Curis(US:CRIS)2021-11-10 03:38Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of $11.1 million or $0.12 per share, compared to a net loss of $6 million or $0.11 per share in Q3 2020 [32] - Revenues for Q3 2021 were $3 million, up from $2.7 million in Q3 2020, while revenues for the nine months ended September 30, 2021, were $7.5 million, down from $7.8 million in the same period in 2020 [33] - Operating expenses for Q3 2021 were $13.1 million, compared to $7.5 million in Q3 2020, with R&D expenses increasing to $8.6 million from $4.7 million in the same period [34][36] Business Line Data and Key Metrics Changes - The lead asset, CA-4948, is being evaluated in nine distinct patient populations across AML, MDS, and B cell cancers, showing a well-tolerated safety profile and improved efficacy [5][7] - CI-8993, a monoclonal anti-VISTA antibody, is currently in a Phase 1 dose escalation study for relapsed or refractory solid tumors, with initial safety data expected in January 2022 [28][30] Market Data and Key Metrics Changes - The company is focusing on the unmet needs in AML and MDS, where many patients currently only have supportive care options [5][20] - CA-4948 has shown potential in crossing the blood-brain barrier, indicating possible applications in primary central nervous system lymphoma [26] Company Strategy and Development Direction - The company aims to expand clinical investment in both monotherapy and combination therapy for CA-4948, targeting a broad spectrum of patients from low-risk MDS to high-risk AML [22] - The combination study of CA-4948 with ibrutinib is expected to enhance anti-tumor activity, with initial data anticipated in 2022 [24][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the potential for CA-4948 to provide a transformative treatment option for patients with AML and MDS [22][25] - The company plans to provide updates on safety and efficacy data in January 2022, which will include a larger dataset than previously presented [30][46] Other Important Information - As of September 30, 2021, the company had cash, cash equivalents, and investments totaling $149.8 million, expected to sustain operations into 2024 [40] - The company is collaborating with regulatory consultants to prepare for discussions with the FDA regarding the potential registrational path for CA-4948 [44][45] Q&A Session Summary Question: FDA conversation timing and patient data sufficiency - Management indicated that discussions with the FDA would likely occur after a more robust data update, aiming for 10 to 20 patients by year-end [42][44] Question: Safety of the ibrutinib combination - Management confirmed that there were no dose-limiting toxicities observed in the combination study, indicating good tolerability [47][48] Question: Expectations for B-cell cancer combo data - Management noted that while specific response rates have not been set, they hope to see durable responses and deeper responses than with BTK inhibitors alone [61] Question: Natural history of MDS and response rates - Management explained that spliceosome mutations occur early in MDS progression and that response rates vary significantly across disease stages [65][67]