Curis, Inc. (CRIS) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call presents a mixed picture: while there are positive elements such as decreased expenses and a cash runway into 2026, the net losses and lack of specific guidance in certain areas temper enthusiasm. The Q&A section reveals confidence in ongoing studies but lacks clarity in some responses. The absence of a market cap limits the assessment of stock reaction sensitivity. Given these factors, the overall sentiment remains neutral, with no strong catalysts to drive significant short-term stock movement.
Key Financial Performance
Net Loss $8.6 million or $0.68 per share for Q2 2025, compared to $11.8 million or $2.03 per share for Q2 2024. The decrease was primarily due to lower employee-related costs, research, consulting, and clinical costs.
Research and Development Expenses $7.5 million for Q2 2025, compared to $10.3 million for Q2 2024. The decrease was primarily attributable to lower employee-related costs, research, consulting, and clinical costs.
Research and Development Expenses (6 months) $16 million for the 6 months ended June 30, 2025, compared to $19.9 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs, research, consulting, and clinical costs.
General and Administrative Expenses $3.5 million for Q2 2025, compared to $4.8 million for Q2 2024. The decrease was primarily attributable to lower employee-related and legal costs.
General and Administrative Expenses (6 months) $7.5 million for the 6 months ended June 30, 2025, compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower employee-related and legal costs.
Cash and Cash Equivalents $10.1 million as of June 30, 2025. This amount, along with proceeds from July 2025 offerings, is expected to fund operations into Q1 2026.
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Operating Highlights
TakeAim Lymphoma study: Progress in evaluating emavusertib in combination with ibrutinib for PCNSL patients. Targeting accelerated submissions in the U.S. and Europe after enrolling 30-40 additional patients.
Emavusertib in CLL and NHL: Exploring potential to improve treatment paradigm by combining emavusertib with BTK inhibitors. Proof-of-concept study for relapsed/refractory CLL to start by year-end.
Emavusertib in AML: Registrational study planned comparing emavusertib versus gilteritinib in relapsed/refractory AML. Emavusertib shows higher composite CR rate compared to gilteritinib.
Emavusertib in MDS: Potential combination with azacitidine to address unmet needs in high-risk MDS patients.
Triplet study in frontline AML: Phase I study ongoing with emavusertib, venetoclax, and azacitidine. Progress to be reported at ASH conference in December.
Financial performance: Net loss of $8.6M in Q2 2025, improved from $11.8M in Q2 2024. Decrease in R&D and G&A expenses contributed to reduced losses.
Cash position: $10.1M in cash and equivalents as of June 30, 2025, with additional $6M raised in July. Funding expected to last into Q1 2026.
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Risk or Challenges
Regulatory Approval Challenges: The company is relying on accelerated submissions to the FDA and EMA for its TakeAim Lymphoma study. Any delays or issues in regulatory approval could significantly impact the timeline and success of their drug development.
Enrollment Challenges: The company needs to enroll 30 to 40 additional patients for the TakeAim Lymphoma study within the next 12 to 18 months. Failure to meet this enrollment target could delay regulatory submissions and subsequent commercialization.
Market Competition: The company faces competition from existing treatments like gilteritinib for AML. The success of emavusertib depends on demonstrating superior efficacy and safety, which is not guaranteed.
Financial Constraints: The company reported a net loss of $8.6 million for Q2 2025 and has cash reserves of $10.1 million, which are expected to fund operations only until Q1 2026. This financial limitation could hinder ongoing and future research and development activities.
Clinical Trial Risks: The success of emavusertib in various studies, including its combination with other drugs, is not guaranteed. Any negative outcomes could impact the company's strategic objectives and market position.
Dependence on Key Studies: The company’s future success heavily depends on the outcomes of its ongoing studies, such as the TakeAim Lymphoma study and the registrational study for AML. Any setbacks in these studies could adversely affect its strategic plans.
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Guidance & Outlook
TakeAim Lymphoma Study: Over the next 12 to 18 months, the company will focus on enrolling 30 to 40 additional patients needed for NDA and EMA submissions. The study aims to support accelerated submissions in both the U.S. and Europe.
Emavusertib Expansion: Plans to expand emavusertib into additional indications in CLL and NHL. A proof-of-concept study targeting 20 to 30 patients with relapsed/refractory CLL is expected to begin by year-end, with initial data anticipated in mid-2026.
AML Registrational Study: The company plans to conduct a registrational study comparing emavusertib versus gilteritinib in the relapsed/refractory AML setting.
High-Risk MDS: The company is exploring the combination of azacitidine with emavusertib to address unmet needs in high-risk MDS, following the failure of the VERONA study.
Triplet Study in Frontline AML: The company is evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine in a Phase I study. Progress updates are expected at the ASH conference in December.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What do you think the bar will be for the BTK combination study in CLL, and how do you think you can fit in considering the evolving landscape in CLL with BTK degraders and next-gen BCL2 inhibitors?
A:The management believes that adding emavusertib to a commercially available BTK inhibitor can lead to MRD-negative or complete remissions, offering a time-limited treatment. They are confident that the standard of care (BTKi) improves when emavusertib is added, potentially providing a safe and tolerable regimen. They also noted that BTK degraders are still in development and not yet approved.
Q:What should we expect from the AML triplet data coming later this year?
A:The company plans to present efficacy and safety data from the 7- and 14-day cohorts at the ASH meeting later this year, pending abstract acceptance.
Q:Can you provide any color on the enrollment progression for the TakeAim Lymphoma study over the next 12 to 18 months?
A:Enrollment is progressing as expected, with over 30 sites open. The company expects to enroll one patient per clinical site per calendar year, which aligns with their plan for this ultra-rare population.
Q:What should we expect in the next data update for PCNSL?
A:The company has not provided specific guidance on the next update but plans to present the data they have at the time, likely at the ASH conference. They are optimistic about the data seen so far.
Q:Are you planning to open additional clinical sites for PCNSL?
A:No, the company is comfortable with the current number of sites and believes enrollment is on track.
Q:What line of therapy are you planning to enroll for the CLL program?
A:The program can enroll patients in any line of therapy as long as they are on a commercially available BTK inhibitor. This includes second-line patients or those who have not achieved complete remission or MRD-negative status on a BTK inhibitor.
Q:Have the changes at the FDA impacted your plans in PCNSL for accelerated approval?
A:No, the company has alignment with the FDA on key activities and is executing on them. They are encouraged by the fact that there are no approved drugs or standards for PCNSL, which supports their discussions with the FDA.
Q:Any update on cash runway or business development efforts?
A:The cash runway extends into 2026. The company is evaluating both dilutive and non-dilutive opportunities to extend it further and plans to progress these programs in the second half of the year.
Q:Is the 21-day dosing for the AML triplet still planned, or are the 7- and 14-day cohorts sufficient?
A:The company is testing different regimens in the clinical setting and is optimistic about the drug's potential. They plan to discuss the data in more detail when it becomes public.
Q:How are you prioritizing development efforts given the progress in PCNSL and other areas?
A:The company is focusing on being capital efficient and disciplined in its spending. They are prioritizing programs that can generate compelling data and progress towards approval.
Q:Any updates on the investigator-sponsored solid tumor studies?
A:There are no updates currently. The company hopes at least one of the five studies will have data to report this year, but timelines are not under their control.
Q:What is your take on the tirabrutinib data for PCNSL, and do you plan to open a second arm with emavusertib?
A:The company finds the tirabrutinib data interesting and expects it to eventually get approval in the U.S. They aim to establish that emavusertib can enhance the efficacy of any BTK regimen, including tirabrutinib, once it is approved.
Q:For the AML triplet frontline, do patients need to reenroll for efficacy readout after completing safety cohorts?
A:The company did not provide specific details but plans to discuss the data in more detail once it becomes public.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers or lacked clarity on the following: 1. Specific expectations for the next PCNSL data update. 2. Details on the 21-day dosing for the AML triplet. 3. Updates on investigator-sponsored solid tumor studies. 4. Specifics on whether patients need to reenroll for efficacy readout in the AML triplet frontline study.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AML dosing
ASH conference
Accounting Officer
Ahmed Hamdy
BTKi inhibitor
BTKi monotherapy
BTKi mutation
CLL NHL
Chief Medical
Co
Duvall
EMA
Institutional Services
JonesTrading Institutional
LLC Research
Lymphoma study
MDS
Medical Officer
Research Division
Services LLC
TakeAim Lymphoma
care
dosing regimen
frontline AML
gilteritinib
patient BTKi
regimen emavusertib
remission patient
setting
study patient
submission
triplet
update progress
venetoclax azacitidine
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