Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Investor Presentation (May 2025)
36 slides from Autolus Therapeutics's investor presentation, May 2025
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies May 2025 Autolus.com
Slide 2: Disclaimer
Developing and Delivering a New Generation of 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 fact
Slide 3: Autolus is positioned for value creation
Developing and Delivering a New Generation of T Cell Therapies Autolus is positioned for value creation Obe-cel product franchise supports multiple growth opportunities • Highly active, fast off-rate CD19 CAR T therapy with well managed safety profile • Commercial presence in 60 US centers by end 20
Slide 4: AUCATZYL
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 5: AUCATZYL now FDA and MHRA approved
Developing and Delivering a New Generation of T Cell Therapies AUCATZYL® now FDA and MHRA approved AUCATZYL indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) • Highly active, fast off-rate CD19 CAR T therapy with a well managed sa
Slide 6: Safety Information
Developing and Delivering a New Generation of T Cell Therapies 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.
Slide 7: We believe AUCATZYL has a unique mechanism of action
Developing and Delivering a New Generation of T Cell Therapies 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
Slide 8: AUCATZYL was approved based on results from the FELIX trial
Developing and Delivering a New Generation of T Cell Therapies 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 (
Slide 9: FELIX trial published in New England Journal of Medicine
Developing and Delivering a New Generation of T Cell Therapies 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
Slide 10: FELIX trial: Tumor burden impact on event-free survival in adult ALL
Developing and Delivering a New Generation of T Cell Therapies 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 lymphode
Slide 11: FELIX trial: Tumor burden impact on overall survival in adult ALL
Developing and Delivering a New Generation of T Cell Therapies 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 lymphodeple
Slide 12: AUCATZYL Launch progress
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® Launch progress A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 13: Strong momentum in first quarter of the U.S. AUCATZYL launch
Developing and Delivering a New Generation of T Cell Therapies Strong momentum in first quarter of the U.S. AUCATZYL® launch Q1 2025 AUCATZYL Net Product Sales 39 Treatment Centers Authorized as of 05/07/25 $9.0 million Physician interest based upon product profile and unmet patient need is driving
Slide 14: AUCATZYL growth opportunities in ALL
Developing Next Generation Programmed T Cell Therapies AUCATZYL growth opportunities in ALL Expansion ✓ Conditional marketing authorization in the UK received April 25, 2025 • EMA decision expected in 2H 2025 Near-Term • Country-by-country launches planned based on pricing and reimbursement New Mark
Slide 15: Over 8,000 new cases of adult ALL annually worldwide
Developing and Delivering a New Generation of T Cell Therapies 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
Slide 16: AUCATZYL is poised to fill the unmet need for r/r ALL patients
Developing and Delivering a New Generation of T Cell Therapies AUCATZYL® is poised to fill the unmet need for r/r ALL patients •We believe AUCATZYL is a transformative product in the r/r B-ALL space •Unique MOA designed to deliver potency and persistency that results in deep and durable efficacy •Fa
Slide 17: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 18: The obe-cel product family and franchise opportunity
Developing and Delivering a New Generation of T Cell Therapies 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 safe
Slide 19: MOA and established commercial capabilities are key differentiators
Developing and Delivering a New Generation of T Cell Therapies 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
Slide 20: Initial data from CARLYSLE SLE P1 trial in patients with severe disease
Developing and Delivering a New Generation of T Cell Therapies Initial data from CARSLYLE SLE P1 trial in patients with severe disease Baseline SLEDAI-2K score ranges from 16 to 28 No high-grade CRS, No ICANS observed Severe patient population No DLTs observed • Patients aged 19 to 50 years had 3 to
Slide 21: Preliminary CARLYSLE results; additional follow up planned for H2 2025
Developing and Delivering a New Generation of T Cell Therapies Preliminary CARLYSLE results; additional follow up planned for H2 2025 10+ point drop in SLEDAI-2K scores and 3 of 6 patients with renal CRs by month 3 #1 GB06002 #2 GB01004 #3 GB01005 #4 GB01006 Rash 30 30 30 30 Renal Involvement 25 25
Slide 22: Lupus nephritis development strategy
Developing and Delivering a New Generation of T Cell Therapies Lupus nephritis development strategy Initial Approval Expanded Indication Leveraging a fast to market strategy Ph1 Dose Ph2 Single Arm Ph3 Randomized Development Rationale Confirmation Pivotal Controlled vs SoC • LN is assessed by quanti
Slide 23: Refractory lupus nephritis is a high unmet medical need
Developing and Delivering a New Generation of T Cell Therapies Refractory lupus nephritis is a high unmet medical need • Kidneys are one of the most common organs involved in SLE - 30% – 40% are lupus nephritis patients US Treated SLE ∼350,000 • High disease activity is associated with inflammatory
Slide 24: Multiple sclerosis development strategy
Developing and Delivering a New Generation of T Cell Therapies Multiple sclerosis development strategy • Anticipate a Establish Phase 1 Clinical Proof of Concept in MS randomised phase 2/3 study design as 3 x 6 dose escalation design - a higher dose path to approval may be required for CNS effect In
Slide 25: Progressive multiple sclerosis is a high unmet medical need
Developing and Delivering a New Generation of T Cell Therapies Progressive multiple sclerosis is a high unmet medical need • MS impacts approximately 1,000,000 individuals in the US1 and there is currently no known cure Obe-cel focus Secondary Progressive MS • Around 30% of patients have progressive
Slide 26: Partnerships, pipeline programs and technologies
Partnerships, pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 27: Pipeline supports growth with multiple development opportunities
Developing and Delivering a New Generation of T Cell Therapies Pipeline supports growth with multiple development opportunities Product Indication Target Preclinical Phase 1 Phase 2/Pivotal Approved Status FDA & MHRA licensed, AUCATZYL® Adult ALL CD19 EMA under review obe-cel Lupus Nephritis CD19 En
Slide 28: Leveraging our industry leading technology platform via partnerships
Developing and Delivering a New Generation of T Cell Therapies 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 ter
Slide 29: Upcoming news flow
Upcoming news flow
Slide 30: Upcoming milestones
Developing and Delivering a New Generation of T Cell Therapies Upcoming milestones Anticipated Anticipated Milestone or Catalyst Timing obe-cel Longer-term follow up from FELIX clinical trial Mid-Year obe-cel Notification from EU regarding MAA decision in adult r/r ALL H2 2025 obe-cel Initial data f
Slide 31: Summary
Summary
Slide 32: Autolus is positioned for commercial execution and market expansion
Developing and Delivering a New Generation of T Cell Therapies Autolus is positioned for commercial execution and market expansion Obe-cel product franchise supports multiple growth opportunities • Highly active, fast off-rate CD19 CAR T therapy with well managed safety profile • Commercially approv
Slide 33: Thank you
Thank you Autolus.com
Slide 34: Appendix
Appendix Autolus.com
Slide 35: 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 36: 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
Autolus Therapeutics — Investor Presentation (May 2025) on 6ix