Q2 2025 Curis Inc Earnings Call
Operator: Good morning and welcome to CURIS Inc.'s second quarter 2025 business update call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After the company's prepared remarks, all participants will have an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please be advised this call is being recorded today, Tuesday, August 5th, 2025. I would now like to turn the conference over to Diantha Duvall, CURIS Inc.'s Chief Financial Officer. Diantha, please go ahead.
Good morning and welcome to curious second quarter, 2025 business update call.
All participants will be in listen-only mode.
Assistance, please signal a conference specialist. By pressing the star key followed by zero.
Prepared remarks call, participants will have an opportunity to ask questions.
to ask a question, you may press star then 1 on your touchtone phone,
Diantha Duvall: Thank you and welcome to Curis Inc.'s 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 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. 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.
To withdraw your question, please press star, then 2, please be advised. This call is being recorded today. Tuesday, August 5th. 2025 I would now like to turn the conference over to Diana. Duval kuras, is Chief Financial Officer. Diantha please. Go ahead.
Thank you and welcome to Kira's 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 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.
Joining me on today's call are Jim denser president and chief executive officer? Jonathan Zoom, Chief development officer and Dr. Akmed Hamdi chief medical officer.
We will also be available for question and answer period at the end of our call.
Jim Dentzer: Thank you, Diantha. Good morning, everyone, and welcome to CURIS Inc.'s 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. After collaborative discussions with 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 will be focused on enrolling 30 to 40 additional patients that we will need for the NDA and EMA submissions.
I'd now like to turn the call over to Jim. Thank you Dan. Good morning, everyone and welcome to curious second quarter business update. Call
we continue to make steady progress in our take game lymphoma study, which is evaluating Emma of assertive in combination with ibrutinib in patients, with pcnsl,
As a reminder.
The take game lymphoma study is a single arm study with an Orr endpoint.
That adds more assertive to a patients, btki regimen. After they have directly progressed on btki monotherapy.
And after collaborative discussions with FDA and dma, we expect the study to support accelerated submissions in both the US and Europe.
Over the next 12 to 18 months, we'll be focused on enrolling 30 to 40 additional patients that we will need for the NDA and EMA submissions.
Jim Dentzer: In June, we attended both the ASCO and EHOC 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. 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.
In June, we attended both the ASCO and ehawk conferences and had the opportunity to engage with a number of Kos, Who Remain excited and supportive about expanding moic in CLL and NHL.
They were especially interested in of assertive potential.
To fundamentally change the treatment Paradigm for CLL and an shell patients currently treated with btki monotherapy.
Overall response rate.
But these patients on btki typically achieve partial responses, not complete remission.
The unsurprising result.
Jim Dentzer: Because they never achieve complete remission, many of these patients develop BTKI-resistant mutations and ultimately progress. We are looking to improve the 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 will recall, at the ASH conference in December, Dr. Eric Weiner from Dana-Farber presented 21 relapsed refractory AML patients with a FLT3 mutation.
Is that patients who are treated with 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 M of assertive 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 21, related, refractory AML patients
Jim Dentzer: These data showed a 38% composite CR rate in the salvage line setting with 10 objective responses in 19 patients, 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 are also excited about the potential of emavusertib in high-risk MDS.
With a flip 3, mutation these data showed a 38% composite CRA in the Salvage line setting.
With 10 objects in 19 patients. And with 7 of the 10 responses reported at the first assessment,
To put these data into context.
Guilt written nib.
The leading Flip 3 inhibitor in relapsed refractory AML.
Was approved with a composite Crescent rate of 21%.
In a patient population where only 13% of the patients had been previously treated with a flit 3 inhibitor.
In the M of research study over, 80% of the patients had been previously treated with a flit 3 inhibitor.
We believe the reason the Emma was sort of data are so compelling.
Is its novel mechanism of action.
Which blocks both Iraq for and Flip 3.
The next step in the development of Emma was Serta and AML is to conduct a registrational. Study comparing Emma assertive versus guilter, written nib in the relapse refractory setting.
We're also excited about the potential of em of assertive in high-risk MDS.
Jim Dentzer: 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 would like to provide an update on our progress with the triplet study in frontline AML. As a reminder, we initiated a Phase 1 study last year of emavusertib as an add-on agent to venetoclax and azacitidine in frontline AML. We are currently evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine.
In June, it was announced that the Verona study testing, the combination of venetoclax and Aiden missed its primary endpoint.
This news generated, a lot of discussion at the medical conferences and heightened interest.
In studying the combination of asoy with Emma Virtua.
We have seen that Emma assertive is active as a monotherapy in HR MDS.
And we believe the M of assertive is decided in 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 1 Study last year of M of assertive as an add-on agent to the net, oclock in a society Dean in Frontline. AML
Jim Dentzer: To date, we have 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 will turn the call back to Diantha for the financial update. Diantha?
We're currently evaluating different dosing, regimens of, M of assertive, venetoclax and Aiden.
To date. We've completed enrollment in the 7-Day and 14-day dosing regimens of mert in a 28 day, triplet cycle.
And we're 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.
Diantha Duvall: 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 six months ended June 30th, 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.
With that, I'll turn the call back to Diana for the financial update fans up.
Thank you. Jim curious, reported a net loss of 8.6 million or 68 cents per share for the second quarter of 2025 compared to a net loss of 11 million, 11.8 million, or 2.3 cents per share for the same period in 2024.
1.3 million for the same period in 2024.
The decrease was primarily attributable to lower employee related, uh, related costs.
Research Consulting and clinical costs.
Research and development. Expenses were 16 million for the for the 6-month ended. June 30th 2025 as compared to 1 9. 9 4.
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.
Diantha Duvall: General and administrative expenses were $7.5 million for the six months ended June 30th, 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's cash and cash equivalents were $10.1 million as of June 30th, 2025, and the company had approximately 10.7 million shares of common stock outstanding. Based upon our current operating plans, we believe that our $10.1 million of existing cash and cash equivalents as of June 30th, 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 would like to open the call for questions. Operator?
General and administrative expenses. Were 7.5 million for the 6-month ended. June 30th 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 dollars.
Keras is cash and cash, equivalents were 10.1 million.
as of the, as of June 30th 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 30th 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, operator.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. To withdraw your question, please press star, then two. Just one moment for our first question. Our first question today comes from Li Watsek from Cantor Fitzgerald. Please go ahead.
You ladies and gentlemen, we will now begin the question and answer session. Should you have a question please? Press the star followed by the 1 on your touchtone phone, 2, withdrawal your question please?
Press star, then 2.
Just 1 moment for our first question.
Our first question today comes from Lee Watson from Cantor, please go ahead.
Li Watsek: Hey, good morning, guys. I guess just a couple of questions here. For the BTK combination study in CLL, what do you think the bar would be? Also, considering the evolving landscape in CLL with BTK degraders and NextGen BCL2 inhibitors, how do you think you can fit in? The second question is for AML triplet data coming later this year. It would be helpful if you can set the expectations for us. Thank you.
Uh, hey, good morning, guys. Um, uh, I guess just a couple questions here, um, for the BTK, uh, combination studying c. L, l, uh, what do you think the bar would be? Um, and also considering that evolving Landscaping, CL with, you know, BDK to graders and next gen, uh, be out, uh, to Inhibitors. How do you think, uh, you can fit in? Um, and then the second question is for, uh, AML, uh, triplet data coming later. This year will be helpful. If you can set the, uh, expectations for us.
Jim Dentzer: All right. Thank you, Li, for the question. I greatly appreciate it. Ahmed, you're probably the best to talk about the CLL study.
Thank you.
All right. Thank you. Lee, for the question. I greatly. Appreciate it. Um, augment, you're probably the best to talk about the CLL study.
Ahmed Hamdy: Sure. Good morning, Li. Good morning, everyone. With the BTK inhibitors, like Jim said, the overall response is usually partial responses where patients can stay on the drug chronically, lifelong, risking mutations, risking toxicities. We believe that adding emavusertib to a commercially available BTK inhibitor can lead to MRD negative or complete remissions. That would lead to a time-limited treatment, which is really the goal for CLL right now with the unmet medical need. As far as degraders, they are 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.
Sure, good morning, Lee. Good morning, everyone. Well, I mean, with a BTK Inhibitors, like Jim said,
The, um, overall responses is usually partial responses.
Where patients can stay on the drug chronically? Lifelong risking mutations. Risking toxicities.
We believe that adding Uomo emo to a BT commercially available BTK inhibitor.
Can lead to.
Mrd negative or complete remissions.
um and that would lead to a Time limited treatment which is really the goal for uh CLL right now with with the unmet medical need
Um, as far as degraders, they're still in development. Um, seems that they're uh, some short-lived responses. Um none of which are approved yet but we intend to combine with commercially available, btki and have inhibitors.
Jim Dentzer: Yeah, let me add.
Ahmed Hamdy: I hope that answers your question, Li.
Jim Dentzer: Let me add to that a little bit as well, Li. I will start where Ahmed Hamdy left off on degraders. Whether you degrade or inhibit BTK, it does not really matter to us. You are still blocking the BCR path. We block the other path, the toll-like receptor path. 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. There are a lot of indications or a lot of drugs being pursued in CLL because it is such a big indication. I expect, just as it is today, there is going to be room for a lot of different competitors. We are feeling pretty confident that the standard of care today, which is BTKI, only gets better when you add emavusertib to it.
Yeah, let me ask you a question me. Yeah, let me add to that a little bit as well, lie. So I I'll start with Rahman left off on the greater 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 toll like receptor path. So, whatever method you use to knock down. BTK is great. Add this to it. It should make it better.
Jim Dentzer: 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 is pretty compelling. Obviously, the investigators do as well. Remains to be seen when we get the data, but at this point, I would say we are pretty excited about it. On the AML triplet study, Jonathan Zung, maybe you could talk to that?
Um, the question about bcl2 I think, is fair, I mean, there are a lot of um 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 there's going to be a 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 Emma to it and it potentially has the ability.
Uh, on the AML triplet um Jonathan Dr. Zeng maybe you could talk to that.
Ahmed Hamdy: Our plans will be to present at the ASH meeting later this year the efficacy and safety data that we see from the 7 and 14-day cohort.
yeah, so our our plans will be to present at at the ash meeting later this year, um, the efficacy and safety data that we see um, from the 7 and 14 day cohort,
Jim Dentzer: Yeah, and obviously, Li, the abstracts need to be accepted, but I think we are feeling pretty comfortable about our ability to present data at that conference. So I will just leave it at that and look forward to talking about it at that time. Thank you, Li.
yeah, and obviously
leave the uh, the abstracts um, need to be accepted. Um, but I think we're feeling pretty comfortable about our, our ability to present data at that conference. So I'll just leave it at that. And um,
Uh, and look forward to talking about it at that time.
Thank you, Lee.
Operator: The next question comes from Sarah Nick at HC Wainwright.
Our next question comes from Sarah Nick at HC, rain Wright.
Li Watsek: Good morning, everyone, and thanks for taking the question. Regarding your TakeAim Lymphoma study and your enrollment progression over the next 12 weeks, 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 seem to be open or kind of progressing as expected. Thanks.
Jim Dentzer: Sure. It is going as we expected, which is it is steady, but it is an ultra-rare population. As you know, we have got over 30 sites open. What we have said in the past, and we continue to say it, is our expectations are that we are going to be able to enroll one patient per clinical site per calendar year. We will 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 is why we have got more than 30 sites. I would say things are going as planned, and we are looking really forward to collecting those data and having a great discussion with FDA and EMA. Thanks, Sarah.
Good morning everyone. And thanks for taking the question. I just regarding your, uh, nickname lymphoma study and your um, enrollment uh progression over the next 12, to 18 months. So just wondering if you could provide any color, um, on how that enrollment is going in those next, you know, targeted 30 to 40 patients. Um, if further side seam to be open or kind of progressing as expected. Thanks.
Sure. So um, it's going as as we expected, which is um, it's steady but it's an ultra rare population. So, as you know, we've got over 30 sites open. Um, 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 1, patient per clinical site per calendar year, so we'll call um, you know, Sloan Kettering and ask them for 1, 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 I'd say things are going, uh, I as planned, and we're looking really forward to collecting those data and having a, a great discussion with FDA and EMA,
thanks Sarah.
Li Watsek: Thank you.
Thank you.
Operator: Thank you. Our third question comes from Diantha Duvall at Truist Securities. Please go ahead.
Thank you. Our third question comes from Daniel bin, hail at Jones. Please go ahead.
Li Watsek: 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? A number of patients or mature data?
Jim Dentzer: Yeah, 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. 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. Thanks.
Hi, thank you and congrats on the progress. Um, I have a few questions, uh, the first 1 for pcnsl, what should we expect in the next data update? Uh, number of patients or, um, a mature data,
Yeah. And for this
Yeah, we haven't given guidance yet on what to expect in the next update. Other than obviously the next the next natural conference would of course be Ash um but our our guidance would is going to be we're going to present the data we have at the time. So uh we continue to enroll, we continue to collect data and um, you know, we'll present what we have. And as I say we're
The data we've seen so far pretty compelling. I hope the data moving forward would continue to show that case that we've got a clear drop uh that works in in patients who are naive or patients who have failed prior BTK so um,
Li Watsek: Are you planning to open additional clinical sites?
I'd say stay tuned. Thanks.
Yeah. And um, are you planning to open uh, additional clinical sites?
Jim Dentzer: I do not think we need to. I think right now we are 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 are coming off of a lot of really great discussions and a lot of excitement among the KOLs. But I would say at this point, there is not a need to increase the number of sites to stay on track.
Um, I don't think we need to, I think, right now, we we're comfortable with the number of sites we have, and, and the enrollments on track. So we feel pretty good about it. Um, obviously coming off the medical conferences. You, we're coming off of a lot of really great discussions and a lot of excitement among the kols. But I say at this point, um, there isn't a need to increase the number of sites to stay on track.
Li Watsek: Last question for the CLL program. What line of therapy are you planning to enroll? Will it all be post-BTKI?
And last question for the CL program. So are you planning what line of therapy? Uh, would most are you planning to enroll? Um are are you supposed to all be post with the Ki?
Jim Dentzer: Yeah, actually, Ahmed, do you want to talk to that?
Yeah, actually uh akma do you want to talk to that?
Ahmed Hamdy: 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.
Sure. Um 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.
Jim Dentzer: Yeah. Just as a reminder, Dana, if you pull the label for ibrutinib or for that matter, for acalabrutinib, you will see the CR rate in those patients in their label is literally zero. 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 is very rare. What we are hoping to be able to do is that we can replicate what we have seen in AML and in primary CNS lymphoma. That is, the drug combines well with other drugs. Because of its novel mechanism, we should be able to repeat what we have seen in PCNSL. That is, we can get complete responses.
yeah, and just as a reminder uh Daniel if you pull the label
For a brute nib or for that matter for a calibrate nib.
You'll see the Crescent rate.
In those patients, in their label is literally zero.
Now, at some at some point I would say of course, there are going to be a lot of studies out there and and there may be some patients who can get to see our but the the greater point is it's very rare.
Jim Dentzer: 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. It offers a really exciting alternative option for them.
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 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 um and it offers a really exciting alternative option for them.
Li Watsek: Sounds great. Thank you very much.
Jim Dentzer: Thank you.
Yeah, sounds sounds great. Thank you very much. Thank you.
Operator: Thank you. Our next question comes from Anna Lee from Truist Securities. Go ahead.
Thank you. Our next question comes from Anna Lee from truist? Go ahead.
Anna Lee: Hi. Good morning, guys. This is Anna on for CURIS Inc. 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? Have you continued to have any discussions with the FDA? The second question in the context of the cash runway, any update on any BD efforts or anything like that? Any broader trends, particularly in oncology, that might have a read-through to CURIS Inc.? Thank you.
Jim Dentzer: Sure. Thank you, Anna. Appreciate the questions. Jonathan, would you like to talk to the FDA?
Hi, good morning guys. This is uh, Anna on for Crystal so 2 questions from us. Um given the changes at the FDA. Can you talk about if anything has impacted your plans in PC NFL or accelerated approval, and have you continue to have any discussions with the FDA and the second question in the context of the cash Runway? Um, any update on any BD efforts or anything like that and any broader Trends particularly in oncology that might have a read through to curious. Thank you. Sure. Um, thank you, Anna. Appreciate the questions. Jonathan, would you like to talk to the FDA?
Ahmed Hamdy: Sure, Jim. 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.
Sure Jim um Anna you know at this point nothing has changed in terms of where we are with the agency we we conducted meetings with them last year um have alignment on on Key activities with them and and we're executing on that.
Jim Dentzer: 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. That is, it's the current era at FDA is a little concerning with its uncertainty. 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. 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, you know that's obviously not affected by the current administration. 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.
yeah, I I would add to that, I
Jim Dentzer: I would encourage everyone to be active in voicing their concerns about that.
I just sort of echo the sentiment, uh, Anna that you're reading in all of the Publications and all the papers. Um, and that is it's the the the current ERA at FDA is a little concerning um, with its uncertainty. I think we take comfort that our lead, uh, our lead Beach, head indication in NHL happens to be in 1 in primary CS lymphoma where there simply are no drugs approved. There is no standard. And and we think that that a very encouraging fact pattern for us as we continue the discussions with FDA, of course. Um, the discussions that in EMA which were equally positive, I would say. Um, you know, that's that's obviously not affected by the current Administration but you know, the the overall tone. Um, while I don't think it has much of an impact on kuras, it certainly has an impact on the Biotech Industry and uh, I would encourage everyone to be active in voice.
Anna Lee: Thank you very much.
Seen their concerns about that.
Jim Dentzer: On the cash runway, Diantha, would you like to talk to that?
Diantha Duvall: Yep. So, I mean, our cash runway goes into 2026, as I previously mentioned. We are continually evaluating both dilutive and non-dilutive opportunities to extend our cash runway. So, it is obviously something we will be looking to do in the second half of this year to progress these programs as we have articulated today.
Thank you very much uh, on the cash Runway. Um, Dana, would you like to talk to that? Yep. So I mean our cash Runway uh, goes into 26 as I as I previously mentioned, you know, we're we're we're continually evaluating uh, both diluted 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, uh, to, you know, progress these programs as we've articulated today.
Jim Dentzer: Thank you, Anna.
Thank you, Anna.
Operator: Our next question today comes from Yale Jin from Lei Lau and Company. Please go ahead.
Our next question, today comes from Yale Jen from late, law and Company. Please go ahead.
Somit Roy: 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 the 7 days and 14 days completed. I remember the last time you guys also mentioned that you might have to do your 21 days dosing. I am just curious whether that 21 days still holds or the two-time point will be sufficient.
Uh, good morning and thanks for taking the questions and congrats on all the progress. Uh, my first question is in terms of the triplets, uh, you mentioned the, uh, 6 7 days and 14 days. Uh, completed, I remember the last time. You guys also mentioned that, uh, you might have to do a 21 days, uh, doing I'm just curious whether that 21 days still holds or the 2 2 time point will be sufficient.
Jim Dentzer: 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. 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. I say for now, I said 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.
Well I I I don't want to talk too much about the data that we have of course because we've, you know, we're hoping to to be able to present this at Ash. I would say that um, 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 while we're in this clinical,
Setting. Um, so I say for now, I said we're very happy, uh, about where we are and we look forward to discussing in more detail, uh, when the data are public. Um, but in the meantime, as I say, I I think,
You can just hear our optimism that having a drug that combines well, with other drugs, and, and has led to published responses in, in really challenging indications, is very encouraging.
Somit Roy: Okay, great. That's very helpful. Just one follow-up question here, which is that you guys are talking about the CLL, and that could be you may start enrolling patients toward the end of the year. You also guys have been talking a lot about the refractory AML. I am just curious, at this point, how would you guys sort of prioritize the next development when you are getting PCNSL on its enrollment? What would be the next sort of priority at this time?
prioritized, uh, the next development when you are getting
Jim Dentzer: Yeah, 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 EHOC 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. 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. 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. I think it's thanks to Diantha and, frankly, the entire company.
PC cnsl on. It's a it's a uh enrollment and what will be the next sort of uh priority at this time. Yeah, it's it's a terrific question. Uh, Yale. Thank you for asking, you know, as you can imagine.
It was kind of a high class headache. We walked into, ask Esco and eha.
With compelling data and walked out with designs for 5 separate trials. Um, we certainly have more studies that we can run with a lot of enthusiasm from the community than 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 way as we possibly can. Um, you know, the it's not a surprise biotech has been in a 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.
Jim Dentzer: Everybody at this company is motivated to get this drug approved and to do it in the smartest, best, and fastest way possible. That is an ongoing effort. Thank you.
And make progress and generate compelling data, despite the financial environment has been because of our discipline. And I think it's, um, it's thanks to Diana and frankly, the entire company. Um, everybody at this company is motivated to get this drug approved and to do it in the smartest best and fastest way possible. And and
That is an ongoing effort.
Somit Roy: Okay, great. Just squeeze one more here. You do have investigator-sponsored and solid tumor study. That is in general where things are. Any updates? Thanks.
Jim Dentzer: Yeah, we do not have an update on those now. As a reminder, and thank you, Yale, we have five separate ISTs that we talk about in our corporate presentation. Of course, because they are ISTs, the good news is that they are sponsored either by the NCI, NIH, or academic partners, and therefore they do not cost a whole lot for CURIS. The downside with any investigator-sponsored trial or IST is, of course, we do not control the timeline for when they are 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 cannot really commit to it because, unfortunately, it is not under our control. So I love that emavusertib is being tried in all sorts of different areas, including five separate solid tumor types.
Thank you. Okay great maybe just just squeeze 1 more here. Uh you do have investigator sponsored and solid tumor study, just in general where things are and any, any updates, and thanks. Yeah. We don't have an update on on those now. Yeah, as a reminder and, and thank you Yale. Um,
Jim Dentzer: I love that it is very cost-effective. 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.
We have 5 separate ists, um, that, that, that we talked 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, uh, partners, and therefore, they don't cost a whole lot for Curious. Um, the downside with any investigator sponsored trial or, or IST is, of course, we don't control the timeline for when they're going to put data out. Um, I am hopeful that at least 1 of those studies is going to have data to report out this year, but we can't really commit to it because um, unfortunately, it's not under our control, so I love that that Emma virtue is being tried in all sorts of different areas, including 5, separate solid tumor types. And I love that. It's very cost-effective. Um, but yeah, I I share your, your eagerness to see the data from those studies, um, and, and look forward to hopefully being able to tell you later.
The share that we can do. So
Somit Roy: Thanks a lot. And congrats on all the progress.
Jim Dentzer: Thank you, Yale. Really appreciate it.
Thanks a lot and congrats on all the progress. Thank thank you, really appreciate it.
Operator: Our next question comes from Somit Roy. Please go ahead.
Our next question comes from Somit Roy. Please go ahead.
Somit Roy: Good morning, everyone, and congrats on all the progress. Give me a question on the PCNSL, the tirabrutinib data that came out at ASCO. I am curious, what is your take on it? One is the response rate and median DR is pretty high, 64%, 9.2 months. But the PFS is sort of lower, 3-ish months versus historic data, five months. Do you think that is an important drug to open up a second arm with the EMA so that EMA remains relevant in PCNSL maybe two years from now if tirabrutinib gets a lot of traction?
Good morning everyone and congrats on all the progress. Um, give me a question on the
On PCNSL, the, uh, BRUT data that came out at ASCO. I'm curious, what's your take on it? The response rate and median DOR are pretty high: 64%, 9.2 months. But the PFS is sort of lower—around 3 months—versus, um, historic data of 5 months.
Jim Dentzer: Thank you, Somit, first. Thank you for the question. The tirabrutinib data certainly look very interesting, and we would expect at some point it should get approval in the U.S. It appears at the minimum, it is the fifth BTK to the U.S. market. It appears to be like Accala, like Zanabrutinib, 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. When it does finally get approval, I think what we would 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 is with tirabrutinib, ibrutinib, the degrader, pick your favorite method, add emavusertib to it, and it should make that efficacy better. That is our ultimate goal.
Do you think that's an important drug to to open up a second arm, um, with the Emma? So that Mr. Remains Irrelevant in pcnsl. Maybe 2 years from now, if tra gets a lot of fraction,
Um, so thank you so much first. Uh, thank you for the question. Um, yeah, the turbo of data is certainly looking very interesting, and we would expect at some point it should get approval in the U.S. I mean, it appears at the minimum.
You know, it's it's the fifth BTK to the US market.
it appears to be like a Kala, um,
um like xana brute nib like perto it looks to be a next Generation BTK which should offer at the minimum, some safety advantage and 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.
Um, established that once you pick up a method.
for blocking the, the BCR pathway, whether it's with tear brute nib, ibrutinib a degrader,
Pick your favorite method.
Jim Dentzer: We were very eager to see their data as well. We look forward to seeing them get approval eventually. I would say just as we look at Zanyu and Accala and Perto, our goal would be eventually to be able to establish that emavusertib is the standard drug you add to a BTK regimen.
Eager to see their data as well. We look forward to seeing them get uh approval eventually. And I would say just as we look at xanu and aala and perto
Somit Roy: Is it a separate trial you are talking about? Because currently you are with ibrutinib, and that is if the trial enrolls 30 patients, gets in the loop.
Um, our goal would be eventually to be able to establish that Emma of assertive, is the standard drug you, you add to a B2K regimen.
Jim Dentzer: Yeah. So tirabrutinib is not approved. 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 two, 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 Accala. But the vast majority of patients with PCNSL in the U.S. 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 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.
Is it a separate trial? You're talking about who are because currently you are with a brutally when that's if the time in those 30 patients, gets in the label.
So it's not approved. So we can't test it with a brute with chair brute. Um because we we can use any commercially available um BTK inhibitor.
But the lion's share of patients, I mean all of our patients except two, I think were on a Bruton name. I think we had one patient that had come from the Tier Bribie study and had progressed, and then maybe one patient that was on a Cal up. But the vast majority of patients with PCNSL in the U.S. and in Europe, they're just, as a factual matter, on Ibrutinib today. Now we would expect, as I think you would agree.
That if truth is eventually successful and does get a first label.
Jim Dentzer: How we do that, whether we'd 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.
In the US. Um, it will be in pcnsl because that's the only study they're running. Um, and I would hope at that point that we could uh, get it added to the label, how we do that, whether we'd have to run, you know, some sort of supplemental study to show that it, it works as well. With any BTK inhibitor, including tarbet nib and that's a discussion we'll have to have with the FDA once tier brute nips approved. But I would certainly expect long term that, um, you know, that that is likely to be the fifth uh, Merc has 1 that will likely be the sixth approved.
Somit Roy: All right. One question on the triplet AML frontline. You already completed the 7-day safety. At ASH, I guess we are expecting the 14 and 21-day safety data. Are these patients, do we have to re-enroll these patients into the efficacy readout?
And and we're just going to be able to combine with all of them is my goal.
Okay.
Jim Dentzer: Yeah, 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 our standard of care. I am just excited to talk about the data that we have that could highlight a potential place for emavusertib as well. But that is going to have to wait until we make the data public.
Oh 1 question on the um triplet AML uh front line. So you already completed the 7-Day safety and then at Ash I guess we are expecting the 14 and 21 day safety. Uh data are these patient. Do we have to re-enroll these patients into the efficacy readout or
Uh, yeah, I want to be really careful about what I say about the the data, frankly, because they said we're planning on submitting it and presenting it at Ash. Um, so I I apologize if it seems a little cakey, but, um, I all I would say is, um, you know, we're really excited to, to talk about the potential for, uh, a triplet combination in the Frontline setting. Um, I I think certainly a society and vanetik clocks, in AML, um,
Um, our uh, our standard of care.
Somit Roy: Right. I am thinking like the next readout is going to be for 14 and 21-day safety only. Are you able to enroll these same patients into the efficacy arm, or do you have to find new patients just to understand how easy it would be or how quick would be the next round of enrollment?
And um I I'm just excited to talk about the data that we have that that could highlight a potential place for M of assertive as well but that's going to have to wait until we we make the data public.
Jim Dentzer: As I said, I want to be really careful about what we are going to present and what it looks like until we can actually talk to it. Let's wait and see whether the abstracts get accepted and whether we have got what kind of presentation we have got before I talk too much about that, if that is all right.
Right. So I'm thinking like the next safety. Uh, next readout is going to be for 14 and 21 day. Safety only, are you able to enroll these same patients into the efficacy, um, arm or you have to find new patients to just to understand the how easy it would be or how quick would be the next round of enrollment.
Somit Roy: Yeah, totally understandable. Thank you.
Yeah. I I as I said, I want to be really careful about what we're going to present and what it looks like until we can actually talk to it. Uh, let's wait and see what, you know, whether the abstracts get accepted. And, and whether we've gotten, uh, what kind of presentation we've got before I, I talked too much about that, if that's all right.
Jim Dentzer: Thank you.
Yeah, totally understandable. Thank 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.
There are no further questions at this time.
Jim denser president and CEO please continue.
Jim Dentzer: Thank you, Operator. Thank you, everyone, for joining today's call. 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?
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 kuras for their hard work and commitment and to our partners at origin. 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.
Ladies and gentlemen, this concludes today's conference call.
For your participation.
Please connect.