Curis Inc Q2 FY2025 Earnings Call

Good morning, and welcome to Curis' Second Quarter 2025 Business Update Call. Please be advised this call is being recorded today, Tuesday, August 5, 2025. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.

Thank you, and welcome to Curis' Second Quarter 2025 Business Update Call. Before we begin, I would like to encourage everyone to go to the Investor section of our website at www.curis.com to find our second quarter 2025 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 expectations 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. Joining me on today's call are Jim Dentzer, President and Chief Executive Officer; Jonathan Zung, Chief Development Officer; and Dr. Ahmed Hamdy, 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.

Thank you, Diantha. Good morning, everyone, and welcome to Curis' second quarter business update call. We continue to make steady progress in our TakeAim Lymphoma study, which is evaluating emavusertib in combination with ibrutinib in patients with PCNSL. As a reminder, the TakeAim Lymphoma study is a single-arm study with an ORR endpoint that adds emavusertib to a patient's BTKi regimen after they have directly progressed on BTKi monotherapy. And after collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. Over the next 12 to 18 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 emavusertib into additional indications in CLL and NHL. They were especially interested in exploring emavusertib'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. 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 emavusertib 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 20 to 30 patients with relapsed/refractory 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-2026. Now let's turn to AML. As you'll recall, at the ASH conference in December, Dr. Eric Winer from Dana-Farber presented data on 21 relapsed/refractory AML patients with a FLT3 mutation. These data showed a 38% composite CR rate in the salvage line setting, with 10 objective responses in 19 patients and with 7 of the 10 responses reported at the first assessment. To put these data into context, gilteritinib, the leading FLT3 inhibitor in relapsed/refractory AML was approved with a composite CR rate of 21% in a patient population where only 13% of the patients had been previously treated with a FLT3 inhibitor. In the emavusertib study, over 80% 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 emavusertib in AML is to conduct a registrational study comparing emavusertib versus gilteritinib in the relapsed/refractory setting. We're also excited about the potential of emavusertib in high-risk MDS. In June, it was announced that the VERONA study testing the combination of venetoclax and azacitidine missed its primary endpoint. 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 hrMDS, and we believe the emavusertib-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 I study last year of emavusertib as an add-on agent to venetoclax and azacitidine in frontline AML. We're currently evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine. To date, we've completed enrollment in the 7-day and 14-day dosing regimens of emavusertib in a 28-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.

Thank you, Jim. Curis reported a net loss of $8.6 million or $0.68 per share for the second quarter of 2025 compared to a net loss of $11.8 million or $2.03 per share for the same period in 2024. Research and development expenses were $7.5 million for the second quarter of 2025 as compared to $10.3 million 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 million for the 6 months ended June 30, 2025, as compared to $19.9 million for the same period in 2024. General and administrative expenses were $3.5 million for the second quarter of 2025 as compared to $4.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $7.5 million for the 6 months ended June 30, 2025, as compared to $9.7 million for the same period in 2024. In July, we completed a registered direct offering and concurrent private placement with net proceeds of approximately $6 million. Curis' cash and cash equivalents were $10.1 million as of June 30, 2025, and the company had approximately 10.7 million shares of common stock outstanding. Based upon our current operating plan, we believe that our $10.1 million 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 first quarter of 2026. With that, I'd like to open the call for questions.

Our first question today comes from Li Wang Watsek from Cantor.

I have a couple of questions regarding the BTK combination study in CLL. What do you believe the benchmarks will be? Also, with the changing landscape in CLL due to BTK degraders and next-generation BCL2 inhibitors, how do you see your position in this market? Additionally, could you provide some expectations for the AML triplet data that is coming out later this year?

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

Sure. Well, I mean, with the BTK inhibitors, like Jim said, the overall responses are usually partial responses where patients can stay on the drug chronically lifelong, risking mutations and toxicities. We believe that adding emavusertib to a commercially available BTK inhibitor can lead to MRD-negative or complete remissions. 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 our approach with commercially available BTKi inhibitors. Does that answer your question, Li?

Yes. Let me add to that a little bit as well, Li. So I'll start where Ahmed left off on degraders. 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 Toll-Like Receptor path. So whatever method you use to knock down BTK is great, add this to it, it should make it better. The question about BCL2, I think, is fair. I 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 going to be room for a lot of different competitors. But we're feeling pretty confident that the standard of care today, which is BTKi, only gets better when you add emavusertib 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. And 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, Dr. Zung, maybe you could talk to that?

Yes. So our plans will be to present the efficacy and safety data that we see from the 7- and 14-day cohort at the ASH meeting later this year.

Yes. And obviously, Li, 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.

The next question comes from Sara Nik at H.C. Wainwright.

Just regarding your TakeAim Lymphoma study and your enrollment progression over the next 12 to 18 months. Just wondering if you could provide any color on how that enrollment is going in those next target 30 to 40 patients, if further sites need to be opened or kind of progressing as expected?

Sure. 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 expectation is that we're going to be able to enroll 1 patient per clinical site per calendar year. So we'll call Sloan Kettering and ask them for one patient over the course of 2025. Now some sites can enroll more than that, some enroll less frequently. That happens with an ultra-rare indication, but 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 the FDA and EMA.

Our third question comes from Danya Ben-Hail at Jones.

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?

Yes. We haven't given guidance yet on what to expect in 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, the 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. So I'd say stay tuned.

Yes. And are you planning to open additional clinical sites?

I don't think we need to. I think right now, we're comfortable with the number of sites we have and the enrollment is 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.

And last question for the CLL program. What line of therapy are you planning to enroll? Will they all be post BTKi?

Yes. Actually, Ahmed, do you want to talk to that?

Sure. Well, it can be any line 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.

Yes. And just as a reminder, Danya, 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 to 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 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 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.

Our next question comes from Anna Lee from Truist.

This is Anna on for Kripa. 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, any update on any BD efforts or anything like that? And any broader trends, particularly in oncology that might have a read-through to Curis?

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

Sure, Jim. Anna, 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.

Yes, I want to add to that. I echo your sentiment, Anna, regarding what you’re seeing in the publications. The current situation at the FDA is a bit worrying due to its uncertainty. However, we find reassurance in our lead indication in NHL, specifically in primary CNS lymphoma, where there are no approved drugs or standards. This is a very positive factor for us as we continue our discussions with the FDA. The conversations with the EMA have also been positive and are not influenced by the current administration. While I don’t believe this situation greatly impacts Curis specifically, it certainly affects the biotech industry overall. I encourage everyone to voice their concerns about this. Diantha, would you like to address the cash runway?

Yes. So I mean our cash runway goes into '26, as I previously mentioned, we're continually evaluating both dilutive and non-dilutive 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.

Our next question today comes from Yale Jen from Laidlaw & Company.

Congrats on the progress. My first question is in terms of the triplets. You mentioned the 7 days and 14 days completed. I remember the last time you guys also mentioned that you might have to do a 21 days dosing. I'm just curious whether that 21 days still holds or the 2-time points will be sufficient?

Well, 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 to want to be mindful of that and test those as fully as we can while we're in this clinical setting. So I'd say for now, we're very happy about where we are, and 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.

Great, that's very helpful. I have a follow-up question. You mentioned that you might start enrolling patients for the CLL by the end of the year, but you've also been discussing refractory AML quite a bit. I'm curious about how you prioritize your next development efforts as you move towards PCNSL enrollment and what your main focus will be at this time.

Yes. It's a 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 5 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. 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. 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.

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

Yes, we don't have an update on those now. Yes, as a reminder, and thank you, Yale, we have 5 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. The downside with any investigator-sponsored 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 to 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 emavusertib is being tried in all sorts of different areas, including 5 separate solid tumor types. And I love that it's very cost-effective. But yes, 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.

Congrats on all the progress.

Thank you, Yale.

Our next question comes from Soumit Roy.

Congrats on all the progress. A question on the PCNSL, the tirabrutinib data that came out at ASCO. I'm curious what's your take on it. One is the response rate and median DOR is pretty high, 64%, 9.2 months, but the PFS is sort of lower 3-ish months versus historic data, 5 months. Do you think that's an important drug to open up a second arm with AMR so that AMR remains relevant in PCNSL maybe 2 years from now if tirabrutinib gets a lot of traction?

So thank you, Soumit. First, thank you for the question. Yes, the tirabrutinib data certainly look very interesting, and we would expect at some point, it should get approval in the U.S. I mean it appears at the minimum it's the fifth BTK to the U.S. market. It appears to be, like Acala, like zanubrutinib, like Pruto, it looks to be a next-generation BTK, which should offer at the minimum some safety advantage and maybe even an efficacy advantage. 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 a method for blocking the BCR pathway, whether it's with tirabrutinib, ibrutinib, or the degrader, pick your favorite method and add emavusertib to it, and it should make that efficacy better. That's our ultimate goal. So yes, 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 zanu and Acala and Pruto, our goal would be eventually to be able to establish that emavusertib is the standard drug you add to a BTK regimen.

Are you referring to a separate trial where you are currently using ibrutinib, and this trial involves those 30 patients potentially getting included in the label?

So tirabrutinib is not approved. So we can't test it with tirabrutinib. Because we can use any commercially available BTK inhibitor, but the lion's share of patients, I mean, all of our patients, except 2, I think, were on ibrutinib. I think we had one patient that had come from the tirabrutinib study and had progressed and then maybe one patient that was on Acala. But the vast majority of patients with PCNSL in the U.S. and in Europe, just as a factual matter, are on ibrutinib today. Now we would expect, as I think you would agree, that if tirabrutinib is eventually successful and does get a first label in the U.S., it will be in PCNSL because that's the only study they're running. 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 tirabrutinib, that's a discussion we'll have to have with the FDA once tirabrutinib 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. And we're just going to be able to combine with all of them is my goal.

One question regarding the triplet AML frontline. You have already completed the 7-day safety assessment, and we are expecting the 14- and 21-day safety data at ASH. Will we need to reenroll these patients for the efficacy readout?

Yes, I want to be really careful about what I say about the data, frankly, 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 standard of care. And I'm just excited to talk about the data that we have that could highlight a potential place for emavusertib as well, but that's going to have to wait until we make the data public.

I'm thinking that the next safety readout will be for 14- and 21-day safety only. Can you enroll the same patients into the efficacy arm, or do you need to find new patients to determine how quickly the next round of enrollment could happen?

Yes. I want to be cautious about how we present our findings until we can discuss them in detail. Let's hold off on sharing our insights until we know if the abstracts are accepted and what type of presentation we have, if that's agreeable.

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

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.

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