Corvus Pharmaceuticals(US:CRVS)2023-05-09 02:24Financial Data and Key Metrics Changes - The net loss for the first quarter of 2023 was $7.9 million, a slight improvement from a net loss of $8.3 million in the same period in 2022 [48] - Cash, cash equivalents, and marketable securities totaled $34.5 million as of March 31, 2023, down from $42.3 million at the end of 2022 [49] - Research and development expenses decreased to $4.6 million in Q1 2023 from $5.1 million in Q1 2022, reflecting a focus on managing cash burn [3][4] Business Line Data and Key Metrics Changes - The ongoing Phase 1/1b trial of CPI-818 in T cell lymphoma has shown promising results, with two complete responses and three partial responses among 19 evaluable patients [15][19] - The median progression-free survival (PFS) for patients with an absolute lymphocyte count (ALC) above 900 was reported at 19.9 months, compared to just 2.1 months for those below 900 [69] Market Data and Key Metrics Changes - The company is preparing for a meeting with the FDA in Q3 2023 to discuss a Phase 3 clinical trial for CPI-818, which is expected to include approximately 150 patients [5][14] - The company is also focused on expanding the application of CPI-818 beyond T cell lymphoma to solid tumors, supported by recent preclinical data [7][10] Company Strategy and Development Direction - The company is prioritizing CPI-818 as its most advanced ITK inhibitor, aiming for a potential registration trial for T cell lymphoma [10][50] - There is an emphasis on establishing collaborations to support the development of product candidates and managing cash burn effectively [4][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of CPI-818 to address unmet needs in cancer treatment [10][19] - The company plans to present additional interim data at the International Conference on Malignant Lymphoma in June 2023, which may further validate the efficacy of CPI-818 [51][60] Other Important Information - The company has extended its intellectual property covering CPI-818, with patents issued in multiple countries [17] - The safety profile of CPI-818 appears favorable, with no dose-limiting toxicities observed in trials [53] Q&A Session Summary Question: What is the expected design for the Phase 3 trial with the FDA? - Management expects to discuss the trial design and standard therapies in the control arm, with a focus on a randomized controlled trial [74][75] Question: What are the historical response rates for the control agents? - The overall response rate (ORR) for standard agents is about 25%, with short-lived responses [76] Question: Will there be an interim look at the data for response rates? - Management confirmed plans for an interim look at the data, consistent with recent FDA guidelines [43] Question: What is the plan for CPI-818 in immune diseases? - The company is still considering whether to move into immune diseases with CPI-818, depending on progress in cancer indications [91] Question: Is there any delay in the ciforadenant trial? - Management clarified that there is no slowdown in the ciforadenant trial, which is actively enrolling patients [92]