Autolus Therapeutics plc

Good day, and thank you for standing by, and welcome to Ottawa's Therapeutics Fourth Quarter 2021 Financial Results Conference Call. At this time, our participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised the call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Lucinda Crabtree, Senior Vice President, Finance. You may begin.

Thank you, Justin. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call on the financial results and operational highlights for the fourth quarter 2021. I am Lucinda Crabtree, Senior Vice President of Finance. With me today are Dr. Christian Iton, our 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 4th, 2021. which can be accessed on the EDCA 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, March 10th, 2022, 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 will see the agenda for today, and it is as follows. Christian will provide an overview of our operational highlights for the fourth quarter of 2021. Andrew will then discuss the company's financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions following our remarks. Over to you, Christian.

All right. Thank you very much, Lucy, and good morning, everybody, and thank you for joining us today. It's my pleasure to review our operating progress for the fourth quarter of 2021. If we move to slide number five, I'd like to give you a run-through of the key operational updates from 2021. First of all, our multi-center Felix study for our lead product, Obicel, is going well, and we're making good progress in our mission. of building a leading acute lymphoblastic leukemia company. We're expecting data from the Felix study in the second half of the year, with full data in the first half of 2023. The program is not only designed for the treatment of acute leukemia, but also has the potential applications in the broader set of non-Hodgkin's lymphoma indications, and has shown a consistent and best-in-class efficacy and safety profile across three BALL Phase I studies in patients with a wide range of age, disease burden, and prior therapies. In November 2021, we were pleased to announce a strategic collaboration and financing agreement with Blackstone Life Sciences, who have committed to invest up to $250 million into the development of OBSEL in adult ALL, supporting the full development of the program towards commercialization, with $150 million already having been received in the shape of equity and project financing. In September, we received the planning approval for our new manufacturing facility in Stevenage, U.K., This 70,000 square foot facility will be leased to Otelus and is another important step for us on our journey to becoming a fully integrated commercial company. The facility will have an initial capacity of approximately 2,000 GMP batches per year with further scope to expand. This capacity will support the launch of OBSEL and secure global supply in the initial indications. We will go into this in more detail later in the presentation. During the course of the year, we expanded our board with two significant appointments. Firstly, we were delighted to announce the appointment of John Johnson as non-executive chairman. John has brought a wealth of commercial oncology and business experience to Otalyst and is a recognized leader in the biopharmaceutical industry, having held a number of executive, operational, and commercial leadership roles. His experience is proving invaluable as we look towards the commercial launch of what we sell. Secondly, In conjunction with the Blackstone collaboration, Dr. William Young joined Otilus as a non-executive director. Bill is one of the pioneers of our industry and brings a wealth of commercial and operational experience to Otilus at a time when we're shaping the product profile and the commercial strategy of Ovisel. In terms of other updates, Andrew Oakley is retiring from his role as CFO with Lucinda Crabtree, who has worked in a number of roles at Otilus, taking over from him on the 31st of March this year. I look forward to working with Lucy in her expanded role and would also like to thank Andrew for his many contributions to Autoless over the years. He leaves the company in a strong position, and I wish him much happiness in the next chapter of his career. Moving on to slide six. This is just a reminder of the terms of the collaboration with Blackstone. It has strengthened our balance sheet, and as I've already mentioned, will allow us to drive the OBSEL program and build up the commercial manufacturing capacity. Importantly, Assuming all the milestones are received, this collaboration supports a catch runway into 2024. With that, let's switch gears and move on to slide number seven. 2021 was a busy year as far as driving our programs and clinical updates were concerned, and I'd like to give you a summary of the key program updates. OBSEL is on track to be the first autoless product candidate tested in a pivotal study. As you remember, our key focus is on delivering the FELIX study in adult patients with relapsed refractory acute lymphoblastic leukemia, with the study enrolling patients who are both post-linituzumab or inituzumab treatment, as well as patients that are just progressing in a rehab setting but may not have received yet inituzumab or linituzumab. The initial FELIX Phase 1b study presented at ASH in December 2021 showed a favorable safety and efficacy profile consistent with the Olkar-19 study, in this patient population. Furthermore, as we presented in December, the duration of response from the OLCAR19 study remains highly encouraging, with morphological event-free survival for OBCL of 46% at 24 months of follow-up, with a median follow-up of 29.3 months, and patients approaching up to 42 months of durability. We continue to see sustained OBCL persistence in those patients as well. As I mentioned earlier, we're also exploring the activity of OB-cell beyond ALL in the context of the old CAR-19 extension study, and the data presented at ASH demonstrated a favorable safety profile with 13 of 13 non-Hodgkin's lymphoma patients achieving complete metabolic remission. It is also important to mention the long-term persistence of OB-cell demonstrated by quantitative PCR in this patient group. We're planning additional updates from the old car extension study at the European Hematology Association meeting in June 2022. In addition to OB cell development, we're working on the next generation product candidate, which forms part of our lifecycle management strategy. For this candidate, we've added a highly potent CD22 car on top of the CD19 car that is the foundation for the OB cell program. This new program, called Auto-122, is currently being evaluated in pediatric patients in the CARPAL extension study. We plan to share additional clinical data on this product at EHA in June. Finally, our program Auto-4 in peripheral T-cell lymphomas made good progress and were moved through the dose escalation. We plan to present initial clinical data from that dose escalation trial at EHA in June as well. Moving to slide number nine, focusing specifically on adult acute lymphoblastic leukemia, there is a very high unmet medical need for these patients. ALL is a very challenging disease. It resides in the bone marrow, and it is formed and driven by cells that are very close to actual stem cells. Those cells have enormous proliferative potential, and they're very challenging to manage. Because they reside in the marrow and crowd out normal marrow cells, the patients tend to become significantly immune suppressed as a consequence of the disease itself. The standard of care that we're using in this space is high-dose combination chemotherapies, which consists of intervals of treatment with short recovery times that are done and repeated in cycles. is a horrendous type of treatment for patients to go through. The outcome, however, is positive from a response perspective. About 90% of the patients achieve complete remission. The challenge, however, is that most of these remissions are short-lived and the patients relapse. In fact, only about 30% of the patients see longer-term benefit after the initial line of therapy. Once you relapse, the outlook is rather poor. The disease tends to progress rapidly.