatibility and combinability with supportive therapy and potential combinability with standard of care AML regimens. Patients with relapsed refractory NPM1-mutant AML deserve new hope. KOMZIFTI's approval marks a turning point, offering a new treatment modality with a strong benefit-risk profile that makes NPM1 mutations actionable for more patients. It is my privilege to introduce Dr. Eunice Wang, Chair of Leukemia Service and Professor of Oncology in the Department of Medicine at the Roswell Park Comprehensive Cancer Center. Dr. Wang is the principal investigator of the KOMET-001 trial and lead author on the recent publication of the KOMET-001 data in the Journal of Clinical Oncology. She will discuss the significance of KOMZIFTI's approval for patients with NPM1-mutated AML. Dr. Wang? Hello. Dr. Wang, you may be on mute. Thank you, Mollie. The FDA approval of KOMZIFTI validates its compelling profile, convenient once-day dosing, deep and durable clinical responses, and its potential compatibility with other anti-leukemic therapies and supportive meds, which are commonly used in this patient population. From a safety and tolerability perspective, treatment-related adverse events are infrequent and manageable with standard concomitant medications. I just wanted to add my thoughts to Mollie's on the importance of the differentiation benefit-risk profile for ziftomenib. This absence of drug-drug interactions and the fact that ziftomenib is not associated with a boxed warning for QTc prolongation and Torsades de Pointes represents a significant clinical benefit for our patients. These patients are frequently on a number of medications which can interact with CYP3A4 and/or prolong the QT interval. As a practicing clinician, if one could choose a menin inhibitor without a drug-drug interaction or a boxed warning, one would prioritize the menin inhibitor with a better benefit-risk profile. This favorable benefit-risk profile of KOMZIFTI has direct relevance to the real world. Several approved AML therapies are CYP3A4 substrates. In the case of a different FDA-approved menin inhibitor, concomitant use with CYP3A4 inhibitors can increase drug exposure and toxicity, including QTc prolongation and the risk of Torsades, and thus every single patient treated with those drugs requires close monitoring. I believe that the interplay between the QTc prolongation and the drug-drug interactions is important across treatment for AML settings. Variability in drug exposure due to drug-drug interactions would be less concerning in the absence of a pronounced risk. Drawing from my multiple extensive years of experience with ziftomenib in clinical practice, I've observed meaningful outcomes for my patients, and I'm exceedingly grateful to have a new option to treat patients. I believe that ziftomenib has the potential to benefit a large number of patients with NPM1-mutated AML. With that, I will hand it back to the Kura team for additional information. Thank you so much, Dr. Wang. With our partner, Kyowa Kirin, we are advancing KOMZIFTI across the AML treatment continuum. Ongoing trials are evaluating KOMZIFTI in frontline, post-transplant maintenance, and relapsed refractory settings combined with 7+3 chemotherapy, venetoclax/azacitidine, FLT3 inhibitors, and other standards of care. Data from the phase I-A, I-B, KOMET-007 trial presented earlier this year showed high rates of complete remission and MRD negativity in newly diagnosed patients with NPM1-mutant and KMT2A rearranged AML treated with KOMZIFTI in combination with 7+3 chemotherapy. Composite CR rates of 93% and 89% were observed in NPM1-mutant and KMT2A rearranged response-available patients, respectively. KOMET-007 also evaluates KOMZIFTI in combination with vene in the frontline and relapsed refractory settings. We're excited to present preliminary vene data next month at the ASH 2025 annual meeting. A new cohort investigating KOMZIFTI with quizartinib, a FLT3 inhibitor in frontline AML patients, is now open. Additionally, our registration-enabling KOMET-017 trial is evaluating KOMZIFTI in newly diagnosed KMT2A rearranged and NPM1-mutant AML in combination with standard of care chemotherapy. To maximize KOMZIFTI's impact, we are continuing to generate and publish robust clinical data. Our medical affairs team will continue to share data with the NCCN Guideline Committee to ensure prescribers are informed about KOMZIFTI's clinical benefits. Our clinical development plan is ambitious and deliberate, aimed at maximizing the potential of KOMZIFTI across lines of therapy, mutational combinations, and standards of care. We're confident in our ability to move our programs forward and widen our lead ahead of others in the field of menin inhibition. Brian Powl will now discuss our strategy and plans for the commercial launch of KOMZIFTI. Brian. Thank you, Mollie. I want to echo what's been said. This is a transformative moment for Kura Oncology. Our commercial team has prepared for this pivotal moment. We built the talent, systems, and strategy needed for a successful U.S. launch of KOMZIFTI. We've worked hand in hand with Kyowa Kirin to align on launch strategy, commercial execution, field engagement, and patient access. Today, our preparations are complete, our teams are ready, and we're confident in our ability to deliver a strong launch for this important new therapy. Market research highlights KOMZIFTI's best-in-class profile and ease of use as highly compelling for prescribers. We believe its proven efficacy, superior safety profile, and once-daily oral dosing will make it the preferred option in the relapsed refractory NPM1-mutated AML setting. We've built a seasoned commercial organization which is fully trained on AML, KOMZIFTI, and its supporting data, and are ready to drive a robust launch. The KOMZIFTI launch is now underway, with product delivery expected within the next few business days. Our energized field teams are actively working to ensure eligible patients can access KOMZIFTI, maximizing the reach and impact. In the next slide, building on Mollie's discussion of the KOMET-001 data and the KOMZIFTI label, we think KOMZIFTI is differentiated on the four pillars of efficacy, safety, compatibility, and simplicity. Our market research supports that this differentiated profile aligns with the priorities of key opinion leaders for a menin inhibitor. We believe the efficacy profile of KOMZIFTI is best in class. KOMZIFTI meets the high bar for monotherapy activity in heavily pretreated patients, including one-third of patients who were treated with KOMZIFTI in the second line where no satisfactory option was available to these relapsed refractory patients, delivering strong CR/CRh rates of five-month median duration of CR/CRh response and improved survival among responders versus non-responders, as demonstrated in our JCO publication. We believe the safety data from KOMET-001 is also best in class. KOMZIFTI has a manageable safety profile, with most adverse events being grade one or two. The KOMZIFTI prescribing information includes clear dose modification guidelines for physicians to follow when DS is suspected. The label is unburdened by the box warning for QTc and Torsades de Pointes, a major advantage in real-world clinical practice. Regarding compatibility, KOMZIFTI's lack of significant DDIs is a key advantage. Unlike other therapies which require dose adjustments when co-administered with anti-infectives, KOMZIFTI can be co-administered without dose modification, offering predictability to practices and reducing complexity and risk. Unlike the other commercially available menin inhibitor, KOMZIFTI does not require extensive monitoring and dose modification when administered with standard supportive therapies. Finally, KOMZIFTI is the only once-daily oral option which is beneficial to patients who are often elderly and on several concomitant medications. To support KOMZIFTI's adoption upon approval, our medical affairs team has been actively engaging with AML key opinion leaders to educate them on the product's emerging clinical profile and the KOMET development program. In parallel, we launched a disease state education campaign to raise awareness on the role of menin inhibition in relapsed refractory AML last year. Our pre-launch research confirms these awareness efforts have generated strong physician enthusiasm, exceeding our expectations. Our commercial strategy positions KOMZIFTI as the menin inhibitor of choice for adult patients with relapsed refractory NPM1-mutated AML, built on three imperatives: drive adoption, ensure broad access, and leverage our partnership with Kyowa Kirin. Our experienced field sales team members were hired and trained this summer. With an average of more than 20 years of industry experience, our outstanding group of sales professionals brings deep hematology expertise as well as established relationships at key institutions to help facilitate uptake. Our field teams will target over 4,000 HCPs to engage with priority accounts and maximize their reach. Their focused messaging will establish that NPM1 is now an actionable mutation, communicate on KOMZIFTI's best-in-class profile as the first and only once-daily oral menin inhibitor, and ensure patients can start and stay on treatment. Speaking to our partnership with Kyowa Kirin, we remain firmly aligned in our mission and culture. Kyowa Kirin's global infrastructure and hematology expertise provide a strong foundation for the KOMZIFTI launch. Kura will benefit from Kyowa Kirin's existing presence in hematology oncology practices and build on their advanced patient-finding capabilities in rare diseases to help identify and engage practices with patients eligible for KOMZIFTI. Between both organizations, we have over 60 highly experienced oncology account managers who will promote KOMZIFTI. Our joint launch readiness meeting was held last month and prepared both teams to introduce KOMZIFTI effectively to HCPs. To ensure broad access, our market access team has educated payers on KOMZIFTI's clinical profile, emphasizing the potential value for AML patients for whom there are limited options. We have engaged in pre-approval information exchanges with the clinical teams at 100% of the targeted payer organizations who are responsible for coverage decisions affecting over 90% of insured lives. We have set a U.S. Launch price for the one-month supply of a once-daily fixed dose of KOMZIFTI at $48,500, reflecting its clinical benefit to patients, prescribers, and the healthcare system. KOMZIFTI is available through a select network of specialty distributors and specialty pharmacies to optimize access, provider satisfaction, and uptake. Our Kura RxKonnect program is now live and offers tailored support for assistance with prior authorization, insurance education and appeals, financial assistance, and patient resources. Shifting now to our market opportunity. Approval in the relapsed refractory AML setting is a critical first step towards establishing KOMZIFTI as a commercial success. Its best-in-class profile in the relapsed refractory NPM1-mutated AML setting positions us to capture significant market share in this high-end med need population. We estimate the U.S. Market for NPM1-mutated relapsed refractory AML is in the range of $350 million-$400 million annually, based upon up to 30% of relapsed refractory AML patients who could benefit from an average of six months of KOMZIFTI treatment. Its efficacy, safety, tolerability, and convenience support this market leadership. This launch will lay the foundation for a larger opportunity for KOMZIFTI in frontline AML, with up to half of the 22,000 annual U.S. AML diagnoses being potentially addressable with a menin inhibitor in combination. We believe KOMZIFTI can become a foundational therapy across newly diagnosed and relapsed refractory AML. Our clinical development plan targets 12-24 months of treatment for these populations, representing a U.S. market potential exceeding $7 billion annually. We are grateful for the opportunity to serve the relapsed refractory NPM1-mutated AML community with KOMZIFTI. Its robust label and compelling value proposition, coupled with our clear commercial strategy and world-class team, position us to launch KOMZIFTI successfully and usher in a new era of AML care with a potentially transformative therapy for patients. I'll now turn the call back to Troy for closing remarks. Thank you, Brian. On behalf of everyone at Kura Oncology, we are honored to deliver KOMZIFTI to the adult AML community. This milestone marks an important next step in our journey to transform AML treatment and to advance KOMZIFTI throughout the continuum of care. Years of focused execution have brought us to today. With a robust commercial strategy and a dedicated and passionate team, we're ready to deliver a successful launch and to drive lasting value. With that, we'll conclude our prepared remarks, and we would welcome your questions. 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 limit yourself to one question, and you're welcome to then re-enter the queue for any follow-up questions. Our first question is from Li Watsek from Cantor Fitzgerald. If you could please unmute your line and ask your question. Hey, team. This is Daniel Bronder on for Lee. First, congratulations on KOMZIFTI's approval. It's a great achievement. Thank you for taking our question. Can you comment on the warning around QTc prolongation and what gives you confidence that at a future time point, it won't get updated or upgraded to a box warning similar to your competitors? Thank you. Yeah. Yeah, Daniel, thank you for the congratulations. Mollie, would you like to take Daniel's question? Yeah. So you know the FDA guidance that I was discussing, it is based entirely on experiments done in healthy volunteers. Ours, of course, was a one-arm study that was done in patients with AML and in patients that are elderly and on many concurrent medications, a lot of which cause QTc prolongation. That being said, the magnitude of the change that we see in patients on these concurrent therapies in their QTc interval is relatively small and is considered not of high, not to be of great clinical risk for patients. It is only once you're crossing that 20-millisecond barrier that there's really an increased risk for sudden cardiac events. With that small change in the QTc interval that was observed in these patients, I think it's extraordinarily unlikely that we will see the QTc labeling become more rigid since it is all completely data-based. As I said during the prepared remarks, we have already started to discuss with the FDA ways to refine the language in the label because we do believe that when we show our patients that are not on these concurrent CYP3A4 inhibitors or that cause QTc prolongation, I'm sorry, that we do not see any change in the QTc interval. As we get more data in settings with placebo-controlled arms, we'll be able to further refine the messaging. Overall, we think that it's demonstrative, the labeling is demonstrative of a relatively low risk for QTc prolongation for these patients. Yeah. Thank you, Mollie. Daniel, I would just add to that. Looking forward to this ASH, we'll see data from us as well as competitors and look at the continued low rates of QTc prolongation in the combinations, as Mollie mentioned. Again, in a single-arm study, you can't exclude, but as you start to look out into a broader and broader data set, I agree with Mollie. I think if anything, we may see a relaxation of the requirements, certainly not a risk of it becoming a more severe restriction. Thanks for the question. Thank you. Thank you. Your next question comes from the line of Jonathan Chang from Leerink Partners. Please unmute your line and ask your question. Hi guys. Congrats on the approval, and thanks for taking my question. I might have missed it, but can you talk about the pricing of KOMZIFTI and maybe help set expectations for your early launch? Yeah. Brian, would you like to take that question? Thanks, Jonathan, for the congrats as well. Yeah. As I said in the prepared remarks, our pricing will be listed for one 30-day supply of KOMZIFTI at $48,500 per bottle. That is based on our research to test kind of the benefit that we would anticipate of KOMZIFTI and has been tested within the competitors within the market. In terms of setting our expectations for launch, as I said in the remarks, our team is ready to go. Product is getting ready to be out in the channel within days. Given that we have had a good dialogue with FDA, the team has been able to do a number of activities at risk that will help us to get product out as quickly as possible. The teams will be certified to launch this week. We'll have an opportunity to get the team out in the field, and we have to start to anticipate that expectation of a launch. It's a little early to say what that comes from from a revenue perspective, as you can imagine, but I think that's the approach we're taking. Understood. Thank you. Thanks, Jonathan. Thank you. Our next question comes from [Mani Benjamin] from JMP Securities. Please unmute your line and ask your question. Hey guys, thanks for taking the questions, and congratulations on this really momentous occasion. The question for me is, when you think about how many patients you treat, what percentage are on these concomitant medications? How many are elderly? Of the patients, maybe this is for Dr. Wang, of the patients you're currently treating, how many would you put on KOMZIFTI? Thank you. Dr. Wang? Go ahead. Sorry. Yeah. I'll take that question. The median age of presentation of acute myeloid leukemia in the general population is 70 years. You can imagine that as the population ages, the majority of these individuals are going to have underlying diseases, including cardiac and other autoimmune diseases, diabetes, hypertension, hyperlipidemia, etc. The overwhelming majority of patients are probably taking multiple other medications, and therefore drug-drug interactions and even the frequency of taking these medications can have a big impact on clinical practice. I do think this is potentially a very differentiating clinical scenario. We also know that given the concomitant cardiac diseases that they have, QTc prolongation can be somewhat onerous. The need for weekly EKGs in our clinical practice and monitoring and differentiating and dose reductions, these are all significant barriers to patients being able to take this drug. These drugs require continued administration for benefit to have the efficacy of the drug be evident because the major mechanism of these drugs is differentiation. You cannot just take them for two or three days and expect to see benefit. You need to have continuous administration and delivery of drug in order to see efficacy. These are clinically very important in our practices. Thanks, Tony. Maybe how many patients? I'm sorry? Just like in your practice, about how many patients would you think would be getting onto KOMZIFTI? I think any patients that, so NPM1-mutated AML represents up to one-third of newly diagnosed patients, and about 50% of them are going to relapse. I am very comfortable starting all of the patients at the time of their relapse on KOMZIFTI in preference to other agents that may or may not be as effective and/or going to provide challenges in terms of weekly management. Thanks. Congratulations. Thanks so much. Thanks, [Mani]. Thank you. Our next question is from Charles Zhu from LifeSci Capital. Please unmute your line and ask your question. Great. Excellent. Thank you for taking the question, and congratulations on the early FDA approval for ziftomenib. I had one. At risk of splitting some hairs, can you talk about some of the nuanced differences between your label versus the competitor's label, specifically on the boxed warning around differentiation syndrome? For whatever reason, it seems the boxed warning seems to have ziftomenib being interrupted on suspected DS, but that's absent from your competitor. Wanted to see, is this a mountain out of molehill, or what's going on here? Thanks. Mollie, do you want to take that? Sure. So you've got eagle eyes. We've already seen that. That was actually something that was part of our differentiation syndrome guidance from the very beginning because ziftomenib has such a long half-life. If they suspect DS, we feel that it is appropriate to interrupt drug while they're evaluating whether or not it is, in fact, DS, just because they will obviously still have drug on board for significant periods of time, even after that interruption, whereas a competitor has an extremely short half-life and thus requires the twice-daily administration. It doesn't really require an interruption because the drug is out of system so quickly. Really, that was our proposed language all along for our treatment of differentiation syndrome, and it was carried over into the label. Got it. Thanks. Thanks, Charles. Thank you. Our next question is from Salim Syed from Mizuho Securities. Please unmute your line and ask your question. Hi. Congratulations on the approval. This is Eric. On for Salim. Just real quickly on the CYP3A strong inhibitors, just could you give any color on the differences between what you've been talking about as not clinically meaningful, CYP3 substrate versus where it is and the language on the label? Thanks. Mollie, do you want to take that? Sure. I think that what you have to notice is that we do not require any dose adjustments for CYP3A4 concurrent inhibitor concurrent administration, which demonstrates, and there is wording, I believe, in the pharmacology portion of the label that states there is no clinically meaningful interaction with CYP3A4 inhibitors. Thus, it is more predictable and easy to treat patients with ziftomenib because most of these patients, or the large number of these patients, will be on concurrent medications that are CYP3A4 inhibitors, and our drug does not need to be adjusted in response to those concurrent medications. Thanks, Eric, for the question. Yep. Thanks. Thank you. Our next question comes from Roger Song from Jefferies. Please unmute your line and ask your question. Great. My congratulations to the earlier approval as well. Thank you for taking the question. I think it will be very good to see how you will refine the label to update the QTc prolongation. Just want to confirm, if that was possible, you will get rid of this monitoring requirement because so far we still see the first four weeks weekly and then later on monthly, the monitoring. Also, another thing for the CYP3A, just want to confirm, you do not require those adjustments, but if you are using the CYP3A, would you be able to dose adjust as you start to see some side effects? Thank you. Mollie, do you want to take that? Sure. During our label negotiations, the real sticking point with regards to the QTc language was around simply the data and the guidance documents that are out there and whether or not this would require any additional monitoring. We have initially discussed with them that their feeling is that because it is a single-arm trial without a placebo control, it is difficult to say definitively whether it is our drug or a concomitant therapy that is causing any QTc prolongation. Again, just looking at the low rates and low level of any QTc prolongation, it becomes obvious that it is not a significant, clinically meaningful, significant adverse event for these patients. We will be generating additional data. We have been generating data in various clinical pharmacology settings and studies that we have ongoing. We will obviously have data from the blinded KOMET-017 trial as it goes on. We do think that there'll be opportunity to help reassure the FDA that our drug does not result in QTc prolongation. That is what I meant by how we'll be able to further refine the label as we move forward and have more data. Yeah. Thank you. Can I make a clinical comment? Thank you. Please, Dr. Wang. Sure. I'm just saying, we have treated potentially more patients with ziftomenib in the clinical trial setting than anyone in the world. Number one, we've never seen any evidence of clinically significant QTc prolongation. Secondly, it's an extremely easy drug to give. If patients are on concomitant meds, we don't have to look at the meds to see whether it needs to be dose-reduced. It's a once-a-day drug, and we do not feel that there needs to be the same adherence to close EKG monitoring as with other drugs. From a clinical perspective, this makes a huge difference. We are not worried that we need to, if a patient goes to see their primary care doctor and they get put on other meds, that we have to do a literature search and see whether they're affecting CYP3A4 and dose-reduce and so forth. Just from clinical practice, it's an extremely easy drug to give, and therefore we feel confident that this would be a significant clinical advance as opposed to other drugs that are in practice. Great. Thank you, Dr. Wang. Thank you. Our next question is from Brad Canino from Guggenheim. Please unmute your line and ask your question. Okay. Hey, hey, team. Congrats on the approval. I recognize some of the comments around kind of working through some labeling updates in the future, but I guess just on the QTc, how do you think the monitoring requirements are going to provide general community physicians with any sort of logistical differentiation versus what they have now with the requirements on EKG with Revumenib? Thanks. Yeah. Maybe I can take a swing at that, Brad, and then let Dr. Wang comment. There are a number of drugs in AML that induce QT. Some of them, like quizartinib, have boxed warnings. Others are in the warning and precaution similar to zifto. I think it's a matter of severity, right? Yes, you do have to be watchful. As Dr. Wang commented, we've not seen anything. You can't prove a negative in a single-arm trial. The FDA is always going to take the view that safety is paramount. They do have grave concern about a competitor compound, so much so that they put a box warning on it due to the magnitude of the QTc prolongation. I think they're being prudent in making sure that there isn't a broader effect. It isn't, as Dr. Wang mentioned, this is a once-a-day oral drug. We've not seen any serious QT. Had we, I think you'd see a box warning because certainly the agency is not shy about imposing a box warning when it feels it's needed. Dr. Wang, maybe you can speak to that if there's any impediment to the monitoring requirements that are in the label from the clinical practice perspective. I think the FDA was being overly cautious in their labeling and providing a warning. However, I would highlight that in the KOMET-001 study, we enrolled 92 patients onto this monotherapy. Out of those 92 patients, only three individuals had evidence of QTc prolongation, and all three individuals had other reasons for them to have QTc prolongation, concomitant medications, or electrolyte abnormalities. That is significantly different from the 20% or more QTc prolongation observed in all patients treated with a competitor drug. I mean, it's just a world of difference. I feel that with further evidence provided to the FDA regarding the role of concomitant medications and other factors that could have led to the QTc, that this is not going to be a significant clinical barrier to the use of this drug. Thank you, Dr. Wang. Thank you. Our next question is from Phil Nadeau from TD Cowen. Please unmute your line and ask your question. Good afternoon. Let us add our congratulations on the approval. Actually, two quick questions from us. First, on the CR/CRh rate, it looks like it's 21%, a little different than the JCO publication. Can you give us a sense of what analysis the FDA did that was different versus what was in JCO? Second, just a brief follow-up. Will you be blocking scripts, or will the prescription services have accurate data on the launch? Thank you. Phil, you snuck two questions in, despite our admin issues to only ask one. Mollie, do you want to take the question on the CR/CRh rate? Sure. You got to notice that in the JCO, there was also a different denominator. We were just showing you the phase two portion of the trial with that data. In the FDA review, they actually looked at all of our patients together, so all the patients that had been treated at 600 mg, because they were the same patient population, and more numbers get you closer to the truth when you look at that. That's the main reason for seeing a difference between CR/CRh rates in the publication and in the label. Yeah. Brian, I'm going to indulge Phil, but only this one time. Brian, do you want to answer Phil's question on the information? Yeah. Yeah. As I mentioned, Phil, our distribution model is going to be a limited distribution network between a couple of specialty pharmacies and a few specialty distributors. It is going to be similar to other AML therapies. There will be a block on a lot of that based on the distribution that we have. Yeah. Great. Thanks for tolerating our two questions. Thank you. Thank you. Our next question is from Jason Zemansky from BofA Securities. Please unmute your line and ask your question. Good afternoon. Congrats on the strong label, and thanks so much for taking our question. As a follow-up to some of the previous questions, I'm trying to understand how disruptive to patients the monitoring requirement is when there's a worry about Torsades. I mean, is it that the monitoring itself is more frequent or intense, or is it something that just weighs on the patient when provided with a number of options out there? Thank you. Yeah. Dr. Wang, do you have a perspective on that in terms of how you think about the two drugs now out in the marketplace and the monitoring requirement? I feel like the need for black-box warnings. Black-box warning means there absolutely is no question that you need to do this monitoring. The issue with the other competitor drug is it's required that you have EKG monitoring weekly, okay, and then to do it with every subsequent consecutive cycle. That's a lot of visits. One of the advantages of having an oral agent and having it in the relapsed or refractory setting is that these patients, they have very limited lifespan, and the ability to have quality of life outside the clinic is really something that's very important to my patients. The fact that one needs to have an EKG done every single week means it needs to be weekly visits and that the patients need to not only have their EKG, they have to wait around, they have to make sure it gets read, that somebody's officially looking at the QTc. I think that that is a significant onerous thing. I think when there is a warning, what that means is that we need to be aware of it. We need to look for it if we have any thought about it. It does not engender the same responsibility and rigidity in that if somebody has a black-box warning, I absolutely need to do these things, and the patient absolutely needs to come every single week to have that EKG done. Otherwise, I would not feel comfortable giving that drug. That is sort of the clinical interpretation of the difference between a warning and a black-box. Yeah. And just thank you, Dr. Wang. And just to add to that, I mean, if you look at the overage 65 population, the rate of QT for KOMZIFTI is 10%. For their competitor, it's 46%, right? So not only are you talking about a much higher frequency. Yeah, exactly. It's a much bigger difference. And the word, Dr. Wang, you didn't use is liability. It is a liability. Yeah. If I do not have somebody coming in every week to get their EKG, and I missed a week, or they went every other week, or every third or fourth week, and they get admitted to a hospital with an arrhythmia, I'm going to have a concern that it could have been due to the drug and that it could have been due to the fact that I did not check the EKG or have them come in for that monitoring. I think that that is a significant issue. If somebody said to you, "The risk of you having a cardiac problem on this drug is 46% versus 10%," yes, it's a rheologic factory disease. Obviously, you would pursue any therapy, but I think that's a significant difference even in counseling patients or consenting them for therapy. Makes complete sense. Thanks for the color. Thanks, Jason. Thank you. Our next question is from [Etta DeRoute] from Barclays. Please unmute your line and ask your question. Hello. Hi. Thank you for taking questions. And congrats on the approval for some quick questions, I guess, in terms of market dynamics. Just wondered around your expectations for maybe duration of therapy for NPM1 patients in the real-world setting, second line versus third line. Just curious about that, if you have any comments around. Thank you. Yeah. Thanks, [Etta]. Thanks for the question. Brian, would you like to take the question on duration of therapy? Sure. Yeah. I think that it's a good question. I think one of the things we'll have to kind of see is how that plays out in the data in the real world. Our expectation is that patients, especially those who are getting a response, will benefit over six months. As you saw, the median duration of response was five months in the label with about almost three months for patients to get to that response on average. That gives us a sense of, for those patients getting a benefit, it could be over eight months. On average, we think for most patients, it will be about six months is what we're expecting right now. Obviously, there may be a different dynamic in the patients who are treated in the second line compared to the third line. The data in small studies, it's sometimes harder to really tease that out, but we do see that patients should be the earlier they're treated, and that's part of the comments and the strategy for our team is to try to get patients treated as early as possible because that's where we anticipate a more significant benefit for them over the long term because the patients haven't had to go through multiple lines of therapy. Our strategy will be to get patients treated as soon as it's reasonable based on their other treatment options, which would be a priority in the second line or, in some cases, the third line, depending on their prior therapies. Great. Thank you. Thanks, Etta. Thank you. If anyone else would like to ask a question, please use the raise hand function at the bottom of your Zoom screen. Our next question is from David Dai from UBS. Please unmute your line and ask your question. Great. Thanks for taking my question. I also want to add my congratulations on the approval. Great. Just to follow up on the previous question, I'm curious in terms of your thoughts around transplantation. Maybe this is a question for Dr. Wang. Do you see either sufficient evidence around these NPM1 patients potentially going to transplantation after treatment and also going to maintenance therapy on zifto? Thanks. I do. We have rendered a number of patients MRD negative. For long-term response, particularly for our younger fit patients, the long-term benefit is achieved with being able to achieve a response or disease control and transitioning them on to subsequent allogeneic stem cell transplantation. On the KOMET-001, we had a number of individuals now, even a couple of years later, that are still alive. Many of them have gotten an allotransplant. We have successfully off-label continued ziftomenib in the post-transplant setting, which, again, offers benefit because you can combine the drug with potential ongoing other medications, immunosuppressive therapy, etc. It is extremely well tolerated. The ability to render patients disease-free and under disease control, and particularly MRD negative, has the potential to move them on to a potentially curative regimen. That is a very important question. We do think that the longest survival for treatment of our patients is to move them forward. I think in the NPM1 mutant patient population, many of us consider this a favorable risk disease and diagnosis, so we do not transplant patients upfront. Unfortunately, that's not always true. When they relapse, our ability to get them to a transplant in that secondary setting, I think, is very important. This drug, I think, has a nice track record of being able to do that. Great. Thank you for taking my questions. Thank you, David. Thank you. There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for any closing remarks. Thank you, Operator. I want to start by thanking Dr. Wang for joining us. She took time away from her practice and her patients to speak to all of you about some of the real-world implications and usage of KOMZIFTI. Dr. Wang, thank you so much. I want to thank everyone at Kura, all of the investigators and the care teams, and most importantly, the patients and their families who have contributed to this day. This is a momentous day for patients. That motivates everything that we do at Kura. We are looking forward to a strong launch and to a continued broad development program. We will be at Jefferies London next week. Of course, we have a number of publications and presentations, including two oral presentations at ASH in Orlando. We look forward to seeing many of you there. In the meantime, if you have any questions, please reach out to Greg, me, or anyone else on the Kura team. We thank you for your time. We thank all the analysts for their questions, and we wish you all a good day. Thanks very much, everyone.