Curis - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 delivered a modest EPS beat and a revenue miss versus consensus: Diluted EPS was -$1.25 vs -$1.26 consensus (beat by ~$0.01), while revenue was $2.38M vs $2.60M consensus (miss by ~$0.22M), driven by Erivedge royalties and lower operating costs year over year. EPS consensus/actual values from S&P Global.*
• Management emphasized continued progress on the accelerated approval path for emavusertib in relapsed/refractory PCNSL, with EMA/FDA alignment in place and Q1 operational momentum adding 37 clinical sites and advancing enrollment.
• Cash runway remains guided into Q4 2025 following recent financings, but filings reiterate the need for substantial additional capital and near-term funding risks in forward-looking statements.
• Near-term catalysts: additional TakeAim Lymphoma data at ASH later this year, further site additions/enrollment progress, and AML program updates (triplet cohort and FLT3 monotherapy signals).

What Went Well and What Went Wrong

What Went Well

• Accelerated approval pathway clarity: “We have made exciting progress with both the FDA and EMA on the potential for accelerated approval of emavusertib in R/R PCNSL… We expect to provide additional data… at ASH later this year” — CEO James Dentzer; Q4 call confirmed EMA/FDA support and the study as registrational.
• Clinical efficacy signals sustained: In PCNSL, 9/13 BTK-experienced showed tumor burden reduction (6 ORR; 4 CR, 2 PR) and 5/6 BTK-naïve showed responses (1 CR, 4 PR) at the Jan 2, 2025 cut-off; several CRs >6 months. AML FLT3 cohort showed a 38% composite CR rate in salvage-line patients where >80% had prior FLT3i exposure.
• Operating discipline: R&D ($8.5M) and G&A ($4.0M) decreased y/y, helping deliver an EPS outcome slightly better than consensus despite a small revenue miss.

What Went Wrong

• Revenue miss vs consensus: Erivedge royalty revenue ($2.38M) fell short of $2.60M consensus; royalty variability continues to drive short-term revenue unpredictability. Consensus from S&P Global.*
• Other expense swung negative ($0.5M) vs prior-year other income ($0.6M), tied to increased expense related to sale of future royalties and lower interest income, pressuring net results.
• Funding overhang: Disclosures caution insufficient cash to support operations for the next 12 months absent additional financing, despite stated runway into Q4 2025, highlighting near-term capital risk.

Transcript

Operator (participant)

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'll conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, May 6th, 2025. I would now like to turn the conference over to Diantha Duvall. Please go ahead.

Diantha Duvall (CFO)

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 investor 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 today 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. We 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.

Jim Dentzer (President and CEO)

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 Ascerta, and Founder and CEO of Vincerx Pharma. Ahmed, welcome.

Ahmed Hamdy (CMO)

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 the U.S. and Europe. I also look forward to expanding its use beyond primary CNS into additional indications like NHL, AML, and solid tumors. Given my experience in 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 and to bring novel therapies to patients.

Jim Dentzer (President and CEO)

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 2nd, 2025, the most recent data cutoff date, 27 patients with relapsed refractory PCNSL have been treated with the emavusertib and ibrutinib combination, including seven 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, nine patients demonstrated a reduction in tumor burden, including six subjective responses, two partial responses, and four complete responses, with three of the four CRs lasting more than six months and one patient who's been in complete remission for almost two years and is still on study. Among six of seven BTKI-naive patients for whom change in tumor burden data were available, five patients demonstrated a reduction in tumor burden, including five objective responses, four partial responses, and one complete response. We expect to have additional data from the TakeAim Lymphoma Study at ASH later this year.

In addition, over the next 12-18 months, we'll be focused on enrolling 30-40 additional patients we'll need for the NDA submission, and we'd like to see six to eight 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 mg b.i.d. These data show a 38% composite CR rate in the salvage line setting, with 10 objective responses in 19 response-available patients and seven 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 seven, 14, and 21-day dosing regimens after they have achieved a CR in ven/aza but are still positive for minimal residual disease. We have successfully completed the seven-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. Diantha?

Diantha Duvall (CFO)

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 31st, 2025, and the company has 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 (participant)

Thank you so much. Ladies and gentlemen, we'll now begin the question-and-answer session. Should you have a question, please press star followed by one on your touch-tone phone. You'll hear a prompt that your hand has been raised. Should you wish to remove your hand from the question-and-answer process, please press star followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment for your first question. Your first question comes from Li Watsek with Cantor. Please go ahead.

Li Watsek (Equity Research Analyst)

Hi, good morning, guys. I 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? The second is, what are the things you're doing or could be doing to potentially accelerate the enrollment of the lymphoma study?

Jim Dentzer (President and CEO)

Thank you, Li. It's Jim. Let me address this briefly, lymphoma versus AML, and then I'll ask Dr. Zung to talk about the things we're doing on enrollment. In lymphoma versus AML, we are moving ahead with both simultaneously. Now, more resources, of course, are dedicated to the PCNSL study. It's farther along, many more sites, many more patients, of course. Our focus in lymphoma is in primary CNS lymphoma and enrolling as many patients as we can towards that 30-40 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. We're trying to evaluate, as you know, emavusertib in combination with venetoclax in the frontline setting.

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. It is a relatively small use of our resources, but it is 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.

Jonathan Zung (Chief Development Officer)

Sure. In terms of the enrollment in the lymphoma program, we've got 37 sites that are currently open. 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. We're doing everything that's normally done in a clinical trial to sort of drive engagement to result in enrollment.

Ahmed Hamdy (CMO)

Good morning, 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. There's more discussions that will be coming down the road on how do we prioritize and when do we prioritize. Obviously, we'll keep everybody posted.

Jim Dentzer (President and CEO)

Yeah. As you can imagine, Li, obviously, we're all thrilled to get Dr. Hamdy here on board as part of the team. 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 join the team and really look forward to our progress. Thank you.

Li Watsek (Equity Research Analyst)

Thank you, guys.

Operator (participant)

Thank you. Your next question comes from Kripa Devarakonda with Truist. Please go ahead.

Kripa Devarakonda (Biotech Equity Analyst)

Hey, guys. Thank you so much for taking my question, and congratulations on bringing Dr. Hamdy aboard. A couple of questions. One for the lymphoma. You noted you have 37 sites open. I think previously you'd 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 12-18 months. Have you had any additional conversations with the FDA? Just given all the changes at 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. Thank you.

Jonathan Zung (Chief Development Officer)

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

Jim Dentzer (President and CEO)

Yeah. On the FDA side, Kripa, I do not 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. I think for Curis' perspective, we were very fortunate in our timing. We are grateful to have their support, and we are pushing ahead. Yeah, we share your concern for the industry as a whole, but I think from Curis' perspective, we are pleased about where we are.

Kripa Devarakonda (Biotech Equity Analyst)

Great. Thank you so much for the color.

Operator (participant)

Your next question comes from Soumit Roy with Jones Research. Please go ahead.

Danya Ben‑Hail (Analyst)

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

Jim Dentzer (President and CEO)

Yeah. So why don't I take the first one, and then actually I'll ask Jonathan to chime in on the second one. On the first one, I think it's a little 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. As we know, the way to treat NHL is to downregulate the overactivity of NF-kappa B. Historically, at least for the last 10 years, paved by pharmaceuticals, the way to do that is with a BTK inhibitor. It blocks the BCR pathway, which is one of the two pathways that drives NF-kappa B. We have the only drug that blocks the other pathway, the TLR pathway.

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 you block both pathways that are driving NF-kappa B, you can maximize the downregulation of NF-kappa B activity, and that's what's driving the benefit to patients. It is less about any particular genetic mutation, and it is more about blocking the fundamental drivers of that oncologic activity. Jonathan, maybe if you could chime in on the second one on the AML.

Jonathan Zung (Chief Development Officer)

Yeah. 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, Dana-Farber presented, we'll come back and talk about what forward plans are on the AML side, whether it's frontline, relapsed refractory, and/or both.

Jim Dentzer (President and CEO)

Yeah. 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 if a BTK inhibitor provides benefit in an NHL indication, whether it's PCNSL, CLL, Waldenstrom's, any of the indications where a 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 indications. It's exactly what we saw in the lab, and it's precisely why we've asked Dr. Hamdy to come on board. I look forward to reporting out that progress.

Danya Ben‑Hail (Analyst)

Okay. Great. Thank you.

Operator (participant)

Thank you so much. As a reminder, if you would like to ask a question, please press star one. At this time, there are no further questions. I would now like to pass the call over to Jim Dentzer for closing remarks.

Jim Dentzer (President and CEO)

Thank you, operator. Thank you, everyone, for joining today's call. 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 Origin, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator.

Operator (participant)

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