Release Date: May 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Curis Inc (CRIS, Financial) has welcomed Dr. Ahmed Hamdy as the new Chief Medical Officer, bringing extensive industry experience.
- The TakeAim lymphoma study shows promising results with emavusertib in combination with ibrutinib, demonstrating significant tumor burden reduction in PCNSL patients.
- Curis Inc (CRIS) reported a decrease in net loss for the first quarter of 2025 compared to the same period in 2024, indicating improved financial performance.
- The company successfully completed a registered direct financing and concurrent private placement, raising approximately $8.8 million.
- Curis Inc (CRIS) has a solid cash position with $20.3 million in cash and cash equivalents, expected to support operations into the fourth quarter of 2025.
Negative Points
- Curis Inc (CRIS) reported a net loss of $10.6 million for the first quarter of 2025, indicating ongoing financial challenges.
- Research and development expenses remain high at $8.5 million for the first quarter of 2025, despite a decrease from the previous year.
- The company faces uncertainties in regulatory approval processes, particularly in expanding emavusertib's use beyond primary CNS lymphoma.
- Enrollment challenges persist in the TakeAim lymphoma study, requiring additional patients for NDA submission.
- Curis Inc (CRIS) is reliant on existing cash reserves, which are only expected to last until the fourth quarter of 2025, necessitating further funding efforts.
Q & A Highlights
Q: How does Curis plan to prioritize between lymphoma and AML, and what steps are being taken to accelerate the enrollment of the lymphoma study?
A: James Dentzer, President and CEO, explained that Curis is advancing both lymphoma and AML simultaneously, with more resources dedicated to the PCNSL study due to its advanced stage. The focus is on enrolling 30 to 40 additional patients for NDA submission. Jonathan Zung, Chief Development Officer, added that they have 37 sites open and are engaging regularly with investigators to drive enrollment.
Q: Are there plans to add more sites for the lymphoma study, and are there any concerns about the FDA's stance given recent changes?
A: Jonathan Zung confirmed that there are no current plans to add more sites beyond the 37 already open. James Dentzer expressed confidence that the FDA's previous agreements will be respected despite recent changes, and Curis is grateful for the collaboration achieved before the current turmoil.
Q: Can you provide insights into the ASCO presentation regarding mutations affecting responses, and any updates on AML development steps for EMA?
A: James Dentzer noted that the primary impact of emavusertib is driven by its mechanism of action rather than specific mutations. Jonathan Zung mentioned that after completing the ongoing triplet safety study, Curis will discuss forward plans for AML development, including potential EMA steps.
Q: What is the strategic focus for expanding emavusertib's use across NHL and AML?
A: James Dentzer highlighted that with Dr. Ahmed Hamdy joining the team, Curis aims to expand emavusertib's use across NHL indications where BTK inhibitors are beneficial. This includes exploring opportunities in CLL, Waldenström's, and other NHL indications.
Q: What are the financial highlights for Curis in the first quarter of 2025?
A: Diantha Duvall, CFO, reported a net loss of $10.6 million for Q1 2025, an improvement from the $11.9 million loss in Q1 2024. The decrease in R&D and G&A expenses was primarily due to lower employee-related costs. Curis completed a financing round with net proceeds of $8.8 million, and cash and cash equivalents totaled $20.3 million as of March 31, 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
