Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Corporate Update (August 2025)
35 slides from Autolus Therapeutics's corporate update, August 2025
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies August 2025 For Investor communication only. Not for use in Autolus.com product promotion.
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 • Approved in US, UK* and EU • Commercial prese
Slide 4: AUCATZYL
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 5: AUCATZYL now approved in US, UK and EU
Developing and Delivering a New Generation of T Cell Therapies AUCATZYL® now approved in US, UK and EU 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 manage
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 other CAT19
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: Data continue to show long term remissions in r/r adult B-ALL
Developing and Delivering a New Generation of T Cell Therapies Data continue to show long term remissions in r/r adult B-ALL At 24 months, overall survival probability was 46.0% Jae H Park et al, EHA 2025, oral presentation #S113 12
Slide 13: AUCATZYL Launch progress
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® Launch progress A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 14: Strong momentum in second quarter of the U.S. AUCATZYL launch
Developing and Delivering a New Generation of T Cell Therapies Strong momentum in second quarter of the U.S. AUCATZYL® launch AUCATZYL Net Product Sales 46 Treatment Centers Authorized as of 08/12/25 Q2 2025: $20.9 million Six Months Ended June 30, 2025: $29.9 million Physician interest based upon p
Slide 15: Building Value with Obe-Cel
Developing and Delivering a New Generation of T Cell Therapies Building Value with Obe-Cel Initial Launch: Launch Phase 2: Launch Phase 3: Top line growth trajectory Optimization Market expansion Strong execution on: Turning focus to: Launching in new indications: Authorized treatment center • Man
Slide 16: AUCATZYL geographic growth opportunities in ALL
Developing and Delivering a New Generation of T Cell Therapies AUCATZYL geographic growth opportunities in ALL Expansion Conditional marketing authorization in the UK received April 2025 • NICE pricing and reimbursement process ongoing European Commission (EC) conditional approval received July
Slide 17: 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 18: 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 19: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 20: Plans for obe-cel development in oncology and autoimmune diseases
Developing and Delivering a New Generation of T Cell Therapies Plans for obe-cel development in oncology and autoimmune diseases Obe-cel characteristics borne out across multiple studies INDICATION STUDY PHASE Development Plans Adult B-ALL FELIX Approved Pediatric B-ALL CATULUS Phase 1 Pediatric ALL
Slide 21: 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: Partnerships, pipeline programs and technologies
Partnerships, pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 29: 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^ & EC AUCATZYL® Adult ALL CD19 approved† obe-cel Pediatric ALL CD19 Initial data H2
Slide 30: 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 31: Upcoming news flow
Upcoming news flow
Slide 32: Upcoming milestones
Developing and Delivering a New Generation of T Cell Therapies Upcoming milestones Anticipated Milestone or Catalyst Anticipated Timing Initial data from PY01 trial in pediatric ALL H2 2025 SLE Phase 1 trial presentation at American College of Rheumatology (ACR) Q4 2025 First patient dosed in Phase
Slide 33: Summary
Summary
Slide 34: 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 • Approved in US, UK* and EU • Commercial prese
Slide 35: Thank you
Thank you Investor Contact: A.Cray@autolus.com Executive Director, Investor Relations & External Communications Autolus.com
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