Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q1 2025 Earnings Presentation
20 slides from Autolus Therapeutics's earnings presentation, May 8, 2025
Slide 1: Q1 2025 Financial Results and Business Updates
Q1 2025 Financial Results and Business Updates May 8, 2025 For Investor communication only. Not for use in product promotion. Not for further distribution. 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: Agenda
Developing and Delivering a New Generation of T Cell Therapies Agenda • Welcome and Introduction: Amanda Cray, ED, Investor Relations & External Communications • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian I
Slide 4: 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 5: AUCATZYL growth opportunities in ALL
Developing and Delivering a New Generation of 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
Slide 6: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 7: Obe-cel drives deep reset of the B cell compartment
Developing and Delivering a New Generation of T Cell Therapies Obe-cel drives deep reset of the B cell compartment Combined with a favorable tolerability profile with low levels of high-grade CRS and ICANS Results we have observed in clinical trials in B cell malignancies • High MRD-negative complet
Slide 8: Inflammation and structural organ damage in autoimmunity
Developing and Delivering a New Generation of T Cell Therapies Inflammation and structural organ damage in autoimmunity • Autoimmune disease is driven by auto-reactive CD19 CAR T therapy will be focused on antibodies redirecting the immune system onto various severe/refractory patients. organs and t
Slide 9: 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 10: 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 11: 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 12: 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 13: 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 14: Multiple sclerosis development strategy
Developing and Delivering a New Generation of T Cell Therapies Multiple sclerosis development strategy Establish Phase 1 Clinical Proof of Concept in MS • Anticipate a randomised phase 3 x 6 dose escalation design - a higher dose 2/3 study design as may be required for CNS effect Initiate Phase 2/3
Slide 15: Financial Results
Financial Results
Slide 16: Financial summary – key metrics
Developing and Delivering a New Generation of T Cell Therapies Financial summary – key metrics* USD ($’ 000) Q1 2025 Q1 2024 Variance Product revenue, net 8,982 - 8,982 License revenue, net - 10,091 (10,091) Cost and operating expenses: Cost of sales (17,951) - (17,951) Research and development expe
Slide 17: Upcoming news flow
Upcoming news flow
Slide 18: Upcoming milestones
Developing and Delivering a New Generation of T Cell Therapies Upcoming milestones Anticipated Milestone or Catalyst Anticipated Timing Longer-term follow up from FELIX clinical trial Mid-Year Notification from EU regarding MAA decision in adult r/r ALL H2 2025 Initial data from PY01 trial in pediat
Slide 19: Autolus is positioned for value creation
Developing and Delivering a New Generation of T Cell Therapies Autolus is positioned for value creation Building on a strong foundation with obe-cel • AUCATZYL US launch: strong first quarter, building to 60 A CD19-directed genetically modified autologous T cell immunotherapy indicated for the treat
Slide 20: Thank you
Thank you Autolus.com