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

Thanks for joining us for the Curis Q4 2025 business update call, and welcome. To start, please visit the investors section on www.curis.com, where you can locate our Q4 2025 business update, the press release, and the associated financial tables. Also, a reminder that forward-looking statements will be made on this call, and those are grounded in what we currently expect and believe. Such statements carry certain risks and uncertainties, and actual results could differ materially; for more information, please refer to our SEC filings. With me on today's call are Jim Dentzer, our President and Chief Executive Officer, Dr. Jonathan Zung, our Chief Development Officer, and Dr. Ahmed Hamdy, our Chief Medical Officer; a question and answer period will also be held at the end of the call. I'd now like to hand things over to Jim.

Thanks, Diantha. Good afternoon, everybody, and thanks for joining Curis's Q4 business update call. Within primary CNS lymphoma — one of the rarest and hardest-to-treat NHL subtypes — our Take Aim Lymphoma study keeps moving forward steadily. Just to remind you, Take Aim Lymphoma is a single-arm registrational trial using an ORR endpoint, and it's testing emavusertib plus ibrutinib in patients whose disease has progressed following BTKI therapy. Following joint discussions with FDA and EMA, we anticipate this study will back accelerated filings in both the U.S. and Europe. Enrollment in this registrational trial continues to go well, and we're grateful for the continued backing of our clinical investigators, key opinion leaders, and regulatory authorities. As you'll remember, during the prior quarter we spoke with a number of KOLs, and they were enthusiastic and strongly in favor of broadening our emavusertib studies into other NHL subtypes. Their particular interest was in exploring whether emavusertib could fundamentally reshape the treatment paradigm for CLL patients, for whom BTKI is the current standard of care. For the past 10 years, BTK inhibitors have served as the standard of care in CLL and NHL, thanks to their capacity to help patients attain objective responses; even so, those responses tend to be partial rather than complete remission. Consequently, patients on a BTK inhibitor wind up remaining on that therapy chronically for the remainder of their lives. On top of that, since complete remission is never reached, a large share of these patients go on to develop BTKI-resistant mutations, and eventually their disease advances. Our aim is to do better than the current standard of care by putting emavusertib into a patient's BTKI regimen, which applies a dual blockade against the two biologic pathways that drive CLL; for patients whose NHL subtype only partially responds to a BTK inhibitor, this dual blockade may allow deeper responses from the combination, including the possibility of complete remission or undetectable disease along with the potential for time-limited treatment. Should we succeed, putting emavusertib together with BTKI could reshape the CLL treatment paradigm, lowering the risk that a treatment-resistant mutation emerges and enhancing a patient's overall quality of life. Testing this hypothesis in CLL begins with our proof of concept study in patients presently receiving BTKI monotherapy who have reached partial remission yet haven't been able to reach complete remission or undetectable MRD; we've started activating clinical sites across the U.S. and Europe and anticipate initial data at the ASH annual meeting in December; from there, let's move on to AML. At December's ASH meeting, we shared data from our ongoing AML triplet study, which tests the triple combination of emavusertib with azacitidine and venetoclax in AML patients who reached complete remission on aza-ven but are still MRD positive; those data covered the first two cohorts, in which patients got emavusertib for either 7 or 14 days within a 28-day cycle. Along with their azacitidine and venetoclax treatment. Looking at this trial, MRD conversion was achieved by 5 out of 8 evaluable patients — meaning they went from being MRD positive to having disease that was undetectable. These early results have us quite optimistic, and we're enthusiastic about what combining emavusertib with azacitidine and venetoclax could offer. It was, as you can tell, a highly productive quarter for us, and naturally we're eager for what should be a thrilling 2026, with our registrational study in PCNSL moving ahead and our proof of concept study in CLL getting underway. Having said that, I'll now hand things over to Diantha for the financial update.

Thanks, Jim. For the fourth quarter of 2025, Curis posted net income of $19.4 million, which works out to $1.23 per share, compared with a net loss of $9.6 million, or $1.25 per share, during the same quarter in 2024. That net income for Q4 2025 stems from a one-time, non-cash gain of $27.2 million tied to our divestiture of Erivedge to Oberland. For the full year that closed on December 31, 2025, Curis recorded a net loss of $7.6 million, or $0.58 per share, versus a net loss of $43.4 million, or $6.88 per share, for the equivalent period in 2024. R&D spending came to $5.8 million in Q4 of 2025, down from $9 million in the same quarter of 2024. That decline largely reflects reduced manufacturing, employee-related, and clinical costs. For the year ended December 31, 2025, research and development expenses totaled $28.3 million, compared with $38.6 million in the comparable period of 2024. G&A expenses were $2.9 million in Q4 of 2025, versus $3.4 million a year earlier in the same period. The drop mainly came from lower employee-related costs. For the year ended December 31, 2025, general and administrative expenses reached $14 million, compared with $16.8 million for the same period in 2024. Curis' cash and cash equivalents at December 31, 2025, plus the initial gross proceeds of $20.2 million we received in January 2026, and anticipated gross proceeds of as much as an additional $20.2 million from exercising the January 2026 PIPE financing Series B warrants upon the public announcement of dosing of the fifth CLL patient in our Take Aim CLL study, which we expect later this year, ought to fund our planned operations into the second half of 2027. With that, I'd like to open the call for questions. Operator?

Hey everyone. We really appreciate you answering our question, and nice work on the advancement. I just want to ask one brief thing about your approach to ranking priorities — specifically how the pivotal PCNSL study stacks up against CLL and AML?

Absolutely. Appreciate the question and thanks for joining the call. You can probably guess that we put a lot of thought into how our resources get prioritized. Fortunately, that January financing gives us a really strong path forward, but even so, we continue to rank our resources so that our spending stays as lean as possible. That being said, NHL clearly comes before AML for us. At present, naturally, we have a strategy with two arms, where we're moving very hard on PCNSL. That happens to be among the rarest and smallest of the NHL subtypes, plus CLL, which is undeniably the biggest one. PCNSL, naturally, is intended for registrational approval, and we're proceeding, you know, quite firmly on schedule with it. Regarding CLL, that trial has only just begun. On the spending side, I'd say the majority of our money goes toward PCNSL. During these initial days, CLL is naturally a lot smaller, though I expect that as time passes, it will grow. My hope is that when we reach the close of the year, we'll have achieved meaningful headway toward a registrational data set in PCNSL and hopefully will have a bit of early data, our first look at CLL. Those two are obviously our top priorities. Once we can bring in additional cash and launch more work, I believe that's the point where we begin examining AML. At this moment, I think most of the AML effort involves evaluating which moves we'd like to make once we have greater resources and which ones make the most sense, and ensuring that from an operational standpoint our attention stays on PCNSL and CLL.

All right, that's great, and I really appreciate it.

Does that answer your question?

Yep.

Oh, good.

Thanks, that's great. I really appreciate you taking the questions. I've got two. First one's about PCNSL. You mentioned enrollment is on track — is there anything you can share at this point? And then I'll follow up.

Absolutely. Beyond confirming that things are proceeding as we've indicated, we've been avoiding sharing enrollment numbers for PCNSL. Everybody understands how hard it is to find these patients. We typically identify one or two per month, though it's quite uneven. Some months, none at all show up, and then the following month brings three. At this point, patients are being enrolled, and as far as margins go, my sense is that things are proceeding as intended. Assuming we've got that right — you know, I've mentioned before that we sit somewhere between twelve and eighteen months away from completing enrollment; that would put us at full enrollment with the possibility that, following six months of tracking patients and filing, we'd land somewhere in the 2027 timeframe. It's quite possible that by year-end we'll be very near that full enrollment figure, and we'll have some solid data to discuss. Ahead of those, I don't anticipate having much at all to share. Is that clear?

Okay, great.

Yeah.

Yeah, that's pretty logical. Perhaps a brief question regarding how we should model the coming years — since you've got that $27 million in non-cash items plus lower revenue in Q4 of last year, ought we assume there won't be any significant revenue for 2026 and possibly afterward, until your product approval and other things come through? Thanks.

Yeah. Thanks, Yale. Actually, I'll have Diantha address that one.

Yes. Yale, you've got that right — there won't be any revenue that matters. Basically, that revenue came to a close in November 2025. On the cash flow side, keep in mind that before we handed Oberland the leftover 15%, we had already sold them the royalty — the entitlement to roughly 85% of those royalties. So when you look at cash flow, that leftover 15% of the cash flows now belongs to Oberland; we won't see any revenue, nor that remaining 15% of cash flows, though you know, the effect on cash flows isn't significant.

Right. The item you noticed in the release essentially represents the non-cash termination of that arrangement. Over the past 2 years, it was a quite minor revenue source tied to Erivedge, and we simply disposed of whatever was left to Oberland in order to tidy everything up. At this point we are fully—

Okay, great.