Autolus Therapeutics plc

Hello ladies and gentlemen and welcome to the On the List Therapeutics third quarter 2020 financial results conference call. As a reminder this conference call is being recorded. I would now like to send the conference over to your host Dr. Lucinda Crabtree, Vice President of Investor Relations. Please go ahead.

Thank you Brandy. Good morning or good afternoon everyone and thank you for taking part in today's call on the financial results and operational highlights for the third quarter 2020. I am Lucinda Crabtree, Vice President of Investor Relations. With me today are Dr. Christian Itin, our Chairman and Chief Executive Officer, and Andrew Oakley, our Chief Financial Officer. Before we begin, I would like to remind you that during today's call, our discussion will contain forward-looking statements. All statements other than statements of historical facts on this call are forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors. including those discussed in the section titled Risk Factors in our annual report on Form 20F filed with the Securities and Exchange Commission on March 3rd 2020 which can be accessed on the EDGAR database at www.sec.gov and in subsequent filings we make with the SEC from time to time. The forward-looking statements on this call reflect the company's views as of today November 5th 2020 regarding future events and should not be relied upon as representing the speakers or the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some future point, the company specifically disclaims any obligation to do so even if the company's views change. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to today. Please be advised that today's call is being recorded and webcast. On slide three, you'll see the agenda for today. and it is as follows. Christian will provide a brief introduction and that will be followed by our operational highlights for the third quarter of 2020. Andrew will next discuss the company's financial results and then Christian will conclude with upcoming milestones and other concluding comments and of course we will welcome your questions following our remarks. So with that I'd like to turn the call over to Christian.

Thank you Lucinda and good morning to all of you and thank you for joining us. I'm pleased to review our progress for the third quarter 2020. Before summarizing our program update on slide five, I would like to briefly address the evolving COVID-19 situation and its potential impact on our operations. At our last financial update call in August, we had entered into a more stable period post the first COVID-19 peak in April May, and our programs have remained on track throughout the third quarter. However, building in September and accelerating through October and into November, We have seen a substantial increase in infection rates in Europe and in the US. And with a few weeks lag, increases in hospitalization and ICU occupation rates followed. In reaction, restrictions on public life have increased across all of Europe end of October. From a company perspective, what helped us involve patients through the first peak of the pandemic was the concentration of cases in few geographic areas in the US. During that period, most of our US clinical trial sites were not impacted. Going into winter now, with an already broad spread of infections across the entire country, the risk for trial disruptions in the US has increased. We will follow the situation closely, and if need be, may have to adjust patient enrollment into our trials. That said, we're working hard with our supply chain and logistics teams, as well as our centers, to ensure uninterrupted supply of essential goods and services for our operations. This includes timely continental and transatlantic deliveries of leukophoresates and final products to ultimately ensure timelines remain on track. As always, our key focus is on patient safety and ensuring data integrity in our trials. While to date our lead programs, Order 1 and Order 3, have not been significantly impacted, We did experience a delay in patient enrollment for our ongoing Phase 1 clinical trial with Auto4 earlier this year. However, for now, the situation has stabilized, and we continue to expect initial data from this Phase 1 study to be available in 2021. With respect to our preclinical programs, these have so far been minimally impacted, and we continue to expect Auto5 and our solid tumor programs, Auto6NG and Auto7, to enter clinical development in 2021. Our first clinical study with Auto-1-22 in pediatric ALL remains on track to begin in the fourth quarter and Auto-8 in multiple myeloma is due to start in the first half of next year. So moving to our corporate highlights and starting with our clinical programs on slide six, we've had a busy quarter across our portfolio with positive data update at ESMO for Auto-3. With respect to Auto-1, as you know, we commenced enrollment of patients with relapsed refractory adult acute lymphoblastic leukemia. into our potential pivotal phase 1b2 auto 1 program and are targeting to have data by the end of next year. As indicated before, timelines will be contingent on the involving COVID-19 situation. Finally, updates on the Alexander study for auto 3 and the oil car 19 study for auto 1 have been accepted for oral presentations at ASH. We're planning to host an analyst call following the release of the presentations at ASH. We will update you on the details in the coming weeks. Moving to slide 7. I would like to briefly recap on our LEAP program Order 1 in adult ALL. Order 1 is designed to combine three key features required for a standalone therapy in adult ALL. First, a very high level of anti-leukemic activity to cope with the rapid growth of the leukemic cells in the bone marrow. Second, very long persistence to put long-term pressure on the leukemia and get to a transformational outcome. And third, a tolerable safety profile, which is particularly important for elderly patients. In terms of the market opportunity within the US and the top five European countries, approximately 3,000 patients every year reach the end of their treatment options, having failed chemotherapy and stem cell transplant, and often also Blinitumab or Inutuzumab, therefore requiring other options. Slide eight. From our phase one experience, we see that OtterOne is about two times as active as Blinitumab, the standard of care for these patients, while maintaining a comparable safety profile. At EHA, we could show first patients who reached 18 months in molecular complete remission without receiving a transplant. Data at ASH will provide a longer follow-up. Currently, there are no CAR-key therapies approved for adult ALL, and we think we have a very significant opportunity with limited competitive pressure in this high medical need setting. So based on this data, turning to slide nine, we have started enrollment into the pivotal program, Auto-1 AL1, in adult ALL. As a reminder, the study has a phase 1b running and the pivotal program comprises a single arm study of approximately 100 relapsed refractory patients. The primary endpoint is complete remission rate and secondary endpoints include molecular complete remission rates, event-free survival, and duration of response. We're targeting data by the end of 21, assuming no COVID disruptions to clinical trial conduct. Finally, on slide 10, I wanted to highlight the broader potential of the Auto1 franchise. In collaboration with our academic partners at UCL, we're exploring Auto1 across other B-cell malignancies. Exploratory studies include primary CNS lymphoma with a planned study starting Q4 this year, as well as obviously Auto1-22 in pediatric ALL. Let's now turn to slide 11, where I would like to switch gears and talk about Auto3, a program that is designed for the treatment of patients with diffuse large B-cell lymphoma. DLBCL is the largest NHL indication with approximately 10,000 patients in last line setting with a very high medical need. Two CAR-T products are approved, Trescart and Chemariah, plus Lysazel or otherwise known as JCAR17 is pending approval. Auto3 is a dual targeting CAR-T product designed to minimize the risks of relapse due to antigen loss. In addition to the unique molecular design of Auto3, we're also using a short cover of Pembrolizumab to counteract PD-L1 mediated checkpoint inhibition as a second potential cause of relapse. On slides 12 and 13, as reported at ESMO, other three showed a high level of complete remissions combined with very favorable safety profile. Across all those cohorts, the overall response rate was 68% and the CRA was 54%. Both cytokine release syndrome and neurotoxicity rates are low across the study. In patients achieving a complete remission and despite robust CAR T expansion, No patient had experienced any neurotoxicity or high-grade cytokine release syndrome. Turning to slide 14. Combining a high level of clinical activity with a good safety profile is particularly important in diffuse large B-cell lymphoma as the vast majority of patients are treated outside of centers of excellence and mostly in outpatient setting. In contrast, over 70% of all patients receiving CAR-T products in 2019 were treated in only 17% of the accredited Centers of Excellence certified to administer these therapies. This concentration on such small number of centers illustrates how very under-penetrated the DLDCL market is with CAR T therapies. Also, Medicare patients make up a large portion of the DLDCL patients. However, less than 13% of patients treated are on Medicare due to the reimbursement challenges in the Part A side. All in all, you can see this creates a significant opportunity for Auto3 to provide a solution here. So let's turn to slide 15. As a reminder, the Alexandra Expansion Court is designed to further assess the feasibility of Auto III use in the outpatient setting. As I've mentioned, we expect to provide efficacy and safety data from patients treated in our outpatient court at ASH, as well as an update across the completed other cohorts. Turning to slide number 16. As we have discussed, Auto3 is a first-in-class CD19-CD22 dual-targeting car designed to combine a high level of clinical activity with a good safety profile for potential use across all settings of care. Finally, on slide 17, I would like to remind you of the broader pipeline of the Next Generation programs we're proud to be developing at the company. Most of the programs are set to move into first clinical trials in 2021. The first is our Auto1-22 dual-targeting program Building on the Strong Pediatric Data for Order 1 and Addressing CD19 Antigen Loss-Driven Relapse in Pediatric ALL. With that, I will turn over the call to Andrew for a third quarter 2020 financial update. Andrew?