CRIS

Image source: The Motley Fool. Thursday, March 19, 2026 at 4:30 p.m. ET Chief Executive Officer — James Dentzer Chief Financial Officer — Diantha Duvall Chief Medical Officer — Ahmed Hamdy Need a quote from a Motley Fool analyst? Email [email protected] James Dentzer: Thank you, Diantha. Good afternoon, everyone, and welcome to our first quarter business update call. We continue to make steady progress in our TakeAim Lymphoma study in 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 registrational study with an ORR endpoint that is evaluating emavusertib in combination with ibrutinib after a patient has progressed on BTKi therapy. And after collaborative discussions with both FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. We anticipate providing updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with relapsed/refractory PCNSL in the first half of 2027. We continue to make good progress on enrollment on this registrational study and appreciate the ongoing support of our clinical investigators, key opinion leaders and regulatory authorities. As you recall, last year, we engaged with a number of key opinion leaders who were excited and highly supportive about 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 BTK inhibitors. Over the last decade, BTK inhibitors have become 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 result is that patients treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, because they never achieve complete remission, many of these patients develop BTKI resistant mutations and ultimately, their disease progresses. We're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, applying a dual blockade to the 2 biologic pathways driving CLL. This dual blockade can enable patients whose NHL subtype partially responds to a BTK inhibitor to achieve deeper responses with the combination, including the ability to achieve complete remission or undetectable disease and the potential for time-limited treatment. If we are successful, adding emavusertib to BTKi could change the treatment paradigm in CLL, reducing the risk of developing a treatment-resistant mutation and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is our proof-of-concept study in patients currently on BTKi monotherapy, who have achieved partial remission but have been unable to achieve complete remission or undetectable MRD. We anticipate the dosing of the initial 5 patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, and we expect to have initial data in December. In January, one of our collaborators, Dr. Patrick Grierson of the Siteman Cancer Center at Washington University in St. Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO GI Cancer Symposium. In this study, patients are treated with emavusertib in combination with FOLFOX and anti-PD-1 plus or minus Herceptin as first-line therapy for metastatic or unresectable gastroesophageal cancers. The initial data showed results for 16 evaluable patients, demonstrating both a manageable toxicity profile and encouraging preliminary results. As you can see, we had a very productive quarter and look forward to an exciting 2026 as we advance our registrational study in PCNSL and our proof-of-concept study in CLL. With that, I'll turn the call back over to Diantha for the financial update. Diantha? Diantha Duvall: Thank you, Jim. Curis reported a net loss of $24.2 million or $1.25 per share for the first quarter of 2026 as compared to a net loss of $10.6 million or $1.25 per share for the same period in 2025. The increase in net loss was primarily due to a change in fair value of warrant liabilities associated with the January 2026 PIPE financing. Research and development expenses were $6.4 million for the first quarter of 2026 as compared to $8.5 million for the same period in 2025. The decrease was primarily attributable to lower employee-related and manufacturing costs. General and administrative expenses were $5.1 million for the first quarter of 2026 as compared to $4.0 million for the same period in 2025. The increase was primarily attributable to expenses associated with the January 2026 PIPE financing, partially offset by lower employee-related costs. Curis' cash and cash equivalents as of March 31, 2026, of $15 million, together with anticipated gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE financing Series B warrants upon the public announcement of dosing of the fifth CLL patient in our TakeAim CLL study expected later this year should enable the company's planned operations into the second half of '27. With that, I'd like to open the call for questions. Operator? Operator: [Operator Instructions] Your first question comes from Sara Nik with H.C. Wainwright. Sara Nik: Regarding the CLL study, you guided to announcing dosing of the first 5 patients by midyear. I was wondering if you could provide as of today, how many patients have been dosed so far? And maybe any color on the current pace of site activation and enrollment? James Dentzer: Sure. Thank you, Sara. I appreciate the question, and thanks for calling in. So we're trying and getting out of the realm as it is 5 is already a pretty small number. We're going to try and get out of the patient-by-patient update. But as I would say, we're obviously very, very confident that we are hitting our target on track and the process of both getting our sites up and running and our patients consented into the study is on track, and we look forward to providing an update mid-summer. Operator: Your next question comes from Yale Jen with Laidlaw & Co. Yale Jen: In terms of PCNSL, you mentioned you're going to have an update in the first half of '27. I wonder that will related to the data or simply just the enrollment status or any other color? James Dentzer: Sure. Again, thanks for calling in and appreciate the question. So on PCNSL, yes, I mean, you're exactly right. What we have said is we expect that we're going to be in a position or at least we're hoping to be in a position where we could be fully enrolled in that study in 2027. So our expectation would be we could have a substantial update on enrollment in the first half of 2027. Right now, of course, we're a long way from that. We'll continue to provide updates as we know more going through the year. But right now, I'd say we're cautiously optimistic. We are on track, and we look forward to having that discussion at that time. Yale Jen: Maybe just to follow up on that. In terms of the current sort of enrollment situations, I know it's very lumpy. But overall, are they within your expectation or either better or worse, at least at this moment? James Dentzer: No, it's on track. You're exactly right. This is one of the issues, of course, when you're developing a drug in an ultra-orphan space, there are just frankly not a lot of those patients around. So we will go, as we have in the past, some months where we don't have any patients, then some months where we get 2 or 3 on any given month, your description is lumpy is spot on. But as we take a step back and we say not on any given month, but are we on track to hit our enrollment targets for -- in time for a disclosure in the first half of 2027. And I'd say, yes, we continue to see the same kind of performance over time that we have been. Excitement continues to be very strong. And as I say, we look forward to providing that update with the full data set in 2027. So -- but stay tuned. We'll provide updated guidance as we go along through the year. Great question. Yale Jen: And again, congrats on the progress. Operator: The next question comes from Kripa Devarakonda with Truist. Unknown Analyst: This is Anna on for Kripa. Just two questions on CLL. I think you mentioned you're evaluating 2 doses kind of to satisfy the Project Optimus. And I know it's a small sample size, but are there any expectations for any meaningful differences in the safety profile when you're kind of adding emavusertib to these combinations? And in terms of the CLL standard of care, I was just wondering how -- if you could remind us kind of how you're differentiating there? James Dentzer: Yes. So let me talk to the first part, and then I'll ask Ahmed to chime in on CLL. So the first question is, yes, as part of the discussions that we had with FDA and EMA, they were very clear that we need to make sure to include data on 100 and 200 in our submissions, which, of course, we will do. I don't anticipate that there is a whole lot of there's a whole lot of question about safety between 100 and 200. I think as you may remember, we have dosed emavusertib as high as 500 milligrams. So I think the safety profile should be manageable at both. It's really a question of we know that the dose is active at both 100 and 200. And we just need to satisfy ourselves that 200 is the best dose as a starting dose for patients and that they have the ability to dose up or down from a safety perspective as needed. Maybe diving into CLL in particular, I'll ask Dr. Hamdy to comment. Ahmed Hamdy: Sure. thanks for the question. I think CLL, although BTKs and BCL-2s have done quite a difference for patients, yet the problem is patients have to continue dosing chronically for extended periods of time, leading to potential resistance and mutations, along with toxicities like cardiovascular and bleeding and bone marrow suppression, which is really one of the hardest things for CLL patients. The treatment goal or the unmet medical need currently in CLL is getting patients to a treatment-free remission period. And when we look at the current state of affairs in CLL, most patients do not achieve a CR or MRD negative, allowing them to stop treatment in a monotherapy setting. And basically, BTKs work by inhibiting the BCR signaling pathway, which would also inhibit the NF-kappaB, which is the driver of the disease. But because those patients are not getting to a CR or MRD negative, there's quite a bit of preclinical work that has been done by renowned key opinion leaders stating that there is a constituent activation of the NF-kappaB through the TLR pathway, which emavusertib inhibits. The concept of combining emavusertib with a BTK inhibitor can potentially lead to a more profound inhibition of the NF-kappaB and therefore, hopefully, we can see more CRs than the monotherapy or with BTK alone. So we think the combo can really make a difference for those patients. On the other hand, as you know, the space has also been trying to combine BTKs with BCL-2s and anti-CD20s, although some of these combinations have a higher CR rate and MRD rate. yet it comes with a high toxicity profile, specifically on the bone marrow with infections and so forth. So I hope we are quite differentiated from what we see right now. And as you've seen with our programs, we've combined with ibrutinib in a lot of patients, and we have not seen any additive toxicities or bone marrow suppression. So we feel that this can really be a paradigm shift in the treatment of CLL in a combination setting when we inhibit 2 nodes in the main pathway that is activating the disease. I hope that helps. Operator: [Operator Instructions] we have a question from Boris Peaker with Jones. Danya Ben-Hail: This is Danya for Boris. My first question is about a follow-up for the CLL trial. What specific signs of activity are you looking for in the initial patients to validate this dual blockade you've been discussing? James Dentzer: Yes. Again, I think that's probably a best question for Dr. Hamdy. Ahmed, if you want... Ahmed Hamdy: I'm sorry, I didn't hear clearly the last part of the question, if you mind repeating it? Danya Ben-Hail: Sure. Just what initial or specific signs of activity are you looking for in the initial patients that you'll be enrolling? Ahmed Hamdy: Well, currently we're combining with zanubrutinib in patients who are currently in a PR or a PRL, which is basically all zanu patients. And the idea is to see deepening of responses where we can see patients inching towards a CR and getting to an undetectable MRD status where we can get patients to a treatment-free remission by stopping those drugs. James Dentzer: Yes. And let me add to that as well. So in these early days, so I'll differentiate a little bit the goal where Ahmed was headed from the early days. So just as a reminder, a patient coming into the study, as Dr. Hamdy said, is currently on zanu and they're in partial remission, meaning their CLL counts, right? They've dropped 50% or more and then they've plateaued. So they can get their cancer level down by 50%, but no lower than that or wherever they've plateaued. At that point, we enroll them in the study and add a second pill, we add ema. So what we really want to see, frankly, is that we can take them from plateauing to decreasing their disease burden. And at that point, from a patient's perspective, of course, any decrease is good. But we want to see the disease trending down. Now from a regulatory perspective, our goal, of course, we expect to see patients with significant reductions, and we're hoping to see patients that are able to do what they can't do on monotherapy, meaning get all the way down to complete remission or MRD and maybe even time-limited treatment. But in these early days, what we're really hoping to see is a patient comes in having plateaued on zanu and if they add a second pill, if they add emavusertib, we can see them reduce their cancer burden. That's what we're hoping. Does that make sense? Danya Ben-Hail: Yes. And just the last question. Are you speaking of commercial partnership for the AML program? James Dentzer: No, not yet. I would say at this point in time, we have addressed the financing of the company with the January financing, and we appreciate that, that gave us the ability to not just continue executing against PCNSL, but add the PCNSL program. And right now, we're focused on generating data in those indications. And of course, what we'd love to be able to do with additional resources is add AML into that same mix and take the next step because the next step in AML would be a registrational study. At some point in time, could a partnership make sense? Absolutely, we have discussions just as every biotech company does. But right now, our goal is to use the resources from the financing that we've gained to continue to push forward both on the registrational study and on the new study in CLL and hopefully be able to continue the success with data that we've seen so far. Operator: There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks. Please continue. James Dentzer: Thank you, operator, and thank you, everyone, for joining today's call. And as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment and to our partners at Aurigene, the NCI and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator? Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Curis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Curis wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Curis (CRIS) Q1 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Curis Inc (NASDAQ:CRIS) is making steady progress in its Teykain lymphoma study, which targets a rare and difficult-to-treat NHL subtype. The company anticipates accelerated submissions for its study in both the U.S. and Europe after collaborative discussions with FDA and EMA. Curis Inc (NASDAQ:CRIS) is exploring the potential of emivusertib to change the treatment paradigm for CLL patients, aiming for deeper responses and complete remission. Initial clinical data in gastric and esophageal cancer showed a manageable toxicity profile and encouraging preliminary results. The company has sufficient cash and cash equivalents to fund planned operations into the second half of 2027. Curis Inc (NASDAQ:CRIS) reported a net loss of $24.2 million for the first quarter of 2026, a significant increase from the previous year. The increase in net loss was primarily due to a change in fair value of warrant liabilities associated with recent financing. Enrollment in the PCNSL study is described as 'lumpy,' indicating potential challenges in patient recruitment. General and administrative expenses increased due to expenses associated with recent financing activities. The company is not currently pursuing commercial partnerships for its AML program, which could limit future growth opportunities. Warning! GuruFocus has detected 5 Warning Signs with CRIS. Is CRIS fairly valued? Test your thesis with our free DCF calculator. Q: Regarding the CLL study, you guided to announcing dosing of the first five patients by mid-year. Can you provide an update on how many patients have been dosed so far and the current pace of site activation and enrollment? A: We are confident that we are on track with our target. The process of getting our sites up and running and having patients consented into the study is progressing well. We look forward to providing an update mid-summer. - Jim Dentzer, CEO Q: For the PCNSL study, will the update in the first half of 2027 be related to data or just enrollment status? A: We expect to be fully enrolled in the study by 2027, and we anticipate providing a substantial update on enrollment in the first half of 2027. We are cautiously optimistic that we are on track. - Jim Dentzer, CEO Q: Are there any expectations for meaningful differences in the safety profile when adding emivusertib to CLL combinations? A: We do not anticipate significant safety differences between the 100 and 200 mg doses. The safety profile should be manageable, and we aim to determine the best starting dose for patients. - Jim Dentzer, CEO Q: What specific signs of activity are you looking for in the initial CLL patients to validate the dual blockade approach? A: We aim to see a deepening of responses, moving patients towards complete remission and undetectable MRD status, allowing for treatment-free remission. - Dr. Ahmed Hamdi, Chief Medical Officer Q: Are you considering commercial partnerships for the AML program? A: Not at this time. We are focused on generating data in our current studies. While a partnership could make sense in the future, our current goal is to use existing resources to advance our studies. - Jim Dentzer, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is focusing on emavusertib as a potential paradigm-shifting treatment for B-cell malignancies by targeting the TLR pathway to inhibit NF-kappaB activation. The TakeAim Lymphoma study in primary CNS lymphoma (PCNSL) is designed as a single-arm registrational study following collaborative discussions with the FDA and EMA for accelerated approval pathways. Strategic expansion into Chronic Lymphocytic Leukemia (CLL) aims to address the limitations of current BTK inhibitor standards of care, which typically achieve only partial responses. The 'dual blockade' strategy combines emavusertib with BTK inhibitors to target two distinct biologic pathways, aiming for complete remission and time-limited treatment rather than lifelong chronic therapy. Management attributes the increased net loss primarily to non-cash fair value adjustments of warrant liabilities from the January 2026 PIPE financing rather than operational overspending. Operational efficiency is reflected in decreased R&D expenses, driven by lower employee-related and manufacturing costs during the quarter. Dosing of the initial five patients in the TakeAim CLL combination study with zanubrutinib is anticipated by mid-2026, with initial data expected in December. Updated clinical data from the TakeAim Lymphoma combination study in relapsed/refractory PCNSL is projected for the first half of 2027. Management expects to be in a position to be fully enrolled in the PCNSL registrational study during 2027, despite the 'lumpy' nature of ultra-orphan patient recruitment. Cash runway is projected into the second half of 2027, contingent upon the exercise of Series B warrants triggered by the public announcement of the fifth CLL patient dosing. Future regulatory submissions for emavusertib will include data for both 100mg and 200mg doses to satisfy Project Optimus requirements. The net loss of $24.2 million was significantly impacted by the change in fair value of warrant liabilities associated with the January 2026 PIPE financing. Patient recruitment for PCNSL remains a challenge due to the ultra-orphan nature of the disease, leading to inconsistent monthly enrollment patterns. The company is currently prioritizing its existing resources on PCNSL and CLL, with a registrational study in AML remaining a future goal dependent on additional resources or partnerships. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to provide a patient-by-patient update but expressed high confidence in hitting the mid-summer target for the first five patients. Site activation and patient consenting processes are confirmed to be on track. The combination aims to overcome BTK inhibitor plateaus by inhibiting the TLR pathway, which provides a secondary activation route for NF-kappaB. Management highlighted the potential for a better safety profile compared to BTK/BCL-2 combinations, noting no additive bone marrow suppression seen in clinical data to date. The primary goal for early patients is to see a decrease in disease burden for those who have already plateaued on zanubrutinib monotherapy. Long-term success is defined as achieving undetectable MRD or complete remission, enabling patients to stop treatment. Management stated they are not seeking a partner yet, as the January financing allows them to focus on generating data for PCNSL and CLL first. While open to discussions, the current priority is advancing the registrational PCNSL study and the CLL proof-of-concept internally.

Management to host conference call today at 4:30 p.m. ET LEXINGTON, Mass., May 12, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today reported its business update and financial results for the quarter ended March 31, 2026. Operational Highlights TakeAim Lymphoma Emavusertib is currently undergoing testing in combination with the Bruton's tyrosine kinase inhibitor (BTKi) ibrutinib in the TakeAim Lymphoma Phase 1/2 open-label, single arm expansion trial in patients with Relapsed or Refractory (R/R) Primary CNS Lymphoma (PCNSL) (CA-4948-101, NCT03328078). Patient enrollment in this study is currently ongoing. As a result of discussions with FDA and EMA, the ongoing phase 1/2 study is intended to support filings for accelerated approval of emavusertib in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL. TakeAim CLL Emavusertib is also being tested in the recently initiated open label TakeAim CLL Phase 2 clinical trial of emavusertib in combination with the BTKi zanubrutinib in patients with Chronic Lymphocytic Leukemia (CLL) (CA-4948-203, NCT07271667). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is the use of BTK inhibitors, which block the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL. Solid Tumors Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO Gastrointestinal Cancers Symposium in January 2026. In this study, patients are treated with emavusertib in combination with FOLFOX and anti-PD1 +/- trastuzumab as first-line therapy for metastatic or unresectable gastroesophageal cancers. The poster titled A phase I trial of emavusertib (CA-4948) in combination with FOLFOX/ PD-1 inhibitor +/- trastuzumab as first-line treatment for untreated unresectable gastric and esophageal cancer showed results for 16 evaluable patients demonstrating a manageable toxicity profile and encouraging preliminary results. Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis will have an abstract titled A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC) available online at http://asco.org/abstracts on May 21, 2026 at 5:00 PM EDT. Upcoming Milestones Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, with data expected in December 2026. Also, the Company expects updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with R/R PCNSL in the first half of 2027. Corporate On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are exercisable at $0.75 per share, subject to conditions defined in the financing agreement with respect to the Series B warrants, and have the following termination conditions: Series A warrants terminate on January 8, 2031; Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement; and Series C warrants terminate on July 8, 2027. First Quarter 2026 Financial Results For the quarter ended March 31, 2026, Curis reported a net loss of $24.2 million, or $1.25 per share on both a basic and diluted basis, as compared to a net loss of $10.6 million, or $1.25 per share on both a basic and diluted basis in 2025. There were no revenues for the quarter ended March 31, 2026 due to the sale of Erivedgeﾮ royalties to Oberland in the fourth quarter of 2025. Revenues, net were $2.4 million for the quarter ended March 31, 2025, comprising royalty revenues from Genentech and Roche's net sales of Erivedgeﾮ. Research and development expenses were $6.4 million and $8.5 million for the quarters ended March 31, 2026 and 2025, respectively. The decrease was primarily attributable to lower employee related and manufacturing costs. General and administrative expenses were $5.1 million and $4.0 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was primarily attributable to expenses associated with the January 2026 PIPE Financing, partially offset by lower employee related costs. Other expense, net was $12.7 million and $0.5 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was attributable to the change in fair value of the warrant liability associated with the January 2026 PIPE Financing, partially offset by no expense related to the sale of future royalties in 2026. As of March 31, 2026, Curis's cash and cash equivalents totaled $15.0 million, and the Company had approximately 40.0 million shares of common stock outstanding. Cash Runway Guidance Curis believes its cash and cash equivalents as of March 31, 2026 of $15.0 million, together with anticipated gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company's planned operations into the second half of 2027. Conference Call Information Curis management will host a conference call today, May 12, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results. To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor, ibrutinib, in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor, zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company's monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis's website at www.curis.com. Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning Curis's cash runway or expectations with respect to the timing or exercise of the January 2026 PIPE Financing Series B Warrants; Curis's expectations with respect to the dosing of the first five patients in the TakeAim CLL study, and the therapeutic potential of emavusertib in combination with zanubrutinib to improve treatment outcomes, achieve complete remissions and/or undetectable MRD, and/or reduce time on treatment for patients with CLL; Curis's expectations with respect to enrollment of BTKi na￯ve and BTKi experienced populations in the TakeAim Lymphoma study; statements regarding updated PCNSL data and the timing of such data from the TakeAim Lymphoma study, or the use of such data to support regulatory filings for approval of emavusertib in PCNSL, and the therapeutic potential and tolerability of emavusertib in patients with PCNSL. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "likelihood", "continue," "potential," "opportunity," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. Curis is dependent on the success of emavusertib and any delays in the development of emavusertib could have a material adverse effect on its business. There can be no guarantee that the collaboration agreement with Aurigene or the CRADA with NCI will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. Curis will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support its continued operations. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate the development of emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA, EMA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control, including its ability to regain and maintain its listing on the Nasdaq Capital Market, could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K, and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. View original content to download multimedia:https://www.prnewswire.com/news-releases/curis-provides-first-quarter-2026-business-update-302769980.html

Kiniksa Pharmaceuticals International, plc (KNSA) came out with quarterly earnings of $0.27 per share, beating the Zacks Consensus Estimate of $0.18 per share. This compares to earnings of $0.11 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +50.00%. A quarter ago, it was expected that this company would post earnings of $0.29 per share when it actually produced earnings of $0.17, delivering a surprise of -41.38%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Kiniksa Pharmaceuticals International, plc, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $214.27 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 5.24%. This compares to year-ago revenues of $137.79 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Kiniksa Pharmaceuticals International, plc shares have added about 5.7% since the beginning of the year versus the S&P 500's gain of 4.8%. While Kiniksa Pharmaceuticals International, plc has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Kiniksa Pharmaceuticals International, plc was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.24 on $221.37 million in revenues for the coming quarter and $1.09 on $910.57 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Curis (CRIS), is yet to report results for the quarter ended March 2026. This drug developer is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +84.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Curis' revenues are expected to be $3 million, up 26.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report Curis, Inc. (CRIS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Thursday, March 19, 2026 at 4:30 p.m. ET Chief Executive Officer — James E. Dentzer Chief Financial Officer — Diantha Duvall Chief Medical Officer — Ahmed M. Hamdy Need a quote from a Motley Fool analyst? Email [email protected] James E. Dentzer: Thank you, Diantha. Good afternoon, everyone, and welcome to Curis, Inc.’s fourth quarter business update call. We continue to make steady progress in our TakeAim Lymphoma study in primary CNS lymphoma, one of the rarest and most difficult to treat of the NHL subtypes. As a reminder, the TakeAim Lymphoma study is a single-arm registrational study with an ORR endpoint that is evaluating emavusertib in combination with ibrutinib after a patient has progressed on BTKi therapy. After collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the US and Europe. We continue to make good progress on enrollment in this registrational study and appreciate the ongoing support of our clinical investigators, key opinion leaders, and regulatory authorities. As you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive about 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. Over the last decade, 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 result is that patients treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, because they never achieve complete remission, many of these patients develop BTKi-resistant mutations, and ultimately their disease progresses. We are looking to improve upon the current standard of care by adding emavusertib to a patient’s BTKi regimen, applying a dual blockade to the two biologic pathways driving CLL. This dual blockade can enable patients whose NHL subtype partially responds to a BTK inhibitor to achieve deeper responses with the combination, including the ability to achieve complete remission or undetectable disease and the potential for time-limited treatment. If we are successful, adding emavusertib to BTKi could change the treatment paradigm in CLL, reducing the risk of developing a treatment-resistant mutation and improving a patient’s overall quality of life. The first step in testing this hypothesis in CLL is our proof-of-concept study in patients currently on BTKi monotherapy who have achieved partial remission but have been unable to achieve complete remission or undetectable MRD. We have begun activating clinical sites in the US and Europe and expect to have initial data at the ASH Annual Meeting in December. With that, let us turn to AML. At the ASH meeting in December, we presented data 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 aza/ven but remain MRD positive. These data were for the first two cohorts where patients received emavusertib for either seven or fourteen days in a 28-day cycle in addition to their azacitidine and venetoclax treatment. In this study, five of eight evaluable patients were able to achieve MRD conversion; that is, they were able to convert from MRD positive to undetectable disease. We are very encouraged by these initial data and the exciting potential of combining emavusertib with azacitidine and venetoclax. As you can see, we had a very productive quarter, and we look forward to a very exciting 2026 as we are advancing our registrational study in PCNSL and initiating our proof-of-concept study in CLL. With that, I will turn the call over to Diantha for the financial update. Diantha Duvall: Thank you, Jim. Curis, Inc. reported net income of $19.4 million, or $1.23 per share, for Q4 2025, as compared to a net loss of $9.6 million, or $1.25 per share, for the same period in 2024. The net income in 2025 is due to a $27.2 million one-time non-cash gain attributable to our sale of Erivedge to Oberland. Curis, Inc. reported a net loss of $7.6 million, or $0.58 per share, for the year ended 12/31/2025, as compared to a net loss of $43.4 million, or $6.88 per share, for the same period in 2024. Research and development expenses were $5.8 million for Q4 2025, as compared to $9.0 million for the same period in 2024. The decrease was primarily attributable to lower manufacturing, employee-related, and clinical costs. Research and development expenses were $28.3 million for the year ended 12/31/2025, as compared to $38.6 million for the same period in 2024. General and administrative expenses were $2.9 million for Q4 2025, as compared to $3.4 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $14.0 million for the year ended 12/31/2025, as compared to $16.8 million for the same period in 2024. Curis, Inc.’s cash and cash equivalents as of 12/31/2025, together with initial gross proceeds of $20.2 million received in January 2026 and expected gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE financing Series B warrants upon the public announcement of dosing of the fifth CLL patient in our TakeAim CLL study, expected later this year, should enable our planned operations into 2027. We will now open 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 number 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 number two. If you are using a speaker phone, please lift the handset before pressing any keys. One moment please for your first question. Operator: Our first question comes from the line of Kripa Devarakonda from Truist Securities. Your line is now open. Kripa Devarakonda: Hi, guys. Thanks so much for taking our question, and congrats on the progress. Just one quick question in terms of how you are thinking about prioritizing the trial progress between the pivotal PCNSL versus CLL and AML? James E. Dentzer: Sure. Thanks for the question, and thanks for calling in. As you can imagine, we are very thoughtful about how we are prioritizing our resources. The January financing puts us on a very solid course, but we are still prioritizing our resources to be as efficient as we can in our spend. With that said, we are definitely prioritizing NHL ahead of AML. Right now, we have a dual-pronged strategy where we are pushing forward very aggressively in PCNSL—that is one of the smallest and most rare of the subtypes of NHL—as well as CLL, which is inarguably the largest. PCNSL, of course, is going to be for registration approval, and we are moving ahead right on track on that one. With CLL, we have just started that study. In terms of spend, I would say the bulk of our spend is going toward PCNSL, and in these early days CLL is much smaller, but I imagine that over time that will get larger. My hope is that by the time we get to the end of the year, we will have made significant progress toward a registrational data set in PCNSL, and hopefully have some initial data, our first view, at CLL. Those two are clearly our first priorities. As we are able to raise more cash, and we can get more work started, I think that is when we start to look at AML. Right now, the bulk of the work in AML is more analyzing what steps we want to take as we have more resources and what makes the most sense, and making sure that operationally our focus is on PCNSL and CLL. Operator: Our next question comes from the line of Yale Jen from Laidlaw & Company. Your line is now open. Yale Jen: Great. Thanks a lot, and I appreciate taking the questions. Just two up here. The first one is in terms of the PCNSL. You mentioned the enrollment is on track. Could you give us any updates at this moment? Then I have a follow-up. James E. Dentzer: Sure. We are trying not to give enrollment on PCNSL other than we are on track for what we have suggested. As you all know, it is very hard to find these patients. We get a patient or two a month, but it is pretty choppy. You might go one month where you do not get any patients, and then the next month you get three. I would say right now we are enrolling patients, and on balance I think everything is going according to plan. If we are correct, I have said in the past that we are somewhere in that 12- to 18-month range from full enrollment. That would place us at full enrollment with the potential to file after six months of following patients somewhere in the 2027 range. We could well be in a position by the end of the year that we are really close to that full enrollment number, and we have some nice data to talk about. But I do not expect we are going to have a whole lot to say ahead of then. Yale Jen: Okay. Great. That makes a lot of sense. Then maybe just a quick question for modeling for next year. Given that you have this $27 million non-cash item as well as reduced revenue in the fourth quarter of last year, should we model that there will be no meaningful revenue for 2026 and maybe beyond before your product approval and other stuff? Thanks. Diantha Duvall: Sure. So, Yale, that is correct. We will have no meaningful revenue. Revenue effectively ended in November 2025. From a cash flow perspective, remember that we had sold the right to about 85% of those royalties to Oberland prior to giving them the remaining 15%. From a cash flow perspective, the remaining 15% of those cash flows are now going to Oberland. There will be no revenue and the remaining 15% of cash flows, but it is not a meaningful impact to cash flows. James E. Dentzer: Yes. What you saw in the release is really the non-cash wind-down of that arrangement. It was a very small revenue stream associated with Erivedge in the last couple of years, and we sold what was remaining to Oberland to clean it all up. We are now completely independent of the Erivedge stream. Yale Jen: Okay. Great. That is very helpful, and congrats with the good balance sheet and the advance of programs forward. James E. Dentzer: Thank you. We really appreciate that. Operator: Our next question comes from the line of Li Watsek from Cantor. Your line is now open. Tanya Brown: Hey, team. This is Tanya Brown around for Li. Congrats on the progress. Just a question from us on the expected or potential update at ASH 2026 on CLL. Just curious what kind of data we should be expecting, how many patients you expect to be able to share at that point, and how you would determine success at that early stage? James E. Dentzer: Sure. I am going to start answering that one, and then I will ask Dr. Hamdy to chime in as well. First and foremost, let us not get too far ahead of ourselves. That is in December, and I think as we get closer we can provide more guidance on what we are looking to talk about. At this stage of the game, it is an execution story. We are getting our sites open, we are enrolling patients, and hoping to be in a position that we have some data to talk through in December. This is more about our plans and our expectations at this point. As we get closer to the conference, of course, we can narrow that down and talk a little more specifically. The second part of your question—what would define success in this first proof-of-concept study—that is a wide-ranging one, and I might ask Dr. Hamdy to chime in on his thoughts. Ahmed M. Hamdy: Sure. Thanks, Jim. As Jim mentioned earlier, we are trying to change the CLL treatment paradigm. BTK inhibitors only get patients to partial responses with MRD positivity. We are aiming to deepen that response and see that patients are moving toward a complete remission and, hopefully, MRD negativity. We still do not understand the kinetics of response in the combination, where we are aiming to inhibit both pathways—the BCR signaling pathway and the TLR pathway—aiming to inhibit the NF-kappa B pathway, which is a driver of the disease, at a much deeper level. We have to dose a lot more patients to understand how fast that conversion from PR to CR happens, and I do not intend to venture there just yet, but I am quite hopeful that by ASH we will have some meaningful data to present. James E. Dentzer: Let me expand on that a little bit more because I know at least for some of the investors who may be listening to this call, a little reminder is helpful. As Dr. Hamdy mentioned, we know there are two pathways driving disease in these patients—the BCR pathway and the TLR pathway. Historically, the standard of care is BTKi. BTKi blocks the BCR pathway, and it works; you are blocking one of the two pathways driving disease. That said, it is also why patients are only getting partial response; they are not getting complete remission because they are only blocking one of the two pathways. In our previous studies, and certainly in our ongoing study in primary CNSL—another NHL subtype where standard of care is BTKi—if you add emavusertib to it, if you add a blockade of the TLR pathway on top of the blockade of the BCR pathway, you get deeper responses. We have seen complete remission, and we have seen time-limited treatment. Our goal is to see if we can repeat that success across all five of the subtypes of NHL where BTKi gets used. The biggest of them by far is CLL. We are very excited about getting into that study and seeing what effect we can have. At this stage, we are learning. The mechanism tells us that it should work. Our previous studies tell us it should work. We cannot wait to see the data, frankly. I hope that longer explanation is helpful. Tanya Brown: May I ask a follow-on? James E. Dentzer: Please. Of course. Tanya Brown: Have you dosed your first patients yet in this study? James E. Dentzer: We have not disclosed that yet. What we are saying for now is that we are in the process of initiating the study. We have sites opening in the US and Europe, and our hope is to have data by the time we get to ASH. We are going to try to get out of the path of month-by-month reporting on where we are in enrollment, if that is alright. Tanya Brown: Thank you so much. James E. Dentzer: Great. Thank you. I really appreciate it. Operator: There are no further questions at this time. I will now turn the call over to James E. Dentzer. Please continue, sir. James E. Dentzer: Thank you, and 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, Inc. for their hard work and commitment, and to our partners at Aurigene, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator? Operator: Thank you. Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Curis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Curis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Curis (CRIS) Q4 2025 Earnings Call Transcript was originally published by The Motley Fool

Management is transitioning from monotherapy to a dual-blockade strategy, combining emavusertib with BTK inhibitors to target both BCR and TLR pathways simultaneously. The strategic rationale addresses a critical gap in the current CLL standard of care, where BTKi monotherapy typically only achieves partial responses and leads to chronic treatment dependency. Performance in the AML triplet study demonstrated proof-of-concept for disease clearance, with five of eight evaluable patients achieving MRD conversion from positive to undetectable. The company is prioritizing resources toward Non-Hodgkin Lymphoma (NHL) subtypes, specifically PCNSL and CLL, due to their high unmet need and market scale respectively. Operational efficiency was improved through a reduction in R&D and G&A expenses, driven by lower manufacturing costs and streamlined employee-related expenditures. The sale of the remaining Erivedge royalty stream to Oberland was a strategic move to simplify the balance sheet and focus exclusively on the core emavusertib pipeline. The TakeAim Lymphoma study in PCNSL is designed as a single-arm registrational trial intended to support accelerated approval submissions in both the US and Europe. Initial data from the CLL proof-of-concept study is expected to be presented at the ASH Annual Meeting in December 2026. Full enrollment for the PCNSL registrational study is projected within a 12-to-18-month window, potentially enabling a regulatory filing in 2027 after six months of patient follow-up. Financial guidance indicates a cash runway into 2027, contingent on the exercise of Series B warrants triggered by the dosing of the fifth CLL patient. Future AML development is currently secondary to NHL, with further expansion dependent on securing additional capital and resource availability. A $27.2 million one-time non-cash gain was recorded in Q4 2025 following the final sale of Erivedge rights to Oberland. Management confirmed that meaningful revenue streams have effectively ended as of November 2025 following the divestment of legacy royalty interests. The company secured a PIPE financing in January 2026, providing $20.2 million in initial gross proceeds with an additional $20.2 million tied to clinical milestones. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explicitly stated they are prioritizing NHL (PCNSL and CLL) over AML to maximize spend efficiency. PCNSL is the immediate priority for registration, while CLL represents the largest long-term market opportunity. AML progress is currently focused on data analysis rather than aggressive clinical expansion until more resources are available. Enrollment is described as 'choppy' but on track, with the company typically seeing one to two patients per month. The company expects to be close to full enrollment by the end of 2026, supporting a potential 2027 filing. Success is defined by the ability to deepen responses from partial remission (PR) to complete remission (CR) and MRD negativity. Management declined to provide specific patient counts for the ASH update, focusing instead on the 'execution story' of site activation and enrollment. The study aims to prove that inhibiting the NF-kappa B pathway via dual blockade can fundamentally change the CLL treatment paradigm. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.