Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q2 2020 Earnings Presentation
23 slides from Autolus Therapeutics's earnings presentation, Aug 6, 2020
Slide 1: Second Quarter Financial Results and Operational Progress
Nasdaq: AUTL Second Quarter Financial Results and Operational Progress August 6, 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: Business update – second quarter 2020
Business update – second quarter 2020 Impact from COVID-19 on our programs has been limited to date • In Q2 our lead programs AUTO1 and AUTO3 were not impacted significantly ― AUTO1 pivotal study was initiated in Q2 as planned and potential impact of infection surges on timelines is being closely mo
Slide 6: Corporate highlights – second quarter 2020
Corporate highlights – second quarter 2020 Advancing our clinical programs to value inflection; positive updates at ASCO & EHA • AUTO1 in adult ALL; ― AUTO1 Ph1 data at EHA continues to show favorable safety profile and high level of clinical activity ― AUTO1 pivotal program initiated and enrolling
Slide 7: Corporate highlights – second quarter 2020
Corporate highlights – second quarter 2020 Advancing next generation preclinical programs to value inflection; positive updates at AACR • AUTO5 in TRBC2+ T-cell lymphomas ― Currently no T cell therapy approved for T cell lymphoma ― Autolus’ TRBC1 programmed T cell product candidate, AUTO4, progressi
Slide 8: Operational highlights – second quarter 2020
Operational highlights – second quarter 2020 Board and Management Team evolution, plus manufacturing flexibility extended • Dr Jay T Backstrom appointed to Board of Directors ― Dr Backstrom currently serves as EVP, Head of Research & Development at Acceleron Pharma Inc ― Prior to Acceleron, Dr Backs
Slide 9: 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 ALL is a significant High unmet medical need opportunity: • Combination chemotherapy enables 90% of adult ALL patients to experience CR, but only 30%
Slide 10: 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 11: AUTO1 is the first Autolus program to move into a pivotal study
AUTO1 is the first Autolus program to move into a pivotal study Preliminary Ph1 data supports development as a stand-alone therapy Pivotal study, AUTO1-AL1, in adult ALL: CTA approved by the MHRA in Ph1b run-in component, 100 relapsed / refractory January 2020 and US IND accepted prior to single arm
Slide 12: 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 13: Encouraging signs of durable complete responses
Encouraging signs of durable complete responses 10 of 11 complete responses ongoing Dose Ongoing RP2D Pembro D-1 x 1 150-450x106 Pembro D14 x 3 No pembro 450x106 PD 150x106 50 x106 0 2 4 6 8 10 12 14 16 18 20 Duration (months) At ≥ 150 x 106 dose, all complete responses are ongoing with a median fol
Slide 14: 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 Approved CD19 CAR T Products 3L+ R/R DLBCL • Patients receive approved products as inpatients in CoEs because of the high rate and severity of toxici
Slide 15: AUTO3 is designed for potential best-in-class efficacy and safety
AUTO3 is designed for potential best-in-class efficacy and safety Differentiated product profile should open access to full market opportunity First-in-class CD19 & CD22 Designed to provide best-in- Potential for best-in-class CAR with novel signaling class efficacy with high rates safety with no ne
Slide 16: 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 AUTO1NG ALL CD19 & CD22 H2 2020 AUTO3NG DLBCL CD19 & CD22 Life cycle mgmt AUTO5 TRBC2+ Peripheral TCL TRBC2 2021 Neuroblastoma; Melanoma; AUTO6NG GD2 2
Slide 17: Financial Results
Financial Results Andrew J. Oakley CFO 17
Slide 18: Financial summary
Financial summary USD m 2Q 2019 2Q 2020 Variance Grant Income 0.3 0.3 (0.0) R&D (26.2) (31.3) (5.1) G&A (11.4) (8.5) 2.9 Total Op Expenses, net. (37.2) (39.5) (2.3) Interest Income 1.1 (0.0) (1.1) Other Income 4.4 0.5 (3.9) Tax Benefit 3.3 7.0 3.7 Net Loss (28.5) (32.0) (3.5) USD m Mar 31 2020 Jun 3
Slide 19: Upcoming Milestones and Conclusions
Upcoming Milestones and Conclusions Dr. Christian Itin Chairman and CEO 19
Slide 20: Multiple clinical data points expected through H2 2020 / 2021
Multiple clinical data points expected through H2 2020 / 2021 Product Indication Target Event B Cell Malignancies • Ph1 long-term follow up Q4 2020 AUTO1 Adult ALL CD19 • Pivotal data end of 2021 AUTO1NG Pediatric ALL CD19 & 22 • Start Ph1 H2 2020 AUTO3 DLBCL CD19 & 22 • Ph1 data update H2 2020 (ESM
Slide 21: Autolus poised for value inflection in 2020
Autolus poised for value inflection in 2020 • AUTO1/AUTO1NG ― 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 AUTO1NG • AUTO3 ― Outpatient treatment cohort started in Q2 2
Slide 22: Q&A Dr. Christian Itin and Andrew Oakley
Q&A Dr. Christian Itin and Andrew Oakley 22
Slide 23: Thank you
Thank you 23