Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q2 2019 Earnings Presentation
25 slides from Autolus Therapeutics's earnings presentation, Aug 8, 2019
Slide 1: Financial Results and Operational Highlights for Q2 2019
Financial Results and Operational Highlights for Q2 2019 August 8, 2019
Slide 2: Disclaimers
Disclaimers These slides and the accompanying oral presentation contain forward-looking statements, including statements about the Company's plans to develop and commercialize its product candidates, the Company's ongoing and planned clinical trials, the anticipated benefits of the Company’s product
Slide 3: Agenda for today
Agenda for today 1. Welcome and Introduction: Dr. Christian Itin, Chairman and CEO 2. Operational Highlights: Dr. Christian Itin 3. Financial Results and Overview: Andrew J. Oakley, Chief Financial Officer 4. Upcoming Milestones and Conclusion: Dr. Christian Itin 5. Q&A: Dr. Christian Itin and Andre
Slide 4: Corporate Overview and Introduction
Corporate Overview and Introduction Dr. Christian Itin Chairman and CEO 4
Slide 5: Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia Adult ALL is a significant commercial opportunity > Potential market size in adult ALL • Up to 8,400 new cases of adult ALL diagnosed yearly worldwide (incl. approx. 6,000 in US & EU5) • Addressable patient population is projected at 3,000 patients US & EU5 > High
Slide 6: AUTO1 designed to reduce high-grade CRS
AUTO1 designed to reduce high-grade CRS > Adult ALL patients are generally more fragile, have more co-morbidities, and are less likely to tolerate toxicity compared to pediatric ALL patients > Adult ALL patients often have a higher tumor burden in the bone marrow, increasing the risk of adverse even
Slide 7: AUTO1 shows enhanced activity vs FMC63 CARs
AUTO1 shows enhanced activity vs FMC63 CARs Preclinical data show higher potency and proliferation › AUTO1 (CAT) binder with lower Fast Off-Rate affinity for CD19 › Half-life of target interaction very On-Rate: Ka [M-1S-1] ]1 Other CD19 Binders AUTO1 Binder - S short compared to Kymriah (FMC63) 1 -
Slide 8: AUTO1 shows excellent expansion and persistence in pALL
AUTO1 shows excellent expansion and persistence in pALL AUTO1 expansion and persistence exceed Kymriah > Enhanced Expansion: • Peak expansion (Cmax) approximately 3 x higher than that reported for Kymriah • Area under the curve (day 0-28) 5 x higher than that reported for Kymriah > Prolonged Persist
Slide 9: Adult ALL – AUTO1: Phase 1 trial is ongoing
Adult ALL – AUTO1: Phase 1 trial is ongoing Phase 1 Status (n=20) Split Dose 1 Split Dose 2 Day 0 Day 9 Initiated Phase 1 ALLCAR19 trial in Q1 2018 ≤ 20% BM Blast 100 MM 310 MM Phase 1 designed to assess safety in adult ALL; conducted in collaboration > 20% BM Blast 10 MM 400 MM with UCL Phase 1 dat
Slide 10: AUTO1 in adult ALL: Favorable safety profile
AUTO1 in adult ALL: Favorable safety profile Interim data from ALLCAR19 Phase 1 Study (N=10) > 5 patients had ≥ 50% BM blasts prior to lympho-depletion (CRS ‘high risk’) > Robust CAR-T cell expansion and persistence > CRS: 0 patients ≥ Grade 3 CRS (Lee criteria) • Only 2 patients with Grade 2 CRS >
Slide 11: AUTO1 in adult ALL: High level of efficacy
AUTO1 in adult ALL: High level of efficacy 8/9 (88%)* of evaluable patients at 1 month achieved molecular CR 10 / 400 x 106 14 10 x 106 13 Closed 100 / 310 x 106 12 Process 100 / 310 x 106 11 10 x 106 9 10 x 106 7 10 / 400 x 106 6 Open 100 / 310 x 106 5 Process 5.3 / 46 x 106 3 10 / 400 x 106 2 Dose
Slide 12: Comparison of AUTO1 vs. Kymriah and Blincyto
Comparison of AUTO1 vs. Kymriah® and Blincyto® AUTO1 – potential for best in class redirected T cell therapy in ALL Pediatric ALL Adult ALL 1Kymriah®- 2AUTO1 - pALL 3AUTO1 aALL 4Blinatumomab pALL Patient Numbers 75 14 10 271 CR Rate 81% 86% 88%* 42% EFS EFS 12m: 50% EFS 12m: 46% tbd EFS 6m: 31% (95%
Slide 13: AUTO1 in aALL - Summary and next steps
AUTO1 in aALL - Summary and next steps First Autolus program to move to a registration trial > Favorable safety profile and high level of clinical activity • Data suggest AUTO1 may be twice as active as blinatumomab, with comparable safety profile > Phase 2: planned start Q4 2019 (pending regulatory
Slide 14: Pediatric ALL
Pediatric ALL Assessing next steps > Pediatric ALL is most common cancer diagnosed in children. Patients respond well to first line therapy • Approx. 3,400 new cases diagnosed in the US every year* > 10-20% of patients are relapsed/refractory, or approx. 1,000 patients US & EU5 combined > Kymriah® a
Slide 15: Pediatric ALL – Focus on AUTO1/AUTO1NG
Pediatric ALL – Focus on AUTO1/AUTO1NG AUTO3 data support dual antigen targeting hypothesis > AUTO3 molecular CRR and safety are comparable to AUTO1 > AUTO1 primary cause of relapse was loss of antigen, which usually occurred within 6 months after AUTO1 infusion > Design premise for AUTO3 is to redu
Slide 16: Diffuse Large B Cell Lymphoma (DLBCL)
Diffuse Large B Cell Lymphoma (DLBCL) DLBCL is a large commercial opportunity > Potential market size in DLBCL • Approx. 24,000 patients diagnosed in the US every year* • Addressable patient population projected at 10,000 patients for US & EU5 combined > Aggressive and rapidly advancing cancer • Mos
Slide 17: DLBCL – AUTO3
DLBCL – AUTO3 Program on track to deliver data H1 2020 > Manufacturing site was licensed in March 2019 but overall 5 months delay in site qualification resulted in a delay in patient recruitment > Interim Phase 1 data planned to be presented at ASH 2019 in December, no presentation at ESMO > Decisio
Slide 18: Other Indications
Other Indications Positioned for additional value inflection in 2020 > Multiple myeloma • AUTO2 is not differentiated from more advanced competitor programs • Expect to present Phase 1 data at ASH 2019 • Focus on moving next generation version into clinic in H1 2020 > T Cell Lymphoma • Patient enrol
Slide 19: Financial Results
Financial Results Andrew J. Oakley Chief Financial Officer 19
Slide 20: Second quarter 2019 financial summary
Second quarter 2019 financial summary USD m 2Q19 2Q18 Variance Grant Income 0.3 0.4 (0.1) > Follow on offering R&D (26.2) (8.9) (17.3) completed April 2019 G&A (11.4) (8.1) (3.3) • $108.8 m aggregate net proceeds raised Total Operating (after UW (37.2) (16.5) (20.7) discounts/before Expenses, net. e
Slide 21: Upcoming Milestones and Conclusion
Upcoming Milestones and Conclusion Dr. Christian Itin CEO and Chairman 21
Slide 22: Clinical newsflow expected through H1 2021
Clinical newsflow expected through H1 2021 Indication Asset Q4 2019 H1 2020 H2 2020 H1 2021 Adult ALL AUTO1 DLBCL AUTO3 AUTO3NG Pediatric ALL AUTO1 AUTO1NG AUTO3 Multiple AUTO2 Myeloma AUTO2NG T Cell AUTO4 Lymphoma AUTO5 GD2+ Tumors AUTO6NG Commence phase 1 Ph 1 interim data Ph 1 data Commence phase
Slide 23: Key Q2 Messages
Key Q2 Messages > AUTO1: • First Autolus portfolio program to move to Phase 2 in adult ALL • Opportunity for best in class CD19 CAR T > AUTO3: • Focus on DLBCL, next data at ASH • Pediatric ALL: data confirm hypothesis, but deprioritized in pALL in favor of AUTO1/AUTO1NG > Opportunity for additional
Slide 24: Q&A
Q&A Dr Christian Itin (Chairman and CEO) Andrew Oakley (CFO) 24
Slide 25: Thank you.
Thank you. Autelus