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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from to OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Financial 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]

Pipeline and Programs - Autolus has a broad clinical-stage pipeline with 4 product candidates across 4 hematological indications and 1 solid tumor program[4] - The company is using a modular programming approach, enabling rapid innovation, with 4 next-generation versions of lead programs planned to enter clinical development in 2020[4] - AUTO1NG, a dual-targeting therapy with CD19 and CD22 CARs, is planned to enter clinical testing in H1 2020 for pediatric ALL[32] - AUTO6NG, designed to address a hostile tumor microenvironment, is planned to commence Phase 1 in H2 2020[78] AUTO1 in Adult ALL - AUTO1 is designed for long-term persistence and reduced high-grade CRS in adult ALL patients[13] - Preliminary data for AUTO1 shows an 87% CR rate in all patients and a 100% CR rate using a closed process[27] - 10 out of 15 (67%) evaluable patients treated with AUTO1 remain disease-free with a median follow-up of 11 months[22] - A potential pivotal study in adult ALL is planned, with a BLA filing targeted for Q4 2021[31] AUTO3 in DLBCL - Preliminary efficacy data for AUTO3 in DLBCL shows an overall response rate of 57% in evaluable patients, with a CR rate of 36%[42] - 4 out of 5 (80%) CRs achieved with AUTO3 are ongoing[42] - 0% severe CRS and 7% severe NT were observed with primary infusion of AUTO3[44] Financials and Manufacturing - Autolus had $229 million in cash as of September 30, 2019, providing a cash runway into H2 2021[4] - The company is expanding to new US/UK facilities and plans a commercial site with a capacity of 5,000 patients per year[4, 11]