Image source: The Motley Fool.
Tuesday, Nov. 10, 2026
Need a quote from a Motley Fool analyst? Email pr@fool.com
Kura Oncology, Inc. (NASDAQ:KURA) reported a period of commercial expansion for its lead oncology product alongside the establishment of a registrational pathway for its second precision medicine candidate. Management stated that growth was driven by increased physician adoption and favorable formulary positioning, while the company strengthened its capital position through a new strategic financing agreement. The company indicated that its development strategy focuses on transitioning its menin inhibitor from a late-line treatment to a foundational frontline therapy. Management noted the creation of a separate entity to advance its pipeline in chronic metabolic diseases, which allows for continued focus on the primary oncology portfolio while preserving future value from noncore indications.
Operator: Good day, everyone. My name is Ronnie, and I will be your conference operator today. At this time, I would like to welcome you to the Cura Oncology third quarter 26 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during this time and if you have joined via the webinar, please use the raised hand icon, which can be found on the bottom of your webinar application. To allow everyone the opportunity to participate, we ask that you please limit yourself to 1 question and 1 follow-up question.
If time permits, at the end of the Q&A session, we invite you to rejoin the queue for additional questions. At this time, I would like to turn the call over to Greg Mann, SVP of Investor Relations and Corporate Affairs of Kura Oncology. Please go ahead.
Greg Mann: Thank you, Ronnie. Good afternoon, everyone. Joining me today are Dr. Troy Edward Wilson, President and Chief Executive Officer; Brian T. Powl, Chief Commercial Officer; Dr. Mollie Leoni, Chief Medical Officer; and Jennifer Fulk, Chief Financial Officer. Today's discussion includes forward-looking statements based on our current expectations and management's judgment as of today. Actual results could differ materially because of risks and uncertainties including those described in our SEC filings. Please refer to these filings, are available through the SEC and on our website for information concerning risk factors that could affect the company. With that, I will turn the call over to Troy.
Troy Edward Wilson: Thank you, Greg. Good afternoon, everyone. I am happy to report we delivered another quarter of strong growth and sustained commercial leadership. COMZIFTI net product revenue reached $13.9 million up 53% sequentially, new patient starts increased 30%. We maintained majority share of menin inhibitor new patient starts reflecting continued physician preference for COMZIFTI. Our priority is to grow our leadership in this setting while building the clinical evidence to support expansion into earlier treatment settings and combinations. We are heading into ASH with an unprecedented Ziftomenib presence, including 4 oral presentations and our first clinical data on Ziftomenib combined with FLT3 inhibitors in both newly diagnosed and relapsed and refractory AML.
Roughly half of patients with NPM1 mutated AML have a concurrent FLT3 mutation, and that prevalence makes FLT3 inhibitor combinations a critical part of our strategy to establish Ziftomenib as a foundational AML therapy. These studies are among 8 Ziftomenib abstracts at ASH and Mollie will discuss how these studies address the opportunity and inform our next development decisions. Turning to our FTI program, we are very excited to announce we have aligned with FDA on a single arm monotherapy registrational study with darlafarnib in HRAS mutant salivary gland cancer. This puts our second potential precision oncology product on a focused path toward registration. All this.
Although this approach may deliver a new class of treatment in a molecularly defined patient population with substantial unmet need Importantly, it could also provide strong clinical, regulatory, and commercial foundation while we pursue larger indications in combination and through supplemental applications. We enter this next phase for Kura from a position of financial strength. Our strategic financing agreement with OrbiMed gives us flexibility to deliver key milestones for Ziftermenib and Darlafarnib. I am pleased to welcome Jennifer to her first call as our Chief Financial Officer. She will discuss the financing, funding outlook, and our capital allocation priorities. Finally, we established Caspian Therapeutics to advance menin inhibitors for diabetes and other chronic metabolic diseases.
Kura contributed KO-7.25 thousand and related intellectual property and know how. Caspian's dedicated leadership and financing allow Kura to maintain our operating focus on oncology while retaining a substantial ownership interest in the program's potential value. With that, I will turn the call over to Brian to discuss our commercial performance.
Brian T. Powl: Thank you, Troy. Pomsifty's third quarter performance reinforces our leadership in the menin inhibitor in relapsed or refractory NPM1 mutant AML. Physician feedback continues to align with our 4 pillars of differentiation. Efficacy, a predictable and manageable safety profile combinability and compatibility with other medicines, and convenient once-daily oral dosing. Together, these attributes are translating into broader adoption and sustained growth. The trend is clear. We grew revenue, added prescribing accounts and increased repeat prescriptions. Our focus is to continue to convert that leadership and momentum into sustained growth. In Q3, 53% over Q2. We recorded approximately 150 new patient starts up approximately 30%, and more than 2.4 thousand total prescriptions, up 65%.
We maintained a majority share of menin inhibitor new patient starts in relapsed or refractory NPM1 mutated AML. These results demonstrate our team's strong execution in a competitive market. New patient starts measure adoption and drive future prescription demand. Total prescriptions grew faster than new starts, which indicates a larger contribution from refills as our treated patient base expands. Our Kura and Kyowa Kirin field teams continue to expand our reach with AML prescribers and care teams. A total of 170 accounts have now prescribed Comzifty up 40% quarter over quarter. Prescribing also increased in high and medium priority accounts.
During the quarter, our combined field teams reached 97% of our highest priority AML accounts, working with physicians, pharmacists, and care teams to identify appropriate patients and support treatment initiation and refills. Access remains a clear strength. Coms IFT has coverage for nearly 100% of covered lives, with favorable formulary positioning in multiple plans. Our patient support program helps patients navigate access and affordability, start treatment promptly, and stay on therapy as prescribed. In the available claims data set nearly half of COMZIFTI patients received it in combination with other approved agents primarily venetoclax and azacitidine, or FLT3 inhibitors.
While our teams promote COMZIFTI only for its approved indication, these real world observational data reflect how physicians are using combination strategies in clinical practice with the goal of improving patient outcomes. We are thrilled with our team's performance and we intend to build on these strong results. For the remainder of this year, our priorities are to sustain growth in the improved population expand the number of prescribing accounts, support timely treatment initiation and refills, and increase repeat prescribing within existing accounts. We will continue to report new patient starts, total prescriptions, and net product revenue so you can track our progress. We continue to strengthen COMZIFTI's position in the approved setting.
The prescribing experience and physician relationships we build today will support future expansion where the benefits of combinability with other standards of care without overlapping toxicity will be the differentiator among menin inhibitors. Early results support our thesis. And we believe our development strategy will establish Ziftomenib as a foundational therapy across AML. With that, I will turn the call over to Mollie for a discussion on the development updates.
Mollie Leoni: Thank you, Brian. Our clinical strategy is to establish Ziftomenib as a backbone therapy across the menin dependent AML treatment continuum and build a second precision oncology franchise with darlafarnib. Our near term focus is the upcoming 017 frontline program, and advancement of darlafarnib's registrational and combination studies. At ASH, we are very pleased to have 8 Ziftomenib abstracts including 4 oral presentations. Among those, we want to draw your attention to our first clinical trial data evaluating Ziftomenib in combination with 2 different FLT3 inhibitors during 2 oral presentations. Data will come from the ongoing Ziptimenib trials, KOMET-007 and -008.
The prevalence of FLT3 mutations in AML makes it a priority to generate this combination data nearly 1/3 of patients with AML and nearly half of all patients with NPM1 mutations have a FLT3 mutation. From the frontline KOMET-007 study, we will be presenting data from the quad combination of ziftomenib plus quizartinib with intensive chemotherapy that shows encouraging results in newly diagnosed NPM1 mutated FLT3ITD plus AML patients, clearly supporting further investigation. KOMET-008 is evaluating Ziptimedip plus gilteritinib in relapsed or refractory NPM1 mutant FLT3 commutated AML. These data will show encouraging activity and tolerability including in patients previously treated with a FLT3 inhibitor.
2 additional poster presentations will add to the evidence supporting Ziftomenib in combination with current standards of care. The first is an update with longer term follow-up on the combination of Ziftomenib plus venetoclax in the frontline setting from KOMET-007. These data support our continued excitement around the NIC portion of our phase III KOMET-017 trial. The second poster will provide additional data from our KOMET-001 trial with an exploratory analysis of Ziftomenib's activity in molecularly defined AML subtypes beyond NPM1 mutated and KMT2A rearranged disease such as DNMT3A mutation driven disease. Informing potential opportunities to reach more patients. Together these presentations will broaden the clinical evidence for Ziftomenib across molecular subtypes, treatment settings, combination regimens.
ASH also will also feature an oral presentation where we present encouraging first results from Blood Cancer United and Princess Maxim's pedal trial of ziftomenib plus fludarabine and cytarabine in heavily pretreated pediatric patients with relapsed or refractory acute leukemia including those previously treated with revumenib. Another oral presentation will highlight preclinical findings and additional subsets of menin associated leukemias. From the beginning, our strategy has been to get combinations and frontline treatments to patients. We are there today. We are presenting combinations with FLT3 and standard of care chemo at ASH next month. Registrational frontline data is next. As we look across our data, we believe we have the broadest development program and the best results for patients.
We would put these results up against any menin inhibitor program. Turning to execution, our phase 3 KOMET-017 program, encapsulating both intensive and non intensive chemotherapy eligible patients in a single program remains on track. With majority of global sites activated and enrollment progressing as planned. We continue to expect the first top line results from the intensive chemotherapy trial in 2028. Our objective is clear: continue to deliver data to broaden the men independent eligible patient population and establish Ziftomenib as the leading menin inhibitor in frontline AML treatment.
Turning to darlafarnib, our next generation farnesyltransferase inhibitor, we are thrilled to have reached alignment with FDA in pursuing a focused monotherapy path to potential registration in HRAS mutant salivary gland cancer. This is a rare disease with few effective systemic treatment options. When the tumors are driven by an HRAS mutation, darlafarnib can inhibit the farnesylation required for HRAS signaling. Our rationale builds on clear physician and KOL interest and confirm durable responses observed with darlafarnib in this patient population. We plan to submit an IND by the end of this year and initiate a single arm registration directed monotherapy study of approximately 40 patients in the first half of 27.
An initial monotherapy approval could establish a clinical and regulatory foundation for darlafarnib while we continue to evaluate darlafarnib in combination with multiple larger patient populations. 1 such population is renal cell carcinoma. FIT-001, we are evaluating darlafarnib plus cabozantinib in a randomized, 3-arm phase 1b study. We expect to complete enrollment in the first half of 27 and report initial data in the second half. The study is designed to assess Darlafarnib's contribution relative to cabozantinib alone, selected dose, and guide subsequent development. We are also preparing to evaluate darlafarnib plus deruxtecan in previously treated KRAS mutant pancreatic ductal adenocarcinoma.
As demonstrated in FIT-001, darlafarnib plus adagrasib produced a 67% confirmed objective response rate in patients with KRAS G12C mutated PDAC. Although a small cohort, we believe these results provide a compelling rationale to evaluate darlafarnib with deruxtecan in a broader KRAS mutant PDAC population. We expect to dose the first patient in the first half of 27 with the potential for preliminary data in the second half. We like to say that believe darlafarnib can make good treatments better. In that spirit, we also continue to advance our platform trial that will allow us to explore additional combination partners and indications.
We are pursuing near term priorities of executing KOMET-017 initiating the planned darlafarnib registrational study, completing randomized RCC enrollment, and beginning the pancreatic cancer combination trial. Each program has a defined next milestone to guide further investment. I will now turn the call over to Jennifer to discuss our third quarter financial results.
Jennifer Fulk: Thank you, Mollie. I joined Kura at an exciting time. Our commercial business is gaining momentum. Our pipeline is advancing toward important milestones, and our balance sheet has strengthened. and strengthened to support execution. My focus is on funding execution, while maintaining discipline on spending, dilution, and future obligations. Ended September with $492 million in cash equivalents and short term investments. During the quarter, we raised approximately $32 million through the at the market equity program and we also renewed the program with $150 million of capacity. The strategic financing agreement we announced today with OrbiMed provides up to $300 million in potential funding.
The agreement strengthens our financial flexibility to support COMZIFTI commercialization, Ziftomenib development and darlafarnib's monotherapy registrational and combination studies. At closing, we received $50 million in debt funding and a $5 million equity investment. The agreement includes a modest single digit cap royalty component tied to US COMZIFTI net sales. The debt has a 7-year term with principal due at maturity. Additional funding is available in stages subject to specified conditions. This structure gives us access to additional capital as our programs advance. We will evaluate further draws against funding needs, clinical results and alternative sources of capital, weighing dilution against financing costs and future obligations.
Turning to our third quarter financial results, COMZIFTI net product revenue was $13.9 million compared with no product revenue in the third quarter of 25. Collaboration revenue from our Kyowa Kirin partnership was $8.9 million compared with $20.8 million in the prior year's quarter. Research and development expenses were down 2% to $67 million and selling, general and administrative expenses decreased 8% to $30.2 million Net loss decreased 5% to $70.2 million and share based compensation expense included in the net loss decreased 25% to $8.2 million We are updating collaboration revenue guidance for 2020 to $40 million to $45 million and maintaining guidance of $90 million to $110 million in each of 2027 and 2028.
This guidance reflects non cash accounting recognition as we fulfill performance obligations under the Kyowa Kirin agreement and does not reflect the timing of cash receipts. Expect our September 30th cash resources together with subsequent financing proceeds and approximately $180 million in anticipated Kyowa Kirin payments, to support our current operating plan beyond the initial Ziftomenib top line results expected in 2028. We expect to reach the readout with meaningful financial flexibility in hand and less dependence on raising capital around that milestone. We will continue to direct capital toward Comzifty commercial growth and the clinical milestones with the greatest potential to build value. And with that, I will turn the call back to Troy.
Troy Edward Wilson: Thank you, Jennifer. This has been the most exciting and rewarding time we have experienced at Kura since inception. Comzifty is leading the market and growing new patient starts in relapsed/refractory NPM1 mutated AML. We are expanding adoption today and building the clinical evidence to reach patients earlier in treatment through our phase 3 KOMET-017 frontline program, as well as initial combination data in FLT3 soon to be unveiled at ASH. We are preparing for a potential registrational path for darlafarnib and beyond that, combination studies in renal cell carcinoma and PDAC are moving forward. Our funding outlook supports our current operating plan beyond the first KOMET-017 readout and we are entering 2027 with a clear mandate.
Extend our leadership and deliver the clinical milestones that can drive Kura's next stage of growth. On a personal note, my wife and I are delighted to announce our own spin out. Our daughter, Poppy Rose, was 4 pounds, 15 ounces at birth and consistent with how we do things at Cura, she arrived 7 weeks early. Mother and baby are both doing very well, but I will be participating in the London meetings at UBS and Jefferies virtually as Poppy's still in the NICU. With that, Ronnie, we are prepared to take questions.
Operator: We will now move to our Q&A session. If you have joined via the webinar, please use the raise hand icon, which can be found on 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 queue. Again, we ask that you please limit yourself to 1 question and 1 follow-up question. You are welcome to then reenter the queue for any follow-up questions. Your first question comes from Roger Song with Jefferies. Please unmute your line and ask your question.
Nabeel Nissar: Hey, team. This is Nabeel on for Roger. Congratulations on the quarter, and more importantly, congratulations also on Poppy. Wish her the best from us. And I will go ahead. Thanks for taking our questions. So just doing some rough math on the total prescriptions, looking. Looks like they grew 60% versus 30% for new patient starts. It looks like the repeat scripts are roughly doubled, and they make up 2/3 of the volume. Just curious what is driving that repeat prescribing and how is time on therapy training against the roughly 5-month duration of response in the label? Thank you.
Troy Edward Wilson: Nabeel, thank you for the for the kind words and, and for the I am gonna ask Brian if he can speak to the relationship between TRx and NPS and what is driving that. Brian?
Brian T. Powl: Yeah. Thank. Thanks, Nabeel. As we said in my prepared remarks, I mean, we have seen growth across both new patient starts, but also repeat prescriptions and also our account extensions. What we are seeing is continued, you know, movement in the right direction. there is not really 1 specific thing that is telling us other than patients are getting on their and staying on therapy, which is something that, as we shared before, we would expect to continue as patients have an opportunity to be on therapy longer.
So we do not have yet, I think, enough mature data to give you a full communication around duration, but we are continuing to guide to the approximately 6 months duration of treatment, and I think this increase in TRx is also supporting that thesis.
Nabeel Nissar: Thank you, team. If I may ask a follow-up. Do we know how many patients are coming from another menin inhibitor? And then how many patients are in combination staying longer than on monotherapy? Thank you.
Brian T. Powl: Yeah. I mean, without getting into the detail, I think the story is that we are getting new patients on therapy I think it is less about a switch from other menin inhibitors to getting the patients who are eligible at the right time. I would say that, as I shared given that half of our patients are being treated in combination with other therapies, that typically are the patients who are earlier in their treatment course rather than in the 3rd or 4th line setting.
So I think that is going to be the strong signal, and what is a strength for us is this combinability message This is what is leading physicians to wanna use Comzifty in combination, because they recognize there may be greater benefit when they are able to do that. And I think our data that be sharing at ASH will also reinforce the that notion of how physicians are using COM50.
Troy Edward Wilson: Thank you, team. Thanks, Nabeel.
Operator: Your next question will come from Li Wang Watsek with Cantor. Please unmute your audio and ask your question.
Li Wang Watsek: Hey, guys. Congrats on the quarter. And, Troy, congrats on the baby as well. I guess just 1 question on some of the, you know, competitor data recently released from the ASH abstracts Wondering if you can share your perspectives on know, the potential headwinds, and what are the ways that you can and perhaps grow the market share?
Troy Edward Wilson: Yeah. Li, thanks. First of all, thanks for the for the congratulations. I know this is a question in probably in a number of people's minds. And I would say this. You gotta put that headline in contents. You know? J and J is third to market. They have gotta make some noise. Right? They are coming a year behind to in incumbents. And so they are gonna present the data that is that is in, you know, in their best interest. But the. But there is a lot of question. A third of the patients are missing from the efficacy calculation. So the, you know, the efficacy evaluable is about a hundred, The, the ITT is about 146.
You have to ask yourself, like, why are those patients not included? Were there deaths? Did they come off early? You know, what. what is going on? Right? We have see. And we have seen this with other companies even in the past several days. They clearly see differentiation syndrome. They clearly see QTc prolongation. And we all know the F is going to use an ITT analysis. So you know, we look at that as that is an abstract. We do not even really know what the data is yet. But I. You know, it changes nothing from our perspective. You asked about, you know, how do how do we grow? How do we continue? We anticipated this.
We anticipated they would they would get here, and, we anticipate that they will file. that is why you see us pushing toward frontline. it is why you see us pushing into combinations. We are the only menin inhibitor that will show you clinical data on not just 1, but both of, or 2 out of the 3 approved FLT3 inhibitors. Nobody else can show that. And we know, we hear it from physicians, I know all of you analysts and investors hear it on your doc calls. The future is combinations. The future is frontline. So this does not really. And we do not see you know, if I would.
As Molly said in her prepared remarks, we would put our data up against anyone. We would put our frontline and our combination data at this point up against any of our competitors. I think we feel like we offer the best benefit for patients. We offer the broadest potential range of mutations. So it really does not change anything at all. Except we are just heads down executing commercially, from a development perspective and continuing to push out the frontier. that is leadership. that is what we are doing. Thank you. Sure.
Operator: Your next question will come from the line of Jason Eron Zemansky with Bank of America. Please unmute your audio and ask your question.
Jason Eron Zemansky: Good afternoon. Congrats on the great progress, and special congrats to you, Troy, and your family. Maybe turning to darlafarnib. What response rates and duration would you need to show from the roughly 40 patients for approval? You know, about how large is the HRAS mutant salivary gland population in The US? Yeah.
Troy Edward Wilson: Jason, thanks for the question. Let me ask Mollie if she can comment sort of on how what, you know, what we would need to see, what we have seen, and what we would need to see in the trial. And then I can talk a little bit about the opportunity. How we think about it. Mollie, you want to start us off?
Mollie Leoni: Absolutely. In this patient population, there is really no significant treatments for patients once they become recurrent or metastatic in their disease and probably not really many up in the frontline either. Once they become recurrent metastatic there is about a 5% response rate overall to this systemic therapies available, and it is probably lower for an HRAS mutant patient population. So really there is enormous room for improvement and enormous room for clinically meaningful improvement for these patients, so even a tripling would be extraordinary. And we think we can do better than that.
So we have shown data previously in the monotherapy setting in the salivary gland carcinoma patient population, and it has clearly exceeded these baseline factors that I have just laid out. So we are really confident that we are gonna be able to make a clinically meaningful impact for these patients.
Troy Edward Wilson: Yeah, and Jason, just to thank you, Bonnie. Just to follow-up on the first part of your question. I think it is notable that Mollie and her team were able to secure a path to a full approval on the basis of a 40-patient study. I mean, we did it with COMZIFTI, but that was 112. You know, this is this is. I do not know if it is unprecedented, but there are not a lot of precedents for this.
And part of the rationale here is there is definitely a high unmet need among these HRAS mutant patients Principally, we are focused in salivary because we know we believe we can run a trial that will get us get us a registration. there is probably a few 100. there is thousands of HRAS mutant solid tumor patients. But Jason, more important piece is this gives you the clinical, the regulatory, the commercial foundation the potential, for example, for premium pricing, to be able to then launch into those combination indications in kidney cancer, in PDAC, and potentially elsewhere. And our intent is this registration and this FDA review will come ahead of those combinations.
So we view this as an opportunity to really derisk the program over all. It was part of frankly of the discussion we had with OrbiMed. The prospect that Cura now is on track to be a 2-commercial product company. This really gets us quickly to market with a with a low risk and sets us up for those combination studies to come.
Jason Eron Zemansky: Got it. Thanks so much for the color.
Operator: The next question comes from the line of Priyanka Grover with JPMorgan. Please unmute your line and ask your question.
Priyanka Grover: Hi, guys. Troy, congratulations from all of us at JPMorgan, especially the entire biotech team. We just have 1 question. Nearly half received Comzisty in combination with other approved agents. That was in the slides in particular. So how are you thinking about and education strategies of the KOL community heading into ASH and the many data updates? And afterwards, especially in regards to the con combination potential here.
Troy Edward Wilson: Yeah. Priyanka, first of all, thank you. And please extend our thanks and my thanks to all of you and all of your colleagues I will I will maybe answer, and then I am gonna I am gonna ask Brian to comment. This is AML. These physicians are very sophisticated. it is a small community. They study the literature. They are data driven. They work off of empirical evidence. For those who have been with us now for several years, this has been our strategy from the beginning. When Molly first introduced the Ziftomenib program, the plan was to demonstrate that ZIFTO had ideal safety, tolerability, combinability, and 1-daily convenience and could be part of any backbone.
And so that is what you are seeing us do is execute you know, study by study, combo by combo, so that when a physician says, want to use this particular regimen, there is already data out there, potentially a publication to support how Comms IFTY might drive better outcomes. that is been, you know, overarching. that is been the strategy. I think to Li's earlier question, what distinguishes us, for example, from our competitors. You look at that J and J abstract, you gotta sort of stop and think about the mile that you are seeing in that abstract. Is that gonna be a problem problematic in combination with venetoclax?
You know it is not from us because you can see both the venetoclax and the frontline data. So that is, you know, just at a very high level the way we think about it. But, Brian, maybe if you.
Brian T. Powl: Any thoughts you wanna add. Yeah. Maybe, Troy, I will add just a little bit of color to that for Priyanka. Thanks. So as Troy said, you know, our strategy has been to develop, Comms if the demonstrate its utilization combination. Since we first had our. The pivotal data for COMMENT zero 1, We shared that with physicians. The consistent feedback we heard from many physicians was you know, this data looks great, but I cannot wait to use this in combination. So they are eager. it is a it is a it is a market that is very eager to use data and cut or use therapies like this in combination, especially earlier in the patient's course.
So our goal, you know, going into ASH is to, of course, get feedback on the on the data that is presented. But our goal is ultimately to get to have these data shared out in the public, publications coming forward. There are, depending on the level of data that we present, we will be submitting a potential, submissions to our. To the guideline. NCCN guidelines and things. Our medical teams are going to be focused on sharing this information and making sure that physicians have the information in front of them. Just to reiterate, our commercial teams are not gonna be doing that. it is really more on the medical side.
But there is certainly an enthusiasm from the community to be able to learn about these data, particularly when it is unique that no other menin inhibitor is demonstrating combinations of FLT3s. that is compelling argument for many.
Operator: Your next question will come from the line of Asika Gunavardenne with Leerink. Please unmute your line and ask your question. Asthika, your line is open. Please unmute your line and ask your question. We will return to your We will move on now to Salim Syed with Mizuho. Unmute your line and ask your question. Salim, your line is open. Please unmute and ask your question.
Salim Syed: Hey. Can you hear me? Hello? Yes. Yeah. Now we can. Yes. Yes. Okay. Greg. Congrats, Troy, on, the birth of Poppy to you and to you and your wife. The picture was very cute. it is 1 from us on just the transplant dynamic that we learned about this quarter. You know, Syndax talked about this in their call about 40% of NPM1 patients, according to them, are going to transplant and then they are coming back to maintenance. Are you seeing a similar dynamic with these patients getting treated you know, earlier than perhaps that they were in trial and we are seeing a little bit more of a transplant dynamic there as well. Thank you.
Troy Edward Wilson: Yeah, Salim, thank you for the congratulations. Samir, honestly, between you and me, I think that is a bit of a distraction. You know, we. We have been. We have been hearing about the potential for KMT2A patients to come back from now for a number of quarters. I do not know that we have seen that. As you know, the NPM 1 population is much older. They are much more fragile. it is much less likely they are gonna get to transplant.
I think both of us saw sort of single digit, maybe 10 percent transplant rates in NPM 1 in the trials. it is it is, you know, it is it is I know it is a lot of anecdotal information, I think if we are looking at frontline there we have a real opportunity to get patients to transplant. And potentially to either keep them on therapy or as we have seen with our data, maybe they never go to transplant. They just stay on continuation therapies. that is not a dynamic we are seeing, but importantly, to Brian's point, NPS is up TRX is up, net product revenue is up.
And, you know, I do not think you need that to be able to grow the market in NPM 1. What you need is you know, combination data need to be able to keep patients on study. Mollie, anything you would want to add on this question of on Salim's question around transplant?
Mollie Leoni: No, I think that really the question of transplant does move to a combination frontline setting, And there, it is not even just a post transplant maintenance, post consolidation maintenance. And 1 thing we have seen in our study of 7 is that yes, some of the NPM1 patients go on to transplant if they require it, but most are able to refrain from having to go on to that additional risk factor. And if with their MRD status being negative, they can continue on Ziftomenib as a monotherapy as post consolidation maintenance. Even in the venetoclax setting, we are seeing them drop the back bone therapy and continue on Ziftomenib as in post consolidation maintenance therapy.
So overall, I think that is the real patient population that we are looking for this maintenance piece.
Salim Syed: Okay. Super helpful. Thanks so much, and congrats on the quarter.
Troy Edward Wilson: Thanks, Salim.
Operator: We now return to the line of Asthika Goonewardene with Leerink. Please unmute your line and ask your question.
Analyst: Hi, guys. Can you hear me? Yes. We can. This is Karina for Ostica. Thanks for taking yeah. This is Karina for Asthika. Thanks for taking my question. I just wanted to follow-up on the JNJ-75.3 million data, the ASH abstract. How do you think the baseline characteristics of this study compared to the registrational data for COMZIFTI in the relapsed refractory setting? Yeah, Karina, thanks for the question.
Troy Edward Wilson: I mean, there is so much we do not know, but, Mollie, any light you can shed for Karina?
Mollie Leoni: Yeah. I saw no major differences. Really within the baseline characteristics. But again, as Troy pointed out, their data in the monotherapy setting is still a bit of a mystery to me I am not really sure what the actual monotherapy efficacy data is, but what I am sure of is that monotherapy is no longer the story, and we have moved on to combination.
And we have seen really good activity in efficacy for all of these combinations with menin inhibitors showing how important menin inhibitors are in that space in the combination frontline space But what we have also seen is that while the efficacy may be really well, really good for each of these combinations, The safety is what the real differentiator, and we see cytopenias, see QT, we see DS, at much different grades and much higher levels in other combinations than we do with zipamen and So again, I think the winning combination for patients is going to be the 1 that is safest and most convenient to take, and that is going to be ziftomenib in the combination setting.
Thank you. And for the cytopenias, they had, like, grade 3 plus of 35% or higher. What do you think is driving that? So we do think yes. So we have theories about how it interferes with potential hepato. Hematopoiesis. It does seem to be somewhat related to half life, maybe a brief half life molecule that requires more than once a day dosing, so the twice a day dosing molecules, they seem to allow less habituation for the system. So these patients tend to have a harder time regaining their counts.
With the longer durabilities and the longer half lives, such as with Ziftomenib, we tend to see much less issues with thrombocytopenia and that is evident even in the data that you have seen and you will continue to see with our post consolidation maintenance where they are only on Ziftomenib therapy and we are not having issues or dose reductions due to cytopenias, whereas others you absolutely see those dose reductions and discontinuation.
Analyst: Very helpful. Thank you so much.
Troy Edward Wilson: Thanks, Karina.
Operator: Your next question comes from the line of Charles Zhu with LifeSci Capital. Please unmute your audio and ask your question.
Peter Green: Hi. This is Peter Green on for Charles. Kura team, congratulations on the quarter. And Troy, congrats from myself and from Charles. On the new addition to your family. Quick question on the Oberlin financing. As you consider this financing and ultimately pursued it, are there any newly anticipated costs associated with the clinical development for Ziftomenib or specifically KOMET-017. That prompted this financing, or is it mostly for Darlafarnib? How should we think about this? Thanks.
Troy Edward Wilson: Yeah. Peter, first of all, thank you again. Thanks for the thanks the. I appreciate the kind comments from everybody. What you did hear from us, Peter, and this was Jennifer talked about it in her prepared remarks, We did tap the ATM for a small amount. At a at a. At an average price of about $12.67. That was in lead up to the to the FDA alignment. Because we wanna hit the ground running. And get darlafarnib to the market as quickly as possible. I think this creates optionality for us. As we now have 2 programs. But Jennifer, I do not know if there is more you want to add on So help Peter think about it.
Jennifer Fulk: Yeah, no, just to add Troy, the OrbiMed partnership and the structure of the deal really fits our operating plan really nicely. And as we look to fund, you know, the operations and the plans that we set forth, including, you know, darlafarnib as we have talked about it earlier today, sets us up really nicely to be able to stable, capitalize, and deliver on those really important milestones for next year. And the really exciting part is, you know, with having potentially 2 significant commercial products that, you know, we can drive value in.
Troy Edward Wilson: what is kind of the point of it is on me. And Peter, just to add to that, just to add to everything Jennifer said, I mean, we have been consistently guiding to these top line results in intensive chemo. Phase III in 2028, I think what this financing. You know, we are very grateful for the partnership with the OrbiMed team. What this now gives us is the potential to really drive value on darlafarnib. And, you know, we have obviously got the RCC cohort enrolling. You know, enrollments going like gangbusters. We are looking forward to dosing the first patients with deruxtecan. I think we have all been a little bit.
You know, we have all been impressed by how rapidly that launch has gone. I do not think we are gonna have any real problems there or patients. As Jennifer mentioned, the potential now to slingshot a second product in right as Zifto is, you know, coming to frontline That was a. That was where we wanted to be. And you know, we are responsible. We are mindful of the share price. We cannot control the volatility. What we can do is align ourselves with good partners and create So that is what you have seen us do. That makes a lot of sense.
Peter Green: Thank you very much.
Troy Edward Wilson: My pleasure. Thank you.
Operator: Your next question comes from the line of Philip Nadeau with TD Cowen. Please unmute your audio and ask your question.
Philip Nadeau: Good afternoon. Troy, us add our congratulations on Poppy. That is that is fantastic news. Best of luck to you and your wife. We did want to ask about script trends. Every quarter, do an analysis where we look at the prior scripts and try to predict what revenue is gonna be for the next quarter as well as scripts. And when we do that, based on a 5 month duration of therapy, we tend to come to more total prescriptions and higher revenue than you are reporting. So I guess we are we are curious why that might be.
Is the duration of therapy now somewhat less than the 5-6 months you have guided to and ramping there as patients go on therapy? Or is there some other part of the analysis that maybe we are forgetting, like, patients go on to transplant or whatnot? Curious to get your thoughts.
Troy Edward Wilson: Yeah, Philip, thank you again. Thank you for the kind words. I would be curious, we do not have to go into it. We will have time 1 on 1, but you know, I think you have to assume a build here, and you are gonna start with your sick patients in your later lines. 5 to 6 months is really steady state. So as Brian indicated, we are still growing. We are still getting there. I think thematically, you are doing the right thing, but you might be jumping the gun. jumping the gun a little bit looking at the way that this. These products have to build in the relapsed refractory setting. But Brian, anything you would add?
Brian T. Powl: Yeah. I think that to. With what with what Troy said, he is. Largely covered it. I think just a just a point to make is that as we are growing, this is growth that we are continuing to show that is only in the NPM 1 population. Right? That. It is consistent for us to be able to show that. And that also hopefully helps to get a little bit more clarity in terms of those new patient start numbers, grow. You may hear from others that they are growing at different rates, and I think if know, we.
What we are showing is if you have got a growth in the n p m 1 population, it is growth in n p m 1. And we are gonna see over there. Over time, that is going to come to fruition. So I think that is that is something that is important for us to understand too.
Philip Nadeau: Greg. And maybe just 1 follow-up. Do you have an estimate for how much of the incident NPM1 population is currently unamended therapy?
Brian T. Powl: Yeah. I think right now, that we are estimating it is just about, half just under half of the patients are getting a menin inhibitor therapy. And, you know, we talked earlier around the various options that are available for these patients. Li, they could be getting venetoclax, or if they are, remember half of these patients are have a commutation with FLT3, Those are the patients that may take a little longer to get on, and that is where you see this dynamic getting to steady state. Takes some time to get those patients.
So we are encouraged about seeing the combination utilization where we got about half those patients, but that will still take time to continue to grow that market.
Philip Nadeau: that is really helpful. Thanks and Troy, congrats again. Thank you, Philip.
Operator: Reminder, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. We will take our next question from Reni Benjamin with Citizens. Please unmute your line and ask your question.
Reni Benjamin: Greg. Thanks for taking the questions, and congratulations Troy, to you and your wife and, of course, baby Poppy. It should alleviate any concerns investors may have about you retiring, anytime soon. So that is that is a good that is a good, good thing to know. Our feature. Our question is really around the PDAC study. Now that it is gonna be in combination with for exoronisib, would love to kinda get your thoughts you know, a little bit more about that study. You are you are you are now going after Pan RAAS versus mutation specific. How translatable is that? Versus the adagrasib study that you did? Frontline or second line?
And I guess most importantly, you know, how are your thinking about the data that could drive a going to this no go decision as you move forward? Thanks.
Troy Edward Wilson: Yeah. Let me start, and I am gonna invite Mollie to comment as well, Rem. And you for the kind words, and you are correct. You know, I am I am. If you cannot tell, I am all in on Cura. I am all in on winning. So, you know, baby Poppy is not going to we are we are gonna celebrate, but we are not going anywhere. In terms of your questions around PDAT, so you might see we have made a deliberate strategy to combine with agents that are the standards of care. That are approved.
And that is to try to minimize the development risk with Darlafarnib. there is lots of things combined with but let's be honest, as you look out across the RAS landscape, a lot of those agents either are not gonna make it or they are gonna fall by the wayside. So it is clear today and probably for the foreseeable future, deruxtecan is the undiscerable standard of care in second and later line PDAC. And that is why I say I think we are quite optimistic that we will be able to enroll the study because the pitch is really if you like deruxtecan, maybe we can make it better. that is the whole pitch around darlafarnib.
Can we improve the response rate? Can we temper the resistance? Can we improve the durability? No, just for everybody on the call, we are not mutational specific. We in principle work for any mutation just like deruxtecan. So there are other options. there is PRMT5, they have had some nice results. But we potentially could go anywhere Deruxtecan could go. The other interesting dynamic is with everybody racing to the frontline, there are going to be a lot of patients whose disease has progressed on a RAS inhibitor.
Might be allele specific, might be a pan RAS, 1 of the unique features of darlafarnib is its ability to drive activity in patients who have already whose disease has already progressed on an agent like that. That was the significance, that is why we showed you all the capozantinib data. that is the impressive aspects of the adagrasive data. So, Reni, there is a lot we have left to learn, but I think again Mollie and her team are doing the right study targeting the agent that is gonna take the lion's share of second line, and let's see how frontline shakes out. Mollie, what would you like, if anything, to add to my comments?
Mollie Leoni: Yeah. So Deruxtecan data was great. There is so much room for improvement still and I think that is what people forget. And we hope to be that agent that can really help with that additional improvement And we will be approaching it in 2 different ways as Troy alluded to. Both patients that are kind of a RAS inhibitor naive patient population, and those that have seen a RAS inhibitor previously. So we will be able to give you a better idea as to what the combination is able to do.
But again, we think that there is lots of room for improvement in both response rate, durability, and that adding Darley is really the way to help these patients most.
Reni Benjamin: Perfect, thanks for taking the questions and congratulations again, Troy. Thanks, Our next question will come from the line of David Dye with UBS.
Operator: Please unmute your audio and ask your question.
David Dai: Greg. Thanks for taking my questions. And I also want to add my congratulations to Troy for the addition in her family. Very exciting here. And I still have a 3-part question. So with 170 accounts now activated, do you see meaningful difference in terms of new patient starts between the academic and the community accounts? that is the first 1. Second 1, how much of the future prescription growth should come from deep utilization within existing high priority AML accounts versus continued expansion to new accounts.
And then thirdly, as you are thinking about the key levers such as early line use, combination use, or post-transplantation resumptions do you think are the main levers to continue to see penetration into the existing accounts.
Troy Edward Wilson: Yeah, David. So we are you asked a 3-part question. I think I think it is really the 2, you know, the. Let me distill it down into 2. First, to take the third part of your question, you know, where do you go from here? This is this is menin inhibitors with every conceivable combination in every line of therapy. that is where you want to get to. Frontline is qualitatively different. that is why we are all driving there. But you are seeing it in development in medical affairs you know, pushing out those boundaries.
And David, we have we have made investments years ago in prioritizing FLT 3 in the way that we are running the 2 phase 3 trials together. You know, we are the only sponsor that is running 2 company sponsored phase threes in intensive and non intensive. We are not relying on cooperative groups or investigator sponsored studies to get to those high value results. So I think what is what we are doing is what is working. We will likely continue doing what we are doing. In terms of the mix between the academic and the community, maybe you could answer David's question Yeah.
Brian T. Powl: Thanks, Troy. So, David, I mean, what we have said before is that we are going where the patients are. Which is largely in the academic setting. I think it is clear to say it is consistently been 85% to 90% of the patients are in the academic setting. But that is, I think, what the beauty is, is we have a team that is executing in both the community setting as well as the academics.
Our partnership with Kyowa Kirin allows for 1 field force to be out trying to identify where those patients may be, and then allow the other to kind of partner with them to kind of close and identify the right patient to get them started on COMZIFTI. And I think that is really something that has showcased how well our growth has come forward. We are continuing to build into new sites New accounts are growing, as we said, and our focus is gonna be continuing to increase the breadth of accounts while also increasing that depth while we get into those accounts as well. So repeat prescriptions within those accounts is a priority.
But also working to identify new patients that are coming from new accounts. So we. I would expect that to continue. I just want to give kudos to our teams for working so well together to achieve the results we have that allow us to expand into these new populations as well.
David Dai: Thanks so much for taking my questions. Thank you, David.
Operator: We return now to the line of Nabil Nassar with Jefferies. Please unmute your audio and ask your question.
Nabeel Nissar: Hey, team. Just jumping on again. Follow-up question. Just taking a big picture So in August, you shared the blood paper covering how ZIFTO binds menin and other and which resistance mutations it covers. I am just kind of curious, looked at some ASH abstracts, we saw that ZIFTO has almost the least MEN 1 mutations out of the menins that were screened. We know that MEN 1 in some comps have. Has led to some relapses. Curious you are getting feedback on physicians on this.
And if you could share more on this binding and if this is also part of what is driving the low heme tox and low tox when you combine with the FLT3 of the structure of the menin. Thank you.
Troy Edward Wilson: Yeah. Nabeel, it was gratifying to see that abstract. Said all along, Zifto, in our hands, induces the lowest amount of MEN 1 mutations But if that. We do not think it is biochemical, which is where your question's going to. It. We think it has to do with exposure. And Molly mentioned it in an answer to a previous question. I am gonna let her comment. But importantly, Zifto takes a little longer to work. Right? We have. It has time dependent accumulation, but in a long half life. But what that does is it means that menin is never uncovered as a target. And if you are thinking about drug resistance, where do you see drug resistance?
You often see it in the brain. Because you get suboptimal exposure in a protected space. Same thing is true here. You are you are trying to hit a system Our competitors dose more frequently and as a. You know, BID, I think, in every case. And as a result, they are leaving menin unprotected, uncovered. ZIFTO does not do that. So there is never really an opportunity for resistance to get a foothold.
And I think that is why we see such strong results when you move into combination when you move into the frontline. it is like, you know, you can I mean, there is gonna be some natural volatility around that competitor's abstract But as Mollie said, look at the data? Look at the frontline data. Look at the activity in the hemotox, Zifto is the winner, Zifto is the leader. Mollie, anything you want to add in terms of Nabil's question around resistance?
Mollie Leoni: Yeah, I just suggest thinking about it like antibiotics if you do not take your prescription as you were told to the resistant strains have a chance to grow out. it is the same thing with the cancer. The resistant clones will have a chance to grow and to take over. So by having constant pressure, having even including menin degradation, the clones, the resistant clones do not have a chance to gain predominance within the cancer space.
So really, it is it is that constant pressure that is very important, but I would like to point out we presented our data on MEN1 mutations previously showing very similar to as you described, very low rates of it, but what we do not expect to see is really to see it in the frontline because again, the constant pressure on the leukemia itself should present prevent the ability for the resistance mutations to arise. So we think this should become less and less of a problem even more so than it that it already is for us.
Troy Edward Wilson: So we are not very worried about it in the frontline or beyond.
Nabeel Nissar: Thank you for the color. Thanks, David.
Operator: Your final question will come from Reni Benjamin with Citizens. Please unmute your line and ask your question.
Reni Benjamin: Hey, guys. Thanks for taking the follow-up. Troy, I probably misheard this when you were going through your prepared remarks, but I wrote down an SBC study could result in full approval. And I am thinking that I probably wrote that down. It should be accelerated approval. And you just clarify that for me? And if it was full, my typing was good, was that you know, was that primarily driven by the rarity of the disease, or I do not remember the prior data. And so, you know, was it driven by know, some outstanding data as a monotherapy from before. Thanks.
Troy Edward Wilson: Sure. Reni, consider this your hearing test. You have asked. You heard it correctly. It was it was full approval. The FDA is aligned on a full approval for darlafarnib with a 40-patient study But I. You know, I am gonna let Mollie speak to it because she and her team were the ones who negotiated with the agency. To get us to that result. Mollie, you want to take Reni's question?
Mollie Leoni: Yeah, sure. So absolutely depends at least in some part on the fact that it is a tiny patient population with a very high unmet need. But even more so we had impressive results that we have shown with monotherapy very durable results in fact, and more so we have had the, you know, 20-year history of tipifarnib that can help guide us as well. And we have seen very good outcomes for patients that have been treated with an HRAS mutant TIPI patients. And we continue to get early access requests for these patients.
In fact, that probably makes up really the confirmatory data for the FDA is we will run the trial with darlafarnib, but the confirmatory can really come from the data that we have collected through compassionate use showing how much of an impact FTIs can make on salivary gland patient population.
Reni Benjamin: Thanks for taking the follow-up. Okay. Congrats. Thank you.
Operator: There are no more questions at this time. I would now like to turn the call over to Troy Edward Wilson for closing remarks.
Troy Edward Wilson: Thank you, Ronnie,, and thank you all for joining us today. I want to thank our colleagues at Kura and Kyowa Kirin the investigators and care teams supporting our studies, and the patients and families who make this work possible I would also like to thank all of you for your kind remarks about Poppy. Debbie and I really appreciate your kind words and your best wishes. At Cura, we are finishing out the year. We are entering 2027 with significant momentum and confidence. I think you can hear that. Our priorities are to expand our leadership of Coms IFT in its approved setting. Deliver these next Ziftomenib clinical updates, and advance darlafarnib toward its registration and combination milestones.
We look forward to discussing our progress with many of you in London, for UBS and Jefferies and then at ASH next month. And if you see me on the iPad, now you will know why. Thank you all again. Good afternoon and good evening.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.