Autolus Therapeutics plc · NASDAQ:AUTL
Autolus Therapeutics — FY2019 Earnings Presentation
30 slides from Autolus Therapeutics's earnings presentation, Mar 3, 2020
Slide 1: Fourth Quarter and Full Year 2019 Financial Results and Operational Progress
Nasdaq: AUTL Fourth Quarter and Full Year 2019 Financial Results and Operational Progress March 3, 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 strategy
Corporate strategy Short term value steps with best in class programs for ALL and DLBCL • Focus on potentially best in class Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B Cell Lymphoma (DLBCL) therapies with major value steps expected in 2020 / 2021 ― First pivotal study of adult ALL to com
Slide 6: Corporate highlights - 2019
Corporate highlights - 2019 • Clinical progress with lead programs ― AUTO1 in adult ALL ― AUTO3 in DLBCL ― AUTO6NG in Neuroblastoma; Melanoma; Osteosarcoma; SCLC ― T-cell lymphomas (AUTO 4/5) • Successful fundraisings ― Net proceeds $109.0 million in April 2019 and approx. $75 million post year end
Slide 7: No approved CAR T therapy for adult ALL patients
No approved CAR T therapy for adult ALL patients Severe toxicities of currently approved products have limited CAR T suitability in adult setting • ALL is a significant opportunity ― Up to 8,400* new cases of adult ALL diagnosed yearly worldwideǂ ― Addressable patient population is projected at 3,00
Slide 8: AUTO1: Key features
AUTO1: Key features Designed for durability of responses without allo-transplant and reduced 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) •
Slide 9: 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 10: First Autolus program to move to late stage development
First Autolus program to move to late stage development Potential pivotal study in adult ALL: • CTA filed in UK in November 2019 US IND to be filed in Q1 2020 • Single arm study • 100 relapsed / refractory adult ALL patients • Primary endpoint: overall complete response rate (CR/CRi) • Secondary end
Slide 11: DLBCL is a large commercial opportunity
DLBCL is a large commercial opportunity AUTO3 - addressable patient population in DLBCL • Potential market size in DLBCL ― Approx. 24,000 patients diagnosed in the US every year • Aggressive and rapidly advancing cancer, survival outcomes remain poor ― Most common type of Non-Hodgkin Lymphoma ― High
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 (JCAR017) Efficacy Safety • Despite high ORR (70-80%) and high best • High rates of severe cytokine release CRR (40-55%), only 29-37% patients achieve syndrome (13-22%) and severe
Slide 13: 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 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 3L+ R/R DLBCL Approved CD19 CAR T Products Approved • Patients receive approved products as inpatients in Products CoEs because of the high rate & se
Slide 15: Preliminary efficacy indication of dose response
Preliminary efficacy* indication of dose response AUTO3 - DLBCL Pre-CAR T-cells Post-CAR T-cells 50 x 106 50 x 106 150 x 106 450 x 106 450 x 106 No Pem D14 Pem D14 Pem D14 Pem D-1 Pem (n=4) (n=3) (n=4) (n=4) (n=3) CR 1 1 2 2 2 PR 1 1 0 1 NA NE 0 1 0 0 0 CRR 25% 33% 50% 50% 66% • 450 million: ORR 5/7
Slide 16: Early encouraging signs of durable complete responses
Early encouraging signs of durable complete responses AUTO3 in DLBCL 88 450x106 77 66 55 150x106 44 33 50x106 22 Median Follow-up: 11 6 months (1 – 18 month) Dose N 0 5 10 15 20 PD (by PET) Ongoing CR 18 patients treated, 7 out of 8 (87%) CRs ongoing, 3 PRs not durable 7 of 7 (100%) CRs* are ongoing
Slide 17: AUTO3 has a safety profile which may allow outpatient use
AUTO3 has a safety profile which may allow outpatient use 1AUTO3 + Pembro 2Yescarta® 3Kymriah® 4JCAR017 ≥ 150 x106 Dose Best CR 55%* 54% 40% 53% CRS ≥ grade 3 0% 11% # 23% 2% # Neurotox any grade 0% 64% 21% 30% Neurotox ≥ Grade 3 0% 28% 12% 10% * All CRs ongoing at a median f/u of 2 months (1-12 mon
Slide 18: Early data encouraging – full read-out expected in mid-2020
Early data encouraging – full read-out expected in mid-2020 AUTO3 in DLBCL • AUTO3 product was successfully manufactured for all patients ― Products manufactured at Catapult in the UK, for US and EU use • No neurotoxicity or severe CRS* in patients treated with AUTO3 at active dose levels • Complete
Slide 19: Unique targeting of TRBC1 and TRBC2 opens new therapeutic approach
Unique targeting of TRBC1 and TRBC2 opens new therapeutic approach AUTO4/5 in Peripheral T Cell Lymphoma Differences between TRBC1 and TRBC2 are small T cell receptor TRBC1 antibody Antibody Binding ▪ Data J o v i- 1 m u t a n t s TRBC1 Binder to TRBC1 TCR • Patient enrolment on AUTO4 Phase 1 study
Slide 20: Encouraging signal of anti tumor effect from AUTO4 treated patient
Encouraging signal of anti tumor effect from AUTO4 treated patient Clinical outcome of patient 1 Baseline PET/CT scan Month 1 PET/CT scan • 57 yr old with Angioimmunoblastic T cell lymphoma Pre-AUTO4 treatment • Past treatments include CHOP (CR) & IVE (refractory) • AUTO4 Treatment ― Treated with 25
Slide 21: Designed to drive anti-tumor activity without inducing neurotoxicity
Designed to drive anti-tumor activity without inducing neurotoxicity AUTO6: GD2-targeted programmed T cell therapy • Programmed T cell product candidate: ― New binder to minimize on-target, off-tumor toxicity R Epitope ― Humanized binder to reduce immunogenicity GD2 CAR Q Epitope ― RQR8 safety switc
Slide 22: Modular approach enhances AUTO6NG for solid tumor environment
Modular approach enhances AUTO6NG for solid tumor environment Next generation programs powered by a technology tool box AUTO6 GD2 CAR dSHP2 dTGFβ Receptor To provide anti-tumor activity To overcome multiple To overcome inhibitory and potential to help address checkpoint pathways effect of TGFβ in ne
Slide 23: Positioned for additional value inflection in 2020
Positioned for additional value inflection in 2020 AUTO6NG • Plan to commence Phase 1 H2 2020 • Encouraging preclinical data on three T cell programming modules presented at SITC 2019 ― Constitutively signaling IL7 cytokine receptor (IL7R_CCR) is shown to enhance persistence ― Dominant negative TGFb
Slide 24: Financial Results
Financial Results Andrew J. Oakley CFO 24
Slide 25: Financial summary
Financial summary USD m Year ended Year ended Variance 31 Dec 2018 31 Dec 2019 • Follow on offering in Jan Grant Income 1.5 2.9 1.4 2020 raised $75m in net R&D (48.3) (105.4) ( 57.1) proceeds G&A (27.3) (39.5) (12.2) Loss on impairment of leasehold improvements - (4.1) (4.1) • Cash runway increased
Slide 26: Upcoming Milestones and Conclusions
Upcoming Milestones and Conclusions Dr. Christian Itin Chairman and CEO 26
Slide 27: Multiple clinical data points expected through 2020
Multiple clinical data points expected through 2020 Product Indication Target Event B Cell Malignancies • Ph 1 long-term follow up Q2 & Q4 2020 AUTO1 Adult ALL CD19 • Start pivotal program H1 2020 AUTO1NG Pediatric ALL CD19 & 22 • Start Ph 1 H1 2020 • Ph 1 data Q2 & Q4 2020 AUTO3 DLBCL CD19 & 22 • D
Slide 28: Autolus poised for value inflection in 2020
Autolus poised for value inflection in 2020 • AUTO1 ― Encouraging data at ASH Dec 2019 ― First Autolus program to move into a pivotal program – Adult ALL ― Opportunity for best in class CD19 CAR T with FDA Orphan drug designation ― Pediatric ALL – moving forward with AUTO1/AUTO1NG • AUTO3 ― Encourag
Slide 29: Q&A
Q&A Dr. Christian Itin (Chairman and CEO) Andrew J. Oakley (CFO) 29
Slide 30: Thank you
Thank you