Autolus Therapeutics plc (NASDAQ:AUTL) Q4 2020 Earnings Conference Call March 4, 2021 8:30 AM ET Company Participants Lucinda Crabtree – Vice President-Investor Relations Christian Itin – Chairman and Chief Executive Officer Andrew Oakley – Chief Financial Officer Conference Call Participants Hannah Adeoye – JP Morgan Mara Goldstein – Mizuho Ingrid Gafanhão – Kempen Matt Phipps – William Blair Nick Abbott – Wells Fargo Biren Amin – Jefferies Operator Hello, ladies and gentlemen, and welcome to the Autolus T ...

Autolus Therapeutics PLC (NASDAQ:AUTL) Q3 2020 Earnings Conference Call November 5, 2020 8:30 AM ET Company Participants Lucinda Crabtree - VP, IR & Corporate Communications Christian Itin - Chairman & CEO Andrew Oakley - CFO & SVP Conference Call Participants James Birchenough - Wells Fargo Securities Gil Blum - Needham & Company Gabriel Fung - Mizuho Securities Graig Suvannavejh - Goldman Sachs Group Dingding Shi - Jefferies Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Thi ...

AUTO1 - Adult Acute Lymphoblastic Leukemia (ALL) - AUTO1 is designed for adult ALL patients, aiming for high activity, long persistence, and good tolerability [12, 13] - In a study with all patients, AUTO1 achieved a complete remission (CR) rate of 84%, and with a closed process, the CR rate was 92% [20] - At 6 months, the event-free survival (EFS) for all patients was 62%, and for those treated with the closed manufacturing process, it was 76% [20] - The company is on track for full data from the pivotal study AUTO1-AL1 by the end of 2021 [31] AUTO3 - Diffuse Large B Cell Lymphoma (DLBCL) - AUTO3, combined with pembrolizumab, demonstrated an overall response rate (ORR) of 65% and a complete response rate (CRR) of 48% across all dose levels [39] - At dose levels ≥ 150 x 10^6 cells, the ORR was 69% and the CRR was 56% [39] - At dose levels ≥ 150 x 10^6 with Day -1 pembro, the ORR was 75% and the CRR was 63% [39] - Notably, there were no Grade 3 or higher cytokine release syndrome (CRS) events observed at ≥ 150 x10^6 cell dose [35] Pipeline and Future Development - The company has a broad pipeline of next-generation programs designed to address limitations of current T cell therapies [8, 69] - Autolus plans to start Phase 1 trials for AUTO1NG, AUTO8 in H2 2020, and AUTO5, AUTO6NG, AUTO7 in 2021 [70, 95] - The company had $212 million cash on hand as of June 30, 2020 [97]

Autolus Therapeutics PLC (NASDAQ:AUTL) Q2 2020 Earnings Conference Call August 6, 2020 8:30 AM ET Company Participants Lucinda Crabtree - VP, IR & Corporate Communications Christian Itin - Chairman & CEO Andrew Oakley - CFO & SVP Conference Call Participants Mara Goldstein - Mizuho Securities Biren Amin - Jefferies Eric Joseph - JPMorgan Chase & Co. James Birchenough - Wells Fargo Securities Asthika Goonewardene - Truist Securities Robert Andrew - William Blair & Company Graig Suvannavejh - Goldman Sachs Gr ...

Clinical Program Updates - AUTO1 pivotal study in adult ALL was initiated in Q2 2020 as planned, with full data expected by the end of 2021[8, 9, 19] - AUTO3 continues to enroll patients in DLBCL study, with outpatient cohort initiated and next data update at ESMO in September 2020 and Q4 2020[8, 10] - AUTO4 Phase 1 clinical trial in TRBC1+ Peripheral TCL experienced enrollment pause due to COVID-19, with first data expected in H1 2021[8] - AUTO1NG in pALL and AUTO8 in multiple myeloma are on track to start Phase 1 in H2 2020[8] - AUTO5, AUTO6NG, and AUTO7 are expected to enter clinical development in 2021[8, 12] Corporate Highlights - Dr Jay T Backstrom was appointed to the Board of Directors[13] - Dr Nushmia Khokhar was promoted to Senior Vice President, Clinical Development[13] - Manufacturing capacity was extended at the Cell and Gene Therapy Catapult to secure initial commercial launch capability[13] Financial Overview - Cash balance as of June 30, 2020, was $212 million[33, 37] - Total operating expenses, net, for Q2 2020 were $39.5 million, compared to $37.2 million for Q2 2019[33] - Net loss for Q2 2020 was $32 million, compared to $28.5 million for Q2 2019[33]

Financial 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]