Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q1 2024 Earnings Presentation
25 slides from Autolus Therapeutics's earnings presentation, May 17, 2024
Slide 1: Q1 2024 Financial Results and Business Updates
Q1 2024 Financial Results and Business Updates 17 May 2024 Autolus.com
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies Disclaimer These slides contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and i
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies Agenda • Welcome and Introduction: Olivia Manser, Director, Investor Relations • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr. Christ
Slide 4: Autolus executed to plan in Q1 2024
Developing Next Generation Programmed T Cell Therapies Autolus executed to plan in Q1 2024 • Obe-cel progressed according to plan – BLA accepted with a PDUFA target date of November 16 – MAA accepted by EMA end of Q1 – Commercial and clinical license received by MHRA for Nucleus manufacturing facili
Slide 5: Obe-cel pooled analysis
ASH 2023 Obe-cel pooled analysis FELIX Phase 1b/2 trial
Slide 6: Reliable obe-cel supply for FELIX despite the COVID–19 pandemic
Developing Next Generation Programmed T Cell Therapies Reliable obe-cel supply for FELIX despite the COVID–19 pandemic • US international airline flights decreased by 41% compared to flights from pre-COVID–19 pandemic1 • BUT international flights are reliable and on time • Sample collection and drug
Slide 7: FELIX Phase 1b/2 pooled analysis: patient disposition
Developing Next Generation Programmed T Cell Therapies FELIX Phase 1b/2 pooled analysis: patient disposition 127/153 (83%) enrolled patients received obe-cel* n (%) Enrolled** Discontinued 26 (17) N = 153 Death 15 (10) Manufacturing-related 7 (5) Adverse event 2 (1) Morphologic disease*** (n = 98) P
Slide 8: FELIX Phase 1b/2 pooled analysis: EFS in all treated patients
Developing Next Generation Programmed T Cell Therapies FELIX Phase 1b/2 pooled analysis: EFS in all treated patients* The event-free survival estimate at 12 months was 50% 100 All treated patients 90 Overall (N = 127) (N = 127) 80 Median EFS 70 11.7 (95% CI), (7.2, NE) 60 months Probability (%) 50 6
Slide 9: FELIX Ph1b/2 pooled: EFS by leukemic burden prior to lymphodepletion
Developing Next Generation Programmed T Cell Therapies FELIX Ph1b/2 pooled: EFS by leukemic burden prior to lymphodepletion* Lower leukemic burden is associated with better outcomes <5% (n = 36) 100 ≥5−≤75% (n = 51) 90 >75% (n = 40) 80 70 Probability (%) 60 50 40 Events, n: <5% 10 30 ≥5−≤75% 22 >75%
Slide 10: FELIX Phase 1b/2 pooled analysis: CRS and ICANS
Developing Next Generation Programmed T Cell Therapies FELIX Phase 1b/2 pooled analysis: CRS and ICANS Low rates of Grade ≥3 CRS and/or ICANS were observed CRS and ICANS in all patients CRS by % BM blasts ICANS by % BM blasts 100 100 100 88% 80 80 80 69% 69% Incidence, % Incidence, % Incidence, % 60
Slide 11: Commercial Launch Readiness
Commercial Launch Readiness
Slide 12: Obe-cel steps to commercialization
Developing Next Generation Programmed T Cell Therapies Obe-cel steps to commercialization Roadmap to a commercial launch in r/r adult ALL Q1 Q2 Q3 Q4 Obe-cel BLA Nucleus MHRA inspection & approval Obe-cel FDA accepted by FDA Obe-cel EMA MAA MHRA PDUFA authorization application Obtained MHRA MIA toge
Slide 13: The Nucleus – Our Commercial Manufacturing Facility
Developing Next Generation Programmed T Cell Therapies The Nucleus – Our Commercial Manufacturing Facility State of the art design and operations established – groundbreaking to complete validation in 2 years • ~70,000 sq ft facility Design Build Operations • Modular build using PAMs • 70% built off
Slide 14: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 15: The obe-cel product family and franchise opportunity
Developing Next Generation Programmed T Cell Therapies The obe-cel product family and franchise opportunity • Optimized CD19 CAR design B-ALL and B-NHL Obe-cel • Potential best-in-class efficacy and safety profile CD19 • Supported by state-of-the-art manufacturing B-cell mediated • Supported by matu
Slide 16: Dynamic environment in cell therapy for autoimmune patients
Developing Next Generation Programmed T Cell Therapies Dynamic environment in cell therapy for autoimmune patients Thoughts on clinical data from compassionate use and limited clinical trial experience • Available clinical data is largely based on compassionate use experience, not clinical trials •
Slide 17: Systemic Lupus Erythematosus (SLE) and autoimmunity: a new space for CAR T
Systemic Lupus Erythematosus (SLE) and autoimmunity: a new space for CAR T Obe-cel is similar to Erlangen CD19 CART • Erlangen CD19 CART was developed for treating Differentiated CD19 engagement (fast off-rate) paediatric ALL Shorter half-life of interaction On-Rate: Ka [M-1S-1] ]1 – CD19 CAR is ide
Slide 18: Phase 1 study in r/r SLE – open for enrollment
Autoimmune Developing Next Generation Programmed T Cell Therapies Phase 1 study in r/r SLE – open for enrollment Primary goal of the Phase 1 study will be confirming the fixed dose in adult SLE patients CARLYSLE Study • A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability an
Slide 19: Other pipeline programs and technologies
Other pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 20: Autolus pipeline
Developing Next Generation Programmed T Cell Therapies Autolus pipeline Obe-cel product family Product Indication Target Study Name Partner Phase Status/Expected Milestones Submitted to EMA and FDA Obe-cel Adult B-ALL CD19 FELIX Pivotal (PDUFA November 16, 2024) Obe-cel Systemic Lupus Erythematosus
Slide 21: Financial Results
Financial Results
Slide 22: Financial summary (unaudited)
Building a fully integrated, next-generation CAR T company Financial summary (unaudited) USD Q1 2024 ($ '000) Q1 2023 ($ '000) Variance ($ '000) License revenues 10,091 1,292 8,799 R&D (30,671) (27,388) (3,283) G&A (18,177) (9,284) (8,893) Loss on disposal of property and equipment - (3,768) 3,768 T
Slide 23: Upcoming news flow
Upcoming news flow
Slide 24: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies Autolus planned news flow Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel FELIX data update at ASCO, EHA & ASH 2024 June & December 2024 Obe-cel Marketing Authorization Application to MHRA Second half 2024 Obe-cel U.S. FDA PDU
Slide 25: Thank you
Thank you Autolus.com