Allogene Therapeutics, Inc.

Thank you for standing by and welcome to Allogene Therapeutics' fourth quarter and full year 2023 conference call. At this time, all participants are in 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 1 1 on your telephone. To remove yourself from the queue, you may press star 1 1 again. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Casiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Casiano, 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 fourth quarter and full year 2023. This press release and today's webcast are both available on our websites. Following our prepared remarks, we will host a Q&A session. We ask you to limit your questions to one per person as we will keep this call to an hour and do our best to get to as many questions as possible. Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, and Jeff Parker, 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, the safety and efficacy of our product candidates, and 2024 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 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 thank you for all who have joined our call today. Rather than looking back, which is the norm for this type of call, I would like to take the opportunity to look ahead. We have recently returned from an investor conference in Boston and were beyond thrilled to feel a renewed enthusiasm for biotech and even more so a resurgence in cell therapy. I would argue this is also true for allergens, a sentiment seemingly shared by many of our investors following the pivot we announced at the beginning of 2024. From our innovative Alpha-3 trial, which is designed to embed semacell as part of a curative first-line regimen for patients with large B-cell lymphoma to specifically creating a CAR T that could meet the unique needs of patients with autoimmune disease and possibly reduce reliance on lymphodepletion. Our development approach focuses on the distinctive attributes of an off-the-shelf alternative and creates an advantage for our CAR T programs. We are no longer developing CAR-T using an outdated playbook. Now that we have established the viability of our allogeneic platform, our product can be developed using a fresh approach created for what we do, both in design of our trial and design of our constructs to meet the current and future needs of patients and dramatically expand opportunity. Alpha-3. which, based on feedback from investors and doctors, is perhaps one of the greatest examples of the role an allogeneic cardiac can play in this resurgence for cell therapy. This is the first pivotal trial for frontline consolidation in large B-cell lymphoma with a goal of improving cure rates. There was significant insight-gathering work and discussion with the FDA in 2023 to inform and finalize Alpha-3. When we revealed the trial in January, there was acknowledgment almost right away that this groundbreaking trial creates the potential to leapfrog all other CAR T and embed semicell in first-line treatment. Equally important, is the innovative concept of treating minimum residual disease, or MRD, together with the benefit of drug in a vial, could open the door to make allogeneic hierarchy available in community-based cancer centers where most early-aligned patients are treated. The more we've talked about Alpha-3, the deeper the understanding this trial design is something truly unique. A rare opportunity in oncology to do a randomized trial against observation and the prospect of becoming new center of care in the first line setting. Based on the addressable market just in the U.S., the revenue potential could be upwards of $3 billion and could easily double when expanded ex-U.S. This type of opportunity only presents itself when you center on patients and their endeavor to be curative. Our second most asked program by Investor After Alpha 3 is Allo329 in Autoimmune Disease, or AID. Enthusiasm for CAR T and AID is palpable. However, we have chosen not to rush into the already crowded field with an undifferentiated approach. The future result of that could mean an uphill battle in trial enrollment or worse, at commercialization. Instead, we are applying our deep and hard-earned experience to specifically design our newer targeting CAR T2.0 for autoimmune disease. Our design is centered on both scalability and reducing or eliminating lymphodepletion, which we believe is absolutely critical for rapid clinical development and future commercial success. We expect to be in clinic with IL-329 in a phase one trial in early 2025. Our next two cohort program also lean into attributes of allogeneic CAR-T. Our new Alpha-2 cohort for semicell in chronic lymphocytic leukemia, or CLL, aims to address the growing unmet need among patients whose disease are not controlled by DTK and or BCL2 inhibitors. Relapsed refractory CLL in the second and third line setting represents a commercially attractive opportunity with revenue potential in the $3 billion range in the U.S. We believe an allogeneic CAR-T product is particularly well-suited to overcome a limitation of atollus CAR-T, where poor T cell fitness is a known barrier to efficacy. New approvals could reopen the door of interest in CLL, and we look to charge through it with our program. Our ongoing trial tackles one of the hardest industry challenges, but one we are willing to undertake, cell tumors. Allo316 in renal cell carcinoma leverages our dagger technology to optimize CAR-T cell expansion and persistence to maximize the potential of an AlloCAR-T. In the second quarter, we plan to publish what we believe to be fundamental discovery, the algorithm that may mitigate the treatment-associated hyperinflammatory response without compromising the CAR-T function needed to eradicate thalassemia. A more comprehensive update from the Traverse trial is planned for year-end 2024. Now, I'd like to turn the call over to Zach to address some of the more commonly asked questions about our programs.