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

Thanks for joining us for the Curis business update covering the first quarter of 2025. To start, please visit the investor portion of our site, www.curis.com, where you can access the press release for our first quarter 2025 business update along with the accompanying financial tables. I also want to note that throughout this call, forward-looking statements will be made, and those reflect what we currently expect and believe; they carry certain risks and uncertainties, and actual results could differ materially. For more information, 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, who joins us today as our new Chief Medical Officer. A question-and-answer period will also take place at the end of the call. I'll now hand the call over to Jim.

Appreciate that, Diantha. Hello, everybody, and glad to have you join Curis' business update call for the first quarter. To kick off this quarter's call, I want to extend a welcome to Dr. Ahmed Hamdy, who has joined the Curis executive team. Dr. Hamdy is a highly regarded and well-known figure in the industry, and he comes to us with a wealth of experience, having served as CMO of Pharmacyclics, as Founder and CMO of Ascerta, and as Founder and CEO of Vincerx Pharma. Ahmed, we're glad to have you.

Jim, thanks so much. Being here is truly a privilege. At such a pivotal moment, it's thrilling to come aboard the Curis team and help push emavusertib forward to regulatory submissions for primary CNS lymphoma across both the U.S. and Europe. Beyond primary CNS, I'm eager to grow its application into other indications, including NHL, AML, and solid tumors. Having worked with ibrutinib as well as acalabrutinib, I hold a particular appreciation for what emavusertib could achieve when paired with BTK inhibition in NHL. I can't wait to collaborate with everyone at Curis and deliver novel therapies to patients.

Thank you, Ahmed. Beyond bringing Dr. Hamdy on board to reinforce our leadership group, we're also seeing consistent advancement with the TakeAim Lymphoma Study, where emavusertib is being assessed alongside ibrutinib in patients with PCNSL. Just to recap, Take Aim Lymphoma is a single-arm trial using an ORR endpoint among PCNSL patients whose disease has worsened following BTKI therapy. Following joint conversations with the FDA and EMA during the past year, we anticipate this study will back accelerated filings across both the U.S. and Europe. Based on the latest cutoff of January 2nd, 2025, a total of 27 relapsed refractory PCNSL patients have received the emavusertib plus ibrutinib regimen — seven of them BTKI naive and 20 previously exposed to BTKI. Out of 13 among those 20 BTKI-experienced individuals with available tumor burden change data, nine showed shrinkage in tumor burden, comprising six subjective responses, two partial responses, and four complete responses — with three of those four CRs persisting beyond six months, and a single patient remaining in complete remission for nearly two years and continuing on the study. For six of the seven BTKI-naive patients with tumor burden change data available, five exhibited a reduction in tumor burden, which included five objective responses, four partial responses, and one complete response. We anticipate sharing more TakeAim Lymphoma findings at ASH toward the end of this year. Furthermore, during the coming 12 to 18 months, our focus will be on enrolling the 30% to 40% additional patients required for the NDA filing, and we hope to observe six to eight responses within that dataset. Now, moving to AML. As you may remember, at December's ASH conference, Dr. Eric Weiner of Dana-Farber shared results on 21 FLT3-mutant patients who had undergone fewer than 3 prior lines of therapy and were given emavusertib as a monotherapy at the RP2D of 300 mg b.i.d. Those findings reveal a 38% composite CR rate in the salvage setting, with 10 objective responses among 19 response-available patients and seven of those 10 responses seen at the initial assessment. To frame this properly, gilteritinib — the foremost FLT3 inhibitor for relapsed/refractory AML — gained approval on a composite CR rate of 21% in a population where just 13% had prior FLT3 inhibitor exposure. In the emavusertib trial, more than 80% of patients had previously received a FLT3 inhibitor. Our view is that what makes the emavusertib results so striking is its novel mechanism of action, targeting both IRAK4 and FLT3. The literature has proposed for several years that IRAK4 blockade may help patients get past adaptive resistance to FLT3 inhibition, and these clinical findings plainly validate that hypothesis. Lastly, I want to update you on where we stand with the triplet study in frontline AML. Just to recap, we started a phase I trial in the prior year examining emavusertib when used as an add-on to venetoclax plus azacitidine for patients facing frontline AML. The purpose of this trial is to evaluate safety and tolerability when emavusertib is combined with a patient's ven/aza treatment using 7-day, 14-day, and 21-day dosing schedules, given after those patients have reached a CR on ven/aza yet continue to test positive for minimal residual disease. The 7-day dosing group has been finished successfully, and right now we are actively enrolling the 14-day group. As you can tell, it has been a highly encouraging and busy quarter for us. We're eager to share further updates as the year moves along. Having said that, I'll hand the call over to Diantha for the financial portion. Diantha?

Thanks, Jim. For the first quarter of 2025, Curis posted a net loss of $10.6 million, which works out to $1.25 per share. That compares with a net loss of $11.9 million, or $2.05 per share, during the same quarter in 2024. R&D expenses came to $8.5 million in the first quarter of 2025, versus $9.6 million a year earlier in the same period. The drop was mostly due to lower costs tied to employees. G&A expenses reached $4.0 million in the first quarter of 2025, compared with $4.9 million for the same period in 2024. That decrease largely stemmed from reduced employee-related costs as well as lower professional, legal, and consulting costs. During March, we closed a registered direct financing alongside a concurrent private placement, generating net proceeds of roughly $8.8 million. As of March 31st, 2025, Curis' cash and cash equivalents came to $20.3 million, and roughly 10.5 million shares of common stock are currently outstanding. Curis anticipates that its current cash and cash equivalents will support its planned operations into the fourth quarter of 2025. With that, I'd like to open things up for questions. Operator?

Hey there, morning everyone. I'd like to extend a welcome to Dr. Hamdy on joining the team. Perhaps just a few questions from our side. I suppose, at a high level, regarding how you're positioning lymphoma against AML — since you've got a comparatively uncomplicated route to approval in CNS lymphoma, whereas you may require a sizable trial in frontline AML. So the question is, first, what quantity of data do you wish to produce in frontline AML in order to either proceed or perhaps hold off and concentrate on the lymphoma chance? And second, what steps are you taking, or might you take, that could speed up enrollment into the lymphoma trial?

Thanks, Li. This is Jim. I'll handle this quickly — lymphoma versus AML — and after that I'll have Dr. Zung discuss what we're doing regarding enrollment. When it comes to lymphoma versus AML, we're advancing both at the same time. Of course, greater resources go toward the PCNSL study. That one is further along, with far more sites and, naturally, far more patients. Our lymphoma emphasis is on primary CNS lymphoma, and we're enrolling as many people as possible to reach that 30 to 40 target required for NDA submission. Regarding AML, the spending is somewhat lower since it's at an earlier stage, yet we're concentrated on our frontline study, getting past that safety study; as you're aware, we're attempting to assess emavusertib combined with venetoclax in the frontline setting. Although we believe that holds very strong long-term potential, in the near term our attention is truly just on enrolling a modest number of patients to get those initial regimens cleared for safety; it's a fairly small draw on our resources, but it remains just as much a strong priority for us as the primary CNS lymphoma side. With that, perhaps Jonathan, if you'd like to weigh in about enrollment.

Absolutely. Regarding how many patients we're bringing into the lymphoma study, 37 sites are up and running right now; these are the key centers of excellence across the U.S., Europe, and Israel, the places where patients receive their diagnosis and care. We hold routine outreach sessions with both the investigators and the coordinators. Every standard activity for a clinical trial is being carried out on our end to encourage that engagement and ultimately boost enrollment.

Good morning, Li — Ahmed here. Clearly, a fair amount of deliberation is happening at the moment regarding the NHL indications as well as the AML. Additional conversations are going to arrive further along about the way we rank these and at what point we rank them. Naturally, we'll make sure everyone stays informed.

Yes, and of course, Li, it's fair to say everyone here is delighted that Dr. Hamdy has joined us on the team. We're not only charging forward with real determination on PCNSL, but also aiming to grow into NHL and AML so that this drug can be used as widely as it offers benefit. Needless to say, we're quite keen to have him with the group, and we genuinely anticipate what we'll achieve going forward. Thanks.

Thanks, everyone.