CURIS INC — Call Transcript 2025

Good afternoon, ladies and gentlemen, and welcome to the Curis Third Quarter 2025 Business Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 6, 2025. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead. Thank you, and welcome to the Curis Third 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 Third Quarter 2025 Business Update Press Release and related financial tables. I'd also like to remind everyone that during the call we will be making forward-looking statements, which are based on 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, Dr. 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 the call. I'd like to now turn the call over to Jim. Thank you, Diantha. Good afternoon, everyone, and welcome to Curis's Third 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 primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. 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 progressed on BTKi monotherapy. 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 12-18 months, we will be focused on enrolling the additional patients we will need to support those submissions. If you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes. They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for CLL patients, where the current standard of care is BTKi monotherapy. BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. However, these responses are typically 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 chronic treatment for the rest of their lives. Additionally, since patients never achieve complete remission, many of these patients develop BTKi-resistant mutations, and ultimately their disease progresses. At Curis, we're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi-resistant mutations and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKi monotherapy who have achieved a PR but have been unable to achieve complete remission or uMRD. We have submitted the study protocol to the FDA. We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH Annual Meeting in December 2026. Now let's turn to AML. Abstracts for the December ASH Meeting were released on Tuesday. Including the abstract for our ongoing AML Triplet Study, which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on AzaVen, but remain MRD positive. The data in the abstract are for the first two cohorts: patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their AzaVen treatment. As of July 2, 2025, 10 patients with a median age of 71 were enrolled. Four in the 7-day cohort and six in the 14-day cohort. MRD conversion to undetectable levels occurred in four of eight evaluable patients within five to eight weeks of adding emavusertib. Among the patients who remained MRD positive, one patient achieved a 40% MRD reduction, and none showed disease progression. Two dose-limiting toxicities, CPK increase and neutropenia, occurred in the 14-day cohort, but both resolved. We're very encouraged by the initial readout from these first two cohorts and the exciting potential of combining emavusertib with AzaVen in frontline AML to enable more patients to achieve undetectable MRD. We continue to explore different dosing regimens for this triplet combination, and we look forward to reporting our progress. As you can see, we've had a very exciting and productive quarter and have a lot of exciting updates coming at the SNO and ASH conferences over the next few weeks. With that, I'll turn the call back over to Diantha for the financial update. Diantha? Thank you, Jim. Curis reported a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2025, as compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024. Curis reported a net loss of $26.9 million, or $2.19 per share, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024. Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower employee-related clinical, consulting, research, manufacturing, and facility costs. Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024. General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024. Curis's cash and cash equivalents were $9.1 million as of September 30, 2025, and the company had approximately 12.7 million shares of common stock outstanding. Based on our current operating plan, we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026. With that, I'd like to open the call for questions. Operator? Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift your hands before pressing any keys. Your first question comes from Sara Nik with H.C. Wainwright. Your line is now open. Hi, team, and thanks for taking the question. Congrats on the ongoing progress. My question was regarding your CLL program. If you have any color you could provide on the FDA discussions and protocol you submitted. Were you mostly aligned with primary endpoints and study design? Any granularity you can provide as of now would be helpful. Thank you. Thank you, Sarah, and thanks for the question. I'll start, and I'll ask Dr. Hamdy to chime in as well. We're very excited about that study. As you know, we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was into PCNSL, and the second one is going into CLL. Obviously, as we move into CLL, it's a much larger indication. Of course, there's a much wider circle of interest among the KOLs. Ahmed, do you want to talk a little bit more about the CLL study in particular? Sure. Hi, Sara. It's Ahmed. Basically, we're trying to address the unmet medical need in the CLL community, which is basically getting patients to a time-limited treatment with a combination of emavusertib plus a BTK inhibitor in patients who are currently on a BTK and have only achieved a PR with MRD positive. We're aligned with the FDA there, and we intend to have a small dose escalation at 100 milligram and expanding into our 200 milligram phase II dose. Great. Thank you. Your next question comes from Li Watsek with Cantor Fitzgerald. Your line is now open. Hey, guys. Thanks for taking our questions. I guess just for the phase two CLL trial, can you maybe just talk a little bit about the size of the study? In terms of the delta you want to achieve in terms of the CR rate? The second is just how you're thinking about resource prioritization at this point, especially as you think about the resources that you might need to move forward the CLL study versus the full-on AML study. Sure. Again, why don't I start on CLL? I'll ask Dr. Hamdy to talk a little more detail and then maybe have Diantha talk a little bit about resources. First, on CLL. We are anticipating a study design at this point in time that anticipates 40 patients. Of course, as we saw in PCNSL, the unmet need is so clear, we're hoping to be able to see a signal long before we get to that point. As a reminder, patients on BTKi monotherapy in CLL, they get PRs. They don't get CRs. They certainly aren't getting MRD either. What we're looking to do in that population is demonstrate simply that by adding emavusertib, by blocking both pathways, not just one, but both pathways that are driving disease, we can end up seeing deeper responses. That's deeper PRs, and we hope also that we'll see CRs and MRD. Ahmed, do you want to chime in a little bit more on that? I think you said it all, Jim. The whole concept here that you do not see CRs. With BTK, and obviously you do not see MRD negative. Getting patients to a CR, and I think anything north of 20% would be very exciting. Obviously, we are going to have to wait until we see a treatment effect in our trial and plan accordingly. We are very hopeful that the dual blockade of inhibiting the TLR pathway along with the BCR pathway would have a much more profound effect on the NF-kB and therefore getting patients to a deeper response and MRD negative. Yeah. Thank you. Diantha, would you mind spending a moment talking about the resources? Absolutely. Li, as you can appreciate, our current priorities are clearly to continue the PCNSL trial and obviously launch the newly initiated CLL trial. Also, as you can appreciate, we'll be looking to bring in additional capital prior to the end of the year. We've been pretty clear about that over the last six months. Neither of those things should be a surprise. That is sort of where we're thinking about our resource allocations. Yeah. In overall messaging, Li, we continue to move forward with great progress in PCNSL. I think the investor interest, not just in PCNSL with the IDU approval, but the ability to move the needle in CLL, it seems to be a very reachable goal and because of the market opportunity, a very exciting goal. Look forward to hearing from us more about that over the next eight weeks. Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Yale Jen with Laidlaw & Company. Your line is now open. Good afternoon, and thanks for taking the questions. I got two here. First of all, in terms of the CLL study. What would you think about the safety side? In other words, in a combination, was there any sort of speculated AE may happen? How would you think about the mitigation for that? I have a follow-up. Okay. Again, let me start, and I'll ask Dr. Hamdy to add to it. I think the critical issue for us is going to be, do we see any DDI with the BTK inhibitors? As you know, we have a great deal of confidence given that we've already tested a number of patients in NHL with ibrutinib, and we aren't seeing DDI. In fact, at the doses that we're testing, 100 and 200 milligrams with MI, it seems to be a very clean profile. Ahmed, would you like to add to that? Yeah. I mean, again, you said it all, Jim. Yale, I mean, we have approximately 25 patients, if not more, combined with ibrutinib. As you know, ibrutinib would be the most unselective of all approved BTKs. We have not seen any additive toxicities. We expect not to see any additive toxicity with the other BTK inhibitors. Of course, we're going to be doing some PK work and DDI following any potential toxicities, but I don't think there are any additive toxicities that we expect. Okay. Great. That's very helpful. Maybe just one more question here. In terms of the SNO meeting in a few days, what should be the investor sort of expectation to talk about? Next slide. Yeah. Obviously, we're going to have to be a little careful not to front-run the conference. Thank you, Yale, for your interest in that. We're going to have several posters, three of them, available at the SNO conference in PCNSL, but also SCNSL. Dr. Grommas and Dr. Nayak in particular will be talking about PCNSL. I think what you can expect to see there is learn a little bit more about what we've seen over the last six months in that study. Of course, the secondary CNS lymphoma, even harder to treat, that will be brand new. I think on both fronts, it should be a really exciting conference for us. Thank you. Okay. Great. Thanks a lot. Congrats on the progress. Thank you so much. There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks. Thank you, Operator. Thank you, everyone, for joining today's call. As always, thank you to the patients and the families participating in our clinical trials, to our team at Curis 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? Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

Speaker 5: Good afternoon, ladies and gentlemen, and welcome to the Curis Third Quarter 2025 Business Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 6, 2025. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead. Good afternoon, ladies and gentlemen, and welcome to the Curis Third Quarter 2025 Business Update Conference Call. good afternoon ladies and gentlemen and welcome to the curis third quarter 2025 business update conference call At this time, all lines are in listen-only mode. at this time all lines are in listen-only mode Following the presentation, we will conduct a question-and-answer session. following the presentation we will conduct a question-and-answer session If at any time during this call you require immediate assistance, please press star zero for the operator. if at any time during this call you require immediate assistance please press star zero for the operator This call is being recorded on Thursday, November 6, 2025. this call is being recorded on thursday november 6 2025 I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. i would now like to turn the conference over to diantha duvall chief financial officer Please go ahead. please go ahead

Speaker 4: Thank you, and welcome to the Curis Third 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 Third Quarter 2025 Business Update Press Release and related financial tables. I'd also like to remind everyone that during the call we will be making forward-looking statements, which are based on 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, Dr. 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 the call. I'd like to now turn the call over to Jim. Thank you, and welcome to the Curis Third Quarter 2025 Business Update Call. thank you and welcome to the curis third 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 Third Quarter 2025 Business Update Press Release and related financial tables. 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 third quarter 2025 business update press release and related financial tables I'd also like to remind everyone that during the call we will be making forward-looking statements, which are based on current expectations and beliefs. i'd also like to remind everyone that during the call we will be making forward-looking statements which are based on current expectations and beliefs These statements are subject to certain risks and uncertainties, and actual results may differ materially. these statements are subject to certain risks and uncertainties and actual results may differ materially For additional details, please see our SEC filings. for additional details please see our sec filings Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, Dr. Jonathan Zung, Chief Development Officer, and Dr. Ahmed Hamdy, Chief Medical Officer. joining me on today's call are jim dentzer president and chief executive officer dr 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 the call. we will also be available for a question-and-answer period at the end of the call I'd like to now turn the call over to Jim. i'd like to now turn the call over to jim

Speaker 2: Thank you, Diantha. Good afternoon, everyone, and welcome to Curis's Third 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 primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. 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 progressed on BTKi monotherapy. 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 12-18 months, we will be focused on enrolling the additional patients we will need to support those submissions. Thank you, Diantha. thank you diantha Good afternoon, everyone, and welcome to Curis's Third Quarter Business Update Call. good afternoon everyone and welcome to curis's third 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 primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. we continue to make steady progress in our takeaim lymphoma study which is evaluating emavusertib in combination with ibrutinib in patients with primary cns lymphoma one of the most rare and most difficult to treat of the nhl subtypes 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 progressed on BTKi monotherapy. 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 progressed on btki monotherapy After collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. 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 12-18 months, we will be focused on enrolling the additional patients we will need to support those submissions. over the next 12-18 months we will be focused on enrolling the additional patients we will need to support those submissions If you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes. They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for CLL patients, where the current standard of care is BTKi monotherapy. BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. However, these responses are typically 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 chronic treatment for the rest of their lives. Additionally, since patients never achieve complete remission, many of these patients develop BTKi-resistant mutations, and ultimately their disease progresses. If you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes. if you recall last quarter we engaged with a number of kols who were excited and highly supportive of expanding our emavusertib studies into additional nhl subtypes They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for CLL patients, where the current standard of care is BTKi monotherapy. they were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for cll patients where the current standard of care is btki monotherapy BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. btk inhibitors have become the standard of care in cll and nhl because of their ability to help patients achieve objective responses However, these responses are typically partial responses, not complete remission. however these responses are typically 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 chronic treatment for the rest of their lives. the unsurprising result is that patients who are treated with a btk inhibitor end up having to stay on it in chronic treatment for the rest of their lives Additionally, since patients never achieve complete remission, many of these patients develop BTKi-resistant mutations, and ultimately their disease progresses. additionally since patients never achieve complete remission many of these patients develop btki-resistant mutations and ultimately their disease progresses At Curis, we're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi-resistant mutations and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKi monotherapy who have achieved a PR but have been unable to achieve complete remission or uMRD. We have submitted the study protocol to the FDA. We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH Annual Meeting in December 2026. Now let's turn to AML. Abstracts for the December ASH Meeting were released on Tuesday. At Curis, we're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi-resistant mutations and improving a patient's overall quality of life. at curis we're looking to improve upon the current standard of care by adding emavusertib to a patient's btki regimen enabling patients to achieve deeper responses and potentially come off treatment reducing the risk of developing btki-resistant mutations and improving a patient's overall quality of life The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKi monotherapy who have achieved a PR but have been unable to achieve complete remission or uMRD. the first step in testing this hypothesis in cll is to initiate a proof-of-concept study in patients currently on btki monotherapy who have achieved a pr but have been unable to achieve complete remission or umrd We have submitted the study protocol to the FDA. we have submitted the study protocol to the fda We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH Annual Meeting in December 2026. we're working to activate clinical sites and we expect to enroll our first patient in late q4 or early q1 with initial data expected at the ash annual meeting in december 2026 Now let's turn to AML. now let's turn to aml Abstracts for the December ASH Meeting were released on Tuesday. abstracts for the december ash meeting were released on tuesday Including the abstract for our ongoing AML Triplet Study, which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on AzaVen, but remain MRD positive. The data in the abstract are for the first two cohorts: patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their AzaVen treatment. As of July 2, 2025, 10 patients with a median age of 71 were enrolled. Four in the 7-day cohort and six in the 14-day cohort. MRD conversion to undetectable levels occurred in four of eight evaluable patients within five to eight weeks of adding emavusertib. Among the patients who remained MRD positive, one patient achieved a 40% MRD reduction, and none showed disease progression. Two dose-limiting toxicities, CPK increase and neutropenia, occurred in the 14-day cohort, but both resolved. Including the abstract for our ongoing AML Triplet Study, which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on AzaVen, but remain MRD positive. including the abstract for our ongoing aml triplet study which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in aml patients who have achieved complete remission on azaven but remain mrd positive The data in the abstract are for the first two cohorts: patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their AzaVen treatment. the data in the abstract are for the first two cohorts patients who received emavusertib for 7 or 14 days in a 28-day cycle in addition to their azaven treatment As of July 2, 2025, 10 patients with a median age of 71 were enrolled. as of july 2 2025 10 patients with a median age of 71 were enrolled Four in the 7-day cohort and six in the 14-day cohort. four in the 7-day cohort and six in the 14-day cohort MRD conversion to undetectable levels occurred in four of eight evaluable patients within five to eight weeks of adding emavusertib. mrd conversion to undetectable levels occurred in four of eight evaluable patients within five to eight weeks of adding emavusertib Among the patients who remained MRD positive, one patient achieved a 40% MRD reduction, and none showed disease progression. among the patients who remained mrd positive one patient achieved a 40% mrd reduction and none showed disease progression Two dose-limiting toxicities, CPK increase and neutropenia, occurred in the 14-day cohort, but both resolved. two dose-limiting toxicities cpk increase and neutropenia occurred in the 14-day cohort but both resolved We're very encouraged by the initial readout from these first two cohorts and the exciting potential of combining emavusertib with AzaVen in frontline AML to enable more patients to achieve undetectable MRD. We continue to explore different dosing regimens for this triplet combination, and we look forward to reporting our progress. As you can see, we've had a very exciting and productive quarter and have a lot of exciting updates coming at the SNO and ASH conferences over the next few weeks. With that, I'll turn the call back over to Diantha for the financial update. Diantha? We're very encouraged by the initial readout from these first two cohorts and the exciting potential of combining emavusertib with AzaVen in frontline AML to enable more patients to achieve undetectable MRD. we're very encouraged by the initial readout from these first two cohorts and the exciting potential of combining emavusertib with azaven in frontline aml to enable more patients to achieve undetectable mrd We continue to explore different dosing regimens for this triplet combination, and we look forward to reporting our progress. we continue to explore different dosing regimens for this triplet combination and we look forward to reporting our progress As you can see, we've had a very exciting and productive quarter and have a lot of exciting updates coming at the SNO and ASH conferences over the next few weeks. as you can see we've had a very exciting and productive quarter and have a lot of exciting updates coming at the sno and ash conferences over the next few weeks With that, I'll turn the call back over to Diantha for the financial update. with that i'll turn the call back over to diantha for the financial update Diantha? diantha

Speaker 4: Thank you, Jim. Curis reported a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2025, as compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024. Curis reported a net loss of $26.9 million, or $2.19 per share, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024. Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower employee-related clinical, consulting, research, manufacturing, and facility costs. Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024. Thank you, Jim. thank you jim Curis reported a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2025, as compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024. curis reported a net loss of $7.7 million or $0.49 per share for the third quarter of 2025 as compared to a net loss of $10.1 million or $1.70 per share for the same period in 2024 Curis reported a net loss of $26.9 million, or $2.19 per share, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024. curis reported a net loss of $26.9 million or $2.19 per share for the nine months ended september 30 2025 as compared to a net loss of $33.8 million or $5.77 per share for the same period in 2024 Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. research and development expenses were $6.4 million for the third quarter of 2025 as compared to $9.7 million for the same period in 2024 The decrease was primarily attributable to lower employee-related clinical, consulting, research, manufacturing, and facility costs. the decrease was primarily attributable to lower employee-related clinical consulting research manufacturing and facility costs Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024. research and development expenses were $22.4 million for the nine months ended september 30 2025 as compared to $29.6 million for the same period in 2024 General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024. Curis's cash and cash equivalents were $9.1 million as of September 30, 2025, and the company had approximately 12.7 million shares of common stock outstanding. Based on our current operating plan, we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026. With that, I'd like to open the call for questions. Operator? General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. general and administrative expenses were $3.7 million for the third quarter of 2025 as compared to $3.8 million for the same period in 2024 The decrease was primarily attributable to lower employee-related costs. the decrease was primarily attributable to lower employee-related costs General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024. general and administrative expenses were $11.2 million for the nine months ended september 30 2025 as compared to $13.4 million for the same period in 2024 Curis's cash and cash equivalents were $9.1 million as of September 30, 2025, and the company had approximately 12.7 million shares of common stock outstanding. curis's cash and cash equivalents were $9.1 million as of september 30 2025 and the company had approximately 12.7 million shares of common stock outstanding Based on our current operating plan, we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026. based on our current operating plan we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026 With that, I'd like to open the call for questions. with that i'd like to open the call for questions Operator? operator

Speaker 5: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift your hands before pressing any keys. Your first question comes from Sara Nik with H.C. Wainwright. Your line is now open. Thank you. thank you Ladies and gentlemen, we will now begin the question-and-answer session. ladies and gentlemen we will now begin the question-and-answer session Should you have a question, please press star followed by the one on your touch-tone phone. should you have a question please press star followed by the one on your touch-tone phone You will hear a prompt that your hand has been raised. you will hear a prompt that your hand has been raised Should you wish to decline from the polling process, please press star followed by the two. should you wish to decline from the polling process please press star followed by the two If you are using a speakerphone, please lift your hands before pressing any keys. if you are using a speakerphone please lift your hands before pressing any keys Your first question comes from Sara Nik with H.C. your first question comes from sara nik with h.c Wainwright. wainwright Your line is now open. your line is now open

Speaker 7: Hi, team, and thanks for taking the question. Congrats on the ongoing progress. My question was regarding your CLL program. If you have any color you could provide on the FDA discussions and protocol you submitted. Were you mostly aligned with primary endpoints and study design? Any granularity you can provide as of now would be helpful. Thank you. Hi, team, and thanks for taking the question. hi team and thanks for taking the question Congrats on the ongoing progress. congrats on the ongoing progress My question was regarding your CLL program. my question was regarding your cll program If you have any color you could provide on the FDA discussions and protocol you submitted. if you have any color you could provide on the fda discussions and protocol you submitted Were you mostly aligned with primary endpoints and study design? were you mostly aligned with primary endpoints and study design Any granularity you can provide as of now would be helpful. any granularity you can provide as of now would be helpful Thank you. thank you

Speaker 2: Thank you, Sarah, and thanks for the question. I'll start, and I'll ask Dr. Hamdy to chime in as well. We're very excited about that study. As you know, we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was into PCNSL, and the second one is going into CLL. Obviously, as we move into CLL, it's a much larger indication. Of course, there's a much wider circle of interest among the KOLs. Ahmed, do you want to talk a little bit more about the CLL study in particular? Thank you, Sarah, and thanks for the question. thank you sarah and thanks for the question I'll start, and I'll ask Dr. Hamdy to chime in as well. i'll start and i'll ask dr hamdy to chime in as well We're very excited about that study. we're very excited about that study As you know, we did have a dose escalation study where we tested across different subtypes in NHL. as you know we did have a dose escalation study where we tested across different subtypes in nhl Our first expansion was into PCNSL, and the second one is going into CLL. our first expansion was into pcnsl and the second one is going into cll Obviously, as we move into CLL, it's a much larger indication. obviously as we move into cll it's a much larger indication Of course, there's a much wider circle of interest among the KOLs. of course there's a much wider circle of interest among the kols Ahmed, do you want to talk a little bit more about the CLL study in particular? ahmed do you want to talk a little bit more about the cll study in particular

Speaker 1: Sure. Hi, Sara. It's Ahmed. Basically, we're trying to address the unmet medical need in the CLL community, which is basically getting patients to a time-limited treatment with a combination of emavusertib plus a BTK inhibitor in patients who are currently on a BTK and have only achieved a PR with MRD positive. We're aligned with the FDA there, and we intend to have a small dose escalation at 100 milligram and expanding into our 200 milligram phase II dose. Sure. sure Hi, Sara. hi sara It's Ahmed. it's ahmed Basically, we're trying to address the unmet medical need in the CLL community, which is basically getting patients to a time-limited treatment with a combination of emavusertib plus a BTK inhibitor in patients who are currently on a BTK and have only achieved a PR with MRD positive. basically we're trying to address the unmet medical need in the cll community which is basically getting patients to a time-limited treatment with a combination of emavusertib plus a btk inhibitor in patients who are currently on a btk and have only achieved a pr with mrd positive We're aligned with the FDA there, and we intend to have a small dose escalation at 100 milligram and expanding into our 200 milligram phase II dose. we're aligned with the fda there and we intend to have a small dose escalation at 100 milligram and expanding into our 200 milligram phase ii dose

Speaker 7: Great. Thank you. Great. great Thank you. thank you

Speaker 5: Your next question comes from Li Watsek with Cantor Fitzgerald. Your line is now open. Your next question comes from Li Watsek with Cantor Fitzgerald. your next question comes from li watsek with cantor fitzgerald Your line is now open. your line is now open

Speaker 3: Hey, guys. Thanks for taking our questions. I guess just for the phase two CLL trial, can you maybe just talk a little bit about the size of the study? In terms of the delta you want to achieve in terms of the CR rate? The second is just how you're thinking about resource prioritization at this point, especially as you think about the resources that you might need to move forward the CLL study versus the full-on AML study. Hey, guys. hey guys Thanks for taking our questions. thanks for taking our questions I guess just for the phase two CLL trial, can you maybe just talk a little bit about the size of the study? i guess just for the phase two cll trial can you maybe just talk a little bit about the size of the study In terms of the delta you want to achieve in terms of the CR rate? in terms of the delta you want to achieve in terms of the cr rate The second is just how you're thinking about resource prioritization at this point, especially as you think about the resources that you might need to move forward the CLL study versus the full-on AML study. the second is just how you're thinking about resource prioritization at this point especially as you think about the resources that you might need to move forward the cll study versus the full-on aml study

Speaker 2: Sure. Again, why don't I start on CLL? I'll ask Dr. Hamdy to talk a little more detail and then maybe have Diantha talk a little bit about resources. First, on CLL. We are anticipating a study design at this point in time that anticipates 40 patients. Of course, as we saw in PCNSL, the unmet need is so clear, we're hoping to be able to see a signal long before we get to that point. As a reminder, patients on BTKi monotherapy in CLL, they get PRs. They don't get CRs. They certainly aren't getting MRD either. What we're looking to do in that population is demonstrate simply that by adding emavusertib, by blocking both pathways, not just one, but both pathways that are driving disease, we can end up seeing deeper responses. Sure. sure Again, why don't I start on CLL? again why don't i start on cll I'll ask Dr. Hamdy to talk a little more detail and then maybe have Diantha talk a little bit about resources. i'll ask dr hamdy to talk a little more detail and then maybe have diantha talk a little bit about resources First, on CLL. first on cll We are anticipating a study design at this point in time that anticipates 40 patients. we are anticipating a study design at this point in time that anticipates 40 patients Of course, as we saw in PCNSL, the unmet need is so clear, we're hoping to be able to see a signal long before we get to that point. of course as we saw in pcnsl the unmet need is so clear we're hoping to be able to see a signal long before we get to that point As a reminder, patients on BTKi monotherapy in CLL, they get PRs. as a reminder patients on btki monotherapy in cll they get prs They don't get CRs. they don't get crs They certainly aren't getting MRD either. they certainly aren't getting mrd either What we're looking to do in that population is demonstrate simply that by adding emavusertib, by blocking both pathways, not just one, but both pathways that are driving disease, we can end up seeing deeper responses. what we're looking to do in that population is demonstrate simply that by adding emavusertib by blocking both pathways not just one but both pathways that are driving disease we can end up seeing deeper responses That's deeper PRs, and we hope also that we'll see CRs and MRD. Ahmed, do you want to chime in a little bit more on that? That's deeper PRs, and we hope also that we'll see CRs and MRD. that's deeper prs and we hope also that we'll see crs and mrd Ahmed, do you want to chime in a little bit more on that? ahmed do you want to chime in a little bit more on that

Speaker 1: I think you said it all, Jim. The whole concept here that you do not see CRs. With BTK, and obviously you do not see MRD negative. Getting patients to a CR, and I think anything north of 20% would be very exciting. Obviously, we are going to have to wait until we see a treatment effect in our trial and plan accordingly. We are very hopeful that the dual blockade of inhibiting the TLR pathway along with the BCR pathway would have a much more profound effect on the NF-kB and therefore getting patients to a deeper response and MRD negative. I think you said it all, Jim. i think you said it all jim The whole concept here that you do not see CRs. the whole concept here that you do not see crs With BTK, and obviously you do not see MRD negative. with btk and obviously you do not see mrd negative Getting patients to a CR, and I think anything north of 20% would be very exciting. getting patients to a cr and i think anything north of 20% would be very exciting Obviously, we are going to have to wait until we see a treatment effect in our trial and plan accordingly. obviously we are going to have to wait until we see a treatment effect in our trial and plan accordingly We are very hopeful that the dual blockade of inhibiting the TLR pathway along with the BCR pathway would have a much more profound effect on the NF-k B and therefore getting patients to a deeper response and MRD negative. we are very hopeful that the dual blockade of inhibiting the tlr pathway along with the bcr pathway would have a much more profound effect on the nf-k b and therefore getting patients to a deeper response and mrd negative

Speaker 2: Yeah. Thank you. Diantha, would you mind spending a moment talking about the resources? Yeah. yeah Thank you. thank you Diantha, would you mind spending a moment talking about the resources? diantha would you mind spending a moment talking about the resources

Speaker 4: Absolutely. Li, as you can appreciate, our current priorities are clearly to continue the PCNSL trial and obviously launch the newly initiated CLL trial. Also, as you can appreciate, we'll be looking to bring in additional capital prior to the end of the year. We've been pretty clear about that over the last six months. Neither of those things should be a surprise. That is sort of where we're thinking about our resource allocations. Absolutely. absolutely Li, as you can appreciate, our current priorities are clearly to continue the PCNSL trial and obviously launch the newly initiated CLL trial. li as you can appreciate our current priorities are clearly to continue the pcnsl trial and obviously launch the newly initiated cll trial Also, as you can appreciate, we'll be looking to bring in additional capital prior to the end of the year. also as you can appreciate we'll be looking to bring in additional capital prior to the end of the year We've been pretty clear about that over the last six months. we've been pretty clear about that over the last six months Neither of those things should be a surprise. neither of those things should be a surprise That is sort of where we're thinking about our resource allocations. that is sort of where we're thinking about our resource allocations

Speaker 2: Yeah. In overall messaging, Li, we continue to move forward with great progress in PCNSL. I think the investor interest, not just in PCNSL with the IDU approval, but the ability to move the needle in CLL, it seems to be a very reachable goal and because of the market opportunity, a very exciting goal. Look forward to hearing from us more about that over the next eight weeks. Yeah. yeah In overall messaging, Li, we continue to move forward with great progress in PCNSL. in overall messaging li we continue to move forward with great progress in pcnsl I think the investor interest, not just in PCNSL with the IDU approval, but the ability to move the needle in CLL, it seems to be a very reachable goal and because of the market opportunity, a very exciting goal. i think the investor interest not just in pcnsl with the idu approval but the ability to move the needle in cll it seems to be a very reachable goal and because of the market opportunity a very exciting goal Look forward to hearing from us more about that over the next eight weeks. look forward to hearing from us more about that over the next eight weeks

Speaker 5: Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Yale Jen with Laidlaw & Company. Your line is now open. Ladies and gentlemen, as a reminder, should you have a question, please press star one. ladies and gentlemen as a reminder should you have a question please press star one Your next question comes from Yale Jen with Laidlaw & Company. your next question comes from yale jen with laidlaw & company Your line is now open. your line is now open

Speaker 6: Good afternoon, and thanks for taking the questions. I got two here. First of all, in terms of the CLL study. What would you think about the safety side? In other words, in a combination, was there any sort of speculated AE may happen? How would you think about the mitigation for that? I have a follow-up. Good afternoon, and thanks for taking the questions. good afternoon and thanks for taking the questions I got two here. i got two here First of all, in terms of the CLL study. first of all in terms of the cll study What would you think about the safety side? what would you think about the safety side In other words, in a combination, was there any sort of speculated AE may happen? in other words in a combination was there any sort of speculated ae may happen How would you think about the mitigation for that? how would you think about the mitigation for that I have a follow-up. i have a follow-up

Speaker 2: Okay. Again, let me start, and I'll ask Dr. Hamdy to add to it. I think the critical issue for us is going to be, do we see any DDI with the BTK inhibitors? As you know, we have a great deal of confidence given that we've already tested a number of patients in NHL with ibrutinib, and we aren't seeing DDI. In fact, at the doses that we're testing, 100 and 200 milligrams with MI, it seems to be a very clean profile. Ahmed, would you like to add to that? Okay. okay Again, let me start, and I'll ask Dr. Hamdy to add to it. again let me start and i'll ask dr hamdy to add to it I think the critical issue for us is going to be, do we see any DDI with the BTK inhibitors? i think the critical issue for us is going to be do we see any ddi with the btk inhibitors As you know, we have a great deal of confidence given that we've already tested a number of patients in NHL with ibrutinib, and we aren't seeing DDI. as you know we have a great deal of confidence given that we've already tested a number of patients in nhl with ibrutinib and we aren't seeing ddi In fact, at the doses that we're testing, 100 and 200 milligrams with MI, it seems to be a very clean profile. in fact at the doses that we're testing 100 and 200 milligrams with mi it seems to be a very clean profile Ahmed, would you like to add to that? ahmed would you like to add to that

Speaker 1: Yeah. I mean, again, you said it all, Jim. Yale, I mean, we have approximately 25 patients, if not more, combined with ibrutinib. As you know, ibrutinib would be the most unselective of all approved BTKs. We have not seen any additive toxicities. We expect not to see any additive toxicity with the other BTK inhibitors. Of course, we're going to be doing some PK work and DDI following any potential toxicities, but I don't think there are any additive toxicities that we expect. Yeah. yeah I mean, again, you said it all, Jim. i mean again you said it all jim Yale, I mean, we have approximately 25 patients, if not more, combined with ibrutinib. yale i mean we have approximately 25 patients if not more combined with ibrutinib As you know, ibrutinib would be the most unselective of all approved BTKs. as you know ibrutinib would be the most unselective of all approved btks We have not seen any additive toxicities. we have not seen any additive toxicities We expect not to see any additive toxicity with the other BTK inhibitors. we expect not to see any additive toxicity with the other btk inhibitors Of course, we're going to be doing some PK work and DDI following any potential toxicities, but I don't think there are any additive toxicities that we expect. of course we're going to be doing some pk work and ddi following any potential toxicities but i don't think there are any additive toxicities that we expect

Speaker 6: Okay. Great. That's very helpful. Maybe just one more question here. In terms of the SNO meeting in a few days, what should be the investor sort of expectation to talk about? Next slide. Okay. okay Great. great That's very helpful. that's very helpful Maybe just one more question here. maybe just one more question here In terms of the SNO meeting in a few days, what should be the investor sort of expectation to talk about? in terms of the sno meeting in a few days what should be the investor sort of expectation to talk about Next slide. next slide

Speaker 2: Yeah. Obviously, we're going to have to be a little careful not to front-run the conference. Thank you, Yale, for your interest in that. We're going to have several posters, three of them, available at the SNO conference in PCNSL, but also SCNSL. Dr. Grommas and Dr. Nayak in particular will be talking about PCNSL. I think what you can expect to see there is learn a little bit more about what we've seen over the last six months in that study. Of course, the secondary CNS lymphoma, even harder to treat, that will be brand new. I think on both fronts, it should be a really exciting conference for us. Thank you. Yeah. yeah Obviously, we're going to have to be a little careful not to front-run the conference. obviously we're going to have to be a little careful not to front-run the conference Thank you, Yale, for your interest in that. thank you yale for your interest in that We're going to have several posters, three of them, available at the SNO conference in PCNSL, but also SCNSL. we're going to have several posters three of them available at the sno conference in pcnsl but also scnsl Dr. Grommas and Dr. Nayak in particular will be talking about PCNSL. dr grommas and dr nayak in particular will be talking about pcnsl I think what you can expect to see there is learn a little bit more about what we've seen over the last six months in that study. i think what you can expect to see there is learn a little bit more about what we've seen over the last six months in that study Of course, the secondary CNS lymphoma, even harder to treat, that will be brand new. of course the secondary cns lymphoma even harder to treat that will be brand new I think on both fronts, it should be a really exciting conference for us. i think on both fronts it should be a really exciting conference for us Thank you. thank you

Speaker 6: Okay. Great. Thanks a lot. Congrats on the progress. Okay. okay Great. great Thanks a lot. thanks a lot Congrats on the progress. congrats on the progress

Speaker 2: Thank you so much. Thank you so much. thank you so much

Speaker 5: There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks. There are no further questions at this time. there are no further questions at this time I will now turn the call over to Jim Dentzer for closing remarks. i will now turn the call over to jim dentzer for closing remarks

Speaker 2: Thank you, Operator. Thank you, everyone, for joining today's call. As always, thank you to the patients and the families participating in our clinical trials, to our team at Curis 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? Thank you, Operator. thank you operator Thank you, everyone, for joining today's call. thank you everyone for joining today's call As always, thank you to the patients and the families participating in our clinical trials, to our team at Curis for their hard work and commitment, and to our partners at Origin, the NCI, and the academic community for their ongoing collaboration and support. as always thank you to the patients and the families participating in our clinical trials to our team at curis 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. we look forward to updating you again soon Operator? operator

Speaker 5: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Ladies and gentlemen, this concludes your conference call for today. ladies and gentlemen this concludes your conference call for today We thank you for participating and ask that you please disconnect your lines. we thank you for participating and ask that you please disconnect your lines