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 2026 financial results earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you have joined via the webinar, please use the 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 one question and one 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 Cura Oncology. Please go ahead.

Thank you, Ronnie. Good afternoon, everyone. Joining me today are Dr. Troy Wilson, President and Chief Executive Officer, Brian Powell, 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, which are available through the SEC and on our website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Greg. Good afternoon, everyone. Oncology, Inc. Reflecting Continued Physician Preference for COM-ZIFTI. 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're heading into ASH with an unprecedented ZIFTA-MENID presence, including four oral presentations and our first clinical data on ZIFTA-MENID combined the three 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 Ziftimenib as a foundational AML therapy. These studies are among eight Ziftimenib abstracts at ASH, and Mollie will discuss how these studies address the opportunity and inform our next development decisions. Turning to our FDI program, we're very excited to announce we've aligned with FDA on a single-arm monotherapy registrational study with Darla Farnib in atras mutant salivary gland cancer. Thank you for joining us. We enter this next phase for Cura from a position of financial strength. Our strategic financing agreement with Oberlin Capital gives us flexibility to deliver key milestones for Zift Amenib and Darla Farnib. I'm pleased to welcome Jennifer to her first call as our Chief Financial Officer. She'll discuss the financing, our funding outlook, and our capital allocation priorities. Thank you for joining us. While retaining a substantial ownership interest in the program's potential value. With that, I'll turn the call over to Brian to discuss our commercial performance. Brian?

Thank you, Troy. POM 50's third quarter performance reinforces our leadership in the menin inhibitor market in relapsed or refractory MPM1 mutant AML. Physician feedback continues to align with our four 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, ComZifty net product revenue was up 53% over Q2. We recorded approximately 150 new patient starts, up approximately 30%, and more than 420 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 Cura and Kiwakiran field teams continue to expand our reach with AML prescribers and care teams. A total of 170 accounts have now prescribed CumZifty, 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. ComSifty 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 ComSifty patients received it in combination with other approved agents, primarily venetoclax and azacitidine or FLT3 inhibitors. While our teams promote ComSifty 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're 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 approved 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 ComZipT'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 MENID inhibitors. Early results support our thesis, and we believe our development strategy will establish Zip2MENID as a foundational therapy across AML. With that, I'll turn the call over to Mollie for a discussion on the development updates. Mollie?

Thank you, Brian. Our clinical strategy is to establish ZIFTA-MENAD as a backbone therapy across the MENAD-dependent AML treatment continuum and build a second precision oncology franchise with Darla Farnham. Our near-term focus is the upcoming ASH data, execution of COMET-17 frontline program, and advancement of Darla Farnham's registrational and combination studies. At ASH, we're very pleased to have eight Zipdimentib abstracts, including four oral presentations. Among those, we want to draw your attention to our first clinical trial data evaluating Zipdimentib in combination with two different FLT3 inhibitors during two oral presentations. Data will come from the ongoing Zipdimentib trials, Comet 007 and 008. The prevalence of flip-free mutations in AML makes it a priority to generate this combination data. Nearly one-third of patients with AML and nearly half of all patients with NPM1 mutations have a flip-free mutation. From the Frontline Comet 007 study, we'll be presenting data from the quad combination of Zifto-Meta plus Quisartinib with intensive chemotherapy that shows encouraging results in newly diagnosed NPM1-mutated FLT3-ITD-positive AML patients clearly supporting further investigation. Comet 008 is evaluating Zifta-Metab plus Giltaritinib in relapsed or refractory MPM1 mutant FLT3 co-mutated AML. These data will show encouraging activity and tolerability, including in patients previously treated with a FLT3 inhibitor. Two additional poster presentations will add to the evidence supporting Zifta-Metab in combination with current standards of care. The first is an update with longer-term follow-up on the combination of Zifta-Metab plus Venizac in the frontline setting from Comet 007. These data support our continued excitement around the NIC portion of our Phase III Comet 17 trial. The second poster will provide additional data from our Comet 001 trial with an exploratory analysis of zyptomenids activity and molecularly defined AML subtypes beyond NPM1-mutated and KMT2A-rearranged disease, such as DNMT3A mutation-driven disease, informing potential opportunities to reach more patients. Thank you so much for joining us. where we present encouraging first results from Blood Cancer United and Princess Maximus Petal Trial of Zifnamenib plus Fludarabine and Citerabine 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're there today. We're presenting combinations with Flip3 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 men inhibitor program. Turning to execution. Our Phase 3 Comet 17 program, encapsulating both intensive and non-intensive chemotherapy-eligible patients in a single program, remains on track, with a 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 MENIN-dependent eligible patient population and establish ZiptoMENIV as the leading MENIN inhibitor in frontline AML treatment. Turning to Darlifarnib, our next-generation farnesotransferase inhibitor, we are thrilled to have reached alignment with FDA in pursuing a focused monotherapy path to potential registration in HRS mutant salivary gland cancer. This is a rare disease with few effective systemic treatment options. When the tumors are driven by an HRS mutation, Darlifarnib can inhibit Our rationale builds on clear physician and KOL interest and confirmed durable responses observed with Darlapharnib 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 2027. An initial monotherapy approval could establish a clinical and regulatory foundation for darlofarnib while we continue to evaluate darlofarnib in combination with multiple larger patient populations. One such population is renal cell carcinoma. FIT001, we are evaluating darlofarnib plus cabozantinib in a randomized three-arm phase 1b study. We expect to complete enrollment in the first half of 2027 and report initial data in the second half. The study is designed to assess darlofarnib's contribution relative to cabozantinib alone, select a dose, and guide subsequent development. We are also preparing to evaluate Darlafarnib plus Daroxonracib and previously treated KRAS mutant pancreatic ductal adenocarcinoma. As demonstrated in FIT001, Darlifarnib 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 Darlifarnib with Daraxoniracib in a broader KRAS mutant PDAC population. We expect to dose the first patient in the first half of 2027 with the potential for preliminary data in the second half. We like to say that we believe Darlifarnib 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 COMET-017, initiating the planned Darlifarnib 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'll now turn the call over to Jennifer to discuss our third quarter financial results. Jennifer?

Thank you, Mollie. I joined CUR at an exciting time. Our commercial business is gaining momentum, our pipeline is advancing toward important milestones, and our balance sheet has been strengthened to support execution. My focus is on funding execution while maintaining discipline on spending, dilution, and future obligations. We ended September with $492 million in cash, 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 Oberlin Capital provides up to $300 million in potential funding. The agreement strengthens our financial flexibility to support ComZifty commercialization, Zipdomative development, and Darlie Farno'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 capped royalty component tied to U.S. ComZifty net sales. The debt has a seven-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, consifting net product revenue was $13.9 million, compared with no product revenue in the third quarter of 2025. Collaboration revenue from our Kiowa-Keran 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 2026 to $40 to $45 million and maintaining guidance of $90 to $110 million in each of 2027 and 2028. This guidance reflects non-cash accounting recognition as we fulfill performance obligations under the Kiowa-Karen Agreement and does not reflect the timing of cash receipts. We expect our September 30th cash resources, together with subsequent financing proceeds and approximately $180 million in anticipated Kiowa-Keran payments, to support our current operating plan beyond the initial Zipto-Meneb 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'll continue to direct capital toward ComZifty commercial growth and the clinical milestones with the greatest potential to build value. And with that, I'll turn the call back to Troy.

Thank you, Jennifer. This has been the most exciting and rewarding time we've experienced at Curris since inception. ComZifty is leading the market in growing new patient starts in relapsed refractory NPM1 mutated AML. We're expanding adoption today and building the clinical evidence to reach patients earlier in treatment We're preparing for a potential registrational path for Darla Farnett, 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 Commodore 17 readout, and we are entering 2027 with a clear mandate. Extend our leadership and deliver the clinical milestones that can drive Cura'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 seven 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're prepared to take questions.

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 the queue. Again, we ask that you please limit yourself to one question and one follow-up question. You're 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.

Hey team, this is Nabil on for Roger. Congratulations on the quarter and more importantly, congratulations also on Poppy. Wish her the best from us. And I'll go ahead. Thanks for taking our questions. So just doing some rough math on the total prescriptions, looks like they grew 60% versus 30% for new patient starts. It looks like The repeat scripts are roughly doubled and they make up two-thirds of the volume. Just curious what's driving that repeat prescribing and how is time on therapy training against the roughly five-month duration of response on the label? Thank you.

Nabeel, thank you for the kind words and for the question. I'm going to ask Brian if he can speak to the relationship between TRX and NPS and what's driving that. Brian?

Yeah, thanks, Nabeel. Yeah, as we said in my prepared remarks, we've seen growth across both new patient starts but also repeat prescriptions and also our account extensions. What we're seeing is continued movement in the right direction. There's not really one specific thing that's telling us other than patients are getting on therapy 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 don't have yet, I think, enough mature data to give you a full communication around duration, but we're continuing to guide to the approximately six months duration of treatment. And I think this increase in TRX is also supporting that thesis.

Thank you, team. If I may ask a follow-up, do we know how many patients are coming from another Mennon inhibitor and then how many patients are in combination staying longer than on monotherapy? Thank you.

Yeah, I mean, without getting into the detail, I think the story is that we're getting new patients on therapy. I think it's 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 third or fourth line settings. So I think that's going to be the strong signal. And what is a strength for us is this combinability message. This is what is leading physicians to want to use CumZifty in combination because they recognize there may be greater benefit when they're able to do that. And I think our data that we'll be sharing at ASH will also reinforce For our next question, we'll come from Lee Watzik with cancer.

Please unmute your audio and ask your question.

Hey guys, congrats on the quarter and Troy, congrats on the baby as well. I guess just one question on some of the competitor data recently released from the Ash Abstracts. Wondering if you can share your perspectives on the potential headwinds and what are the ways that you can defend and perhaps grow the market share?

Yeah, Lee, thanks. First of all, thanks for the congratulations. I know this is a question probably in a number of people's minds, and I'd say this. You've got to put that headline in context. You know, J&J is third to market. They've got to make some noise, right? They're coming a year behind two entrenched incumbents. And so they're going to present the data that's in their best interest. But there's a lot of questions. A third of the patients are missing from the efficacy calculation. So the efficacy evaluable is about 100. The ITT is about 146. You have to ask yourself, why are those patients not included? Were there deaths? Did they come off early? What's going on? And we've 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 FDA is going to use an ITT analysis. So we look at that as that's an abstract. We don't even really know what the data is yet. It changes nothing from our perspective. You asked about how do we grow, how do we continue? We anticipated this. We anticipated they would get here and we anticipate that they'll file. That's why you see us pushing toward frontline. It's why you see us pushing into combinations. We're the only menin inhibitor that will show you clinical data on not just one, but two out of the three Thank you for joining us. So this doesn't really – and we don't see – as Mollie said in her prepared remarks, we'd put our data up against anyone. We'd 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 – Thank you. Sure. Your next question will come from the line of Jason Zemanski with Bank of America. Please unmute your audio and ask your question.

Good afternoon. Congrats on the great progress and special congrats to you, Troy, and your family. Maybe turning to Darlie Farnham, 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 U.S.?

Yeah, Jason, thanks for the question. Let me ask Mollie if she can comment sort of on what we would need to see, what we've seen and what we would need to see in the trial. And then I can talk a little bit about the opportunity and how we think about it.

Mollie, you want to start us off? Absolutely. So in this patient population, there's really no significant treatments for patients once they become recurrent or metastatic in their disease and probably not really many up in the front line either. Once they become recurrent metastatic, there's about a 5% response rate overall to the systemic therapies available, and it's probably lower for an HRS mutant patient population. So really there's enormous room for improvement and enormous room for clinically meaningful improvement for these patients. So even a doubling, 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've just laid out. So we're really confident that we're going to be able to make a clinically meaningful impact for these patients.

Yeah, Jason, just to thank you, Molly, just to follow up on the first part of your question. I think it's notable that Molly 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 COMS-IFTI, but that was 112. You know, this is... I don't know if it's unprecedented, but there's not a lot of precedents for this. And part of the rationale here is there's definitely a high unmet need among these HRAS mutant patients. Principally, we're focused in salivary because we believe we can run a trial that will get us a registration. There's probably a few hundred. There's thousands of HRAS mutant solid tumor patients. But Jason, the more important piece is This gives you the clinical, the regulatory, the commercial foundation Thank you for joining us. It was part of, frankly, of the discussions we had with Oberlin. The prospect that Cura now is on track to be a two commercial product company. This really gets us quickly to market with a low risk and sets us up for those combination studies to come.

Got it. Thanks so much for the call, Eric.

The next question comes from the line of Priyanka Grover with J.P. Morgan. Please unmute your line and ask your question.

Hi, guys. Troy, congratulations from all of us at J.P. Morgan, especially the entire biotech team. We just have one question. Nearly half received ComSifty in combination with other approved agents. That was in the slides in particular. So how are you thinking about messaging and education strategies of the KOL community heading into ASH and the many data updates and afterwards, especially in regards to the combination potential here?

Yeah, Priyanka, first of all, thank you. And please extend our thanks and my thanks to you and all of your colleagues. I'll maybe answer, and then I'm going to ask Brian to comment. Thank you for joining us. Thank you for watching. Thank you for joining us. is that going to be problematic in combination with Veneza? You know it isn't from us because you can see both the Veneza and the frontline data. So that's, you know, just at a very high level the way we think about it. But Brian, maybe if you have any thoughts you want to add.

Yeah, maybe, Troy, I'll add just a little bit of color to that for Priyanka. Thanks. So as Troy said, you know, our strategy has been to develop CompZipT and demonstrate its utilization and combination. Since we first had the pivotal data for COVID-001, we shared that with physicians. The consistent feedback we heard from many physicians was, you know, this data looks great, but I can't wait to use this in combination. So they're eager. It's a market that's very eager to use therapies like this in combination. Thank you for joining us. There are, you know, depending on the level of data that we present, we'll be submitting potential submissions to the 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 going to be doing that. It's really more on the medical side. But there's certainly an enthusiasm from the community to be able to learn about these data, particularly when it's unique that no other meta-inhibitor is demonstrating combinations with FLT3s. That's a compelling argument for many.

Your next question will come from the line of Astika Gunavardhani with LERINK. Please unmute your line and ask your question. Asika, your line is open. Please unmute your line and ask your question. We will return to your question. We will move on now to Salim Saeed with Mizuho. Please unmute your line and ask your question. Salim, your line is open. Please unmute and ask your question.

Can you hear me?

Hello? Yes. Yeah, now we can.

Yeah, yeah. Okay, great. Congrats, Troy, on the birth of Poppy. To you and your wife, the picture was very cute. It's one from us on just the transplant dynamic that we learned about this quarter. You know, Syndex talked about this on their call. About 40% of MPM1 patients, according to them, are going to transplant. And then, of course, they're coming back to maintenance. Are you seeing a similar dynamic with these patients getting treated earlier than perhaps that they were in trial and we're seeing a little bit more of a transplant dynamic there as well?

Yeah, Salim, thank you for the congratulations. Salim, honestly, between you and me, I think that's a bit of a distraction. We've been hearing about the potential for KMT2A patients to come back from transplant now for a number of quarters. I don't know that we've seen that. As you know, the NPM1 population is much older. They're much more fragile. It's much less likely they're going to get to transplant. Thank you so much for joining us. That's not a dynamic we're seeing, but importantly, to Brian's point, NPS is up, TRX is up, net product revenue is up, and I don't think you need that to be able to grow the market in NPM1. What you need is combination data. You need to be able to keep patients on study. Mollie, anything you'd want to add on Salim's question around transplant?

No, I think that really the question of transplant does move to a combination frontline setting. Thank you for joining us. 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 with their MRD status being negative, and they can continue on Zipdomenib as a monotherapy as post-consolidation maintenance. Even in the Veneza setting, we are seeing them drop the backbone therapy and continue on Zipdomenib as in post-consolidation maintenance therapy. So overall, I think that is the real patient population that we're looking for for this maintenance piece.

Okay, super helpful. Thanks so much and congrats on the quarter.

Thanks, Celine.

We now return to the line of Astika Gunavardhani with Lering. Please unmute your line and ask your question.

Hi, guys. Can you hear me?

Yes, we can.

This is Karina for ASTICA. Thanks for taking my question. So I just wanted to follow up on the black cemented data, the ash abstract. How do you think the baseline characteristics of this study compare to the registrational data for comZipC in the relapsed refractory setting?

Yeah, Karina, thanks for the question. I mean, there's so much we don't know, but Mollie, any light you can shed for Karina?

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'm 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've moved on to combination. And we've seen really good activity and efficacy for all of these combinations with metal inhibitors showing how important metal inhibitors are in that space, in the combination frontline space. But what we have also seen is that while the efficacy may be really good for each of these combinations, the safety is the real differentiator. And we see cytopenias, we see QT, we see DS at much different grades and much higher levels. Thank you. And for the cytopenias, they had like grade three 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 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 Zyptomenib, we tend to see much less issues with thrombocytopenia and neutropenia. And that's evident even in the data that you have seen and you will continue to see with our post-consolidation maintenance, where they're only on Zyptomenib therapy and we're not having issues or dose reductions due to cytopenias, whereas others, you absolutely see those dose reductions and discontinuation.

Very helpful.

Thank you so much.

Thanks, Karina.

Our next question comes from the line of Charles Xu with LifeSite Capital. Please unmute your audio and ask your question.

Hi, this is Peter Green on for Charles. Cura 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 Zifto-Menin or specifically Comet 017 that prompted this financing? Or is it mostly for Darley Farnham? How should we think about this? Thanks.

Peter, first of all, thank you again. 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. Thank you so much for joining us. So that was helping Peter think about it.

Yeah, no, just to add, Troy, the Oberlin 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, Charlie Farnham, as we've talked about him earlier today, sets us up really nicely to be able to Peter, just to add to everything Jennifer said,

We've been consistently guiding to these top-line results in intensive chemo, Phase 3 and 28. I think what this financing, you know, we're very grateful for the partnership with the Oberlin Capital team. What this now gives us is the potential to really drive value on Darlie. And, you know, we've obviously got the RCC cohort enrolling, you know, enrollments going like gangbusters. We're looking forward to dosing the first patients with Derox Onrisib. I think we've all been a little bit, you know, we've all been impressed by how rapidly that launch has gone. I don't think we're going to have any real problems there recruiting patients. As Jennifer mentioned, the potential now to slingshot a second product in right as Zifto is, you know, coming to frontline, that was where we wanted to be. And We're responsible. We're mindful of the share price. We can't control the volatility. What we can do is align ourselves with good partners and create optionality. So that's what you've seen us do.

That makes a lot of sense. Thank you very much. My pleasure. Thank you.

Good afternoon. Troy let us out our congratulations on Poppy. That is fantastic news. Best of luck to you and your wife. We did want to ask about script trends. Every quarter we do an analysis where we look at the prior scripts and try to predict what revenue is going to be for the next quarter as well as scripts. And when we do that based on a five-month duration of therapy, we tend to come to more total prescriptions and higher revenue than you're reporting. So I guess we're curious about Thank you again. Thank you for the kind words.

I'd be curious, we don't have to go into it, we'll have some time one-on-one, but I think you have to assume a build here, and you're going to start with your sicker patients in your later lines. Five to six months is a really steady state, so as Brian indicated, we're still growing, we're still getting there. I think thematically you're doing the right thing, but you might be jumping the gun a little bit, looking at the way that these products have to build in the relapsed refractory set

Yeah, I think that with what Troy said, he largely covered it. I think just a point to make is that as we are growing, this is growth that we're continuing to show that's only in the NPM1 population, right? 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 What does new patient start numbers grow? You may hear from others that they're growing at different rates. And I think what we're showing is if you've got a growth in the NPM1 population, it's growth in NPM1. And we're going to see over time that that's going to come to fruition. So I think that's something that's important for us to understand, too.

Great. And maybe just one follow-up. Do you have an estimate for how much of the incident NPM1 population is currently on ameninine therapy?

Yeah, I think right now we're estimating it's just about half, just under half of the patients are getting them in an inhibitor therapy. And, you know, we talked earlier around the various options that are available for these patients, like they could be getting Vanesa, or if they're, remember, half of these patients have a commutation with FLT3, those are the patients that may take a little longer to get on. And that's where you see this dynamic of getting to steady state take some time to get those patients. So we're encouraged about seeing the combination utilization, you know, where we got about half those patients, but that will still take time to continue to grow that market.

That's really helpful. Thanks. And Troy, congrats again. Thank you, Phil.

As a 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 Renny Benjamin with Citizens. Please unmute your line and ask your question.

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's a good thing to know. Our question is really around the PDAC study. Now that it's going to be in combination with Draxoronis, I would love to kind of get your thoughts, you know, a little bit more about that study. You're now going after PanRAS versus mutation-specific. How translatable is that versus the Adagrass study that you did, frontline or second line? And I guess most importantly, you know, how are you thinking about the data that could drive a go-no-go decision as you move forward?

Yeah, let me start, and I'm going to invite Mollie to comment as well, Ren, and thank you for the kind words. And you're correct. You know, if you can't tell, I'm all in on Cura. I'm all in on winning. So, you know, baby Poppy is not going to – we're going to celebrate, but I'm not going anywhere. In terms of your questions around PDAC, so you might see we've made a deliberate strategy to combine with – Thank you for joining us. and that's why I say I think we're quite optimistic that we'll be able to enroll the study because the pitch is really, if you like Derox Onrecid, maybe we can make it better. That's the whole pitch around Darla Farnham. Can we improve the response rate? Can we temper the resistance? Can we improve the durability? Thank you for joining us. Thank you for joining us. That was the significance. That's why we showed you all the capozantinib data. That's the impressive aspects of the adagrassib data. So, Ren, there's 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 going to 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?

Yeah, so Derox data was great. There is so much room for improvement still, and I think that's what people forget. And we hope to be that agent that can really help with that additional improvement. And we'll be approaching it in two 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'll be able to give you a better idea as to what the combination is able to do. But again, we think that there's lots of room for improvement in both response rate, durability, and that adding Darlie is really the way to help these patients most.

Perfect. Thanks for taking the questions and congratulations again, Troy. Thank you, Ren.

Our next question will come from the line of David Dai with UBS. Please unmute your audio and ask your question.

Great. Thanks for taking my questions. I also want to add my congratulations to Troy for the addition of her family. They're exciting here. And so I have a three-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's the first one. Second one, how much of the future prescription growth should come from deep regularization within existing high-priority AML accounts versus continued expansion to new accounts? And thirdly, as you're thinking about the key levers, such as early-aligned use, combination use, or post-transplantation resumptions, what do you think are the remaining levers to continue to see penetration into the existing accounts?

Yeah, David, so we're... You asked a three-part question. Let me distill it down into two. First, to take the third part of your question, where do you go from here? This is menin inhibitors with every conceivable combination in every line of therapy. That's where you want to get to. Frontline is qualitatively different. That's why we're all driving there. But you're seeing it in development, in medical affairs, pushing out those boundaries. And David, we've made investments years ago in prioritizing FLT3 in the way that we're running the two phase three trials together. We're the only sponsor that's running two company-sponsored phase threes in intensive and non-intensive. We're not relying on Thanks, Troy.

Yeah, so David, I mean, what we've said before is that we're going where the patients are, which is largely in the academic setting. I think it's clear to say it's consistently been 85 to 90 percent of the patients are in the academic setting. But that's, I think, what the beauty is, is we have a team that's executing in both the community setting as well as the academics. Our partnership with Kiowa Cure allows for One field for us 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 ComSifty. And I think that's really something that has showcased how well our growth has come forward. We're continuing to build into new sites. New accounts are growing, as we said, and our focus is going to be continuing to grow. 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 I would expect that to continue. And 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.

Thank you so much for taking my questions. Thank you, David.

We return now to the line of Nabil Nassar with Jefferies. Please unmute your audio and ask your question.

Hey team, just jumping on again, a 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 resistant mutations it covers. I'm just kind of curious, we looked at some ash abstracts and we saw that Zifto has Thank you.

Yeah, Nabil, it was gratifying to see that abstract. We've said all along, like, ZIFTO in our hands induces the lowest amount of MEN1 mutations, but we don't think it's Biochemical, which is where your question's going to. We think it has to do with exposure. And Mollie mentioned it in an answer to a previous question. I'm going to let her comment. But importantly, Zipto takes a little longer to work. It has time-dependent accumulation and a long half-life. But what that does is it means that menin is never uncovered as a target. And if you're thinking about drug resistance, like where do you see drug resistance? You often see it in the brain because you get suboptimal exposure, you know, in a protected space. Same thing is true here. You're trying to hit a system. Our competitors dose more frequently and as a BID, I think, in every case. And as a result, they're leaving men unprotected, uncovered. Zipto doesn't do that. So there's never really an opportunity for resistance to get a foothold. And I think that's why we see such strong results when you move into combination, when you move into the front line. That's why, you know, you can, I mean, there's going to 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 heme talks. Zipto is the winner. Zipto is the leader. Mollie, anything you want to add in terms of Nabil's question around resistance?

Yeah, I just suggest thinking about it like antibiotics. If you don't take your prescription, as you were told to, the resistant strains have a chance to grow out. It's the same thing with the cancer. The resistant clones will have a chance to grow and to take over. So by having constant pressure, including men and degradation, the resistant clones don't have a chance to come to predominance within the cancer space. So really, it's that constant pressure that's very important. But I'd 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 don't expect to see is really to see it in the front line. Because again, the constant pressure on the Thank you for the call. Thanks, Nabil.

Your final question will come from Rennie Benjamin with Citizens. Please unmute your line and ask your question.

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 the SPC study could result in full approval, and I'm thinking that I probably wrote that down. It should be accelerated approval. Can you just clarify that for me? And if it was full, my typing was good. Was that, you know... Thank you.

Sure. Ren, consider this your hearing test you passed. You heard it correctly. It was full approval. The FDA is aligned on a full approval for Darla Farner with a 40-patient study. But I'm going to 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 Ren's question? Sure.

Yeah, sure. So absolutely depends, at least in some part, on the fact that it's a tiny patient population with a very high unmet need. But even more so, we had impressive results that we've shown with mono-Darley therapy, very durable results, in fact. And more so, we've had the 20 years history of TIPI that can help guide us as well. And we've seen very good outcomes for TIPI patients that have been treated with TIPI. for atrius mutant tippy 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'll run the trial with Darlie, but the confirmatory can really come from the data that we've collected through compassionate use showing how much of an impact FTIs can make on a salivary gland patient population.

Thanks for taking the follow-up, and congrats.

Thank you.

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

Thank you all, Ronnie, and thank you all for joining us today. I want to thank our colleagues at CURA and CURE-CURIN, the investigators and care teams supporting our studies. and the patients and families who make this work possible. I'd also like to thank all of you for your kind remarks about POPI. Debbie and I really, really appreciate your kind words and your best wishes. At Cura, we're finishing out the year. We're entering 2027 with significant momentum and confidence. I think you can hear that. Our priorities are to expand our leadership of COMS-IFTI in its approved setting, deliver these next SIFT-amended clinical updates, and advance Darla Farnib 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'll know why. Thank you all again. Good afternoon and good evening.