Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — FY2023 Earnings Presentation
31 slides from Autolus Therapeutics's earnings presentation, Mar 14, 2024
Slide 1: Full Year 2023 Financial Results and Business Updates
Full Year 2023 Financial Results and Business Updates March 14, 2024
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, and
Slide 3: Agenda
Developing Next Generation Programmed T Cell Therapies 3 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. Chri
Slide 4: Strategic updates
Developing Next Generation Programmed T Cell Therapies 4 Strategic updates Strong cash position: Year-end 2023 cash of $240M & gross proceeds of $600M from activities in February 2024 • In February 2024 completed an underwritten registered direct equity financing – Gross proceeds of $350M Financing
Slide 5: Obe-cel highlights in r/r B-ALL
Developing Next Generation Programmed T Cell Therapies 5 Obe-cel highlights in r/r B-ALL FELIX data, regulatory review and preparation for launch • Obe-cel in relapsed / refractory (r/r) adult ALL - pooled analysis presented at ASH in December 2023 Clinical – FELIX Phase 1b/2 study - prolonged event
Slide 6: Other pipeline highlights
Developing Next Generation Programmed T Cell Therapies 6 Other pipeline highlights Expanding opportunity beyond ALL • Obe-cel in B-cell mediated autoimmune diseases – Phase 1 CARLYSLE Study Obe-cel in Autoimmune – Phase 1 dose confirmation study in refractory SLE patients – first trial site opened f
Slide 7: Organizational changes
Developing Next Generation Programmed T Cell Therapies 7 Organizational changes • Promotions of Dr Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel • Dr. Edgar Braendle to step down as Chief Development Officer to pursue other oppor
Slide 8: Obe-cel
LEAD CLINICAL PROGRAM Obe-cel A standalone, potentially best-in-class CD19 CAR T cell therapy candidate
Slide 9: We believe obe-cel has a unique mechanism of action
Developing Next Generation Programmed T Cell Therapies 9 We believe obe-cel has a unique mechanism of action Designed for increased activity and reduced toxicity Differentiated CD19 binder Fast off-rate Shorter half-life of interaction compared On-Rate: Ka [M-1S-1] ]1 CD19 binder with - - S1 Other C
Slide 10: Obe-cel pooled analysis
ASH 2023 Obe-cel pooled analysis FELIX Phase 1b/2 trial
Slide 11: FELIX Phase 1b/2 pooled analysis: patient disposition
Developing Next Generation Programmed T Cell Therapies 11 FELIX Phase 1b/2 pooled analysis: patient disposition 127/153 (83%) enrolled patients received obe-cel* n (%) Discontinued Enrolled** 26 (17) N = 153 Death 15 (10) Manufacturing-related 7 (5) Morphologic disease*** (n = 98) Adverse event 2 (1
Slide 12: FELIX Phase 1b/2 pooled analysis: leukemic burden in all treated patients
Developing Next Generation Programmed T Cell Therapies 12 FELIX Phase 1b/2 pooled analysis: leukemic burden in all treated patients Leukemic burden at screening is not predictive of leukemic burden prior to lymphodepletion BM blasts % 118/127 (93%) patients received BM blasts % prior at screening br
Slide 13: FELIX Ph1b/2 pooled: EFS by leukemic burden prior to lymphodepletion
Developing Next Generation Programmed T Cell Therapies 13 FELIX Ph1b/2 pooled: EFS by leukemic burden prior to lymphodepletion* Lower leukemic burden is associated with better outcomes <5% (n = 36) 100 ≥5−≤75% (n = 51) 90 >75% (n = 40) 80 70 Probability (%) 60 50 40 Events, n: <5% 10 30 ≥5−≤75% 22 >
Slide 14: FELIX Phase 1b/2 pooled analysis: CRS and ICANS
Developing Next Generation Programmed T Cell Therapies 14 FELIX Phase 1b/2 pooled analysis: CRS and ICANS Low rates of Grade ≥3 CRS and/or ICANS were observed CRS and ICANS CRS by ICANS by in all patients % BM blasts % BM blasts 100 100 100 88% 80 80 80 69% 69% Incidence, % Incidence, % Incidence, %
Slide 15: Obe-cel pooled analysis
ASH 2023 Obe-cel pooled analysis ALLCAR19 Phase 1b /FELIX Ph 1b
Slide 16: Long-term follow up in R/R B-ALL demonstrates favorable EFS and OS
Developing Next Generation Programmed T Cell Therapies 16 Long-term follow up in R/R B-ALL demonstrates favorable EFS and OS Median follow up 36.5 months; pooled analysis Phase 1b ALLCAR19/Phase 1b FELIX With censoring*: Median OS: 16.4 months (95% CI: 7.1–N/A) • Median EFS: 9.0 months (95% CI: 5.1–
Slide 17: Durable remissions and prolonged persistence in patients with R/R B-ALL
Developing Next Generation Programmed T Cell Therapies 17 Durable remissions and prolonged persistence in patients with R/R B-ALL Pooled analysis Phase 1b ALLCAR19 / Phase 1b FELIX No. Months since infusion • ORR: 80.6% (95% CI: 64.0–91.8) • Ongoing CAR T persistence • All patients in ongoing remiss
Slide 18: Commercial Launch Readiness
Commercial Launch Readiness
Slide 19: Obe-cel steps to commercialization in r/r adult B-ALL
Developing Next Generation Programmed T Cell Therapies 19 Obe-cel steps to commercialization in r/r adult B-ALL Roadmap to a 2024 commercial launch Q1 Q2 Q3 Q4 Obe-cel BLA MHRA Nucleus inspection & approval Obe-cel FDA accepted by MHRA PDUFA FDA Obe-cel EU authorization application authorization app
Slide 20: Expanding the obe-cel opportunity
Expanding the obe-cel opportunity Deep value program with potentially broad applicability
Slide 21: The obe-cel product family and franchise opportunity
Developing Next Generation Programmed T Cell Therapies 21 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 m
Slide 22: Phase 1 SLE study – CARLYSLE trial
Developing Next Generation Programmed T Cell Therapies 22 Phase 1 SLE study – CARLYSLE trial A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus (SLE) • Stud
Slide 23: Other pipeline programs and technologies
Other pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies
Slide 24: Autolus pipeline
Developing Next Generation Programmed T Cell Therapies 24 Autolus pipeline Obe-cel product family PRODUCT INDICATION TARGET STUDY NAME PARTNER PHASE STATUS/EXPECTED MILESTONES H1 2024: MAA Application to EMA Obe-cel Adult B-ALL CD19 FELIX Pivotal November 16, 2024: PDUFA date Obe-cel Systemic Lupus
Slide 25: Financial Results
Financial Results
Slide 26: Financial summary (unaudited)
Building a fully integrated, next-generation CAR T company 26 Financial summary (unaudited) USD Q4 2023 YTD ($ '000) Q4 2022 YTD ($ '000) Variance ($ '000) Grant Income - 166 (166) License revenues 1,698 6,194 (4,496) R&D1 (130,481) (117,354) (13,127) G&A (46,745) (31,899) (14,846) Loss on disposal
Slide 27: Upcoming news flow
Upcoming news flow
Slide 28: Autolus planned news flow
Developing Next Generation Programmed T Cell Therapies 28 Autolus planned news flow Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel FELIX data update at ASCO, EHA & ASH 2024 June & December 2024 Obe-cel Marketing Authorization Application to MHRA Second half 2024 Obe-cel U.S. FDA
Slide 29: Summary
Summary
Slide 30: Building a leading CAR T company developing therapies for cancer and autoimmune diseases
Developing Next Generation Programmed T Cell Therapies 30 Building a leading CAR T company developing therapies for cancer and autoimmune diseases Scaling company toward commercialization $ Obe-cel potentially best in Pipeline expansion Scalable manufacturing Strategic Strong cash position class CAR
Slide 31: Thank you
Thank you autolus.com