Allogene Therapeutics, Inc.

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to Allogene Therapeutics' first quarter 2021 conference call. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. 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 welcome to our first quarter 2021 conference call. After the market closed today, Allogene issued a press release that provides a corporate update and financial results for Q1 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 Amato, 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 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. As a reminder for these calls, we will continue to limit questions to one per person, so we can do our best to answer all questions during the hour. I'll now turn the call over to David.

Thank you, Christine, and good afternoon. We are pleased to provide an update on our progress during the first quarter of 2021, which builds on our exceptional performance in 2020. Just days ago, we celebrated the third anniversary of Allogene. As I've reflected on this milestone, we have many things to be proud of. Most importantly, each and every patient we have treated so far with our allocardy candidates. From the first patients with relapsed refractory non-Hodgkin lymphoma treated with allo501 in 2019 to the start of our first allotumor trial with allo316 earlier this year, we are continuing to define, shape, and advance the field of cardiac therapy. While the initial standards in this field were set by the groundbreaking autologous cell therapies, we are increasingly able to shine a spotlight on the inherent benefits of allogeneic cell therapy and our ultimate goal of improving outcomes for a broader set of patients. Allogeneic cardiac therapies, of course, also come with inherent challenges. We believe our platform is capable of addressing these challenges, and we are proud to continue advancing the depth and breadth of our pipeline our next-generation technologies, and our state-of-the-art manufacturing capabilities. On the clinical front, we are expanding our Allocarchy trials to encompass new targets, new cancers, and new technologies. As we indicated during our last quarterly call, we targeted this year's American Society of Clinical Oncology Annual Meeting for an update on our CD19 program. While Rafael will cover most of what to expect for ASCO during his remark, I would like to note that we recognize the importance of this most advanced allogeneic CAR-T program in the field, and we look forward to discussing not just the data we will present as part of ASCO, but also our broader vision for the program during our virtual CD19 forum on May 19th. I think it is also important to note that while we are still treating and collecting data from our Alpha and Alpha 2 trials to evaluate the full data set prior to next phase, it remains our goal to advance Allo501A to a pivotal Phase 2 trial by the end of 2021. We continue to build on the positive momentum from our presentation of the universal trial at last year's American Society of Hematology Annual Meeting. Interim findings from this ongoing trial demonstrated for the first time that an allogeneic cardiac therapy directed at PCMA can achieve deep clinical responses in heavily pretreated patients with refractory multiple myeloma while eliminating both the need for bridging therapy and treatment delays associated with otolaryx cardiac manufacturing. Our recent regenerative medicine advanced therapy, or RMET designation for allo715, was supported by our proof of concept data. We have continued to execute on our three-pronged anti-DCMA strategy in multiple myeloma. Through our collaboration with SpringWorks Therapeutics, we have started dosing patients in the combination arm of the universal trial to evaluate allo715 in conjunction with SpringWorks' Investigation of Gamma Secretase Inhibitor, Neurogasospat. In addition, we have received IND clearance for allo605, our eagerly awaited first TurboCard candidate, and remain on track to initiate our Phase I IGNITE trial in the coming months. We are excited about the potential of each approach to deliver meaningful results for these patients. I will let Rafael dive into the details of these innovative approaches designed to further advance the potential of allocardial therapy in myeloma. While our initial candidates target blood cancers and follow in the footsteps of autologous cardiac therapies, we have begun to blaze new trails in solid tumors. We are very excited to be dosing patients in the TRAVERSE trial with allo316, which targets CD70 for the treatment of renal cell carcinoma. We believe demonstration of activity in this setting has the potential to accelerate the development of CAR T therapy in siloed tumors and rapidly alter the trajectory of allogeneic CAR T and look forward to executing this study. From our first day at Allogene just three years ago, controlling our own manufacturing has been core to our vision of ensuring that our therapies are available and accessible to eligible patients within a matter of days. Under the skillful leadership of Dr. Alison Moore, our Chief Technical Officer, we are well on our way of achieving that goal. We believe producing our Allocardia therapies at Cell Forge One our state-of-the-art manufacturing facility in Newark, California, will allow us to scale production, control costs, and equally importantly, continually improve and enhance the quality of the output. We have begun engineering runs at our new facility and are on track to initiate GMP production later this year. As we execute towards a new vision for CAR-T therapies, one that allows us to embrace the inherent benefits afforded to an off-the-shelf therapy, the ability to treat every eligible patient, the ease with which to consolidate therapy or even re-dose patients, the potential to extend access into community setting, and the possibility of making therapy available to patients with follow tumors. We are excited about what is to come, and the role we are playing in redefining the future of this therapeutic modality. I will now turn the call over to Rafael for further updates on our research and development activities. Thank you, David. Our research and clinical teams have been pursuing numerous projects, all aimed at strengthening our current AllocardT pipeline and platform while preparing to meet future challenges associated with extending the potential of allogeneic cell therapy. Last week, we were pleased to announce that we will be presenting updated data on the Phase I Allo501 study together with initial results from our Allo501A study at ASCO. The update on Allo501 will include longer-term follow-up from the 22 patients that were initially reported on at ASCO 2020. In addition, we will provide information on additional patients treated subsequent to ASCO 2020 with a particular focus on CAR-T naive patients. As part of this readout, we do intend to break down responses between follicular lymphoma and large B-cell lymphoma. Initial data from 501A alpha-2 trial will report on the phase 1 dose escalation portion of this trial. Recall that the alpha-2 dose escalation phase was designed to quickly confirm that the findings seen with allo501 translate into allo501A prior to advancing this construct forward into a potential pivotal phase 2 study. For that reason, this trial focuses on a homogeneous large T cell lymphoma patient population. Dose escalation was completed late last year, and as such, the duration of follow-up will be limited in the alpha-2 trial. More recently, we have begun treating patients in alpha and alpha-2 under our consolidation dosing protocol. This regimen allows patients who have not progressed after an initial dose of therapy to receive a second scheduled administration of CAR T cells with the goal of improving or extending their response. Our ASCO presentation will include results on the first few patients treated with consolidation therapy, although the duration of follow-up will, as a result, be shorter. ASCO will also feature a separate presentation on the safety and biomarker data on Allo647. As you are aware, Allo647 is a key component of our platform. and we believe that it enables a differentiated approach to lymphodepletion in our trials. We look forward to reporting data across our CD19 program later this month. Given that ASCO meeting is just weeks away, we will not be discussing any further details between now and the presentation, but do hope that you will join us at our CD19 forum on May 19th. The structure of ASCO as a virtual meeting will allow us and a select group of clinical trial investigators to discuss the full set of clinical results being presented at the conference and provide the allogene team an opportunity to share our vision for the future of allogeneic heart disease therapy. As David mentioned earlier, we're pleased with the progress we've made across our multi-pronged BCMA strategy for relapsed refractory multiple myeloma. Our most advanced program is ALO715, which received RMAT designation by the FDA following updated proof-of-concept data presented from the universal trial last year at ASH. We continue to enroll patients in this trial, and as we announced a few weeks ago, we have begun treating patients in the combination arm of the study, which is evaluating ALO715 in combination with Neurogastastat, an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics. last month we also announced progress on the third prong of our myeloma strategy with ind clearance for allo 605 our first turbo car candidate we are very excited about allo 605 as we prepare to launch the phase 1 ignite trial and learn more about how this proprietary next generation technology performs in the clinic as you may recall turbo cars are designed to provide selective programmable cytokine signaling to CAR T-cells in order to counter T-cell exhaustion, improve T-cell function and potency, and potentially reduce cell dose requirements. Should Allo 605 demonstrate the benefit of this technology, we would look forward to the potential of applying it across our platform. We feel confident in the approach we're taking to maximize the benefit rates of allogeneic cell therapy and hopefully our ability to deliver a much-needed alternative to patients with multiple myeloma and who progressively failed treatment. Lastly, but definitely not least, we're excited to extend our Allocard T platform into solid tumors. Earlier this year, we began dosing patients in our first solid tumor trial with Allo316 targeting CD70. The traverse trial is enrolling patients with advanced or metastatic renal cell carcinoma, and it's designed to explore various Allo316 cell doses. The endpoints being assessed are safety, tolerability, depth and duration of lymphodepletion, cell expansion, and antitumor activity. Given the high prevalence of RCC and the lack of new treatment modalities for patients with advanced disease who have failed standard therapy, we look forward to working closely with leading kidney cancer centers and cell therapy specialists to explore allogeneic cell therapy in patients with renal cell cancer as a potential meaningful treatment option. Beyond this trial, we are leveraging internal innovation to expand the utility of our turbo car technology platform to address specific biology, namely that of tumor microenvironment in solid tumors. Preclinical data presented at the 2021 American Association for Cancer Research Annual Meeting demonstrates the ability to engineer inducible turbo cars, which confer cytokine signaling upon binding to PD-L1 and PD-L2 in the tumor macroenvironment, or when stimulated with an anti-PD-1 antibody. In addition to supplying cytokine signaling, these turbo cards are designed to enhance the therapeutic index of allocard T cells within an immunosuppressive solid tumor microenvironment. As our clinical work proceeds, we remain committed to our deep pipeline and broad research to make allogeneic CAR T therapy the modality of the future. And now, I'd like to turn the call over to Eric to review financials.