Curis Inc Q1 FY2025 Earnings Call

Good morning ladies and gentlemen and welcome to the Curis Provides First Quarter 2025 Business Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. This call is being recorded on Tuesday, May 6, 2025. I would now like to turn the conference over to Diantha Duvall. Please go ahead.

Thank you and welcome to the Curis first quarter 2025 business update call. Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our first quarter 2025 business update press release and related financial tables. I would also like to remind everyone that during the call, we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and actual results may differ materially. For additional details, please see our SEC filings. Joining me on today's call are Jim Dentzer, President and Chief Executive Officer; Jonathan Zung, Chief Development Officer; and Dr. Ahmed Hamdy, who is joining us today as our new Chief Medical Officer. He will also be available for a question-and-answer period at the end of the call. I'd now like to turn the call over to Jim.

Thanks, Diantha. Good morning, everyone and welcome to Curis' first quarter business update call. I'd like to start this quarter's call by welcoming Dr. Ahmed Hamdy to the Curis Executive team. Dr. Hamdy is a well-known and respected leader in the industry and brings a wealth of experience as the CMO of Pharmacyclics, Founder and CMO of Acerta, and Founder and CEO of Vincerx. Ahmed, welcome.

Thank you, Jim. It's a great pleasure to be here. I'm excited to join the Curis team at this very critical time to advance emavusertib towards regulatory filings in primary CNS lymphoma in both U.S. and Europe. We also look forward to expanding its use beyond primary CNS into additional indications like NHL, AML, and solid tumors. Given my experience with both ibrutinib and acalabrutinib, I have a special appreciation for the potential of emavusertib in combination with BTK inhibition in NHL. I look forward to working with the team here at Curis to bring novel therapies to patients.

Thanks, Ahmed. In addition to strengthening our leadership team with Dr. Hamdy, we continue to make steady progress in our TakeAim lymphoma study which is evaluating emavusertib in combination with ibrutinib in PCNSL patients. As a reminder, the TakeAim lymphoma study is a single-arm study with an ORR endpoint in patients with PCNSL who have progressed on BTKI treatment. After collaborative discussions with FDA and EMA over the last year, we expect the study to support accelerated submissions in both the U.S. and Europe. As of January 2, 2025, the most recent data cutoff date, 27 patients with relapsed/refractory PCNSL have been treated with the emavusertib and ibrutinib combination, including 7 BTKI naive patients and 20 BTKI experienced patients. Among 13 of the 20 BTKI experienced patients for whom change in tumor burden data were available, 9 patients demonstrated a reduction in tumor burden, including 6 objective responses, 2 partial responses, and 4 complete responses. With 3 of the 4 complete responses lasting more than 6 months and 1 patient who has been in complete remission for almost 2 years and is still on study. Among 6 of 7 BTKI-naive patients for whom change in tumor burden data were available, 5 patients demonstrated a reduction in tumor burden, including 5 objective responses, 4 partial responses, and 1 complete response. We expect to have additional data from the TakeAim lymphoma study at ASH later this year. In addition, over the next 12 to 18 months, we'll be focused on enrolling 30 to 40 additional patients we'll need for the NDA submission. We'd like to see 6 to 8 responses in that data set. Now, let's turn to AML. As you'll recall, at the ASH conference in December, Dr. Eric Weiner from Dana-Farber presented data for 21 patients with a FLT3 mutation who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the RP2D of 300 milligrams BID. These data show a 38% composite CR rate in the salvage line setting with 10 objective responses in 19 response-evaluable patients and 7 of the 10 responses reported at the first assessment. To put these data into context, gilteritinib, the leading FLT3 inhibitor in relapsed/refractory AML was approved with a composite CR rate of 21%. In a patient population where only 13% of patients had been previously treated with a FLT3 inhibitor. In the emavusertib study, over 80% of the patients had been previously treated with a FLT3 inhibitor. We believe the reason the emavusertib data are so compelling is its novel mechanism of action. It blocks both IRAK4 and FLT3. For several years, it has been suggested in the literature that blocking IRAK4 can enable patients to overcome adaptive resistance to FLT3 inhibition. These clinical data clearly support that thesis. Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, we initiated a Phase I study last year, of emavusertib as an add-on agent to venetoclax and azacitidine in frontline AML. This study is assessing safety and tolerability, where emavusertib is added to a patient's ven-aza regimen in 7, 14, and 21-day dosing regimens after they have achieved a complete response in ven-aza but are still positive for minimal residual disease. We have successfully completed the 7-day dosing cohort, and enrollment of the 14-day cohort is currently ongoing. As you can see, we've had a very exciting and productive quarter. We look forward to providing additional updates as the year progresses. With that, I'll turn the call back to Diantha for a financial update.

Thank you, Jim. Curis reported a net loss of $10.6 million or $1.25 per share for the first quarter of 2025 compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024. Research and development expenses were $8.5 million for the first quarter of 2025 as compared to $9.6 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $4.0 million for the first quarter of 2025 as compared to $4.9 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs, professional, legal, and consulting costs. In March, we've completed a registered direct financing and concurrent private placement with net proceeds of approximately $8.8 million. Curis' cash and cash equivalents totaled $20.3 million as of March 31, 2025, and the company had approximately 10.5 million shares of common stock outstanding. Curis expects its existing cash and cash equivalents will enable its planned operations into the fourth quarter of 2025. With that, I'd like to open the call up for questions.

And your first question comes from Li Watsek with Cantor.

Wanted to welcome Dr. Hamdy to the team. Maybe just a couple of questions from us. I guess, big picture on your positioning of lymphoma versus AML. Just given you have a relatively straightforward path to approval in CNS lymphoma you might need a large study in frontline AML. I guess the question is, number one, how much data do you want to generate in frontline AML to either move forward or maybe pause and focus on the lymphoma opportunity? And the second is what are the things you're doing or could be doing to potentially accelerate the enrollment of the lymphoma study.

Thank you, Li. It's Jim. So let me address this briefly lymphoma versus AML and then I'll ask Dr. Zung to talk about things we're doing on enrollment. So in lymphoma versus AML, we are moving ahead with both simultaneously. Now more resources, of course, are dedicated to the PCNSL study, it's further along with many more sites and many more patients, of course. So our focus in lymphoma is in primary CNS lymphoma and enrolling as many patients as we can towards that 30% to 40% target we need to get to NDA submission. On the AML side, the spend is a little lighter because it's earlier stage but we're focused on our frontline study getting through that safety study. So we're trying to evaluate, as you know, emavusertib in combination with ven-aza, in the frontline setting. And while we think that has a long-term, very strong potential, in the short term, our focus is really just enrolling a small number of patients to clear those initial regimens for safety. So it's a relatively small use of our resources but it's absolutely just as strong a focus for us as the primary CNS lymphoma side. With that, maybe, Jonathan, if you'd like to chime in on the enrollment.

Sure. In terms of the enrollment in the lymphoma program, we've got 37 sites that are currently opened. We're at the major centers of excellence in the U.S., Europe, and Israel, where the patients are seen and treated. We have regular site engagement outreaches with the investigators and the coordinators. So we're doing everything that's normally done in a clinical trial to sort of drive engagement to result in enrollment.

Li, this is Ahmed. Obviously, there's quite a bit of thinking that's going on right now as far as the NHL indications and the AML. So there's more discussion that will be coming down the road on how do we prioritize and when do we prioritize? Obviously, we'll keep everyone posted.

Yes. And as you can imagine, Li, obviously, we're all thrilled to get Dr. Hamdy here on board as part of the team. And as we not just push ahead aggressively towards PCNSL but look to expand across NHL and AML to make the most of this drug wherever it provides utility. Obviously, we're very eager to advance the team and look forward to our progress.

Your next question comes from Kripa Devarakonda with Truist.

Congratulations on bringing Dr. Hamdy on board. I have a couple of questions. First, regarding the lymphoma, you mentioned having 37 sites open, up from 30 previously. Is this the final number, or are you planning to add more sites? Are you still on track to complete enrollment in the 12 to 18-month timeframe you mentioned last time? Also, have you had any further discussions with the FDA? Given the recent changes at the FDA, I am curious if there are any concerns about the continuation of the agreement you reached with them.

So Jim, this is Jonathan. So on the enrollment side, there are no real changes there. We're constantly looking at the sites that we have opened; we opened, as we had mentioned in previous calls, additional sites last year. So that's where we are.

Yes. On the FDA side, Kripa, I don't think we have any concerns at all that there will be a change. I think we are grateful to be blunt that we were able to get to the FDA to get the collaboration that we needed last quarter before this current turmoil started. I worry about the industry and about companies who have to reach out to gain similar effort from the FDA in this climate. But I think from Curis' perspective, we were very fortunate in our timing. We're grateful to have their support and we're pushing ahead. So yes, we share your concern for the industry as a whole. But I think from Curis' perspective, we're pleased about where we are.

Your next question comes from Soumit Roy with Jones Research.

This is Danya for Soumit Roy. I have a question about your ASCO presentation. Can you give any color on what type of mutations might affect responses? And I have another question for AML. Are there any updates on potential development steps for EMA in the relapsed/refractory AML?

Yes. So why don't I take the first one and then actually, I'll ask Jonathan to chime in on the second one. So on the first one, I think it's too early to talk about mutations and their impact. I think the primary impact that we see with emavusertib is really driven by the mechanism of action more broadly. So as we know, the way to treat NHL is to down-regulate the overactivity of NF-kappaB. Historically, at least for the last 10 years, paved by Pharmacyclics. The way to do that is with a BTK inhibitor. It blocks the BCR pathway, which is one of the 2 pathways driving NF-kappaB. We have the only drug that blocks the other pathway, the TLR. Our thesis has panned out in the lab and we now see in the clinical data that it's panning out as well. When we block both pathways that are driving NF-kappaB, we can maximize the down-regulation of NF-kappaB activity and that's what's driving the benefit to patients. So it's less about any particular genetic mutation and more about blocking the fundamental drivers of that oncologic activity. And Jonathan, maybe if you could chime in on the second one on AML.

Yes. So on the AML development side, obviously, once we complete the ongoing triplet study, the safety study along with the data that we've presented, we'll come back and talk about what the forward plans are on the AML side, whether it's frontline, relapsed/refractory and/or both.

Yes, I want to emphasize that one of the key benefits of having Dr. Hamdy join our team is that we now have a clear strategy for primary CNS lymphoma. We are looking to expand our efforts in non-Hodgkin lymphoma, wherever BTK inhibitors can be beneficial. The BTK inhibitor is effective in NHL indications, including PCNSL, CLL, and Waldenstrom's, and these areas present opportunities for additional benefit through blocking the second pathway. This aligns with our initial findings and laboratory results, which is why we were eager to bring Dr. Hamdy on board. I look forward to sharing updates on our progress.

And at this time, there are no further questions. I would now like to pass the call over to Jim Dentzer for closing remarks.

Thank you, operator. And thank you, everyone, for joining today's call. And as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment, and to our partners at Aurigene, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon.

Ladies and gentlemen, this concludes today's conference call. Thank you so much for your participation. You may now disconnect.