Allogene Therapeutics, Inc.

Hello, thank you for standing by. Welcome to Allogene Therapeutics Door Quarter 2024 conference call. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be aware that today's conference call is being recorded. I would now 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 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 third quarter 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 one hour. 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, 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. You are cautioned not to place undue reliance on these forward-looking statements. and Allogene explains any obligation to update these segments. I'll now turn the call over to David.

Thank you, Christine, and welcome to those on the call today. Today, I am excited to share our recent progress and upcoming milestones as we continue our mission to redefine cell therapy for both cancer and autoimmune disease. In the third quarter, our groundbreaking achievements include, one, in heme malignancy, We continue to activate sites and advance the pivotal phase 2 alpha 3 trial of Semacel for large B-cell lymphoma. This trial marks a significant step forward as Semacel could become the first CAR-T therapy integrated into the first-line treatment. With its focus on patients at high risk for relapse and the ability to potentially predict who those patients might be, This trial could transform first-line treatment and set a new standard for patient outcomes. PhthaloTumor. Allo316 is showing unprecedented efficacy in phthalo tumors through the baseline reverse trial for renal cell carcinoma, achieving a confirmed response rate of 33% and best overall response rate of 50% in heavily pre-treated patients with high CD70 expression. We define high CD70 expression as tumor proportion score greater than 50%, which represents the majority of patients. This breakthrough led to the RMIT designation from the FDA, positioning allo316 as a promising treatment for advanced renal cell carcinoma. Pipeline. Pipeline innovation extends into autoimmune diseases with allo329. the first dual CD19-CD70 CAR designed to target CD19-positive B cells and CD70-positive T cells, both key drivers of autoimmune dysfunction. By addressing both B cells and activated T cells, we are tackling a broader spectrum of autoimmune mechanisms, which could significantly enhance therapeutic outcomes and expand the range of autoimmune diseases we can address. But what really differentiates Allo329 is our proprietary Dagger technology. This technology, now clinically validated via the Allo316 program, could enable Allo329 to overcome one of the biggest anticipated barriers to cardiac therapy in autoimmune disorders, lymphodepletion. We believe this unique feature of Allo329 will allow us to reduce or eliminate the need for lymphodepleting chemotherapy. which we believe is a significant barrier to advance CAR-T beyond severe cases of autoimmune disorders. Beyond its technical strength, Allo329 is designed as an off-the-shelf and once-and-done solution, which differentiates Allo329 from otitis CAR-T or by specific T-cell engagers and allow us to potentially reach these larger patient population more efficiently. We anticipate an IND filing in first quarter 2025 with peripheral concept data by year end 2025. A sneak peek at the potential of ALO329 in preclinical models will be presented at the American College of Rheumatology Convergence on November 18, 2024. Looking ahead to 2025, DE's development reflects a potential paradigm shift highlighting the Allocarchy platform's unique ability to address diverse patient needs. This journey is not without challenge, as each trial brings its own level of complexity in a highly competitive field. It's for this reason we crafted each program with a long-term vision in mind. As Wayne Gretzky famously said, skate to where a puck is going to be, not where it has been. That's precisely our approach. By pursuing what we believe are best-in-class therapies with differentiated development approaches to maximize the key attributes of Allocard T, we are confident that this strategy of anticipating future needs will yield remarkable outcomes. Each of these programs has the potential to revolutionize the application of Card T therapy in treating disease and shaping the future of medical practice. Now, I would like to handle the call over to Zach to discuss the status of Alpha 3 trial and provide a deeper dive into the latest data from our Allo316 program.