Curis(US:CRIS)2024-05-08 00:08Financial Data and Key Metrics Changes - Curis reported a net loss of $11.9 million or $2.05 per share for Q1 2024, compared to a net loss of $11.6 million or $2.39 per share for the same period in 2023 [43] - Research and development expenses increased to $9.6 million in Q1 2024 from $9.1 million in Q1 2023, primarily due to higher employee-related costs [43] - General and administrative expenses were $4.9 million for Q1 2024, slightly up from $4.8 million in Q1 2023 [19] Business Line Data and Key Metrics Changes - The company is focusing on three key areas: emavusertib as a monotherapy for relapsed/refractory AML, as a doublet therapy for primary CNS lymphoma, and as a triplet therapy in frontline AML [15] - Enrollment has begun for the triplet therapy study, which combines emavusertib with azacitidine and venetoclax [7][18] Market Data and Key Metrics Changes - The company expects to report data for 30 relapsed/refractory AML patients treated with emavusertib, including 25 new patients [4] - The response rate for existing treatments in the splicing factor mutation population is notably low, with a benchmark of 0% response rate for Aza-ven [6] Company Strategy and Development Direction - Curis aims to establish emavusertib as a best-in-class treatment for FLT3 AML and to explore its potential in the splicing factor mutation population, which currently has no approved therapies [17][84] - The company is also looking to develop a companion diagnostic for genetically driven populations, depending on FDA discussions [46] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming clinical data and the potential for emavusertib to show significant activity in challenging patient populations [42][84] - The company is preparing for discussions with the FDA regarding the registration path for both FLT3 and splicing factor mutation studies [72][93] Other Important Information - Curis has a solid cash position with $40.7 million in cash, cash equivalents, and investments as of March 31, 2024, which is expected to support operations through 2025 [19] - The company is experiencing strong enrollment rates in its studies, reflecting a significant unmet need in AML [61] Q&A Session Summary Question: Will data for both FLT3 and spliceosome mutants be presented? - Yes, data for both populations will be presented, with a top-line review expected [45] Question: Will there be additional data at the EHA conference? - Yes, additional details will be provided at both conferences compared to the abstract data [27] Question: What is the expected response rate benchmark for FLT3 patients? - The benchmark for FLT3 inhibition is gilteritinib, which has a CR/CRh rate of 21% [40] Question: How will the company approach the development of a companion diagnostic? - The company plans to consider a companion diagnostic for genetically driven populations, depending on FDA guidance [46] Question: What is the enrollment status for BTK-naive patients in the lymphoma study? - The study includes both BTK-naive and BTK-experienced patients to compare outcomes [60]