Autolus Therapeutics plc

Hello, ladies and gentlemen, and welcome to the Autoless Therapeutics first quarter 2021 financial results conference call. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Oakley, the company's chief financial officer. Please go ahead.

Thank you, Rebecca, and 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 first quarter of 2021. I am Andrew Oakley, the Chief Financial Officer, and with me today is Dr. Christian Eiten, our Chief Executive 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 4, 2021, which can be accessed on the EDGA 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, May 6, 2021, 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 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 will 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 first quarter of 2021. I 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 now turn the call over to Christian.

Thank you, Andrew, and good morning to all of you, and thank you for joining us. I'm pleased to review our progress for the first quarter of 2021. First, and before we get to the update on our programs, we're very pleased to see the progress in the US, the UK, and the EU with the COVID vaccinations, and seeing gradual decline of the case numbers. This bodes well for the conduct of our clinical trials as we move through 2021 and into 2022. With the expected opening of travel for vaccinated people between the US and Europe, we also expect flight operations to start to gradually normalize, which will relax the pressure on logistics. We continue to work hard with our supply chain and logistics teams, as well as our clinical centers, to ensure timely continental and transatlantic deliveries of leukophoresates, final products, and samples for analysis in order to support our clinical trials and ensure timely data availability and integrity. While we feel optimistic about the developments, we continue to monitor them very carefully with a particular focus on patient safety. In the fourth quarter last year, we provided data updates from the Phase I All-Cars Study at ASHE, The FELIX study is progressing well and remains on track with data expected in 2022. In Q1, we have received the INN for Auto-1 and can now be referred to as Obiceptactin autosal for Obicel. We also announced recently that we have received prime designation from the European Medicines Agency, again highlighting the innovative nature of Obicel. We're also exploring the potential of Obicel for the treatment of B-cell non-Hodgkin's lymphoma and we will have first aid at EHA in June. Our next-generation program, Auto 122, is being evaluated in pediatric patients with data expected for ASH at the end of this year. Phase 1 enrollment of Auto 4 continues, and importantly, we recently received an ILAP designation for Auto 4 from the UK Medicines and Health Products Regulatory Agency, the MHRA, which may potentially accelerate regulatory review of the development candidates. Moving on to slide number six to discuss the corporate highlights for the quarter. In January and February, we strengthened our balance sheet with the sale of ADSs under our ATM facility for net proceeds of approximately $15 million and also a public offering of ADSs, raising approximately $107 million in net proceeds. In January, we highlighted our focus on the Auto One program and the conduct of the Felix study. As part of this outlook, we announced our intention to partner our DLBCL program, Auto3. We also reviewed our commercial manufacturing strategy and decided to build on our manufacturing setup in the UK, being able to fully leverage our current manufacturing operations, experience, and skill, resulting in a more economical manufacturing platform while minimizing operational risk. In that process, we have terminated our lease of the U.S. manufacturing facility in Rockwell. Moving on to slide number seven. We would like to remind you of the clinical profile of Auto-1 and how it compares to the standard of care. The primary treatment option for patients is Blenatumumab, while inotuzumab may typically be used as a bridging therapy. If you look at the event-free survival, we are approximately twice as active as Blenatumumab at six months, and even at 12 months, we're at 52% for Auto-1 in terms of event-free survival, which substantially exceeds the six months value for Blinutumab at 31%. When looking at the Auto-1 data, it is important to realize that 70% of the patients had either received prior Blinutumab or Inutuzumab and failed on those therapies before entering the Auto-1 trial. Despite the elevated Auto-1 activity compared to Blinutumab, cytokine release syndrome and neurotoxicity are very comparable. Put very simply, with AutoOne, we're looking at a program that has at least twice the level of clinical activity to Blinnatumumab, which is the current standard of care, with a comparable safety profile. We believe that data is very strong and an excellent foundation to move our product into the registrational study. Moving to slide number eight, just another quick view on two of the key programs and products that are approved in the space, but from a commercial perspective. We'll look at a Blincyto or Blinotumab and Besponsa or Inotuzumab. As you can see, Blincyto reached in 2020 annual sales of 379 million. Typically, patients received an average of two cycles of the product, which translates to approximately 2,100 patients treated with this commercial product globally. Note that the majority of patients, approximately 1,800, who received the product are adults. We understand the key driver for sales accelerating into the fourth quarter, which was 29% year over year, was the expansion to the community hospital segment in the U.S. beyond the academic transplant centers where the product was initially launched in. While Blinzaita and ALL is moving to non-academic centers, we also expect the launch of Brianzi in the LBCL to establish car key experience in those centers. Both developments bode well for a product with the properties of AutoOne. Let's now turn to slide number nine. First off, obviously the auto one program at this point is in motion in the Felix phase one B2 pivotal study. It is a single arm study with approximately 100 patients with relapsed refractory disease. The primary endpoint is overall complete response rate. Secondary endpoints include molecular responses as well as eventually survival and duration of response. This program is ongoing and will recruit through the course of this year and into early next year. As I have mentioned, we're also conducting some additional studies to explore the activity of Auto-1 beyond the adult ALL population. That includes indolent lymphomas as well as other B-cell non-Hodgkin's lymphomas and chronic lymphoblastic leukemia. As mentioned earlier, we're also exploring the activity in primary CNS lymphoma, which is typically a neglected indication. In December, we also started a next-generation version of the Auto-1 program called Auto-1-22, that looks at minimizing the relapse rate in pediatric ALL driven by CD19 antigen loss. The Auto1-22 program builds on Auto1 with its unique properties and adds a novel highly active CD22 chimeric antigen receptor. We are planning to present data on this trial in the fourth quarter of this year. In summary, we believe there's a significant commercial opportunity to build on Auto1 and a franchise around the Auto1 program anchored in ALL both with adult and pediatric patients and have an opportunity to expand further into the B-cell non-Hodgkin's indications. Moving to slide number 10, Auto4 is our T-cell informal program currently active in the clinic, and we expect to have a clinical update by the end of this year and expect a good understanding by that point of the clinical profile of the product. The sister program, Auto 5, is prepared for an IND towards the end of 21. The medical need in T cell lymphoma is high, with very limited available treatment options for patients months relapsed after frontline therapy. Moving to slide 11. Always good to remind you all of the technology toolkit we have developed at Ovilus, particularly as it relates to the suite of next-generation programs, some of which you will recall we showcased at AACR last year. We're looking to move several programs into the clinic through 2021 and into 2022, including our first solid tumor programs, which we're very excited to be progressing. Our cell program models are designed to provide T-cells with a high degree of specificity and activity against cancer cells, while strengthening the T-cell's resilience to withstand the hostile environment cancer cells create to fend off T-cell attack. Slide number 12, as you can see, we have tabulated here the next generation programs alongside the expected phase one start dates. I would like to briefly highlight two of our programs. You will note, as discussed, we started the pediatric ALL clinical trial for auto 122 in December last year and are planning for a data update at the end of this year. We haven't yet mentioned, of course, Auto6NG, which we expect to start a phase one trial in children with neuroblastoma towards the end of 2021. This program builds on the positive clinical experience with Auto6NG published end of last year in Science Translational Medicine. All programs will initially be explored clinically in collaboration with our academic partners and will drive clinical news flow in 2022 and beyond. With that, I will turn over the call to Andrew for our first quarter 2021 financial update. Andrew?