Carisma Therapeutics (CARM) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended 2019 with approximately $48 million in cash and cash equivalents, which is deemed sufficient to fund strategic priorities into 2021 [35] - The company has no debt and ended the year with 106.8 million shares of common stock outstanding, equating to $136 million on a fully diluted basis [35] Business Line Data and Key Metrics Changes - Vicinium is positioned to address a significant unmet need in bladder cancer treatment, with a projected $6 billion burden on payers in the U.S. alone for the year [8] - In Phase III data, 76% of patients were able to avoid radical cystectomy for at least three years, showcasing a strong clinical benefit [12] Market Data and Key Metrics Changes - Approximately 80,000 patients are diagnosed with bladder cancer each year in the U.S., with urologists managing the majority of treatment journeys [8] - Market research indicates that physicians prefer Vicinium over Keytruda for high-risk non-muscle invasive bladder cancer patients about 80% of the time [17] Company Strategy and Development Direction - The company aims to complete its Biologics License Application (BLA) submission this year, with a clear regulatory path forward based on recent FDA meetings [7][31] - A focused commercial model is planned, targeting approximately 1,500 urologists who prescribe the majority of treatments in this category [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path forward and the potential for a successful launch of Vicinium, emphasizing the strong advocacy from stakeholders [36] - The company has not experienced any business disruptions due to the COVID-19 pandemic and is executing risk mitigation strategies [45] Other Important Information - The company has partnered with Fuji and Baxter for manufacturing capabilities to meet global demand for Vicinium [32] - The company plans to initiate a confirmatory trial prior to approval, projecting possible approval in the first half of 2021 [51] Q&A Session Summary Question: Differences in Keytruda data for approval in the U.S. versus outside - Management noted a significant disparity in Keytruda's overall data, with a 41% complete response rate globally compared to roughly 31% in the U.S. [39] Question: Stability data for Vicinium's manufacturing and analytical comparability - Management outlined that the FDA will look for analytical release testing, biophysical characterization, forced degradation studies, and long-term stability studies [41] Question: Modifications due to the pandemic and status of confirmatory trial - Management confirmed that there are currently no significant regulatory or manufacturing risks due to COVID-19 and that the confirmatory trial is projected to start in the first half of 2021 [50][51]