Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Q3 2019 Earnings Presentation
23 slides from Autolus Therapeutics's earnings presentation, Nov 7, 2019
Slide 1: Financial Results and Operational Highlights for Q3 2019
Financial Results and Operational Highlights for Q3 2019 November 7, 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: Operational Highlights
Operational Highlights Dr. Christian Itin Chairman and CEO 4
Slide 5: Upcoming ASH Meeting Presentations
Upcoming ASH Meeting Presentations Data highlights progress of foundational AUTO1 program > Adult ALL (AUTO1) - Saturday December 7, oral presentation > Pediatric ALL (AUTO1) - Saturday December 7, oral presentation > Integration Site Analysis (AUTO1) – Saturday December 7, oral presentation > DLBCL
Slide 6: 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 • Addressable patient population is projected at 3,000 patients US & EU5 > High unmet medical need • Combination c
Slide 7: AUTO1 in Adult ALL: Durable remissions observed
AUTO1 in Adult ALL: Durable remissions observed AUTO1 may be best-in-class for Adult ALL > As of July 24, 2019: • 10 of 12 (83%) evaluable patients achieved MRD negative CR at 1 month • 7 of 12 (58%) evaluable patients remain on study in flow/molecular MRD negative remission with a median follow-up
Slide 8: Comparison of AUTO1 vs. Kymriah and Blincyto
Comparison of AUTO1 vs. Kymriah® and Blincyto® AUTO1 may be best-in-class, redirected T cell therapy in ALL Pediatric ALL Adult ALL 1Kymriah®- 2AUTO1 - pALL 3AUTO1 aALL 4Blinatumomab pALL Patient Numbers 75 14 13 271 CR Rate 81% 86% 83%* 42% EFS EFS 12m: 50% EFS 12m: 52% TBD EFS 6m: 31% (95% CI, 35
Slide 9: AUTO1 in aALL - Summary and next steps
AUTO1 in aALL - Summary and next steps First Autolus program to move to a registration trial > Potential to have best-in-class profile > Favorable safety profile and high level of clinical activity • Data suggest AUTO1 may be twice as active as current standard of care, blinatumomab, with comparable
Slide 10: Pediatric ALL – Focus on AUTO1/AUTO1NG
Pediatric ALL – Focus on AUTO1/AUTO1NG AUTO3 data support dual antigen targeting hypothesis > Development in pediatric ALL will focus on AUTO1 and AUTO1NG > Pediatric program (PIP) with AUTO1 > Dual-targeting AUTO1NG with CD19 CAR of AUTO1 and a novel CD22 CAR expected to enter first clinical trial
Slide 11: 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 12: DLBCL – AUTO3
DLBCL – AUTO3 Program on track for a mid 2020 decision point > Interim Phase 1 data planned to be presented at ASH 2019 in December, including patients at the 450 mm dose level > First US patient consented and currently being manufactured at Cell and Gene Therapy Catapult at Stevenage in the UK > De
Slide 13: Multiple Myeloma
Multiple Myeloma Transitioning to next generation CAR in 2020 > AUTO2 is not differentiated from more advanced competitor programs > Phase 1 data will be presented at ASH > Next generation program to enter into the clinic in H2 2020 • Addresses need for increased persistence and tumor defense mechan
Slide 14: T Cell Lymphoma
T Cell Lymphoma Positioned for value inflection in 2020 > Patient enrolment in AUTO 4 Phase 1 study will resume in Q1 2020 > Expect to present initial AUTO4 Phase 1 data H2 2020 > AUTO5 Phase 1 decision based on AUTO4 data > Companion diagnostic development on track 14
Slide 15: Solid tumor programs–AUTO6NG (GD2+ solid tumors)
Solid tumor programs–AUTO6NG (GD2+ solid tumors) Positioned for additional value inflection in 2020 > Plan to commence Phase 1 H2 2020 > Encouraging pre-clinical data on three T cell programming modules to be presented at SITC 2019 • Constitutively signaling IL7 cytokine receptor (IL7R_CCR module) i
Slide 16: Corporate Update
Corporate Update UK clinical manufacturing site full operational > Manufacturing update • Catapult fully operational for European and US patients • First US patient enrolled, manufacturing ongoing > Significant change in shareholder base • In September, PPF Group announced that they had acquired, ma
Slide 17: Financial Results
Financial Results Andrew J. Oakley Chief Financial Officer
Slide 18: Third quarter 2019 financial summary
Third quarter 2019 financial summary USD m 3Q19 3Q18 Variance Grant Income 0.3 0.3 (0.0) R&D (27.3) (10.1) (17.2) > Cash runway expected G&A (8.6) (7.3) (1.3) into second half of 2021 Total Operating (35.6) (17.1) (18.5) Expenses, net. Other Income 3.8 2.0 1.8 Tax Benefit 4.6 2.2 2.4 Net Loss (27.2)
Slide 19: Upcoming Milestones and Conclusion
Upcoming Milestones and Conclusion Dr. Christian Itin CEO and Chairman 19
Slide 20: Newsflow expected through 2020
Newsflow expected through 2020 Product Indication Target Event B Cell Malignancies AUTO1 Pediatric ALL CD19 • Ph 1 data 4Q 2019 • Ph 1 (ALLCAR19) data 4Q 2019 AUTO1 Adult ALL CD19 • Start pivotal program H1 2020 AUTO1NG Pediatric ALL CD19 & 22 • Start Ph 1 H1 2020 • Ph 1 interim data 4Q 2019 AUTO3 D
Slide 21: Key Q3 Messages
Key Q3 Messages > AUTO1: • First Autolus program to move into a pivotal program - Adult ALL • FDA granted orphan drug designation for treatment of ALL • Opportunity for best in class CD19 CAR T • Pediatric ALL: moving forward with AUTO1/AUTO1NG > AUTO3: • Focus on DLBCL, Phase 2 decision point mid-2
Slide 22: Q&A
Q&A Dr Christian Itin (Chairman and CEO) Andrew Oakley (CFO) 22
Slide 23: Thank you.
Thank you. Autelus