Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q1 2020 Earnings Presentation
20 slides from Autolus Therapeutics's earnings presentation, May 7, 2020
Slide 1: First Quarter Financial Results and Operational Progress
Nasdaq: AUTL First Quarter Financial Results and Operational Progress May 7, 2020 Nasdaq: AUTL
Slide 2: Disclaimer
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, including statements about the Company's plans to develop and commercialize its product candid
Slide 3: Agenda
Agenda 1. Welcome and Introduction: Dr. Christian Itin, Chairman and CEO 2. Operational Highlights: Dr. Christian Itin 3. Financial Results and Overview: Andrew J. Oakley, CFO 4. Upcoming Milestones and Conclusion: Dr. Christian Itin 5. Q&A: Dr. Christian Itin and Andrew J. Oakley 3
Slide 4: Operational Highlights
Operational Highlights Dr. Christian Itin Chairman and CEO 4
Slide 5: Corporate highlights – first quarter 2020
Corporate highlights – first quarter 2020 Advancing our clinical programs to value inflection • AUTO1 in adult ALL; AUTO1-AL1 pivotal study initiated ― IND accepted; US sites will be initiated starting Q2 2020 ― First site opened in the UK March 2020 (MHRA CTA approval in January) ― On track for ful
Slide 6: Corporate highlights – first quarter 2020
Corporate highlights – first quarter 2020 Advancing our pre-clinical programs to value inflection • Pre-clinical data updates expected at AACR II ― AUTO5 in T-cell lymphomas ― AUTO6NG in SCLC ― AUTO7 in Prostate Cancer ― Investor call planned post AACR II • Manufacturing ― Continued to manufacture,
Slide 7: AUTO1: Key features
AUTO1: Key features Designed for durability of responses without allo-transplant and no severe CRS Conventional CD19 CARs AUTO1 • Approved and near approved CD19 CAR Ts • AUTO1 has an optimized CD19 CAR with a use identical high affinity CD19 binder lower affinity and a fast off rate (FMC63) • FMC63
Slide 8: AUTO1 may be best-in-class redirected T cell therapy
AUTO1 may be best-in-class redirected T cell therapy Relapsed/refractory Adult ALL clinical data 2AUTO1 1Blincyto All patients Closed Process3 Patient Numbers 271 16 9 CR Rate 42% 87%◊ 100% EFS 6m 31% 68%◊ 100% CRS ≥ Grade 3 3% 0% 0% Neurotox ≥ Grade 3 13% 19%ǂ 12%ǂ ◊ 15 patients evaluable for effic
Slide 9: AUTO1 is the first Autolus program to move into a pivotal study
AUTO1 is the first Autolus program to move into a pivotal study Pivotal study, AUTO1-AL1, in adult ALL: • CTA approved by the MHRA in January 2020 and US IND accepted by the FDA in April 2020 • Ph1b run-in component in Q2, prior to single arm Ph2 pivotal study • 100 relapsed / refractory adult ALL p
Slide 10: Desired characteristics for broad use of a CAR T therapy for DLBCL
Desired characteristics for broad use of a CAR T therapy for DLBCL Sustained CRs, low toxicity & toxicity management and broad healthcare utilization • High sustained complete response rate ― Preventing target negative relapse ― Preventing checkpoint mediated resistance / exhaustion • Safety profile
Slide 11: Widespread adoption of CAR T products has been limited by toxicities
Widespread adoption of CAR T products has been limited by toxicities High rates and severity of toxicities require intensive management and inpatient care Yescarta# Kymriah/ JCAR017# AUTO3 Best CRR 54% 40-53% 55%* Ongoing CR rate 36% at 6m 29-35% at 6m tbd CRS ≥ grade 3 11% 2-23% 0% NTX any grade 64
Slide 12: AUTO3 is designed to reach total addressable r/r DLBCL population
AUTO3 is designed to reach total addressable r/r DLBCL population AUTO3 has the potential to be a true outpatient therapy US Site of Care Distribution 3L+ R/R DLBCL Approved CD19 CAR T Products 20% Approved • Patients receive approved products as inpatients in Products CoEs because of the high rate
Slide 13: Opportunity to expand the current Alexander study
Opportunity to expand the current Alexander study Enhanced value proposition for AUTO3 in the outpatient setting • Company on track to deliver further data from Ph1/2 Alexander study at ASCO and EHA • Ph2 decision point mid-2020 • Positive safety profile supports outpatient use • Plan to add a 20 pa
Slide 14: Financial Results
Financial Results Andrew J. Oakley CFO 14
Slide 15: Financial summary
Financial summary USD m 1Q 2019 1Q 2020 Variance Grant Income 2.0 0.3 (1.7) R&D (22.6) (31.3) (8.7) G&A (9.6) (7.6) 2.0 Total Op Expenses, net. (30.2) (38.6) (8.4) Interest Income 0.5 0.5 0.0 Other Income (0.9) 4.5 5.4 Tax Benefit 3.4 3.7 0.3 Net Loss (27.2) (29.9) (2.7) USD m Dec 31 2019 Mar 31 202
Slide 16: Upcoming Milestones and Conclusions
Upcoming Milestones and Conclusions Dr. Christian Itin Chairman and CEO 16
Slide 17: Multiple clinical data points expected through 2020
Multiple clinical data points expected through 2020 Product Indication Target Event B Cell Malignancies • Ph1 long-term follow up Q2 & Q4 2020 AUTO1 Adult ALL CD19 • Ongoing recruitment and dose last patient H1 2021 AUTO1NG Pediatric ALL CD19 & 22 • Start Ph1 H1 2020 • Ph1 data Q2 & Q4 2020 AUTO3 DL
Slide 18: Autolus poised for value inflection in 2020
Autolus poised for value inflection in 2020 • AUTO1 ― Initiating recruitment for UK & US in Autolus’ first pivotal program in Adult ALL in Q2 2020 ― Granted orphan drug designation by the FDA for treatment of ALL ― Pediatric ALL – moving forward with AUTO1/AUTO1NG • AUTO3 ― Ph1 data update to be pre
Slide 19: Q&A
Q&A Dr. Christian Itin (Chairman and CEO) Andrew J. Oakley (CFO) 19
Slide 20: Thank you
Thank you