Allogene Therapeutics, Inc.

and Chief Executive Officer, Dr. Zachary Roberts, 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 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 2023 financial guidance, among certain 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 many thanks to all of you for joining today's call. When we launched Allogen in May 2018, we understood that our mission to bring forth a new generation of CAR-T products was an important one. Like other industry pioneers, we knew that along our journey, we might face many obstacles, that our progress would be marked by several first-in-class milestones, and that a scientific approach to decision-making would guide us on the best path to success. Most of all, we knew that our compass had to be centered on doing right for patients. This is why each year, on the company's founding anniversary, we celebrate Patient Day at Allergy. This year, we were honored to have two patients join us live at our headquarters. One who received Allo501 for the treatment of relapsed refractory non-Hudson's lymphoma, and one who received allo715 for relapsed refractory multiple myeloma, each of whom continues in long-term response. They both spoke eloquently of their own journey with cancer, their decision to place their trust in allergen, and the impact that our Allocard T product candidates have had on their lives. Why do I mention this? We often get questions about our stock price weakness. Yes, the market is challenging. Yes, cell therapy stocks are temporarily out of favor. And yes, many of us in the industry find it frustrating that progress is not always rewarded in real time. But during times like this, it helps to remember that best marker of success is not necessarily a stock price. Rather, it is the impact companies in our sector are having on patients. We at Allergen not only have the confidence in the clinical data sets that we have delivered, but know that we are on the right path by having looked into the eyes of patients who are with us today because of our investigational products. The two patients I met earlier this week are living proof of Allergen's success. As we hear their stories, We also hear the growing rumble of discontent around the inability of autologous cardiac therapies to satisfy patient demand. By 2030, it is estimated that 300,000 patients with lymphoma or myeloma will be eligible for an autologous cardiac therapy as it moves to earlier lines. Only a few, an estimated 10%, will be able to receive treatment. yet achieving even that goal will require 30,000 individual manufacturing runs. Last year, based on the reported sales, 6,000 to 7,000 runs were required, which alone strained the system. We are keenly aware that shareholder interest is best served by bringing Alucard products to the market as soon as possible. But the real sense of urgency that we feel originates from many patients who are on the sidelines today, waiting their turn. In contrast to autologous cell therapies, patients in our trials don't have to wait on the sidelines. They are able to start treatment within days of enrollment and without the need of undergoing bridging therapy, which often comes with marginal benefits, but with toxicities. Treatment consists of a one-time infusion of cells. free of hassles and inconvenience of having to return to the clinic for treatment again and again, and without the cumulative toxicities that often comes with lengthy chronic therapy. AllocRT is unique in its ability to potentially provide a one-time off-the-shelf product capable of achieving long-term remissions. As we march towards our goal of a ELA submission for Allo501A, upon completion of the Alpha 2 trial and evaluate manufacturing process across our BCMA candidates to achieve optimal clinical performance. I am particularly excited to welcome Tim Moore to Allogene as our new chief technical officer. Tim was my colleague at KITE, and he was trusted to deliver CAR T products for every patients we enrolled in clinical studies and post-approval. As the Executive Vice President of Technical Operations, he oversaw the global development of the most commercially successful Otales car team manufacturing processes in the industry. More importantly, he successfully navigated the complex CMC processes for the VLA submission of Yaskata that led to an on-time approval of Yaskata and Kite's commercial manufacturing facility. He is a true pioneer who defined operational strategy to reduce manufacturing risk and mitigate supply chain challenges inherent to engineered cell therapy. His joining Allogen is a recognition that the only way to deliver CAR-T at scale and in a timely manner is through an allogeneic approach. Of course, to get to a VLA, we need to execute on clinical development, which is Zach Roberts' main focus. With that in mind, I now turn the call over to Zach for an update on our R&D activities.

Thank you, David. When Allogene began this journey, the biggest question facing the field was whether or not the safety and efficacy of an Allogeneic product could be comparable to approved autologous CAR-T therapies, and in particular, whether AlloCAR-T could achieve the longer-term remissions that are the hallmark of cell therapy. While data from our ongoing Phase II trials will be required for confirmation, We strongly believe that the available data from the Phase 1 Alpha and Alpha 2 trials establish the feasibility of this new modality. The unique experience and track record we have across our teams derived from previous success developing autologous CAR-T therapies that led to approvals in late and earlier Lyme disease gives us the confidence in our approach and clinical data. When you combine that history with the nearly 200 patients we have treated with our Allocart T investigational products, including nearly 50 patients alone with LBCL, we are in an unparalleled position when it comes to depth of understanding. Our experience now extends even further with the addition of Tim to our team. I doubt there are any better positions to ensure that our capabilities and product sciences scale successfully with our advances in the clinic. Another important benefit of our experience in the field is our long-standing relationships with investigators. recently held a meeting with many of our phase two investigators as we progress enrollment of the alpha 2 trial and begin enrolling patients in the expand trial as our clinical safety and efficacy data continue to mature the more excited our investigators are of the potential of allogeneic rt in an effort to increase awareness of our programs to an even broader set of positions we are very pleased to be presenting updated phase one data from our trials with aloe 501 and Allo 501A at the upcoming American Society of Clinical Oncology annual meeting in Chicago. While the field of allogeneic CAR T has been marred by inconsistent data sets, especially as they relate to durability of response, we believe the data we presented at our R&D showcase late last year demonstrate that our CD19 Allo CAR T product candidates have the potential to provide durability that is on par with autologous therapies. We believe we have succeeded where many have fallen short by virtue of being able to control premature CAR T-cell rejection. Our platform is enabled by Allo647, our anti-CD52 monoclonal antibody that permits an extended window of CAR T-cell expansion and persistence. What Allo647 does cannot be reproduced even with high doses of chemotherapy that might be associated with severe toxicity. I am pleased to report that we have recently initiated the Phase II EXPAND trial designed to support the licensure of allo647 as a lymphodepletion agent for allo501A in LBCL. This study is designed to demonstrate the superiority of allo647-containing lymphodepletion regimens over a regimen of Flucide alone. The preponderance of data we've already presented from our CD19 program point to improved clinical performance with allo647 in terms of depth and durability of response. And our safety data to date are generally comparable to that of autologous CAR-Ts. We've now observed GVHD or severe ICANS have relatively low rates of CRS, and our rates and severity of cytopenias and infections are in line with what has been reported for autologous CAR-T. Based on our emerging product profile, you can understand why we remain very confident in the potential outcome of both of our ongoing Phase II trials. I'd like to next turn your attention to our ALLO 316 program where we recently had an oral presentation of our interim phase one data in renal cell carcinoma at the clinical trials plenary session of the American Association of Cancer Research annual meeting. Clear cell renal cell carcinoma is the most common form of kidney cancer. The unmet need in patients with metastatic or advanced disease who have progressed on standard of care therapies, tyrosine kinase inhibitors, and immune checkpoint inhibitors is high. Once patients have progressed on these two classes of drugs, there are limited options. In fact, it's estimated that 90% of patients with advanced or metastatic RCC will die from their disease within five years. The data we presented at ADCR showed that ALLO316 has the potential to make a difference for patients with RCC whose disease progressed on TKIs and immune checkpoint inhibitors. Initial results from the dose escalation portion of the trial showed that a single infusion of Allo316 demonstrated anti-tumor activity in patients with CD70-expressing tumors, providing a 100% disease control rate, meaning tumors shrank or remained stable over a certain time period. In the 10 patients whose tumors were known to express CD70, the overall response rate was 30%, including three partial responses, meaning the size of the tumors were reduced by at least 30%. The longest partial response lasted to month eight. This is remarkable given that we're still in the dose escalation phase of the study, with most patients being treated with relatively low doses, 40 or 80 million total allocard T cells. As in our CD19 program, the safety profile of allo316 to date appears generally consistent with what is seen with autologous CAR T cell therapies. With all 19 patients in the phase one study, including nine who did not have CD70 expressing tumors or had CD70 expression unknown, There was a single case of grade 3 CRS. Neurotoxicity, which is now defined more broadly, was generally low-grade and reversible, with most events being fatigue or headache. There were no cases of GVHD or ICANS. Infections occurred in eight patients and included four cases of grade 3 or higher infection. Grade 3 or higher prolonged cytopenia was observed in three patients. One dose limiting toxicity of grade 3 autoimmune hepatitis was reported. This event, which has been resolved, may have been confounded by prior use of a checkpoint inhibitor. One feature of ALLO316 that we are particularly excited about is the expansion and persistence of ALLO316, which we believe compares favorably with what has been reported for autologous CAR-T therapies. ALLO316 was engineered so the anti-CD70 CAR can exhibit an additional function beyond cancer cell killing. avoidance of premature rejection by the host immune system. Because CD70 is expressed on activated T cells, there is a potential for Allo316 to target and eradicate alloreactive T cells in addition to CD70 positive cancer cells. This unique feature of Allo316, highlighted in the traverse translational data shared at AACR, is the basis of our proprietary dagger technology that now has become the foundation of our next generation anti-rejection approach. Dagger technology is designed to prevent early rejection of allocard T cells by suppressing host immune cells, thereby supporting CAR T cell expansion and enabling a prolonged window of persistence. We are excited by the possibility to deploy Dagger alongside CARs directed at other antigen targets in the same cell for the purpose of creating a novel allogeneic CAR T platform for a suite of next-generation products that are less dependent on traditional chemotherapy-based lymphodipletion. I will now turn the call over to Eric.