Curis Q3 2025 Earnings Report

Curis EPS Results

• Actual EPS: -$0.49
• Consensus EPS: -$0.62
• Beat/Miss: Beat by +$0.13
• One Year Ago EPS: N/A

Curis Revenue Results

• Actual Revenue: $3.18 million
• Expected Revenue: $2.86 million
• Beat/Miss: Beat by +$316.00 thousand
• YoY Revenue Growth: N/A

Curis Announcement Details

• Quarter: Q3 2025
• Date: 11/6/2025
• Time: After Market Closes
• Conference Call Date: Thursday, November 6, 2025
• Conference Call Time: 4:30PM ET

Curis (NASDAQ:CRIS) is a biotechnology company focused on the discovery, development and commercialization of targeted small molecule and antibody therapeutics for the treatment of cancer. The company’s research centers on exploiting key signaling pathways and tumor microenvironment interactions to develop compounds with the potential to address unmet medical needs. Curis’ proprietary pipeline includes multiple programs at various stages of clinical and preclinical development, reflecting its emphasis on innovative oncology drug candidates.

Among Curis’ lead assets is CA-4948, an oral inhibitor of interleukin-1 receptor–associated kinase 4 (IRAK4) partnered with Ikena Oncology, which is being evaluated in hematologic malignancies and solid tumors. The company’s earlier success includes the development of vismodegib, marketed as Erivedge® through a collaboration and subsequent acquisition by Genentech, for the treatment of advanced basal cell carcinoma. Curis continues to pursue partnerships to advance its pipeline and leverage external expertise for product registration and commercialization.

Founded in 1997 and headquartered in Lexington, Massachusetts, Curis operates research facilities in the greater Boston area and collaborates with academic institutions and industry partners worldwide. The company’s integrated discovery and development platform has been instrumental in generating therapeutic candidates across multiple cancer indications, with a strategic focus on precision medicines that offer the potential for improved patient outcomes and differentiated safety profiles.

Curis is led by President and Chief Executive Officer Ali Fattaey, Ph.D., who joined the company in 2019 and brings extensive experience in oncology research and drug development. The senior management team comprises seasoned professionals in clinical development, regulatory affairs and commercial strategy, underscoring Curis’ commitment to advancing its pipeline candidates through critical regulatory milestones and toward potential market approval.

Curis Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Curis says its TAKE‑AIM PCNSL study of emavusertib plus ibrutinib is expected to support accelerated submissions in the U.S. and Europe after FDA/EMA discussions, and the company will focus on enrolling additional patients over the next 12–18 months.
• Positive Sentiment: The company submitted a protocol to the FDA for a proof‑of‑concept CLL study (planned ~40 patients) adding emavusertib to BTKI monotherapy, targeting first patient dosing in late Q4/early Q1 and initial data at ASH December 2026.
• Neutral Sentiment: Early AML triplet data (emavusertib + azacitidine + venetoclax) showed MRD conversion to undetectable in 4 of 8 evaluable patients within 5–8 weeks, though two dose‑limiting toxicities occurred in the 14‑day cohort and both resolved as dosing regimens continue to be explored.
• Negative Sentiment: Curis reported a smaller net loss and reduced R&D/G&A spend, but with only $9.1 million in cash and equivalents management expects runway into 2026 and plans to raise additional capital before year‑end.

Presentation

[Operator]

Good afternoon, ladies and gentlemen, and welcome to the Curis Third 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. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 6, 2025. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead.

[Diantha Duvall, CFO at Curis]

Thank you, and welcome to the Curis Third 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 Third Quarter 2025 Business Update Press Release and related financial tables. I'd also like to remind everyone that during the call we will be making forward-looking statements, which are based on 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, Dr. Jonathan Zung, Chief Development Officer, and Dr. Ahmed Hamdy, Chief Medical Officer. We will also be available for a question-and-answer period at the end of the call. I'd like to now turn the call over to Jim.

[Jim Dentzer, President and CEO at Curis]

Thank you, Diantha. Good afternoon, everyone, and welcome to Curis's Third Quarter Business Update Call. We continue to make steady progress in our TakeAim Lymphoma study, which is evaluating emavusertib in combination with ibrutinib in patients with primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. As a reminder, the TakeAim Lymphoma study is a single-arm study with an ORR endpoint that adds emavusertib to a patient's BTKi regimen after they have progressed on BTKi monotherapy. After collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. Over the next 12-18 months, we will be focused on enrolling the additional patients we will need to support those submissions.

[Jim Dentzer, President and CEO at Curis]

If you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes. They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for CLL patients, where the current standard of care is BTKi monotherapy. BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. However, these responses are typically partial responses, not complete remission. The unsurprising result is that patients who are treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, since patients never achieve complete remission, many of these patients develop BTKi-resistant mutations, and ultimately their disease progresses.

[Jim Dentzer, President and CEO at Curis]

At Curis, we're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi-resistant mutations and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKi monotherapy who have achieved a PR but have been unable to achieve complete remission or uMRD. We have submitted the study protocol to the FDA. We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH Annual Meeting in December 2026. Now let's turn to AML. Abstracts for the December ASH Meeting were released on Tuesday.

[Jim Dentzer, President and CEO at Curis]

Including the abstract for our ongoing AML Triplet Study, which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on AzaVen, but remain MRD positive. The data in the abstract are for the first two cohorts: patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their AzaVen treatment. As of July 2, 2025, 10 patients with a median age of 71 were enrolled. Four in the 7-day cohort and six in the 14-day cohort. MRD conversion to undetectable levels occurred in four of eight evaluable patients within five to eight weeks of adding emavusertib. Among the patients who remained MRD positive, one patient achieved a 40% MRD reduction, and none showed disease progression. Two dose-limiting toxicities, CPK increase and neutropenia, occurred in the 14-day cohort, but both resolved.

[Jim Dentzer, President and CEO at Curis]

We're very encouraged by the initial readout from these first two cohorts and the exciting potential of combining emavusertib with AzaVen in frontline AML to enable more patients to achieve undetectable MRD. We continue to explore different dosing regimens for this triplet combination, and we look forward to reporting our progress. As you can see, we've had a very exciting and productive quarter and have a lot of exciting updates coming at the SNO and ASH conferences over the next few weeks. With that, I'll turn the call back over to Diantha for the financial update. Diantha?

[Diantha Duvall, CFO at Curis]

Thank you, Jim. Curis reported a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2025, as compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024. Curis reported a net loss of $26.9 million, or $2.19 per share, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024. Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower employee-related clinical, consulting, research, manufacturing, and facility costs. Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024.

[Diantha Duvall, CFO at Curis]

General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024. Curis's cash and cash equivalents were $9.1 million as of September 30, 2025, and the company had approximately 12.7 million shares of common stock outstanding. Based on our current operating plan, we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026. With that, I'd like to open the call for questions. Operator?

[Operator]

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift your hands before pressing any keys. Your first question comes from Sara Nik with H.C. Wainwright. Your line is now open.

[Sara Nik, VP of Equity Research at H.C. Wainwright]

Hi, team, and thanks for taking the question. Congrats on the ongoing progress. My question was regarding your CLL program. If you have any color you could provide on the FDA discussions and protocol you submitted. Were you mostly aligned with primary endpoints and study design? Any granularity you can provide as of now would be helpful. Thank you.

[Jim Dentzer, President and CEO at Curis]

Thank you, Sarah, and thanks for the question. I'll start, and I'll ask Dr. Hamdy to chime in as well. We're very excited about that study. As you know, we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was into PCNSL, and the second one is going into CLL. Obviously, as we move into CLL, it's a much larger indication. Of course, there's a much wider circle of interest among the KOLs. Ahmed, do you want to talk a little bit more about the CLL study in particular?

[Ahmed Hamdy, Chief Medical Officer at Curis]

Sure. Hi, Sara. It's Ahmed. Basically, we're trying to address the unmet medical need in the CLL community, which is basically getting patients to a time-limited treatment with a combination of emavusertib plus a BTK inhibitor in patients who are currently on a BTK and have only achieved a PR with MRD positive. We're aligned with the FDA there, and we intend to have a small dose escalation at 100 milligram and expanding into our 200 milligram phase II dose.

[Sara Nik, VP of Equity Research at H.C. Wainwright]

Great. Thank you.

[Operator]

Your next question comes from Li Watsek with Cantor Fitzgerald. Your line is now open.

[Li Watsek, Director of Biotech Equity Research at Cantor Fitzgerald]

Hey, guys. Thanks for taking our questions. I guess just for the phase two CLL trial, can you maybe just talk a little bit about the size of the study? In terms of the delta you want to achieve in terms of the CR rate? The second is just how you're thinking about resource prioritization at this point, especially as you think about the resources that you might need to move forward the CLL study versus the full-on AML study.

[Jim Dentzer, President and CEO at Curis]

Sure. Again, why don't I start on CLL? I'll ask Dr. Hamdy to talk a little more detail and then maybe have Diantha talk a little bit about resources. First, on CLL. We are anticipating a study design at this point in time that anticipates 40 patients. Of course, as we saw in PCNSL, the unmet need is so clear, we're hoping to be able to see a signal long before we get to that point. As a reminder, patients on BTKi monotherapy in CLL, they get PRs. They don't get CRs. They certainly aren't getting MRD either. What we're looking to do in that population is demonstrate simply that by adding emavusertib, by blocking both pathways, not just one, but both pathways that are driving disease, we can end up seeing deeper responses.

[Jim Dentzer, President and CEO at Curis]

That's deeper PRs, and we hope also that we'll see CRs and MRD. Ahmed, do you want to chime in a little bit more on that?

[Ahmed Hamdy, Chief Medical Officer at Curis]

I think you said it all, Jim. The whole concept here that you do not see CRs. With BTK, and obviously you do not see MRD negative. Getting patients to a CR, and I think anything north of 20% would be very exciting. Obviously, we are going to have to wait until we see a treatment effect in our trial and plan accordingly. We are very hopeful that the dual blockade of inhibiting the TLR pathway along with the BCR pathway would have a much more profound effect on the NF-kB and therefore getting patients to a deeper response and MRD negative.

[Jim Dentzer, President and CEO at Curis]

Yeah. Thank you. Diantha, would you mind spending a moment talking about the resources?

[Diantha Duvall, CFO at Curis]

Absolutely. Li, as you can appreciate, our current priorities are clearly to continue the PCNSL trial and obviously launch the newly initiated CLL trial. Also, as you can appreciate, we'll be looking to bring in additional capital prior to the end of the year. We've been pretty clear about that over the last six months. Neither of those things should be a surprise. That is sort of where we're thinking about our resource allocations.

[Jim Dentzer, President and CEO at Curis]

Yeah. In overall messaging, Li, we continue to move forward with great progress in PCNSL. I think the investor interest, not just in PCNSL with the IDU approval, but the ability to move the needle in CLL, it seems to be a very reachable goal and because of the market opportunity, a very exciting goal. Look forward to hearing from us more about that over the next eight weeks.

[Operator]

Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Yale Jen with Laidlaw & Company. Your line is now open.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Good afternoon, and thanks for taking the questions. I got two here. First of all, in terms of the CLL study. What would you think about the safety side? In other words, in a combination, was there any sort of speculated AE may happen? How would you think about the mitigation for that? I have a follow-up.

[Jim Dentzer, President and CEO at Curis]

Okay. Again, let me start, and I'll ask Dr. Hamdy to add to it. I think the critical issue for us is going to be, do we see any DDI with the BTK inhibitors? As you know, we have a great deal of confidence given that we've already tested a number of patients in NHL with ibrutinib, and we aren't seeing DDI. In fact, at the doses that we're testing, 100 and 200 milligrams with MI, it seems to be a very clean profile. Ahmed, would you like to add to that?

[Ahmed Hamdy, Chief Medical Officer at Curis]

Yeah. I mean, again, you said it all, Jim. Yale, I mean, we have approximately 25 patients, if not more, combined with ibrutinib. As you know, ibrutinib would be the most unselective of all approved BTKs. We have not seen any additive toxicities. We expect not to see any additive toxicity with the other BTK inhibitors. Of course, we're going to be doing some PK work and DDI following any potential toxicities, but I don't think there are any additive toxicities that we expect.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay. Great. That's very helpful. Maybe just one more question here. In terms of the SNO meeting in a few days, what should be the investor sort of expectation to talk about? Next slide.

[Jim Dentzer, President and CEO at Curis]

Yeah. Obviously, we're going to have to be a little careful not to front-run the conference. Thank you, Yale, for your interest in that. We're going to have several posters, three of them, available at the SNO conference in PCNSL, but also SCNSL. Dr. Grommas and Dr. Nayak in particular will be talking about PCNSL. I think what you can expect to see there is learn a little bit more about what we've seen over the last six months in that study. Of course, the secondary CNS lymphoma, even harder to treat, that will be brand new. I think on both fronts, it should be a really exciting conference for us. Thank you.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay. Great. Thanks a lot. Congrats on the progress.

[Jim Dentzer, President and CEO at Curis]

Thank you so much.

[Operator]

There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks.

[Jim Dentzer, President and CEO at Curis]

Thank you, Operator. Thank you, everyone, for joining today's call. As always, thank you to the patients and the 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]

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

Participants

Executives

• Ahmed Hamdy, Chief Medical Officer
• Jim Dentzer, President and CEO
• Diantha Duvall, CFO

Analysts

• Li Watsek, Director of Biotech Equity Research at Cantor Fitzgerald
• Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company
• Sara Nik, VP of Equity Research at H.C. Wainwright