Allogene Therapeutics, Inc.

Thank you for standing by and welcome to Allogene Therapeutics first quarter 2022 conference call. At this time, all participants on a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be aware that today's call is being recorded. If you require any further assistance, please press star zero. I would now like to turn the call over to Christine Calciano. Chief Communications Officer, please go ahead.

Thank you, Operator, and welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the first quarter of 2022. This press release and today's webcast are both available on our website. As a reminder for this call, we ask that all keep their questions to one per person. 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 2022 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 the latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allergan disclaims any obligation to update these statements. I'll now turn the call over to David.

Thank you, Christine, and good afternoon. This month marks the fourth anniversary of Allergen's inception. We founded Allergen with a belief that for cell therapy to truly change the landscape, it would need to be industrialized. Today, as a report on the first quarter of 2022, I'm immensely proud of all we have accomplished in the last four years. This includes delivering peripheral concept data from our CD19 and BCMA programs, that is differentiated in the field, including the most comprehensive set of allogeneic CAR-T data demonstrating durability, as well as operationalizing CellForge-1, advancing our allo-CAR-T programs into solid tumors, progressing multiple clinical programs with each testing innovative concepts that have the potential to fuel the growth of allogeneic CAR-T, and most importantly, bringing our lead Allocardy product candidate to a cusp of a pivotal trial. We are proud to have treated more patients with our Allocardy candidates than any other player in the field. But the true promise of allogeneic therapy comes not from treating tens or even hundreds of patients in clinical trials, but from being able to serve tens of thousands of patients in a commercial setting. With each advance we make in manufacturing, clinical development, research, and execution, we are one step closer to achieving our vision of creating a new reality for patients, a reality in which all eligible patients can access this important modality. As someone who has had the privilege of playing a role in the development of autologous CAR T therapy, I am proud of the progress the field is continuously making. Just last month, the first autologous CAR T therapy was approved by the FDA as the second-line treatment for adults with large B-cell lymphoma that is resistant to initial therapy or relapsed within one year of the start of the frontline treatment. This treatment is also the first CAR T therapy to receive a National Comprehensive Cancer Network Category 1 recommendation based on high level of clinical evidence that the therapy is appropriate. In February, the FDA approved the second BCMA-directed otologous cardiac therapy for patients with relapsed or refractory multiple myeloma. These are meaningful advances that will change the practice of medicine, and we are pleased to see the increase in the number of patients who can potentially benefit from cardiac therapy. but broader treatment recommendations create inherent challenges for therapists that must be manufactured and delivered on an individual patient basis. The logistical challenges and cost of manufacturing, patient by patient, as well as waiting times and potential for manufacturer failure must all be addressed in order for the field to move forward. Markets like Second Line Large B-cell Lymphoma and relapsed refractory multiple myeloma are large, consisting of many thousands of potentially suitable patients. Autologous therapies have simply not been able to keep up with demand. Sadly, no matter how efficacious an autologous cardiac therapy may be, its benefits do not extend to those patients who are left in waiting. The recent approvals and expected approval of additional indications will place more pressure on the supply bottleneck. Autologous companies are building up manufacturing capacity in response to growing demand, but creating ready, available, and scalable supply with personalized therapies simply isn't possible when production runs need to be individually tailored. For an autologous therapy to serve 25,000 patients, it must successfully execute 25,000 manufacturing runs. The most efficient way to meet such demand is an allogeneic CAR-T product, which also provides the promise of growing the market. Based on our experience with Allo501A, we project that at scale we can manufacture approximately 20,000 patient doses annually and reduce the number of required manufacturing runs hundredfold as compared to autologous CAR-T therapies, while importantly delivering this product on demand to any eligible patient in need. We think this type of step function improvement in both efficiency and production and speed of treatment will be a requisite for treating the large number of patients who stand to benefit from CAR-T therapy. We recently conducted a virtual unveiling of our new manufacturing facility, Cell Forge One, or CF1, in Newark, California. From the beginning, we knew that controlling the production of our allocarty products would be key to our ability to deliver off-the-shelf carty products faster, more reliably, and at greater scale. Hence, our decision to build out our own cell manufacturing facility at an early time point. CF1 was built to support clinical and commercial manufacturing, analytical testing, and the distribution of our cell therapy products with a flexibility that would allow optimization of all steps in the manufacturing process and incorporation of new learnings for next generation of allocarpy products. Thank you for those who participated in this facility's virtual unveiling. In this case, I truly believe a picture is worth a thousand words, and our virtual event provided powerful visualization of the unique aspects of our facility design. And based on the feedback, we are thrilled so many of you found this event to be insightful and highly educational. On the clinical front, as most are aware, we promptly resumed clinical study activities after the FDA lifted our clinical hold early this year. We are actively enrolling patients in our trials for allo715 and allo605 in relapsed refractory multiple myeloma and allo316 in advanced or metastatic renal cell carcinoma. We have also chosen to continue enrollment in our Phase I study of allo501A in advance of initiating our pivotal trial that is projected to start mid-year. We are completing CMC activities that should enable us to initiate the pivotal program using materials produced at CF1. We view this as strategically important and a major competitive advantage that could reduce timeline to BLA filing and potential FDA approval. Lastly, I would like to take a few minutes to welcome Susie Lundeen, our new Chief People Officer, to our senior leadership team. In this newly created position at Allogene, Susie will oversee our human resources efforts as we scale our teams in support of advancing our pipeline. Her breadth of experience in designing and implementing systems and strategies to support companies as they transition from development to commercial stage will be key to our success. Thank you for joining us today. We are grateful for your support as our vision for the future of allogeneic heart disease continues to materialize with each patient we treat. I will now turn the call over to Rafael for further updates on our research and development activities. Thank you, David. Our clinical teams have been incredibly engaged with clinical trial sites and investigators as we enroll patients across four active studies. Universal for Allo715 and Ignite for Allo605 in relapse or refractory multiple myeloma, Traverse for Allo316 in renal cell carcinoma, and the extended Phase I portion of the Alpha-2 trial for Allo501A in relapse or refractory large-scale lymphoma. We are keenly focused on initiating our pivotal trial on allo501A in third-line large piece of lymphoma around the middle of this year. Given ongoing FDA discussions directed at finalizing clinical trial design, chemistry, manufacturing, and controls requirements, and the competitive nature of the field, we will share details about this single-arm study at the time of initiation. In the meantime, and as noted by David, We continue to enroll in the Phase I portion of the study to offer Allo501A to patients in need. Separate from Alpha-2 pivotal trial, we are preparing to launch the EXPAND trial to support registration of Allo647, our proprietary anti-CD52 monoclonal antibody. EXPAND is designed to establish the contribution of Allo647 to the lymphodepletion regimen. We deploy Allo647 as part of our lymphodepletion regimen in order to enable enhanced expansion and persistence of Allocard T cells, and we have shown a strong correlation between serum concentrations of Allo647 and the likelihood of clinical response. Based on this data, we believe this trial will not only result in a positive outcome, but also competitively differentiate our platform by demonstrating that Allo647 contributes to superior outcomes. In particular, we believe the rate and durability of responses demonstrated to date with allo501A is in part related to the degree of lymphodepletion enabled by the use of allo647, which differentiates our platform from that of others in the allogeneic field. To that end, we do intend to have an update on longer-term follow-up from the alpha studies by the end of the year. Our BCMA program is the first and only allocarty BCMA program to generate clear proof-of-concept data. Data from the universal trial on allo715 continue to be well-received by investigators, and we are optimistic that we will have a competitive product for the treatment of relapsed refractory multiple myeloma. As David mentioned, there is tremendous unmet need in myeloma, and despite the recent approvals of autologous CAR-T therapies, There remains strong interest in a product that can be delivered in days and without need of bridging chemotherapy. Our approach to myeloma gives us four shots in all, with our first allo715 as a monotherapy, already demonstrating a profile that appears attractive relative to that of abecma, and approved autologous CAR T-therapy. We are also evaluating Allo715 utilizing consolidated dosing and in combination with SpringWorks Therapeutics Investigational Gamma Secretase Inhibitor Neogazostat. Lastly, Allo605, our first TurboCAR candidate, is in Phase 1 evaluation. As you may recall, TurboCARs are designed to provide selective, programmable cytokine signaling to CAR T cells to counter T cell exhaustion, improved T cell function and potency, and potentially reduced cell dose requirements. Just last week, allo-605 was granted orphan drug designation by the FDA. Notably, in March, we announced the publication of clinical results in cancer research communications, which demonstrated strong evidence of the superior long-term myeloma-killing activity of allogeneic anti-BCMA CAR T cells manufactured from healthy donors compared with anti-BCMA CAR T cells from patients with multiple myeloma. We intend to provide a holistic update on our BCMA program by the end of the year. We remain eager to better understand the potential of our allocardies in solid tumors. Our first candidate, allo316, targeting CD70 for the treatment of advanced or metastatic clear cell renal cell carcinoma, is proceeding through phase 1 dose escalations. Last month, we presented preclinical data at the 2022 American Association for Cancer Research annual meeting, which supports the clinical evaluation of ALO316 for the treatment of patients with renal cell carcinoma and other CD70-expressing tumors. The findings, simultaneously published in Cancer Research, followed our announcement in March that the FDA granted ALO316 fast-track designation based on its potential to address the unmet need for patients with renal cell carcinoma who have failed standard therapy. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, creating a necessity for scientific innovation. While we still have a long road ahead of us, we continue to make progress and look forward to generating data from our ongoing Phase I Traverse trials as we plan for the testing of Allo 316 in other CD70 expressing two more times. In addition to advancing our clinical work, our research teams are making good progress progressing multiple preclinical candidates and innovative technologies. We expect these to ensure Allogene's leadership position in the field of allogeneic heart disease for years to come. I'd like to now turn the call over to Eric for an update on our financials.