Allogene Therapeutics, Inc.

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Allergy Therapeutics First Quarter 2020 conference call. After this speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 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 good morning. We appreciate you joining us today and sincerely hope you are all doing well. Before market opened today, Allogene issued a press release that provides a corporate update and financial results for the first quarter ended March 31, 2020. This press release is available on our website at www.allogene.com. We remind listeners that today's call is being webcast on our website and will be available for replay. Joining me on the call today are Dr. David Chang. President and Chief Executive Officer, Dr. Rafael Amato, Executive Vice President of Research and Development and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. Please note that we are conducting our call today from different locations, so we appreciate your patience and understanding should we have any technical difficulties. 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 filing, future research and development efforts, manufacturing capabilities, and 2020 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2019, our Form 8-K filed on March 27, 2020, as well as our upcoming Form 10-Q for the quarter ended March 31, 2020. 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 Dr. David Chang.

Thank you, Christine. Good morning, everyone, and thank you for taking time to join us for our first quarter conference call. It has been just over two months since our last earnings call, but the world seems a different place. We hope you and your loved ones are safe and well. Our sincerest thanks to many of you who have reached out to ask about Arie Belldegrun after he announced that he had tested positive for COVID-19. We all feel very fortunate that his symptoms were relatively mild and he has fully recovered. At the same time, we are profoundly sorry about how the current pandemic has claimed so many lives and created hardship for everyone globally. Across our industry, it is inspiring to see the way in which our scientific and regulatory communities have joined together to identify potential treatments and hopefully a vaccine. the pharmaceutical and biotech industry in the business of handling some of the toughest medical challenges. One thing is clear during this time, scientific innovation is our cornerstone and true north. At Allogene, our priorities have been to protect the health of our employees, do our best to support our community, including the patients we serve and those fighting on the front lines, and maintain as much of our business momentum as possible. On prior calls, you've heard us speak about the caliber of talents we are fortunate to have at Allergy. Now more than ever, the ability of our employees to demonstrate our values, to innovate, focus, collaborate and lead matters. We acted quickly to protect our workforce, implementing worked from home policy for the great majority of employees in advance of local and statewide shutdowns. By maintaining a small lab presence directed at critical path activities and relying on the resourcefulness of our organization, we have been able to mitigate some of the effects of COVID-19 on our business. As a result, we remain on track to achieve our five key milestones for 2020. Number one, reporting initial Allo501 Phase I clinical data. Number two, initiating our Allo501A Phase I trial both this quarter. Number three, initiating our Allo715 combination trial with a gamma secretase inhibitor, NeuroGet-Zest-Test in the second half. Number four, reporting our initial Allo715 Phase I data in the fourth quarter. And number five, submitting our anti-CD70 Allocard T candidate, Allo 316-IND, by year end. This is not to say that it has been business as usual. Our partners surveyed suspended recruitment in the UCARD-19 studies due to the exceptional circumstances related to COVID-19 in March. And we're working diligently to maintain much of the momentum in our trials of Allo 501 in relapsed, refractory, non-Hodgkin's lymphoma, and Alo715 in relapsed refractory multiple myeloma. We, along with our clinical investigators, recognize that many patients are not in a position to defer treatments or risk supply chain delays that could be further complicated by the pandemic. Our investigators were unanimous in their desire to keep these trials open for the patients who had rapidly progressing disease or lacked alternative treatment options. Our technical operations and supply team maintain vigilant oversight to ensure we can deliver Allocarchy Therapy to sites in time. In a world in which hospitals are overburdened and scheduling and logistics have become even more challenging, the benefits of being able to provide an on-demand Allogeneic Therapy have proven to be even more acute. We adjusted to the need of each site as we worked through COVID-19 related challenges. and facilitated best practice sharing between sites for study conduct. We also developed rigorous process to maintain trial integrity while utilizing remote monitoring and data entry as well as using the patient's local point of care or follow-up sample collection and tumor assessments to reduce travel exposure. We remain on track to initiate the Alpha-2 phase one trial of LO501A this quarter. As you may recall, we have eliminated the Rituxim recognition domain in Allo501A, which allows Allo501A to be used in a broader non-Hodgkin's lymphoma patient population. The current Alpha study, including the ongoing work to optimize the dose of Allo647 and Allo501, has informed the design of the Alpha 2 Phase 1 study, as we seek to confirm the safety and efficacy of Allo501A ahead of launching the potentially pivotal Phase II portion of the Alpha-2 trial. As we look at the differences between autologous cardiotherapy and allocardiotherapy, the foundational questions must be addressed. First, can we effectively manufacture genetically edited products from normal donor and safely administer allogeneic cell therapy without causing graft-versus-host disease? Can we safely utilize allo647 to create a period of lymphodepletion and prevent early CAR-T cell rejection? We are making progress on these two critical questions, which allows us as an industry to focus on optimal cell dose and optimal length and depth of lymphodepletion as we work towards the goal of demonstrating durable responses. We continue to believe our lymphodepletion strategy based on the use of allo647 allows us to explore and determine the optimal window for allocardic cell expansion and persistence in a variety of clinical settings. Last week, we announced that our initial allo501 data had been selected for an oral presentation at the virtual American Society of Clinical Oncology meeting later this month. Our Alpha Phase 1 trial began with a 3 plus 3 dose escalation designed to evaluate the safety and efficacy of a range of cell doses as well as different lymphodepletion regimens that vary the dose of allo647. While Rafael will provide additional details on what to expect from the ASCO presentation, I would like to note that ASCO Abstract, which has data as of January, will be released on May 13th. The virtual presentation, which will be released on May 29th during ASCO, will include additional patients, including those treated with a higher dose of allo647. On that day, we will host a conference call to review the data with you. We see this initial data as an important step towards realizing the potential of allogeneic cardiac therapy. Exactly two years ago this week, Allogene launched operations. From the beginning, We have been consistent in our goal to have allogeneic cell therapy follow the success of otologous CAR T therapy while providing major benefits in time, convenience, reliability, and scale. Our development strategy and trial design have been structured to make this goal a reality. While there are some outstanding questions that only time and experimentation will answer, we are pleased with the progress we have made to date and look forward to sharing our study progress with you at ASCO. Before I turn the call over to Rafael, I would like to say how proud I am of all 200 plus employees at Allogene who, despite working through their own personal challenges during these times, have remained unwavering in their commitment to Allogeneic Cell Therapy. Rafael will now update you further on the research and development activities.