Curis Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 5, 2025

Key Takeaways

  • Positive Sentiment: We are enrolling an additional 30 to 40 patients in the open-label PCNSL study of emivasertib plus ibrutinib and expect these data to support accelerated submissions with the FDA and EMA.
  • Positive Sentiment: A proof-of-concept trial in relapsed/refractory CLL will start by year-end, testing whether adding emivasertib to commercial BTKi therapy achieves complete remissions or MRD negativity and enables time-limited treatment.
  • Positive Sentiment: In relapsed/refractory FLT3-mutant AML, emivasertib demonstrated a 38% composite CR rate versus 21% for gilteritinib, and plans are in place for a registrational head-to-head study.
  • Positive Sentiment: Following the Varonis study miss, there is strong interest in combining emivasertib with azacitidine in high-risk MDS, leveraging emivasertib’s monotherapy activity to address an unmet need.
  • Neutral Sentiment: With $10.1 million in cash plus $6 million of July financing, Curis expects to fund operations into 2026 while evaluating further capital-efficient opportunities.
AI Generated. May Contain Errors.
Earnings Conference Call
Curis Q2 2025
00:00 / 00:00

There are 8 speakers on the call.

Operator

Good morning and welcome to Curis' Second Quarter twenty twenty five Business Update Call. All participants will be in listen only mode. After the company's prepared remarks, call participants will have an opportunity to ask questions. Please be advised this call is being recorded today, Tuesday, 08/05/2025. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer.

Operator

Diantha, please go ahead.

Speaker 1

Thank you, and welcome to Curis' second quarter twenty twenty five business update call. Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our second quarter twenty twenty five business update press release and related financial tables. I would also like to remind everyone that during the call, we will be making forward looking statements, which are based on our current expectation and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings.

Speaker 1

Joining me on today's call are Jim Dentzer, President and Chief Executive Officer Jonathan Zung, Chief Development Officer and Doctor. Ahmed Hamdi, Chief Medical Officer. We will also be available for a question and answer period at the end of our call. I'd now like to turn the call over to Jim.

Speaker 2

Thank you, Diantha. Good morning, everyone, and welcome to Curis' second quarter business update call. We continue to make steady progress in our take aim lymphoma study, which is evaluating emigosertib in combination with ibrutinib in patients with PCNSL. As a reminder, the taking lymphoma study is a single arm study with an ORR endpoint that adds emigosertib to a patient's BTKi regimen after they have directly progressed on BTKi monotherapy. And after collaborative discussions with FDA and EMA, we expect the study to support accelerated submissions in both The US and Europe.

Speaker 2

Over the next twelve to eighteen months, we'll be focused on enrolling 30 to 40 additional patients that we'll need for the NDA and EMA submissions. In June, we attended both the ASCO and EHA conferences and had the opportunity to engage with a number of KOLs who remain excited and supportive about expanding emivosertib into additional indications in CLL and NHL. They were especially interested in exploring emivacertib's potential to fundamentally change the treatment paradigm for CLL and NHL patients currently treated with BTKi monotherapy. BTKi inhibitors became standard of care in CLL and NHL because they deliver a good overall response rate. But these patients on BTKi typically achieve partial responses, not complete remission.

Speaker 2

The unsurprising result is that patients who are treated with a BTK inhibitor end up having to stay on it in lifelong chronic treatment. And because they never achieve complete remission, many of these patients develop BTKi resistant mutations and ultimately progress. We're looking to improve current standard of care by adding emivacertib to a BTK inhibitor, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi resistant mutations and improving a patient's quality of life. The first step in testing this hypothesis is to initiate a proof of concept study in approximately twenty to thirty patients with relapsedrefractory CLL who are currently responding to their BTK inhibitor, but unable to achieve complete remission or MRD negativity. We have completed the design for this study and are targeting first patient in by year end, and initial data in mid-twenty twenty six.

Speaker 2

Now let's turn to AML. As you'll recall, at the ASH conference in December, Doctor. Eric Weiner from Dana Farber presented twenty one relapsedrefractory AML patients with a FLT3 mutation. These data showed a thirty eight percent composite CR rate in the salvage line setting, with 10 objective responses in 19 patients and with seven of the 10 responses reported at the first assessment. To put these data into context, gilteritinib, the leading FLT3 inhibitor in relapsedrefractory AML, was approved with a composite CR rate of twenty one percent in a patient population where only thirteen percent of the patients had been previously treated with a FLT3 inhibitor.

Speaker 2

In the emivocertib study, over eighty percent of the patients had been previously treated with a FLT3 inhibitor. We believe the reason the emavusertib data are so compelling is its novel mechanism of action, which blocks both IRAK4 and FLT3. The next step in the development of emivasertib in AML is to conduct a registrational study comparing emivasertib versus gilteritinib in the relapsedrefractory setting. We're also excited about the potential of emivacertib in high risk MDS. In June it was announced that the Varonis study, testing the combination of venetoclax and azacitidine, missed its primary endpoint.

Speaker 2

This news generated a lot of discussion at the medical conferences and heightened interest in studying the combination of azacitidine with emavusertib. We have seen that emavusertib is active as a monotherapy in HR MDS and we believe the emovasertib azacitidine combination has the potential to address a clear unmet need and offer a compelling new treatment option for patients with MDS. Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, we initiated a phase one study last year of emivosertib as an add on agent to venetoclax and azacitidine in frontline AML. We're currently evaluating different dosing regimens of emivacertib, venetoclax and azacitidine.

Speaker 2

To date, we've completed enrollment in the seven day and fourteen day dosing regimens of emobusertib in a twenty eight day triplet cycle and are excited to report our progress in this study at the ASH conference in December. As you can see, we had a very exciting and productive quarter. And we look forward to providing additional updates as the year progresses. With that, I'll turn the call back to Diantha for the financial update. Diantha?

Speaker 1

Thank you, Jim. Curis reported a net loss of $8,600,000 or $0.68 per share for the 2025 compared to a net loss of $11,800,000 or $2.03 per share for the same period in 2024. Research and development expenses were $7,500,000 for the 2025 as compared to $10,300,000 for the same period in 2024. The decrease was primarily attributable to lower employee related costs, research, consulting and clinical costs. Research and development expenses were $16,000,000 for the six months ended 06/30/2025, as compared to $19,900,000 for the same period in 2024.

Speaker 1

General and administrative expenses were $3,500,000 for the 2025, as compared to $4,800,000 for the same period in 2024. The decrease was primarily attributable to lower employee related and legal costs. General and administrative expenses were $7,500,000 for the six months ended 06/30/2025, as compared to $9,700,000 for the same period in 2024. In July, we completed a registered direct offering and concurrent private placement with net proceeds of approximately $6,000,000 Curis' cash and cash equivalents were $10,100,000 as 06/30/2025, and the company had approximately 10,700,000.0 shares of common stock outstanding. Based upon our current operating plan, we believe that our $10,100,000 of existing cash and cash equivalents as of June 30, together with the proceeds from the July 2025 offerings, should enable us to fund our existing operations into the 2026.

Speaker 1

With that, I'd like to open the call for questions. Operator?

Operator

Today comes from Lee Watsick from Cantor. Please go ahead.

Speaker 3

Hey, good morning guys. Guess just a couple of questions here. For the BTK combination study in CLL, what do you think the bar would be? And also considering the evolving landscape in CLL with BTK degraders and next gen BCL2 inhibitors, how do you think you can fit in? And then the second question is for AML triplet data coming later this year.

Speaker 3

It would be helpful if you can set the expectations for us. Thank you.

Speaker 2

Thank you, Lee, for the question. Greatly appreciate it. Ahmed, you're probably the best to talk about the CLL study.

Speaker 4

Sure. Good morning, Lee. Good morning, everyone. Well, I mean, with the BTK inhibitors, like Jim said, the overall responses is usually partial responses where patients can stay on the drug chronically lifelong, risking mutations, risking toxicities. We believe that adding emoflucerta to a commercially available BTK inhibitor can lead to MRD negative or complete remissions.

Speaker 4

And that would lead to a time limited treatment, which is really the goal for CLL right now with unmet medical need. As far as degraders, they're still in development. It seems that there are some short lived responses, none of which are approved yet, but we intend to combine with commercially available BTK inhibitors. That answers your question, Lee.

Speaker 2

Yeah, let me add to that a little bit as well, Lee. So I'll start where Akhmed left off on degraders. So whether you degrade or inhibit BTK, it doesn't really matter to us. I mean, you're still blocking the BCR path. We block the other path, the Tollic receptor path.

Speaker 2

So whatever method you use to knock down BTK is great. Add this to it, it should make it better. The question about BCL two, I think is fair. Mean, there are a lot of indications or a lot of drugs being pursued in CLL because it's such a big indication. And I expect just as it is today, there's gonna be room for a lot of different competitors.

Speaker 2

But we're feeling pretty confident that the standard of care today, which is BTKi, only gets better when you add EMA to it and it potentially has the ability to offer a safe and tolerable regimen that could enable people to go to a time limited treatment. We think that's pretty compelling and obviously the investigators do as well. Remains to be seen when we get the data, but at this point I'd say we're pretty excited about it. On the AML triplet, Jonathan, Doctor. Zung, maybe you could talk to that.

Speaker 2

Our plans will be to present at the ASH meeting later this year, the efficacy and safety data that we see from the seven and fourteen day cohort. Yeah, and obviously, Lee, the abstracts need to be accepted. But I think we're feeling pretty comfortable about our ability to present data at that conference. So I'll just leave it at that and look forward to talking about it at that time. Thank you, Leigh.

Operator

The next question comes from Sarah Nick at H. C. Wainwright. Good morning, everyone, and thanks for taking the question. Just regarding your lymphoma study and your enrollment progression over the next twelve to eighteen months, just wondering if you could provide any color on how that enrollment is going in those next targeted 30 to 40 patients, if further sites seem to be open or kind of progressing as expected?

Operator

Thanks.

Speaker 5

Sure.

Speaker 2

So it's going as we expected, which is it's steady but it's an ultra rare population. So as you know, we've got over 30 sites open. What we have said in the past and we continue to say it is our expectations is that we're going to be able to enroll one patient per clinical site per calendar year. So we'll call Sloan Kettering and ask them for one patient over the course of twenty twenty five. Now some sites can enroll more than that, some enroll less frequently.

Speaker 2

That happens with an ultra rare indication, that's why we've got more than 30 sites. So I'd say things are going as planned and we're looking really forward to collecting those data and having a great discussion with FDA and EMA. Thanks Sarah.

Operator

Thank you. Thank you. Our third question comes from Danya Binhael at Jones. Please go ahead.

Speaker 6

Hi, thank you and congrats on the progress. I have a few questions. The first one for PCNSL. What should we expect in the next data update? Number of patients or mature data?

Speaker 2

We haven't given guidance yet on what to expect at the next update other than obviously the next natural conference would of course be ASH. But our guidance is going to be we're going to present the data we have at the time. So we continue to enroll, we continue to collect data, and we'll present what we have. And as I say, data we've seen so far are pretty compelling. I hope the data moving forward would continue to show that case, that we've got a clear drug that works in patients who are naive or patients who have failed prior BTK.

Speaker 2

I'd say stay tuned.

Speaker 6

Yeah, and are you planning to open additional clinical sites?

Speaker 2

I don't think we need to. I think right now we're comfortable with the number of sites we have and the enrollment's on track. So we feel pretty good about it. Obviously coming off the medical conferences, we're coming off of a lot of really great discussions and a lot of excitement among the KOLs. But I'd say at this point, there isn't a need to increase the number of sites to stay on track.

Speaker 6

And last question for the CLL program. So are you planning what line of therapy would most are you planning to enroll? I I suppose they will all be post BTKi?

Speaker 2

Yeah, actually, Ahmed, do you want to talk to that?

Speaker 4

Sure. Well,

Speaker 5

it can be any line

Speaker 4

of therapy provided that the patients are on a commercially available BTK inhibitor. So that can be in second line, can be patients who have been on a BTK and have not achieved a complete remission or MRD negative.

Speaker 2

Just as a reminder, Dania, if you pull the label for ibrutinib or for that matter for acalabrutinib, you'll see the CR rate in those patients in their label is literally zero. Now at some point I would say, of course, there are going be a lot of studies out there and there may be some patients who can get to CR, but the greater point is it's very rare. What we're hoping to be able to do is that we can replicate what we've seen in AML and in primary CNS lymphoma. And that is the drug combines well with other drugs, and because of its novel mechanism, we should be able to repeat what we've seen in PCNSL, and that is, we can get complete responses. And as long as we can deepen the responses and offer the patients the ability to go to a time limited treatment, I think we fundamentally change the way they can be treated, And it offers a really exciting alternative option for them.

Speaker 6

Sounds great. Thank you very much.

Speaker 2

Thank you.

Operator

Thank you. Our next question comes from Anna Lee from Truist. Go ahead.

Speaker 6

Hi, good morning, guys. This is

Speaker 7

Anna on for Krista. So, two questions from us. Given the changes at the FDA, can you talk about if anything has impacted your plans in PCNSL for accelerated approval? And have you continued to have any discussions with the FDA? And the second question, in the context of the cash runway, update on any BD efforts or anything like that?

Speaker 7

And any broader trends, particularly in oncology, that might have a read through to CURA? Thank you.

Speaker 2

Sure. Thank you, Anna. Appreciate the questions. Jonathan, would you like to talk to the FDA? Sure, Jim.

Speaker 2

Anna, you know, at this point nothing has changed in terms of where we are with the agency. We conducted meetings with them last year, have alignment on key activities with them and we're executing on that. Yeah, I would add to that. I just sort of echo the sentiment, Anna, that you're reading in all of the publications and all the papers. And that is the current era at FDA is a little concerning with its uncertainty.

Speaker 2

I think we take comfort that our lead beachhead indication in NHL happens to be in one in primary CNS lymphoma where there simply are no drugs approved, there is no standard. And we think that that's a very encouraging fact pattern for us as we continue the discussions with FDA. Of course, the discussions in EMA, which were equally positive, I would say, that's obviously not affected by the current administration. But the overall tone, while I don't think it has much of an impact on Curis, it certainly has an impact on the biotech industry. And I would encourage everyone to be active in voicing their concerns about that.

Speaker 2

On the cash runway, Diantha, would you like to talk to that?

Speaker 1

Yes, so our cash runway goes into '26 as I previously mentioned. We're continually evaluating both dilutive and nondilutive opportunities to extend our cash runway. So it's obviously something we'll be looking to do in the second half of this year to progress these programs as we've articulated today.

Speaker 2

Thank you, Anna.

Operator

Our next question today comes from Yale Jen from Laidlaw and Company. Please go ahead.

Speaker 5

Good morning, and thanks for taking the questions, and congrats on all the progress. My first question is in terms of the triplets. You mentioned seven days and fourteen days completed. I remember the last time you guys also mentioned that you might have to do your twenty one days dosing. I'm just curious whether that twenty one days still holds or the two time point will be sufficient.

Speaker 2

I don't want to talk too much about the data that we have, of course, because we're hoping to be able to present this at ASH. I would say that I would expect that there are a number of different regimens that will get tried in the real world setting and we're going want to be mindful of that and test those as fully as we can while we're in this clinical setting. So I say for now, I say we're very happy about where we are We look forward to discussing in more detail when the data are public. But in the meantime, as I say, I think you can just hear our optimism that having a drug that combines well with other drugs and has led to published responses in really challenging indications is very encouraging.

Speaker 5

Okay, great. That's very helpful. And just one follow-up question here, which is that you guys talking about the CLL, and that could be, you could, you may start enrolling patients toward end of the year, but you also guys have been talking a lot about the refractory AML. So I'm just curious at this point, how would you guys sort of prioritize the next development when you are getting PC CNSL on enrollment, and what will be the next priority at this time?

Speaker 2

Yeah, it's terrific question, Yale. Thank you for asking. As you can imagine, it was kind of a high class headache. We walked into ASCO and EHA with compelling data and walked out with designs for five separate trials. We certainly have more studies that we can run with a lot of enthusiasm from the community than frankly we can afford to.

Speaker 2

So we do have very active discussions internally about how we spend in as capital conscious a way and as capital efficient a way as we possibly can. It's not a surprise. Biotech has been in a tough financial environment for a long time. And I think the way we have been able to thread the needle over the last few years and make progress and generate compelling data despite the financial environment has been because of our discipline. And I think it's thanks to Diantha and frankly the entire company.

Speaker 2

Everybody at this company is motivated to get this drug approved and to do it in the smartest, best and fastest way possible. And that is an ongoing effort. Thank you.

Speaker 5

Okay, great. Maybe just squeeze one more here. You do have investigator sponsored solid tumor study, just in general where things are, and any updates? And thanks.

Speaker 2

Yeah. We don't have an update on those now. Yeah. As a reminder, thank you, Yale, we have five separate ISTs that we talk about in our corporate presentation. Of course, because they're ISTs, the good news is that they're sponsored either by the NCI, NIH, or academic partners, and therefore they don't cost a whole lot for Curis.

Speaker 2

The downside with any investigator trial or IST is of course we don't control the timeline for when they're going to put data out. I am hopeful that at least one of those studies is going have data to report out this year, but we can't really commit to it because unfortunately it's not under our control. So I love that emivosertib is being tried in all sorts of different areas, including five separate solid tumor types. And I love that it's very cost effective. But yeah, I share your eagerness to see the data from those studies and look forward to hopefully being able to tell you later this year that we can do so.

Speaker 5

Thanks a lot and congrats on all the progress.

Speaker 2

Thank you, Yale. Really appreciate it.

Operator

Our next question comes from Soumit Roy. Please go ahead.

Speaker 5

Good morning, everyone, and congrats on all the progress. Give me a question on the on PCNSL, the tiraprutinib data that came out at ASCO. I'm curious what's your take on it. One is the response rate and median DRR is pretty high, 64%, nine point two months. But the PFS is sort of lower three ish months versus historic data, five months.

Speaker 5

Do you think that's an important drug to open up a second arm with MR so that MR remains relevant in PCNSL maybe two years from now if terabrutinib gets a lot of traction?

Speaker 2

So thank you, Shumak. First, thank you for the question. Yeah, the terabrutinib data certainly looked very interesting and we would expect at some point it should get approval in The US. I mean it appears at the minimum it's the fifth BTK to The US market. It appears to be like Acala, zanubrutinib, like Perto, it looks to be a next generation BTK which should offer at the minimum some safety advantage and maybe even an efficacy advantage.

Speaker 2

And when it does finally get approval, I think what we'd like to do is, just as we would with any of the BTK inhibitors, or for that matter BTK degraders, establish that once you pick up a method for blocking the BCR pathway, whether it's with terabrutinib, ibrutinib, a degrader, pick your favorite method, add emavasertib to it and it should make that efficacy better. That's our ultimate goal. So yeah, we were very eager to see their data as well. We look forward to seeing them get approval eventually. And I would say just as we look at XANU and Akala and PERTO, our goal would be eventually to be able to establish that emivacertib is the standard drug you add to a BTK regimen.

Speaker 5

Is it a separate trial you're talking about? Currently you are with ibrutinib and that's if the trial enrolls 30 patients, gets in the label. So

Speaker 2

tiributinib is not approved. So we can't test it with ibrutinib Because with we can use any commercially available BTK inhibitor, but the lion's share of patients, I mean all of our patients except two, I think, were on ibrutinib. I think we had one patient that had come from the terabrutinib study and had progressed, and then maybe one patient that was on a CALA. But the vast majority of patients with PCNSL in The US and in Europe, just as a factual matter, they're on ibrutinib today. Now we would expect, as I think you would agree, that if tiributinib is eventually successful and does get a first label in The US, it will be in PCNSL because that's the only study they're running.

Speaker 2

And I would hope at that point that we could get it added to the label. How we do that, whether we have to run some sort of supplemental study to show that it works as well with any BTK inhibitor including terabrutinib. That's a discussion we'll have to have with the FDA once terabrutinib is approved. But I would certainly expect long term that that is likely to be the fifth. Merck has one that will likely be the sixth approved.

Speaker 2

And we're just gonna be able to combine with all of them, is my goal.

Speaker 5

One question on the triplet AML frontline. So you already completed the seven day safety. And then at ASH, I guess we are expecting the fourteen and twenty one day safety data. Are these patients do we have to reenroll these patients into the efficacy readout? Or

Speaker 2

Yeah, I want to be really careful what I say about the data, because I said we're planning on submitting it and presenting it at ASH. So I apologize if it seems a little cagey, but all I would say is, we're really excited to talk about the potential for a triplet combination in the frontline setting. I think certainly azacitidine and venetoclax in AML are our standard of care. And I'm just excited to talk about the data that we have that could highlight a potential place for emivosertib as well. But that's going to have to wait until we make the data public.

Speaker 5

Right. So I'm thinking, like, the next safety re next readout is gonna be for fourteen and twenty one day safety only. Are you able to enroll these same patients into the efficacy arm? Or you have to find new patients to just to understand how easy would be or how quick would be the next round of enrollment?

Speaker 2

Yeah. I as I said, wanna be really careful about what we're gonna present and what it looks like until we can actually talk to it. Let's wait and see what you know, whether the abstracts get accepted and and whether we've gotten what kind of presentation we've got before I I talk too much about that. If that's alright?

Speaker 5

Yeah. Totally understandable. Thank

Speaker 2

you. Thank you.

Operator

There are no further questions at this time. I will now turn the call over to Jim Dentzer, President and CEO. Please continue.

Speaker 2

Thank you, Operator. And thank you everyone for joining today's call. And as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment, and to our partners at Aurigene, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator?

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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