Allogene Therapeutics, Inc.

Hello. Thank you for standing by, and welcome to Allogene Therapeutics' second quarter 2023 conference call. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will 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 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 our call. Today, after market closed, Allogene issued a press release that provides a business update and financial results for the second quarter of 2023. This press release and today's webcast are both available on our website. 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 Dr. Eric Schmidt, 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, and 2023 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.

Thank you, Christine, and thank you for those joining the call today. During the second quarter, we presented updated Phase I data on our lead allogeneic CAR-T program targeting CD19 for relapse and refractory lymphoma. We are immensely proud that our off-the-shelf product candidate has shown the ability to generate durable, complete responses that by all accounts appear to be similar to approved otolaryngo CAR-T therapies. This is a significant milestone for the field and represents a great opportunity to reflect on the current state of CAR T, including the advancement of allogeneic options. To that end, I would like to focus my comments today on the allogeneic CAR T field at large. I will then ask Zach to talk specifically about our CD19 program, including reviewing the data presented in June at the American Society of Clinical Oncology, European Hematology Association, and Lugana meetings. During the Q&A, we will welcome questions on other programs within our pipeline. First, let's talk about the field of cell therapy. As Otala's CAR-T franchise reports increasing sales and detailed initiatives to address manufacturing constraints, some ask if there is a place for an allogeneic product. Indeed, as one of the early developers of autologous CAR T therapy, I am proud that this modality has become a commercial success capable of changing the lives of many patients. On the other hand, allogeneic CAR T products represent a fundamentally different modality with properties that are inherently more attractive than autologous CAR T therapy and therefore capable of vastly changing and expanding the landscape of CAR-T access. Perhaps the most fundamental difference between the OTALIS therapy and an allogeneic product is that the former represents an individualized procedure that can never be manufactured at scale. As OTALIS CAR-T therapies move into earlier lines, the potential patient population that is eligible for therapy will undergo dramatic expansion, and companies producing therapies at linear scale will be hard-pressed to keep up with accelerating demand. Today, in the market for refractory lymphoma and myeloma, we are seeing that only a fraction of eligible patients can gain access to these revolutionary therapies, potentially left out of the mix are patients who cannot readily secure a manufacturing slot, patients with rapidly progressing disease, or patients who cannot undergo successful collection of cells. Also, as CAR T therapies move to earlier lines, patients now need to be referred from the community-based oncology centers to specialized CAR T centers, which leads to yet another potential delay. By 2030, it is estimated that the number of patients with lymphoma or myeloma who will be eligible for CAR T will grow to 300,000. To put this figure in perspective, it is estimated that approximately 10,000 patients will receive CAR T therapies in 2023. Several autologous providers are making large investments in manufacturing infrastructure and delivery that are designed to increase capacity. These companies are now forecasting the ability to perform as many as 10,000 individual manufacturing runs in a few years' time. But even if successful, the forecasted supply is dwarfed by the number of patients who could benefit from treatment. The unfortunate outcome is that even under more optimistic forecasts for capacity expansion, there will be far more patients without access to this modality than those who can be treated. Adding more and more linear-scale manufacturing is simply not a viable model for serving an increasingly large addressable market, which will most likely lead to a stunted market and patients without access to a potentially life-saving treatment. My next point of reflection focuses on the innovative nature of allogeneic CAR-T products. The trillion-dollar biopharmaceutical industry is based on very few therapeutic modalities. Often, new classes of drugs are met with skepticism or even disbelief. In 2012, Kite and National Cancer Institute entered into Cooperative Research and Development Agreement, or CRADA, that would ultimately lead to the approval of Yaskata. But what many forget or may not know is how many biopharmaceutical companies will first offer the same opportunity as Kite, but decline. The development of otolaryngotherapy therapies, now a multi-billion dollar industry, was a lonely endeavor. The cacophony of naysayers and the development challenges that needed to be overcome required an undaunted belief in the science. As the year progressed and wealth of data on this new modality accumulated, there was a shift in attitude towards autologous CAR-T therapies. History doesn't repeat itself, but it often rhymes. We are very excited to see progress, not just from allergens, but others who are developing allogeneic CAR-T products. We view this as a sign that the viability of the modality is becoming increasingly evident. The more companies that enter the arena with promising approaches, the more investment we see from large pharma companies, the better it is for the field. The work we have done to progress our clinical trial has allowed us to accumulate and master technical knowledge that is second to none. The learnings that must come from the phase one trial are often hard won, but the outcomes we have seen in our recent data set makes it clearly worthwhile and keep us excited for what is to come, a future where patients do not have to wait and fight for access to CAR T. They can start treatment within days and without the need to undergo leukoparesis or bridging therapy. An allogeneic CAR T product provides one if not the only way to broaden the use of CAR-T therapy, making the delivery of therapy much easier and convenient for patients and their treating physicians. Ultimately, I believe the convenience of an off-the-shelf allogeneic CAR-T product is the only way to introduce the potentially lifesaving modality of CAR-T to a wider community setting where the majority of early-aligned patients are currently cared for while preserving the potential for a one-time treatment. An off-the-shelf option that is free of the hassle and inconvenience of having to return to the clinic for treatment again and again, and without the cumulative toxicities that often come with lengthy chronic therapy. With that, now I would like to turn the call over to Zach.