Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — FY2022 Earnings Presentation
32 slides from Autolus Therapeutics's earnings presentation, Mar 7, 2023
Slide 1: Full Year Financial Results and Fourth Quarter Operational Progress
Full year Financial Results and Fourth Quarter Operational Progress March 7, 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, an
Slide 3: Agenda
Building a fully integrated, next-generation CAR T company 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
Slide 4: Obe-cel and pipeline highlights – fourth quarter 2022
Building a fully integrated, next-generation CAR T company 4 Obe-cel and pipeline highlights – fourth quarter 2022 Continued progress against strategic and operational goals • obe-cel in relapsed / refractory (r/r) adult ALL – FELIX pivotal Phase 2 trial met primary end point and confirmed the well
Slide 5: Operational highlights – fourth quarter 2022
Building a fully integrated, next-generation CAR T company 5 Operational highlights – fourth quarter 2022 Continued progress against strategic and operational goals • Successful public offering raising c.$164m gross proceeds • Receipt of $70m in milestones from Blackstone Life Sciences – $35m on mee
Slide 6: Obe-cel
LEAD CLINICAL PROGRAM Obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 7: Obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies 7 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 8: Obe-cel is a potentially transformational therapy for adult ALL
Developing Next Generation Programmed T Cell Therapies 8 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 Swi
Slide 9: FELIX Phase 2 Study Overview
Developing Next Generation Programmed T Cell Therapies 9 FELIX Phase 2 Study Overview Interim analysis completed Q4 2022 – met primary endpoint – next data readout expected mid 2023 Primary endpoint overall complete response rate Pivotal phase 2 trial in relapsed / (CR/CRi) refractory (r/r) adult AL
Slide 10: FELIX Phase 2 Pivotal trial met primary endpoint
Developing Next Generation Programmed T Cell Therapies 10 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 11: Obe-cel showed consistent clinical profile across three clinical studies
Developing Next Generation Programmed T Cell Therapies 11 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 12: Obe-cel at ASH 2022 – B-ALL long term follow up from Ph1 ALLCAR19 trial
Developing Next Generation Programmed T Cell Therapies 12 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 13: New innovative options needed in r/r adult ALL despite approved agents
Developing Next Generation Programmed T Cell Therapies 13 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 14: Over 8,000 new cases of adult ALL annually worldwide
Developing Next Generation Programmed T Cell Therapies 14 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 15: Obe-cel could launch into an expanding ALL market if approved
Developing Next Generation Programmed T Cell Therapies 15 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) 700 supporting approx
Slide 16: Obe-cel next steps to commercialization
Developing Next Generation Programmed T Cell Therapies 16 Obe-cel next steps to commercialization Data and path to approval Manufacturing Commercialization • FELIX – clinical data presentation • Bespoke commercial manufacturing • Focus in 2023 on Medical affairs, planned for Q2 2023 facility built i
Slide 17: Building the obe-cel opportunity
Building the obe-cel opportunity Deep value program with potentially broad applicability
Slide 18: Obe-cel lifecycle outlook - NHL/CLL and Pediatric ALL - ASH 2022
Developing Next Generation Programmed T Cell Therapies 18 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 19: Pipeline
Pipeline A broad portfolio of potential next generation modular T cell therapies
Slide 20: A broad toolkit which is core to our strategy of modular innovation
Developing Next Generation Programmed T Cell Therapies 20 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 21: Leveraging our industry leading technology platform via partnerships
Developing Next Generation Programmed T Cell Therapies 21 Leveraging our industry leading technology platform via partnerships Technology partnerships • Leveraging our modular programming • Moderna Tx technology to generate safer and more effective – Access to propriety binders for the therapies dev
Slide 22: Early-stage pipeline
Developing Next Generation Programmed T Cell Therapies 22 Early-stage pipeline Leveraging academic collaborations to generate opportunity for non-dilutive funding opportunities Next data readouts expected in 2023/2024
Slide 23: AUTO4 and AUTO5 for Peripheral T-Cell Lymphoma
Developing Next Generation Programmed T Cell Therapies 23 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 24: AUTO4 for Peripheral T-Cell Lymphoma: ASH 2022
Developing Next Generation Programmed T Cell Therapies 24 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 25: Manufacturing
Manufacturing
Slide 26: Commercial manufacturing facility on track
Developing Next Generation Programmed T Cell Therapies 26 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 27: Financial Results
Financial Results
Slide 28: Financial summary
Building a fully integrated, next-generation CAR T company 28 Financial summary Cash runway into 2025 USD FY 2022 ($ '000) FY 2021 ($ '000) Variance ($ '000) Grant Income 166 823 (657) License Income 6,194 1,507 4,687 R&D (141,992) (134,789) (7,203) G&A (31,899) (31,865) (34) Loss on disposal of lea
Slide 29: Summary
Summary
Slide 30: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies 30 Autolus planned news flow Obe-cel Pipeline Manufacturing • FELIX - Phase 2 clinical data • Updates on AUTO1/22 and AUTO 4 • Qualification of Nucleus facility presentation planned for Q2 2023 planned for 2023 in H1 2023 • Biologics License App
Slide 31: The Autolus opportunity
Developing Next Generation Programmed T Cell Therapies 31 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 32: Thank you
Thank you autolus.com