Allogene Therapeutics, Inc.

Hello, thank you for standing by and welcome to Allogene Therapeutics' fourth quarter and full year 2024 conference call. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please be aware that today's conference call is being recorded. I would like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Ms. Cassiano, please go ahead.

Thank you, Operator, and thanks to all of you for joining this call. After the market closed, Allergy issued a press release that provided a business update and financial results for the fourth quarter and full year of 2024. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that historically questions have been multifaceted, but note that we will endeavor to keep this call to under an hour. I'm joined today by 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, commercial market forecasts, and 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. Your caution not to place undue reliance on these forward-looking statements and Allogene explains any obligation to update these statements. I'll now turn the call over to David.

Thank you and welcome, everyone. It's a pleasure to be speaking with you today. At the start of 2024, we set forth a bold strategy that some viewed as merely words on PowerPoint with a distant horizon. A year later, we stand on the brink of a transformative year at Allogene. Pioneering allogeneic CAR T therapy was never expected to be easy. It demands vision, rigorous science, relentless persistence, and operational excellence. Today, all three of our key programs are approaching critical milestones, marking the tangible progress of our dedication. We enter 2025 stronger than ever with a differentiated pipeline and the clear path to shaping the future of allogeneic CAR-T. Our programs in large B-cell lymphoma, autoimmune disease, and renal cell carcinoma are breaking new ground, reinforcing our commitment to making off-the-shelf cell therapy a new standard of care. Our pivotal Phase II Alpha-3 trial for semacell in first-line consolidation large B-cell lymphoma is widely considered to be groundbreaking. We are immensely proud of the innovation behind this trial. The enthusiasm from both community cancer centers and leading academic institutions has been truly energizing, and momentum continues to build with 40 sites now activated. We anticipate reaching a critical milestone with the lymphodepletion selection and fertility analysis around mid-2025. This interim analysis will provide essential insight into whether our approach is on track to meet its objectives, providing a clear signal of progress when we select our lymphodeflation regimen. Beyond oncology, 2024 also marks our official expansion into autoimmune disease with ALLO329. The first of its kind, CD19-CD70, dual targeting allogeneic CAR T product candidate, powered by our proprietary Dagger technology. Earlier this year, we secured FDA clearance for our phase one resolution basket trial in rheumatology, an important step towards delivering a scalable off-the-shelf CAR T options to the best number of patients who stand to benefit. The IND clearance for allo329 cements allogen as a true innovator in the autoimmune disease space. We did not follow the crowd. We deliberately took the time to ensure our approach was differentiated, developing both an investigational product and trial specifically to address the unique challenges of autoimmune disease. Allo329 is designed to induce lasting remission by targeting both B cells and activated T cells. An equally important design feature is incorporation of our Dagger technology, which has the potential to reduce or even eliminate the need for lymphodepletion. If successful, this breakthrough could fundamentally change how CAR-T therapy is deployed in autoimmune diseases. With a resolution trial slated to launch in mid-2025 and peripheral concept data expected by year-end, we believe allo329 represents a new frontier in allogeneic cell therapy that will showcase the power of our platform to redefine treatment paradigms beyond oncology. In solid tumors, allo316 is emerging as a promising and potentially groundbreaking asset in renal cell carcinoma. The phase one data we presented last year underscores the potential of allogeneic cardiac therapy to drive meaningful responses in cell tumors, an area where cell therapies have historically faced immense challenges. With our regenerative medicine advanced therapy designation, Allo316 has the potential to redefine treatment for advanced renal cell carcinoma, bringing a much-needed innovation to patients with limited options. In mid-2025, we plan to share an update from our Phase 1b cohort focusing on durability, a key factor in improving long-term patient outcomes. From a broader perspective, the momentum across our program highlights the potential of allogeneic cardiac therapy to disrupt multiple disease areas. We aim to not just compete with autologous therapies. We are demonstrating that allogeneic approaches can surpass them in accessibility and scalability. Our bold pivot in 2024, coupled with our relentless execution, affirms that we have the right team, science, and strategy to make 2025 a breakthrough year for allogene, one that defines the future of allogeneic cardiotherapy. I would like to now hand the call over to Zach to provide further details on our clinical programs.