Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q3 2020 Earnings Presentation
24 slides from Autolus Therapeutics's earnings presentation, Nov 5, 2020
Slide 1: Third Quarter Financial Results and Operational Progress
Nasdaq: AUTL Third Quarter Financial Results and Operational Progress November 5, 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 safety, therapeutic potential and commercial opportunity of AUT
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: Business update – third quarter 2020
Business update – third quarter 2020 Impact from COVID-19 has been limited to date, but situation poses a risk to AUTO1 • AUTO1 pivotal program currently on track ― AUTO1 pivotal program was initiated in Q2 as planned ― Potential impact of infection surges on timelines continues to be closely monito
Slide 6: Corporate highlights – third quarter 2020
Corporate highlights – third quarter 2020 Advancing our clinical programs to value inflection • AUTO1 in adult ALL; ― AUTO1 pivotal program initiated and enrolling ― Targeting data by end 2021, assuming no COVID-19 disruptions to clinical trial conduct • AUTO3 in DLBCL ― AUTO3 data at ESMO continue
Slide 7: No approved CAR T therapy for adult ALL patients
No approved CAR T therapy for adult ALL patients Successful therapy requires high level of activity and long persistence paired with good tolerability High unmet medical need ALL is a significant • Combination chemotherapy enables 90% of adult ALL patients to opportunity: experience CR, but only 30%
Slide 8: AUTO1 potentially has a superior efficacy profile compared to standard of care
AUTO1 potentially has a superior efficacy profile compared to standard of care Comparable and manageable safety profile 1AUTO1 Standard of Care All patients Closed Process 2Blinatumumab 3Inotuzumab Patient Numbers 19 13 271 218 CR Rate 84% 92% 44% 80.7% EFS 6m 62% 76% 31% mPFS 5m CRS ≥ Grade 3 0% 0%
Slide 9: AUTO1 is the first Autolus program to move into a pivotal program
AUTO1 is the first Autolus program to move into a pivotal program Preliminary Ph1 data supports development as a standalone therapy • Ph1b run-in component, prior to single arm Ph2 pivotal study Pivotal program, AUTO1- CTA approved by the • 100 relapsed / refractory adult MHRA in January 2020 ALL pa
Slide 10: Capitalizing on the unique profile of AUTO1
Capitalizing on the unique profile of AUTO1 AUTO1 in late phase development in adult ALL, with four related Ph1 trials enrolling by Q1 2021 PRODUCT INDICATION TARGET CTA Enabling Phase 1/2 Pivotal AUTO1 Adult ALL CD19 ALLCAR19 AUTO1-AL1 AUTO1 iNHL & CLL CD19 ALLCAR19 ext. Study ongoing AUTO1 Primary
Slide 11: Current status of CAR T Cell therapies in DLBCL
Current status of CAR T Cell therapies in DLBCL Two approved products (Yescarta® and Kymriah®) and one near to approval (liso-cel) Efficacy Safety • Despite high ORR (70-80%) and high best • High rates of severe cytokine release CRR (40-55%), only 29-37% patients syndrome (13-22%) and severe achieve
Slide 12: Complete Response Rate (CRR) - Completed Cohorts Only
Complete Response Rate (CRR) - Completed Cohorts Only Dose level ≥ 150 x 106 cells with day -1 pembro selected as Phase 2 dosing regimen (RP2D) 150-450 x106 150-450 x 106 50 x106 AUTO3 50 x106 AUTO3 AUTO3 AUTO3 Total no pem D14 pem D14 pem D-1 pem RP2D (N=30) (N=4) (N=3) (N=8) (N=15) N evaluable* 4
Slide 13: Cytokine Release Syndrome and Neurotoxicity – All Patients
Cytokine Release Syndrome and Neurotoxicity – All Patients No severe CRS and low rates of NT 150-450 x106 150-450 x 106 50 x106 AUTO3 50 x106 AUTO3 AUTO3 AUTO3 Total no pem D14 pem D14 pem D-1 pem RP2D (N=35) (N=4) (N=3) (N=8) (N=20) Grade 1 CRS 1 0 2 5 8 (22.9%) Grade 2 CRS 0 0 2 2 4 (11.4%) > Grad
Slide 14: Approved CAR T’s have not penetrated outpatient setting
Approved CAR T’s have not penetrated outpatient setting Creates significant upside for AUTO3 with potential to go where patients reside Percentage of patients who currently receive a • 97% of patients receive approved CAR Ts as inpatients CAR T in outpatient or inpatient setting in CoEs because of t
Slide 15: Expansion cohort is assessing feasibility in outpatient setting
Expansion cohort is assessing feasibility in outpatient setting • Purpose of the ALEXANDER expansion cohort is to assess the feasibility of using AUTO3 in an outpatient setting ― Opportunity to evaluate additional safety and efficacy data with more patients’ data ― Enables centers to broaden their e
Slide 16: AUTO3 is designed for potential best-in-class clinical profile
AUTO3 is designed for potential best-in-class clinical profile Differentiated product profile should open access to full market opportunity • AUTO3 is designed to provide Outpatient cohort best-in-class clinical profile, which initiated with data negates the need for intensive First-in-class CD19 &
Slide 17: Broad pipeline of next generation programs
Broad pipeline of next generation programs Designed to address limitations of current T cell therapies PRODUCT INDICATION TARGET PRECLINICAL PHASE 1 AUTO1/22 Pediatric ALL CD19 & CD22 Q4 2020 AUTO3NG DLBCL CD19 & CD22 Life cycle mgmt AUTO5 TRBC2+ Peripheral TCL TRBC2 2021 Neuroblastoma; Melanoma; AU
Slide 18: Financial Results
Financial Results Andrew J. Oakley CFO 18
Slide 19: Financial summary
Financial summary USD m 3Q 2020 3Q 2019 Variance Grant Income 0.4 0.3 0.1 License Revenue 0.2 - 0.2 R&D (33.5) (27.3) (6.2) G&A (9.8) (8.6) (1.2) Total Op Expenses, net. (42.7) (35.6) (7.1) Interest Income 0.0 0.5 (0.5) Other Income (2.5) 3.3 (5.8) Tax Benefit 7.9 4.6 3.3 Net Loss (37.3) (27.2) (10.
Slide 20: Upcoming Milestones and Conclusions
Upcoming Milestones and Conclusions Dr. Christian Itin Chairman and CEO 20
Slide 21: Multiple clinical milestones expected through Q4 2020 / 2021
Multiple clinical milestones expected through Q4 2020 / 2021 PRODUCT INDICATION TARGET EVENT AUTO1 Adult ALL CD19 Ph1 long-term follow up at ASH AUTO1/22 Pediatric ALL CD19 & CD22 Start Ph1 Q4 2020 AUTO3 DLBCL CD19 & CD22 Ph1 data update at ASH AUTO4 TRBC1+ Peripheral TCL TRBC1 Ph1 interim data 2021
Slide 22: Autolus poised for value inflection
Autolus poised for value inflection • AUTO1 and AUTO1/22 ― Currently enrolling Autolus’ first Ph1b / 2 pivotal program in adult ALL ― Granted orphan drug designation by the FDA for treatment of ALL ― Pediatric ALL – moving forward with AUTO1/22 ― ALLCAR study extension in iNHL and CLL ongoing ― Oppo
Slide 23: Q&A Dr. Christian Itin and Andrew Oakley
Q&A Dr. Christian Itin and Andrew Oakley 23
Slide 24: Thank you
Thank you 24