Autolus(US:AUTL)2020-03-03 19:38Financial Data and Key Metrics Changes - Total net operating expenses for the year ended December 31, 2019, were $146 million, up from $74.1 million in 2018, primarily due to increased development activity and headcount [31] - Research and development expenses rose to $105.4 million in 2019 from $48.3 million in 2018, with cash costs increasing to $83.4 million from $41.5 million [32] - Net loss attributable to ordinary shareholders was $123.8 million for 2019, compared to $57.9 million in 2018, with a basic and diluted net loss per share of $2.88 versus $1.48 in the previous year [34] Business Line Data and Key Metrics Changes - AUTO1 in adult ALL showed a complete response rate of 87% compared to 42% for blinatumomab, with event-free survival at 68% versus 31% for blinatumomab [17] - AUTO3 in DLBCL demonstrated a response rate of 71% with no patients experiencing grade 3 or higher cytokine release syndrome [25] - The manufacturing capabilities at the Catapult site are fully operational, with plans to increase capacity to treat 5,000 patients per year [11] Market Data and Key Metrics Changes - Approximately 8,400 patients are diagnosed with adult ALL annually, with 6,000 from the U.S. and top 5 European countries, indicating a significant market opportunity [11] - DLBCL represents a large commercial opportunity with about 24,000 patients diagnosed each year in the U.S., and an addressable population of approximately 10,000 patients in the U.S. and EU5 combined [19] Company Strategy and Development Direction - The company is focused on progressing AUTO1 and AUTO3, with pivotal studies expected to commence in 2021 and target approval in 2022 [6][7] - Plans to initiate Phase I studies for AUTO1NG in pediatric ALL and AUTO8 in multiple myeloma in 2020, along with ongoing development of AUTO4 and AUTO6NG [35] - The company aims to solidify its scalable manufacturing platform to support clinical programs and expand its product pipeline [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in AUTO1's potential to be a best-in-class CD19 CAR T therapy for adult ALL, citing positive safety and efficacy data [36] - The company anticipates a busy 2020 with multiple clinical milestones and updates across various programs [35] - Management highlighted the importance of addressing the high unmet need in relapsed/refractory settings for both adult ALL and DLBCL [12][20] Other Important Information - The company completed two successful fundraisings in 2019, raising approximately $184 million in net proceeds [10] - Cash and cash equivalents at the end of 2019 totaled $210.6 million, providing a runway into 2022 [34] Q&A Session Summary Question: What are the barriers to outpatient treatment with AUTO CAR Ts in DLBCL? - Management noted that current CAR T therapies require intense management due to adverse event profiles, limiting outpatient treatment [38][40] Question: What is the acceptable level of neurotoxicity for AUTO3? - A low level of neurotoxicity is acceptable, with management aiming to avoid high-grade cytokine release syndrome [44] Question: What are the expectations for the AUTO4 program? - Management seeks good response levels and durability of responses in T-cell lymphoma patients, with a lower bar compared to other indications [46] Question: What is the status of the AUTO1 pivotal trial? - Enrollment in the U.K. is expected to start soon, with the U.S. IND filing anticipated this month [68][70]