CURIS INC Q2 FY2025 earnings call

• TakeAim Lymphoma study: Evaluating emavusertib + ibrutinib in PCNSL, expect accelerated submissions in US and Europe, need to enroll 30-40 more patients for NDA/EMA. Attended ASCO/EHA, KOLs interested in expanding emavusertib to CLL/NHL.
• CLL proof-of-concept study: Design completed, targeting first patient by year-end, initial data mid-2026.
• AML: ASH data showed 38% composite CR rate in relapsed/refractory AML with FLT3 mutation, plan to conduct registrational study vs gilteritinib; excited about emavusertib in high-risk MDS, potential combo with azacitidine.
• AML triplet study: Phase I study of emavusertib + venetoclax + azacitidine in frontline AML, completed enrollment in 7-day and 14-day regimens, to present at ASH 2025.
• Financials: Completed registered direct offering in July 2025, cash as of June 30, 2025, is $10.1M, expects to fund operations into Q1 2026.

No detailed segment performance by product segments provided; financials noted: Q2 2025 net loss $8.6M, R&D expenses $7.5M (down from $10.3M in 2024), G&A expenses $3.5M (down from $4.8M in 2024); 6 months ended June 30, 2025, R&D $16M (down from $19.9M in 2024), G&A $7.5M (down from $9.7M in 2024); cash/cash equivalents $10.1M as of June 30, 2025.

• TakeAim Lymphoma study: Enroll 30-40 additional patients over 12-18 months for NDA/EMA submissions.
• CLL proof-of-concept study: Target first patient by year-end, initial data mid-2026.
• AML triplet: Expect to present data at ASH 2025.
• Cash: Existing cash and July offerings expected to fund operations into Q1 2026.

• Uncertainties in FDA and EMA submissions for TakeAim Lymphoma study.
• Competition from BTK degraders and next-gen BCL2 inhibitors in CLL.
• Uncertainties in timing and data from investigator-sponsored solid tumor studies.
• General risks related to clinical trial outcomes and regulatory approvals.

Q: For the BTK combination study in CLL, what's the bar and how fits in with BTK degraders?

A: Adding emavusertib to BTK inhibitor can lead to MRD-negative/complete remissions, intend to combine with commercially available BTKi, degraders still in development.

Q: On AML triplet data, expectations?

A: Plan to present efficacy/safety data from 7-day and 14-day cohorts at ASH 2025.

Q: Enrollment plans for CLL program?

A: Patients post BTKi, on commercially available BTK inhibitor, can be in second line etc.

Q: PCNSL data update and clinical sites?

A: Stay tuned for data, currently sites on track, no need to open additional sites.

Q: Impact of FDA changes on PCNSL accelerated approval?

A: No change in plans, had alignment with FDA, lead indication in PCNSL has no approved drugs.

Q: Cash runway and BD efforts?

A: Cash runway into 2026, continually evaluating dilutive/non-dilutive opportunities.

Q: Prioritization of development programs?

A: Active discussions on capital-efficient spending, disciplined approach.

Q: Tirabrutinib data in PCNSL and relevance?

A: Tirabrutinib data interesting, goal is to add emavusertib to any BTK regimen for better efficacy.

Q: Triplet AML frontline safety and efficacy?

A: Excited to present data at ASH, careful not to pre-empt data release.