Curis, Inc. Q2 2025: Unraveling Contradictions in Enrollment Strategy, FDA Dynamics, and PCNSL Data Expectations

Enrollment strategy and site expansion, company's stance on FDA leadership changes, PCNSL data and enrollment expectations, EMA's expectations for PCNSL data, PCNSL development and regulatory alignment are the key contradictions discussed in Curis, Inc.'s latest 2025Q2 earnings call.



Progress in PCNSL and AML Studies:
- Curis continues to advance its TakeAim Lymphoma study, evaluating emavusertib in combination with ibrutinib in patients with PCNSL, with an ORR endpoint.
- The company expects the study to support accelerated submissions in the U.S. and Europe and plans to enroll 30 to 40 additional patients for NDA and EMA submissions.
- The progress is driven by collaborative discussions with FDA and EMA and promising data from AML studies.

Potential of Emavusertib in CLL:
- Curis aims to initiate a proof-of-concept study in relapsed/refractory CLL patients, targeting 20 to 30 patients, to evaluate the potential of emavusertib in combination with BTK inhibitors.
- The goal is to achieve deeper responses and potentially enable patients to come off treatment, reducing the risk of BTKi-resistant mutations.
- This strategy is based on the enthusiasm and support from KOLs, who believe emavusertib could fundamentally change the treatment paradigm for CLL and NHL patients.

AML and MDS Developments:
- Curis is focusing on developing emavusertib in the relapsed/refractory AML setting by comparing it to gilteritinib in a registrational study.
- Emavusertib's novel mechanism, which blocks both IRAK4 and FLT3, has shown promising composite CR rates in salvage line settings.
- The company is also exploring the potential of emavusertib in high-risk MDS, following the announcement that the VERONA study testing the combination of venetoclax and azacitidine missed its primary endpoint.

Financial Update and Cash Runway:
- Curis reported a net loss of $8.6 million or $0.68 per share for Q2 2025, compared to $11.8 million or $2.03 per share in Q2 2024.
- Research and development expenses decreased primarily due to lower employee-related costs, research, consulting, and clinical costs.
- The company completed a registered direct offering with net proceeds of approximately $6 million, extending its cash runway into Q1 2026.