Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q2 2023 Earnings Presentation
38 slides from Autolus Therapeutics's earnings presentation, Aug 3, 2023
Slide 1: Second Quarter Financial Results and Operational Progress
Second Quarter Financial Results and Operational Progress August 3, 2023
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies 2 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
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies 3 Agenda • Welcome and Introduction: Julia Wilson, Communications Consultant • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Dr. Lucinda Crabtree, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr
Slide 4: Obe-cel highlights
Developing Next Generation Programmed T Cell Therapies 4 Obe-cel highlights Continued progress against strategic and operational goals • obe-cel in relapsed / refractory (r/r) adult ALL – FELIX data presented at ASCO and EHA in June from all patients treated showed 76% of patients achieved a respons
Slide 5: Pipeline highlights
Developing Next Generation Programmed T Cell Therapies 5 Pipeline highlights Continued progress against strategic and operational goals • Expanding the obe-cel opportunity – Company sponsored Phase 1 dose confirmation study in refractory systemic lupus erythematosus (SLE) to start in early 2024 – AL
Slide 6: Strengthening the Autolus team
Developing Next Generation Programmed T Cell Therapies 6 Strengthening the Autolus team Dr Robert Iannone Rob Dolski Dr Veronica Hersberger Miranda Neville Non-Executive Director Chief Financial Officer SVP, Medical Affairs SVP, Project Management • EVP, Global Head of R&D of • Prior CFO of Checkmat
Slide 7: Obe-cel
LEAD CLINICAL PROGRAM Obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 8: FELIX data at ASCO and EHA 2023
Developing Next Generation Programmed T Cell Therapies 8 FELIX data at ASCO and EHA 2023 eligibility, endpoints, and disposition 84% of enrolled patients were infused with obe-cel Key eligibility criteria Enrolled • R/R adult B-ALL* N = 112 • Aged ≥18 years • ≥5% BM blasts at screening (Cohort IIA)
Slide 9: FELIX: baseline characteristics
Developing Next Generation Programmed T Cell Therapies 9 FELIX: baseline characteristics Heavily pre-treated patients with high disease burden Total infused (N = 94) Age years, median (range) 50 (20–81) Gender male/female, n 47/47 Philadelphia chromosome-positive, n (%) 25 (26.6) Prior therapies, me
Slide 10: FELIX: disease response per IRRC assessment
Developing Next Generation Programmed T Cell Therapies 10 FELIX: disease response per IRRC assessment 76% of infused patients achieved CR/CRi 100 90 80 70 21.3% 60 CRi ORR: 76% ORR, % 50 95% CI (66, 84) 40 p<0.0001* 30 54.3% 20 CR 10 0 97% of responders with evaluable samples were MRD negative at 10
Slide 11: FELIX: duration of remission
Developing Next Generation Programmed T Cell Therapies 11 FELIX: duration of remission 61% responders in ongoing remission without subsequent anti-cancer therapies 100 90 Median follow-up: 9.5 months 80 70 Probability, % 60 50 40 30 20 10 Events, n = 18; Median DoR: 14.1 months (95% CI: 5.9, NE) 0 0
Slide 12: FELIX: subgroup analysis of CR/CRi (IRRC assessment)
Developing Next Generation Programmed T Cell Therapies 12 FELIX: subgroup analysis of CR/CRi (IRRC assessment) High risk subgroups include EMD and high BM blasts at pre-conditioning Total ORR Subgroup N (%) % (95% CI) Overall 94 (100) 76 (66, 84) Age, years 18–39 31 (33) 58 (39, 75) 40–64 42 (45) 79
Slide 13: FELIX: safety – CRS and ICANS
13 Developing Next Generation Programmed T Cell Therapies 13 13 FELIX: safety – CRS and ICANS Low rates of Grade ≥3 CRS and/or ICANS were observed BM blasts ≤20% BM blasts >20% All infused patients at pre-conditioning at pre-conditioning (N = 37) (N = 57) (N = 94) CRS Any grade, n (%) 24 (64.9) 47 (
Slide 14: FELIX: obe-cel expansion and persistence
Developing Next Generation Programmed T Cell Therapies 14 FELIX: obe-cel expansion and persistence CAR T cellular kinetics are consistent with the ALLCAR19 study1 Mean (SE) for CAR-T therapy by PCR in peripheral blood FELIX ALLCAR19 100,000 (N = 94) (N = 20) Cmax, copies/ug 114,982 127,152 copies/ug
Slide 15: Obe-cel - Tandem Meeting - long term follow up from ALLCAR19
Developing Next Generation Programmed T Cell Therapies 15 Obe-cel - Tandem Meeting - long term follow up from Phase 1 ALLCAR19 study ‘Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR, in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia and Factors Associated with Durable Response’ ALLCA
Slide 16: FELIX: conclusions
Developing Next Generation Programmed T Cell Therapies 16 FELIX: conclusions • Obe-cel infusion resulted in a CR/CRi rate of 76%, with 97% of responders becoming MRD negative – With a median of 9.5 months’ follow-up, 61% of responders remain in remission • Obe-cel infusion resulted in very low rates
Slide 17: Manufacturing
Manufacturing
Slide 18: Product supply
Developing Next Generation Programmed T Cell Therapies 18 Product supply Critical success factors for a personalized cell therapy Reliable and timely delivery of every batch with consistent quality is critical for each patient • Process – Consistent manufacturing process performance over a wide rang
Slide 19: Supply of FELIX study pressure tested all aspects of product delivery
Developing Next Generation Programmed T Cell Therapies 19 Supply of FELIX study pressure tested all aspects of product delivery New approach to manufacturing – requires new thinking to be successful • Semi-automated manufacturing process optimized to manage wide range of apheresis materials • Effici
Slide 20: The Nucleus
Developing Next Generation Programmed T Cell Therapies 20 The Nucleus State of the art design and operations established – validation on track Design Build Operations • ~70,000 sq ft facility • Nov 8, 2021 ground breaking • Dec 14, 2022 first Prodigy operational • Modular build using PAMs • Nov 25,
Slide 21: Preparing for obe-cel commercial launch
Preparing for obe-cel commercial launch Deep value program with potentially broad applicability
Slide 22: Obe-cel next steps to commercialization
Developing Next Generation Programmed T Cell Therapies 22 Obe-cel next steps to commercialization Data and path to approval Manufacturing Commercialization • Filing of Biologics License Application • Bespoke commercial manufacturing • Focus in 2023 on Medical affairs, (BLA) to US Food and Drug facil
Slide 23: Selection of Cardinal Health as US distribution partner
Developing Next Generation Programmed T Cell Therapies 23 Selection of Cardinal Health as US distribution partner Covers three key elements of obe-cel commercialization in the US Distribution Order-to-Cash Depot Model Standard suit of services including: Includes collection of US Revenues Maintain c
Slide 24: Building the obe-cel opportunity and other pipeline highlights
Building the obe-cel opportunity and other pipeline highlights
Slide 25: The obe-cel product family and franchise opportunity
Developing Next Generation Programmed T Cell Therapies Autolus.com 25 The obe-cel product family and franchise opportunity • Optimal CD19 CAR design B-ALL and B-NHL Obe-cel • Potential best-in-class efficacy and safety profile CD19 • Supported by state-of-the-art manufacturing B-cell mediated • Supp
Slide 26: Obe-cel in B-NHL/CLL: High level clinical activity with durable outcomes
Developing Next Generation Programmed T Cell Therapies Collaboration with 26 Obe-cel in B-NHL/CLL: High level clinical activity with durable outcomes Long term persistence driving durable outcomes ALLCAR19 – B-NHL and CLL Median follow-up 12.9 months N 25 ORR All patients 92% Follicular Lymphoma 100
Slide 27: Obe-cel: expanding into B-cell mediated autoimmune disease
Developing Next Generation Programmed T Cell Therapies 27 Obe-cel: expanding into B-cell mediated autoimmune disease Systemic Lupus Erythematosus (SLE) • SLE is a multi-organ systemic autoimmune disease that Rationale for obe-cel in SLE affects approximately 160K - 320K patients in the US1 • High un
Slide 28: AUTO1/22 in pediatric ALL
Developing Next Generation Programmed T Cell Therapies Collaboration with 28 AUTO1/22 in pediatric ALL No antigen negative relapse seen in responding patients CARPALL Disease Response (n=12) • Favourable tolerability profile with no severe CRS Molecular MRD neg CR/Cri by d30 10 (83%) Disease progre
Slide 29: AUTO8: combining a sensitive BCMA CAR with the CD19 CAR
Confidential Developing Next Generation Programmed T Cell Therapies Collaboration with 29 AUTO8: combining a sensitive BCMA CAR with the CD19 CAR from obe-cel Designed to induce deep and durable responses NT Screening for high sensitivity BCMA 72h cytotoxicity binders 72h cytotoxicity APRIL BCMA CAR
Slide 30: AUTO4 and AUTO5 for Peripheral T-Cell Lymphoma
Developing Next Generation Programmed T Cell Therapies 30 AUTO4 and AUTO5 for Peripheral T-Cell Lymphoma T-Cell Lymphoma is an aggressive disease with a very poor prognosis • A large portion of T-Cell Lymphoma patients are refractory/relapse following first-line treatment (68%)1 9,200 • Standard of
Slide 31: AUTO4 for Peripheral T-Cell Lymphoma: ICML 2023
Developing Next Generation Programmed T Cell Therapies 31 AUTO4 for Peripheral T-Cell Lymphoma: ICML 2023 Process A Median follow-up 13.8 months • At the highest dose (450x106) 4 out of 4 patients achieved a response (Process A) • On-going complete metabolic responses in AITL 2 out of 4 patients at
Slide 32: Autolus pipeline
Developing Next Generation Programmed T Cell Therapies Autolus.com 32 Autolus pipeline PRODUCT INDICATION TARGET STUDY NAME COLLABORATION PHASE UPCOMING CATALYST Q4 2023: FELIX data updates Obe-cel Adult B-ALL CD19 FELIX Pivotal Q4 2023: BLA filing with FDA Systemic Lupus Obe-cel CD19 TBD Preclinic
Slide 33: Financial Results
Financial Results
Slide 34: Financial summary
Building a fully integrated, next-generation CAR T company 34 Financial summary Cash runway into 2025 USD Q2 2023 ($ '000) Q2 2022 ($ '000) Variance ($ '000) Grant Income - - - License Income - - - R&D (36,742) (38,212) 1,470 G&A (11,122) (8,269) (2,853) Loss on disposal of property and equipment (2
Slide 35: Summary
Summary
Slide 36: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies 36 Autolus planned news flow Obe-cel Pipeline Manufacturing • FELIX -Data update expected at ASH • Update on AUTO 8 planned for 2023 • Commencement of GMP operations 2023 in H2 2023 • Multiple academic clinical studies • Biologics License Applic
Slide 37: The Autolus opportunity
Developing Next Generation Programmed T Cell Therapies 37 The Autolus opportunity Building a fully integrated CAR T company - Expanding excellence in R&D and manufacturing to commercialization • Deliver on obe-cel opportunity in oncology • Established CAR T process development and – Potential best i
Slide 38: Thank you
Thank you autolus.com