Curis(CRIS)2024-11-14 16:02Financial Data and Key Metrics Changes - Curis reported a net loss of $10.1 million or $1.70 per share for Q3 2024, an improvement from a net loss of $12.2 million or $2.13 per share in Q3 2023 [11] - For the nine months ended September 30, 2024, the net loss was $33.8 million or $5.77 per share, compared to a net loss of $35.7 million or $6.96 per share for the same period in 2023 [11] - Research and development expenses decreased to $9.7 million in Q3 2024 from $10.4 million in Q3 2023, primarily due to lower consulting and employee-related costs [12] - General and administrative expenses were $3.8 million in Q3 2024, down from $4.8 million in Q3 2023, attributed to lower legal and employee-related costs [13] - Cash and cash equivalents totaled $31.6 million post-offering, expected to fund operations into mid-2025 [14] Business Line Data and Key Metrics Changes - The TakeAim Leukemia Study is evaluating emavusertib in combination with ibrutinib for relapsed/refractory PCNSL patients, showing early promising results with 3 complete responses and 1 unconfirmed complete response among 10 evaluable patients [7][8] - In the TakeAim Leukemia Study for relapsed/refractory AML, 6 of 11 evaluable patients achieved an objective response, including 3 complete responses [9] Market Data and Key Metrics Changes - The company is actively engaging with regulatory authorities in the U.S., Europe, and Israel to define the registrational path for emavusertib [8] - The market for primary CNS lymphoma is highlighted as having a critical unmet need, with no approved drugs currently available [18] Company Strategy and Development Direction - The company is prioritizing the development of emavusertib for primary CNS lymphoma due to the promising data and the significant unmet need in this area [34] - There is an ongoing exploration of combining emavusertib with other agents for MDS, with upcoming data expected to inform future strategies [25][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the data from ongoing studies and the potential for accelerated approval pathways with the FDA [18] - The company anticipates maintaining a burn rate of around $10 million in 2025, with variations based on manufacturing timing [20] Other Important Information - Curis completed a registered direct offering and private placement in October 2024, raising approximately $10.8 million [14] - The company is preparing for data presentations at upcoming ASH meetings, which are expected to provide further insights into their studies [10] Q&A Session Summary Question: Alignment with FDA on PCNSL - Management clarified that discussions with the FDA are ongoing and not out of alignment, aiming for an accelerated approval path due to promising early data [16][18] Question: Future Expense Projections - Management indicated that the historical burn rate is expected to stabilize around $10 million for 2025, with some variability [20] Question: MDS Potential and Gene Signatures - Management acknowledged the exciting potential in MDS and the need for further data to understand the broader implications of their findings [25] Question: PCNSL Trial and FDA Concerns - Management confirmed that discussions with the FDA are evolving, and the study design is intended to address potential questions regarding treatment efficacy [28][30] Question: Prioritization of Programs - Management stated that primary CNS lymphoma is currently the highest priority due to the clear unmet need and promising data, while also considering other therapeutic areas [34][35] Question: Data Package for Primary CNS Lymphoma - Management discussed the need for a sufficient safety database and the potential for a smaller study size if accelerated approval is granted [43] Question: Enrollment Challenges in Triplet Study - Management noted that challenges in enrollment are related to identifying suitable patients rather than safety concerns, and they plan to expand sites once safety is established [46]