Good afternoon, ladies and gentlemen, welcome to the Curis first quarter 2026 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 zero for the operator. This call is being recorded on Tuesday, May 12th, 2026. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead.
Thank you. Welcome to the Curis first quarter 2026 business update call. Before we begin, I'd like to encourage everyone to go to the investor section of our website at www.curis.com to find our first quarter 2026 business update press release and related financial tables. I would also like to remind everyone that during the call, we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Actual results may differ materially. For additional details, please see our SEC filings. Joining me today 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 now like to turn the call over to Jim.
Thank you, Diantha. Good afternoon, everyone, and welcome to our first quarter business update call. We continue to make steady progress in our Take Aim Lymphoma study in primary CNS lymphoma, 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 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 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 Take Aim 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 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-resisting 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 five patients in the Take Aim 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 Cancers 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?
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 31st, 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 up the fifth CLL patient in our Take Aim CLL study expected later this year, should enable the company's planned operations into the second half of 2027. With that, I'd like to open the call for questions. Operator?
Your first question comes from Sara Nik with H.C. Wainwright & Co. Please go ahead.
Hi, good afternoon, thanks for taking my question. Regarding the CLL study, you guided to announcing dosing of the first five patients by mid-year. 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. Thank you.
Sure. Thank you, Sara. I appreciate the question, and thanks for calling in. Yeah, we're trying getting out of the realm as it is. Five is already a pretty small number. We're gonna try and get out of a patient-by-patient update. As I would say, we're obviously very, very confident that we are hitting our target on track. 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 midsummer.
Okay. Thank you.
Sure. Thank you.
Your next question comes from the Yale Jen with Laidlaw & Company. Please go ahead.
Good afternoon, and thanks for taking the questions. In terms of a PCNSL, you mentioned you're gonna have updates in the first half of 2027. Wonder that will related to the data or simply just the enrollment status or any other colors? Thanks.
Sure. Hi, Yale. Again, thanks for calling in and appreciate the question. On PCNSL, yeah, I mean, you're exactly right. What we have said is we expect that we're gonna 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. 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. Right now, I'd say we're cautiously optimistic. We are on track, we look forward to having that discussion at that time.
Maybe just to follow up on that. In terms of the current sort of enrollment situations, I know it's a very lumpy, but overall, are they within your expectation or either better or worse, or at least at this moment? Thanks.
No, thank you. 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. We will go, as we have in the past, some months where we don't have any patients, then some months where we get two or three. You know, on any given month, your description is lumpy is spot on. As we take a step back and we say, not on any given month, are we on track to hit our enrollment targets in time for a disclosure, first half of 2027? 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, as I say, we look forward to providing that update with the full data set in 2027. Stay tuned.
Okay.
We'll provide update, updated guidance as we go along through the year. Great question.
Okay, great. Thanks a lot. Again, congrats on the progress.
Thank you very much. I appreciate it.
The next question comes from Srikripa Devarakonda with Truist. Please go ahead.
Hi. This is Anna on for Kripa. Thanks so much for taking our question. Just two questions on CLL. I think you mentioned you're evaluating two 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? In terms of the CLL standard of care, if you could remind us kind of how you're differentiating there. Thanks.
Yeah. Let me talk to the first part, and then I'll ask Ahmed to chime in on CLL. 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 question about safety between 100 and 200. I think as you may remember, we have dosed emavusertib as high as 500 mg. 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?
Sure. Thanks for the question. I think, you know, CLL, although BTKs and BCL2s have done quite a bit of difference for patients, yet the problem is patients have to continue dosing chronically for extended periods of time, leading to, you know, potential resistance and mutations, along with toxicities like cardiovascular and bleeding and bone marrow suppression, which is really one of the hardest thing for CLL patients. The treatment goal or the unmet medical need currently in CLL is getting patients to a treatment-free remission period. 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.
Basically BTKs work by inhibiting the BCR signaling pathway, which would also inhibit the NF-κB, which is the driver of the disease. 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 constitutive activation of the NF-κB 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-κB and therefore, hopefully we can see more CRs than the monotherapy or with BTK alone. We think the combo can really make a difference for those patients.
As you know, the space has also been trying to combine BTKs with BCL2s 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. 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. We feel that this can really be a paradigm shift in the treatment of CLL in a combination setting when we inhibit two nodes in the main pathway that is activating the disease. Hope that helps.
Yep. Thanks so much.
Yeah. Thank you, Anna. Appreciate you calling in.
As a reminder, if you wish to ask a question, please press star one. We have a question from Boris Peaker with JonesTrading. Please go ahead.
Hi. Thank you for taking our questions. This is Dania for Boris. My first question is about the, as 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 we've been discussing?
Yeah. Again, I think that's probably a best question for Dr. Hamdy. Ahmed, if you wouldn't mind.
I'm sorry. I didn't hear clearly the last part of the question. If you mind repeating it?
Sure. Just what initial or specific signs of activity are you looking in the initial patients that you'll be enrolling?
Well, currently we're combining with zanubrutinib in patients who are currently in a PR or a PR, which is basically all zanu patients. 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 both drugs.
Great. Thanks.
Yeah, let me add to that as well. In these early days, so I'll differentiate a little bit the goal where Ahmed was headed from the early days. Just as a reminder, a patient coming into the study, as Dr. Hamdy said, is currently on zanubrutinib, and they're in partial remission, meaning their CLL counts, right? They've dropped 50% or more, and then they've plateaued. 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 emavusertib. What we really wanna see, frankly, is that we can take them from plateauing to decreasing their disease burden.
At that point, from a patient's perspective, of course, any decrease is good. We wanna see the disease trending down. 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. 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?
Yes. Thank you very much.
Great.
Just the last question. Are you speaking of commercial partnership for the AML program?
No, not yet. I would say at this point in time, you know, 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. Right now we're focused on generating data in those indications. 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. You know, at some point in time, could a partnership make sense? Absolutely. We have discussions just as every biotech company does.
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.
Thank you very much.
Thank you very much. Appreciate the call.
There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks. Please continue.
Thank you, operator, 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 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?
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.