Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q3 2023 Earnings Presentation
23 slides from Autolus Therapeutics's earnings presentation, Nov 2, 2023
Slide 1: Third Quarter Financial Results and Operational Progress
Third Quarter Financial Results and Operational Progress November 2, 2023
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies 2 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
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies 3 Agenda • Welcome and Introduction: Julia Wilson Communications Consultant • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr. Christian
Slide 4: Obe-cel highlights
Developing Next Generation Programmed T Cell Therapies 4 Obe-cel highlights Continued progress against strategic and operational goals • obe-cel in relapsed / refractory (r/r) adult ALL Clinical – Oral presentation on longer follow up of FELIX study at ASH conference on Dec 9, 2023 – Initiation of p
Slide 5: Other pipeline highlights during the period
Developing Next Generation Programmed T Cell Therapies 5 Other pipeline highlights during the period • Expanding the obe-cel opportunity – Phase 1 dose confirmation study in refractory systemic lupus erythematosus (SLE) to start in early 2024 – ALLCAR19 extension study of obe-cel in r/r B-NHL and CL
Slide 6: Obe-cel
LEAD CLINICAL PROGRAM Obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 7: Obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies 7 Obe-cel has a unique mechanism of action Designed for increased activity and reduced toxicity Differentiated CD19 binder Fast off-rate Shorter half-life of interaction compared On-Rate: Ka [M-1S-1] ]1 CD19 binder with - - S1 Other CD19 Binders
Slide 8: Summary of FELIX data at ASCO and EHA 2023
Developing Next Generation Programmed T Cell Therapies 8 Summary of FELIX data at ASCO and EHA 2023 • CR/CRi rate of 76%, with 97% of responders becoming MRD negative – With a median of 9.5 months’ follow-up, 61% of responders remain in remission • Very low rates of Grade ≥3 CRS (3.2%) and low rates
Slide 9: Data updates planned for ASH, December 9 – 12, 2023
Developing Next Generation Programmed T Cell Therapies 9 Data updates planned for ASH, December 9 – 12, 2023 Abstracts published online today Obe-cel: Oral presentation of FELIX study - pooled Obe-cel: Pooled analysis from ALLCAR19 and analysis of Phase Ib and Phase II cohorts FELIX, and ALLCAR19 ex
Slide 10: Commercial Launch Readiness
Commercial Launch Readiness
Slide 11: Obe-cel steps to commercialization
Developing Next Generation Programmed T Cell Therapies 11 Obe-cel steps to commercialization Roadmap to a 2024 commercial launch H2 2023 H1 2024 Manufacturing BLA filing GMP license EU authorization Facility application Filing of Biologics Filings of EU marketing License Application authorization ap
Slide 12: The Nucleus
Developing Next Generation Programmed T Cell Therapies 12 The Nucleus State of the art design and operations established – validation completed Design Build Operations • ~70,000 sq ft facility • Nov 8, 2021 ground breaking • Dec 14, 2022 first Prodigy operational • Modular build using PAMs • Nov 25,
Slide 13: Building the obe-cel opportunity and pipeline
Building the obe-cel opportunity and pipeline
Slide 14: The obe-cel product family and franchise opportunity
Developing Next Generation Programmed T Cell Therapies Autolus.com 14 The obe-cel product family and franchise opportunity • Optimal 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 • Supp
Slide 15: Uniquely positioned to deliver CAR T therapy in autoimmune disease
Developing Next Generation Programmed T Cell Therapies 15 Uniquely positioned to deliver CAR T therapy in autoimmune disease Obe-cel’s potential advantages Supporting evidence Outstanding tolerability to drive physician and ✓ Potential best-in-class risk/benefit profile in pivotal FELIX trial in adu
Slide 16: Obe-cel ideally positioned as potential best in class and fastest to market
Developing Next Generation Programmed T Cell Therapies 16 Obe-cel ideally positioned as potential best in class and fastest to market Could offer fastest and lowest risk cell therapy approach for B-cell mediated autoimmune diseases Established Established Manufacturing Commercial Comment Tolerabilit
Slide 17: Autolus pipeline
Developing Next Generation Programmed T Cell Therapies Autolus.com 17 Autolus pipeline PRODUCT INDICATION TARGET STUDY NAME COLLABORATION PHASE UPCOMING CATALYST Q4 2023: FELIX data updates Obe-cel Adult B-ALL CD19 FELIX Pivotal Q4 2023: BLA filing with FDA Systemic Lupus Obe-cel CD19 TBD Preclinic
Slide 18: Financial Results
Financial Results
Slide 19: Financial summary
Building a fully integrated, next-generation CAR T company 19 Financial summary Cash runway into 2025 USD Q3 2023 ($ '000) Q3 2022 ($ '000) Variance ($ '000) Grant Income - - - License Income 406 2,369 (1,963) R&D (37,237) (37,632) 395 G&A (10,611) (8,231) (2,380) Impairment of operating lease right
Slide 20: Summary
Summary
Slide 21: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies 21 Autolus planned news flow Milestone or Data Catalysts Timing Obe-cel Biologics License Application (BLA) to FDA By end 2023 Obe-cel FELIX data update at ASH Dec 2023 AUTO8 update (MCARTY) at ASH Dec 2023 AUTO6NG Phase 1 study start (MAGNETO)
Slide 22: Building a leading CAR T company developing transformational therapies for cancer and autoimmune diseases
Developing Next Generation Programmed T Cell Therapies 22 Building a leading CAR T company developing transformational therapies for cancer and autoimmune diseases Established excellence in R&D and Manufacturing; scaling company toward commercialization $ Obe-cel approaching Pipeline expansion Scala
Slide 23: Thank you
Thank you autolus.com