Earnings call transcript: Kura Oncology Q2 2025 shows revenue miss, EPS below forecast

Kura Oncology (market cap: $516 million) Q2 2025 earnings call revealed a significant miss in revenue expectations, with actual figures at $15.3 million compared to the forecasted $39.1 million, representing a 60.88% shortfall. Earnings per share (EPS) were also lower than anticipated, with a reported loss of $0.75 versus the expected loss of $0.41. The company’s stock saw a slight decline of 1.16% in after-hours trading, closing at $5.96. According to InvestingPro data, analysts maintain a strong buy consensus, with 5 analysts recently revising their earnings expectations upward.

Key Takeaways

• Kura Oncology’s revenue fell short of forecasts by 60.88%.
• EPS came in lower than expected at a $0.75 loss.
• Stock price decreased by 1.16% in after-hours trading.
• The company is advancing its lead program, ZIFTOMENIB, with an FDA priority review.
• Strong cash position with $630.7 million to fund operations into 2027.

Company Performance

Kura Oncology reported a challenging quarter with a net loss of $66.1 million, up from $50.8 million in the same period last year. Despite the revenue shortfall, the company remains focused on its lead program developments and strategic collaborations. The biotech firm is actively preparing for the potential commercial launch of its lead drug, ZIFTOMENIB, aimed at treating acute myeloid leukemia (AML).

Financial Highlights

• Revenue: $15.3 million, up from $0 last year, but below the $39.1 million forecast.
• EPS: Loss of $0.75, compared to the forecasted loss of $0.41.
• R&D expenses: $62.8 million, increased from $39.7 million last year.
• General and administrative expenses: $25.2 million, up from $16.7 million last year.
• Cash and equivalents: $630.7 million as of June 30, 2025.

Earnings vs. Forecast

Kura Oncology’s earnings report revealed a significant miss on both revenue and EPS forecasts. The EPS surprise was a negative 82.93%, marking a substantial deviation from expectations. This performance highlights the challenges the company faces in meeting market expectations, contrasting with previous quarters where the focus was primarily on advancing clinical trials.

Market Reaction

Following the earnings announcement, Kura Oncology’s stock dipped by 1.16% in after-hours trading, reflecting investor concerns over the revenue shortfall and larger-than-expected EPS loss. The stock remains near its 52-week low of $5.41, indicating ongoing market apprehension. InvestingPro analysis suggests the stock is currently undervalued, with a beta of 0.4 indicating lower volatility compared to the broader market. For deeper insights into undervalued opportunities, visit our Most Undervalued Stocks list.

Outlook & Guidance

Despite the current challenges, Kura Oncology maintains a robust outlook, with plans to initiate two Phase III trials for ZIFTOMENIB in the second half of 2025. The company is also exploring combination therapies and expanding its Farnesyltransferase Inhibitor program. Future revenue forecasts show potential growth, with projections for FY 2026 reaching $218.3 million. Analyst targets range from $8 to $40 per share, reflecting significant upside potential. Get comprehensive analysis and detailed metrics with the Pro Research Report, available exclusively on InvestingPro, covering this and 1,400+ other top US stocks.

Executive Commentary

CEO Troy Wilson expressed optimism about ZIFTOMENIB’s potential, stating, "We believe ZIFTOMENIB represents a potential best-in-class menin inhibitor for AML." Brian Powell, Chief Commercial Officer, highlighted the comprehensive development plan, aiming to benefit patients for extended periods.

Risks and Challenges

• Revenue shortfall and EPS miss may affect investor confidence.
• High R&D and administrative expenses could pressure financial resources.
• Market competition in the AML treatment space remains intense.
• Regulatory hurdles and approval timelines pose potential delays.
• Macroeconomic factors and funding environment may impact operations.

Q&A

During the Q&A session, analysts questioned the company’s revenue projections and strategic focus on ZIFTOMENIB. Executives emphasized confidence in the clinical trial design and potential market impact, highlighting ongoing collaborations with Kyowa Kirin to enhance commercial strategies.

Full transcript - Kura Oncology Inc (KURA) Q2 2025:

Operator/Britney, Conference Call Operator: Thank you for your continued patience. Your meeting will begin shortly. Thank you for your continued patience. Your meeting will begin shortly. Thank Thank you for your continued patience.

Your meeting will begin shortly. If you need assistance at any time, please press 0 and a member of our team will be happy to help you. Hello, and welcome, everyone, joining today’s Second Quarter twenty twenty ’5 Cura Oncology, Inc. Financial Results Conference Call. At this time, all participants are in a listen only mode.

Later, you will have an opportunity to ask questions during the question and answer session. Please note this call is being recorded. I am standing by should you need any assistance. It is now my pleasure to turn the meeting over to Greg Mann, SVP of Investor Relations and Corporate Affairs. Please go ahead.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology: Thank you, Britney. Good afternoon, and welcome to Cura Oncology’s second quarter twenty twenty five conference call. Joining the call today are Doctor. Troy Wilson, President and Chief Executive Officer Doctor. Molly Leone, Chief Medical Officer Brian Powell, Chief Commercial Officer and Tom Doyle, Senior Vice President of Finance and Accounting.

Before I turn the call over to Doctor. Wilson, 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 cause actual results to differ materially from expected results. Please refer to Kura’s filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I’ll turn the call over to Troy.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Greg. Good afternoon and thank you all for joining us. At Kura, we’re committed to transforming outcomes for patients with AML. Today we’ll provide updates on our global development progress for our lead program ZYFT DEMENED, regulatory status of our new drug application, preparations for commercialization with our partners at Kewa Kirin and advances in our pipeline, including menin inhibitors for treatment of GIST and diabetes as well as farnesyl transferase inhibitors or FTIs for solid tumors. Starting with development, we were thrilled to present positive monotherapy data from the COMET one trial at ASCO.

Zivtomenib showed promising results in relapsed or refractory NPM1 mutated AML offering hope for this heavily pretreated population. We’re also encouraged by ZiftoMenib’s consistent safety and tolerability profile in this setting. We were pleased to announce FDA accepted our NDA for ZiftoMenib in adults with relapsed or refractory NPM1 mutant AML granting priority review with a PDUFA target action date of 11/30/2025. We’re encouraged by the FDA’s engagement and are focused on achieving a successful review outcome by our PDUFA date. In the frontline setting, we reported updated combination data for ZIFTOMENIB with intensive chemotherapy in newly diagnosed AML and EHA.

These results highlight ZIFTOMENIB’s potential as an early intervention, offering a meaningful opportunity to improve patient outcomes. Building upon the EHA data as well as emerging data for Ziftamenib combined with venetoclax and azacitidine or Venaza, which we plan to share later this year, we’re accelerating development of Ziftamenib in frontline AML. For this end, we are in study startup for the two Phase three frontline trials under the COMMENT-seventeen protocol. Along with the opportunity to treat FLT3 mutant AML patients, these two Phase three trials could open up the opportunity to impact up to fifty percent of patients with AML. Molly will expand on our development activities for Ziftermenib later in this call.

On pre commercial activities, we’re actively preparing for potential approval by building commercial supply and quality systems, advancing pre approval inspection readiness for Centimeters and C and manufacturing, and recruiting and training our sales force, as well as collaborating with our partner, Kyowa Kirin on launch planning. Brian will elaborate on our commercial readiness later in the call. Our partnership with KuoCuren continues to bolster the global development and commercialization of Zifdomenib. We’re aligned on advancing both relapsedrefractory and frontline programs and we value our shared commitment to bringing Zifdomenib to patients. Beyond menin inhibitors, we’re making strong progress with our fully owned next generation farnesyltransferase inhibitor KO-two thousand eight hundred and six.

We’re excited to announce three clinical abstracts from our FTI program have been accepted for presentation at the twenty twenty five ESMO Congress. Molly will share more of the details on the upcoming presentations a bit later. We’re also thrilled to welcome Greg Mann to our leadership team as our Senior Vice President, Investor Relations and Corporate Affairs. Greg brings an extensive biotechnology and pharmaceutical experience with a proven track record of strategic communications and investor engagement, fostering strong relationships with analysts, investors and key stakeholders. As of 06/30/2025, Kerr had $630,700,000 in cash, cash equivalents and short term investments.

Under our Keogh Kirin collaboration, we stand to receive up to $375,000,000 in additional near term milestones, including significant milestones tied to initiation of our Phase three frontline trials, as well as first commercial sale of ZiftoMenib in the relapsed refractory setting. As our data continues to demonstrate, we believe ZIFTOMENIB represents a potential best in class menin inhibitor for AML and GIST. And with our reserve, our current cash reserves and anticipated milestones, were well funded to become the market leader, continue to advance our ZIFTOMENIB AML program through to commercialization in the frontline setting and drive our pipeline to multiple value inflection points. With that overview, let’s dive in starting with ZIFTOMENDIM. I’ll turn it over to Molly to highlight our development activities.

Molly.

Molly Leone, Chief Medical Officer, Kura Oncology: Thank you, Troy. Let’s begin with highlights from our ZIFTOMENDIM development program. At ASCO twenty twenty five, Doctor. Eunice Wang of Roswell Park presented data from the COMET one trial evaluating zyptometed monotherapy in ninety two heavily pretreated relapsedrefractory patients with NPM1 mutant AML. The trial achieved a CRCRH rate of 23 surpassing historical controls with consistent activity across pre specified subgroups, including those with prior transplant, prior venetoclax, those with numerous prior therapies, and those with FLT3 or IDH co mutations.

At the time of the data cut, sixty three percent of responders were MRD negative. Zithrombin’s consistent safety and tolerability profile, including effective management of differentiation syndrome, low rate of myelosuppression, lack of clinically significant QTc prolongation, and absence of drug drug interactions underscores favorable benefit risk profile for patients with relapsedrefractory MPM1 mutated AML. We’re progressing through regulatory milestones for our NDA submission, including information requests and preapproval inspections, in line with timelines for priority review. As Troy noted, our interactions with FDA remain collaborative and constructive. Ziptomenib’s favorable safety profile supports its broad use in combinations in both the relapsedrefractory and frontline settings.

COMET-seven and COMET-eight are evaluating ziptaminid in combination with various standards of care in patients with both newly diagnosed and heavily pretreated disease. At the twenty twenty five EHA Congress, Doctor. Harry Erba of Duke University presented Phase 1a1b data from the COMET seven trial testing Zithrombin at a six hundred milligram once daily dose plus intensive chemotherapy in newly diagnosed MPM1 mutant and KMT2A rearranged AML. Despite available therapies, it’s important to remember that up to seventy percent of AML patients relapse within three years, highlighting a substantial unmet need and only a third are alive at the five year mark. COMET seven data were highly encouraging with rates of complete remission and MRD negativity across the seven plus three cohorts and a safety profile consistent with previous reports.

The safety profile observed with zyptomenib in combination with intensive chemotherapy was actually similar to what is expected in patients treated with seven plus three alone. Zyptomenib’s continuous daily dosing was maintained through count recovery therapy, as well as maintenance without delaying neutrophil or platelet recovery or causing any additional myelosuppression. A single case of grade three differentiation syndrome in a patient with KMT2A rearranged AML was successfully managed. Composite complete remission rates were ninety three percent for patients with MPM1 mutant and eighty nine percent for KMT2A rearranged AML. Complete remission rates were eighty four percent and seventy four percent respectively at the time of this data cut.

Ninety six percent of MPM1 mutated and eighty eight percent of KMT2A rearranged patients remained alive and on study with a median follow-up of twenty five and sixteen weeks respectively. MRD negativity was achieved in sixty eight percent of NPM1 mutant and eighty three percent of KMT2A rearranged patients with a composite CR at medians of four point seven and four point one weeks respectively. We anticipate presenting preliminary clinical data from the COMMENT-seven trial evaluating cipdometab at six hundred milligram dose with venetoclax and azacitidine in both newly diagnosed and relapsedrefractory AML patients in the second half of this year, potentially at ASH. Last quarter, we broke new ground aligning with FDA and EMA on the COMET-seventeen protocol, which comprises two independent randomized double blind placebo controlled Phase III trials. The first is COMET-seventeen IC, which is Zipto Menib with seven plus three intensive chemotherapy.

And the second is COMET-seventeen NIC, Zipto Menib with venetoclax and azacitidine or non intensive chemotherapy. FDA alignment on the use of MRD negative CR and CR as dual primary endpoints for accelerated approval in both trials could substantially shorten development timelines. The single protocol design streamlines trial startup and is attractive to clinical sites because it accommodates nearly all eligible frontline patients. COMID-seventeen is now in study startup and on track for initiation in the second half of this year. Turning our attention to Zifdomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors or GIST.

Approximately four thousand to six thousand new cases of GIST are diagnosed each year in The United States. Advanced GIST patients have limited treatment options. Imatinib, the current frontline standard of care for advanced GIST, targets KIT via tyrosine kinase inhibition, but resistance often develops due to secondary KIT mutations. The COMET-fifteen trial will be combining a dose escalation to evaluate the safety tolerability and preliminary antitumor activity of zyptomentinib in combination with imatinib in adults with GIST who are currently on or have previously been treated with imatinib. We’re advancing in dose escalation, and we will share clinical data updates as it becomes appropriate.

Progress also continues in our next generation Menin inhibitor program for diabetes. We see strategic potential to expand Menin inhibition to diabetes and cardiometabolic disease. We’ve nominated a next generation development candidate for diabetes and will share development plans and timelines in a future update. Moving now from menin to our FTI development programs. Our FIT one trial evaluating our next generation Farnesyl Transferase Inhibitor, KO-two thousand eight hundred and six is progressing significantly.

Our innovative approach combines FTIs with targeted therapies to overcome resistance and enhance response durability, reshaping the FTI story and expanding the use of these combinations. As Troy mentioned, three clinical abstracts from our FTI program were accepted for presentation at the twenty twenty five ESMO Congress covering KO-two thousand eight hundred and six with cabozantinib and renal cell carcinomas, KO-two thousand eight hundred and six monotherapy in advanced RAS mutant solid tumors, and tipifarnib and alpelisib in patients with PIK3CA mutant head and neck squamous cell carcinoma. We’ll plan to host a virtual event in concordance with the ESMO Congress in October to discuss the emerging clinical data, and we’ll share more details ahead of that conference. We’re also evaluating KO-two thousand eight hundred and six and adagrafib in patients with KRAS G12C mutant solid tumors and are already encouraged by the data being generated in dose escalation. We will look to share data from this combination likely next year.

And with that, I’ll turn it over to Brian to discuss our commercial readiness activities.

Brian Powell, Chief Commercial Officer, Kura Oncology: Thank you, Molly. With the ZYPTEMET and PDUFA date of November 30 well in sight, our pre commercial activities continue at a brisk pace. We’re confident Kura’s commercial organization will be fully prepared for launch ahead of potential approval. As Molly noted, the COMMENT-one and COMMENT-seven clinical data were well received by the clinical community. We’re encouraged by positive feedback from the KOLs, highlighting four key aspects of ZYFTOMEDIB in the relapsedrefractory setting.

First is efficacy. Strong CRCR rates CRH rates and durable responses in heavily pretreated patients with overall survival among responders exceeding the KOLs expectations. Second, simplicity. The once daily dosing facilitates adoption and integrates seamlessly into patient care benefiting both providers and patients. Third, compatibility.

No clinically meaningful drug drug interactions with CYP3A4 inhibitors enable combination with antifungals or other concomitant medications. And fourth, safety, the low rates of QTc prolongation eliminate the need for burdensome weekly cardiac monitoring and alleviate concerns of combining with other agents known to prolong QT. This KOL feedback reinforces IFTEMENED’s potentially best in class profile in the relapsedrefractory space and their enthusiasm for its use in combination with frontline standard of care therapy in patients with newly diagnosed AML. On commercial readiness, our team is focused on raising awareness about menin inhibition in NPM1 mutated AML ensuring access and upon approval communicating ciptaminid’s best in class potential to accelerate adoption and build trust with patients and providers. Our medical affairs and market access teams are fully staffed to engage thought leaders, payers and group purchasing organizations or GPOs.

We’re executing educational initiatives on disease awareness and Menin inhibition in NPM1 mutant AML alongside ongoing pre approval information exchanges with key stakeholders including payers, GPOs and other market decision makers. We’ve recently onboarded our sales team selected through a rigorous nationwide screening process. The group has deep experience in hematology oncology with over twenty one years average experience in sales and over seven years average experience in hematology. As they deploy, they will work alongside the experienced Kewakiran U. S.-based field team.

As the lead party in The U. S, we are building capabilities across commercial functions while working collaboratively with Kewokiran on field operations, account planning, training materials and team building. Our market access trade and distribution team has identified patient support needs and is designing programs to help eligible patients navigate their treatment journey. Finally, we are implementing a focused distribution network to maximize Ziptaminib access at oncology centers, enhance provider satisfaction and drive early uptake to ensure a rapid launch of ZYPTUMENIB upon FDA approval. Together with Kyowa Kirin, we are confident in our commercial readiness and ability to deliver ZYPTUMENIB to eligible patients at launch.

The relapsedrefractory AML population is our initial market entry and a critical step toward building a successful commercial product. ZYPTUMENIV’s potential best in class profile in NPM1 mutant AML gives us confidence in capturing robust market share in this high unmet need population. We estimate the total addressable market for NPM1 mutated relapsed refractory AML is between $350,000,000 to $400,000,000 annually, driven by a patient population that can reach up to 30 of relapsedrefractory AML patients who could benefit from an average of six months of treatment. ZYPTEMEDIB’s efficacy, safety, tolerability and convenience position it for market leadership share in this setting. Our launch planning for the NPM1 mutated relapsedrefractory AML market lays the groundwork for the substantial opportunity we see in the frontline AML space.

For transformative impact, a therapy must deliver deep durable responses to the maximum number of patients with a tolerable profile for extended use. ZYFTOMENIB’s data unhindered by complex dosing, excessive myelosuppression or burdensome monitoring support its potential best in class profile. Of the 22,000 newly diagnosed AML cases in The U. S, we believe menin inhibitors can reach fifty percent of patients where the KMT2A pathway is a driver of their disease. This includes both NPM1 mutated and KMT2A rearranged.

Our comprehensive development plan is designed to address multiple populations where patients may benefit from ZIFTOMENIB for twelve to twenty four months or more of ZIFTOMENIB leading to a total addressable U. S. Market potential of over $7,000,000,000 per year. I will now turn it over to Tom to provide the second quarter financial highlights. Tom?

Thank you, Brian,

Tom Doyle, Senior Vice President of Finance and Accounting, Kura Oncology: and good afternoon everyone. Collaboration revenue from our Veracurin partnership for the 2025 was $15,300,000 compared to no revenue for the 2024. Research and development expenses for the 2025 was $62,800,000 compared to $39,700,000 for the 2024, driven by spending on our Zipto amended combination clinical trials. General and administrative expenses for the 2025 were $25,200,000 compared to $16,700,000 for the 2024. This increase was predominantly due to pre commercial activities.

Net loss for the 2025 was $66,100,000 compared to a net loss of $50,800,000 for the 2024. This included non cash share based compensation expense of $6,900,000 compared to $8,400,000 for the same period in 2024. As of 06/30/2025, Kura had cash, cash equivalents and short term investments of $630,700,000 compared to $727,400,000 as of 12/31/2024. Based on our current plans, we believe that our cash, cash equivalents and short term investments as of June 30 will be sufficient to fund our current operating expenses into 2027. If we include anticipated collaboration funding and milestones under our Kilo Karen agreement, Kura’s financial resources should support advancement of our zeptomentid AML program into commercialization in the frontline combination setting.

I’ll now turn the call back over to Troy for final comments. Troy?

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Tom. Before we jump into the question and answer session, let me just lay out our anticipated upcoming milestones. For Zifdomenib and our menin inhibitor programs, we look forward to continued engagement with FDA reviewers as we approach our PDUFA target action date of November 30 or Zifdomenib as monotherapy for patients with relapsed refractory NPM1 mutant AML. Initiating COMMIT-seventeen are two independent Phase three registration enabling trials in frontline intensive and non intensive AML in the 2025 and presenting preliminary clinical data from the COMET-seven Phase 1b expansion cohort evaluating Zifdemanib with venetoclax and azacitidine at a medical meeting in the 2025. For our farnesyltransferase inhibitor programs we expect the following milestones.

We initiate one or more expansion cohorts of KO-two thousand eight hundred six and cabozantinib in patients with advanced renal cell carcinoma in the 2025. We also plan to have a strong presence at the twenty twenty five ESMO Congress this October with three presentations. Data from the FIT-one Phase one monotherapy dose escalation of KO-two thousand eight hundred and six in patients with RAS mutations. Data from the FIT-one Phase one trial evaluating KO-two thousand eight hundred and six and cabozantinib in patients with renal cell carcinoma. And finally data from the current HN trial evaluating tipifarnib and delpelisib in PIK3CA mutant head and neck squamous cell carcinoma.

As Molly mentioned, we expect to host a virtual event around the time of the ESMO Congress in October to discuss the clinical data for our FTI programs, more details and a safety date to come. With that, Brittany, we’re now ready for questions.

Operator/Britney, Conference Call Operator: Thank you. Our first question comes from Jonathan Chang with Leerink Partners. Please go ahead. Your line is now open.

Jonathan Chang, Analyst, Leerink Partners: Hi guys. Thanks for taking the questions. A couple. First, can you give us some color on how the regulatory interactions on Zifdomenib have progressed as we look towards the PDUFA date later this year? And then second question, how are you thinking about the scope of the Fernazol transferase inhibitor opportunity between the possible combinations and tumor types?

What do you see as an area or areas that CURA can move forward with alone? And which do you see as areas better suited for potential partner? Thank you.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Jonathan, thanks for the questions. Let’s take them in turn. With respect to any additional color on the regulatory interactions, Molly, would you like to comment to the extent that we can?

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah, And as Troy’s alluding to, we’re currently within our active NDA review. And so, can’t really provide details about every evolving interaction with the FDA. But the interactions have all been collaborative. They’ve been very constructive, a lot of back and forth. And everything we’ve seen to date is in alignment with the timeline for a priority review with an approval of November 30.

So, again, we’re very encouraged by the way things have progressed thus far.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, thanks Molly. And Jonathan, on your second question, maybe I’ll take a crack at it. Then again, I’ll ask Molly to add her comments. As she said, I think in her prepared remarks, what I think you’re going to see is really a reshaping of the story. So, we’re showing you data, not only with two thousand eight hundred and six as a monotherapy, but in two of the of the three possible opportunities.

So, cell carcinoma, where there’s obviously been a lot of activity with HIF2 alpha TKIs as well as PI3 kinase alpha, where again, we’ve seen work from Scorpion from relay and really a lot of a lot of interesting opportunity. The third one where hopefully we’ll have something to share next year is, of course, in the KRAS space. And we’ve put out a lot of preclinical data that’s available on our website. You’ll see us set the context and I think help analysts and investors set expectations as we as we get closer to ESMO. But suffice it to say, with each of these areas, RCC, PI3 kinase and KRAS, they all have the common problem of innate and adaptive resistance.

That’s what we’re looking to address and we’re looking to share further data with you. Molly, anything you’d add to that?

Molly Leone, Chief Medical Officer, Kura Oncology: No, that was a good segue. I was actually going to comment that not only does this reshape the STI field, it also reshapes these other targeted agencies targeted agents, excuse me, as we look to prevent or prolong these patients’ ability to respond to these drugs. And there’s no reason to think that the results from one particular combination wouldn’t be generalizable to similar drugs in the same class. So we’re very excited to see where this leads.

Jonathan Chang, Analyst, Leerink Partners: Understood. Thanks for taking the questions.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Jonathan.

Operator/Britney, Conference Call Operator: Thank you. We’ll go next to Leigh Watsick with Cantor Fitzgerald. Please go ahead. Your line is now open.

Leigh Watsick, Analyst, Cantor Fitzgerald: Hey guys, congrats on the progress. Maybe a little curious about your thoughts on the Menin class launch so far. It looks like even in KMG2A patients, the market opportunity could be quite sizable. Any way through to your own launch dibtomatinib? And then in terms of Phase III trial starts in the second half this year, wondering if you can elaborate a little bit more in terms of the progress that you made since last quarter And then your confidence that you could still potentially be first in class in the frontline?

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Sure. Yeah, Leigh, thanks for the questions. Again, let’s take them in turn. So, Brian, could you address Lee’s first couple of questions, which is our impression of the KMT2A relapse refractory market opportunity and some of the results we’ve seen from our some of our competitors and perhaps any read through to our own thinking or our own program?

Brian Powell, Chief Commercial Officer, Kura Oncology: Thanks Troy. And thanks Lee for the question. Yes, I think we’ve obviously been watching closely as you have on understanding kind of the launch first launch in the KMT2A space of the men in class. I mean, I think our first impression is that it’s great news for patients that there is a new class of therapies available that could help to target a broader range of patients with a high unmet need. The KMT2A population has, as we know is smaller population in incidence relative to the MPM1 mutated population.

And I think we’re encouraged to see the preliminary uptake in activity of our competitor. When we think about what that means as we read it through into ZYFTOMENIB, first we understand that this will be a competitive space. We feel pretty confident as we mentioned in our prepared remarks that ZYPTEMENIB has the properties that we believe have the potential of being best in class as their profile across both the efficacy, the safety, the combinability of the drug and also the convenience. We think that as we bring our or hopefully get to our FDA approval, our commercial, our medical and market access teams will be able to quickly begin communicating and be able to be competitive in this space where we see a very high unmet need for this population who are in need of new therapies.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Brian. And Molly for you on the maybe on the second question, I’m just going to restate it. Looking at the Phase three starts here in the second half of the year for COMMOD017, can we elaborate on the progress since the last quarter? And what gives us confidence will be potentially first and best in class in those combinations?

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah. I mean, I think I’d like to remind just what the seven data has taught us. It taught us how much need there is for this patient population. How quickly these patients enroll. How much these sites want dedicated trials to treat these types of AML.

So with 17, we have put both trials under a single protocol. So what does that do? That makes it easier for every single site, every IRB, all of your contracting resources to go through one contracting process and not laboriously go through multiple stages or multiple negotiations, and not have to choose one trial over another. Choosing our 17 trial gives you access to two trials in one. We hear enormous amounts of excitement coming from all of our sites that have kind of put their hands up to participate.

We continue to make a lot of progress. It does take time to get a study started. We have to work out all of the contracts and everything else, as you know. But it’s going quickly. And I have no doubt that we will start that trial the second half of this year.

And I have no doubt that the enrollment will be really impressive and will get us to that twenty twenty eight additional high level data that we’ve been talking about all along. And keep in mind, this really does allow any patient with a KMT2A or NPM1 mutation, well almost any patient with those mutations, to have a place to go in their frontline treatment setting. So I think that the potential patient population that we will be able to address is going to be enormous. So I look forward to very robust enrollment and a broad patient base to be able to treat in this particular 17 trial.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Molly. Thanks, Lee, for the questions.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Roger Song with Jefferies. Please go ahead. Your line is open.

Roger Song, Analyst, Jefferies: Great. Congrats for the progress and thanks for taking questions. So seeing your upcoming milestone, you talk about the RCC expansion cohort since you already made the decision. If that’s the case, what’s the criteria for the expansion cohort? And then what will be the next step in timing for JK3C and KRAS and the program?

And the second question relates to regulatory interaction. Given all the changes within FDA, have you had any recent interaction with the FDA regarding your Phase III pivotal design? And I understand you’re about to start, but any last minute kind of feedback you’re getting from the FDA? Thank you.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yes. Roger, if we may, Molly is going to answer both of those questions. Molly, maybe we can take them in reverse order. Let’s start with the first one, which is any recent interactions with the agency on the Phase III designs for COMMODOSEventeen?

Molly Leone, Chief Medical Officer, Kura Oncology: No, and thank you for that. No, it’s the usual interactions, just making sure we’re all in agreement on even the nitty gritty. But overall, it was agreed to back months ago what the design would be. And now it’s really just operationalizing. There hasn’t been any additional concern or additives by people coming or going from the FDA.

So, all is holding pretty steady for us.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, and maybe just to build on that Roger on Molly’s comment. I mean, this is nothing new in oncology, right? When the agency gives you the pathway to accelerated approval, whether that’s monotherapy or in combo, that the condition is always that you come back with the data. I think maybe what’s different here is there’s a recognition in AML that it may not be or it isn’t in the best interest of patients to wait around for survival endpoints in some cases. And so there’s a real willingness on the part of the FDA to consider accelerated approvals or pathways to accelerate approval.

And that’s what Molly and her team were so skilled in coordinating with the FDA. So everything is on track from our perspective. Molly, on the first question, it’s probably a little early, but Roger asked, what’s our decision making process for RCC, for KRAS? You wanna speak a little bit to that? I know it’s early in where we are.

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah, it’s early. I’ll focus on RCC because that’s probably the easier story to explain at this point. So, we’re going through our dose escalation, of course. And we had our gono go criteria that we established prior to starting the study. I will say that we’ve not really shared publicly our gono go criteria, but we had no problems in meeting that.

And currently when we talk about our expansion cohort, it’s really with the thought of correctly fulfilling Project OPTIMATH and giving them the data that they want. So we will expand out to at least two doses and look to see which dose is best tolerated and most efficacious at the same time. And at that time obviously we will be, you know, we will look for convincing data that you’re seeing more than just a cabo monotherapy activity. Which these patients that have already failed cabo shouldn’t be that hard to demonstrate. Similarly with adaggressive, as we keep on with the dose escalation we’ll probably proceed in a very similar fashion.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Molly. Thanks, Roger, for the questions.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Jason Zemanski with Bank of America. Your line is now open.

Jason Zemanski, Analyst, Bank of America: Great. Good afternoon. Thanks for taking our questions and congrats on the progress. Maybe a high level question for you Troy. Now that the die has been cast regarding timelines so to speak, can you speak to some of the puts and takes regarding the commercial dynamics in the relapsedrefractory NPM1 setting?

How much is your competitor’s first to market advantage and current inroads as a hurdle? I mean, ultimately, how quickly do you think you can overcome any residual or at least initial physician inertia here? And then maybe secondarily, what are your expectations regarding the evolution of NCCN guidelines for the class? Whether they include ZIFTO specifically or sort of just reference the larger menin inhibitor class? Thanks.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, Jason. Thanks for the questions. Let me, maybe I’ll just make a couple of overarching comments and then I’m going to ask Brian to speak to your question. I think if I were to steal your question down, it’s really like what’s the meaning of a first mover advantage, Right? What does that mean here?

What I’d say is everything we’re seeing, I think is good for patients. We’ve seen strong interest and strong uptake in menin inhibitors. As you’ve heard us say, potentially best in class. I think not only in NPM1 mutated AML, but increasingly as you’ll see in combination, we think it’s going to be very competitive in the KMT2A rearranged subset. And we’re looking forward to giving physicians and patients options for therapy.

These patients are in desperate need and, I’ll let Brian speak, really to the feedback that we’ve heard from and sort of the positioning. And then we’ll come back to your question on NCCN and when he’s done with that. Brian, could you maybe build on my comments?

Brian Powell, Chief Commercial Officer, Kura Oncology: Sure, Troy. And thanks Jason for the great question. Yeah, I think as Troy said, we’ve been working towards, I think building that first our presence and first approval in this market. As you said, we’re happy that patients may have a number of options available for that. Our team has been working for really the last two years to start to begin this preparation.

We’ve actually from a medical perspective have been engaging with KOLs with our MSL team over the last two years or more. Our market access team has actually been out in the field and engaging with payers through pre approval information exchanges over the last year. And we’re really building a strong reputation among those teams. A lot of that’s actually built, I would say as Kura Oncology based on the strong reputation that Molly and her team have really built in executing on these clinical trials and how quickly they’ve been able to enroll patients and really partner strongly with a number of The U. S.

Physicians. So I think that there will be of course we recognize there’ll be some competition coming forward between potentially two approved agents in the space. We’re confident in the profile that ZYPTO MENAP has that we’d be able to rapidly engage with physicians upon approval. Our sales teams will actually begin some profiling once they finish their training in short timeframe between now and as they get closer to the approval, they could start to engage and get to introduce and engage on Kura’s behalf as we get closer to our approval. So we think that we’re going to we’re doing all the right things that a company like Kura needs to do.

And while there may be some initial awareness from some of the competitors, we think that the need is substantially high and the enthusiasm we’ve heard around ZYPTUMENIB continues to be high that we’ll be in a good position once we get that approval.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Brian. Brian, do you want to just add to that and address Jason’s second question, which is around how do we think about the evolution of the NCCN guidelines? Is it Menin as a class? Is it ZIFTA Any color you want to give?

Brian Powell, Chief Commercial Officer, Kura Oncology: Yes, absolutely. I mean, I would say at the highest level Jason since we only have external visibility to what the NCCN AML committee does. We can’t really comment as to when they will be addressing the NPM1 mutated population. Our intent within our team is as soon as our data are published and we have our approval, we’ll be submitting the application to for consideration on the guidelines as soon as possible. It’s one of those key early launch metrics that we’ll be putting towards to get ZIFTIMENIB on those guidelines.

Molly, would you want to add anything else to that?

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah, I thought the question about whether they would list out individual drugs or Menin as a class is an interesting one. I mean, obviously we don’t know. But as we are the only companies that will really have strong data packages already produced, I would think at least for the foreseeable future, it would be named MEND inhibitors in the guidelines rather than just a class.

Jason Zemanski, Analyst, Bank of America: Yeah, got it. Thanks so much for the good color. Appreciate it.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Jason.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Ellen Horst with TD Cowen. Please go ahead. Your line is open.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology0: Hi, guys. Congrats on such an exciting quarter, and thanks for taking the question. I’m just wondering what you think are the biggest potential risks to the pivotal program timelines, if there’s anything that could potentially push initial data out past 2028? And then is there any risk to running combined studies with both the KMT-2A population and the NPM1 population? Thanks.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, thanks Ellen for the questions. Molly, you wanna speak to that risks to timelines sort of getting extended or risks to running the blended populations?

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah, I mean, obviously we can’t predict the future and if something really unexpected happens, obviously it could push out the readout dates. But we’re very, very conservative. And so we only released that 2028 date when we felt very confident in our ability to be able to meet it. With regards to mixing of the populations, again, I will go back to our seven trial. It has taught us so much.

We understand what these patients now look like in these settings to a great extent with very robust data sets. So, the mixing of the populations doesn’t frighten us, and we’ve obviously approached it from many different scenarios to make sure that this was the appropriate way for us to proceed as a company. So, seven really was the best building block for this big trial.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Mohammad. Thank you, Ellen, for the questions.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Peter Lawson with Barclays. Please go ahead. Your line is open.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology1: Great. Thank you so much. I joined late, so I apologize if, the question’s already been asked, just around about your FDA dialogue, how that’s proceeding, if it’s changed in frequency, or any emphasis has changed around that? And the second question would be around the importance of the AML maintenance setting, and do you think you have the ability to kind of capture that market as well?

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, Peter. Molly, can you just maybe summarize, the FDA dialogue

Molly Leone, Chief Medical Officer, Kura Oncology: Sure. You know, we’re under active review. We are regularly interacting as you would expect being on a priority review timeline. And we really haven’t seen any change in the quality, the quantity, or the frequency of interactions with the agency.

So things have been progressing as expected.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: And then Molly, maybe you can take the second question around how one thinks about maintenance. And then Brian, I’ll probably ask you to build on that from a commercial perspective. But Molly, do you want to start?

Molly Leone, Chief Medical Officer, Kura Oncology: No. So, obviously in our one trial, we’re not pursuing a maintenance indication. But obviously, as we’ve heard, there are folks that would expect some use in that setting already. But seven has taught us, again, us a lot. And while most of our NPM1 patients don’t need to go to transplant in that frontline setting, the ones that do have in general come back onto a maintenance protocol.

And the KMT-2A’s especially are very apt to come back to trial. So I think the maintenance indication that has been built in to the 17 design is going to be extremely valuable in appropriately capturing that patient population.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Brian, is there anything you’d like to add on Peter’s question around maintenance?

Brian Powell, Chief Commercial Officer, Kura Oncology: Thanks, Troy. Maybe just to add on that, I think that the way we view it from a commercial perspective, a lot of the post transplant maintenance or extended non post transplant that would likely be something we would observe or expect to see in that in the newly diagnosed setting. So as COMMOD-one 117 builds out, we think that gives us an opportunity for significant durations of treatment in both of the IC and the non IC setting. That could lead to anywhere from twelve to twenty four months of continuous therapy for patients. In the relapsed refractory space, based on what we’ve seen in the market so far, KMT-two way there may be more patients who would go to transplant relative to the older population of MPM1 mutated patients in the relapsed refractory setting.

So we’re observing and we’ll be following to see, but that we expect that to be a lower rate of transplant for those relapsed refractory MPM1 mutated patients. But we’ll be tracking that and try to understand. And our goal of course will be to get patients on therapy and to stay on therapy for a longer period of time.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Brian. Thanks Peter for the questions.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Charles Zhou with LifeSci Capital. Please go ahead. Line is open.

Brian Powell, Chief Commercial Officer, Kura Oncology: Hi, this is Peter on for Charles. A couple of questions from my end. First of all, for the 2,806 data in RCC at ESMO this fall, just wondering if you could provide some color on patient baselines, how heavily pretreated rates of prior cabozantinib exposure? And then second question, as you’re looking down the nose of approval in relapsedrefractory MPM1 for ZystoMenib, just wondering what your plans are, if any, for additional data disclosures in that setting? For example, at ASH or in a journal release?

Thanks and congrats on all the progress.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Peter. Molly, do you want to take those questions? I mean, we don’t want to go into too much detail, but any additional color we can give on RCC?

Molly Leone, Chief Medical Officer, Kura Oncology: That’s exactly what I would say is I don’t want to preempt the abstracts, but they will be sharing all of that data with you. But you can expect, you know, a typical phase one patient population where initially it could be your most heavily pretreated and then as investigators feel more comfortable, you come further and further in line. So you’ll see a variety of patients at baseline.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Great. And Molly, about Peter’s second question about any additional disclosures on the monotherapy? Could the comment on one study for people to look forward to?

Molly Leone, Chief Medical Officer, Kura Oncology: Additional data disclosures? Well, we Yes, should be expecting was what I was getting at. Yeah, so you should expect a publication within the coming months.

Brian Powell, Chief Commercial Officer, Kura Oncology: Peter. Thanks.

Roger Song, Analyst, Jefferies: Yeah, our pleasure.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Salam Syene with Mizuho. Please go ahead. Your line is now open.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology2: Hi, thanks for taking our question. This is Eric on for Suneem. I just wanted to get your thoughts on potential launch ramp as you get into relapsedrefractory NPM1M given what we’ve seen with the KMT2A launch here recently and given that there was no really good reason to expect any warehouses of warehousing of patients with KMT2ER in relapsedrefractory, but might there be a bit with the NPM1N population? Thanks.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, thanks Eric. Brian, you to address Eric’s question about any launch dynamics?

Brian Powell, Chief Commercial Officer, Kura Oncology: Eric, thanks for that question. I mean, think that we’re I don’t think we’re ready to disclose what our expected launch ramp up will be. What I can tell you is the focus that we’ve been working towards right now is to immediately get product available for patients, get access from with our payers and build on the work the team is working on so far and really communicating around the areas where we see ZYPTOMENEV is differentiated as I’ve said before around our robust efficacy, safety and tolerability, the convenience and the ability to have a kind of simplicity of dosing without some significant additional monitoring challenges as some of the competition may have. So our expectation, your second question around whether or not you would expect to see a bolus, we haven’t actually we don’t expect to see a large bolus. This is not a patient population where patients are waiting for a new therapy to come forward unfortunately because of this very high unmet need.

These are going to be elderly relapsed refractory patients that have probably been significantly pretreated and may not have the expected life expectancy in this space is pretty short unfortunately. So I think there’s less of a dynamic of a pool of patients we think that have already been taken up by other therapies by the time we get to approval. I hope that helps with some clarity.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yes. And Eric, to build on Brian’s comments, and another thing you’ll look forward to is, as Molly indicated, we’re going to give an update on the combinations of Zipta with venetoclax. We’re also looking at combinations with other standards of care, including gilteritinib. All of that data is coming while we’ll be promoting on label. We’re looking really to publish as much data as possible to help inform physicians and patients and those four pillars that Brian hit on.

I think that’s really ultimately going to allow us iftamenib to potentially become the market leader, the efficacy, the safety, the compatibility and the convenience. So we’re excited to get out there and offer more options to patients. It’s going be an exciting next few quarters.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology2: All right. Thank you. Okay. Yes, thank you.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from Jeet Mukherjee with BTIG. Please go ahead. Your line is now open.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Great. Thank you for taking my question. Just to follow-up on maybe your comments previously, just any sense from your investigators about their willingness to use ZIFTO off label frontline or perhaps in the relapsed refractory setting in combination pending potential approval? And my second question was, can you provide any commentary on the percent site overlap you have with your approved competitor at least among your current clinical trials? Thank you.

Yeah, so let’s tease those two questions apart. Molly, do you want to speak to the feedback from we’ve heard from KOLs on Jeet, think your question was sort of a willingness to combine a willingness to combine Ziftaminib with other standards of care.

Molly Leone, Chief Medical Officer, Kura Oncology: Yeah, I mean, what we hear is ultimately they’re gonna do what’s best for the patient. And if they have a safe way to administer our drug in combination that would they feel would be more beneficial to the patient, then they would. With regards to in the frontline, they have the option of putting them on our trial. So I’m hoping that they will do that so that we can fill up just as quickly as we plan to. But yes, we do hear not just our investigators but other KOLs discuss liking to have the information available to be able to safely use drugs in combination.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: The on the Yeah, the site overlap.

Molly Leone, Chief Medical Officer, Kura Oncology: Yep, that’s all right. So for one, the monotherapy study, it was very few. Handful, probably mostly in The United States. With expect that number to drop precipitously because sites don’t have the capability of conducting multiple phase three studies in the same or similar indication.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, just to build on that. I mean, that’s part of why we designed dose 17 the way that we did, because it’s really a one stop shop for these clinical sites. And were really looking to build relationships with many of the leading centers all over the world. And if they can treat nearly all eligible patients in the front line with one trial, they’ve shown us that that’s what they’re going to do. So we’re not to Lee’s earlier question.

We’re not overly concerned. It’s not really first patient in. It’s going to be last patient in and who gets the data. And I think we’re very well positioned to compete on that. Appreciate your questions.

Operator/Britney, Conference Call Operator: Thank you. We’ll take our next question from David Day with UBS. Please go ahead. Your line is now open.

Greg Mann, SVP of Investor Relations and Corporate Affairs, Kura Oncology2: Hi. This is Eric Massanza asking for David Day. Thanks for asking taking our question. About the commercial readiness, could you share some more details about how Keora Kirin’s existing commercial sales force could help expedite the commercial execution? How many salespeople do you think will be needed for a successful launch?

And then just a quick follow-up on that. J and J just initiated their Phase three trials for blexamenib and frontline AML. How are you planning to catch up or potentially leapfrog?

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Yeah, thanks Eric for the two questions. Let’s start with the commercial readiness question and the relationship with Kiokirin. Brian, do you want to address Eric’s question?

Brian Powell, Chief Commercial Officer, Kura Oncology: Sure. Thank you, Eric for that question. Yes, so the our team, our commercial team has been as I mentioned has been fully built out. Our sales organization will share probably as we get up to launch a bit more details of the size of that field force and how they’ll be working with KK. What I can say is that our team is building out based on the target physicians that we’ve outlined for the AML space.

We’ll have a national coverage of with CURA field representatives and they’ll partner very closely with the national team that KK already has in the field. You may know that they have a product that they currently are promoting in the lymphoma space, which has a pretty significant overlap at an account level with the AML population. So, what we’re working on is have their team will have a portion of their effort focused on ZYPTOMENEV. The other rest of their effort will be focused on their other product. And for ZYPTOMENIB, they will be partnering very closely with our team to essentially give a broader depth and breadth of our ability to reach physicians than we would if we were to be alone.

So we think this is going to be a significant advantage for ZYPTOMENIB as we launch because we’ll have a field force that is maybe broader, more dedicated to extend to more physicians to have more frequent interactions and contacts, so that we’ll be able to communicate our messages and support patients who are in the community who may need to or have that potential to get ZYPTOMENIB. So, as we’re working towards that launch, we’ll be able to provide a little bit more detail. But I could tell you that the teams have been working very well together. They’re going through their training to be ensured that as we get to our launch, they’ll be ready to go and start to communicate both from the Cura side as well as our partners at KK.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thanks, Brian. And Eric, I’ll take your second question around the timelines for Janssen. I mean, everyone knows Janssen’s a formidable development organization. I think though, answer is kind of in your question, right? You mentioned the two phase three trials to our knowledge, they’ve only initiated, the one Camelot study in the frontline Venaza.

And as Molly indicated, I mean, we’ve just seen overwhelming enthusiasm and enrollment in both seven and enthusiasm for 17. So, I think we’ll be very well positioned to compete with them in terms of enrollment globally. And you’ll see us initiate those trials here shortly in the second half and we’re looking forward to it. So thanks for the questions.

Operator/Britney, Conference Call Operator: Thank you. At this time, this concludes our question and answer session. I will now turn the meeting back over to Troy Wilson.

Troy Wilson, President and Chief Executive Officer, Kura Oncology: Thank you, Brittany. Thank you all once again for joining the call today. We’ll be participating in several investor conferences over the next couple of months as well as the ESMO Congress in Berlin. Whereas Molly mentioned, we’re planning to hold a virtual investor event to discuss our presentations of clinical data from our FTI program. In the meantime, if you have any additional questions, please feel free to reach out.

So thank you all again and have a good evening everyone.

Operator/Britney, Conference Call Operator: This brings us to the end of today’s meeting. We appreciate your time and participation. You may now disconnect. Thank you.

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