Curis, Inc. (CRIS) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights several risks, including regulatory challenges, financial constraints, and competition. The company reported a net loss, though reduced compared to the previous year, and has limited cash reserves. The Q&A section reveals a lack of detailed guidance and an emphasis on securing additional capital, indicating financial strain. Despite some positive clinical updates, the overall sentiment leans negative due to financial and strategic uncertainties.
Key Financial Performance
Net Loss (Q3 2025) $7.7 million or $0.49 per share, compared to $10.1 million or $1.70 per share in Q3 2024. This represents a decrease in net loss, attributed to reduced research and development expenses and general administrative costs.
Net Loss (9 months ended September 30, 2025) $26.9 million or $2.19 per share, compared to $33.8 million or $5.77 per share for the same period in 2024. The decrease is due to lower research and development and general administrative expenses.
Research and Development Expenses (Q3 2025) $6.4 million, compared to $9.7 million in Q3 2024. The decrease is primarily due to lower employee-related clinical consulting, research, manufacturing, and facility costs.
Research and Development Expenses (9 months ended September 30, 2025) $22.4 million, compared to $29.6 million for the same period in 2024. The reduction is attributed to lower employee-related clinical consulting, research, manufacturing, and facility costs.
General and Administrative Expenses (Q3 2025) $3.7 million, compared to $3.8 million in Q3 2024. The slight decrease is due to lower employee-related costs.
General and Administrative Expenses (9 months ended September 30, 2025) $11.2 million, compared to $13.4 million for the same period in 2024. The decrease is primarily due to lower employee-related costs.
Cash and Cash Equivalents (as of September 30, 2025) $9.1 million. This figure reflects the company's financial position at the end of the reporting period.
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Operating Highlights
TakeAim Lymphoma study: Progressing with emavusertib in combination with ibrutinib for primary CNS lymphoma. Expecting accelerated submissions in the U.S. and Europe within 12-18 months.
CLL proof-of-concept study: Initiating a study to test emavusertib with BTKi monotherapy for deeper responses and reduced resistance. First patient enrollment expected late Q4 2025 or early Q1 2026.
AML triplet study: Evaluating emavusertib with azacitidine and venetoclax in AML patients. Initial data shows MRD conversion in 4 of 8 evaluable patients. Exploring dosing regimens.
Market expansion in CLL and NHL: Engaging with KOLs to expand emavusertib studies into additional NHL subtypes and CLL, aiming to improve treatment paradigms.
Financial performance: Net loss reduced to $7.7M in Q3 2025 from $10.1M in Q3 2024. Cash reserves of $9.1M expected to fund operations into 2026.
R&D and G&A expenses: R&D expenses decreased to $6.4M in Q3 2025 from $9.7M in Q3 2024. G&A expenses slightly decreased to $3.7M in Q3 2025 from $3.8M in Q3 2024.
Strategic focus on emavusertib: Prioritizing emavusertib development across multiple studies to address unmet needs in CNS lymphoma, CLL, and AML.
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Risk or Challenges
Regulatory Approval Challenges: The company is awaiting FDA and EMA approval for its TakeAim Lymphoma study and proof-of-concept study in CLL. Delays or rejections could impact strategic timelines and market entry.
Clinical Trial Risks: The success of ongoing trials, including the TakeAim Lymphoma study and AML triplet study, is critical. Any failure to achieve desired outcomes or manage dose-limiting toxicities could hinder progress.
Financial Constraints: The company reported a net loss of $7.7 million for Q3 2025 and has $9.1 million in cash reserves, which may only fund operations into 2026, raising concerns about long-term financial sustainability.
Market Competition: BTK inhibitors are the current standard of care in CLL and NHL. Competing against established treatments and gaining market share could be challenging.
Patient Recruitment Challenges: The company needs to enroll additional patients for its studies to support regulatory submissions, which could face delays or difficulties.
Toxicity and Safety Concerns: Dose-limiting toxicities, such as CPK increase and neutropenia, were observed in the AML triplet study, which could impact patient safety and trial outcomes.
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Guidance & Outlook
TakeAim Lymphoma Study: The study is evaluating emavusertib in combination with ibrutinib in patients with primary CNS lymphoma. Over the next 12 to 18 months, the company will focus on enrolling additional patients to support accelerated submissions in the U.S. and Europe.
Expansion into Additional NHL Subtypes: Plans to expand emavusertib studies into additional NHL subtypes, particularly for CLL patients, aiming to improve the standard of care by achieving deeper responses and potentially reducing the risk of BTKi resistant mutations.
Proof-of-Concept Study in CLL: A new study protocol has been submitted to the FDA to test emavusertib in CLL patients currently on BTKi monotherapy. The first patient enrollment is expected in late Q4 2025 or early Q1 2026, with initial data anticipated at the ASH Annual Meeting in December 2026.
AML Triplet Study: The ongoing study evaluates the combination of emavusertib with azacitidine and venetoclax in AML patients. Initial data shows promising MRD conversion rates, and further exploration of dosing regimens is planned.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide any details on the FDA discussions and protocol submitted for the CLL program? Were you aligned with primary endpoints and study design?
A:The company is addressing unmet medical needs in the CLL community by combining emavusertib with a BTK inhibitor for patients who are MRD positive. They are aligned with the FDA and plan a small dose escalation at 100 mg, expanding into a 200 mg Phase II dose.
Q:What is the size of the Phase II CLL trial, and what delta in CR rate are you aiming for? How are you prioritizing resources between the CLL study and the frontline AML study?
A:The Phase II CLL trial is designed for 40 patients, but the company hopes to see a signal before reaching that number. They aim for a CR rate north of 20%, which would be exciting. Resource prioritization focuses on continuing the PCNSL trial, launching the CLL trial, and securing additional capital before year-end.
Q:What are your thoughts on the safety of the CLL study, particularly regarding potential adverse events (AEs) in the combination therapy?
A:The company does not expect additive toxicities with BTK inhibitors, as they have tested over 25 patients with ibrutinib and observed a clean safety profile. They will conduct PK work and monitor for any potential toxicities.
Q:What should investors expect from the upcoming SNO meeting?
A:The company will present three posters at the SNO conference, focusing on PCNSL and SCNSL. Dr. Grommes and Dr. Nayak will discuss findings from the last six months and new data on secondary CNS lymphoma, which is harder to treat.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on the delta they aim to achieve in CR rate for the CLL trial, stating only that anything above 20% would be exciting. Additionally, they did not provide detailed financial plans for resource allocation, only mentioning the need to secure additional capital before year-end.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AML Abstracts
AML patient
ASH Annual
Abstracts ASH
Annual Meeting
BTKi monotherapy
BTKi mutation
BTKi regimen
CLL proof
CPK increase
Conference Instructions
Director afternoon
Dr Chief
FDA site
Instructions Thursday
Lymphoma study
MRD cohort
MRD conversion
MRD dosing
MRD patient
MRD reduction
Meeting AML
NHL ability
NHL subtypes
Officer CFO
Officer Dr
TakeAim Lymphoma
aza
disease
life
patient BTKi
patient MRD
patient remission
remission patient
standard care
triplet
week
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