Curis, Inc. (CRIS) Earnings Call Transcript & Summary

Thanks for joining us. This is the Curis business update call for the first quarter of 2026. To start, please visit the investor section on our site, www.curis.com, where the press release covering our first quarter 2026 business update and the accompanying financial tables can be found. Also, a reminder that forward-looking statements will be made on this call, and those reflect what we currently expect and believe. Certain risks and uncertainties apply to these statements. Results in reality could differ materially. For more on that, please refer to our SEC filings. On the call with me today are Jim Dentzer, our President and Chief Executive Officer, Dr. Jonathan Zung, our Chief Development Officer, and Dr. Ahmed Hamdy, our Chief Medical Officer. There will also be a question-and-answer period once the call ends. Jim, I'll hand it over to you now.

Thanks, Diantha. Hello, everybody, and thanks for joining our call covering business updates for the first quarter. Within our Take Aim Lymphoma trial, we keep achieving consistent forward movement in primary CNS lymphoma, which ranks among the rarest and hardest-to-treat NHL subtypes. Let me remind you that Take Aim Lymphoma is a registrational, single-arm trial using an ORR endpoint, and it's assessing emavusertib together with ibrutinib following disease progression on BTKI therapy. Following joint conversations with the FDA and EMA, we believe this trial will back accelerated filings across both the U.S. and Europe; we're expecting to share refreshed emavusertib clinical results from the Take Aim Lymphoma combination trial pairing the drug with ibrutinib in relapsed refractory PCNSL patients during the first half of 2027. Enrollment in this registrational trial keeps advancing nicely, and we're grateful for the continued backing from our clinical investigators, key opinion leaders, and regulatory authorities. You'll remember that during the past year we spoke with numerous key opinion leaders who felt enthusiastic and strongly supportive about broadening our emavusertib trials into further NHL subtypes. They showed particular enthusiasm for investigating whether emavusertib might radically alter the treatment paradigm for CLL patients, for whom BTK inhibitors represent the present standard of care. Throughout the prior 10 years, BTK inhibitors became the standard of care in CLL and NHL owing to their capacity to help patients attain objective responses. Even so, such responses generally amount to partial responses rather than complete remission. Consequently, patients given a BTK inhibitor wind up remaining on that therapy chronically for the remainder of their lives. Furthermore, since complete remission is never reached, a large share of these patients acquire mutations conferring BTKI resistance, and eventually their disease advances. Our aim is to enhance the existing standard of care by introducing emavusertib into a patient's BTKI regimen, delivering a dual blockade against the two biologic pathways that propel CLL; this dual blockade may allow patients whose NHL subtype only partially responds to a BTK inhibitor to reach deeper responses through the combination, encompassing the capacity to attain complete remission or undetectable disease along with the prospect of time-limited treatment. Should we succeed, incorporating emavusertib into BTKI therapy might transform the treatment paradigm in CLL, lowering the danger of acquiring a treatment-resisting mutation and enhancing a patient's overall quality of life. Testing this hypothesis in CLL begins with our proof-of-concept trial enrolling patients presently receiving BTKI monotherapy who have reached partial remission yet could not reach complete remission or undetectable MRD. We expect to dose the first 5 patients in the Take Aim CLL combination trial with zanubrutinib by the middle of 2026, and initial data should arrive in December. Back in January, a collaborator of ours, Dr. Patrick Grierson from the Siteman Cancer Center at Washington University in St. Louis, delivered a poster featuring early clinical data in gastric and esophageal cancer at the ASCO GI Cancers Symposium. For this trial, individuals receive emavusertib alongside FOLFOX and anti-PD-1, with or without Herceptin, given as frontline treatment for gastroesophageal cancers that are metastatic or unresectable. Early findings covered 16 patients who could be evaluated, showing a toxicity profile that can be managed along with preliminary results that are encouraging. As you can see, the quarter was highly productive, and we're eager for an exciting 2026 as we move forward our registrational study in PCNSL and our proof of concept study in CLL; with that, I'll hand the call back to Diantha for the financial update. Diantha?

Thanks, Jim. For the first quarter of 2026, Curis posted a net loss of $24.2 million, which works out to $1.25 per share, versus a net loss of $10.6 million, or $1.25 per share, during the same quarter in 2025. That larger net loss stemmed mainly from a shift in the fair value of warrant liabilities tied to the January 2026 PIPE financing. Research and development expenses came in at $6.4 million for Q1 2026, compared with $8.5 million in the equivalent 2025 period. This decline largely reflected reduced employee-related and manufacturing costs. General and administrative expenses totaled $5.1 million in the first quarter of 2026, versus $4.0 million a year earlier. That rise was mostly driven by costs connected to the January 2026 PIPE financing, partly offset by lower employee related costs. As of March 31st, 2026, Curis held cash and cash equivalents of $15 million, and when combined with anticipated gross proceeds of up to an additional $20.2 million from exercise of the January 2026 PIPE financing Series B warrants, which would follow the public announcement of dosing the fifth CLL patient in our Take Aim CLL study, expected later this year, this should fund the company's planned operations into the second half of 2027. With that, I'd like to open the call for questions. Operator?

Hello, and good afternoon. I appreciate you taking my question. About the CLL trial, your guidance was that dosing of the initial 5 patients would be announced by the middle of the year. I wanted to ask whether you can tell us, as of right now, the number of patients dosed to date, and perhaps some detail on how quickly sites are currently being activated and enrollment is proceeding. Thank you.

Of course. Thanks, Sara. I appreciate that question, and I appreciate you joining the call. Yeah, we're trying to move away from that approach as things stand. 5 is already a fairly small figure; we're going to attempt to step away from updating on each individual patient. As I'd put it, we clearly have a great deal of confidence that we're reaching our goal as planned. Both the work of getting our sites operational and our patients consented into the study is proceeding on schedule, and we look forward to giving an update in midsummer.

Okay. Thank you.

Sure. Thank you.

Hello, and I appreciate your time for these questions. Regarding PCNSL, you said there would be news during the first half of 2027. I'm curious whether that involves the data itself, just where enrollment stands, or some other detail? Thanks.

Certainly. Hello, Yale. Thanks again for joining the call, and I appreciate the question. About PCNSL, yes, you've got it right. What we've communicated is that we anticipate being able—or at least we hope to be able—to reach full enrollment in that trial during 2027. Our hope is that a meaningful enrollment update could come in the first half of 2027. At this moment, naturally, that's still quite far off. As we learn more throughout the year, we'll keep sharing updates. At this point, I'd describe us as cautiously optimistic. Things are proceeding as planned, and we look forward to addressing this when that time arrives.

Perhaps I could just ask a quick follow-up on that point. Regarding how enrollment is going right now, I realize it's quite uneven, but on the whole, would you say things are matching what you expected, or are they either stronger or weaker, or at least as things stand today? Thanks.

No, I appreciate that. No, we're on schedule. That's exactly correct. Of course, this is among the challenges you face when you're working on a drug in an ultra-orphan space. Honestly, there simply aren't many of those patients out there. Just like before, we'll have stretches of some months with zero patients, followed by months in which two or three come in. You know, in any particular month, calling it uneven is precisely right. When we zoom out and ask ourselves, not month by month, whether we're on schedule to reach our enrollment targets in time for a disclosure, first half of 2027? I'd say yes. Over time, we keep observing the same sort of performance that we've had. As I mentioned, enthusiasm remains very strong, and we look forward to giving that update with the full data set in 2027. Stay tuned.

All right.

As we move through the year, we're going to give you updated guidance along the way. That's a great question.

Alright, that's excellent. Many thanks. Once more, congratulations on how far things have come.

I really appreciate that. Thanks so much.

Hello, Anna here, filling in for Kripa. We really appreciate you answering our question. There are just a couple of things we wanted to ask about CLL. From what I understand, you said you are looking at 2 dose levels partly in order to meet Project Optimus requirements, and while I realize the sample is limited, should we expect any notable variation in the safety profile when emavusertib is being combined with these regimens? Regarding the standard of care for CLL, could you also walk us through how you are setting yourselves apart there? Thank you.

Sure. I'll handle the first portion, then I'll turn it over to Ahmed for CLL. On that first item, the answer is yes — during our conversations with FDA and EMA, they made it very clear that data from both 100 and 200 must be included in what we submit, and naturally that is what we will do. My expectation is that there won't be much of a safety question distinguishing 100 from 200. As you probably recall, we have given emavusertib at doses up to 500 mg. At either level, I believe the safety profile ought to be manageable. What it comes down to is this: we already know the dose works at 100 and at 200, and we simply have to convince ourselves that 200 is the optimal starting dose for patients, and that from a safety standpoint they can go up or come down as circumstances require. Perhaps to focus specifically on CLL, I'll have Dr. Hamdy weigh in. Ahmed?

Absolutely, and I appreciate you asking. From my perspective, CLL is a case where BTK inhibitors and BCL2 inhibitors have genuinely helped a lot of people, but the difficulty is that treatment has to keep going on a chronic basis for very long stretches. That opens the door to resistance and mutations, plus side effects such as cardiovascular issues, bleeding, and suppression of the bone marrow — and that last one is truly among the toughest challenges for those living with CLL. What we're aiming for, the unmet need in CLL right now, is to get patients into a remission where they no longer need treatment. If you examine where things stand today in CLL, the majority of patients don't reach a CR or MRD negativity that would let them halt therapy when a single agent is used. Essentially, BTK inhibitors act by blocking the BCR signaling pathway, and that in turn blocks NF-κB, which is what drives this disease. Since those individuals aren't arriving at a CR or MRD negative state, a substantial amount of preclinical research from well-known key opinion leaders shows there's constitutive activation of NF-κB occurring through the TLR pathway, and emavusertib is what inhibits that. The idea behind pairing emavusertib with a BTK inhibitor is that it might produce deeper suppression of NF-κB, and so ideally we'd observe more CRs compared with a single agent or with a BTK inhibitor by itself. In our view, this combination could truly change things for those patients. As you're aware, the field has also been attempting to pair BTK inhibitors with BCL2 inhibitors and anti-CD20 agents, and while a number of those regimens yield a higher rate of CR and MRD, they bring along a heavy toxicity burden, particularly involving the bone marrow, with infections and similar problems. My hope is that we look quite distinct from the current landscape, and as our programs have shown, we combined with ibrutinib across many patients and observed no added toxicities or bone marrow suppression. We believe this could represent a genuine paradigm shift for treating CLL in a combination approach, by inhibiting two nodes within the primary pathway that activates the disease. I hope that answers it.