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Autolus(AUTL) - 2019 Q4 - Annual Report
2020-03-03 21:53
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 ...
Autolus(AUTL) - 2019 Q4 - Earnings Call Transcript
2020-03-03 19:38
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]
Autolus Therapeutics (AUTL) Presents At 38th Annual J.P. Morgan Healthcare Conference - Slideshow
2020-01-16 18:56
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]
Autolus(AUTL) - 2019 Q3 - Earnings Call Transcript
2019-11-10 06:47
Autolus Therapeutics plc (NASDAQ:AUTL) Q3 2019 Earnings Conference Call November 7, 2019 8:30 AM ET Company Participants Silvia Taylor - Vice President Global Corporate Affairs & Communications Christian Itin - Chairman & Chief Executive Officer Andrew Oakley - Chief Financial Officer Conference Call Participants Gil Blum - Needham & Company Jim Birchenough - Wells Fargo Matt Phipps - William Blair Aaron Welch - H.C. Wainwright Graig Suvannavejh - Goldman Sachs Biren Amin - Jefferies Miles Dixon - Peel Hun ...
Autolus(AUTL) - 2018 Q4 - Annual Report
2019-02-25 22:16
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 o ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from October 1, 2018 to December 31, 2018 OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECUR ...