Cure Oncology at Barclays Conference: Strategic Insights on Trials and Partnerships

On Tuesday, 11 March 2025, Cure Oncology (NASDAQ: KURA) presented at the Barclays 27th Annual Global Healthcare Conference. The discussion, led by CEO Troy Lawson and CMO Molly Leone, highlighted the company’s strategic focus on clinical trials and partnerships. Despite challenging market conditions, Cure Oncology remains optimistic about its robust pipeline, emphasizing innovation and execution.

Key Takeaways

• Cure Oncology plans to submit a New Drug Application (NDA) for siftamenib next quarter.
• Two Phase III trials are set to begin later this year, targeting AML and GIST.
• The company maintains a strong cash position with support from its partnership with Kyneara Kirin.
• Cure Oncology is exploring partnerships for its diabetes program, which is in the preclinical stage.
• The company anticipates releasing data at major medical meetings throughout the year.

Financial Results

• Funding:

- Cure Oncology funds its own trials, with additional financial support from Kyneara Kirin for Phase III trials.

• Cash Position:

- The company aims to sustain a strong cash position to support its strategic initiatives.

Operational Updates

• Supply Chain:

- Adjustments made during COVID-19 have mitigated potential supply chain disruptions.

• FDA Communication:

- Communication with the FDA remains stable, with no significant changes reported.

• Clinical Trials:

- Robust enrollment in trials, particularly in VENAZA and 7+3 combinations.

- NDA submission for siftamenib is expected next quarter, with potential commercialization later this year or early next year.

Future Outlook

• Pipeline Expansion:

- Focus on AML innovation and initiating a trial in GIST.

- FTI program data may be released at ESMO in the second half of the year.

• Diabetes Program:

- Plans to nominate a development candidate and explore partnerships for clinical development.

• Global Trials:

- Expansion plans leveraging the Kyneara Kirin partnership for global trial operations.

Q&A Highlights

• Supply Chain and Tariffs:

- No anticipated disruptions from tariffs or macroeconomic factors.

• Safety and Tolerability:

- Zifedimentib shows promising results in terms of safety and drug interactions.

• VENAZA and 7+3 Combinations:

- Strong enrollment with 7+3 being the preferred treatment option.

• MRD Negative CR:

- Data for accelerated approval expected in 2028.

Cure Oncology remains committed to advancing its clinical programs and partnerships. Readers interested in more details can refer to the full conference call transcript.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Pete Lawson, Biotech Analyst, Barclays: So my name is Pete Lawson. I’m one of the biotech analysts at Barclays. So I have the pleasure of covering Cure Oncology up on stage with me. I’ve got Troy Lawson, President and CEO and also Molly Leone, the CMO.

Questions we have been asking today have just been kind of some macro questions around whether do you think there’s any impact of on the supply chain with tariffs and any worries or learnings from COVID as we think about the new environment that we’re in?

Troy Lawson, President and CEO, Cure Oncology: Sure. First of all, thank you, Peter and Barclays for the invitation to participate in the conference. With respect to the macro, during COVID and actually during the bio secure debate, we actually took a long look at our supply chain and made some adjustments. So we’re not we at Cura specifically aren’t experiencing or anticipating any kind of disruptions or slowdowns from either tariffs or any of the kind of macro features. As well as there are some questions just around federal headcount in the agency, the FDA.

We’re also not expecting anything But we’re being vigilant and we’ll be prepared in the event that that happens.

Pete Lawson, Biotech Analyst, Barclays: Got you. Has there been any changes in the rate of communication and any levels of confusion there or? No,

Troy Lawson, President and CEO, Cure Oncology: not that we’ve seen. It’s been pretty much just business as usual. We’ve not seen any difference at all. Got you.

Pete Lawson, Biotech Analyst, Barclays: And I know you’re funding your own trials, but are there any kind of knock on effects that we should be thinking around for NIH budgetary funding and if that trickles through to clinical trial sites or?

Troy Lawson, President and CEO, Cure Oncology: I think that’s a longer term issue. Most of the in the trial sites back to your question around COVID, a lot of the trial sites are still recovering from the bolus of trials that went through during COVID. And a lot of unfortunately, a lot of those clinical sites have lost staff due to the sponsors, recruiting good people out of the clinical sites. So that’s a constant kind of work in progress. We haven’t again seen anything immediate from any of the NIH cuts.

That will probably be a longer term issue for the sector. Got you.

Pete Lawson, Biotech Analyst, Barclays: And maybe before we dive into the Q and A around the various aspects, but if there’s kind of any kind of state of the union or any kind of initial lead ins you want to prepare or talk through around the kind of catalyst that we should be thinking through over the next six to twelve months?

Troy Lawson, President and CEO, Cure Oncology: Sure. Yes. So as we look out six to twelve months, we beginning with siftamenib, we’re expecting to submit an NDA next quarter. Hopefully that would lead to review this year and potentially commercialization either late this year or early next year. That’s in the monotherapy setting.

In the combination setting, we will initiate the two Phase three randomized trials in the fit and unfit segments later this year. We’ve guided to second half. That’ll I think we’ll talk a little bit about the timing there, but that’s really a big push into the front line. You’ll see us continue, Peter, to innovate in the AML space. You’ll see us starting the trial in GIST with ziptummenim and ematinib.

We’re quite excited about that. And then you’ll see us release data for the FTI program here in the second half potentially at ESMO. And that will I think start to get hopefully get people to pay attention to the FTI programs. So if you look back, I mean, we are And at And at this point now, we’re looking at how can we make a big difference for patients, whether it be in AML, in GIST or in solid tumors. We’re hoping to have clinical data at every major medical meeting this year and on into next year.

So it’s going to be a good year. It’s tough out there in the markets, but we’re in the enviable position of being able to keep our heads down and just execute. Got you.

Pete Lawson, Biotech Analyst, Barclays: Thank you. And then just specifically around like COMET one and you’ve got the 2Q top line data kind of where do we see that data? Is that kind of an ASCO thing, abstract? How do we how much do we see?

Troy Lawson, President and CEO, Cure Oncology: Yes. Potentially at ASCO, that’s where we’ve submitted. And the abstract release I think is in late May. The titles come out early a little earlier than that. We’re hopeful.

It is a positive pivotal trial. So we’re hopeful that it gets a proper venue.

Pete Lawson, Biotech Analyst, Barclays: What should we expect to be seen in terms of CRCRH rates and response rates in that dataset?

Troy Lawson, President and CEO, Cure Oncology: Yes. So we’ve consistently guided the trial was designed to deliver between a 2030% CRCRH rate. I I think we’ve never once wavered from that. It is within that range and I think we’ve said it’s not on the boundary. So in terms of the safety, tolerability clinical activity, we think it’s going to be very competitive with what’s already out there.

We’ll look forward to sharing that data initially in the abstract and then hopefully in an oral presentation potentially as I said at ASCO.

Pete Lawson, Biotech Analyst, Barclays: Good. And how should we think about like patients that are pre treated with venetoclax? Does that have any impact on the results and or does that matter?

Troy Lawson, President and CEO, Cure Oncology: So I can’t really speak to the second half of the question of does it matter. The first half of the question is the rate of venetoclax pretreatment is consistent with what we saw in the Phase 1b. And so that’ll be one of the things if we look at the forest plot, I think that’ll be one of the things that we can talk about when we have the data. It’s actually a really interesting data set and looking forward to sharing it with you.

Pete Lawson, Biotech Analyst, Barclays: Got you. And remind us the number of patients you expect to see. And then also I guess on the side effect profile, is it differentiation syndrome that kind of we hone in on or are there other components that we should be thinking about?

Troy Lawson, President and CEO, Cure Oncology: Yes. So the number of patients we over enrolled in the pivotal registrational study. I think it’s ninety two something like that. Is that right? Yes.

Ninety two. Yes. And in terms of the safety and tolerability profile, yes, I mean the big questions for the class are presence or absence of drug drug interactions, QT prolongation, myelosuppression and differentiation syndrome. Those are the four things you watch, right? Because that’s what’s going to impact your ability to combine with other agents.

I think you’ll see we score very highly on all four of those metrics. I think and you can and Molly is going to speak to it, I know in your next set of questions. But I think the safety and tolerability of zifedimentib on a once daily schedule is part of what allows us has allowed us to combine so effectively with the standards of care and is what is driving enrollment to be so robust. It’s just it’s very, very easy to work with. Differentiation syndrome, Peter, as you know, really wasn’t much of an issue in the NPM1 segment as a monotherapy and it really becomes well managed, well mitigated in combination.

Pete Lawson, Biotech Analyst, Barclays: Okay, perfect. And then are you on track for the BLA submission? Yes. For the NDA. NDA,

Troy Lawson, President and CEO, Cure Oncology: sorry.

Pete Lawson, Biotech Analyst, Barclays: What are the gating factors that we should be thinking about?

Troy Lawson, President and CEO, Cure Oncology: The team just has to the team to think we’re like whipping them. It’s really down to the team doing the work to put the application together. It’s in its it’s 90 plus percent of the way there. You’re just finishing it off. There’s a lot of QA and QC that goes into it.

But it’s in very good shape. We’re on track to hit that second quarter and the team will hit it.

Pete Lawson, Biotech Analyst, Barclays: But it’s not kind of last minute 2Q you’re thinking or

Troy Lawson, President and CEO, Cure Oncology: No, I don’t think it’s last minute. Just

Pete Lawson, Biotech Analyst, Barclays: to transform you.

Troy Lawson, President and CEO, Cure Oncology: We’ve given our we try now to give ourselves some room to breathe, some room to maneuver. So we’re in good shape. Got you. The team’s done a phenomenal job.

Pete Lawson, Biotech Analyst, Barclays: And then COMET seven, so the FIT population seven plus three and for that data set kind of when should we expect that 2Q and kind of what do you want us to hone in on that data set? Do you want to take that?

Molly Leone, CMO, Cure Oncology: Sure. So, yes, Q2, we as Troy said, we’re submitting to as many major conferences as we can with our data. So, you’re going to want to hone in again on the safety, tolerability and combinability. That’s the biggest thing. That’s where drugs win or lose is combinability.

And then, of course, just to continue to see the positive trends we set in the data we’ve already shared previously at ASH, continuation of really good efficacy and safety in these patients.

Troy Lawson, President and CEO, Cure Oncology: Got you.

Pete Lawson, Biotech Analyst, Barclays: And for that combinability and what we should hone in on in a particular segments of that safety profile that we should be focused on around?

Molly Leone, CMO, Cure Oncology: For the seven plus three, the patients continue on with our drug as a monotherapy for significant periods of time in addition to using it in combination with the backbone therapies. However, you’ll notice that patients don’t require dose reductions or dose interruptions, etcetera, to handle adverse events, when they continue on as a monotherapy. That will be a very important piece to hone in on.

Pete Lawson, Biotech Analyst, Barclays: Got you. Okay. For the seven plus three alone, what’s the best bar that we should be thinking about?

Molly Leone, CMO, Cure Oncology: I was thinking about the seventy year old treatment, so there’s so many references out there, but usually the ranges are between fifty percent to eighty percent for a complete response rate in these patients. NPM1 probably higher, probably closer to that eighty percent and KMT2A a little bit lower just because they have a harder time with all treatments in general.

Pete Lawson, Biotech Analyst, Barclays: And how do what’s a good path for success when you add on top of something that’s already getting kind of eighty percent or do we think about it in terms of durability, etcetera?

Molly Leone, CMO, Cure Oncology: Yes, that’s exactly right. At this point with adding targeted therapies on top of these really good backbones, it’s like for instance with the CUSARTINIB trial, they didn’t see a significant increase in the complete response rate. They saw a significant increase in the durability and the overall survival. And it’s looking for markers of that increase in the durability and the overall survival that are extremely important, because it is hard to make an improvement upon an enormous CR rate in the backbone. So that’s why this MRD negative CR endpoint becomes so important, because it likely is one of the best markers to be looking at for that increased in durability and increased in overall survival.

Pete Lawson, Biotech Analyst, Barclays: Got it.

Troy Lawson, President and CEO, Cure Oncology: Thank you.

Pete Lawson, Biotech Analyst, Barclays: And then, I guess, moving on to the unfit population, so the VENAZA, kind of what should we be thinking about for the VENAZA arm? And what’s the appropriate bar for VENAZA? And kind of where do you want that to go? And again around durability, how should we be thinking about that?

Molly Leone, CMO, Cure Oncology: Yes. So the VLEA study, which is still the premier source of information on that, puts the CR rate at about thirty eight percent for these patients. Obviously, people are used to seeing the mix CRC rate where it gets you closer to sixty percent, but FDA is only focused on CR. So, you’d want to see about a forty percent with the Venesa backbone alone. So we do look to improve upon that forty percent in the front line.

Pete Lawson, Biotech Analyst, Barclays: Got you. Did we get any other doses with the updates? Like do we get higher dose levels with

Molly Leone, CMO, Cure Oncology: the updates? So when we share this data, you’re going to be seeing for the first time the frontline VENAZA data because we did our dose escalation in the relapsedrefractory setting. So, you’ll be seeing the VENZA at the six hundred milligram dose level. And so, again, the safety and combinability is the first, second, third thing you should be looking at because if you can’t combine it well, if you have to keep reducing the venetoclax or interrupting the ziptonemetib, that would be a problem. But luckily these are not things we are seeing because it is so easily combined.

Pete Lawson, Biotech Analyst, Barclays: Got you. So there’s no worry that physicians in the real world setting will end up dose reducing one of these components whether it’s

Molly Leone, CMO, Cure Oncology: I think that’s actually the goal. I think physicians would love to be able to back off on the venetoclax dosing at least the the amount of dosing per month, because we see that in the real world. It is very toxic and these patients have a hard time with that and with infections and with bleeds and everything else. So, if we have a drug that can help get these patients into a response, help maintain them into in their response and you can lessen that backbone therapy, you’re actually making a huge improvement for these patients. And as we shared at the previous update, we got agreement with FDA to formalize a dose reduction for the venetoclax backbone in our pivotal trial, so that we do not have to be adhering to label dosing and can go to a lower dosing over the course of the trial.

Pete Lawson, Biotech Analyst, Barclays: How’s enrollment proceeding as you kind of think about the VENAZA versus the three plus or seven plus three combination? Is there any kind of delta between the two? Is there anything to read between the lines?

Molly Leone, CMO, Cure Oncology: They are both keeping the team extraordinarily busy. It is the enrollment rate is extraordinarily robust. It does appear that seven plus three is still the treatment of choice for the majority of these patients. But still the enrollment is incredibly quick for both patient populations, the Venesa and the 7 3.

Pete Lawson, Biotech Analyst, Barclays: Okay. Is there any reason to believe menin is going to combine better or generate better results with seven plus three versus MENAZA or?

Molly Leone, CMO, Cure Oncology: Certainly not combine better. There’s theoretically always been that assumption that maybe there’s some synergy with venetoclax. But the populations are so different that you’re not going to be able to compare head to head to seven plus three of the venetoclax patient population. But they both do very, very well on treatment and it’s a very robust effect.

Pete Lawson, Biotech Analyst, Barclays: What’s the read through from these studies to the frontline study? I mean, you mentioned the frontline data with Venison six hundred milligrams. Are there other read throughs we should be thinking about triangulating between this dataset and future data sets?

Molly Leone, CMO, Cure Oncology: It’s really taught us a lot. I think as you’ve seen with others developing in this space, it was the belief that it was venetoclaxase and cytidine that was the preferred combination partner. And our data, our experience, and our investigators and KOLs have showed us that that is not necessarily true that it really is both the seven plus three and the Venetes that are extremely important to developing this molecule. That’s one of the biggest read throughs we’ve had from our trial in general. And secondly, it’s the ability to get these patients on, get them into a response and maintain them, at least for the MPM1s, in that response without necessarily having to go to transplant.

And these patients are doing overall, especially the MPM1s, extremely well not having to go to transplant. And if you can avoid that toxicity, it’s huge for this population as a whole.

Pete Lawson, Biotech Analyst, Barclays: Got you. And then thinking about 1717 kind of when what are the timelines for initiation for that pivotal study?

Molly Leone, CMO, Cure Oncology: So as we shared, we’ve obviously already had our regulatory interactions and we hope to be fully operationalized and rolling by the end of the year.

Pete Lawson, Biotech Analyst, Barclays: Okay. What are the gating factors there?

Molly Leone, CMO, Cure Oncology: I was saying to Troy at one point, my team is going to to kill me if we do not stop pressing them to do everything very quickly all at once. But it’s really just operationalizing. It takes time to get the sites up. It takes time to get the contracting done. That’s where we are now.

We’re in those bureaucratic hang ups rather than any scientific jiggering or anything from our end. It’s really just actually getting through the red tape.

Troy Lawson, President and CEO, Cure Oncology: We’re in the process of study startup. And for big global trials like this that can take a while. The contracting, the budgeting, just the blocking and tackling that has to happen for a study to for sites to open and the study to begin.

Molly Leone, CMO, Cure Oncology: And that’s why we did it as two studies in one because now we only have to do it once rather than twice for VENZA and seven plus three.

Pete Lawson, Biotech Analyst, Barclays: Yes. No, it’s a clever design. And just the rationale for the partner, Kyneara Kirin, kind of how what do they add to that process? Do they slow it down?

Troy Lawson, President and CEO, Cure Oncology: Do they speed it up? Yes, they definitely they’ve been very additive. They definitely don’t slow it down in any way. I mean, the first, I think, is obviously financials. So you commented the trials, it’s clever design, right?

You’re doing two Phase III studies under a single protocol. There’s a significant some significant operational synergies that I don’t know we could have done alone with just the capital markets as our partner. That would have been challenging, particularly given we haven’t shown frontline VENAZA data yet, right? So we’re starting a Phase III when you and the market hasn’t yet seen the VENAZA data. Obviously, Curekirin has, the FDA have.

So that’s part of it. In terms of operationalizing it, Kewakuren has people on the ground in territories where we just have no hope. So Europe, Asia, these are going to be global studies. And sometimes it’s helpful to have someone there who can go and just physically walk around the site and help keep things lubricated and keep things moving along. We are of course driving global development.

We’re driving commercial strategy. But Kewa Kirin is we’re being very thoughtful with them about how can we work together to help move things forward. And then the final thing Peter is there’s two additional opportunities that are under the collaboration in AML. One is in the frontline FLT3 population, one is in the post transplant maintenance population. Remember that those are also included under the collaboration.

You’ll see us take those on in due course. So it really gives us the ability to compete effectively in all of the relevant segments of the frontline population. Got

Pete Lawson, Biotech Analyst, Barclays: you. And the MRD negative CR that’s changed the field and kind of I guess what drove that all the new trials in frontline do you think are going to be MRD negative CRs?

Molly Leone, CMO, Cure Oncology: Yes. You have to realize we’ve been thinking about this for four years and preparing for the idea of this for four years. So the fact that it’s actually come to fruition is a testament to the team and its preparation. Yes, I think it will help change the field. I think it will help get our these poor patients treatments more quickly.

And it’s something that our KOLs are extremely excited about. I get texts regularly congratulating us and thanking us for helping to pioneer this.

Pete Lawson, Biotech Analyst, Barclays: Got you. Okay. And then how should we think about interim analysis? When would you want if there is that built in?

Molly Leone, CMO, Cure Oncology: So we had previously shared that we will be doing that we expect the data for the accelerated approval. That would be the MRD negative CR in 2028.

Pete Lawson, Biotech Analyst, Barclays: Okay, perfect. And kind of the expectations of the control arms, whether it’s for the MRD negative CR rates or event free survivals?

Molly Leone, CMO, Cure Oncology: Sure. So, again, we’re looking in the bone marrow for the MRD negativity. In the bone marrow with KMT2As, you’re seeing in the thirty percent -ish area and in of MRD negativity. And in the NPM1. It’s a little higher in the 40s.

So depending on the mixture of patients we see, we expect to see about for that control arm a forty percent MRD negativity rate.

Troy Lawson, President and CEO, Cure Oncology: Got you.

Pete Lawson, Biotech Analyst, Barclays: It’s like three minutes or so on the clock. I’d love to kind of pivot a bit to the diabetes program and kind of what we should expect to see over the next six to twelve months? Yes.

Troy Lawson, President and CEO, Cure Oncology: So, our next goal is to nominate a development candidate for clinical development in diabetes. We have a range of potential candidates that we can choose. It’s one has to kind of ask like what exposure do you want? Do you want it to be a menin degrader or just a menin inhibitor? We have all of it.

We have all of the various flavors. So I would look for us to nominate that candidate. We are currently evaluating different options of moving it forward into the clinic. We want to be mindful that we keep the company in a strong cash position and we maximize the value for patients and shareholders. So we’re going to we’re running multiple options in parallel and we’ll have kind of more to say about where we go beyond the development candidate in due time.

Pete Lawson, Biotech Analyst, Barclays: So the assumption would be it’s probably not just your own spend as you go go into something like diabetes?

Troy Lawson, President and CEO, Cure Oncology: Yes. I mean, you could do some modest early clinical development, but I think it probably isn’t appropriate for an oncology company to be considering doing mid to late stage diabetes trials, right? That’s big pharma stuff. And there’s certainly an appetite for novel therapies in diabetes as you know.

Pete Lawson, Biotech Analyst, Barclays: Got you. And does the competitor Menin drug, does that kind of help inform that process or are you looking more broadly?

Troy Lawson, President and CEO, Cure Oncology: You take all the data into account. At the moment, I would say our and we really only have preclinical data. Our preclinical data would not have us limit the utility of a next gen MENON inhibitor to what they’re doing. I’m not entirely sure why they’re making those decisions. We’re we think there’s an opportunity in both type two and type one.

And that’s part of thinking about, Peter, how you develop it clinically and commercially, you want to maximize the value. And we’d also ideally be in a position where maybe you could take more than one menin inhibitor forward because for these big when you’re talking about millions of patients, I think you really want to have the very best compound to move forward. We certainly have the chemical material. We have the our chemistry group is phenomenal. Now we just have to find the right way to translate it into the clinic.

Pete Lawson, Biotech Analyst, Barclays: And so degrader versus inhibitor is that where are you in the That’s

Troy Lawson, President and CEO, Cure Oncology: just yes, and that’s just one example. I can tell you ZYPTO MENIB hits menin about as hard as it can be hit. It’s not obvious to us you need to hit it quite that hard in diabetes. You may be able to dial it back. You may actually want to do that.

Pete Lawson, Biotech Analyst, Barclays: Okay. That’s perfect. Thank you so much.

Troy Lawson, President and CEO, Cure Oncology: Our pleasure. Thank you. Pleasure.

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