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

Thanks for joining us for the Curis Third Quarter 2025 Business Update Call. To start, please visit the Investors area of our site, www.curis.com, where you'll find the press release covering our third quarter 2025 business update along with the related financial tables. I also want to note that on this call, forward-looking statements will be made, and those reflect our present expectations and beliefs. Such statements carry certain risks and uncertainties, so actual results could differ materially. For more information, please refer to our SEC filings. 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 at the end of the call. I'd now like to hand the call over to Jim.

Thanks, Diantha. Hello, everyone, and good afternoon. Welcome to the business update call for Curis' third quarter. We keep making consistent headway with our TakeAim Lymphoma trial, which is testing emavusertib alongside ibrutinib in people who have primary CNS lymphoma — among the rarest and hardest-to-treat NHL subtypes. As a reminder, TakeAim Lymphoma is a single-arm trial with an ORR endpoint that adds emavusertib to a patient's BTKi regimen once they have progressed on BTKi monotherapy. Following joint discussions with the FDA and EMA, we anticipate this trial will back accelerated submissions in both the U.S. and Europe. Across the coming 12 to 18 months, our focus will be on enrolling the extra patients required to support those submissions. You may recall that during the prior quarter, we spoke with a number of KOLs who are enthusiastic and strongly in favor of extending our emavusertib studies into further NHL subtypes. They showed particular interest in investigating emavusertib's capacity to radically reshape the treatment paradigm for CLL patients, for whom BTKi monotherapy is the present standard of care. BTK inhibitors became the standard of care in CLL and NHL owing to their capacity to help patients reach objective responses. Yet those responses are usually partial responses rather than complete remission. The predictable outcome is that patients given a BTK inhibitor wind up remaining on it as chronic treatment for the remainder of their lives. Moreover, because patients never reach complete remission, a large share of them acquire BTKi resistant mutations and eventually their disease advances. Here at Curis, our aim is to build on the existing standard of care by adding emavusertib to a patient's BTKi regimen, helping patients reach deeper responses and possibly discontinue treatment, lowering the chance of BTKi resistant mutations arising and enhancing a patient's overall quality of life. Testing this hypothesis in CLL begins with launching a proof-of-concept study in patients presently on BTKi monotherapy who have achieved a PR yet have not been able to achieve complete remission or UMRD. The study protocol has been submitted to the FDA. We're working to activate clinical sites, and we anticipate enrolling our first patient in late Q4 or early Q1, with initial data expected at the ASH Annual Meeting in December 2026. Now let's move to AML. Abstracts for the December ASH meeting came out on Tuesday, among them the abstract for our ongoing AML triplet study, which is assessing the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on aza-ven but remain MRD positive. The data in the abstract cover the first 2 cohorts, patients who received emavusertib for 7 or 14 days in a 28-day cycle in addition to their aza-ven treatment. As of July 2, 2025, 10 patients with a median age of 71 were enrolled, 4 in the 7-day cohort and 6 in the 14-day cohort. When emavusertib was added, 4 out of 8 evaluable patients saw their MRD drop to undetectable levels within 5 to 8 weeks. For those still testing MRD positive, a 40% decrease in MRD was seen in 1 patient, and no one had their disease worsen. In the 14-day cohort, two dose-limiting toxicities appeared — CPK increase and neutropenia — though both were resolved. These first 2 cohorts' initial readout has us very encouraged, and we're excited about what combining emavusertib with aza-ven in frontline AML could mean for helping more patients reach undetectable MRD. We're still investigating various dosing schedules for this triplet combination, and we can't wait to share our progress. As you can see, it's been a highly exciting and productive quarter, with plenty of exciting updates headed our way at the SNO and ASH conferences in the coming weeks. With that, I'll hand the call back to Diantha for the financial update. Diantha?

Thanks, Jim. For the third quarter of 2025, Curis posted a net loss of $7.7 million, which works out to $0.49 per share, versus a net loss of $10.1 million, or $1.70 per share, during the same quarter in 2024. Over the 9 months that ended September 30, 2025, the net loss came to $26.9 million, or $2.19 per share, compared with a net loss of $33.8 million, or $5.77 per share, across the equivalent period in 2024. R&D expenses totaled $6.4 million in the third quarter of 2025, down from $9.7 million a year earlier in the same period. That decline stemmed mainly from reduced costs tied to employees, clinical consulting, research, manufacturing, and facilities. For the 9 months concluded September 30, 2025, R&D expenses reached $22.4 million, versus $29.6 million during the matching period in 2024. G&A expenses came in at $3.7 million for the third quarter of 2025, compared with $3.8 million in the same period of 2024. This reduction was chiefly the result of lower employee-related costs. G&A expenses amounted to $11.2 million for the 9 months finished September 30, 2025, compared with $13.4 million in the corresponding period of 2024. As of September 30, 2025, Curis' cash and cash equivalents stood at $9.1 million, and roughly 12.7 million shares of common stock were outstanding. Given our present operating plan, we expect our current cash and cash equivalents will be sufficient to fund our existing operations into 2026; with that said, I'd like to turn the call over to questions. Operator?

Congratulations on the continued momentum. I wanted to ask about the CLL program. If you have any details to share about the conversations with the FDA and the protocol that was submitted — did you find yourselves largely in agreement when it came to the primary endpoints and the way the study was designed? Whatever level of detail you can offer at this point would be appreciated.

Thanks, Sara. I appreciate the question. I'll kick things off, and then I'll invite Dr. Hamdy to add his thoughts too. We're really enthusiastic about this trial. As you're aware, we ran a dose escalation study in which we evaluated various subtypes within NHL. PCNSL was where our first expansion took place, and CLL is where the second one is headed. Clearly, with CLL, the indication is significantly bigger. And naturally, there's a far broader circle of interest among the KOLs. Ahmed, would you like to go into more depth on the CLL study specifically?

Yes, Sara — Ahmed here. Essentially, what we're aiming to do is tackle the unmet medical need within the CLL community. That really means bringing patients to a time-limited treatment through combining emavusertib with a BTK inhibitor, in patients who are presently on a BTK and who have achieved only a PR while being MRD positive. So — and on this we're aligned with the FDA, and our plan is to run a small dose escalation at 100 milligram, then expand into our 200-milligram Phase II dose.

Also, regarding the Phase II CLL study, could you perhaps describe how large the trial will be and what kind of delta in the CR rate you're aiming for? Then the second thing is, how are you approaching resource prioritization right now, particularly when you consider what might be needed to advance the CLL study as opposed to the frontline AML study?

Sure. So once more, perhaps I should begin with CLL, then I'll invite Dr. Hamdy to provide a bit more detail, and after that maybe have Diantha discuss resources somewhat. So first, regarding CLL, what we're expecting for a study design right now is something that anticipates 40 patients; but naturally, as was seen in PCNSL, the unmet need is so evident that we're hoping a signal can be observed well before reaching that number. As a reminder, CLL patients receiving BTKi monotherapy get PRs. CRs are not what they get. And MRD is certainly not something they're getting either. So in that population, what we're seeking to do is show simply that through adding emavusertib, through blocking both pathways, not merely one, but both pathways that are driving disease, we can ultimately see deeper responses; meaning deeper PRs, and we hope CRs and MRD will also be seen. Ahmed, would you like to add a little more on that?

Jim, I believe you covered everything. The entire idea here is that with BTK, you don't observe CRs. And clearly, you don't observe MRD negative either. So, bringing patients to a CR — and I believe anything above 20% would be really thrilling. But clearly, we'll need to hold off until we observe a treatment effect in our trial and then plan in line with that. Still, we're quite optimistic that blocking both the TLR pathway and the BCR pathway would produce a far more significant impact on NF-kappaB, and as a result, bring patients to a deeper response in MRD negative.

Absolutely, and thanks. Diantha, could you take a moment to walk us through the resources?