Autolus Therapeutics plc · NASDAQ:AUTL
Autolus Therapeutics — Investor Presentation (November 2022)
31 slides from Autolus Therapeutics's investor presentation, November 2022
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies November 2022
Slide 2: Disclaimer
Building a fully integrated, next-generation CAR T company Autolus.com 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 hist
Slide 3: Autolus Overview
Building a fully integrated, next-generation CAR T company Autolus.com 3 Autolus Overview Building a fully integrated CAR T company Promising Pipeline Scalable Collaboration lead asset manufacturing • Lead product • Pipeline built on • In house cell • Collaboration with candidate obe-cel modular inn
Slide 4: obe-cel
LEAD CLINICAL PROGRAM obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 5: We believe obe-cel has a unique mechanism of action
Building a fully integrated, next-generation CAR T company Autolus.com 5 We believe obe-cel has a unique mechanism of action • Fast off-rate obe-cel has a shorter half-life of interaction CD19 binder On-Rate: Ka [M-1S-1] ] 1 - Other CD19 Binders obe-cel Binder compared to binders used in approved S
Slide 6: obe-cel showed sustained event-free survival beyond 30 months
Building a fully integrated, next-generation CAR T company Autolus.com 6 obe-cel showed sustained event-free survival beyond 30 months Long term CAR T persistence may drive durability of response Median CAR T cell levels in peripheral blood ALLCAR19 Event-Free Survival Median CAR T cell levels by fl
Slide 7: obe-cel is a potentially transformational therapy for adult ALL
Building a fully integrated, next-generation CAR T company Autolus.com 7 obe-cel is a potentially transformational therapy for adult ALL Unique CAR T design observed to drive differentiated product profile obe-cel • Unique mechanism of action built on a fast off-rate from CD19 target antigen Orphan
Slide 8: obe-cel showed consistent clinical profile across three clinical studies
Building a fully integrated, next-generation CAR T company Autolus.com 8 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 1b #3 Peds ALL Adult ALL Adult ALL • obe-cel demonstrated a n 14 2
Slide 9: obe-cel for adult ALL: high unmet need
Building a fully integrated, next-generation CAR T company Autolus.com 9 obe-cel for adult Acute Lymphoblastic Leukemia (ALL): high unmet need Successful therapy requires high level of activity and sustained persistence paired with good tolerability • Median overall survival is < 1 year in r/r adult
Slide 10: Unmet medical need in r/r adult ALL despite approved agents
Building a fully integrated, next-generation CAR T company Autolus.com 10 Unmet medical need 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 FDA approved Blincyto®2 Besponsa®3 Tecartus™4 (blinatumomab) (inotuz
Slide 11: obe-cel could launch into an expanding ALL market if approved
Building a fully integrated, next-generation CAR T company Autolus.com 11 obe-cel could launch into an expanding ALL market if approved Blincyto®, current market leader, shows annual revenue growth of c.25% Reported Blincyto® sales1 • Blincyto® sales price estimated to be $178k2 (for 2 cycles) suppo
Slide 12: Next steps: obe-cel initial results (FELIX) expected in Q4 2022
Building a fully integrated, next-generation CAR T company Autolus.com 12 Next steps: obe-cel initial results (FELIX) expected in Q4 2022 obe-cel is the first Autolus program to move into a pivotal program Primary endpoint: Q4 2022 overall complete Pivotal Phase 2 trial in adult ALL Initial results
Slide 13: Building the obe-cel opportunity
Building the obe-cel opportunity Deep value program with potentially broad applicability
Slide 14: Capitalising on the unique profile of obe-cel
Building a fully integrated, next-generation CAR T company Autolus.com 14 Capitalising on the unique profile of obe-cel • Clinical data supports differentiated product profile ― High degree of activity and persistence -> believed to drive long term outcomes ― Attractive tolerability profile -> poten
Slide 15: NHL/CLL: ALLCAR19 Phase 1 Study
Building a fully integrated, next-generation CAR T company Autolus.com 15 NHL/CLL: ALLCAR19 Phase 1 Study High level of clinical activity with favorable tolerability profile – follow up at ASH, December 2022 ALLCAR19 – B-NHL and CLL Median Follow-Up Time: FL/DLBCL: 9.2 Months (Range 1.9-19.1) n 20 M
Slide 16: Primary CNS Lymphoma: CAROUSEL Phase 1 Study
Building a fully integrated, next-generation CAR T company Autolus.com 16 Primary CNS Lymphoma: CAROUSEL Phase 1 Study Favorable tolerability profile with encouraging initial response rates and durability – follow up expected 2023 CAROSUEL – PCNSL n 6 CR + PR 4 (67%) Median Follow-Up Time: CR 2 (33%
Slide 17: Pediatric ALL: AUTO1/22 CARPALL study
Building a fully integrated, next-generation CAR T company Autolus.com 17 Pediatric Acute Lymphoblastic Leukemia: AUTO1/22 CARPALL study CD19 negative antigen escape is a common cause of treatment failure Screening for high sensitivity CARPALL Study CD22 binders n 14 CR Rate 86% 54% EFS 12m (95% CI,
Slide 18: Pediatric Acute Lymphoblastic Leukemia: AUTO1/22
Building a fully integrated, next-generation CAR T company Autolus.com 18 Pediatric Acute Lymphoblastic Leukemia: AUTO1/22 Efficacy data presented at EHA June 2022 – longer follow up at ASH, December 2022 Total N=11 Molecular MRD neg CR/Cri by d60 9 (82%) Disease progression 2 (18%) Events in respon
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
Building a fully integrated, next-generation CAR T company Autolus.com 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 Allogeneic Programming Module
Slide 21: Pipeline
Building a fully integrated, next-generation CAR T company Autolus.com 21 Pipeline Designed to address limitations of current T cell therapies PARTNER PRODUCT INDICATION TARGET STUDY PRE PHASE 1 PHASE 2/ BLA CLINICAL PIVOTAL obe-cel Adult ALL CD19 FELIX obe-cel B-NHL & CLL CD19 ALLCAR19 Ext obe-cel
Slide 22: AUTO4 and AUTO5 for Peripheral T-Cell Lymphoma
Building a fully integrated, next-generation CAR T company Autolus.com 22 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 9,200 following first-line treatment (68%)
Slide 23: Three key elements to address T-Cell Lymphomas
Building a fully integrated, next-generation CAR T company Autolus.com 23 Three key elements to address T-Cell Lymphomas A companion diagnostic: AUTO4 and AUTO5 Current Development > ~40% of T cell lymphomas are TRBC1+ 1 Milestone AUTO4 – TRBC1+ TCL • Phase 1 dose escalation Multiple Stratify into •
Slide 24: AUTO4 in T cell lymphoma: Initial data encouraging
Building a fully integrated, next-generation CAR T company Autolus.com 24 AUTO4 in T cell lymphoma: Initial data encouraging All patients treated at highest dose level had a complete metabolic response – follow up to be presented at ASH, Dec 2022 • Favourable tolerability profile – no patient experi
Slide 25: Manufacturing
Manufacturing
Slide 26: Build of facility in Stevenage, UK, progressing on track
Building a fully integrated, next-generation CAR T company Autolus.com 26 Build of facility in Stevenage, UK, progressing on track Building a fully integrated manufacturing and logistics platform • Phase 1 of build project on schedule to complete in Q4 2022 Manufacturing • CMC package for submission
Slide 27: Blackstone Collaboration
Blackstone Collaboration
Slide 28: Blackstone Life Sciences to invest up to $250m to develop obe-cel in adult ALL
Building a fully integrated, next-generation CAR T company Autolus.com 28 Blackstone Life Sciences to invest up to $250m to develop obe-cel in adult ALL Investment of $100m in equity and up to $150 million in product financing • Blackstone purchased $100 million of Autolus’ American Depositary Share
Slide 29: Summary
Summary
Slide 30: Autolus Planned Newsflow
Building a fully integrated, next-generation CAR T company Autolus.com 30 Autolus Planned Newsflow • obe-cel – FELIX - Phase 2 trial in adult ALL first update expected in Q4 2022; data in mid-2023 – ALLCAR19 Phase 1b trial in adult ALL trial follow up data expected at ASH, Dec 2022 – ALLCAR19 Phase
Slide 31: Thank you
Thank you autolus.com
Autolus Therapeutics — Investor Presentation (November 2022) on 6ix