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

Thanks, and welcome everyone to Curis' business update call for the third quarter of 2026. First, I'd like to invite all of you to visit the Investor section on our website, www.curis.com, where you can locate the press release covering our third quarter 2026 business update along with the related financial tables. I also want to remind everyone that we'll be making forward-looking statements during this call, and those are based on what we currently expect and believe. Such statements carry certain risks and uncertainties, and actual results could differ materially. For more details, 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. A question-and-answer period will also be available at the end of the call. I'd now like to hand the call over to Jim.

Thanks, Diantha. Everyone, good afternoon, and welcome to the Curis call covering our third-quarter business update. I'll start with PCNSL, which is our lead program and our first NHL study. Primary CNS lymphoma is among the rarest NHL subtypes and the toughest to treat, and our TakeAim Lymphoma study continues to advance steadily. As a reminder, TakeAim Lymphoma is a registrational trial testing emavusertib in combination with ibrutinib among patients whose relapsed refractory PCNSL. During this quarter, we shared updated data covering seven BTK-naive patients along with 39 salvage line patients whose disease had progressed while being treated with a BTK inhibitor. Those updated results demonstrate an 86% response rate among BTKi-naive patients, with six of the seven patients responding. To put this in context, it's worth noting that published research on BTK inhibitors in PCNSL has typically reported response rates ranging from 39% to 67%. It's clear that emavusertib combined with a BTKi looks superior to a BTKi by itself. Among salvage-line patients—those whose disease progressed during treatment with a BTK inhibitor—the updated results demonstrate a 26% response rate, with 10 of 39 patients responding to the emavusertib plus BTKi combination after prior progression on BTKi monotherapy; as background, patients who have failed both frontline therapy and a BTKi face a very poor prognosis, and many of them go straight to hospice or best supportive care. It's really encouraging that emavusertib is helping patients alter that story and reverse their disease. Basically, the fresh data from both BTKi-naive and salvage line patients give added proof of meaningful clinical activity and keep supporting the possibility of accelerated approval filings in both the U.S. and Europe. We're eager to finish full enrollment in this registrational study on schedule in 2027. Let's now move to CLL, our second NHL study, which kicked off earlier this year. As you remember, last year we talked with a number of key opinion leaders regarding which NHL subtype to study following PCNSL. They showed interest in our early data spanning several NHL subtypes, and they voiced specific enthusiasm about investigating how emavusertib might fundamentally reshape the frontline treatment approach for CLL patients, whose current standard of care consists of BTK inhibitors. Over the past ten years, BTK inhibitors have emerged as the standard of care in CLL and NHL owing to their capacity to block the BCR pathway and assist patients in achieving objective responses. Even so, such responses generally turn out to be partial rather than complete remission. Consequently, patients receiving a BTK inhibitor ultimately must remain on that therapy chronically for the remainder of their lives. On top of that, since full remission is never reached in these individuals, a large number of them go on to acquire mutations that make their disease resistant to BTKi therapy, and eventually their illness worsens. What we aim to do is improve upon the current standard of care by adding emavusertib to a patient's BTKi treatment, which sets up a dual blockade targeting the two biologic pathways responsible for driving CLL. With this dual blockade—the BTKi shutting down the BCR pathway and emavusertib shutting down the TLR pathway—patients whose cancer has shown only a partial response to a BTK inhibitor may be able to achieve deeper responses from the combination, including the potential to reach complete remission or undetectable disease, as well as the possibility of time-limited treatment. If it works, adding emavusertib to BTKi therapy may fundamentally change how CLL is treated—reducing the chance that a treatment-resistant mutation emerges and improving patients' quality of life overall. To begin testing this idea in CLL, we are running a proof-of-concept trial enrolling people who are currently receiving BTKi monotherapy and who have achieved partial remission but have not reached complete remission or undetectable MRD. Eleven clinical sites are now open for enrollment, 12 patients are on study, and we expect to report initial data later this year. Should the CLL results match what we previously saw in NHL, our expectation is that we'd see early signs of anticancer activity, which might eventually lead to less tumor burden and more substantial objective responses. I'm familiar with our clinicians, and especially with our patients — they're enthusiastic about the potential for emavusertib to boost how well BTK inhibitors work in frontline CLL. In summary, this year we've made meaningful headway in both NHL studies. For PCNSL, our lead NHL program, the updated findings show consistent efficacy and are highly encouraging as we progress toward complete enrollment and a potential first regulatory submission. Regarding CLL, which is our second NHL program, we are still on schedule to share first clinical findings before the year closes — that's only a matter of weeks from now. So with that said, I'll return the call to Diantha for the financial portion. Diantha?

Thanks, Jim. For the third quarter of 2026, Curis posted a net loss of $8.1 million, equal to $1.94 per share, versus a net loss of $7.7 million, or $9.86 per share, during the same period in 2025. Over the nine months ended September 30th, 2026, Curis recorded a net loss of $40.9 million, or $16.77 per share, compared with a net loss of $26.9 million, or $43.82 per share, for the same period in 2025. Research and development expenses came in at $5.6 million for the third quarter of 2026, compared with $6.4 million for the same period in 2025. That decline was mainly due to lower employee-related costs, partly offset by higher clinical costs. For the nine months ended September 30th, 2026, research and development expenses were $18.8 million, compared with $22.4 million for the same period in 2025. General and administrative expenses totaled $3.2 million for the third quarter of 2026, compared with $3.7 million for the same period in 2025. That decrease was primarily driven by lower employee-related costs, partially offset by an increase in legal costs. General and administrative expenses were $11.4 million for the nine months ended September 30th, 2026, compared with $11.2 million for the same period in 2025. As of September 30th, 2026, Curis' cash and cash equivalents stood at $5 million, and the company had roughly 4.1 million shares of common stock outstanding. Under our current operating plan, we believe our existing cash and cash equivalents, together with the financing from October, should allow us to fund our existing operations into 2027. With that, I'd like to open the call for questions. Operator?

Good afternoon, and thank you for taking our questions, and congratulations on all the progress. We have just two. The first is that regarding the 12 patients in the CLL study, for the December data release, how many of them might be available for reporting in terms of having completed a certain number of treatment cycles? Then I have a follow-up.

Okay. First, thank you, Yale, for joining the call. We appreciate it. As you can imagine, those 12 patients came on at very different time points. What we aim to do at this point is report as much data as possible when we release, and that of course means we will have more mature data, patients who have been on drug for three or four cycles, as well as potentially some patients with data in for only a cycle or two. Exactly how many patients fall into which category, of course, we are going to release the data in real time, and we will give as much data as we have. I hope that is helpful.

All right, yes it does. Perhaps a related question as well: regarding the data release, this is really a two-part question. First, which venue might you have to report that in, and second, what the context of the data will be — whether that's safety, perhaps biomarker, perhaps some response rate, or whatever else — or maybe give us a bit of color ahead of time, and thanks.

Sure. On the venue, I'd say stay tuned. My sense is we would anticipate reaching out and making it broadly available regardless of which method we choose for putting that out, so stay tuned, I'd say. The second part concerns what data we are going to have. As I mentioned in the remarks earlier, what we truly hope to see first and foremost is a combination of what has been observed in our other NHL studies and, frankly, what BTK inhibitor studies have demonstrated. We want to see that we have signs of clinical activity. Does it work in CLL the same way it works in other NHL subtypes? We expect that it does, and we want to see data showing that we have activity. If that activity can lead to tumor reduction, of course, or the potential to eventually get there, that would be ideal. How long it takes before tumor reduction is seen remains to be seen, but what we are looking for at this stage of the game is, of course, full stop, whether this drug, whether emavusertib can add efficacy in BTK, with BTK in CLL the same way it does in PCNSL. If that holds true, of course, it is going to be very exciting.

Is that going to be biomarker data, or perhaps further safety data, to confirm it?

There would definitely be some safety data, I believe, though precisely what data we'll present, I'll save that for the presentation. As a reminder, though, I think what has been demonstrated in other BTK studies is evidence of lymphocytosis. Will we observe that? We don't know at this point; those data are being collected, but we will definitely provide an update on whatever we do observe as we approach the end of the year.

All right, that's great. I appreciate it, and I'm looking forward to the data that's coming soon.

Great. Thanks very much.