Allogene Therapeutics, Inc.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Allogene Therapeutics' third quarter 2020 conference call. At this time, all participants are in the listen-only mode. After the speaker presentation, there will be a question-and-answer session. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano, please go ahead.

Thank you, Operator, and good morning. Before market opened today, Allogene issued a press release that provides a corporate update and financial results for the third quarter ended September 30th, 2020. This press release is available on our website at www.allogene.com. Today's call is being webcast on our website and will be available for replay. Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado, Executive Vice President of Research and Development, and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities and 2020 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-Q, for the quarter ended September 30, 2020. Your caution not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'll now turn the call over to Dr. David Chang.

Thank you, Christine, and my thanks to all of you for joining us on our third floor conference call during a very busy week and news cycle. Given that this promises to be an eventful morning, we are going to keep today's prepared remarks short and focus on a few key areas. I will start with CD19, specifically our plans with allo501 and allo501A and our path to investigating allocardial therapy in follow tumors. Later in the call, Rafael will speak to the work we are doing to advance our BCMA-directed therapies, including our plans to present our initial Phase I data from our first BCMA product candidate, Alloc715, in an upcoming scientific meeting later this year. Let's start with our CD19 program in relapse and refractory non-Hodgkin lymphoma. We believe the proof of concept data we presented at ASCO provides a strong foundation of support of our efforts to make allocardial therapy a reality. However, one outstanding question for the allogeneic field is durability of response. Durability is critical to the value proposition of any CAR-T therapy, and we firmly believe that the answer to durability lies in how we utilize lymphodepletion, optimize cell dose, and embrace dosing flexibility that is viable and scalable with an off-the-shelf cell therapy. We have spoken at length about lymphodepletion and how we are optimizing the dose of allo-647, our anti-CD52 monoclonal antibody, in concert with a standard clodarabine and cyclophosphamide, while flucide regimen to create the ideal depth and duration of lymphodepletion to allow robust expansion and persistence of alopecia cells. In our view, such a controlled immune suppression is necessary to maximize the tumor cell killing while minimizing the risk of cytopenia and opportunistic infection. We continue to believe that this approach of utilizing allo647 as a differentiated component will help us to achieve our goal of providing a meaningful clinical benefit with allogeneic cardiac therapy. The initial readout from the alpha phase one trial also gave us a glimpse at What may be one of the more exciting benefits of our potential off-the-shelf therapy? The ability to re-dose patients. In the case study presented at ASCO, one patient dosed with 120 million cells of Allo501 following the lymphodepletion with a standard full-size and the 39-milligram dose of Allo647 achieved a partial response but subsequently progressed in month two. Shortly after progression, the patient was retreated with 120 million cells of Allo 501, and this time with a fluci and a 90 milligram dose of Allo 647, which led to a complete response. In the autologous setting, CAR-T dosing regimens are shaped by the inherent limitations in cell supply. Rather than applying autologous thinking to the design of an allogeneic trial, we want to exploit the benefit of allogeneic therapies to better understand the potential for repeat dosing. In particular, we plan to explore the risk-benefit profile of a scheduled repeat dosing, which we will refer to as consolidation therapy in the alpha trial. Practically speaking, the consolidation therapy entails treating patients without disease progression after the first Allocard T therapy with a second dose of Allocard T approximately five to six weeks later. Our hope is that this back-to-back dosing or consolidation might enable more patients to achieve deeper responses and maintain a durable remission. As enrollment continues in our Alpha and Alpha-2 Phase I trials, we expect a rich data set to emerge Pending data, our current plan is to initiate a potential pivotal Phase 2 trial of Allo501A in 2021. We look forward to showcasing this holistic view on the CD19 program's progress, including additional data from Allo501 Alpha trial and the dose escalation phase of Allo501A Alpha 2 study in the first half of 2021. The next update I would like to provide is on Allo316, our anti-CD70 Allocard T candidate. As we prepare to file our IND in renal cell carcinoma, or RCC, this quarter, our enthusiasm increases for the start of our clinical trial in 2021 and the potential to explore Allo316 in solid tumors. We look forward to presenting additional preclinical data this year and believe RCC may be just the beginning of what can be addressed by Allo 316 given the expression of CD70 in lung cancer, glioblastoma and hematologic malignancies. We could not be prouder of our teams at Allogene and the progress made not just to close our development pipeline but also the work being done to complete our state-of-the-art manufacturing facility which we expect will begin producing clinical GMP labs in 2021. Our unwavering focus on bringing Allocardia therapy to patients has allowed us to quickly advance multiple Allocardia candidates. In 2021, just our third full year as a company, we expect to have five clinical trials underway, including one pivotal trial, our initial endeavor into solid tumors, and our first study using our TurboCAR-T technology. I will now turn the call over to Rafael for further updates on our research and development activities with a specific focus on allo715 and our BCMA program.