Autolus Therapeutics plc · NASDAQ:AUTL
Autolus Therapeutics — Investor Presentation (November 2025)
35 slides from Autolus Therapeutics's investor presentation, November 2025
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies November 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 • Target of 60 US
Slide 4: Building value with obe-cel
Developing and Delivering a New Generation of T Cell Therapies Building value with obe-cel Launch Optimize Expand Strong execution in r/r B-ALL: Leveraging investments: Potential “pipeline in a product" Market leadership • Evolution of team to support next new indications: Broad market access /
Slide 5: AUCATZYL
AUTOLUS’ FIRST APPROVED PRODUCT AUCATZYL® A potentially best-in-class, standalone CD19 CAR T cell therapy
Slide 6: 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 7: 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 8: 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 9: 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 10: 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 11: 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 11
Slide 12: Duration of response: median 42.6 months at last data cut
Developing and Delivering a New Generation of T Cell Therapies Duration of response: median 42.6 months at last data cut More than half of patients still in remission at 24 months 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: Expect strong first year of U.S. AUCATZYL launch
Developing and Delivering a New Generation of T Cell Therapies Expect strong first year of U.S. AUCATZYL® launch AUCATZYL Net Product Sales Executing on Product Delivery & Patient Access Q3 2025: $21.1 million Deferred Revenue: $7.6 million Nine Months Ended September 30, 2025: • 60 authorized treat
Slide 15: 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 16: 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 17: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 18: Pipeline-in-a-product: expanding obe-cel's potential beyond adult B-ALL
Developing and Delivering a New Generation of T Cell Therapies Pipeline-in-a-product: expanding obe-cel's potential beyond adult B-ALL Indication Trial Status CATULUS Pediatric r/r B-ALL Initial data at ASH 2025; RMAT designation received Phase 1/2 CARSLYLE Systemic Lupus (SLE) Initial data at ACR 2
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: Obe-cel shows promise as a new approach for SLE/LN
Private & confidential 20 Obe-cel shows promise as a new approach for SLE/LN 50 million cell dose selected as recommended Phase 2 dose Patient population: Patients (50M cell cohort n=6) were significantly impaired with their kidney function and had across the board some of the highest SLEDAI-2K scor
Slide 21: Obe-cel is well tolerated with no DLTs, ICANS or high-grade CRS
Developing and Delivering a New Generation of T Cell Therapies Obe-cel is well tolerated with no DLTs, ICANS or high-grade CRS 50 million cell dose patient cohort (n=6) Key Safety Findings Infused patients (N=6) Any grade, n (%) Grade ≥3, n (%) • No DLTs were observed following obe-cel infusion Any
Slide 22: All patients achieved significant and sustained SLEDAI-2K reductions
Developing and Delivering a New Generation of T Cell Therapies 22 All patients achieved significant and sustained SLEDAI-2K reductions (50M cell dose cohort, n=6) • All non-renal descriptors resolved by month four • Median SLEDAI-2K reduction of 14 points (range 3-18) at month six • Three patients (
Slide 23: Five patients (83.3%) achieved DORIS with median onset of 5.1 months
Developing and Delivering a New Generation of T Cell Therapies 23 Five patients (83.3%) achieved DORIS with median onset of 5.1 months 50 million cell dose patient cohort (n=6) • Responses ongoing with no flare as of last follow-up • Median onset of DORIS remission: 5.1 months (range: 4.9 – 8.9) • N
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 at
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 clinical data from CATULUS trial in pediatric ALL ASH Annual Meeting 2025 Longer-term follow up data from CARLYSLE trial ASH Annual Meeting 2025 Expect to d
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 • Target of 60 US
Slide 35: Thank you
Thank you Investor Contact: [email protected] Executive Director, Investor Relations & External Communications Autolus.com
Autolus Therapeutics — Investor Presentation (November 2025) on 6ix