Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q4 2021 Earnings Presentation
37 slides from Autolus Therapeutics's earnings presentation, March 2022
Slide 1: Fourth Quarter Financial Results and Operational Progress
Fourth Quarter Financial Results and Operational Progress March 2022
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies Autolus.com Disclaimer These slides and the accompanying oral presentation contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies Autolus.com 3 Agenda • Welcome and Introduction: Dr. Lucinda Crabtree, SVP, Finance • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Andrew J. Oakley, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A:
Slide 4: Pipeline and Corporate Highlights
Pipeline and Corporate Highlights
Slide 5: Key operational updates – fourth quarter 2021
Developing Next Generation Programmed T Cell Therapies Autolus.com 5 Key operational updates – fourth quarter 2021 Continued progress on building a leading ALL company with Blackstone collaboration providing up to $250 million financing • Obe-cel shows highly consistent and best in class efficacy an
Slide 6: Blackstone Life Sciences to invest up to $250m to develop obe-cel in adult ALL
Developing Next Generation Programmed T Cell Therapies Autolus.com 6 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 S
Slide 7: Program updates – fourth quarter 2021
Developing Next Generation Programmed T Cell Therapies Autolus.com 7 Program updates – fourth quarter 2021 FELIX study progressing, Phase 1b data consistent with ALLCAR19, data in 2022 • Obe-cel in relapsed / refactory (r/r) adult ALL – Data at ASH in December 2021 – Data from the FELIX Phase 1b por
Slide 8: Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia obe-cel — Potential as a standalone therapy
Slide 9: High unmet need for adult ALL patients
Developing Next Generation Programmed T Cell Therapies Autolus.com 9 High unmet need for adult ALL patients Successful therapy requires high level of activity and sustained persistence paired with good tolerability HIGH UNMET MEDICAL NEED • Combination chemotherapy enables 90% of adult ALL patients
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 (CR & CRi) (9
Slide 11: obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies Autolus.com 11 obe-cel has a unique mechanism of action Fast off rate supports physiological engagement of target cells and avoids over-activation and exhaustion of CART cells • obe-cel is designed to improve potency and Enhanced Cytotoxicity pe
Slide 12: obe-cel shows consistent clinical profile across three Phase 1 ALL studies
Developing Next Generation Programmed T Cell Therapies Autolus.com 12 obe-cel shows consistent clinical profile across three Phase 1 ALL studies Data from 3 studies across range of age groups and patient conditions CARPALL #1 ALLCAR19 #2 FELIX 1b #3 Peds ALL Adult ALL Adult ALL n 14 20 16 ORR (CR &
Slide 13: obe-cel shows sustained event-free survival beyond months
Developing Next Generation Programmed T Cell Therapies Autolus.com 13 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 cytome
Slide 14: obe-cel has the potential for a transformational therapy in adult ALL
Developing Next Generation Programmed T Cell Therapies Autolus.com 14 obe-cel has the potential for a transformational therapy in adult ALL Unique CAR T design drives differentiated product profile • Obe-cel has a unique mechanism of action built on a fast-off rate from CD19 target antigen • Obe-cel
Slide 15: FELIX Phase 2 study is under way with data expected in 2022
Developing Next Generation Programmed T Cell Therapies Autolus.com 15 FELIX Phase 2 study is under way with data expected in 2022 Obe-cel is the first Autolus program to move into a pivotal program • Phase 1b run-in component, prior to single arm Phase 2 potential pivotal trial Pivotal program, Phas
Slide 16: obe-cel could potentially launch into an expanding ALL market
Developing Next Generation Programmed T Cell Therapies Autolus.com 16 obe-cel could potentially 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 (based on 2 cycles) supportin
Slide 17: Stevenage Manufacturing Facility Update
Autolus.com 17 Stevenage Manufacturing Facility Update First UK CAR T commercial facility expected to be ready for GMP operations in mid 2023. • For commercial supply, Autolus new 72,000 square foot manufacturing facility in Stevenage, UK is currently under construction • This new Stevenage facility
Slide 18: Unique profile of obe-cel offers potential across broader indications
Developing Next Generation Programmed T Cell Therapies Autolus.com 18 Unique profile of obe-cel offers potential across broader indications Evaluation of obe-cel activity in additional B-Cell malignancies to capitalize on potential market opportunity Opportunity to pursue in earlier lines of therapy
Slide 19: B-NHL
B-NHL Obe-cel
Slide 20: Favorable tolerability profile of obe-cel reproduced in B-NHL
Developing Next Generation Programmed T Cell Therapies Autolus.com 20 Favorable tolerability profile of obe-cel reproduced in B-NHL No ICANS or severe CRS AEs of Special Interest Event All N = 16 Grades Grade 1 Grade 2 Grade 3 Grade 4 patients n (%) n (%) n (%) n (%) n (%) CRS* 9 (56%) 6 (38%) 3 (19
Slide 21: obe-cel shows excellent T cell expansion and engraftment
Developing Next Generation Programmed T Cell Therapies Autolus.com 21 obe-cel shows excellent T cell expansion and engraftment ALLCAR19 – B-NHL Patients Cmax (CAR transgene per ug gDNA) n 9 ALL is a Mean 336234 significant CV% 50.2% opportunity Time to Cmax (Days) n 9 Median 9 Range 7-17 Time last m
Slide 22: ALLCAR19 shows encouraging obe-cel efficacy in B-NHL/CLL
Developing Next Generation Programmed T Cell Therapies Autolus.com obe-cel ALLCAR19 –shows B-NHL/CLL encouraging patients efficacy and duration of response in NHL/CLL N (%) Disease assessment not reached Follicular Lymphoma Disease assessment not reached CR + PR 7 (100%) CR 7 (100%) DLBCL CR + PR 3
Slide 23: Summary and next steps for obe-cel in B-NHL
Developing Next Generation Programmed T Cell Therapies Autolus.com 23 Summary and next steps for obe-cel in B-NHL • Favorable safety profile in B-NHL with no ICANS or severe Grade ≥ 3 CRS events, consistent with safety profile observed in r/r B-ALL • Out of 14 patients evaluable for efficacy, 100% O
Slide 24: Pediatric ALL
Pediatric ALL
Slide 25: Autolus CAR T approach to treating pediatric ALL
Developing Next Generation Programmed T Cell Therapies Autolus.com 25 Autolus CAR T approach to treating pediatric ALL CD19 negative antigen escape is a common cause of treatment failure • obe-cel (AUTO1) in relapsed / refractory pediatric ALL is CARPALL Study highly active and has a favourable safe
Slide 26: AUTO1/22: enhanced in vivo anti-tumor efficacy
Developing Next Generation Programmed T Cell Therapies Autolus.com 26 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 27: AUTO1/22 – A dual targeting CAR T therapy
Developing Next Generation Programmed T Cell Therapies Autolus.com 27 AUTO1/22 – A dual targeting CAR T therapy Currently being tested in pediatric ALL • AUTO1/22 builds on excellent CD19 targeting of obe-cel with its high activity and good safety profile and adds potent second CAR to target CD22 •
Slide 28: Pipeline
Pipeline A broad portfolio of next generation modular T cell therapies
Slide 29: T Cell Lymphoma
Developing Next Generation Programmed T Cell Therapies Autolus.com 29 T Cell Lymphoma No standard of care after first relapse and no T cell therapy approved Three key elements to address T cell lymphomas: • T cell lymphoma is an aggressive disease with a very AUTO4, AUTO5 and a companion diagnostic
Slide 30: A broad toolkit which is core to our strategy of modular innovation
Developing Next Generation Programmed T Cell Therapies Autolus.com 30 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 31: SS-IL12 module maintains potent adjuvant activity with no toxicity
Developing Next Generation Programmed Cell Therapies Autolus.com 31 SS-IL12 module maintains potent adjuvant activity with no toxicity Module prevents toxicity by drastically reducing IL12 secretion • IL-12 is a potent adjuvant that promotes a powerful anti-tumour response when combined with checkpo
Slide 32: Next generation programs
Developing Next Generation Programmed T Cell Therapies Autolus.com 32 Next generation programs Designed to address limitations of current T cell therapies
Slide 33: Financial Results
Financial Results
Slide 34: Financial summary
Developing Next Generation Programmed T Cell Therapies Autolus.com 34 Financial summary USD m FY 2021 FY 2020 Variance Grant Income 0.8 1.5 (0.7) License Income 1.5 0.2 1.3 R&D (134.8) (134.9) 0.1 G&A (31.9) (35.0) 3.1 Loss on disposal of leasehold improvements (0.7) - (0.7) Total Op Expense, Net (1
Slide 35: Next Steps
Next Steps
Slide 36: Autolus poised for potential value inflection
Developing Next Generation Programmed T Cell Therapies Autolus.com 36 Autolus poised for potential value inflection obe-cel pivotal data in adult ALL in 2022 obe-cel • FELIX Phase 2 study in adult ALL data expected in 2022 with full data in H1 2023 • Evaluation in relapsed/refractory B-NHL and CLL o
Slide 37: Thank you
Thank you autolus.com