Autolus(US:AUTL)2020-05-10 13:38Financial Data and Key Metrics Changes - Net total operating expenses for Q1 2020 were $38.6 million, up from $30.2 million in Q1 2019, primarily due to increased clinical trial activity and headcount [33] - Research and development expenses rose to $31.3 million from $22.6 million year-over-year, with cash costs increasing to $25.6 million from $17.5 million [34] - The net loss attributable to ordinary shareholders was $29.9 million for Q1 2020, compared to $27.2 million for the same period in 2019 [36] - Cash and cash equivalents at the end of Q1 2020 totaled $243.3 million, compared to $210.6 million at the end of December 2019, providing a runway into 2022 [36] Business Line Data and Key Metrics Changes - AUTO1, the lead CAR-T product candidate, received FDA acceptance for its IND application, allowing the initiation of clinical sites for the pivotal study in the U.S. [12] - The AUTO3 program for diffuse large B-cell lymphoma (DLBCL) is ongoing, with plans to present updated data at ASCO [24][29] - The company plans to add a 20-patient outpatient cohort to the ongoing ALEXANDER study for AUTO3 in the second half of the year [32] Market Data and Key Metrics Changes - The market for relapsed/refractory adult ALL is approximately three times the size of pediatric ALL, with about 3,000 patients annually in the U.S. and top five European countries requiring alternative treatment options [17] - The DLBCL indication is about four times larger than relapsed/refractory adult ALL, with approximately 10,000 patients in need of treatment [24] Company Strategy and Development Direction - The company aims to ensure business continuity and maintain clinical trial operations despite COVID-19 challenges, focusing on high medical need patients [9] - The strategy includes expanding access to CAR-T therapies by developing outpatient treatment options, which could significantly increase patient accessibility [41][51] - The company is committed to providing updates on clinical data and milestones throughout 2020, with a focus on pivotal trials for AUTO1 and AUTO3 [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver clinical data on time despite potential COVID-19 impacts, with expectations for continued treatment of severely ill patients [11][23] - The company anticipates that the adjustments made for clinical trial operations will remain relevant throughout the ongoing infection cycle [11] - Management highlighted the importance of both sustained complete responses and safety profiles to improve patient access to therapies [41][44] Other Important Information - The company plans to present preclinical data updates at AACR II in late June, including programs for prostate cancer and small cell lung cancer [15] - The company has a strong balance sheet, providing a runway into 2022, which positions it well for upcoming clinical milestones [39] Q&A Session Summary Question: What is more important for DLBCL, patient accessibility or duration of response? - Management stated that both aspects are crucial, emphasizing the need for sustained complete responses and an excellent safety profile to reach a broader patient population [41][44] Question: What is the profile of patients in the AUTO3 outpatient program? - Management indicated that the outpatient cohort would not differ significantly from inpatient patients, as the need for inpatient treatment is primarily due to the management of therapy-induced toxicities [50][51] Question: If a no-go decision is made on AUTO3, will the outpatient study continue? - Management expressed confidence in the program and indicated that generating data from the outpatient cohort would still be valuable, regardless of the decision on the Phase II portion [53] Question: What are the plans for treating Grade I/II CRS in the outpatient cohort? - Management noted that treatment would vary by institution, with some patients potentially managed in facilities close to the treatment center [78]