Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Investor Presentation (March 2025)
33 slides from Autolus Therapeutics's investor presentation, Mar 20, 2025
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies March 2025 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: Autolus is positioned for commercial execution and market expansion
Developing Next Generation Programmed T Cell Therapies Autolus is positioned for commercial execution and market expansion Obe-cel product franchise supports multiple growth opportunities • EU/UK approvals expected 2H 2025 • Expanding obe-cel opportunity in hem-oncology and autoimmune diseases • Dev
Slide 4: AUCATZYL: Autolus' first approved product
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 5: AUCATZYL now FDA approved
AUCATZYL® now FDA approved ✓ AUCATZYL indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) ✓ First chimeric antigen receptor T-cell (CAR T) therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigatio
Slide 6: Important Safety Information
Important Safety Information • The safety of AUCATZYL includes a boxed warning for CRS, neurologic toxicities, and secondary hematological malignancies. ICANS, including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL. T-cell malignancies have occurred following treatmen
Slide 7: We believe AUCATZYL has a unique mechanism of action
We believe AUCATZYL® has a unique mechanism of action Clinical data show increased activity and reduced toxicity Fast off-rate 107 Shorter half-life of interaction Other CD19 Binders Obe-cel Binder compared to binders used in On-Rate: Ka [M-1S-1] CAT19 fast off-rate binder² 106 approved products FMC
Slide 8: AUCATZYL was approved based on results from the FELIX trial
AUCATZYL was approved based on results from the FELIX trial Background FELIX Phase 1b/2 • Open-label, multinational, single-arm Phase 1b/2 trial in adult patients with R/R B-ALL1-2; largest CAR T cell therapy trial in R/R B-ALL to date (N=153 enrolled) Cohort IA Cohort IIA ≥5% BM blast ≥5% BM blast
Slide 9: FELIX trial published in New England Journal of Medicine
FELIX trial published in New England Journal of Medicine1 Favourable response rate and tolerability, despite challenging patient population High overall response rate with deep molecular responses Excellent tolerability profile • Durable responses, particularly in patients with a low-to- • Very low
Slide 10: FELIX trial: Tumor burden impact on event-free survival in adult ALL
FELIX trial: Tumor burden impact on event-free survival in adult ALL Survival outcomes show potential of long-term plateau with 12-month EFS rates 49.5% • In all patients, the median EFS was 11.9 months • Lower disease burden at lymphodepletion was associated with better outcomes 1. Roddie C, et al
Slide 11: FELIX trial: Tumor burden impact on overall survival in adult ALL
FELIX trial: Tumor burden impact on overall survival in adult ALL Estimated 6- and 12-month overall survival rates were 80.3% and 61.1%, respectively • In all patients, the median OFS was 15.6 months • Lower disease burden at lymphodepletion was associated with better outcomes 1. Roddie C, et al "Ob
Slide 12: AUCATZYL is poised to fill the unmet need for r/r ALL patients
AUCATZYL® is poised to fill the unmet need for r/r ALL patients •We believe AUCATZYL is a transformative product in the r/r ALL space •Unique MOA designed to deliver potency and persistency that results in deep and durable efficacy •Favorable tolerability profile •Customized tumor-burden guided dosi
Slide 13: Commercial Launch
Commercial Launch
Slide 14: Pillars to drive commercial success
Pillars to drive commercial success Prioritizing authorization of centers Scalable, efficient and reliable supply Post-approval The Nucleus: Autolus’ state-of-the-art, dedicated purpose-built facility 30 key centers primed for activation covering ~ 60% of r/r B-ALL target population Target vein-to-r
Slide 15: Early Momentum in the AUCATZYL Launch
Early Momentum in the AUCATZYL® Launch 33 Treatment Centers Authorized as of 3/19/25 Patient Access is on Track >85% of total U.S. medical lives covered • 30 centers covering 60% of target population completed • Anticipated payor mix: approximately 60% ahead of plan commercial and 40% government/o
Slide 16: The Nucleus: Manufacturing facility supports commercial execution
Developing Next Generation Programmed T Cell Therapies The Nucleus: Manufacturing facility supports commercial execution State of the art design and in-house operations established – groundbreaking to complete validation in 2 years Design Build Operations • Designed for 2,000+ batches per year • Tim
Slide 17: ALL: unmet need and market overview
ALL: unmet need and market overview
Slide 18: Over 8,000 new cases of adult ALL annually worldwide
Over 8,000 new cases of adult ALL annually worldwide Successful therapy requires high level of activity and sustained persistence paired with good tolerability • Median overall survival is < 1 year in r/r adult ALL • 1st line therapy is based on high dose chemotherapy cycles given over a 8,4001 New
Slide 19: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 20: The obe-cel product family and franchise opportunity
The obe-cel product family and franchise opportunity Potential value-creation through multiple life-cycle management and market expansion opportunities • Optimized CD19 CAR design B-ALL Obe-cel • Potential best-in-class efficacy and safety profile B-NHL CD19 • Supported by state-of-the-art manufactu
Slide 21: MOA and established commercial capabilities are key differentiators
MOA and established commercial capabilities are key differentiators Obe-cel is the only CD19 CAR with an FDA approval outside of autoimmune disease Autolus Potential Advantage Favorable tolerability to drive acceptability in non-oncology indications Deep cut into the CD19+ B and plasma cell Supports
Slide 22: Phase 1 study in r/r SLE – enrollment ongoing
Phase 1 study in r/r SLE – enrollment ongoing 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 and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Se
Slide 23: Partnerships, pipeline programs and technologies
Partnerships, pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 24: Pipeline supports growth with multiple development opportunities
Pipeline supports growth with multiple development opportunities Product Indication Target Preclinical Phase 1 Phase 2/Pivotal Approved Status Obe-cel product family AUCATZYL® Adult ALL CD19 MAA review EMA & MHRA obe-cel Systemic Lupus Erythematosus CD19 Initial data Q1 2025 obe-cel Pediatric ALL C
Slide 25: Leveraging our industry leading technology platform via partnerships
Leveraging our industry leading technology platform via partnerships Technology partnerships Potential for value Leveraging our Tumor targeting, Validating creation through near modular programming pharmacological collaborations with term option exercise technology to generate control and activity l
Slide 26: Upcoming news flow
Upcoming news flow
Slide 27: Autolus planned news flow
Autolus planned news flow Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel FELIX data update at ASH 2024 December 2024 Initial data from SLE Phase 1 trial Q1 2025 Obe-cel UK and EU approvals 2H 2025 Initial data from PY01 trial in pediatric ALL 2H 2025 SLE Phase 1 trial presentatio
Slide 28: Summary
Summary
Slide 29: Autolus is positioned for commercial execution and market expansion
Developing Next Generation Programmed T Cell Therapies Autolus is positioned for commercial execution and market expansion Obe-cel product franchise supports multiple growth opportunities • EU/UK approvals expected 2H 2025 • Expanding opportunity for obe-cel in hem-oncology and autoimmune diseases •
Slide 30: Thank you
Thank you Autolus.com
Slide 31: Appendix
Appendix Autolus.com
Slide 32: The FELIX phase 1b/2 pivotal study
The FELIX phase 1b/2 pivotal study 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 product delivery we
Slide 33: Strategic multi-platform R&D collaboration with BioNTech
Strategic multi-platform R&D collaboration with BioNTech CAR T Cell Therapies Commercial Infrastructure Access Deal Financials BioNTech to financially support obe-cel BioNTech to receive option to access Upfront Payments planned/potential commercial launch in Autolus’ GMP product supply and • $200 m
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