Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q2 2024 Earnings Presentation
26 slides from Autolus Therapeutics's earnings presentation, Aug 8, 2024
Slide 1: Q2 2024 Financial Results and Business Updates
Q2 2024 Financial Results and Business Updates 8 August 2024 Autolus.com
Slide 2: Disclaimer
Developing Next Generation Programmed T Cell Therapies 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 i
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies Agenda • Welcome and Introduction: Olivia Manser, Director, Investor Relations • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr. Christ
Slide 4: Autolus executed to plan in Q2 2024
Developing Next Generation Programmed T Cell Therapies Autolus executed to plan in Q2 2024 • Obe-cel progressing according to plan – FDA PDUFA target date of November 16 – MAA submitted to MHRA in Q3; MAA accepted by EMA – SLE Phase 1 CARLYSLE study first patient dosed in Q2, enrolment ongoing Clini
Slide 5: ASCO/EHA 2024
OBE-CEL IN ADULTS WITH R/R B-ALL ASCO/EHA 2024 FELIX Phase 1b/2 trial
Slide 6: FELIX study all cohorts: Majority of responders show durable response (n=127)
Developing Next Generation Programmed T Cell Therapies FELIX study all cohorts: Majority of responders show durable response (n=127) 40% of responders are in ongoing remission without consolidative SCT and 18% had consolidative SCT Infused Data cut-off date: N = 127 February 7, 2024 No response or n
Slide 7: FELIX study all cohorts: Event-free survival (n=127)
Developing Next Generation Programmed T Cell Therapies FELIX study all cohorts: Event-free survival (n=127) Subset of patients benefit from standalone treatment with obe-cel 100 90 Censoring for SCT (main analysis) Without censoring for SCT 80 Probability (%) 70 60 50 40 30 20 Censoring for SCT With
Slide 8: FELIX study all cohorts: Overall survival (n=127)
Developing Next Generation Programmed T Cell Therapies FELIX study all cohorts: Overall survival (n=127) Potential long-term plateau 100 90 Censoring for SCT 80 Without censoring for SCT (main analysis) Probability (%) 70 60 50 40 30 20 Censoring for SCT Without censoring for SCT 10 Median (95% CI),
Slide 9: FELIX study all cohorts: CAR T persistence and predicted relapse
Developing Next Generation Programmed T Cell Therapies FELIX study all cohorts: CAR T persistence and predicted relapse Ongoing CAR T persistence correlates with long-term EFS 1.0 1.0 Ongoing CAR T persistence Ongoing B-cell aplasia Loss of CAR T persistence at Month 12 B-cell recovery at Month 12 0
Slide 10: ASCO 2024 takeaway messages
Developing Next Generation Programmed T Cell Therapies ASCO 2024 takeaway messages FELIX study - pooled analysis of all cohorts • 40% of responders in ongoing remission without subsequent SCT/other therapy, with a median follow-up of 21.5 months • Survival outcomes show potential of long-term platea
Slide 11: Commercial Launch Readiness
Commercial Launch Readiness
Slide 12: Obe-cel steps to commercialization
Developing Next Generation Programmed T Cell Therapies Obe-cel steps to commercialization Roadmap to a commercial launch in r/r adult ALL 2024 Q1 Q2 Q3 Q4 Obe-cel BLA Nucleus MHRA Obe-cel FDA accepted by FDA inspection MHRA PDUFA & approval authorization Obe-cel EMA MAA application Obtained MHRA MIA
Slide 13: US treatment center timelines for authorization and first patient readiness
Developing Next Generation Programmed T Cell Therapies US treatment center timelines for authorization and first patient readiness 2024 2025 Now-Oct Nov Dec Jan Feb Mar Activation Qualification (activities ongoing) Activation Activities Complete = Authorization Trigger PDUFA* (Nov 16th) Centers have
Slide 14: Key steps from approval to patients dosed
Developing Next Generation Programmed T Cell Therapies Key steps from approval to patients dosed Final steps of center activation are driven by the actual label 2024 2025 Key steps Anticipated Timing Complete site accreditation 2 – 12 weeks (e.g. final label, training plans, REMS and Out of Specific
Slide 15: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 16: The obe-cel product family and franchise opportunity
Developing Next Generation Programmed T Cell Therapies The obe-cel product family and franchise opportunity • Optimized CD19 CAR design B-ALL and B-NHL Obe-cel • Potential best-in-class efficacy and safety profile CD19 • Supported by state-of-the-art manufacturing B-cell mediated • Supported by matu
Slide 17: Dynamic environment in cell therapy for autoimmune patients
Autoimmune Developing Next Generation Programmed T Cell Therapies Dynamic environment in cell therapy for autoimmune patients EULAR updates continue to support overall proof of concept/biology in autoimmune disease • Available clinical data is largely based on compassionate use experience with more
Slide 18: Obe-cel is similar to Erlangen CD19 CART
Autoimmune Developing Next Generation Programmed T Cell Therapies Obe-cel is similar to Erlangen CD19 CART • Erlangen CD19 CART was developed for treating Differentiated CD19 engagement (fast off-rate) paediatric ALL Shorter half-life of interaction On-Rate: Ka [M-1S-1] ]1 – CD19 CAR is identical to
Slide 19: Phase 1 study in r/r SLE – enrollment ongoing
Autoimmune Developing Next Generation Programmed T Cell Therapies Phase 1 study in r/r SLE – enrollment ongoing Primary goal of the Phase 1 study will be confirming the fixed dose in adult SLE patients CARLYSLE Study • A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and
Slide 20: Other pipeline programs and technologies
Other pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 21: Autolus pipeline
Developing Next Generation Programmed T Cell Therapies Autolus pipeline Obe-cel product family Product Indication Target Study Name Partner Phase Status/Expected Milestones Submitted to EMA, MHRA and FDA Obe-cel Adult B-ALL CD19 FELIX Pivotal (PDUFA November 16, 2024) Obe-cel Systemic Lupus Erythema
Slide 22: Financial Results
Financial Results
Slide 23: Financial summary (unaudited)
Building a fully integrated, next-generation CAR T company Financial summary (unaudited) USD ($’ 000) Q2 2024 Q4 2023 Variance Cash and cash equivalents 705,939 239,566 466,373 Q2 2024 Q2 2023 Variance Operating expenses: R&D (36,612) (33,232) (3,380) G&A (21,903) (11,122) (10,781) Loss on disposal
Slide 24: Upcoming news flow
Upcoming news flow
Slide 25: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies Autolus planned news flow Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel U.S. FDA PDUFA target action date November 16, 2024 Obe-cel FELIX data update at ASH 2024 December 2024 Obe-cel in autoimmune disease – initial data fro
Slide 26: Thank you
Thank you Autolus.com