Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Curis Inc (CRIS, Financial) reported encouraging early data from their PCNSL study, showing three complete responses and two partial responses among 10 evaluable patients.
- The company is actively engaging with regulatory authorities to define the registrational path for Emavusertib, indicating progress towards potential approval.
- Curis Inc (CRIS) has shown promising results in their leukemia study, with six of 11 evaluable patients achieving an objective response.
- The company completed a registered direct offering and concurrent private placement, raising approximately $10.8 million, strengthening their financial position.
- Curis Inc (CRIS) expects its existing cash and cash equivalents to support planned operations into mid-2025, providing a stable financial outlook.
Negative Points
- Curis Inc (CRIS) reported a net loss of $10.1 million for the third quarter of 2024, indicating ongoing financial challenges.
- Research and development expenses remain high, with $9.7 million spent in the third quarter of 2024, reflecting significant ongoing investment needs.
- The company faces challenges in patient enrollment for their triplet study, impacting the progress of clinical trials.
- There is uncertainty regarding the FDA's approval path for Emavusertib, which could affect the timeline for bringing the drug to market.
- Curis Inc (CRIS) must prioritize between multiple promising programs, which could lead to resource allocation challenges.
Q & A Highlights
Q: What needs to be done to gain alignment with the FDA for the PCNSL study, and what is the ideal pathway to approval?
A: James Dentzer, President & CEO, clarified that they are not out of alignment with the FDA but are engaging in discussions to explore an accelerated approval path due to promising data in salvage line therapy. The goal is to have clarity on this path by Q1 2025.
Q: How should we think about Curis's expenses going forward, especially considering the recent decrease in general administrative and R&D costs?
A: Diantha Duvall, CFO, stated that the historical burn rate has been in the $10 million to $12 million range. They expect the burn rate to remain around $10 million in 2025, with some variability due to manufacturing timing.
Q: What is the broader potential of Emavusertib in HR MDS, and how representative are mutations in the MDS patient population?
A: James Dentzer noted that MDS is an exciting area with significant potential. They are exploring different dosing regimens and combinations with other agents. The Verona readout will influence future combinations, and they look forward to data updates at ASH.
Q: How will Curis prioritize between the PCNSL program and the AML & MDS programs moving forward?
A: James Dentzer explained that primary CNS lymphoma is currently a high priority due to ongoing discussions with the FDA and the clear unmet need. However, they are also focused on AML & MDS, with upcoming data readouts at ASH that will guide future prioritization.
Q: What is needed for the data package for primary CNS lymphoma, and what are the challenges in enrolling the triplet study?
A: James Dentzer mentioned that discussions with the FDA are ongoing to determine the data package requirements. For the triplet study, the challenge is finding patients who are MRD positive and stable enough for the study. They aim to ensure safety and tolerability before expanding the study.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
