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. [Operator Instructions] 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 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 expand its use beyond primary CNS into additional indications like NHL, AML and solid tumors. Given my experience in both ibrutinib, 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. And 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 CRs lasting more than 6 months and 1 patient who's 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. And 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…

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. Operator?

[Operator Instructions] 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 PCNSL study, it's further along many more sites, 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 everyday posted.

Yes. And as you can imagine, Li, obviously, we're all thrilled to get Dr. Hamdy here onboard 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 [indiscernible] the team and really look forward to our progress.

Your next question comes from Kripa Devarakonda with Truist.

And congratulations on bringing Dr. Hamdy aboard. So a couple of questions. One for the lymphoma. You noted you have 37 sites opened. I think previously, you had mentioned 30. Just wondering if this is the final or you're planning to add more sites? And are you still on track to complete enrollment in the time frame that you had mentioned, I think, last time you had said 12 to 18 months. And -- any -- have you had any additional conversations with the FDA? Just given all the changes of the FDA, just was wondering if there's any concern that the agreement that you came to with the FDA will continue to be respected with all the changes that are happening.

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 for 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 [ph] 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 drive NF-kappaB. We have the only drug that blocks the other pathway, the TLR. And our thesis which panned out in the lab and we now see in the clinical data, it's panning out as well is that when block both pathways that are driving NF-kappaB, you 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 it's 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 Eric Weiner of Dana-Farber 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 would -- and I would close also in saying one of the things that should be very clear to everyone on the call, certainly very clear to us on the team is one of the biggest advantages of having Dr. Hamdy join the team is now that we've got a solid path on primary CNS lymphoma, we're looking to expand across NHL to everywhere, where BTK inhibitors provide benefit because the BTK inhibitor provides benefit in an NHL indication, whether it's PCNSL, CLL, Waldenstrom's any of the indications where BTK inhibitor gets used, that's going to be an opportunity where blocking the second pathway could provide benefit. It's exactly what we see in our first indication, it's exactly what we saw in the lab and it's precisely why we've asked Dr. Hamdy to come onboard. So I look forward to reporting out that progress.

[Operator Instructions] 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. Operator?

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