Allogene Therapeutics, Inc.

Hello and thank you for standing by and welcome to Allogene Therapeutics' fourth quarter and year end 2021 conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during this session, you'll need to press star one on your telephone. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications 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 fourth quarter and full year 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, Dr. Eric Schmidt, Chief Financial Officer, and a new voice on our quarterly calls, Dr. Allison Moore, Chief Technical 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, and 2022 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 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.

Thanks, Christine. And thank you all who have joined our call. I am very excited to talk about what we believe will be an important year for Allergen as we are working to advance three exciting clinical programs, from initiating our first pivotal trial in non-Hodgkin's lymphoma to progressing our mid-stage program in multiple myeloma to pivotal readiness and advancing our solid tumor clinical program to potential proof of concept. 2021 was both a year of significant pipeline achievement and unexpected challenge associated with the clinical whole, both of which played a meaningful role in moving allergens and the field of allergenic cell therapy forward. With our CD19 program, we demonstrated an important first for our field as the phase one data from our alpha trials continue to support the promise of our platform and our ability to provide safe and durable alternative to approve autologous CAR-T therapies in patients with relapsed refractory non-Hodgkin's lymphoma. Our next most advanced clinical program targeting BCMA is the leading allogeneic CAR-T program in multiple myeloma. Our universal study opened the door for this modality as the first and still only trial to demonstrate substantive profile concept for allogeneic CAR-T in this disease setting. While we are proud to have established profile concept safety and efficacy data in both lymphoma and myeloma, we are even more excited about the potential for allo-CAR-T products to overcome the inherent limitations of autologous therapies. Today's marketplace for autologous cell therapy is constrained by treatment delays supply limitations, and often a requirement that patients receive breathing chemotherapy. No matter how compelling the data on autologous therapies might be, they are of no value to the many patients who cannot gain access. With our Allocarti products, we have shown the ability to deliver treatments to patients within days rather than weeks. Patients who enrolled in our studies can be nearly guaranteed to receive our products. In the alpha trials, 98% of enrolled patients received our products within a median time of two to five days from enrollment to the start of treatment. By comparison, in trials deploying otitis therapies for non-oxygen lymphoma, up to 30% of patients who underwent successful leukapheresis for cell manufacturing was still unable to receive treatment due to interval disease progression while waiting for CAR T cell products or due to manufacturing failures. Treatment delays are even more critical in the multiple myeloma setting, as many patients with rapidly progressing disease require bridging therapy as they wait for the manufacturing of their autologous CAR T cells and those who are unable to tolerate effective breathing chemotherapy may not be considered candidates for autologous therapy. Shortening time to treatment and ensuring access for nearly all suitable patients is just the beginning of how we are leveraging the attributes of Allocard T product. Our first allogeneic candidates are only the beginning of product innovation in the field of Allocard T. Our next generation products based on our turbo car and other technologies are aiming to enhance the efficacy and safety of allogeneic cell therapy. Aside from the data presented in 2021 came an unexpected challenge, our clinical hold. While no company wants to be faced with a hold, the situation provided us the opportunity to retest our manufacturing processes and reconfirmed the quality of our product. In responding to and quickly resolving the hold, our team, under the deft stewardship of Rafael, demonstrated the quality of leadership, collaboration, innovation, and focus required to be a pioneer in the field of Alocarp. I am incredibly proud of the manner in which our employees rose to this challenge. In retrospect, This experience provided us with an insight that we believe will give us a competitive edge as we look to leave the field of allogeneic cell therapy. We look forward to sharing the results from our scientific investigation in a peer-reviewed forum. As we prepare for the next stage in our life cycle with a planned allofibro 1A hibidro trial for relapsed refractory large B-cell lymphoma in mid-2022, We are also determined to minimize hurdles that could create delays at the time of a biologic license application submission. This brings us to our technical operations, product sciences, and manufacturing organizations. From the beginning, we have maintained that having in-house manufacturing capabilities is key to controlling the delivery of off-the-shelf CAR T therapies faster, more reliably, and at a greater scale, and we have invested heavily in this area. Our state-of-the-art manufacturing facility in Newark, California, called Cell Forge One, is now fully operational and producing GMP material with the intent of supplying LO501A in our planned pivotal study. Our incredible technical operations team is led by Dr. Alison Moore. In early 2018, as we were forming Allogene, I knew Allison was the person I wanted as our chief technical officer. When you are building something that has never been built before, there is no blueprint. You need someone who knows technology operations inside out. Allison came to Allogene with over 25 years of experience in chemistry, manufacturing, and controls, or CMC, at Amgen and Genentech, from process and product development to manufacturing, supply chain, global operations planning, and CMC regulatory affairs. I am immensely proud to work alongside Alison and know there is no one better to navigate the evolving CMC landscape. We are excited to have her join the call today. I now would like to invite Rafael to preview our R&D priorities for the upcoming year.