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

Thanks for joining us for Curis' Second Quarter 2025 Business Update Call. To start, we'd ask that all of you visit the Investor portion of our site, www.curis.com, where you'll find the press release covering our second quarter 2025 business update along with the accompanying financial tables. Also, a reminder that forward-looking statements will be made on this call. Those are grounded in what we currently expect and believe, they carry certain risks and uncertainties, and actual results 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; Jonathan Zung, our Chief Development Officer; and Dr. Ahmed Hamdy, our Chief Medical Officer. There will also be a question-and-answer period once our call concludes. I'll hand things over now to Jim.

Thanks, Diantha. Good morning to all of you, and thanks for joining Curis' call covering our second quarter business update; steady forward movement continues in our TakeAim Lymphoma trial, where we're studying emavusertib given together with ibrutinib in PCNSL patients. Let me remind you that TakeAim Lymphoma uses a single-arm design with an ORR endpoint, layering emavusertib onto a patient's BTKi regimen once they've progressed straight through BTKi monotherapy. Following joint talks with FDA and EMA, our expectation is that this trial will back accelerated filings across both the U.S. and Europe. During the coming 12 to 18 months, our focus will be on bringing in 30 to 40 more patients, the number required for the NDA and EMA submissions. We were at both ASCO and EHA in June, where we got to speak with quite a few KOLs, and they stay enthusiastic and supportive regarding moving emavusertib into further indications in CLL and NHL. What intrigued them most was exploring whether emavusertib could truly reshape the treatment paradigm for CLL and NHL patients who currently receive BTKi monotherapy. BTKi inhibitors became standard of care in CLL and NHL thanks to delivering a solid overall response rate. Yet those patients on BTKi generally get partial responses rather than complete remission. Not surprisingly, patients given a BTK inhibitor wind up remaining on it as lifelong chronic treatment. And since complete remission is never reached, a large share of these patients acquire BTKi resistant mutations and eventually progress; our aim is to better the current standard of care by combining emavusertib with a BTK inhibitor, letting patients reach deeper responses and possibly discontinue treatment, which lowers the chance of BTKi resistant mutations emerging and enhances a patient's quality of life. Testing this hypothesis begins with launching a proof-of-concept study in roughly 20 to 30 patients who have relapsed/refractory CLL and are presently responding to their BTK inhibitor, yet cannot reach complete remission or MRD negativity; the design for this study is finished, and we're aiming for first patient in by year-end plus initial data in mid-2026. Now let's shift to AML. You may remember that Dr. Eric Winer of Dana-Farber presented, at the ASH conference in December, 21 relapsed/refractory AML patients carrying a FLT3 mutation; those data demonstrated a 38% composite CR rate in the salvage line setting, with 10 objective responses among 19 patients, and 7 of those 10 responses seen at the first assessment. For context, gilteritinib, the top FLT3 inhibitor in relapsed/refractory AML, won approval with a composite CR rate of 21% in a patient population where just 13% had prior treatment with a FLT3 inhibitor. In the emavusertib study, more than 80% of patients had prior treatment with a FLT3 inhibitor. Our view is that emavusertib's data are so compelling because of its novel mechanism of action, blocking IRAK4 as well as FLT3. Looking ahead for emavusertib in AML, the upcoming move is to run a registrational trial pitting emavusertib against gilteritinib among patients who are relapsed or refractory. We're equally enthusiastic about what emavusertib might do in high-risk MDS. Back in June, word came out that the VERONA trial, which examined pairing venetoclax with azacitidine, did not hit its primary endpoint. That development sparked considerable conversation at medical conferences and made people more eager to explore combining azacitidine with emavusertib. We've observed emavusertib working as a monotherapy in hrMDS, and our belief is that teaming emavusertib with azacitidine could tackle an obvious unmet need and deliver a strong new option for MDS patients. Last, I want to share where things stand with our triplet trial in frontline AML. To recap, we launched a Phase I trial during the prior year examining emavusertib as an add-on to venetoclax plus azacitidine in frontline AML. Right now we are assessing various dosing schedules for emavusertib, venetoclax and azacitidine. So far, enrollment has wrapped up for both the 7-day and 14-day emavusertib dosing schedules within a 28-day triplet cycle, and we're eager to share how this trial is going at the ASH conference in December. As is clear, this was a highly exciting and productive quarter for us, and we anticipate offering further updates as the year moves along. With that, I'll hand the call back to Diantha for the financial update. Diantha?

Thanks, Jim. For the second quarter of 2025, Curis posted a net loss of $8.6 million, which works out to $0.68 per share, versus a net loss of $11.8 million, or $2.03 per share, during the same period in 2024. R&D expenses came in at $7.5 million in the second quarter of 2025, compared with $10.3 million in the same period of 2024. That decline was mainly driven by reduced employee-related costs along with research, consulting and clinical costs. For the 6 months ended June 30, 2025, research and development expenses totaled $16 million, versus $19.9 million in the same period of 2024. G&A expenses were $3.5 million in the second quarter of 2025, compared with $4.8 million in the same period of 2024. That reduction largely reflected lower employee-related and legal costs. For the 6 months ended June 30, 2025, general and administrative expenses reached $7.5 million, compared with $9.7 million in the same period of 2024; during July, we closed a registered direct offering and concurrent private placement, generating net proceeds of approximately $6 million. As of June 30, 2025, Curis' cash and cash equivalents stood at $10.1 million, and roughly 10.7 million shares of common stock were outstanding. On the basis of our current operating plan, we expect that our $10.1 million of existing cash and cash equivalents as of June 30, combined with the proceeds from the July 2025 offerings, should allow us to fund our existing operations into the first quarter of 2026. With that, I'd like to open the call for questions. Operator?

I suppose I have a few things to ask regarding the BTK combination trial in CLL. Where do you expect the bar to be set? And given how the CLL landscape keeps shifting, with BTK degraders and next-gen BCL2 inhibitors in play, how do you see yourselves fitting in? Then my second question concerns the AML triplet data expected later this year — it would help if you could lay out what we should expect.

Li, thanks for asking. We really appreciate it. Ahmed, you are probably in the best position to address the CLL study.

Okay, so when it comes to BTK inhibitors, as Jim mentioned, what you typically see is partial responses, and patients end up taking that medication on a chronic, lifelong basis, which brings risks of mutations and toxicities. Our thinking is that if emavusertib is added to a BTK inhibitor that's commercially available, you could get MRD-negative remissions or complete remissions. That in turn would allow for treatment that's time-limited, and honestly that's what everyone is aiming for in CLL at this point, given the unmet medical need. Now regarding degraders, those are still being developed. There appear to be some responses that are short-lived, and none have received approval so far, but our plan is to combine them with BTKi inhibitors that are commercially available; does that address what you were asking, Li?

Right. Let me jump in on that too, Li, picking up where Ahmed stopped regarding degraders. It makes no difference to us whether you degrade BTK or inhibit it. You're blocking the BCR pathway either way. Our compound blocks the other pathway — the Toll-Like Receptor pathway. So any approach that takes down BTK is fine, combine it with ours, and results ought to improve. On BCL2, the question is reasonable. There are many indications, or many drugs, being developed in CLL, since it's such a large indication; and my expectation is that, just like now, plenty of different competitors will find room. Still, we have strong confidence that today's standard of care, BTKi, improves only when ema is added, and it may be able to deliver a regimen that is safe and tolerable, one that could let patients move to time-limited treatment; we find that quite compelling. And clearly, the investigators agree. We'll have to wait for the data to see, but right now, I'd say we're quite excited; regarding the AML triplet, Jonathan, Dr. Zung, could you perhaps address that?

Correct — so what we intend to do is share the efficacy and safety findings from the 7-day and 14-day cohorts at the ASH conference toward the end of this year.

Yeah. And clearly, Li, those abstracts have to get accepted. That said, I'd say our confidence is fairly high when it comes to our capacity to share data at that conference. So that's all I'll say on it, and I'm looking forward to discussing it then.

I wanted to ask about the TakeAim Lymphoma trial and how accrual will move forward across the coming 12 to 18 months. Could you share any detail on how that accrual is proceeding among those next 30 to 40 target patients — whether additional sites still need to open, or whether it's moving along about as anticipated?

Of course. It's proceeding the way we anticipated — steady — though this is an ultra-rare population. As you're aware, more than 30 sites are now open. Our stated expectation previously, and we keep stating it, is that each clinical site should be able to enroll 1 patient per calendar year; for instance, we'll phone Sloan Kettering and request a single patient during 2025. Certain sites may enroll more, while others do so at a lower frequency. That's simply what occurs in an ultra-rare indication, and it's the reason we have more than 30 sites. So I'd characterize it as on track, and we're very eager to gather those data and hold a productive conversation with FDA and EMA.

Congratulations on the advancement. I've got a handful of questions. The initial one concerns PCNSL. Regarding the upcoming data update, ought we to anticipate patient count or mature data?

Right. We've not yet provided any direction on what that next update will hold, beyond the obvious fact that the next suitable conference would naturally be ASH; however, what we're telling people is that whatever data exists when that time comes is what we'll show. Enrollment therefore keeps going. Data collection keeps going, and whatever we've got is what we'll present. And like I said, what we've observed up to now is fairly compelling. My hope is that going forward, the data will keep demonstrating that same point — that we possess a clearly effective drug for patients who are naive or for those whose prior BTK therapy failed. So, I'd suggest keeping an eye out.

Right; and do you have any plans to bring more clinical sites on board?

That doesn't seem necessary to me. As things stand, the quantity of sites we currently have works well for us, and enrollment is proceeding as expected. So our confidence level is fairly high. Of course, fresh from the medical conferences, we've had numerous excellent conversations and plenty of enthusiasm from the KOLs. Still, I would say as of now, adding more sites isn't required in order to remain on schedule.

And for the CLL program, one final question. So what line of therapy do you expect most patients to be in — which one are you intending to enroll? Is your assumption that every one of them will have had a BTKi already?

Yes. In fact, Ahmed, would you like to address that?

Absolutely. So it could be used in any treatment line, as long as those individuals are receiving a BTK inhibitor that's commercially available; that means it may be in second line, or it may be people who've taken a BTK and haven't gotten to a complete remission or MRD negativity.

Right, and as a quick note, Danya, when you look at the prescribing information for ibrutinib—or for acalabrutinib too, for that matter—the CR rate shown for those patients is exactly 0. Now, at some point, obviously, many trials are going to exist, and a few patients might be able to reach CR, but the bigger takeaway is that this happens very seldom. What we hope we can accomplish is to reproduce what has been observed in AML as well as in primary CNS lymphoma. That means the agent pairs well with other therapies. Given its novel mechanism, we ought to be able to repeat what has been observed in PCNSL, which is that complete responses can be achieved. And if we are able to deepen those responses and give patients the chance to move to a time-limited treatment, then I believe we truly transform how they can be managed, and it provides a genuinely exciting alternative for them.

Anna here, filling in for Kripa. We have two things to ask. With what's been going on at the FDA, could you say whether any of it has affected your PCNSL accelerated approval plans? And have talks with the FDA been ongoing? Then second, when it comes to the cash runway, is there anything new on BD efforts or similar? And are there any wider trends, oncology especially, that could have a read-through to Curis?

Absolutely. Thanks, Anna. We appreciate those questions. Jonathan, do you want to address the FDA?

Absolutely, Jim. Anna, as far as the agency situation goes, right now there's been no shift at all in where we stand. We held meetings with them during last year, we've got agreement on the main activities together with them, and we are carrying those out.