Allogene Therapeutics, Inc.

Hello, thank you for standing by and welcome to Allogene Therapeutics' third quarter 2021 conference call. At this time, all participant lines are in 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 keypad. Please be aware that today's conference is being recorded. I would now like to hand the conference over to Christine Casiano, Chief Communications Officer. Ms. Casiano, you may begin.

Thank you, Operator, and welcome to all who have joined the call. After the market closed today, Allogene issued a press release that provides a corporate update and financial results for Q3 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 timing and ability to advance our clinical trials and regulatory matters, our clinical data, and 2021 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and the expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. There are 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 David.

Thank you, Christine, and good afternoon. In October, we communicated that the FDA had placed a clinical hold on our Allocarti clinical programs based on a chromosomal abnormality observed in one patient in Alpha-2 trials. Although we have been unable to treat patients while the hold is in place, multiple other work streams at Allogen continue, including preparation for a Phase II pivotal trial on Allo501A, advancement of our Cell Forge 1 manufacturing facility, and all our preclinical work on solid tumor targets and next-generation technologies. On today's call, we will share a brief update on the clinical hold and perhaps even more importantly, the ultimate reason that we remain committed to advancing our platform, our data, and the potential impact to patients in need. Let me first start with what's on top of mind. Since we announced the clinical hold on October 7th, we have been actively engaged with the FDA in discussions that we hope will lead to a timely resolution. We are extremely appreciative of the time and attention that the FDA has devoted to this matter, which we believe has implications not only for the field of allogeneic cell therapy, but also the broader field of cell therapy. I'm also grateful to our team at Allogene, which are making great progress in generating information for us and the field to understand and properly address the chromosomal abnormalities observed in our patients. The FDA's stated mission is to ensure the safety and efficacy of medical products, but the agency has also been mandated by Congress to expedite product development. As FDA leadership has shared at recent public forums, they have identified the development of allogeneic CAR-T derived from healthy donor cells as a potential way to increase access to the therapy and decrease manufacturing time and cost. We recognize the FDA's responsibility to ensure patient safety while supporting innovation. The FDA has continued its review of our end of phase one material submitted in anticipation for a potential allofibro 1A pivotal phase two trial. From Allergen's perspective, we understand our own responsibility that comes with being a pioneer in the field of cell therapy. and look forward to doing everything necessary to facilitate a safe and timely resumption of our clinical studies. During our interaction with the FDA, we have remained in close contact with our investigators, including the clinician who is caring for a patient who subsequently received an allogeneic stem cell transplant. We have heard from many of these investigators. They look forward to re-initiation of our trials and view our Allocarti product as an important therapeutic option for patients, calling out how many of their patients cannot wait for the delivery of Atalas-Carti cells or don't want to risk manufacturing failure. Most importantly, we believe in the potential of our Allocarti products and have treated now more than 130 patients with lymphoma, multiple myeloma, and renal cell carcinoma across five Phase I studies. In the Alpha-1 trial alone, we have treated over 60 lymphoma patients, and we are excited to share updated data at the ASH conference in December. I will now turn the call over to Rafael to preview our upcoming data presentation. Thank you. As David has noted, I will focus my comments today on data updates from both our anti-CD19 and BCMA programs, which will be presented at next month's ASH conference. We believe the data disclosed in the ASH abstract for ALO501 and ALO501A continue to validate our consolidation strategy. ASH will feature an oral presentation on our Phase I Alpha-2 trial with ALO501A and a poster presentation on an alpha study with ALO501. Consistent with the data presented at ASCO earlier this year, the updates in the ASH abstract continue to support a favorable clinical profile for AllocardZ in non-Hodgkin's lymphoma and demonstrate that consolidation dosing is well tolerated with the potential for enhanced efficacy compared to a single dose of cell. We chose the term consolidation to describe our unique approach to redosing which goes beyond simple retreatment. Our proprietary lymphodepletion strategy, enables us to provide a second dose of cells without re-administration of chemotherapy, allowing cells that persist from an initial dose to remain active while newly administered cells can work to consolidate a response to therapy. While the data are early, we believe this strategy holds advantages over other retreatment paradigms that are being studied. As you may recall, data presented from the Alpha-2 study at ASCO earlier this year included six evaluable large B-cell lymphoma patients treated with a single dose of allofibroin A and five evaluable large B-cell lymphoma patients from the consolidation cohort in this study. As of the ASHAFTRA data cutoff date in July, 15 patients had received allofibroin A, six in the single-dose cohort and nine in the consolidation cohort. with 12 patients, or six each, available for response at day 28. In the consolidation cohort, both the overall response rate and complete response rate were at 67%, with all three partial responses converting to CRs following consolidation. We look forward to presenting data on additional patients from the consolidation cohort at ASH, recognizing that a few in this group were not able to receive a second dose following the clinical hold. The safety profile of Allofil 501A continues to be manageable in both the single-dose and consolidation cohorts. Events of interest in the single-dose cohort were previously reported at the 2021 ASCO Annual Meeting. In the consolidation cohort, there was no cytokine release syndrome, no graft-versus-host disease, no IGAMS, no dose-limiting toxicity, no dose reductions or grade 3 plus infections, and infusion reactions were a grade 2. Among all treated patients, hadopenias were the most common adverse event that occurred in 72% of patients. The patient with aplastic anemia and the chromosomal abnormality treated in the Alpha-2 trial was not referenced in the ASHA abstract due to the timing of the data cutoff. Meanwhile, we continue to prepare for the advancement of the Allo5018 program into a pivotal phase to study. with the understanding that certain work streams are being delayed by the whole and subject to ongoing discussions with the FDA. In the ash abstract for the poster presentation of the Allo501-alpha trial, the updated data continues to highlight that allogeneic cardiac therapy can be effectively and conveniently delivered to patients with relapsed refractory non-Hodgkin's lymphoma with responses observed across all cell doses and tumor histologies. In data presented across 36 CAR-T naive patients, response rates continue to be similar to those seen in autologous CAR-T therapy trials, and the modified intent-to-treat population remain nearly identical to the intent-to-treat population, with 46 of 47 enrolled patients receiving therapy and an average time from enrollment to start of therapy of five days. As of the July ASH abstract data cutoff, five additional patients were treated relative to the data previously reported at ASCO earlier this year. Overall response rate and CR rates remain at 75% and 50%, respectively. In the 13 CAR-T naive patients with large visa lymphoma, the overall response rate was 62%, and the CR rate was 46%. In the 23 CAR-T naive patients with follicular lymphoma, the overall response rate was 83% and the CR rate was 52%. Four of the seven follicular lymphoma patients enrolled in the consolidation cohort were evaluable for assessment after consolidation dosing at the time of the data cutoff with an overall response rate and CR rate of 100% and 75% respectively. As with Alpha-2, we will report on additional patients treated in the consolidation cohort of Alpha at the ASH meeting, with a few not able to receive a second dose following the clinical hall. The percent of patients remaining in CR at six months following a single infusion of Allo501 was 36% in large vessel lymphoma, which is similar to six-month CR rates reported in the pivotal trials of autologous CAR-T cell therapies, with the longest ongoing CR at 15-plus months as of the data cutoff. The six-month CR rate in follicular lymphoma was 28%. There were no cases of GVHD or DLTs observed. As noted previously, one case of Grade 3 ICANNs was reported. Grade 1-2 CRS occurred in 22% of patients with one case of Grade 3 CRS. All were managed with standard protocol. Cytopenias were the most common adverse events and occurred in 83% of patients. Infection rates remained similar to those observed in autologous CAR-T trials. There were no new treatment emerging deaths reported in this abstract. The oral presentation I asked from our multiple myeloma program was focused on a single administration of allo715 at higher cell dose cohorts. Subject to the whole, we continue to target 2022 for data from the combination of allo715 with neurogastastat, consolidation dosing with allo715, and our allo605 turbo CAR study. Findings from universal abstract indicate that an allogeneic CAR-T cell therapy can be delivered rapidly and without the need for bridging therapy to patients with refractory multiple myeloma with a single dose of therapy capable of inducing deep response. The ASH abstract contains data as of June, with 42 patients treated at escalating doses of allo715 and doses of allo647 ranging from 39 milligrams to 90 milligrams. As with the alpha trials, the median time from enrollment to lymphodepletion was five days. Patients were in advanced stage of disease with a median of five prior lines of therapy, and 43% of patients were pentarefractory. The trial did not permit bridging therapy. When the initial universal dataset was presented at ASH 2020, we reported on 26 evaluable patients across all doses. The efficacy analysis for this ASH presentation, however, will focus on those patients treated at the highest two-dose levels of 320 million and 480 million CAR positive cells. At the time of the abstract, 26 patients were treated at the highest two-cell dose levels along with fludarabine, cyclophosphamide, and allo647 lymphodepletion. The overall response rate was 62%, with a very good partial response or better, or VGPR+, rate of 38.5%. Medium follow-up for these patients was 7.4 months, with a medium duration of response of 8.3 months. Of the 10 patients with the best response of VGPR+, 8 were found to be MRD-negative. No GDHD was observed. The most common grade 3 plus adverse events included cytopenias. CRS was reported in 52% of patients, in all cases grades 1 and 2, except for one patient with grade 3. One patient with grade 2 CRS experienced grade 1 neurotoxicity that resolved. Grade 3 plus infections occurred in 13% of patients, including two previously reported grade 5 events. We are pleased that the data from Universal showed that multiple myeloma patients treated with Allo715 can achieve and maintain meaningful response rates. We look forward to providing updated data across our lead product candidates at ASH in December. We remain enthusiastic about our differentiated AllocardT platform and what its potential may mean for patients. I'd like now to turn over the call to Eric for an update on our financials.