Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Investor Presentation (May 2022)
32 slides from Autolus Therapeutics's investor presentation, May 2022
Slide 1: Developing Next Generation Programmed T Cell Therapies
Developing Next Generation Programmed T Cell Therapies May 2022
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies Autolus.com 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
Slide 3: Autolus Overview
Developing Next Generation Programmed T Cell Therapies Autolus.com 3 Autolus Overview Building a fully integrated CAR T company Best-in-class Pipeline Scalable Collaboration lead asset manufacturing • Lead product obe-cel • Pipeline built on • In house cell • Collaboration with potentially best-in-
Slide 4: obe-cel
LEAD CLINICAL PROGRAM obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy
Slide 5: obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies Autolus.com 5 obe-cel has a unique mechanism of action o Fast off-rate obe-cel has lower CD19 affinity and shorter CAT binder with On-Rate: Ka [M-1S-1] ] 1 - Other CD19 Binders Obe-cel Binder half-life of interaction compared to binders S lower
Slide 6: obe-cel for adult ALL: high unmet need
Developing Next Generation Programmed T Cell Therapies Autolus.com 6 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 ALL
Slide 7: obe-cel is a potentially transformational therapy for adult ALL
Developing Next Generation Programmed T Cell Therapies Autolus.com 7 obe-cel is a potentially transformational therapy for adult ALL Unique CAR T design drives differentiated product profile obe-cel • Unique mechanism of action built on a fast off-rate from CD19 target antigen Orphan Drug designatio
Slide 8: obe-cel shows consistent clinical profile across three clinical studies
Developing Next Generation Programmed T Cell Therapies Autolus.com 8 obe-cel shows 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 has a favourable n 14 20 1
Slide 9: obe-cel shows sustained event-free survival beyond months
Developing Next Generation Programmed T Cell Therapies Autolus.com 9 obe-cel shows sustained event-free survival beyond 30 months Long term CAR T persistence drives durability of effect Median CAR T cell levels in peripheral blood ALLCAR19 Event-Free Survival Median CAR T cell levels by flow cytomet
Slide 10: Unmet medical need in r/r adult ALL despite approved agents
Developing Next Generation Programmed T Cell Therapies 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 ALL Standard of Care Recently FDA approved Blincyto1 Besponsa2 Tecartus3 N 271 109 54 ORR 44% 81% 65% E
Slide 11: obe-cel could launch into an expanding ALL market
Developing Next Generation Programmed T Cell Therapies Autolus.com 11 obe-cel could launch into an expanding ALL market Blincyto®, current market leader, shows annual revenue growth of 25% Reported Blincyto® sales1 • Blincyto® sales price estimated to be $178k3 (for 2 cycles) supporting approx. >2,0
Slide 12: Next steps: obe-cel initial data (FELIX) expected in H2 2022
Developing Next Generation Programmed T Cell Therapies Autolus.com 12 Next steps: obe-cel initial data (FELIX) expected in H2 2022 obe-cel is the first Autolus program to move into a pivotal program: full data in H1 2023 Primary endpoint: H2 2022 overall complete Initial data response rate (CR/Cri)
Slide 13: Building obe-cel into a franchise
Building obe-cel into a franchise Deep value program with broad applicability
Slide 14: Capitalising on the obe-cel profile in additional indications
Developing Next Generation Programmed T Cell Therapies Autolus.com 14 Capitalising on the obe-cel profile in additional indications Unique profile allows applicability in a broad range of indications Clinical data supports differentiated product profile • High degree of activity and persistence -> d
Slide 15: B-cell Non-Hodgkin Lymphoma: Favorable tolerability profile reproduced
Developing Next Generation Programmed T Cell Therapies Autolus.com 15 B-cell Non-Hodgkin Lymphoma: Favorable tolerability profile reproduced Adverse Events of Special Interest Event N = 16 All Grades Grade 1 Grade 2 Grade 3 Grade 4 patients n (%) n (%) n (%) n (%) n (%) • Consistent safety profile f
Slide 16: obe-cel shows excellent T cell expansion and engraftment
Developing Next Generation Programmed T Cell Therapies Autolus.com 16 obe-cel shows excellent T cell expansion and engraftment ALLCAR19 – B-NHL Patients Cmax (CAR transgene per ug gDNA) ALL is a n 9 significant Mean 336234 CV% 50.2% opportunity Time to Cmax (Days) n 9 Median 9 Range 7-17 Time last m
Slide 17: obe-cel shows encouraging efficacy and duration of response in NHL/CLL
Developing Next Generation Programmed T Cell Therapies Autolus.com 17 obe-cel shows encouraging efficacy and duration of response in NHL/CLL Long term persistence of obe-cel demonstrated by qPCR N (%) • Out of 14 patients evaluable for efficacy, Disease assessment not reached 100% ORR and 13/14 (93%
Slide 18: AUTO1/22: Pediatric Acute Lymphoblastic Leukemia
Developing Next Generation Programmed T Cell Therapies Autolus.com 18 AUTO1/22: Pediatric Acute Lymphoblastic Leukemia CD19 negative antigen escape is a common cause of treatment failure CARPALL Study • obe-cel (AUTO1) in relapsed / refractory pediatric ALL is highly active and has a favourable safe
Slide 19: AUTO1/22: enhanced in vivo anti-tumor efficacy
Developing Next Generation Programmed T Cell Therapies Autolus.com 19 AUTO1/22: enhanced in vivo anti-tumor efficacy Dual targeting of CD19 and CD22 addresses CD19-negative target cells and enhances overall activity Nalm-6 WTNalm-6 WT Nalm-6 WT NT AUTO1 AUTO1/22 NT 10 11 AUTO1 3 10 10 Total Flux [p/
Slide 20: Summary and next steps for obe-cel
Developing Next Generation Programmed T Cell Therapies Autolus.com 20 Summary and next steps for obe-cel Building a franchise through broad applicability • Favorable and consistent safety profile demonstrated in a number of indications • Encouraging efficacy and duration in small patient numbers • L
Slide 21: Pipeline
Pipeline A broad portfolio of next generation modular T cell therapies
Slide 22: A broad toolkit which is core to our strategy of modular innovation
Developing Next Generation Programmed T Cell Therapies Autolus.com 22 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 Modules Vi
Slide 23: Pipeline
Developing Next Generation Programmed T Cell Therapies Autolus.com 23 Pipeline Designed to address limitations of current T cell therapies 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 Primary CNS
Slide 24: AUTO4: T Cell Lymphoma
Developing Next Generation Programmed T Cell Therapies Autolus.com 24 AUTO4: T Cell Lymphoma No standard of care after first relapse and no T cell therapy approved • T cell lymphoma is an aggressive disease with a very Three key elements to address T cell lymphomas: poor prognosis for patients AUTO4
Slide 25: Manufacturing
Manufacturing
Slide 26: Manufacturing operations
Developing Next Generation Programmed T Cell Therapies Autolus.com 26 Manufacturing operations First UK CAR T commercial facility expected to be ready for GMP operations in mid 2023 • Highly experienced team running manufacturing operations and supporting new facility build • 70,000 ft2 commercial f
Slide 27: Blackstone Collaboration
Blackstone Collaboration
Slide 28: Blackstone Life Sciences to invest up to $250m to develop obe-cel in adult ALL
Developing Next Generation Programmed T Cell Therapies 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 agreed to purchase $100 million of Autolus’ American Depositary
Slide 29: Summary
Summary Multiple catalysts in H2 2022
Slide 30: Autolus poised for potential value inflection
Developing Next Generation Programmed T Cell Therapies Autolus.com 30 Autolus poised for potential value inflection obe-cel pivotal data in adult ALL in 2022 • obe-cel – FELIX Phase 2 study in adult ALL ongoing; initial data expected in H2 2022 and full data in H1 2023 – Evaluation in r/r B-NHL and
Slide 31: Autolus key newsflow timeline
Autolus key newsflow timeline EHA – June 2022 • obe-cel in r/r B-NHL and CLL (Phase 1) • obe-cel in primary CNS lymphoma (Phase 1) H2 2023 • AUTO4 in T Cell Lymphoma H2 2022 Submit BLA for obe-cel in ALL (interim Phase 1) FELIX Phase 2 initial data • AUTO1/22 in pediatric ALL (Phase 1) 2022 2023 202
Slide 32: Thank you
Thank you autolus.com
Autolus Therapeutics — Investor Presentation (May 2022) on 6ix