Allogene Therapeutics, Inc.

Hello and thank you for standing by and welcome to Allogene's Therapeutics third quarter of 2022 conference call. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1 1 on your phone. Please limit yourself to one question and 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 our Q3 call. After market closed, we issued a business update and financial results press release for the third quarter of 2022. This press release and today's webcast are available on our website. 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 as possible. Joining me today are Dr. David Cheng, President and Chief Executive Officer, Dr. Rafael Amado, Executive Vice President of Research and Development, 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 capability, 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 Alexine disclaims any obligation to update these statements. I'll now turn the call over to David.

Thank you, Christine, and good afternoon. I will start today's call focused on our most important milestone, the initiation of our Phase II trial with Allo501A for the treatment of relapsed or refractory large B-cell lymphoma. Advancing our off-the-shelf Allogeneic CD19 CAR-T product candidate to a Phase II trial brings us one step closer to making this potentially lifesaving therapy more readily available to the patients. It is a culmination of our singular focus over the last three years and signifies our leadership in the development of allocardia products. And in my view, an advancement for the entire field of cell therapy. As you might imagine, we were very pleased last month to share that we have initiated the industry's first potentially pivotal phase two trial for an allogeneic CAR-T product. Being the first comes with a special set of challenges, but it also comes with an enormous sense of accomplishment and responsibility. When we started our journey, we knew there would be a unique set of challenges that we would have to address. Ensuring the safety of Allokar Q products, especially with respect to the graft-versus-host disease, protecting Allokar Q cells from being prematurely rejected by the patient's immune system, demonstrating meaningful responses, and managing reliable manufacturing of allococci products. Our depth of understanding around each of these elements, combined with the breadth of our clinical programs and the translational knowledge we have generated puts us at the forefront of science. The journey of drug development is often a winding road. And as we proceed through this journey and work towards addressing the challenges, we are tasked with keeping our focus. We have been unwavering in our commitment to ourselves, patients, and investors to create and lead the next revolution in cancer treatment by delivering to patients the first allogeneic CAR-T products for blood cancers and cellulose tumors. And initiating this phase two trial places us one meaningful step close to that ultimate goal. To that end, we are very much looking forward to providing a clinical update on our CD19 Alpha studies and our BCMA universal trial and our R&D showcase in New York on November 29th. While our usual practice for such updates is to target medical conferences, we believe our R&D showcase will provide more time and flexibility to fully review the clinical findings of our lead programs and discuss them in the context of a restfully evolving landscape. Before I turn the call over to Rafael, I would like to make a few more comments related specifically to the importance of collaboration with like-minded individuals and institutions. Our success to date in advancing cell therapy can only be accomplished with a partnership and support of engaged patient-focused investigators, and clinical trial sites. Their dedication to patient care is to be commended, and their desire to bring about options for their patients is underscored by the launch of a first-of-its-kind effort we call CAR-T Together. Real-world access challenges have emerged since the commercial introduction of McCann's CAR-T five years ago. Chief among them, the supply bottleneck created by the complex, individualized manufacturing process inherent in the delivery of autologous CAR-T therapy. This pioneering initiative, conducted in collaboration with key opinion leaders from top oncology centers, is aimed at supporting the advancement of allogeneic CAR-T products to address bottlenecks through collaboration, education, and clinical trial enrollment. Inaugural members of this initiative include lead investigators from Moffitt Cancer Center, the Sarah Cannon Colorado Blood Cancer Institute, the Mayo Clinic, and City of Hope. These dedicated physicians and the many more who participate in clinical trials sponsored by Allogene and others are leading the vanguard of scientific innovation. On a personal note, I had the pleasure of working with many of the same KOLs as we traveled the role towards bringing otologous CAR T therapies to patients, and I'm honored that they have chosen to join us again on this next chapter. As we noted last quarter, we started AlloGEN with the goal of making CAR T readily available to all eligible patients. As we near the conclusion of our fourth year together, we believe we are well along the path to transforming CAR therapy from a complex, individualized procedure to an off-the-shelf, on-demand pharmaceutical product. My sincere thanks to all our employees, investors, collaborators, and patients who have joined us on this journey. I will now turn the call over to Rafael. Thank you, David. As David noted, our teams are very pleased to have initiated our potentially registrational alpha-2 trial. Activities are also underway to launch our companion EXTEND-SAFE-2 trial. The ALPHA-2 trial utilizing allo501A in patients with relapsed or retracted large piece of lymphoma will deploy a single dose of allo501A at 120 million CAR-positive cells with a lymphodepletion regimen comprised of fludarabine and cyclophosphamide plus allo647. This single-arm trial will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-C19 therapy. The primary endpoint of this trial is overall response rate, with a key secondary endpoint of duration of response. As we onboard clinical sites for alpha-2 in the U.S., we're also continuing our discussions with the European Medicines Agency to initiate the alpha-2 study at European clinical sites. The EXPAND trial, a separate potentially registrational trial, is intended to demonstrate the contribution of allo-647 to the standard fludarabine and cyclophosphamide lymphodepletion regimen. Patients will be randomized to receive the same single 120 million cell dose of allo-5-ONA as in the alpha-2 trial and either lymphodepletion with fludarabine and cyclophosphamide alone, control on, or the same lymphodepletion regimen of the alpha-2 trial The trial is expected to enroll approximately 70 patients with a primary endpoint of progression-free survival and the key secondary endpoints of overall response rate and duration of response. We are looking forward to sharing clinical data from our CIM-19 program at our R&D showcase at the end of the month. We are planning to share longer-term follow-up data from the ALSA and ALSA2 Phase 1 trials including our rationale for selecting the dose and schedule of Allo501A being deployed in phase two. We also expect to share outcomes from patients treated with our alloy manufacturing process. Our R&D showcase will also feature updated data from our BCMA program, the only such allogeneic cell therapy program to have established proof of concept. At the event, we plan to share longer-term data from a single-dose Allo715 in the treatment of patients with rehabs or refractory multiple myeloma. The Allo715 program is increasingly exciting as we recognize the growing unmet need for BCMA-directed cell therapy and the transformational opportunity that AllocardT may play in addressing the need for treatment in these advanced patients. We recognize that the myeloma market is dynamic and believe that multiple innovative approaches will be required to further advance patient care. This is exactly what has transpired for the past 20 years in myeloma. Nonetheless, the profile we are targeting with allo715 appears differentiated among the competition in having the potential to provide patients an immediate off-the-shelf option with one-time dosing. Based upon physician interest in this profile and the clinical outcomes that we have previously shared, we believe that allo-7-1-5 could play a very important role in the myeloma treatment paradigm. Over the next few days and weeks, we expect a lot of discussion around the potential for innovation in treating blood cancers. At Allogene, we believe we now have line of sight not just to potential innovation but to potential products. We look forward to continuing to execute on this mission and sharing an update with you on November 29th. I'll now turn the call over to Eric.