Allogene Therapeutics, Inc.

Hello, thank you for standing by, and welcome to Allogene Therapeutics' second quarter 2021 conference call. At this time, all 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 will need to press star 1 on your telephone. 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 to all on the line, welcome. We will continue to limit questions to one per person so we can get to as many as possible during the hour. After the market closed today, Allogene issued a press release that provides a corporate update and financial results for Q2 2021. This press release and today's webcast are both available on our website. 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, including the timing and ability to advance our Alpha-Q trial to Phase II, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2021 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned 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 David.

Thank you, Christine, and good afternoon. We launched Allogene in the second quarter of 2018 with a bold mission, to create and lead the next revolution in cancer treatment by delivering to patients the first allocardial therapies for blood cancers and cell tumors. Three years later, we have made a giant leap for both Allogene and the field of cell therapy, as data from our lead program bring us one major step closer to realizing our goal of commercializing a first-in-class and best-in-class off-the-shelf cell therapy. As we enter a new stage in our life cycle, our focus turns towards advancing our lead development candidate, Allo501A, into a pivotal phase two trial for relapsed refractory non-Hodgkin's lymphoma by the end of 2021. Following initial data presented at our CD19 forum in May and ASCO in June, we are increasingly confident in the safety and efficacy profile of Allo501A and its path forward. As we shared during the CD19 forum, the alpha trial demonstrated that Allo501 can achieve deep and durable responses in patients with relapsed refractory non-Hodgkin's lymphoma who are CAR-T-naive. with an overall response rate of 75% and CR rate of 50%, and the six-month CR rate of 36% in patients with large B-cell lymphoma histology, which is the patient population of our first pivotal trial. The safety profile was also very encouraging. No dose-limiting toxicities or graft-versus-host disease and limited ICANN and cytokine release syndromes observed. I have been involved in the development of CAR T therapies from the early days, and the available efficacy and safety profile of Allo501 and Allo501A clearly show that all the key principles that we learned from autologous CD19 CAR T therapies are holding true in our allogeneic CAR T therapy. Setting aside the limitations of drawing a cross-trial comparison, what we are seeing in our studies both in the initial responses, durability of responses, and the safety profile from a single infusion of LO501 or LO501A are on par with the data from pivotal trials of FDA-approved autologous CD19 CAR T therapies. Meanwhile, we have exceeded the bar set by the autologous therapies in other respects. our Allocarti therapies can be delivered to patients within days rather than weeks. And patients who enrolled in our studies can be nearly guaranteed to receive our products. In the Alpha trial, 98% of the enrolled patients received Allo501 within a median time of five days from enrollment to start of therapy. By comparison, in trials deploying autologous therapies, up to 30% of patients who have undergone leukoparesis for some manufacturing were unable to receive treatment due to interval disease progression while waiting for the CAR T-cell products, or even worse, due to manufacturing failures. Given the tremendous benefit that Allo501A can bring to patients, we remain highly focused on execution. Top of mind today is our preparation for the industry's first allogeneic pivotal trial. As our planning towards this important milestone progresses, we look forward to providing a clinical update on our CD19 program in the fourth quarter. Shortening the time to treatment and ensuring access for nearly all suitable patients is just the beginning of how we can leverage the attributes of allogeneic CAR-T therapies. As we look down the line to next generation therapies, our aim is potentially enhance the efficacy and safety of our products beyond that of autologous therapies. Our research team is actively working on new strategies to evade premature ejection, enhance cell potency, improve product consistency, and overcome the solid tumor microenvironment. Some of these technologies such as our turbo car key approach, have now advanced into clinical development. Others are progressing nicely behind the scenes. So while the initiation of our first pivotal trial will represent a critically important milestone for Allergen, it represents just the beginning of our new product innovation cycle. We are now also preparing for the potential transition from a clinical stage company to a commercial enterprise. We have begun to build our commercial team, which will focus on product positioning, maximizing adoption, and ensuring access. We have bolstered our internal efforts by expanding our board with the appointment of Liz Barrett and Vicky Saddle as directors. Liz, currently the president and CEO of Urogen and former CEO of Novartis Oncology, is one of the rare executives with deep experience in the commercialization and launch of novel oncology therapies, including in autologous CAR T therapy. Vicky, a former professor in practice of molecular and cell biology at Harvard University and president of Vertex, has an exceptional track record of operational execution at several leading biotechnology companies. Our new board members will be vitally important as we prepare for the potential launch of a first-in-class product. Which brings us to manufacturing. From the beginning of Allergen, we have maintained that having in-house manufacturing capabilities would be key to controlling our ability to deliver off-the-shelf cut-key cell therapies faster, more reliably, and at greater scale to all patients. Later this month, we will host an event to inaugurate our CellForgeOne state-of-the-art manufacturing facility in Newark, California. The facility is intended to house commercial manufacturing, analytical testing, formulation, packaging, and distribution of cell therapies, allowing us to optimize important steps in the cell therapy production process and allow allocardial therapies to be available to patients within days. We are excited to showcase the convergence of scientific excellence and cutting-edge manufacturing at our CellForge-1 facility. The rapid build-out and operationalization of this facility is yet to gain another example of our team's determination to let nothing, including the unforeseen challenges presented by a global pandemic, getting in the way of our goal to bring the first allogeneic CAR T therapy to patients. I thank them for these tireless efforts to bring this facility online in preparation for CGMP manufacturing in the second half of 2021. Positive phase one data from our alpha and alpha two as presented at ASCO and our CD19 forum continue to validate our allogeneic platform. and we are aggressively advancing our pipeline with more confidence than ever before. We currently have five clinical trials underway, two in our CD90 program, as noted, two candidates that target BCMA, including one that incorporates our novel turbo car technology, and one program in solid tumors. Our robust multiple myeloma program is an example of how we've been able to rapidly advance optimize, and deliver meaningful progress across multiple strategic approaches to allogeneic CAR-T. Beyond our ongoing universal trial, we were pleased that our first TurboCAR clinical candidate, Alof605, received US FDA Fast-Track designation for the treatment of patients with relapsed and refractory multiple myeloma. We are excited to announce that we have begun dosing patients in phase one of IGNITE study of allo605. We also have our sights set on confronting solid tumors, where the need is unquestionably high for a new innovation. We remain optimistic for the potential of our Allocarti platform to rise to the challenge. Our initial program targets CD70, and earlier this year, we launched our Traverse trial evaluating allo316 in clear cell renal cell carcinoma. As we continue to treat patients, we plan to share initial data next year. Over the next 6 to 12 months, we expect to have an increasing amount of data across multiple programs that will provide critical insights and inform how we best optimize the promise of our platform. Unwavering execution has already allowed us to generate the largest set of clinical and translational data on allocardial therapies, which we will continue to deploy towards enhancing our product candidates. We are incredibly proud of what we have achieved to date, only made possible by our team's steadfast focus on making allogeneic cardiac therapy a reality for patients. While being an industry leader often entails overcoming tall obstacles, it also provides the privilege of being able to set the pace of innovation, shape important parameters in the field, and define success. At Allogene, we believe we are up to this challenge, and we are grateful for your support as our vision for the future of allogeneic cardiac therapies is continuing to materialize. I will now turn the call over to Rafael for a more in-depth look at our research and development activities. Thank you, David. As you might anticipate, our research and clinical teams have been increasingly focused on advancing our portfolio of allocardial therapies. As David mentioned, we are on track with our plans to initiate a pivotal phase two trial for allo501A in non-Hodgkin's lymphoma. We view the data that we reported in May for the alpha trial, including a 36% complete response rate at six months in large piece of lymphoma, as a sign that we are on the right track and look forward to exploring whether the use of consolidation therapy might lead to even greater promise. Across all non-Hodgkin's lymphoma histology, all of 501 demonstrated an overall response rate of 75% and a CR rate of 50% across histologists and CAR-T naive patients. At the time of the data cutoff, the longest ongoing complete response was at 15 months in both large basal lymphoma and follicular lymphoma. Importantly, given our intent to move Allo501A into our pivotal study, we were also able to demonstrate that Allo501A, which eliminates the rituximab recognition domains in Allo501 to allow for use in a broader patient population, has comparable safety and efficacy to Allo501. As we look to find ways to maximize all levers afforded to us by the nature of our allogeneic platform, one area of distinction for us is our lymphodepletion platform, which supports consolidated dosing. During our CD19 day, we also highlighted the initial data on consolidation therapy, which leverages the unique attributes of the off-the-shelf allogeneic cell therapy and our proprietary lymphodepletion regimen. We are highly encouraged by the results, especially the tolerability of consolidation and observed conversion of initial PR to CR. Pending additional follow-up, we plan to incorporate consolidation into our pivotal study design. Our approach to consolidation dosing is not currently available for autologous therapies or even other allogeneic therapies that traditional lymphodepletion regimens will eliminate previously infused cells. In contrast, Allo647, as the sole lymphodepletion agent for the second dosing, is capable of supplementing the activity of the first dose, allowing for expansion and persistence after the second dose. This is an important advantage and one that we plan to fully investigate in both our CD19 and BCMA portfolios. We are currently finalizing our proposed plan to discuss proceeding to the Phase II trial with the FDA. And in the collection of data and favorable FDA feedback on the design of the trial for the registration of both Allo501A and Allo647, we currently intend to initiate the Phase II portion of the Alpha-2 trial at the end of 2021. I have been fortunate to have been involved in the development and approval of multiple cancer therapeutics and know firsthand how much effort is involved in the preparation towards pivotal trials, including extensive and complex regulatory interactions clinical development, and manufacturing activities. I would like to extend my thanks to the allogene teams who are working tirelessly to lead us to the pioneering activities required for the execution of our first pivotal allogeneic cell therapy trial. Although we're furthest along in our CD19 program, we're committed to advancing allocardia therapies across a broad spectrum of targets in both liquid and solid tumors. We were pleased to have received Regenerative Medicine Advanced Therapy designation granted by the FDA for Allo715 based on early clinical data and the potential to benefit patients with unmet medical needs. The universal trial continues to enroll patients to Allo715, including in combination with Neurogastastat, a gamma secretase inhibitor from SpringWorks Therapeutics, and in consolidation therapy. We anticipate having updated data to share from the Allo 715 monotherapy arm of our universal trial by the end of the year, and we are on course to provide updates on Allo 715 in combination with Neurogastastat in 2022. We're also thrilled to be dosing patients in our IGNITE clinical trial with Allo 605, our first TurboCAR clinical candidate and part of our broader anti-BCMA strategy. TurboCAR represents a next-generation cell therapy with built-in cytokine signaling, eliminating the need for systemic cytokine administration and the potential to induce broader immune system stimulation. With TurboCAR, we anticipate being able to improve the potency and persistence of Allocard T cells while delaying exhaustion, traits that are key to our performance in both liquid and solid tumors. Finally, we're progressing in the dose escalation portion of the TRAVERSE trial, our first venture into solid tumors with ALOS316 in clear cell renal cell carcinoma. We expect to present data on this important program next year. I'd like to echo David in thanking you for your ongoing support. Our science and clinical teams are making consistent programs in advancing a promising portfolio of Allocard C candidates for patients in need. something that we could not achieve without the backing of the investment community. I'd like to now turn the call over to Eric for an update on our financials.