Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q1 2023 Earnings Presentation
34 slides from Autolus Therapeutics's earnings presentation, May 4, 2023
Slide 1: First Quarter Financial Results and Operational Progress
First Quarter Financial Results and Operational Progress May 4, 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
Building a fully integrated, next-generation CAR T company 3 Agenda • Welcome and Introduction: Alexandra Deschner, IR 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 pipeline summary
Building a fully integrated, next-generation CAR T company 4 Obe-cel pipeline summary Continued progress against strategic and operational goals • obe-cel in relapsed / refractory (r/r) adult ALL – Long term follow up data from ALLCAR19 was presented at Tandem Meetings with 35% of r/r adult ALL pati
Slide 5: Other pipeline updates
Building a fully integrated, next-generation CAR T company 5 Other pipeline updates Continued progress against strategic and operational goals • LibrA T1 Phase 1 trial of AUTO4 in Peripheral T Cell Lymphoma – data at ASH demonstrated high metabolic CR rate – AUTO4 update accepted for an oral present
Slide 6: Operational highlights – first quarter 2023
Building a fully integrated, next-generation CAR T company 6 Operational highlights – first quarter 2023 Continued progress against strategic and operational goals • Commercial manufacturing facility in Stevenage, UK progressing on track – Qualification and validation of the commercial manufacturing
Slide 7: Operational highlights – post period end
Building a fully integrated, next-generation CAR T company 7 Operational highlights – post period end Continued progress against strategic and operational goals • Establishing core distribution capabilities required to commercialize a CAR T-cell therapy in the US including selecting distributor, Car
Slide 8: Obe-cel
LEAD CLINICAL PROGRAM Obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 9: Obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies 9 Obe-cel has a unique mechanism of action Fast off-rate CD19 binder with Obe-cel has a shorter half-life of interaction On-Rate: Ka [M-1S-1] ] Obe-cel Binder fast off-rate 1 - S 1 - Other CD19 Binders compared to binders used in approved [M K :
Slide 10: Obe-cel is a potentially transformational therapy for adult ALL
Developing Next Generation Programmed T Cell Therapies 10 Obe-cel is a potentially transformational therapy for adult ALL Unique CAR T design to drive differentiated product profile Obe-cel – Key Properties Obe-cel – Key Data Regulatory Designations • Target engagement with fast off-rate ALLCAR19 Sw
Slide 11: FELIX Phase 2 Study Overview
Developing Next Generation Programmed T Cell Therapies 11 FELIX Phase 2 Study Overview Interim analysis completed Q4 2022 – met primary endpoint – next data readout at ASCO & EHA Primary endpoint overall complete response rate Pivotal phase 2 trial in relapsed / (CR/CRi) refractory (r/r) adult ALL p
Slide 12: FELIX Phase 2 Pivotal trial met primary endpoint
Developing Next Generation Programmed T Cell Therapies 12 FELIX Phase 2 Pivotal trial met primary endpoint Positive data is a catalyst for the next stage of growth and preparation for commercialization • Phase 2 pivotal FELIX study of obe-cel in r/r adult ALL has • Encouraging tolerability data obse
Slide 13: Obe-cel showed consistent clinical profile across three clinical studies
Developing Next Generation Programmed T Cell Therapies 13 Obe-cel showed consistent clinical profile across three clinical studies Data from 3 studies - range of ages and patient conditions CARPALL #1 ALLCAR19 #2 FELIX P1b #3 FELIX P2 Peds ALL Adult ALL Adult ALL Adult ALL Obe-cel demonstrated n 14
Slide 14: Obe-cel at ASH 2022
Developing Next Generation Programmed T Cell Therapies 14 Obe-cel at ASH 2022 – B-ALL long term follow up from Ph1 ALLCAR19 trial ‘Safety, Efficiency and Long-Term Follow-up of obe-cel, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell Malignancies
Slide 15: Treatment landscape is changing with the introduction of immuno-therapies
Developing Next Generation Programmed T Cell Therapies 15 Treatment landscape is changing with the introduction of immuno-therapies However, allo SCT continues to be ‘Gold Standard’ for long term remission and/or curative therapy BLINATUMOMAB Standard of Care A bi-specific CD19-directed CD3 T-cell e
Slide 16: New innovative options needed in r/r adult ALL despite approved agents
Developing Next Generation Programmed T Cell Therapies 16 New innovative options needed in r/r adult ALL despite approved agents Current standard of care and recently approved agents in r/r adult ALL1 STANDARD OF CARE RECENTLY APPROVED Blincyto®2 Besponsa®3 Tecartus™4 (blinatumomab) (inotuzumab ozog
Slide 17: Over 8,000 new cases of adult ALL annually worldwide
Developing Next Generation Programmed T Cell Therapies 17 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 • Combination chemotherapy
Slide 18: Obe-cel could launch into an expanding ALL market if approved
Developing Next Generation Programmed T Cell Therapies 18 Obe-cel could launch into an expanding ALL market if approved Blincyto®, current market leader, shows annual revenue growth of c.24% Reported Blincyto® sales1 • Blincyto® sales price estimated to be $207k2 (for 2 cycles) 900 supporting approx
Slide 19: Obe-cel next steps to commercialization
Developing Next Generation Programmed T Cell Therapies 19 Obe-cel next steps to commercialization Data and path to approval Manufacturing Commercialization • FELIX – clinical data presentations at • Bespoke commercial manufacturing • Focus in 2023 on Medical affairs, ASCO and EHA facility built in S
Slide 20: Building the obe-cel opportunity
Building the obe-cel opportunity Deep value program with potentially broad applicability
Slide 21: Obe-cel lifecycle outlook - NHL/CLL and Pediatric ALL
Developing Next Generation Programmed T Cell Therapies 21 Obe-cel lifecycle outlook - NHL/CLL and Pediatric ALL - ASH 2022 High level of clinical activity with well manageable safety profile • Clinical data supports differentiated product profile in Adult ALL, B-NHL (obe-cel) and Pediatric ALL (AUTO
Slide 22: Pipeline
Pipeline A broad portfolio of potential next generation modular T cell therapies
Slide 23: A broad toolkit which is core to our strategy of modular innovation
Developing Next Generation Programmed T Cell Therapies 23 A broad toolkit which is core to our strategy of modular innovation Advanced T cell programming Viral Vector Advanced Targeting Modules Pharmacological Control Modules Activity Enhancement Modules Activity Enhancement Modules Viral Vector TAR
Slide 24: Early-stage pipeline
Developing Next Generation Programmed T Cell Therapies 24 Early-stage pipeline Leveraging academic collaborations to generate opportunity for non-dilutive funding opportunities Next data readouts expected in 2023/2024
Slide 25: AUTO4 and AUTO5 for Peripheral T-Cell Lymphoma
Developing Next Generation Programmed T Cell Therapies 25 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 26: AUTO4 for Peripheral T-Cell Lymphoma: ASH 2022
Developing Next Generation Programmed T Cell Therapies 26 AUTO4 for Peripheral T-Cell Lymphoma: ASH 2022 Patients achieve durable metabolic complete responses • AUTO4 treatment was well tolerated with no dose-limiting toxicities • Ongoing responses at 9 and 12 months post-dosing at the highest dose
Slide 27: Manufacturing
Manufacturing
Slide 28: Commercial manufacturing facility on track
Developing Next Generation Programmed T Cell Therapies 28 Commercial manufacturing facility on track Building a fully integrated manufacturing and logistics platform • Phase 1 of build project completed in Q4 2022 – handover of first clean rooms to Autolus on Nov 25, 2022 Manufacturing • Equipment i
Slide 29: Financial Results
Financial Results
Slide 30: Financial summary
Building a fully integrated, next-generation CAR T company 30 Financial summary Cash runway into 2025 USD Q1 2023 ($ '000) Q1 2022 ($ '000) Variance ($ '000) Grant Income 0 166 (166) License Income 1,292 0 1,292 R&D (31,344) (33,963) 2,619 G&A (9,284) (7,987) (1,297) Loss on disposal of property and
Slide 31: Summary
Summary
Slide 32: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies 32 Autolus planned news flow Obe-cel Pipeline Manufacturing • FELIX - Phase 2 clinical presentation • Updates on AUTO1/22 and AUTO 4 • Qualification of Nucleus facility ASCO and EHA in June planned for 2023 in H1 2023 • Biologics License Applica
Slide 33: The Autolus opportunity
Developing Next Generation Programmed T Cell Therapies 33 The Autolus opportunity Building a fully integrated CAR T company - Expanding excellence in R&D and manufacturing to commercialization • Obe-cel, a potentially best in class product • Purpose-built commercial manufacturing candidate, met prim
Slide 34: Thank you
Thank you autolus.com