Q3 2025 Curis Inc Earnings Call
Speaker #3: Good afternoon , ladies and gentlemen , and welcome to the curious . Third quarter 2025 Business Update conference call . At this time , all lines are in listen only mode .
Speaker #3: 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 .
Speaker #3: For the operator . This call is being recorded on Thursday , November 6th , 2025 . I would now like to turn the conference over to Diantha Duvall Chief Financial Officer .
Speaker #3: Please go ahead .
Speaker #4: Thank you , and welcome to the Curious Third Quarter 2025 Business Update . Call . Before we begin , I would like to encourage everyone to go to the section of our website at .
Speaker #4: 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 .
Speaker #4: These statements are subject to certain risks and uncertainties and actual results may differ materially . For additional details , please see our SEC filings .
Speaker #4: Joining me on today's call are Jim Dentzer , President and Chief Executive Officer . Doctor Jonathan Zung , chief development officer . And doctor Ahmed Hamdi , chief medical officer .
Speaker #4: 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 .
Speaker #5: Thank you . Diantha . Good afternoon everyone , and welcome to Curis third quarter Business Update . Call . We continue to make steady progress in our take Aim Lymphoma study , which is evaluating emavusertib in combination with ibrutinib in patients with primary CNS lymphoma .
Speaker #5: One of the most rare and most difficult to treat of the NHL subtypes . As a reminder , the take aim Lymphoma study is a single arm study with an oral endpoint that adds Emavusertib to a patient's btki regimen .
Speaker #5: After they have progressed on btki monotherapy and after collaborative discussions with the FDA and EMA . We expect the study to support accelerated submissions in both the US and Europe over the next 12 to 18 months .
Speaker #5: We'll be focused on enrolling the additional patients we'll 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.
Speaker #5: They were especially interested in exploring Emavusertib as 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 .
Speaker #5: 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 .
Speaker #5: Additionally , since patients never achieve complete remission , many of these patients develop btki resistant mutations and ultimately their disease progresses at Cureus , we're looking to improve upon the current standard of care by adding Emavusertib to a patient's BTK regimen , enabling patients to achieve deeper responses and potentially come off treatment , reducing the risk of developing BTK resistant mutations and improving a patient's overall quality of life .
Speaker #5: The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTK monotherapy who have achieved a partial response (PR) but have been unable to achieve complete remission or undetectable minimal residual disease (UMRD).
Speaker #5: 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 .
Speaker #5: 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 M of assertive with Azacitidine and Venetoclax in AML patients who have achieved complete remission on A7 .
Speaker #5: 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 .
Speaker #5: In addition to their A7 treatment . As of July 2nd , 2025 , ten patients with a median age of 71 were enrolled for in the seven day cohort and six in the 14 day cohort .
Speaker #5: MRD conversion to undetectable levels occurred in four of eight evaluable patients within 5 to 8 weeks of adding emavusertib . Among the patients who remained MRD positive , one patient achieved a 40% MRD reduction and none showed disease progression .
Speaker #5: 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 A7 in frontline AML to enable more patients to achieve undetectable MRD .
Speaker #5: 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 Snow and Ash conferences over the next few weeks.
Speaker #5: With that , I'll turn the call back over to Diantha for the financial update . Diantha .
Speaker #4: Thank you Jim . Kira 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 2020 .
Speaker #4: For Curis reported net loss of $26.9 million , or $2.19 per share , for the nine months ended September 30th , 2025 , as compared to a net loss of $33.8 million , or $5.77 per share , for the same period in 2020 .
Speaker #4: For 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 2020 .
Speaker #4: For . 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 30th , 2025 , as compared to $29.6 million for the same period in 2020 .
Speaker #4: For 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 2020 .
Speaker #4: For the decrease was primarily attributable to lower employee related costs . General and administrative expenses were $11.2 million for the nine months ended September 30th , 2025 , as compared to 13.4 million for the same period in 2020 .
Speaker #4: For Curis , cash and cash equivalents were 9.1 million as of the end . As of September 30th , 2025 , and the company had approximately 12.7 million shares of common stock outstanding .
Speaker #4: 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 .
Speaker #4: With that , I'd like to open the call for questions . Operator .
Speaker #3: 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 touchtone phone .
Speaker #3: 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 .
Speaker #3: If you are using a speaker , please lift your handset before pressing any keys . Your first question comes from Sarah Nick with H .
Speaker #3: Wainwright . Your line is now open .
Speaker #6: Hi , Tim , and thanks for taking the question . Congrats on the ongoing progress . My question was regarding your CLL program , and if any color you could provide on the FDA discussions and protocol you submitted where you mostly aligned with , you know , primary endpoints and study design .
Speaker #6: Any granularity you can provide as of now would be helpful. Thank you.
Speaker #5: Thank you sir , and thanks for the question . I'll start and I'll ask Doctor Hamdy to to chime in as well . So we're very excited about that , about that study .
Speaker #5: So as you know , we we did have a a dose escalation study where we tested across different subtypes of NHL . Our first expansion was into Pcnsl .
Speaker #5: And the second one is going into CLL . Obviously , as we move into CLL , it's a much larger indication . And of course , there's a much wider circle of interest among the kols .
Speaker #5: Ahmed , do you want to talk a little bit more about the CLL study in particular ?
Speaker #7: Sure . Hi , Sarah , it's Ahmed , so basically we're trying to address the unmet medical need in the CL community , which is basically getting patients to a time limited treatment with with a combination of Versata plus a BTK inhibitor in patients who are currently on BTK and have only achieved a PR with MRD positive .
Speaker #7: So and we're aligned with the FDA , there and we intend to have a small dose escalation at 100mg and expanding into our 200 milligram phase two dose .
Speaker #6: Great . Thank you .
Speaker #3: Your next question comes from Lee Watzke with Cantor . Your line is now open .
Speaker #8: Hey , guys . Thanks for taking our questions . And I guess just for the phase two CLL trial , can you maybe just talk a little bit about the size of this study ?
Speaker #8: And in terms of the delta , you want to achieve in terms of the CR rate , and then secondly , just how you're thinking about resource prioritization at this point , especially , you know , as you think about the resources that you might need to move forward with the sales study versus the frontline AML study .
Speaker #5: Sure . So again , why don't I start on CLL ? I'll ask Doctor Hamdy to to talk a little more detail and then maybe have Diantha talk a little bit about resources .
Speaker #5: So first on CLL , you know , we are anticipating a study design at this point in time that anticipates 40 patients . But of course , as we saw in Pcnsl , the unmet need is so clear .
Speaker #5: We're hoping to 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 .
Speaker #5: They don't get CRS . They certainly aren't getting MRD either . So what we're looking to do in that population is , is demonstrate simply that by adding m of assertive , by blocking both pathways , not just one , but both pathways that are driving disease that we can we can end up seeing deeper responses .
Speaker #5: So, 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?
Speaker #7: I think you said it all , Jim . The whole concept here that you don't see CRS in with BTK and obviously you don't see MRD negative .
Speaker #7: So getting patients to a CR and I think , you know , anything north of 20% would be very exciting . But obviously we're going to have to wait until we see a treatment effect in our trial .
Speaker #7: And , you know , plan accordingly . But 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 kappa B and therefore getting patients to a deeper response .
Speaker #7: And MRD negative .
Speaker #5: Yeah . Thank you . And , Diantha , would you mind spending a moment talking about resources ?
Speaker #4: Absolutely . So as you can appreciate , you know , our current priorities are clearly to continue the Pcnsl trial . And obviously launch the newly initiated CLL trial .
Speaker #4: And 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 .
Speaker #4: So neither of those things should be a surprise . So so that's sort of where we're thinking about our resource allocations .
Speaker #5: Yeah . And in overall messaging , we we continue to move forward with great progress in Pcnsl . And I think the investor interest , not just in Pcnsl with the with the eye approval , but the ability to move the needle in CLL , it seems to be a very reachable goal .
Speaker #5: And because of the the market opportunity , a very exciting goal . So look forward to hearing from us more about that over the next eight weeks .
Speaker #3: Ladies and gentlemen , as a reminder , should you have a question , please press star one . Your next question comes from Yale .
Speaker #3: Jen with Laidlaw and Company. Your line is now open.
Speaker #9: Good afternoon and thanks for taking the questions . I got two here . First of all , in terms of the CEO study , what would you think about the safety side ?
Speaker #9: In other words , in the combination , was there any sort of speculative . May happen . And how would you think about the mitigation or for that .
Speaker #9: And then I have a follow up .
Speaker #5: Okay . Again , let me start and I'll ask Doctor Hamdy to to add to it . So I think the critical issue for us is going to be do we see any DDE with the BTK inhibitors .
Speaker #5: And as you know , we have a great deal of confidence , given that we've already tested a number of patients in in NHL with ibrutinib .
Speaker #5: And and we aren't seeing DDE , in fact , at the doses that we're testing , 100 and 200mg with Emma , it seems to be very a very clean profile .
Speaker #5: Ahmed , would you like to add to that ?
Speaker #7: Yeah . I mean , again , you said it all , Jim . But yeah , I mean , we have approximately 25 patients , if not more , combined with ibrutinib .
Speaker #7: And as you know , ibrutinib is probably would be the most unselective of all approved BTK . And we have not seen any additive toxicities .
Speaker #7: And we expect not to see any additive toxicity with the other BTK inhibitors . Of course , we're going to be doing , you know , some PK work in DDE following any potential toxicities .
Speaker #7: But I don't think there's any additive toxicities that we expect .
Speaker #9: Okay . Great . That's helpful . And maybe just one more question here . In terms of the snow meeting in a few days , what should be the investor very sort of expectation to talk about .
Speaker #9: And then thanks a lot .
Speaker #5: Yeah . So obviously we're going to have to be a little careful not to front run the conference . But thank you , Yael , for for your interest in that .
Speaker #5: Yeah . We're going to have several posters . Three of them available at the Snow conference in Pcnsl , but also Scnsl Doctor Grams and Doctor Nayak in particular , will be talking about Pcnsl .
Speaker #5: So 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 , and of course , the secondary CNS lymphoma , even harder to treat .
Speaker #5: That will be brand new . So on both fronts , it should be a really exciting conference for us . Thank you .
Speaker #9: Okay , great . Thanks a lot . And congrats on the progress .
Speaker #5: Thank you so much .
Speaker #3: No further questions at this time . I will now turn the call over to Jim Dentzer for closing remarks .
Speaker #5: Thank you . Operator . And thank you , everyone , for joining today's call . And 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 .
Speaker #5: We look forward to updating you again soon . Operator .
Speaker #3: Ladies and gentlemen , this concludes our conference call for today . We thank you for participating and ask that you please disconnect your lines .